registration report part a extension of uses risk

Part A National Assessment - Germany

Goltix Titan AG-QMM1-565 SC

Registration Report –Central Zone

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Applicant: ADAMA Deutschland GmbH Evaluator: DE

Date: 01/06/2016

REGISTRATION REPORT

Part A

EXTENSION OF USES

Risk Management

Product code: Goltix Titan

(AG-QMM1-565 SC)

Active Substances: Metamitron 525 g/L and

Quinmerac: 40 g/L

COUNTRY: Germany

Central Zone

Zonal Rapporteur Member State: Germany

NATIONAL ASSESSMENT

Applicant: ADAMA Deutschland GmbH

Date: 01/06/2015


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Table of Contents

PART A – Risk Management 4

1 Details of the application 4

1.1 Application background 4

1.2 Annex I inclusion 4

1.3 Regulatory approach 6

1.4 Data protection claims 6

1.5 Letters of Access 6

2 Details of the authorisation 6

2.1 Product identity 6

2.2 Classification and labelling 7

2.2.1 Classification and labelling under Directive 99/45/EC 7

2.2.2 Classification and labelling under Regulation (EC) No 1272/2008 8

2.2.3 Standard phrases under Regulation (EC) No 547/2011 9

2.3 Other phrases notified under Regulation (EC) No 547/2011 9

2.3.1 Restrictions linked to the PPP 9

2.3.2 Specific restrictions linked to the intended uses 10

2.4 Product uses 11

3 Risk management 13

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform

Principles 13

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 13

3.1.2 Methods of analysis (Part B, Section 2, Point 5) 13

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 13

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 14

3.1.3 Mammalian Toxicology 14

3.1.3.1 Acute Toxicity 14

3.1.3.2 Operator, Worker, Bystander, and Resident Exposure Exposure 14

3.1.3.3 Groundwater Metabolites 14

3.1.4 Residues and Consumer Exposure 15

3.1.4.1 Residues 15

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 15

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 15

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 19

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 19

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 19


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3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)

20

3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6)

20

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 20

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 20

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna)

(Part B, Section 6, Point 10.8) 20

3.1.7 Efficacy (Part B, Section 7, Point 8) 21

3.2 Conclusions 23

3.3 Further information to permit a decision to be made or to support a review of the

conditions and restrictions associated with the authorisation 23

Appendix 1 – Copy of the product authorisation 24

Appendix 2 – Copy of the product label 28

Appendix 3 – Letter of Access 29


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PART A – Risk Management

This document describes the acceptable use conditions required for the extension of uses on Goltix Titan

containing metamitron and quinmerac in Germany. This evaluation is required subsequent to the approval

of metamitron and quinmerac.

The risk assessment conclusions are based on the information, data and assessments provided in

Registration Report, Part B Sections 1-8 and Part C and where appropriate the addendum for Germany.

The information, data and assessments provided in Registration Report, Parts B includes assessment of

further data or information as required at national registration by the EU review. It also includes

assessment of data and information relating to Goltix Titan where that data has not been considered in the

EU review. Otherwise assessments for the safe use of Goltix Titan have been made using endpoints

agreed in the EU review of metamitron and quinmerac.

This document describes the specific conditions of use and labelling required for Germany for the

extension of uses of Goltix Titan.

Appendix 1 of this document provides a copy of the final product authorisation in Germany.

Appendix 2 of this document is a copy of the approved product label for Germany

The submitted draft product label has been checked by the competent authority. The applicant is

requested to amend the product label in accordance with the decisions made by the competent authority.

The final version of the label has to fulfil the requirements according to Article 16 of Directive

91/414/EEC.

Appendix 3 of this document contains copies of the letters of access to the protected data / third party data

that was needed for evaluation of the formulation.

Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

1 Details of the application

1.1 Application background

This application was submitted by Feinchemie Schwebda GmbH on 30/01/2014. However, during the

registration process the name of the applicant was changed to ADAMA Deutschland GmbH.

The application was for extension of uses of AG-QMM1-565 SC (in Germany: Goltix Titan), a

suspension concentrate containing 525 g/L Metamitron and 40 g/L Quinmerac, for use as herbicide

against annual monocotyledonous weeds, Galium aparine and other annual dicotyledonous weeds in

splitting applications.

1.2 Annex I inclusion

Metamitron

The active substance Metamitron was listed on Annex I of Directive 91/414 with effect date 1 September

2009 (Commission Directive 2008/125/EC) and implemented under Regulation (EU) No 540/2011. Only


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uses as herbicide may be authorised. The applicant informs that MAK-FSG was main notifier (see

SANCO/208/08 final – 06/01/2009).

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the

active substance Metamitron, and in particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this

overall assessment:

In this overall assessment Member States must pay particular attention to:

- operator safety and ensure that conditions of use prescribe the application of adequate personal

protective equipment where appropriate;

- the protection of groundwater, when the active substance is applied in regions with vulnerable

soil and/or climatic conditions;

- the risk to birds and mammals and non-target terrestrial plants.

The Member States concerned shall request the submission of further information:

- on the impact of soil metabolite M3 on groundwater,

- on residues in rotational crops

- on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may

be contaminated by the intake of water in field

They shall ensure that the notifier at whose request metamitron has been included in this Annex provide

such information to the Commission by 31 August 2011 at the latest. These data have been submitted in

the meantime.

Quinmerac

The active substance Quinmerac was listed on Annex I of Directive 91/414 with effect date 1 May 2011

(Commission Directive 2010/89/EU) and implemented under Regulation (EU) No 540/2011. Only uses as

herbicide may be authorised.

.

The applicant informs that MAK-FSG has submitted data to support their own source of Quinmerac to the

RMS UK for equivalence evaluation. The RMS UK has assessed the active substance source of MAK-

FSG as being equivalent to the notified source of Quinmerac. The decision was taken on 16 December

2010 and is published on CIRCA for the other Member States.

Further to this MAK-FSG owns an Annex II data compensation dossier, to match protected data

according to the published “List of Annex II studies which were considered as relied upon for the

evaluation with a view to Annex I inclusion and for which the main data submitter has claimed data

protection, version 2, February 2011, RMS UK”, which has been submitted on 19 April 2011 to RMS

UK.

On 13 September 2011 the RMS UK confirmed that they considered the MAK-FSG Annex II data

package to be complete. The evaluation of the RMS UK is available for other MS on CIRCA.

The Annex II compensation data for Quinmerac however already have been summarised and are

submitted with this dossier.

For the implementation of the Uniform Principles of Annex VI, the conclusions of the review report on

Quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the

Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

- the protection of groundwater when the active substance is applied in regions with vulnerable soil

and/or climatic conditions;


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- the dietary exposure of consumers to residues of Quinmerac (and its metabolites) in succeeding

rotational crops;

- the risk to aquatic organisms and the long term risk for earthworms

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of information as regards:

- the potential of plant metabolism to result in an opening of the quinoline ring;

- residues in rotational crops and the long term risk for earthworms due to the metabolite

BH 518-5.

They shall ensure that the applicant provides such confirmatory data and information to the Commission

by 30 April 2013.

Concerns that are relevant for this application have been addressed within this submission.

1.3 Regulatory approach

To obtain extension of uses the product Goltix Titan must meet the conditions of Annex I inclusion and

be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to

Uniform Principles, using Annex I agreed end-points.

This application was submitted in order to allow extension of uses of an already approved product in

Germany accordance with the above.

1.4 Data protection claims

Where protection for data is being claimed for information supporting registration of Goltix Titan, it is

indicated in the reference lists in Appendix 1 of the Registration Report, Part B, sections 1-8 and

Part C.

1.5 Letters of Access

A letter of access isn’t necessary. ADAMA is the holder of the main authorisation.

2 Details of the authorisation

2.1 Product identity

Product Name Goltix Titan

Authorization Number

(for re-registration)

007529-00/01

Function Herbicide

Applicant ADAMA Deutschland GmbH

Composition 525 g/L metamitron and 40 g/L quinmerac

Formulation type Suspension concentrate [Code: SC]

Packaging 1, 5, 10 and 20 L HDPE bottle or canister


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2.2 Classification and labelling

2.2.1 Classification and labelling under Directive 99/45/EC

The following labelling is proposed in accordance with Directive 1999/45/EC:

Symbol(s)/Indication(s) of danger:

N Dangerous for the environment

Risk phrases:

R 51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic

environment

RA105 Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions.

Safety phrases:

S2 Keep out of the reach of children

S24 Avoid contact with skin

S36/37 Wear suitable protective clothing and gloves.

S35 This material and its container must be disposed of in a safe way.

S46 If swallowed, seek medical advice immediately and show this container or label

S57 Use appropriate container to avoid environmental contamination.

SP001 To avoid riks to man and the environment, comply with the instructions for use.

Specific labelling requirement:

To avoid risks to man and the environment, comply with the instructions for use.

Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions.


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2.2.2 Classification and labelling under Regulation (EC) No 1272/2008

The following labelling is proposed in accordance with Regulation (EC) No 1272/2008:

Hazard classes and categories:

Hazard pictograms:

GHS09 environment

Signal word:

Hazard statements:

H411 Toxic to aquatic life with long lasting effects.

Precautionary statemtents:

Not proposed by zRMS Germany, to be decided by applicant

Special rule for labelling of PPP:

EUH401 To avoid risks to man and the environment, comply with the instructions for use.

Further labelling statements under Regulation (EC) No 1272/2008:

EUH 208-0098 - Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions.


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2.2.3 Standard phrases under Regulation (EC) No 547/2011

None

2.3 Other phrases notified under Regulation (EC) No 547/2011

2.3.1 Restrictions linked to the PPP

The authorization of the PPP is linked to the following conditions (mandatory labelling):

Human health protection

SB001 Avoid any unnecessary contact with the product. Misuse can lead to health

damage.

SB005 If medical advice is needed, have product container or label at hand.

SB110 The directive concerning requirements for personal protective gear in plant

protection, "Personal protective gear for handling plant protection products" of

the Federal Office of Consumer Protection and Food Safety must be observed.

SB166 Do not eat, drink or smoke when using this product.

SB199 When applying the product with tractor-mounted, trailed or self-propelled

application equipment, only vehicles with closed pressurized cabins (e.g. cabin

category 3, if no respiratory protective equipment or particle-filtering masks are

necessary or category 4, if gas-tight respiratory protective equipment is needed

acc. to EN 15695-1 and -2) are suited to replace personal protective equipment

during application. During all other activities outside of the cabin the prescribed

personal protective equipment must be worn. In order to avoid contamination of

the cabin, it is not permitted to enter the cabin with contaminated personal

protective equipment (it should be deposited e.g. in an appropriate storage

facility). Contaminated gloves should be washed before removing the gloves and

hands should be washed before entering the cabin with pure water, respectively.

SF1891 Re-entering the treated areas/crops are only possible on the day of application

wearing personal protective equipment which is specified for applying the

particular product. Successive work on/in treated areas/crops may fundamentally

not be carried out until 24 hours after applying the product. Within the first 48

hours, protective suits against pesticides and standard protective gloves (plant

protection) are to be worn.

SS110 Wear standard protective gloves (plant protection) when handling the undiluted

product.

SS120 Wear standard protective gloves (plant protection) when handling/applying the

product ready for application.

SS2101 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots)

when handling the undiluted product.

SS2202 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots)

when applying/handling the product ready for application.

Integrated pest management (IPM)/sustainable use

WMC1 Mode of action (HRAC-group): C1 (for metamitron)

WMO Mode of action (HRAC-group): O (for quinmerac)

WH951 The risk of resistance has to be indicated on the package and in the


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instructions of use. Particularly measures for an appropriate risk management

have to be declared.

NB6641 The product is classified as non-hazardous to bees, even when the maximum

application rate, or concentration if no application rate is stipulated, as stated for

authorisation is applied. (B4)

Ecosystem protection

NW 262 The product is toxic for algae.

NW 263 The product is toxic for aquatic invertebrates.

NW 265 The product is toxic for higher aquatic plants.

NW468 Fluids left over from application and their remains, products and their remains,

empty containers and packaging, and cleansing and rinsing fluids must not be

dumped in water. This also applies to indirect entry via the urban or agrarian

drainage system and to rain-water and sewage canals.

The authorization of the PPP is linked to the following conditions (voluntary labelling):

Integrated pest management (IPM)/sustainable use

NN1001 The product is classified as non-harmful for populations of relevant beneficial insects.

NN1002 The product is classified as non-harmful for populations of relevant beneficial predatory

mites and spiders.

2.3.2 Specific restrictions linked to the intended uses

The authorised use no. 001 is linked to the following conditions (mandatory labelling):

See 2.4 (Product uses)

Efficacy

WH9161 The instructions for use must include a summary of weeds which can be controlled

well, less well and insufficiently by the product, as well as a list of species and/or

varieties showing which crops are tolerant of the intended application rate and which

are not.

Ecosystem protection

NW 642-1 The product may not be applied in or in the immediate vicinity of surface or coastal waters.

Irrespective of this, the minimum buffer zone from surface waters stipulated by state law

must be observed. Violations may be punished by fines of up to 50 000 EUR.

NG404 Between treated areas with an incline of more than 2% and surface water - except only

occasionally but including periodically water-bearing surface water - there must be a

border under complete plant cover. The border's protective function must not be impaired

by the use of implements. It must be at least 20 m wide. This border is not necessary if: -

sufficient catching systems are available for the water and soil transported by run-off,

which do not flow into surface water or are not connected with the urban drainage system

or - the product is used for mulch or direct drilling methods.


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Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

2.4 Product uses

GAP-Table of intended uses for Germany

GAP rev. (No), date: 2014-04-14

PPP (product name/code) Goltix Titan

active substance 1 Metamitron

active substance 2 Quinmerac

Formulation type: SC

Conc. of as 1: 525 g/L


Applicant: Feinchemie Schwebda GmbH

Zone(s): central/EU

professional use X

non professional use

Verified by MS: yes

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I

Pests or Group of pests

controlled

(additionally:

developmental stages of

the pest or pest group)

Application Application rate PHI

(days) Remarks:

e.g. safener/synergist per ha

e.g. recommended or

mandatory tank mixtures

Method /

Kind Timing / Growth

stage of crop &

season

Max. number

(min. interval

between

applications)

a) per use

b) per crop/

season

kg, L product /

ha

a) max. rate per

appl.

b) max. total rate

per crop/season

g, kg as/ha

a) max. rate

per appl.

b) max. total

rate per

crop/season

Water L/ha

min / max

001 DE Sugar beet

BEAVA

fodder beet

BEAVC

F Annual

monocotyledonous

weeds

TTTMS

Annual dicotyledonous

weeds

TTTDS

Spraying

splitting 4

applications

Spring

BBCH 00 – 19

1st treatment before-

emergence

2nd to 4th treatment

after emergence

a) 4

b) 4

the 2nd to 4th

treatment with

an interval of 5

to 10 days

a)

timing 1: 3 L/ha

timing 2: 1 L/ha

timing 3: 1 L/ha

timing 4: 1 L/ha

a)

timing 1:

Metamitron

1575 g as/ha

Quinmerac

120 g as/ha

timing 2:

Metamitron

200 - 400 *XF WH9161

‚Annual

monocotyledonous

weeds‘ are withdrawn by the

applicant, because not

enough data regarding

efficacy available.

NG404, NW 642-1

Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

b) 6 L/ha

maximum

application rate

for the intented

crop per year

525 g as/ha

Quinmerac

40 g as/ha

timing 3:

Metamitron

525 g as/ha

Quinmerac

40 g as/ha

timing 4:

Metamitron

525 g as/ha

Quinmerac

40 g as/ha

b)

Metamitron

3150 g as/ha

Quinmerac

240 g as/ha

maximum

application rate

for the intented

crop per year

*The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI

in days is not required resp.

Remarks: (1) Numeration of uses in accordance with the application/as verified by MS

(2) Member State(s) or zone for which use is applied for

(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use

situation should be described (e.g. fumigation of a structure)

(4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)

(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages

(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of

equipment used must be indicated

(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of

application

(8) The maximum number of applications possible under practical conditions of use for each single

application and per year (permanent crops) or crop (annual crops) must be provided

(8) Min. interval between applications (days) were relevant

(10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season

must be given in metric units (e.g. kg or L product / ha)

(11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per

crop/season must be given in metric units (e.g. g or kg / ha)

(12) The range (min/max) of water volume under practical conditions of use must be given

(L/ha)

(13) PHI - minimum pre-harvest interval

(14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.


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3 Risk management

3.1 Reasoned statement of the overall conclusions taken in accordance with the

Uniform Principles

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4)

Overall Summary:

AG-QMM1-565 SC is an off-white homogenous suspension with characteristic odour. It has no explosive

and oxidising properties. AG-QMM1-565 SC has a self-ignition temperature of 505 °C and it is a surface

active mixture. Results of the technical tests (spontaneity of dispersion, suspensibility, wet sieve test,

pourability and particle size distribution) showed that AG-QMM1-565 SC fulfils the general requirements

of the FAO/WHO manual (2010). The formulation is stable when stored for 2 years in the commercial

packaging at ambient temperature and after 14 days at 54° C.

The technical characteristics are acceptable for a SC formulation.

Implications for labelling: none

Compliance with FAO specifications:

There is no FAO specifications for quinmerac. For metamitron only specifications for TC, TK, WP and

WG formulations are published.

Compliance with FAO guidelines:

The product AG-QMM1-565 SC complies with the general requirements according to the FAO/WHO

manual (2010).

Compatibility of mixtures:

A complete report regarding physical and chemical compatibility of the tank mixes with Powertwin Plus,

Oleo FC, Debut, Arma, Lontrel 100, Agil-S, Belvedere Extra and Kontakt 320 SC has been submitted

which has demonstrated compatibility. These tank mixes can therefore be mentioned on the product label

for AG-QMM1-565 SC.

.

Nature and characteristics of the packaging:

Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,

leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents

of the packaging, have been submitted, evaluated and is considered to be acceptable.

Nature and characteristics of the protective clothing and equipment:

Information regarding the required protective clothing and equipment for the safe handling of GOLTIX

TITAN has been provided and is considered to be acceptable.

3.1.2 Methods of analysis (Part B, Section 2, Point 5)

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)

The analytes are determined by HPLC on an Inertsil ODS-3V column. Detection is performed with a UV

detector at 238 nm. The mobile phase consists of acetonitrile : acidified water 40:60 (v/v).

With respect to precision, accuracy, linearity and specificity the method provided is suitable for the

determination of metamitron and quinmerac in the SC-formulation.


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3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)

Concerning the analytical methods for the determination of residues there is no change with respect to the

main application. Adequate analytical methods are available to monitor all compounds given in the

respective residue definition, i.e. metamitron in food of plant and animal origin, soil, water and air, and

quinmerac in food of plant and animal origin and quinmerac and its metabolites BH 518-2 and BH 518-5

in soil and water.

Metamitron residues can be monitored in food of plant and animal origin, soil, water and air by LC-

MS/MS. Additionally, adequate validation data for the QuEChERS method (European Standard EN

15662:2008) are published in EURL Data Pool (http://www.crl-pesticides-datapool.eu/) for food of plant

origin.

Quinmerac residues can be monitored in food of plant and animal origin, soil and water by LC-MS/MS.

An analytical method for quinmerac in air is not required because it is not classified as Xi, Xn, T or T+.

Methods for body fluids and tissues are also not required since metamitron and quinmerac are not

classified as toxic or highly toxic.

3.1.3 Mammalian Toxicology

3.1.3.1 Acute Toxicity

Acute toxicity studies of Goltix Titan were not evaluated as part of the EU review of metamitron and

quinmerac. Therefore, all relevant data were provided and are considered adequate.

Goltix Titan, containing 525 g/L metamitron and 40 g/L quinmerac, has a low toxicity in respect to acute

oral and dermal toxicity and is not irritating to the rabbit eye. It has been found to be not irritating to

rabbit skin and is not a skin sensitiser to the guinea pig. Taking into account all submitted data some

safety phrases are considered necessary due to the conent of 1,2-benzisothiazole-3(2H)-one (see 2.2).

3.1.3.2 Operator, Worker, Bystander, and Resident Exposure Exposure

The risk assessment according to the German model has shown that the estimated exposure towards

metamitron and quinmerac in Goltix Titan will not exceed the particular systemic AOEL for operators,

workers, bystanders and residents. Operator and worker exposure will be below the systemic AOEL only,

if prescribed PPE is worn.

The risk assessment according to the UK-POEM has shown that the estimated exposure towards

metamitron in Goltix Titan exceeds the particular systemic AOEL for operators. The risk assessment

according to an exposure study has shown that the estimated exposure towards metamitron in Goltix Titan

will not exceed the particular systemic AOEL for operators. Operator exposure will be below the

systemic AOEL only, if prescribed PPE is worn.


quinmerac in Goltix Titan will not exceed the particular systemic AOEL for operators.

If the product is used properly and according to the intended conditions of use, adverse health effects for

operators, workers, bystanders and residents will not be expected.

Implications for labelling resulting from operator, worker, bystander assessments:

See 2.2 and 2.3

3.1.3.3 Groundwater Metabolites

The quinmerac metabolites BH518-2 and BH518-5 are predicted to occur in groundwater in

concentrations above 0.1 µg/L. The toxicological relevance assessment of these groundwater metabolites

according to the EC guidance document SANCO/221/2000 –rev.10 is presented in Section 8 of the RR.

Concentrations of these metabolites can be accepted up to the trigger value of 10 µg/L.


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3.1.4 Residues and Consumer Exposure

3.1.4.1 Residues

Regarding aspects of seasonal application rates the cGAP of application 007529-00/01 is comparable to

that of the basic application of the product on sugar/fodder beets (007529-00/00). Hence, the statement

basically apply also for application 007529-00/01.

The available data is considered sufficient for risk assessment. An exceedance of the current MRLs of

0.2 mg/kg for metamitron and 0.5 mg/kg for quinmerac in sugar beet as laid down in Reg. (EU) No

396/2005 is not expected.

A no-residue situation is indicated from the supervised residue trials for both actives and regarding both

roots and leaves with tops. It is therefore not anticipated that the intended uses impact residues in

commodities of animal origin.

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)

An estimation of dietary intake using EFSA PRIMo results in a maximum consumption of the respective

ADIs/ARfDs below 100 %.

Substance ADI/ARfD Model / Diet ADI/ARfD

Consumption

Metamitron ADI: 0.03 mg/kg bw TMDI, EFSA PRIMo, UK

toddler

26.5 %

ARfD: 0.1 mg/kg bw IESTI, EFSA PRIMo, UK

children aged 4-6 years

3 %

Quinmerac ADI: 0.08 mg/kg bw TMDI, EFSA PRIMo, UK

toddler

18.4 %

ARfD: 0.3 mg/kg bw IESTI, EFSA PRIMo, UK

children aged 4-6 years

3 %

The chronic and the short-term intake of metamitron and quinmerac residues are unlikely to present a

public health concern.

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)

A full exposure assessment for the plant protection product GOLTIX TITAN in its intended uses in beets

(sugar and fodder) is documented in detail in the core assessment of the plant protection product GOLTIX

TITAN dated from May 2015 performed by the applicant.

The following chapters summarize specific exposure assessment for soil and surface water and the

specific risk assessment for groundwater for the authorization of GOLTIX TITAN in Germany according

to its intended use in beets (sugar and fodder) (use No. 01-001).

Metabolites

Metamitron

No new study on the fate and behaviour of metamitron has been performed. The risk assessment for the

metabolite desamino-metamitron of metamitron has already been performed for EU approval (see EFSA


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Scientific Report(2008) 185,1-95). The metabolite desamino-metamitron is considered ecotoxicologically

not relevant. The metabolite desamino-metamitron did not penetrate into groundwater.

For details see Part B, core assessment, section 5.3.3 (Metabolites of metamitron).

However, in the EU review report for the inclusion of metamitron in Annex I of Directive 91/414/EEC in

the list of studies to be generated, information as regards the impact of soil metabolite M3 on

groundwater is postulated (SANCO/208/08 final, 6 January 2009, point 7). The metabolite M3 did

penetrate into groundwater with a default Koc value of 0.

Quinmerac

No new laboratory studies on the degradation of quinmerac in soil and water/sediment have been

performed. The risk assessment for the metabolites of of quinmerac has already been performed for EU

approval (see EFSA Journal 2010; 8(3):1523). The metabolites are considered ecotoxicologically not

relevant. Therefore no new risk assessment hence no exposure assessment for these metabolites is

necessary.

For details see Part B, core assessment, section 5, chapter 5.4.3 (metabolites of quinmerac).

The soil metabolites BH 518-2 and BH 518-5 of quinmerac were also included in the groundwater risk

assessment considering the entry path surface run-off and drainage with subsequent bank filtration.

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points

9.4 and 9.5) For the intended use of the plant protection product GOLTIX TITAN in beets (sugar and fodder)

according to use No 01-001 PECsoil was calculated for the active substances quinmerac and metamitron

considering a soil depth of 2.5 cm. Due to the fast degradation of the active substances quinmerac and

metamitron in soil the accumulation potential was not considered. Details are given in Part B National

Addendum-Germany, Section5, chapter 5.6.

The results for PECsoil for the active substances and their metabolites were used for the ecotoxicological

risk assessment.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,

Section 5, Point 9.6)

1. Direct leaching into groundwater

Metamitron

According to the results of the groundwater simulation with FOCUS-PELMO 5.5.3, a groundwater

contamination of the active substance metamitron in concentrations of ≥ 0.1 µg/L is not expected for the

intended use in sugar beet.

For the metabolite desamino-metamitron, a groundwater concentration of ≥ 0.1 µg/L can be excluded for

the application in sugar beet according to the results of the groundwater simulation with FOCUS-PELMO

5.5.3.

For the metabolite M3 a groundwater concentration of ≥ 0.1 µg/L cannot be excluded for the application

in sugar beet according to the results of the groundwater simulation with FOCUS-PELMO 5.5.3. In the

EU review report for the inclusion of metamitron in Annex I of Directive 1107/2009 (SANCO/208/08

final document, 6 January 2009) information as regards the impact of soil metabolite M3 on groundwater

was postulated in the list of studies to be generated. The inclusion directive (2008/125/EC resp. regulation

540/2011) lists the missing data on M3 as confirmatory data to be delivered to the Commission till

August 2011. The evaluation of the information by the RMS is still ongoing. Therefore the relevance of

the metabolite M3 for groundwater cannot be evaluated. No information is available concerning the

ecotoxicological activity. However, subject to the provisions of the confirmatory data, the risk for

organisms exposed via groundwater is expected to be low, because the PECgw was calculated using a

worst case default Koc value of 0.

Quinmerac


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Results of modelling show that the active substance quinmerac is not expected to penetrate into

groundwater at concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites BH 518-2

and BH 518-5 concentrations of ≥ 0.1 µg/L in groundwater cannot be excluded in all of the FOCUS

groundwater scenarios in the intended use.

Higher tier leaching studies indicate a lower leaching potential of metabolite BH 518-5 as expected from

the lower tier modelling. It has to be considered that the degradation rate used for modeling of DT50 =

601.5 d is a geomean that includes several default values of 1000 d.

However the metabolites BH 518-2 and BH 518-5 are classified as not relevant for groundwater.

For details see Part B, National Addendum-Germany, Section 5, chapter 5.8.1.

Consequences for authorization:

As published in Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 the Member

States concerned shall request the submission of further information on the impact of soil metabolite M3

on groundwater. According to the applicant these confirmatory data have been submitted to the

Commission (dRR Part B, Sect. 5, Core Assessment, Oct.2011).

2. Ground water contamination by bank filtration due to surface water exposure via run-off and

drainage

Metamitron

According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L by

the active substance metamitron due to surface run-off and drainage into the adjacent ditch with

subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of 20

m) are applied.

Quinmerac

According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L by

the active substance quinmerac and its metabolites BH 518-2 and BH 518-5 due to surface run-off and

drainage into the adjacent ditch with subsequent bank filtration can be excluded.

For details see Part B, National Addendum-Germany, Section 5, chapter 5.8.1.


The authorisation of the plant protection product GOLTIX TITAN is linked with following labeling:

Use No. 001 NG404

Between treated areas with an incline of more than 2% and surface water - except only occasionally

but including periodically water-bearing surface water - there must be a border under complete plant

cover. The border's protective function must not be impaired by the use of implements. It must be at

least 20 m wide. This border is not necessary if: - sufficient catching systems are available for the

water and soil transported by run-off, which do not flow into surface water or are not connected with

the urban drainage system or - the product is used for mulch or direct drilling methods.

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section

5, Points 9.7 and 9.8)

For the intended use of the plant protection product GOLTIX TITAN in beets (sugar and fodder)

according to use No 01-001 PECsw was calculated for the active substances metamitron and quinmerac

considering the two routes of entry (i) spraydrift and (ii) run-off, drainage separately. The vapour pressure

at 20 °C of the active substances metamitron and quinmerac is < 10-5 Pa. Hence the active substances are

regarded as non-volatile. Therefore exposure of surface water by the active substances metamitron and

quinmerac due to deposition following volatilization was not considered as relevant.

Details are given in Part B, National Addendum-Germany, Section5, chapter 5.7.


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The results for PECsw for the active substances and their metabolites were used for the ecotoxicological

risk assessment.

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point

9.9)

The vapour pressures of the active substances metamitron and quinmerac are < 10-5 Pa. Hence the active

substances are regarded as non-volatile.

Implications for labelling resulting from environmental fate assessment

For the authorisation of the plant protection product GOLTIX TITAN following labeling and conditions

of use are mandatory:

Classification and labelling

Based on the data on the active substances metamitron and quinmerac of the plant protection product

GOLTIX TITAN are considered to be not readily degradable in the sense of the CLP regulation.

The formulation GOLTIX TITAN is regarded as a candidate for R 53.

Standard Phrases for special risks and safety precautions under Regulation (EU) 547/2011 Annex II and

III / conditions of use

Use No. 001:

NG404 Between treated areas with an incline of more than 2% and surface

water - except only occasionally but including periodically water-

bearing surface water - there must be a border under complete plant

cover. The border's protective function must not be impaired by the use

of implements. It must be at least 20 m wide. This border is not

necessary if: - sufficient catching systems are available for the water

and soil transported by run-off, which do not flow into surface water or

are not connected with the urban drainage system or - the product is

used for mulch or direct drilling methods.


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3.1.6 Ecotoxicology (Part B, Section 6, Point 10)

A full risk assessment according to Uniform Principles for the plant protection product GOLTIX TITAN

in its intended uses in beets (sugar and fodder) is documented in detail in the core assessment of the plant

protection product GOLTIX TITAN dated from October 2011 performed by Feinchemie Schwebda

GmbH. The intended use of GOLTIX TITAN in Germany is generally covered by the uses evaluated in

the course of the core assessment by zonal rapporteur member state Germany.

The following chapters summarise specific risk assessment for non-target organisms and hence risk

mitigation measures for the authorisation of GOLTIX TITAN in Germany according to its intended use in

beets (sugar and fodder) (use No. 01-001).

Only information relevant for the prescription of national labelling and environmental restrictions are

mentioned in the following chapters. Details of ecotoxicological studies and risk assessment are described

in the Core Assessment and the National Addendum Germany, Part B, Section 6, respectively.

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)

There is no unacceptable risk for terrestrial vertebrates.

For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.2 (birds) and 6.3

(terrestrial vertebrates other than birds) and National Addendum Germany, Section 6, Point 6.1 (birds)

and Point 6.2 (other terrestrial vertebrates), respectively.

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)

For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.4 and National

Addendum Germany, Section 6, Point 6.3 respectively.

Based on the intrinsic properties of the active substances metamitron and quinmerac, following national

labelling and environmental restrictions are prescribed as mandatory:

Risk mitigation measures:

Use No.

001

NW642:

The product is not authorized for use in or in the immediate vicinity of surface waters or

coastal waters (§ 6 (2) 'PflschG' [Plant Protection Act]). Irrespective of this fact, the binding

minimum buffer zone to be kept from surface waters, provided for by state law, must be

observed. Violations may be punished by fines of up to Euro 50.000.

Use No.

001

NW468:

Fluids left over from application and their remains, products and their remains, empty

containers and packaging, and cleansing and rinsing fluids must not be dumped in water.

This also applies to indirect entry via the urban or agrarian drainage system and to rain-

water and sewage canals.

Labelling:

Because of the toxicity of the active ingredients as well as the formulation following labels must be given:

NW262: The product is toxic for algae.

NW263: The product is toxic for aquatic invertebrates.

NW265: The product is toxic for higher aquatic plants.

Studies of the acute toxicity of GOLTIX TITAN for algae [EbC50Metamitron = 0.4 mg/L (P. subcapitata;

EC50Goltix Titan = 2.0 mg/L (P. subcapitata)], daphnia [LC50Metamitron = 5.7 mg/L (D. magna)] and aquatic

plants [EbC50Metamitron = 0.4 mg/L (L. gibba); EbC50Goltix Titan = 0.86 mg/L (L. gibba)] showed that this

product should be labelled as very toxic for aquatic organisms.


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3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and

10.5)

Bees

In the honey bee risk assessment for the main application it was concluded that the risk to bees is

acceptable when Goltix Titan (AG-QMM1-565 SC) is used up to 6 L product/ha in pre-emergence or

early post-emergence fodder and sugar beet fields. Since the recommended application rate does not

exceed this rate no further risk assessment is required. Labelling phrase NB6641 is applied.

Other non-target arthropods

No risk management measures are required for other arthropod species for the intended use pattern.

For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.5 and 6.6 and National

Addendum Germany, Section 6, Point 6.4 and 6.5 respectively.

3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point

10.6)

No risk management measures are required for the protection of earthworms and other soil macro-

organisms for the intended use pattern.

For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.7 and National

Addendum Germany, Section 6, Point 6.6 respectively.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)

For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.7.8.

No risk management measures are required for the protection of earthworms and other soil macro-

organisms for the intended use pattern.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)

No risk management measures are required for the protection of non-target soil micro-organisms for the

intended use pattern.

For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.8.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and

Fauna) (Part B, Section 6, Point 10.8)

No risk management measures are required for the protection of non-target plants for the intended use

pattern.

For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.9.

Implications for labelling resulting from ecotoxicological assessment:


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Relevant toxicity data

Goltix Tiitan

EyC50 = 1.5 mg/L (Lemna gibba)

EyC50 = 1.99 mg/L (P. subcapitata)

Classification & Labelling according directives 67/548/EEC, 78/631/EEC and 1999/45/EEC

Danger Symbol N, dangerous for the environment

Risk Phrases R 51/53

C&L according directive 1272/2008

Danger Symbol GHS 09

Hazard Statements H 411

3.1.7 Efficacy (Part B, Section 7, Point 8)

Information on the active ingredients (Uptake and mode of action) Metamitron belongs to the chemical group of triazinones. Metamitron is a selective herbicide to be used

in fodder- and sugar beet for the control of mono- and dicotyledonous weeds. Primarily it is taken up by

plant roots and shoots and is translocated acropetally to the chloroplasts. Also a plant uptake through the

leaves is possible. Like other triazinones, metamitron acts as an inhibitor of photosynthetic electron

transport at the photosystem II receptor site (Hill-reaction). Selectivity of weeds is based on different

metabolisation. Susceptible weed seedlings become chlorotic, exhibit yellowed and cleared discolouration

and finally get withered. Metamitron is highly selective in fodder and sugar beets. Metamitron is readily

degraded by aqueous photolysis. The major metabolite in sugar beet is deaminated metamitron. Mode of

action (HRAC-group): C1

Labelling phrase WMC1

Quinmerac belongs to the chemical group of quinolinecarboxylic acids. Quinmerac is absorbed primarily

via the root system but can also be absorbed from the foliage. Adequate soil moisture supports the uptake

by roots and the onset of activity. Uptake by leaves depends on the concentration of the active ingredient

and time. Its mode of action has been proposed as root growth inhibition which exhibits auxin type effects

(similar to phenoxycarboxylic acids). Based on the auxin effects quinmerac stimulates the formation of

the phytohormone ethylene in sensitive plants, leading to epinasty, altered uptake and other effects. In the

biosynthesis the enzymatic activity of 1-aminocyclopropane-1-carboxylic-acid synthase will be induced.

As a result an accumulation of abscisic acid (ABA) in the plant tissue occurs. The consequences are:

deformation of plants, occlusion of stomata, inhibition of transpiration, CO2-assimilation and growth as

well as the death of plant cells. The selective effect is based on plant tissue/target location selectivity in

crop plants. In sugar beet the tolerance is supported by a faster degradation. Uptake and translocation has

no great significance for herbicide efficacy. Mode of action (HRAC-group): O

Labelling phrase WMO

Minimum effective dose

The dose response results against some weed species show that there is a trend that for most of the weed

species the efficacy is reduced and the variability of the level of control is increased, if rates lower than 3

+ 3 x 1 L/ha of AG-QMM1-565 SC are applied.

Efficacy

A total of 17 efficacy trials were carried out in 2010, 2011, and 2012 in Belgium, Germany and the

Netherlands.. The applied application rate of AG-QMM1-565 SC was 3 L/ha pre-emergence followed by


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up to 3 post-emergence splitting applications of 1 L/ha each. It can be concluded that AG-QMM1-565 SC

provides sufficient control of a number of annual dicotyledonous weed species in fodder and sugar beets.

POAAN and ECHCG are documented only in 2 trials. More annual monocotyledonous weed species

didn’t occur in the efficacy trials. So no final evaluation for annual monocotyledonous weed species

could be done.

Labelling phrase: WH9161.

Effect on the yield and quality

Based on the results of 8 selectivity trials carried out in sugar beets in Germany and the Netherlands in

2013 it can be concluded that there are no indications for a negative impact on quality of plants and plant

products in sugar or fodder beets if the product is applied at the intended target application rates, even if

the product is applied at double rate.

Effects on the Processing Procedure Neither from trial experience nor from practical use of the active ingredients metamitron and quinmerac

any cases were reported about negative influences on parameters influencing the processing procedure of

sugar beets. Thus no special trials were carried out for the assessment of these criteria.

Effects on the yield of treated plants and plant products

There are no indications for a negative impact on quantity of yield in sugar or fodder beets if AG-QMM1-

565 SC is applied at the intended target application rates. Even at the double rate there is no substantial

risk for an impact on yield quantity.

Phytotoxicity to host crop

The effects AG-QMM1-565 SC applied in splitting applications (3 L/ha pre-emergence + 3 x 1 L/ha post-

emergence) on the target crop were rated in a total of 25 trials.The results show that the product is

tolerated well by sugar beets. For this indication only one year results (2013) are available from trials

carried out with the double rate included under almost weed free conditions.

Impacts on succeeding and on adjacent crops

According to EPPO standard PP1/207 no unacceptable risk for all succeeding crops in common crop

rotations could be shown.

Information on the possible Occurrence of the Development of Resistance or Cross-Resistance

The evaluation of the inherent risk for resistance development of AG-QMM1-565 SC shows that for the

active ingredient metamitron there is a high risk for the development of weed resistance while the

inherent risk of target weeds to develop resistance against quinmerac is considered low to medium.

The applicant claims that the risk for the development of resistant weed biotypes in major sugar beet

production areas is considered medium because of the fact that despite many years of intensive use of

metamitron only very occasional proven problems with weed resistance are reported in Europe, and that

no proven problems of quinmerac with this active ingredient are reported. This conclusion cannot be fully

followed. As the number of metamitron resistance cases reported for Chenopodium album has

substantially increased in the last years, the resistance risk for metamitron has to be rated as high

especially for Germany and Belgium. As the spectrum of weed species controlled by metamitron and

quinmerac is not overlapping and because the above mentioned high risk weed species (especially

Chenopodium album) are nor controlled by quinmerac, the resistance risk of the herbicide has to be rated

a medium to high. Due to this resistance risk, management strategies are required. The applicant claims

that basic recommendations for resistance risk management will be clearly recommended on the label.

Labelling phrase: WH951.


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Adverse effects on beneficial organisms other than bees

Under extended laboratory test conditions effects of less than 25 % at the proposed application rate of

maximum 6 L/ha per year were demonstrated. The herbicide AG-QMM1-565 SC is therefore considered

to be harmless for Aphidius rhopalosiphi and Typhlodromus pyri.

Besides the two indicator species, only the rove beetle Aleochara bilineata was tested with SC-

formulations of the both active ingredients of the test product, metamitron and quinmerac. Metamitron

was shown to be slightly harmful with an effect between 30 – 80 % under worst case conditions. No

effects occurred in a laboratory study with the combination product AG-QM2-500 SC and in an extended

laboratory study with metamitron, but the latter test did not fulfil the validity criteria. Thus it could not be

excluded, that the test product can be slightly harmful for Aleochara bilineata.

On the basis of the results of an extended laboratory study with Metamitron, the test product has to be

considered as slightly harmful for the ladybird beetle Coccinella septempunctata.

Labelling phrases: NN1001, NN1002.

3.2 Conclusions

With respect to physical, chemical and technical properties and analytical methods (formulation, residues)

an authorisation can be granted

Regarding toxicology, residues and consumer protection an authorisation can be granted.

With respect to efficacy an authorization can be granted for the control of annual dicotyledonous

weeds. Due to the letter of the applicant dated 2015-01-13 the control of annual monocotyledonous

weeds is no longer pursued.

Concerning fate and ecotoxicology an authorisation can be granted.

The product is classified as non-hazardous to bees.

An authorisation can be granted.

3.3 Further information to permit a decision to be made or to support a review of the

conditions and restrictions associated with the authorisation

No further information is required.


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Appendix 1 – Copy of the product authorisation


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Appendix 2 – Copy of the product label

The submitted draft product label has been checked by the competent authority. The applicant is

requested to amend the product label in accordance with the decisions made by the competent

authority. The final version of the label has to fulfil the requirements according to Article 16 of

Directive 91/414/EEC.


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Appendix 3 – Letter of Access

Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

Part B – Section 1

Core Assessment –

Germany

AG-QMM1-565 SC

Goltix Titan

Registration Report – Central Zone

Page 1 of 23

Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

REGISTRATION REPORT

Part B

Section 1: Identity, physical and chemical

properties, other information

Detailed summary of the risk assessment


(AG-QMM1-565 SC)

Active Substance: Metamitron 525 g/L

Quinmerac 40 g/L

Central Zone

Rapporteur Member State: Germany

CORE ASSESSMENT


Submission Date: January 2014

Date : February 2016


Core Assessment –

Germany

AG-QMM1-565 SC

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Table of Contents

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT .............................. 6

IIIA 1.1 Applicant ................................................................................................................ 6

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the

Active Substance(s) ............................................................................................... 6

IIIA 1.2.1 Manufacturer(s) of the preparation .................................................................... 6

IIIA 1.2.2 Manufacturer(s) of the active substance(s) ......................................................... 7

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the

active substance(s) ................................................................................................. 7

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation .......... 7

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition

of the Preparation .................................................................................................. 7

IIIA 1.4.1 Content of active substance and formulants ....................................................... 7

IIIA 1.4.2 Certified limits of each component ...................................................................... 8

IIIA 1.4.3 Common names and code numbers for the active substance(s) ........................ 8

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name,

specification and function. .................................................................................... 8

IIIA 1.4.5 Formulation process .............................................................................................. 9

IIIA 1.4.5.1 Description of formulation process ...................................................................... 9

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern .................. 9

IIIA 1.5 Type of Preparation and Code ............................................................................. 9

IIIA 1.6 Function .................................................................................................................. 9

IIIA 1.7 Other/Special Studies ............................................................................................ 9

IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF

THE PLANT PROTECTION PRODUCT ....................................................... 10

IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15.......... 13


Core Assessment –

Germany

AG-QMM1-565 SC

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IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION

PRODUCT ........................................................................................................... 13

IIIA 3.1 Field of Use ........................................................................................................... 13

IIIA 3.2 Nature of the Effects on Harmful Organisms ................................................... 13

IIIA 3.3 Details of Intended Use ....................................................................................... 13

IIIA 3.3.1 Details of existing and intended uses ................................................................. 13

Please refer to Appendix 2 – Critical Uses – and Part B Section 7. ........................................ 13

IIIA 3.3.2 Details of harmful organisms against which protection is afforded ............... 13


IIIA 3.3.3 Effects achieved ................................................................................................... 13

Please refer to Part B Section 7. ................................................................................................. 13

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) ................. 13


IIIA 3.5 Concentration of the Active Substance in the Material Used ......................... 13


IIIA 3.6 Method of Application, Type of Equipment Used and Volume of

Diluent .................................................................................................................. 13


IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop

and Harmful Organism) and Duration of Protection ...................................... 14

IIIA 3.7.1 Maximum number of applications and their timings ...................................... 14


IIIA 3.7.2 Growth stages of crops or plants to be protected ............................................. 14


IIIA 3.7.3 Development stages of the harmful organism concerned ................................ 14


IIIA 3.7.4 Duration of protection afforded by each application ....................................... 14


Core Assessment –

Germany

AG-QMM1-565 SC

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IIIA 3.7.5 Duration of protection afforded by the maximum number of

applications .......................................................................................................... 14


IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic

Effects on Succeeding Crops .............................................................................. 14

IIIA 3.8.1 Minimum waiting periods or other precautions between last application

and sowing or planting succeeding crops .......................................................... 14


IIIA 3.8.2 Limitations on choice of succeeding crops ........................................................ 14


IIIA 3.8.3 Description of damage to rotational crops ........................................................ 14


IIIA 3.9 Proposed Instructions for Use as Printed on Labels ........................................ 14

IIIA 3.10 Other/Special Studies .......................................................................................... 14

IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION

PRODUCT ........................................................................................................... 15

IIIA 4.1 Packaging and Compatibility with the Preparation ........................................ 15

IIIA 4.2 Procedures for Cleaning Application Equipment ............................................ 15

IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment ............... 15

IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop ...................................... 15

IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed ......................... 15

IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces

treated ................................................................................................................... 15

IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs ................................... 15

IIIA 4.3.5 Waiting period (in days) between application and handling of treated

products ................................................................................................................ 15

IIIA 4.3.6 Waiting period (in days) between last application and sowing or

planting succeeding crops ................................................................................... 15


Core Assessment –

Germany

AG-QMM1-565 SC

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IIIA 4.3.7 Information on specific conditions under which the preparation may or

may not be used ................................................................................................... 15

IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and

Precautions and Handling Procedures to Minimise Those Risks ................... 15

IIIA 11 FURTHER INFORMATION............................................................................. 15

IIIA 11.1 Information of Authorisations in Other Countries .......................................... 15

IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other

Countries .............................................................................................................. 15

IIIA 11.3 Justified Proposals for Classification and Labelling ........................................ 16

IIIA 11.4 Proposals for Risk and Safety Labels ............................................................... 16

IIIA 11.5 Proposed Label .................................................................................................... 16

IIIA 11.6 Specimens of Proposed Packaging ..................................................................... 16

Appendix 1: List of data used in support of the evaluation .................................................. 17

Appendix 2: Critical Uses – justification and GAP tables ..................................................... 18

Introduction

This document summarises the information related to the identity, the physical and chemical properties,

the data on application, further information and the classification for the product AG-QMM1-565 SC

containing the active substances metamitron and quinmerac which were approved according to

Regulation (EC) No 1107/2009.

This product was not the representative formulation. The product has not been previously evaluated

according to Uniform Principles.

Where appropriate this document refers to the conclusions of the EU review of metamitron and

quinmerac. This will be where:

• the active substance data are relied upon in the risk assessment of the formulation; or when

• the EU review concluded that additional data/information should be considered at national re-

registration.

New annex II data of quinmerac have been generated to match protected data. These data are summarised

in Annex 4 of this section.

The SANCO report for Metamitron (SANCO/208/08 final – 6 Januar 2009) and Quinmerac

(SANCO/12192/2010 final – 7 December 2010) are considered to provide the relevant review


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Page 6 of 23


information or a reference to where such information can be found. Each section will begin with a table

providing the EU endpoints to be used in this evaluation.

This Part B document only reviews data (Annex II or Annex III) and additional information that has not

previously been considered within the EU review process, as part of the Annex I inclusion decision.

The following table provides the EU endpoints to be used in the evaluation.

Agreed EU End-points

End-Point Metamitron

(Reg. (EU) No. 540/2011) Quinmerac

(Reg. (EU) No. 540/2011)

Purity of active substance min 960 g/kg min 980 g/kg

Appendix 1 of this document contains the list of references included in this document for support of the

evaluation.

Appendix 2 of this document is the table of intended uses for AG-QMM1-565 SC.

Information on the detailed composition of AG-QMM1-565 SC can be found in the confidential dossier

of this submission (Registration Report - Part C).

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT

IIIA 1.1 Applicant

ADAMA Deutschland GmbH

Edmund-Rumpler-Straße 6

D-51149 Köln

Germany

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active

Substance(s)

IIIA 1.2.1 Manufacturer(s) of the preparation

Name: ADAMA Agan Ltd.

Address: Industrial Zone

P.O. Box 262,

Ashdod, 77102, Israel


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AG-QMM1-565 SC

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Contact:

E-mail:

Dr. Tali Ehrlich

Tel.: +972 7 32321330

[email protected]

Location of manufacturing site

CONFIDENTIAL information – data provided separately (Part C).

IIIA 1.2.2 Manufacturer(s) of the active substance(s)

Confidential information - data provided separately (Part C).

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active

substance(s)

Metamitron: minimum 980 g/kg

Quinmerac: minimum 980 g/kg

Further information/justification is provided in Part C.

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation

Trade name: Goltix Titan for Germany.

Company code number:

development code: AG-QMM1-565 SC

FSG-code: FSG 02122 H

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the

Preparation

IIIA 1.4.1 Content of active substance and formulants

The formulation was not the representative formulation.

Pure active substance:

content of pure metamitron: 525 g/L

content of pure quinmerac: 40 g/L

limits metamitron: 500 – 550 g/L

limits quinmerac: 36 – 44 g/L


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Goltix Titan


Page 8 of 23


Technical active substance:

content of technical metamitron

at minimum purity (98.0 %):

535.7 g/L

content of technical quinmerac

at minimum purity (98.0 %):

40.8 g/L

None of the active substances in the formulation are present in the form of a salt, ester, anion or cation.

Further information on the active substances and on the certified limits of formulants is considered

confidential and is provided separately (Part C).

IIIA 1.4.2 Certified limits of each component

This is not an EC data requirement/ not required by regulation (EU) 2011/545.

IIIA 1.4.3 Common names and code numbers for the active substance(s)

Data

Point

Type Name/Code Number

1.4.3.1 ISO common name Metamitron Quinmerac

1.4.3.2 CAS No. 41394-05-2 90717-03-6

1.4.3.2 EINECS No. 255-349-3 None

1.4.3.2 CIPAC No. 381 563

1.4.3.2 ELINCS None 402-790-6

1.4.3.3 Salt, ester anion or cation

present

None None

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and

function.

CONFIDENTIAL information - data provided separately (Part C).


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Goltix Titan


Page 9 of 23


IIIA 1.4.5 Formulation process

IIIA 1.4.5.1 Description of formulation process

This is not an EC data requirement/ not required regulation (EU) 2011/545.

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern

There are no relevant impurities in the technical active Substances metamitron and quinmerac as

manufactured and the manufacturing process of the formulation AG-QMM1-565 SC is such that no new

relevant impurities can be formed.

IIIA 1.5 Type of Preparation and Code

Type : Suspension concentrate Code : SC

IIIA 1.6 Function

The product will be used as herbicide.

IIIA 1.7 Other/Special Studies

None.


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IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT

The product AG-QMM1-565 SC is already registered in Germany, Belgium and Netherlands. The complete set of studies on physical, chemical properties

of the product has been evaluated and accepted. The storage stability at ambient temperature over a period of 2 years was submitted post authorisation. The

results are adequate and demonstrate that the technical characteristics of AG-QMM1-565 SC are acceptable for the suspension concentrate formulation.

This study is presented in the following table:

Test or study

& Annex point

Method

used /

deviations

Test material purity

and specification

Findings GLP

Y/N

Reference Acceptability /

comments

Ambient

temperature

shelf life

(IIIA 2.7.5)

Standard

Operating

procedures

of AGAN,

based on

CIPAC

methods.

Quinmerac 40 g/L +

Metamitron 525 g/L

SC

batch K6001

41.3 g/L quinmerac

540.2 g/L metamitron

The product was stable during a two-year storage

stability test when stored in original HDPE commercial

containers:

1. Appearance and stability of packaging:

Initial results: off-white suspension, characteristic

odour

Final results: same as initial.

After storage slight bleeding (~15 %) and slight

sedimentation. Nonetheless the product was

homogenous after five inversions.

2. A.I. content (g/L)

Initial results:

Metamitron 540 g/L (46.45%)

Quinmerac 41.2 g/L (3.54%)

Final results:

Metamitron 541.31 g/L (46.33%)

Quinmerac 41.0 g/L (3.53%)

Y Edelson, 2012,

(F10-03/5)

2205911

Acceptable


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Test or study

& Annex point

Method

used /

deviations


and specification

Findings GLP

Y/N


comments

3. pH 1% in deionized water

Initial result:3.7

Final result: 3.8

4. pH undiluted

Initial result:4.4

Final result: 4.3

4. Spontaneity of dispersion (%)

(water D) 5% v/v

Initial result:

Quinmerac 94%, Metamitron 95%

Final results:


5. Suspensibility (%), water D at 0.5% and at 2.0%

Initial results at 0.5%


Final result at 0.5%:


Initial results at 2.0%:


Final result at 2.0%:


6. Wet sieve residue (%)

Initial results: 0.017

Final results: 0.025


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Test or study

& Annex point

Method

used /

deviations


and specification

Findings GLP

Y/N


comments

7. Particle size distribution (%)

Initial results:

D (0.9) 9.44

D (0.5) 3.08

D (0.1) 0.81

Final results:

D (0.9) 11.31

D (0.5) 2.28

D (0.1) 0.55

8. Pourability (%)

Initial results: 3.05

Final results: 2.17

. Rinsed (%)

Initial result: 0.17

Final result: 0.23

Conclusion: The product was stable during a two-year

storage stability test when stored in original HDPE

commercial containers.


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AG-QMM1-565 SC

Goltix Titan


Page 13 of 23


IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15

The storage stability at ambient temperature over a period of 2 years showed good stability in terms of

active substance content and product characteristics.

In the present application the lowest in use concentration is 0.25 % (1 L in 400 L water), while in the

main application the lowest in use concentration is 0.5 %. No information is available on the

suspensibility at 0.25 %, but this is considered acceptable, as the results at 0.5 % are > 90 %.

IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT

IIIA 3.1 Field of Use

The application was for approval of AG-QMM1-565 SC (in Germany: Goltix Titan), a suspension

concentrate containing 525 g/L Metamitron and 40 g/L Quinmerac, for use as herbicide against annual

monocotyledonous weeds, Galium aparine and other annual dicotyledonous weeds in splitting

applications.

IIIA 3.2 Nature of the Effects on Harmful Organisms

Metamitron belongs to the chemical group of triazinones. Metamitron is a selective herbicide to be used

in fodder- and sugar beet for the control of mono- and dicotyledonous weeds. Primarily it is taken up by

plant roots and shoots and is translocated acropetally to the chloroplasts. Also a plant uptake through the

leaves is possible. Like other triazinones, metamitron acts as an inhibitor of photosynthetic electron

transport at the photosystem II receptor site (Hill-reaction). Mode of action (HRAC-group): C1

Quinmerac belongs to the chemical group of quinolinecarboxylic acids. Quinmerac is absorbed primarily

via the root system but can also be absorbed from the foliage. Adequate soil moisture supports the uptake

by roots and the onset of activity. Uptake by leaves depends on the concentration of the active ingredient

and time. Light increases the uptake rate. In contrast dependence on temperature is slight. Its mode of

action has been proposed as root growth inhibition which exhibits auxin type effects (similar to

phenoxycarboxylic acids). Mode of action (HRAC-group): O

IIIA 3.3 Details of Intended Use

IIIA 3.3.1 Details of existing and intended uses

Please refer to Appendix 2 – Critical Uses – and Part B Section 7.

IIIA 3.3.2 Details of harmful organisms against which protection is afforded


IIIA 3.3.3 Effects achieved

Please refer to Part B Section 7.

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation)


IIIA 3.5 Concentration of the Active Substance in the Material Used


IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent



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IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful

Organism) and Duration of Protection

IIIA 3.7.1 Maximum number of applications and their timings


IIIA 3.7.2 Growth stages of crops or plants to be protected


IIIA 3.7.3 Development stages of the harmful organism concerned


IIIA 3.7.4 Duration of protection afforded by each application


IIIA 3.7.5 Duration of protection afforded by the maximum number of applications


IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding

Crops

IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or

planting succeeding crops


IIIA 3.8.2 Limitations on choice of succeeding crops


IIIA 3.8.3 Description of damage to rotational crops


IIIA 3.9 Proposed Instructions for Use as Printed on Labels

Please refer to Registration Report – Part A, Appendix 2 for the relevant country.


This is not an EC data requirement/ not required by Directive 91/414/EEC.


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Goltix Titan


Page 15 of 23


IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT

IIIA 4.1 Packaging and Compatibility with the Preparation

There is no change compared to the main application. Therefore no further evaluation is necessary.

IIIA 4.2 Procedures for Cleaning Application Equipment


IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment

IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop

See section 4.

IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed

See section 4.

IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces treated

See section 4.

IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs

See section 4.

IIIA 4.3.5 Waiting period (in days) between application and handling of treated products

See section 4.

IIIA 4.3.6 Waiting period (in days) between last application and sowing or planting succeeding crops

See section 4.

IIIA 4.3.7 Information on specific conditions under which the preparation may or may not be used

See section 4.

IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and Precautions

and Handling Procedures to Minimise Those Risks


IIIA 11 FURTHER INFORMATION

IIIA 11.1 Information of Authorisations in Other Countries

An overview of the existing approvals in EC member states of metamitron and quinmerac is given in

Appendix 3A and Appendix 3B, respectively.

IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries

MRLs set at European Level are stated in the Regulation (EC) No 396/2005 (see: EU Pesticides database,

as published on June 8, 2010, Internet: http://ec.europa.eu/sanco_pesticides/public/

index.cfm). See also Table 8.7.2-1 and Table 8.7.2-7 in chapter 8.7.


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AG-QMM1-565 SC

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MRLs established in exporting countries for pyraclostrobin and epoxiconazole are given in

Appendix 3C and Appendix 3D, respectively.

IIIA 11.3 Justified Proposals for Classification and Labelling

Proposals for classification and labelling of AGG-QMM1-565 SC in accordance with the EC Directive on

dangerous preparations 1999/45/EC and Directive 2001/59/EC (as amended) are presented below:

Physico - chemical properties


Toxicology

Please refer to Registration Report – Part B section 3.

Ecotoxicology/Environment

Please refer to Registration Report – Part B section 6.

IIIA 11.4 Proposals for Risk and Safety Labels

Please refer to Registration Report – Part A.

IIIA 11.5 Proposed Label

Please refer to Registration Report – Part A.

IIIA 11.6 Specimens of Proposed Packaging

Specimens of the packaging were not provided as there was no request.

.


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Appendix 1: List of data used in support of the evaluation

Annex point/

reference No

Author(s) Year Title

Source (where different from

company)

Report-No.

GLP or GEP status (where relevant)

Data

protection

claimed

Owner How

considered in

dRR

Study-Status /

Usage*

KIIIA 2.7.5 Edelson, T.,

Nahmoud, S.

2012 Determination of storage stability and

phys-chem properties of (quinmerac

40 g/l + metamitron 525 g/l) SC

stored at ambient temperature for two

years

AGAN Chemical Manufacturers,

Ltd., Ashdod, Israel

Quena Plant Protection N.V.,

F10-03/5,

GLP: Yes

Published: No

yes ADAMA 1

* 1 accepted (study valid and considered for evaluation)

2 not accepted (study not valid and not considered for evaluation)

3 not considered (study not relevant for evaluation)

4 not submitted but necessary (study not submitted by applicant but necessary for evaluation)

5 supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)


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Appendix 2: Critical Uses – justification and GAP tables

GAP-Table of intended uses for Germany

GAP rev. (No), date: 2014-04-14








Zone(s): central/EU

professional use X


Verified by MS: yes

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I


controlled

(additionally:




(days) Remarks:


e.g. recommended or


Method /


stage of crop &

season

Max. number

(min. interval

between

applications)

a) per use

b) per crop/

season

kg, L product /

ha

a) max. rate per

appl.

b) max. total rate

per crop/season

g, kg as/ha

a) max. rate

per appl.

b) max. total

rate per

crop/season

Water L/ha

min / max

001 DE Sugar beet

BEAVA

fodder beet

BEAVC

F Annual

monocotyledonous

weeds

TTTMS

Annual dicotyledonous

weeds

TTTDS

Spraying

splitting 4

applications

Spring

BBCH 00 – 19


emergence


after emergence

a) 4

b) 4

the 2nd to 4th

treatment with

an interval of 5

to 10 days

a)

timing 1: 3 L/ha

timing 2: 1 L/ha

timing 3: 1 L/ha

timing 4: 1 L/ha

a)

timing 1:

Metamitron

1575 g as/ha

Quinmerac

120 g as/ha

timing 2:

Metamitron

200 - 400 *XF WH9161

‚Annual

monocotyledonous

weeds‘ are withdrawn by the

applicant , because not

enough data regarding

efficacy available.


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b) 6 L/ha

maximum

application rate

for the intented

crop per year

525 g as/ha

Quinmerac

40 g as/ha

timing 3:

Metamitron

525 g as/ha

Quinmerac

40 g as/ha

timing 4:

Metamitron

525 g as/ha

Quinmerac

40 g as/ha

b)

Metamitron

3150 g as/ha

Quinmerac

240 g as/ha

maximum

application rate

for the intented

crop per year

*The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI

in days is not required resp.


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application









(L/ha)




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GAP-Table of intended uses for all cMS (without Germany), not verified by zRMS

PPP (product name/code) AG-QMM1-565 SC



active substance

safener -

synergist -

Formulation type: SC (suspension concentrate)



Conc. of as:

Conc. of safener: -

Conc. of synergist: -


Zone(s): central/EU

professional use


Verified by MS: no

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination

/ purpose of crop)

F

G

or

I

Pests or Group of

pests controlled

(additionally:

developmental

stages of the pest or

pest group)

Application Application rate PHI (days)

Remarks:


e.g. recommended or


Method /

Kind

Timing /

Growth

stage of crop

& season

Max. number (min.

interval between

applications)

a) per use

b) per crop/ season

kg, L product / ha

a) max. rate per

appl.

b) max. total rate

per crop/season

g as/ha

a) max. rate per

appl.

b) max. total

rate per

crop/season

Water

L/ha

min /

max

1 NL, BE Beets (sugar and F GALAP and other

annual spraying BBCH 10- a) 1-3 (5) a) 2

a) Metamitron:

1050

200 /

400 F

Max. 2.0 L product/ha per

treatment


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fodder)

Use already

authorised

dicotyledonous

weed species

19 b) 3 b) 6 Quinmerac: 80

b) Metamitron:

3150

Quinmerac: 240

Total 6.0 L product/ha

Max. once per three years

on same field

2 NL, BE

Beets (sugar and

fodder) F

Poa annua

POAAN,

Galium aparine

GALAP ,

annual

dicotyledonous

weeds (TTTDS)

spraying

BBCH 00-

09 a) 1

b) 1

a) 3

b) 3

a) Metamitron:

1575

Quinmerac: 120

b) Metamitron:

1575

Quinmerac: 120

200 /

400 F


Max. once per three years

on same field

BBCH 10-

19 a) 1-3 (5)

b) 3

a) 1

b) 3

a) Metamitron:

525 Quinmerac:

40

b) Metamitron:

1575

Quinmerac: 120

200 /

400 F

3 NL, BE

Beets (sugar and

fodder)

withdrawn by

applicant on 14

February 2014

F

POAAN, GALAP

and other annual

dicotyledonous

weed species spraying

BBCH 00-

09 a) 1

b) 1

a) 3

b) 3

a) Metamitron:

1575

Quinmerac: 120

b) Metamitron:

1575

Quinmerac: 120

200 /

400 F

Pre-emergence:

1 × 3.0 L fp/ha

Post-emergence:

Max. individual application

rate: 3.0 L fp/ha,

E.g. 1× 3.0 L;

1 × 1.25 L + 1 × 1.0 L + 1 ×

1.0 L;

1 × 1.5 L + 1 x 1.75 L fp/ha;

or combinations of other

uses with 0.75 L/ha min).

Max. total post-emergence

applied of 3.25 L fp/ha

Max use rate of 250 g/ha

Quinmerac is restricted on

BBCH 10-

19 a) 1-4 (5)

b) 4

a) 1,25

b) 3,25

a) Metamitron:

656 Quinmerac:

50

b) Metamitron:

1706

Quinmerac: 130

200 /

400 F

BBCH 10-

19

a) Metamitron:

525 Quinmerac:

40

b) Metamitron:

1575

Quinmerac: 120

200 /

400 F


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Page 23 of 23


the same field per year.

withdrawn by applicant

on 14 February 2014

4 NL, BE

Beets (sugar and

fodder)

withdrawn by

applicant on 14

February 2014

F

POAAN, GALAP

and other annual

dicotyledonous

weed species spraying

BBCH 10-

19 a) 1 (5)

b) 6

a) 0,75

b) 1,25

a) Metamitron:

394 Quinmerac:

30

b Metamitron:

656 Quinmerac:

50

200 /

400 F

Max. individual application

rate: 1.25 L fp/ha, e.g.

5 × 1.25 L fp/ha or uses in

between

Max use rate of 250 g/ha

Quinmerac is restricted on

the same field per year.

withdrawn by applicant

on 14 February 2014

Indication 1 is already authorised

Indication 3 and 4 only as national addendum – withdrawn by applicant on 14 February 2014

Part B Section 2

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Goltix Gold


Page 1 of 4

Applicant ADAMA Deutschland GmbH Evaluator: DE Date: June 2015

REGISTRATION REPORT

Part B

Section 2 Analytical Methods



(AG-QMM1-565 SC)

Active Substance: Metamitron 525.0 g/L

Quinmerac 40.0 g/L

Central Zone

Rapporteur Member State: Germany

CORE ASSESSMENT


Submission Date: October 2011

Date: June 2015

Part B Section 2

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Goltix Gold


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Table of Contents

IIIA 5 METHODS OF ANALYSIS ....................................................................... 3

IIIA 5.1 Analytical Standards and Samples ......................................................... 3

IIIA 5.2 Methods for the Analysis of the Plant Protection Product ................... 3

IIIA 5.3 Description of Analytical Methods for the Determination of Residues ................................................................................................... 3

IIIA 5.4 Other/Special Studies .............................................................................. 3

Appendix 1 – List of data submitted in support of the evaluation ..................... 4

Part B Section 2

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Goltix Gold


Page 3 of 4


IIIA 5 METHODS OF ANALYSIS

This document summarises the information related to the analytical methods for the product Goltix Titan

(AQMM1-565 SC) containing the active substances metamitron and quinmerac which were approved

according to Regulation (EC) No 1107/2009.

This product was not the representative formulation. The product has not been previously evaluated

according to Uniform Principles.

Where appropriate this document refers to the conclusions of the EU review of metamitron and

quinmerac. This will be where:

• the active substance data are relied upon in the risk assessment of the formulation; or when

• the EU review concluded that additional data/information should be considered at national re-

registration.

The SANCO report for Metamitron (SANCO/208/08 final – 6 Januar 2009) and Quinmerac

(SANCO/12192/2010 final – 7 December 2010) are considered to provide the relevant review

information or a reference to where such information can be found.

This Part B document only reviews data (Annex II or Annex III) and additional information that has not

previously been considered within the EU review process, as part of the Annex I inclusion decision.

The Annex I Inclusion Directive for Metamitron (2008/125/EC) and Quinmerac (2010/89/EU) provides

specific provisions under Part B which need to be considered by the applicant in the preparation of their

submission and by the MS prior to granting an authorisation.

However, these provisions do not pertain the methods of analysis of the active ingredients and the

authorization of the product AG-QMM1-565 SC.

Appendix 1 of this document contains the list of references included in this document for support of the

evaluation.

Information on the detailed composition of AG-QMM1-565 SC can be found in the confidential dossier

of this submission (Registration Report - Part C).

IIIA 5.1 Analytical Standards and Samples

There is no change compared to the main application. Therefore, no further evaluation is necessary.

IIIA 5.2 Methods for the Analysis of the Plant Protection Product


IIIA 5.3 Description of Analytical Methods for the Determination of Residues



None

Part B Section 2

Core Assessment –

Germany

AG-QMM1-565 SC

Goltix Gold


Page 4 of 4


Appendix 1 – List of data submitted in support of the evaluation

Annex

point

OECD

Author Year Title


company)

Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

Data

protection

claimed

Yes/No

Owner

- - - - - -

GOLTIX TITAN – ZV1 007529-00/01

Part B – Section 3 - Core Assessment

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REGISTRATION REPORT

Part B

Section 3: Mammalian Toxicology


Product name/code: GOLTIX TITAN

Active Substances: Metamitron (525 g/L)

Quinmerac (40 g/L)

Central Zone


CORE ASSESSMENT


Date: April 2016



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Table of Contents

3 Mammalian Toxicology (IIIA 7) ................................................................. 3

3.1 Summary ......................................................................................................... 3

3.2 Toxicological Information on Active Substances........................................... 5

3.3 Toxicological Evaluation of Plant Protection Product ................................... 5

3.4 Toxicological evaluation of groundwater metabolites ................................... 5

3.5 Dermal Absorption (IIIA 7.6) ......................................................................... 5

3.5.1 Justification for proposed values - metamitron .............................................. 6

3.5.2 Justification for proposed values - quinmerac ................................................ 6

3.6 Exposure Assessment of Plant Protection Product ......................................... 6

3.6.1 Selection of critical use and justification ........................................................ 7

3.6.2 Operator exposure (IIIA 7.3) .......................................................................... 7

3.6.2.1 Estimation of operator exposure ..................................................................... 7

3.6.2.2 Measurement of operator exposure ................................................................ 8

3.6.3 Worker exposure (IIIA 7.5) ............................................................................ 8

3.6.3.1 Estimation of worker exposure ....................................................................... 8

3.6.3.2 Measurement of worker exposure .................................................................. 8

3.6.4 Bystander and resident exposure (IIIA 7.4) .................................................... 8

3.6.4.1 Estimation of bystander and resident exposure .............................................. 8

3.6.4.2 Measurement of bystander and/or resident exposure ..................................... 9

3.6.5 Statement on combined exposure ................................................................... 9

Appendix 1 Exposure calculations ................................................................................. 10

A 1.1 Operator exposure calculations (IIIA1 7.3.1) ............................................... 10

A 1.1.1 Calculations for metamitron ......................................................................... 10

A 1.1.2 Calculations for quinmerac ........................................................................... 13

A 1.2 Worker exposure calculations (IIIA1 7.5.1) ................................................. 17



A 1.3 Bystander and resident exposure calculations (IIIA1 7.4.1)......................... 18





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3 Mammalian Toxicology (IIIA 7)

3.1 Summary

Table 3.1-1: Information on Goltix Titan/AG-QMM1-565 SC *

Product name and code Goltix Titan/AG-QMM1-565 SC (ADD-02122-H-0-SC)

Formulation type Suspension concentrate

Active substances (incl. content) Metamitron; 525 g/L

Quinmerac; 40 g/L

Function Herbicide

Product already evaluated as the ‘representative

formulation’ during the Annex I inclusion

No

Toxicity and other GAPs for this product previously

evaluated according to Uniform Principles

Yes, in Germany

* Information on the detailed composition of Goltix Titan/AG-QMM1-565 SC can be found in the

confidential Part C of the RR (main application).

Justified proposals for classification and labelling

In accordance to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of

the Council of 16 December 2008 the following classification and labelling with regard to toxicological

data is proposed for the preparation:

Table 3.1-2: Justified proposals for classification and labelling

C&L according to Regulation (EC) No 1272/2008

Hazard classes, categories: None

Signal word: None

Hazard statements: None

Precautionary statements: None

Additional labelling phrases: To avoid risks to human health and the environment, comply with the instructions

for use. [EUH401]

'Contains 1,2-Benzisothiazol-3-(2H)-one (CAS No. 2634-33-5). May produce an

allergic reaction.' [EUH208] *

* This phrase is necessary due to the concentration of this compound (> 0.005 %) in the formulation according to Regulation

(EC) No 286/2011 in conjunction with Regulation (EC) No 1272/2008

Table 3.1-3: Summary of risk assessment for operators, workers, bystanders and residents

for Goltix Titan/AG-QMM1-565 SC

Result PPE / Risk mitigation measures

Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to

health damage. [SB001]

- If medical advice is needed, have product container or label at hand.

[SB005]

- Keep out of children's reach. [SB010]

- The directive concerning requirements for personal protective gear in

plant protection, "Personal protective gear for handling plant protection



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products" of the Federal Office

of Consumer Protection and Food Safety must be observed. [SB110]

- Do not eat, drink or smoke when using this product. [SB166]

- When applying the product with tractor-mounted, trailed or self-

propelled application equipment, only vehicles with closed pressurized

cabins (e.g. cabin category 3, if no respiratory protective equipment or

particle-filtering masks are necessary or category 4, if gas-tight

respiratory protective equipment is needed acc. to EN 15695-1 and -2)

are suited to replace personal protective equipment during application.

During all other activities outside of the cabin the prescribed personal

protective equipment must be worn. In order to avoid contamination of

the cabin, it is not permitted to enter the cabin with contaminated

personal protective equipment (it should be deposited e.g. in an

appropriate storage facility). Contaminated gloves should be washed

before removing the gloves and hands should be washed before entering

the cabin with pure water, respectively. [SB199]

- Wear standard protective gloves (plant protection) when handling the

undiluted product. [SS110]

- Wear standard protective gloves (plant protection) when

handling/applying the product ready for application. [SS120]

- Wear a protective suit against pesticides and sturdy shoes (e.g. rubber

boots) when handling the undiluted product. [SS2101]

- Wear a protective suit against pesticides and sturdy shoes (e.g. rubber

boots) when applying/handling the product ready for application.

[SS2202]

Workers Acceptable - Re-entering the treated area(s)/crop(s) is only possible on the day of

application wearing personal protective equipment which is specified for

applying the particular product. Successive work on/in treated

areas/crops may fundamentally not be carried out until 24 hours after

applying the product. Within the first 48 hours, protective suits against

pesticides and standard protective gloves (plant protection) are to be

worn. [SF1891]

Bystanders Acceptable None

Residents Acceptable None

The risk assessment according to the German model has shown that the estimated exposure towards

metamitron and quinmerac in Goltix Titan/AG-QMM1-565 SC within this extended application will not

exceed the particular systemic AOEL for operators, workers, bystanders and residents. Operator and

worker exposure will be below the systemic AOEL only, if prescribed PPE is worn.


metamitron and quinmerac in Goltix Titan/AG-QMM1-565 SC within this extended application will

exceed the particular systemic AOEL for operators even if PPE is worn.

Further reduction of exposure is to be expected due to necessary PPE allocated according to dangerous

substances regulations.

A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and

bystanders/residents is presented in Table 3.1-4.



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Table 3.1-4: Critical uses and overall conclusion of exposure assessment

1 2 3 4 5 6 7 8

Crops 1) and

situation

(e.g. growth

stage of crop)

F/G

or I 2)

Application Application rate Remarks:

(e.g. surfactant (L /ha))

critical gap for operator,

worker, bystander or

resident exposure based

on [Exposure model]

Acceptability of

exposure

assessment

Method / Kind

(incl.

application

technique 3))

Max. number

(min. interval

between

applications)

a) per use

b) per crop/

season

kg as/ha

a) max. rate per

appl.

b) max. total rate

per crop/season

Water

L/ha

min / max

Op

era

tor

Wo

rker

By

sta

nd

er

Res

iden

ts

Sugar and

fodder beet

(BBCH 00-19),

1st application

pre-emergence,

2nd to 4th appli-

cation post-

emergence

F Spraying,

splitting: 4

applications;

LCTM

a) 4

b) 4

(2nd to 4th

application:

5-10 days)

a) Metamitron:

1st: 1.575 kg/ha

2nd: 0.525 kg/ha

3rd: 0.525 kg/ha

4th: 0.525 kg/ha

Quinmerac:

1st: 0.120 kg/ha

2nd: 0.040 kg/ha

3rd: 0.040 kg/ha

4th: 0.040 kg/ha

b) Metamitron:

3.150 kg/ha

Quinmerac:

0.240 kg/ha

200 - 400 German model

UK POEM

Exposure acceptable without PPE / risk mitigation measures

Further refinement and/or risk mitigation measures required

Exposure not acceptable/ Evaluation not possible 1) Pooled critical GAPS with the same max. application rate per application and using the same application technique 2) F: field or outdoor application, G: greenhouse application, I: indoor application 3) LC: low crops, TM: tractor-mounted

3.2 Toxicological Information on Active Substances

For the toxicological information on the active substances quinmerac and metamitron it is referred to the

RR in the context of the main application.

3.3 Toxicological Evaluation of Plant Protection Product

For the toxicological evaluation for Goltix Titan/AG-QMM1-565 SC it is referred to the RR in the

context of the main application. The resulting classification and labelling for Goltix Titan/AG-QMM1-

565 SC is given above in Table 3.1-2.

3.4 Toxicological evaluation of groundwater metabolites

The quinmerac metabolites BH 518-2 and BH 518-5 are predicted to occur in groundwater in

concentrations above 0.1 µg/L. The toxicological relevance assessment of these groundwater metabolites

according to the EC guidance document SANCO/221/2000 –rev.10 is presented in Section 8 of the dRR.

3.5 Dermal Absorption (IIIA 7.6)

A summary of the dermal absorption endpoints for the active substances in Goltix Titan/AG-QMM1-565

SC is presented in Table 3.5-1.



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Table 3.5-1: Dermal absorption endpoints used for the risk assessment for active

substances in Goltix Titan/AG-QMM1-565 SC

Metamitron Quinmerac

Value Reference Value Reference

Concentrate 1 % EFSA Conclusion for

Goltix SC 700

75 % Default according to EFSA

Guidance on Dermal

Absorption, EFSA Journal

2012; 10(4): 2665

Dilution

(1 : 400)

20 % EFSA Conclusion for

Goltix SC 700

75 % Default according to EFSA

Guidance on Dermal

Absorption, EFSA Journal

2012; 10(4): 2665

3.5.1 Justification for proposed values - metamitron

Proposed endpoints for metamitron are based on dermal absorption studies with the very similar

formulation Goltix 700 SC containing 700 g/L metamitron. The studies were summarised in the EFSA

conclusion on metamitron (EFSA Scientific Report (2008) 185, 1-95, ASB2012-3584). Goltix 700 SC, in

comparison to Goltix Titan, contains the same or similar co-formulants in similar amounts. It is noted that

the highest tested dilution in the studies was 1:200 (3.5 g/L metamitron) whereas the highest dilution for

this use is 1:400 (1.3 g/L).

Since the studies have already been assessed and accepted at EU level no summaries are provided.

3.5.2 Justification for proposed values - quinmerac

Since the composition of the product tested in the dermal absorption study submitted for the main

application of Goltix Titan, i.e. an SC formulation containing 125 g/L quinmerac and 375 g/L

metazachlor (Fuego Top, 007459-00), cannot be considered comparable to Goltix Titan according to the

criteria by EFSA Guidance on Dermal Absorption (content of co-formulants exceeds ± 25 % w/w of that

in the reference formulation), the results of this study (ASB2011-9378) cannot be used for this risk

assessment. Therefore, default values are taken into account for the risk assessment within this extended

authorisation. Thus, 75 % dermal absorption have to be considered for the concentrate (< 5 % w/w of

active substance in the product) as well as for the dilution.

In contrast to the present evaluation, bridging of the submitted dermal absorption study on Fuego Top was

accepted for the risk assessment during the main application procedure, because this was carried out prior

to implementation of the criteria laid down in the EFSA Guidance on Dermal Absorption.

3.6 Exposure Assessment of Plant Protection Product

Table 3.6-1: Product information and toxicological reference values used for exposure

assessment

Product name and code Goltix Titan/AG-QMM1-565 SC (ADD-02122-H-0-SC)

Formulation type Suspension concentrate

Category Herbicide

Container sizes, short

description

Bottles (1 L) and canisters (5-20 L), HDPE, openings 46-67.2 mm

Active substance(s)

(incl. content) Metamitron

525 g/L Quinmerac

40 g/L

AOEL systemic 0.036 mg/kg bw/d 0.08 mg/kg bw/d

Inhalative absorption 100 % 100 %

Oral absorption 100 % 100 %



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Dermal absorption Concentrate: 1 %

Dilution: 20 % (tested: 3.5 g/L)

Goltix SC 700

Concentrate: 75 % (active substance <

5 % w/w in the product)

Dilution: 75 % (active substance < 5 %

w/w in the spray dilution)

Both values defaults

3.6.1 Selection of critical use and justification

The critical GAP used for the exposure assessment within the scope of this approval extension for the

plant protection product is shown in Table 3.1-4.

3.6.2 Operator exposure (IIIA 7.3)

3.6.2.1 Estimation of operator exposure

A summary of the exposure models used for estimation of operator exposure to the active substances

during application of Goltix Titan/AG-QMM1-565 SC according to the critical use presented in Table

3.6-2. Outcome of the estimation is presented in Table 3.6-3. Detailed calculations are in Appendix 1.

Table 3.6-2: Exposure models for intended uses

Critical use Sugar and fodder beets (max. 3 L product/ha)

Model German model

[Uniform Principles for Safeguarding the Health of Applicators of Plant Protection

Products (Uniform Principles for Operator Protection), Mitteilungen aus der

Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277,

1992]

Critical use Sugar and fodder beets (max. 3 L product/ha)

Model Revised UK-POEM

[Estimation of Exposure and Absorption of Pesticides by Spray Operators, Scientific

subcommittee on Pesticides and British Agrochemical Association Joint Medical Panel

Report (UK MAFF), 1986 and the Predictive Operator Exposure Model (POEM) V 1.0,

(UK MAFF), 1992]

Table 3.6-3: Estimated operator exposure


Model data Level of PPE Total

absorbed dose

(mg/kg/day)

% of

systemic

AOEL

Total absorbed

dose

(mg/kg/day)

% of

systemic

AOEL

Tractor mounted boom spray application outdoors to low crops

Application rate: 1.575 kg a.s./ha

0.120 kg a.s./ha

German Model Body weight: 70 kg

no PPE1) 0.195120 542.0 0.114226 142.8

+ Gloves mixing/loading

and application as well as

protective suit

application)

0.013770 38.3 0.004370 5.5

UK POEM

Application volume:

200 L/ha

Container: 10 L,

63 mm closure

Body weight: 60 kg

no PPE2) 1.164188 3233.9 0.687225 859.0

+ Gloves mixing/loading

and application 0.180469 501.3 0.067725 84.7

1) no PPE: Operator wearing T-shirt and shorts 2) no PPE: Operator wearing long sleeved shirt, long trousers (“permeable”) but no gloves



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3.6.2.2 Measurement of operator exposure

Since the operator exposure estimations carried out according to the German model indicated that the

acceptable operator exposure level (AOEL) will not be exceeded under conditions of intended uses, a

study to provide measurements of operator exposure was not necessary and was therefore not performed.

3.6.3 Worker exposure (IIIA 7.5)

3.6.3.1 Estimation of worker exposure

Table 3.6-4 shows the exposure model used for estimation of worker exposure after entry into a

previously treated area or handling a crop treated with Goltix Titan/AG-QMM1-565 SC according to the

critical use. Outcome of the estimation is presented in Table 3.6-5. Detailed calculations are in

Appendix 1.


Critical use Sugar and fodder beets (max. 6 L product/ha and year *), ‘worst case’

Model German re-entry model, Krebs et al. (2000)

[Uniform Principles for Safeguarding the Health of Workers Re-entering Crop

Growing Areas after Application of Plant Protection Products, Nachrichtenbl. Deut.

Pflanzenschutzdienst., 52(1), p. 5-9]

* maximum application rate in theses crops per year irrespective of number of applications

Table 3.6-5: Estimated worker exposure


Model data Level of PPE Total absorbed

dose

(mg/kg/day)

% of systemic

AOEL

Total absorbed

dose

(mg/kg/day)

% of systemic

AOEL

Max. application rate per year: 3.150 kg a.s./ha 0.240 kg a.s./ha

2 hours/day 1),

TC: 2500 cm2/person/h 2)

Body weight: 60 kg

no PPE 3) 0.052500 145.8 0.015000 18.8

with PPE 4) 0.002625 7.3 0.000750 0.9

1) 2 h/day for professional applications for maintenance, inspection or irrigation activities etc. 2) US-EPA policy paper [EPA, Science Advisory Council for Exposure; 2000; Agricultural Default Transfer Coefficients,

Policy # 003.1, May 7 1998 revised 7 August 2000]. 3) no PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves 4) with PPE: see 'Instructions for use'

3.6.3.2 Measurement of worker exposure

Since the worker exposure estimations carried out indicated that the acceptable operator exposure level

(AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of

worker exposure was not necessary and was therefore not performed.

3.6.4 Bystander and resident exposure (IIIA 7.4)

3.6.4.1 Estimation of bystander and resident exposure

Table 3.6-6 shows the exposure model used for estimation of bystander and resident exposure to

metamitron and quinmerac. Outcome of the estimation is presented in Table 3.6-7. Detailed calculations

are in Appendix 1.



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Critical use Sugar and fodder beets (max. 3 L product/ha (bystander) or 6 L product/ha and year,

‘worst case’, with 4 applications * (resident), respectively)

Model Martin, S. et al. (2008) [Guidance for Exposure and Risk Evaluation for Bystanders and

Residents Exposed to Plant Protection Products During and After Application; J. Verbr.

Lebensm. 3 (2008): 272-281 Birkhäuser Verlag Basel] and Bundesanzeiger (BAnz), 06

January 2012, Issue No. 4, pp. 75-76

* maximum application rate in theses crops per year irrespective of number of applications

Table 3.6-7: Estimated bystander and resident exposure


Model data Total absorbed

dose (mg/kg/day)

% of systemic

AOEL

Total absorbed

dose (mg/kg/day)

% of systemic

AOEL



0.120 kg a.s./ha

Bystanders (adult)

Drift rate: 2.77 % (1 m)

Body weight: 60 kg

0.014550 40.4 0.004156 5.2

Bystanders (children)

Drift rate: 2.77 % (1 m)

Body weight: 16.15 kg

0.011361 31.6 0.003243 4.1



0.240 kg a.s./ha

Residents (adult)

Drift rate: 1.85 % *(1 m)

Body weight: 60 kg

0.001418 3.9 0.000405 0.5

Residents (children)

Drift rate: 1.85 % *(1 m)

Body weight: 16.15 kg

0.002778 7.7 0.000605 0.8

* for 4 applications

3.6.4.2 Measurement of bystander and/or resident exposure

Since the bystander and/or resident exposure estimations carried out indicated that the acceptable operator

exposure level (AOEL) for metamitron and quinmerac will not be exceeded under conditions of intended

uses, a study to provide measurements of bystander/resident exposure was not necessary and was

therefore not performed.

3.6.5 Statement on combined exposure

The product is a mixture of two active substances.

From a scientific point of view it is regarded necessary to take into account potential combination effects.

However, the evaluation of cumulative or synergistic effects as requested by §4 (3b) of Regulation (EC)

No. 1107/2009 should only be performed, if harmonised scientific methods accepted by the authorities

are available.

The combined toxicological effect of metamitron and quinmerac has not been investigated with regard to

repeated dose toxicity.



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Appendix 1 Exposure calculations

A 1.1 Operator exposure calculations (IIIA1 7.3.1)

A 1.1.1 Calculations for metamitron

Table A 1: Input parameters considered for the estimation of operator exposure

Formulation type: SC Application technique:

Field Crop Tractor

Mounted (FCTM) Application rate (AR): 1.575 kg a.s./ha

Area treated per day (A): 20 ha Dermal hands m/l (DM(H)): 2.4 mg/person/kg a.s.

Dermal absorption (DA): 1 % (concentr.) Dermal hands appl. (DA(H)): 0.38 mg/person/kg a.s.

20 % (dilution) Dermal body appl. (DA(B)): 1.6 mg/person/kg a.s.

Inhalation absorption (IA): 100 % Dermal head appl. (DA(C)): 0.06 mg/person/kg a.s.

Body weight (BW): 70 kg/person Inhalation m/l (IM): 0.0006 mg/person/kg a.s.

AOEL 0.036 mg/kg bw/d Inhalation appl. (IA): 0.001 mg/person/kg a.s.

Table A 2: Estimation of operator exposure towards metamitron using the German

model

Without PPE With PPE

Operators: Systemic dermal exposure after application in sugar and fodder beets

Dermal exposure during mixing/loading

Hands Hands

SDEOM(H) = (DM(H) x AR x A x DA) / BW SDEOM(H) = (DM(H) x AR x A x PPE 1) x DA) / BW

(2.4 x 1.575 x 20 x 1%) / 70 (2.4 x 1.575 x 20 x 0.01 x 1%) / 70

External dermal

exposure 75.6 mg/person

External dermal


External dermal

exposure 1.08 mg/kg bw/d

External dermal


Systemic dermal


Systemic dermal


Dermal exposure during application

Hands Hands

SDEOA(H) = (DA(H) x AR x A x DA) / BW SDEOA(H) = (DA(H) x AR x A x PPE x DA) / BW

(0.38 x 1.575 x 20 x 20%) / 70 (0.38 x 1.575 x 20 x 0.01 x 20%) / 70

External dermal


External dermal


External dermal


External dermal


Systemic dermal


Systemic dermal


Body Body

SDEOA(B) = (DA(B) x AR x A x DA) / BW SDEOA(B) = (DA(B) x AR x A x PPE 2) x DA) / BW

(1.6 x 1.575 x 20 x 20%) / 70 (1.6 x 1.575 x 20 x 0.05 x 20%) / 70

External dermal


External dermal


External dermal


External dermal


Systemic dermal


Systemic dermal


Head Head

SDEOA(C) = (DA(C) x AR x A x DA) / BW SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW

(0.06 x 1.575 x 20 x 20%) / 70 (0.06 x 1.575 x 20 x 1 x 20%) / 70

External dermal


External dermal


External dermal 0.027 mg/kg bw/d External dermal 0.027 mg/kg bw/d



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exposure exposure

Systemic dermal


Systemic dermal


Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H)

+ SDEOA(B) + SDEOA(C)



Total external dermal








Total systemic

dermal exposure 0.1944 mg/kg bw/d

Total systemic


Operators: Systemic inhalation exposure after application in sugar and fodder beets

Inhalation exposure during mixing/loading

SIEOM = (IM x AR x A x IA) / BW SIEOM = (IM x AR x A x PPE x IA) / BW

(0.0006 x 1.575 x 20 x 100%) / 70 (0.0006 x 1.575 x 20 x 1 x 100%) / 70

External inhalation


External inhalation


External inhalation


External inhalation


Systemic inhalation


Systemic inhalation


Inhalation exposure during application

SIEOA = (IA x AR x A x IA) / BW SIEOA = (IA x AR x A x PPE x IA) / BW

(0.001 x 1.575 x 20 x 100%) / 70 (0.001 x 1.575 x 20 x 1 x 100%) / 70

External inhalation


External inhalation


External inhalation


External inhalation


Systemic inhalation


Systemic inhalation


Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total systemic inhalation exposure: SIEO = SIEOM + SIEOA

Total external

inhalation exposure 0.0504 mg/person

Total external


Total external

inhalation exposure 0.00072 mg/kg bw/d

Total external


Total systemic


Total systemic


Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure: SEO = SDEO + SIEO

Total systemic


Total systemic


Total systemic


Total systemic


% of AOEL 542.0 % % of AOEL 38.3 % 1) reduction factor for gloves is 0.01 (professional appl.) 2) reduction factor for protective garment is 0.05 (professional appl.)

Table A 3: Estimation of operator exposure towards metamitron using the UK POEM

Without PPE

Active substance Metamitron

Product Goltix Titan (AG-QMM1-565 SC)

Formulation type water-based

Concentration of a.s. 525 mg/mL

Dose 3 L preparation/ha (1.575 kg a.s./ha)

Application volume 200 L/ha

Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles

Container 10 litres 63 mm closure

Work rate/day 50 ha

Duration of spraying 6 h

PPE during mix./loading None



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PPE during application None

Dermal absorption from product 1 %

Dermal absorption from spray 20 %

EXPOSURE DURING MIXING AND LOADING

Container size 10 Litres

Hand contamination/operation 0,05 mL

Application dose 3 Litres product/ha

Work rate 50 ha/day

Number of operations 15 /day

Hand contamination 0.75 mL/day

Protective clothing None

Transmission to skin 100 %

Dermal exposure to formulation 0.75 mL/day

DERMAL EXPOSURE DURING SPRAY APPLICATION

Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles

Application volume 200 spray/ha

Volume of surface contamination 10 mL/h

Distribution Hands Trunk Legs

65% 10% 25%

Clothing None Permeable Permeable

Penetration 100% 5% 15%

Dermal exposure 6.5 0.05 0.375 mL/h

Duration of exposure 6 h

Total dermal exposure to spray 41.55 mL/day

ABSORBED DERMAL DOSE

Mix/load

Application

Dermal exposure 0.75 mL/day 41.55 mL/day

Concen. of a.s. product or spray 525 mg/mL 7.875 mg/mL

Dermal exposure to a.s. 393.75 mg/day 327.20625 mg/day

Percent absorbed 1 % 20 %

Absorbed dose 3.9375 mg/day 65.44125 mg/day

INHALATION EXPOSURE DURING SPRAYING

Inhalation exposure 0.01 mL/h


Concentration of a.s. in spray 7.875 mg/mL

Inhalation exposure to a.s. 0.4725 mg/day

Percent absorbed 100 %

Absorbed dose 0.4725 mg/day

PREDICTED EXPOSURE

Total absorbed dose 69.85125 mg/day

Operator body weight 60 kg

Operator exposure 1.164188 mg/kg bw/day

Amount of AOEL 3233.9 %

With PPE









Work rate/day 50 ha


PPE during mix./loading Gloves

PPE during application Gloves





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Work rate 50 ha/day



Protective clothing Gloves








65% 10% 25%

Clothing Gloves Permeable Permeable






Mix/load

Application













PREDICTED EXPOSURE





A 1.1.2 Calculations for quinmerac

Table A 4: Input parameters considered for the estimation of operator exposure

Formulation type: SC Application technique:

Field Crop Tractor

Mounted (FCTM) Application rate (AR): 0.12 kg a.s./ha

Area treated per day (A): 20 ha Dermal hands m/l (DM(H)): 2.4 mg/person/kg a.s.

Dermal absorption (DA): 75 % (concentr.) Dermal hands appl. (DA(H)): 0.38 mg/person/kg a.s.

75 % (dilution) Dermal body appl. (DA(B)): 1.6 mg/person/kg a.s.

Inhalation absorption (IA): 100 % Dermal head appl. (DA(C)): 0.06 mg/person/kg a.s.

Body weight (BW): 70 kg/person Inhalation m/l (IM): 0.0006 mg/person/kg a.s.

AOEL 0.08 mg/kg bw/d Inhalation appl. (IA): 0.001 mg/person/kg a.s.



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Table A 5: Estimation of operator exposure towards quinmerac using the German model

Without PPE With PPE

Operators: Systemic dermal exposure after application in sugar and fodder beets

Dermal exposure during mixing/loading

Hands Hands

SDEOM(H) = (DM(H) x AR x A x DA) / BW SDEOM(H) = (DM(H) x AR x A x PPE 1) x DA) / BW

(2.4 x 0.12 x 20 x 75%) / 70 (2.4 x 0.12 x 20 x 0.01 x 75%) / 70

External dermal


External dermal


External dermal


External dermal


Systemic dermal


Systemic dermal


Dermal exposure during application

Hands Hands

SDEOA(H) = (DA(H) x AR x A x DA) / BW SDEOA(H) = (DA(H) x AR x A x PPE x DA) / BW

(0.38 x 0.12 x 20 x 75%) / 70 (0.38 x 0.12 x 20 x 0.01 x 75%) / 70

External dermal


External dermal


External dermal


External dermal


Systemic dermal


Systemic dermal


Body Body

SDEOA(B) = (DA(B) x AR x A x DA) / BW SDEOA(B) = (DA(B) x AR x A x PPE 2) x DA) / BW

(1.6 x 0.12 x 20 x 75%) / 70 (1.6 x 0.12 x 20 x 0.05 x 75%) / 70

External dermal


External dermal


External dermal


External dermal


Systemic dermal


Systemic dermal


Head Head

SDEOA(C) = (DA(C) x AR x A x DA) / BW SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW

(0.06 x 0.12 x 20 x 75%) / 70 (0.06 x 0.12 x 20 x 1 x 75%) / 70

External dermal


External dermal


External dermal


External dermal


Systemic dermal


Systemic dermal














Total systemic


Total systemic


Operators: Systemic inhalation exposure after application in Sugar and fodder beets

Inhalation exposure during mixing/loading

SIEOM = (IM x AR x A x IA) / BW SIEOM = (IM x AR x A x PPE x IA) / BW

(0.0006 x 0.12 x 20 x 100%) / 70 (0.0006 x 0.12 x 20 x 1 x 100%) / 70

External inhalation


External inhalation


External inhalation


External inhalation




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Systemic inhalation


Systemic inhalation


Inhalation exposure during application

SIEOA = (IA x AR x A x IA) / BW SIEOA = (IA x AR x A x PPE x IA) / BW

(0.001 x 0.12 x 20 x 100%) / 70 (0.001 x 0.12 x 20 x 1 x 100%) / 70

External inhalation


External inhalation


External inhalation


External inhalation


Systemic inhalation


Systemic inhalation


Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total systemic inhalation exposure: SIEO = SIEOM + SIEOA

Total external


Total external


Total external


Total external


Total systemic


Total systemic


Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure: SEO = SDEO + SIEO

Total systemic


Total systemic


Total systemic


Total systemic


% of AOEL 142.8 % % of AOEL 5.5 % 1) reduction factor for gloves is 0.01 (professional appl.) 2) reduction factor for protective garment is 0.05 (professional appl.)

Table A 6: Estimation of operator exposure towards quinmerac using the UK POEM

Without PPE

Active substance Quinmerac








Work rate/day 50 ha


PPE during mix./loading None

PPE during application None







Work rate 50 ha/day



Protective clothing None










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65% 10% 25%

Clothing None Permeable Permeable






Mix/load

Application



Dermal exposure to a.s. 30 mg/day 24.93 mg/day










PREDICTED EXPOSURE





With PPE

Active substance Quinmerac








Work rate/day 50 ha


PPE during mix./loading Gloves

PPE during application Gloves







Work rate 50 ha/day



Protective clothing Gloves








65% 10% 25%

Clothing Gloves Permeable Permeable




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Mix/load

Application













PREDICTED EXPOSURE





A 1.2 Worker exposure calculations (IIIA1 7.5.1)


Table A 7: Input parameters considered for the estimation of worker exposure

Intended use(s): Sugar and fodder beets Dislodgeable foliar

residues (DFR): 1 µg/cm2/kg a.s.

Application rate (AR): 3.15 kg a.s./ha 1) Transfer coefficient (TC): 2500 cm2/person/h

Number of applications (NA): 1 see explanation below Work rate per day (WR): 2 h/d

Body weight (BW): 60 kg/person PPE 5 %

Dermal absorption (DA): 20 % ('worst case')

AOEL 0.036 mg/kg bw/d 1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), ‘worst case’

Table A 8: Estimation of worker exposure towards metamitron using the German re-

entry model

Without PPE 1) With PPE 2)

Worker (re-entry): Systemic dermal exposure after application in sugar and fodder beets

SDEW = (DFR x TC x WR x AR x NA x DA) / BW SDEW = (DFR x TC x WR x AR x NA x PPE x DA) / BW

(1 x 2500 x 2 x 3.15 x 1 x 20%) / 60 (1 x 2500 x 2 x 3.15 x 1 x 5% x 20%) / 60

External dermal exposure 15.75 mg/person External dermal exposure 0.7875 mg/person

External dermal exposure 0.2625 mg/kg bw/d External dermal exposure 0.013125 mg/kg bw/d

Total systemic exposure 3.15 mg/person Total systemic exposure 0.1575 mg/person

Total systemic exposure 0.0525 mg/kg bw/d Total systemic exposure 0.002625 mg/kg bw/d

% of AOEL 145.8 % % of AOEL 7.3 % 1) acceptable without PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves 2) acceptable only with PPE: see 'Instructions for use'



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Table A 9: Input parameters considered for the estimation of worker exposure

Intended use(s): Sugar and fodder beets Dislodgeable foliar

residues (DFR): 1 µg/cm2/kg a.s.

Application rate (AR): 0.24 kg a.s./ha 1) Transfer coefficient (TC): 2500 cm2/person/h

Number of applications (NA): 1 see explanation below Work rate per day (WR): 2 h/d

Body weight (BW): 60 kg/person PPE 5 %

Dermal absorption (DA): 75 % ('worst case')

AOEL 0.08 mg/kg bw/d 1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), ‘worst case’

Table A 10: Estimation of worker exposure towards quinmerac using the German re-entry

model

Without PPE 1) With PPE 2)

Worker (re-entry): Systemic dermal exposure after application in sugar and fodder beets

SDEW = (DFR x TC x WR x AR x NA x DA) / BW SDEW = (DFR x TC x WR x AR x NA x PPE x DA) / BW

(1 x 2500 x 2 x 0.24 x 1 x 75%) / 60 (1 x 2500 x 2 x 0.24 x 1 x 5% x 75%) / 60

External dermal exposure 1.2 mg/person External dermal exposure 0.06 mg/person

External dermal exposure 0.02 mg/kg bw/d External dermal exposure 0.001 mg/kg bw/d

Total systemic exposure 0.9 mg/person Total systemic exposure 0.045 mg/person

Total systemic exposure 0.015 mg/kg bw/d Total systemic exposure 0.00075 mg/kg bw/d

% of AOEL 18.8 % % of AOEL 0.9 % 1) acceptable without PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves 2) acceptable only with PPE: see 'Instructions for use'

A 1.3 Bystander and resident exposure calculations (IIIA1 7.4.1)


Table A 11: Input parameters considered for the estimation of bystander exposure

Intended use(s): Sugar and fodder beets Drift (D): 2.77 % (FC, 1 m)

Application rate (AR): 1.575kg a.s./ha Exposed body surface area

(BSA):

1 m² (adults)

157.5mg/m2 0.21 m² (children)

Body weight (BW):

60kg/person (adults) Specific Inhalation

Exposure (I*A):

0.001 mg/kg a.s. (6 hours,

adults)

16.15kg/person (children) 0.000575 mg/kg a.s. (6 hours,

children)

Dermal absorption (DA): 20% ('worst case') Area Treated (A): 20

ha/d (based on

FCTM) Inhalation absorption (IA): 100%

AOEL: 0.036mg/kg bw/d Exposure duration (T): 5 min

Table A 12: Estimation of bystander exposure towards metamitron

Adults Children

Bystander: Systemic dermal exposure during/after application in (via spray drift)

SDEB = (AR x D x BSA x DA) / BW SDEB = (AR x D x BSA x DA) / BW

(157.5 x 2.77% x 1 x 20%) / 60 (157.5 x 2.77% x 0.21 x 20%) / 16.15

External dermal


External dermal


External dermal


External dermal


Systemic dermal


Systemic dermal




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Bystander: Systemic inhalation exposure during/after application in Sugar and fodder beets (via spray drift)

SIEB = (I*A x AR x A x T x IA) / BW SIEB = (I*A x AR x A x T x IA) / BW

(0.001 / 360 x 1.575 x 20 x 5 x 100%) / 60 (0.000575 / 360 x 1.575 x 20 x 5 x 100%) / 16.15

External inhalation


External inhalation


External inhalation


External inhalation


Systemic inhalation


Systemic inhalation


Total systemic exposure: SEB = SDEB + SIEB Total systemic exposure: SEB = SDEB + SIEB

Total systemic


Total systemic


Total systemic


Total systemic


% of AOEL 40.4 % % of AOEL 31.6 %

Table A 13: Input parameters considered for the estimation of resident exposure

Intended use(s): Sugar and fodder beets Drift (D): 1.85 % (FC, 1 m, 4 appl.)

Application rate (AR): 3.15 kg a.s./ha 1) Transfer coefficient

(TC):

7300 cm2/h (adults)

0.0315 mg/cm2 2600 cm2/h (children)

Number of applications

(NA): 1 see explanation below

Turf Transferable

Residues (TTR): 5 %

Body weight (BW):

60 kg/person (adults) Exposure Duration (H): 2 h

16.15 kg/person (children) Airborne Concentration

of Vapour (ACV): 0

mg/m3

Dermal absorption (DA): 20 % ('worst case') Inhalation Rate (IR):

16.57 m3/d (adults)

Inhalation absorption (IA): 100 % 8.31 m3/d (children)

Oral absorption (OA): 100 % Saliva Extraction Factor

(SE): 50 %

AOEL: 0.036 mg/kg bw/d Surface Area of Hands

(SA): 20 cm2

Frequency of Hand to

Mouth (Freq): 20 events/h

Dislodgeable foliar

residues (DFR): 20 %

Ingestion Rate for

Mouthing of Grass/Day

(IgR):

25 cm2/d

1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), ‘worst case’

Table A 14: Estimation of resident exposure towards metamitron

Adults Children

Residents: Systemic dermal exposure after application in sugar and fodder beets (via deposits caused by spray drift)

SDER = (AR x NA x D x TTR x TC x H x DA) / BW SDER = (AR x NA x D x TTR x TC x H x DA) / BW

(0.0315 x 1 x 1.85% x 5% x 7300 x 2 x 20%) / 60 (0.0315 x 1 x 1.85% x 5% x 2600 x 2 x 20%) / 16.15

External dermal


External dermal


External dermal


External dermal


Systemic dermal


Systemic dermal


Residents: Systemic inhalation exposure after application in sugar and fodder beets (via vapour)

SIER = (ACV x IR x IA) / BW SIER = (ACV x IR x IA) / BW

(0 x 16.57 x 100%) / 60 (0 x 8.31 x 100%) / 16.15

External inhalation

exposure none

External inhalation

exposure none

Systemic inhalation

exposure none

Systemic inhalation

exposure none



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Residents: Systemic oral exposure (hand-to-mouth

transfer)

SOER(H) = (AR x NA x D x TTR x SE x SA x Freq x H x

OA) / BW

(0.0315 x 1 x % x 5% x 50% x 20 x 20 x 2 x 100%) / 16.15

External oral


External oral


Systemic oral


Residents: Systemic oral exposure (object-to-mouth

transfer)

SOER(O) = (AR x NA x D x DFR x IgR x OA) / BW

(0.0315 x 1 x % x 20% x 25 x 100%) / 16.15

External oral


External oral


Systemic oral


Total systemic exposure: SER = SDER + SIER Total systemic exposure: SER = SDER + SIER + SOER(H) +

SOER(O)

Total systemic


Total systemic


Total systemic


Total systemic


% of AOEL 3.9 % % of AOEL 7.7 %


Table A 15: Input parameters considered for the estimation of bystander exposure

Intended use(s): Sugar and fodder beets Drift (D): 2.77 % (FC, 1 m)

Application rate (AR): 0.12 kg a.s./ha Exposed body surface

area (BSA):

1 m² (adults)

12 mg/m2 0.21 m² (children)

Body weight (BW):

60 kg/person (adults) Specific Inhalation

Exposure (I*A):

0.001 mg/kg a.s. (6

hours, adults)

16.15 kg/person

(children) 0.000575

mg/kg a.s. (6

hours, children)

Dermal absorption (DA): 75 % ('worst case') Area Treated (A): 20

ha/d (based on

FCTM) Inhalation absorption (IA): 100 %

AOEL: 0.08 mg/kg bw/d Exposure duration (T): 5 min

Table A 16: Estimation of bystander exposure towards quinmerac

Adults Children

Bystander: Systemic dermal exposure during/after application in sugar and fodder beets (via spray drift)

SDEB = (AR x D x BSA x DA) / BW SDEB = (AR x D x BSA x DA) / BW

(12 x 2.77% x 1 x 75%) / 60 (12 x 2.77% x 0.21 x 75%) / 16.15

External dermal

exposure 0.3324 mg/person External dermal exposure 0.069804 mg/person

External dermal

exposure 0.00554 mg/kg bw/d External dermal exposure 0.004322 mg/kg bw/d

Systemic dermal


Systemic dermal


Bystander: Systemic inhalation exposure during/after application in sugar and fodder beets (via spray drift)

SIEB = (I*A x AR x A x T x IA) / BW SIEB = (I*A x AR x A x T x IA) / BW

(0.001 / 360 x 0.12 x 20 x 5 x 100%) / 60 (0.000575 / 360 x 0.12 x 20 x 5 x 100%) / 16.15



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External inhalation


External inhalation


External inhalation


External inhalation


Systemic inhalation


Systemic inhalation


Total systemic exposure: SEB = SDEB + SIEB Total systemic exposure: SEB = SDEB + SIEB

Total systemic

exposure 0.249333 mg/person Total systemic exposure 0.052372 mg/person

Total systemic

exposure 0.004156 mg/kg bw/d Total systemic exposure 0.003243 mg/kg bw/d

% of AOEL 5.2 % % of AOEL 4.1 %

Table A 17: Input parameters considered for the estimation of resident exposure

Intended use(s): Sugar and fodder beets Drift (D): 1.85 % (FC, 1 m, 4 appl.)

Application rate (AR): 0.24 kg a.s./ha 1) Transfer coefficient

(TC):

7300 cm2/h (adults)

0.0024 mg/cm2 2600 cm2/h (children)

Number of applications

(NA): 1 see explanation below

Turf Transferable

Residues (TTR): 5 %

Body weight (BW):

60 kg/person (adults) Exposure Duration (H): 2 h

16.15 kg/person (children) Airborne Concentration

of Vapour (ACV): 0

mg/m3

Dermal absorption (DA): 75 % ('worst case') Inhalation Rate (IR):

16.57 m3/d (adults)

Inhalation absorption (IA): 100 % 8.31 m3/d (children)

Oral absorption (OA): 100 % Saliva Extraction Factor

(SE): 50 %

AOEL: 0.08 mg/kg bw/d Surface Area of Hands

(SA): 20 cm2

Frequency of Hand to

Mouth (Freq): 20 events/h

Dislodgeable foliar

residues (DFR): 20 %

Ingestion Rate for

Mouthing of Grass/Day

(IgR):

25 cm2/d

1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), ‘worst case’

Table A 18: Estimation of resident exposure towards quinmerac

Adults Children

Residents: Systemic dermal exposure after application in sugar and fodder beets (via deposits caused by spray drift)

SDER = (AR x NA x D x TTR x TC x H x DA) / BW SDER = (AR x NA x D x TTR x TC x H x DA) / BW

(0.0024 x 1 x 1.85% x 5% x 7300 x 2 x 75%) / 60 (0.0024 x 1 x 1.85% x 5% x 2600 x 2 x 75%) / 16.15

External dermal

exposure 0.032412 mg/person External dermal exposure 0.011544 mg/person

External dermal

exposure 0.00054 mg/kg bw/d External dermal exposure 0.000715 mg/kg bw/d

Systemic dermal


Systemic dermal


Residents: Systemic inhalation exposure after application in sugar and fodder beets (via vapour)

SIER = (ACV x IR x IA) / BW SIER = (ACV x IR x IA) / BW

(0 x 16.57 x 100%) / 60 (0 x 8.31 x 100%) / 16.15

External inhalation

exposure none

External inhalation

exposure none

Systemic inhalation

exposure none

Systemic inhalation

exposure none

Residents: Systemic oral exposure (hand-to-mouth

transfer)



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SOER(H) = (AR x NA x D x TTR x SE x SA x Freq x H x

OA) / BW

(0.0024 x 1 x % x 5% x 50% x 20 x 20 x 2 x 100%) / 16.15

External oral exposure 0.000888 mg/person

External oral exposure 0.000055 mg/kg bw/d

Systemic oral exposure 0.000055 mg/kg bw/d

Residents: Systemic oral exposure (object-to-mouth

transfer)

SOER(O) = (AR x NA x D x DFR x IgR x OA) / BW

(0.0024 x 1 x % x 20% x 25 x 100%) / 16.15

External oral exposure 0.000222 mg/person

External oral exposure 0.000014 mg/kg bw/d

Systemic oral exposure 0.000014 mg/kg bw/d

Total systemic exposure: SER = SDER + SIER Total systemic exposure: SER = SDER + SIER + SOER(H) +

SOER(O)

Total systemic

exposure 0.024309 mg/person Total systemic exposure 0.009768 mg/person

Total systemic

exposure 0.000405 mg/kg bw/d Total systemic exposure 0.000605 mg/kg bw/d

% of AOEL 0.5 % % of AOEL 0.8 %



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DRAFT REGISTRATION REPORT

Part B

Section 4: Metabolism and Residues


Product name: GOLTIX TITAN

Active Substance: Metamitron (525 g/L)

Quinmerac (40 g/L)

Central Zone


CORE ASSESSMENT


Date: March 2015



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Table of Contents

4 METABOLISM AND RESIDUES DATA ................................................ 3

4.1 Evaluation of the active substances ............................................................... 3

4.2 Evaluation of the intended uses ..................................................................... 3

4.2.1 Selection of critical use and justification ....................................................... 3

4.2.2 Sugar/fodder beet ........................................................................................... 6

4.2.2.1 Residues in primary crops .............................................................................. 6

4.2.2.2 Distribution of the residue in peel/pulp ......................................................... 6

4.2.2.3 Residues in processed commodities............................................................... 7

4.2.2.4 Proposed pre-harvest intervals, withholding periods ..................................... 7

4.3 Consumer intake and risk assessment ............................................................ 7

4.3.1 Metamitron ..................................................................................................... 7

4.3.2 Quinmerac ...................................................................................................... 7

4.4 Proposed maximum residue levels (MRLs) ................................................... 8

4.5 Conclusion ..................................................................................................... 8

Appendix 1 Reference list ................................................................................................ 9

Appendix 2 Detailed evaluation of the additional studies relied upon ...................... 10

A 2.1 Storage stability ........................................................................................... 10

A 2.1.1 Storage stability of residues in plant products ............................................. 10

A 2.1.2 Storage stability of residues in animal products .......................................... 12

A 2.2 Residues in primary crops ............................................................................ 12

A 2.2.1 Nature of residues ........................................................................................ 12

A 2.2.2 Magnitude of residues in sugar beets ........................................................... 13

A 2.3 Residues in processed commodities............................................................. 23

A 2.4 Residues in rotational crops ......................................................................... 23

A 2.5 Residues in livestock.................................................................................... 23

A 2.6 Other studies/information ............................................................................ 23

Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) ...................................... 24



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4 METABOLISM AND RESIDUES DATA

4.1 Evaluation of the active substances

It is referred to the main application procedure of Goltix Titan®.

4.2 Evaluation of the intended uses

4.2.1 Selection of critical use and justification

The critical GAPs used for consumer intake and risk assessment are presented in Table 4.2-1.



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Table 4.2-1: Critical Uses (worst case) used for consumer intake and risk assessment

1 2 3 4 5 6 7 8 9 10 11 12 13

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

(a)

F

G

or

I

(b)

Pests or Group of

pests controlled

(additionally:

developmental

stages of the pest or

pest group)

(c)


(days)

(i)

Remarks:

e.g. safener/synergist

per ha

e.g. recommended or

mandatory tank

mixtures

(j)

Method /

Kind

(d-f)

Timing / Growth

stage of crop &

season

(g)

Max. number

(min. interval

between

applications)

a) per use

b) per crop/

season

(h)

L product / ha

a) max. rate

per appl.

b) max. total

rate per

crop/season

kg as/ha

a) max. rate per appl.

b) max. total rate per

crop/season

Water

L/ha

min /

max

1 DE Sugar beet, Fodder

beet

F Annual

monocotyledonous

weeds, Annual

dicotyledonous weeds

Spraying Spring,

BBCH 00-19

before emergence

(1st treatment),

after emergence

(2nd to 4th treatment)

a) 4

b) 4

2nd to 4th

treatment at

intervals of 5 to

10 days

a) timing 1: 3

timing 2: 1

timing 3: 1

timing 4: 1

b) 6

a) timing 1:

Metamitron: 1.58

Quinmerac: 0.12

timings 2-4:

Metamitron: 0.53

Quinmerac: 0.04

b) Metamitron: 3.15

Quinmerac: 0.24

200-400 F Total 6.0 L product/ha

2 NL, BE Sugar beet, Fodder

beet

F Annual


Spraying BBCH 10-19 a) 1-3 (5 days)

b) 3

a) 2

b) 6

a) Metamitron: 1.05

Quinmerac: 0.08

b) Metamitron: 3.15

Quinmerac: 0.24


3 NL, BE Sugar beet, Fodder

beet

F Annual


Spraying BBCH 00-09 a) 1

b) 1

a) 3

b) 3

a) Metamitron: 1.58

Quinmerac: 0.12

b) Metamitron: 1.58

Quinmerac: 0.12


(max. once per 3 years on

the same field)

BBCH 10-19 a) 1-3 (5 days)

b) 3

a) 1

b) 3

a) Metamitron: 0.53

Quinmerac: 0.04

b) Metamitron: 1.58

Quinmerac: 0.12

200-400 F



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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant,

the use situation should be described (e.g. fumigation of a structure)

(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)

(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds

(d) All abbreviations used must be explained

(e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting,

drench

(f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the

plants - type of equipment used must be indicated

(g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season

at time of application

(h) The minimum and maximum number of application possible under practical

conditions of use must be provided

(i) PHI - minimum pre-harvest interval

(j) Remarks may include: Extent of use/economic importance/restrictions



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4.2.2 Sugar/fodder beet

4.2.2.1 Residues in primary crops

The following tables are summarizing the results of the supervised residue trials selected for the

assessment of metamitron in sugar beet. For more details on those residue trials used in evaluating the

GAP, it is referred to Appendix 2.

Table 4.2-2: Overview of the selected supervised residue trials for metamitron

Commodity Region (a) Outdoor/

Indoor

Individual trial results (mg/kg) STMR

(mg/kg) (b)

HR

(mg/kg) (c)

Existing

MRL

(mg/kg)

Median

CF (d) Enforcement

(metamitron)

Risk assessment

(metamitron)

beet root NEU Outdoor 3 x <0.010; 4 x <0.050 3 x <0.010; 4 x <0.050 0.050 0.050 0.2 1

beet leaves

and tops

NEU Outdoor 3 x <0.010; 4 x <0.050 3 x <0.010; 4 x <0.050 0.050 0.050 0.2 1

(a): NEU, SEU, EU or Import (country code).

(b): Median value of the individual trial results according to the risk assessment residue definition.

(c): Highest value of the individual trial results according to the risk assessment residue definition.

(d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors

for each residues trial.

Table 4.2-3: Overview of the selected supervised residue trials for quinmerac

Commodity Region (a) Outdoor/

Indoor

Individual trial results (mg/kg)

STMR

(mg/kg) (b)

HR

(mg/kg) (c)

Existing

MRL

(mg/kg)

Median

CF (d)

Enforcement

(quinmerac)

Risk assessment

(quinmerac + BH 518-

2 + BH 518-4,

expressed as quinmerac)

beet root NEU Outdoor 3 x <0.05; 4 x <0.01 3 x <0.14; 4 x <0.10 0.10 0.14 0.5 n.a.

beet leaves

and tops

NEU Outdoor 3 x <0.05; 4 x <0.01 3 x <0.14; 4 x <0.10 0.10 0.14 0.5 n.a.

(a): NEU, SEU, EU or Import (country code)..

(b): Median value of the individual trial results according to the risk assessment residue definition.

(c): Highest value of the individual trial results according to the risk assessment residue definition.

(d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors

for each residues trial.

(§) molecular masses of BH 518-2 and BH 518-4 are 251.6 and 237.6 g/mol respectively (conversion factors 0.88, 0.93)

It is emphasized that in four of the trials the samples were stored frozen for periods considerably longer

than 12 months prior to extraction.

Storage stability of residues of parent quinmerac and its metabolites BH 518-2 and BH 518-4 was

reported in the DAR for at least 24 months in sugar beet roots and leaves.

Storage stability of residues of parent quinmerac and its metabolites BH 518-2 and BH 518-4 in watery

matrices (wheat green matter) was demonstrated in a study of the applicant for only 12 months

(ASB2011-9249). It is unclear if the applicant has access to a study cited in the DAR (ASB2010-13949)

demonstrating sufficient stability in/on sugar beet items over at least 24 months. If there would be no such

right of use the number of trials in support of the no-residue situation would be insufficient (i.e. < n=4)

for sugar beets, which is a major crop in northern Europe.

4.2.2.2 Distribution of the residue in peel/pulp

Not relevant.



zRMS version

Page 7 / 24

4.2.2.3 Residues in processed commodities

Not relevant. Due to low residues at harvest, no processing studies are required.

4.2.2.4 Proposed pre-harvest intervals, withholding periods

The proposed pre-harvest interval (PHI)/withholding period is deemed appropriate, due to application at

early growth stage of the crop.

4.3 Consumer intake and risk assessment

4.3.1 Metamitron

The consumer intake and risk assessment is based on the input values given in Table IIIA 4.3-1 and the

toxicological reference values stated in Table IIIA 4.3-2. For the detailed calculation results it is referred

to Appendix 3.

Table IIIA 4.3-1: Residue input values for the consumer risk assessment

Commodity

Chronic risk assessment Acute risk assessment

Input value

(mg/kg)

Comment Input value

(mg/kg)

Comment

Sugar beet 0.05 STMR 0.05 STMR

All other commodities of

Annex I to Reg (EC) No

396/2005

variable

MRLs

as laid down in Reg.

(EC) No 149/2008

not calculated

Table IIIA 4.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)

ADI 0.03 mg/kg bw

TMDI (% ADI) according to EFSA PRIMo 26.5 % (based on UK toddlers diet).

NTMDI (% ADI) according to German NVS II-

model

17.1 % (based on DE children, aged 2-4 years, individual

consumption/body mass ratio)

IEDI (EFSA PRIMo) (% ADI) not required

NEDI (German NVS II-model) (% ADI) not required

Factors included in IEDI and NEDI none

ARfD 0.1 mg/kg bw

IESTI (EFSA PRIMo) (% ARfD) Sugar beet: 3 % (based on UK children 4-6 years)

NESTI (German NVS II-model) (% ARfD) Sugar beet: <1 % (based on DE children 2-4 years)

Factors included in IESTI and NESTI none

4.3.2 Quinmerac

The consumer intake and risk assessment is based on the input values given in Table IIIA 4.3-1 and the

toxicological reference values stated in Table IIIA 4.3-2. For the detailed calculation results it is referred

to Appendix 3.

In the absence of conversion factors for the vast majority of plant commodities and information on the

GAPs underlying the MRLs the dietary intake is based on the MRLs. Although this approach will



zRMS version

Page 8 / 24

underestimate consumer intake it is nevertheless anticipated with a view to the TMDI (based almost

completely on LOQs for important commodities) that long-term dietary intake of EU consumers will not

exceed the ADI of quinmerac.

Table IIIA 4.3-3: Residue input values for the consumer risk assessment

Commodity

Chronic risk assessment Acute risk assessment

Input value

(mg/kg)

Comment Input value

(mg/kg)

Comment

Sugar beet 0.10 STMR 0.10 STMR

All other commodities

variable

MRLs

as laid down in Reg.

(EC) No 149/2008

not calculated

Table IIIA 4.3-4: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)

ADI 0.08 mg/kg bw

TMDI (% ADI) according to EFSA PRIMo 18.4 % (based on UK toddlers diet)

NTMDI (% ADI) according to German NVS II-

model

6.6 % (based on DE children aged 2-4 years, individual

consumption/body mass ratio)

IEDI (EFSA PRIMo) (% ADI) not required

NEDI (German NVS II-model) (% ADI) not required

Factors included in IEDI and NEDI none

ARfD 0.3 mg/kg bw

IESTI (EFSA PRIMo) (% ARfD) Sugar beet: 3 % (based on UK children 4-6 years)

NESTI (German NVS II-model) (% ARfD) Sugar beet: <1 % (based on DE children 2-4 years)

Factors included in IESTI and NESTI none

4.4 Proposed maximum residue levels (MRLs)

No new MRL is required.

4.5 Conclusion

Regarding aspects of seasonal application rates the cGAP of application 007529-00/01 is comparable to

that of the basic application of the product on sugar/fodder beets (007529-00/00). Hence, the statement

basically apply also for application 007529-00/01.

The available residue data is sufficient for dietary risk assessment, provided that there is access of the

applicant to a storage stability study showing storage stability of quinmerac and its relevant metabolites in

watery matrices for up to 17 months (such storage stability was reported up to 24 months in the DAR, but

access is unclear for the application under consideration). If there is no such right of use, the number of

independent trials is too small (n=3) to support a no-residue situation in sugar/fodder beets for quinmerac.

Residues of quinmerac and its metabolites were continuously seen below the respective LOQ. Hence, no

meaningful statement can be made for converting residues of quinmerac in compliance with the existing

residue definition for enforcement to that of risk assessment.

An exceedance of the current MRL of 0.2 mg/kg for metamitron and 0.5 mg/kg for quinmerac in sugar



zRMS version

Page 9 / 24

beet roots as laid down in EU residue legislation (Reg. (EC) No 14972009) is not expected.

A no-residue situation is indicated from the supervised residue trials for both actives and regarding both

roots and leaves with tops. It is therefore not anticipated that the intended uses impact residues in

commodities of animal origin.

The long-term and the short-term intake of residues of metamitron and quinmerac residues is unlikely to

present a public health concern.

With respect to consumer health protection issues, BfR/Germany agrees with the authorization of the

intended uses on sugar and fodder beet.

Appendix 1 Reference list

Table A 1: Reference list

Annex

point/

reference

No


Report-No.

Authority registration No

Data

protection

claimed

Owner How

considered in

dRR *

OECD KIIA

6.1.1

Mackenroth, C.;

Krotzky, A.

1995 Investigation of the storage stability in sugar beet

95/10753 ! 3996 ! DE-H-LST/Z-91

GLP: Yes

Published: No

BVL-1989467,

ASB2010-13949

Yes BAS Add

OECD KIIA

6.1.1

Meyer, M. 2011 Determination of the storage stability of Quinmerac

and metabolites in plant matrices

IF-09/01173993

GLP: Yes

Published: No

BVL-2123934, BVL-2125702, BVL-2203833,

ASB2011-9249

Yes FSG Add**

OECD KIIA

6.3.1

Fuchsbichler, G. 1996 Determination of the residues of metamitron and

desamino-metamitron in sugar beets

2 (3) ! HVA 8/95 ! GER 94400/1

ASB2008-4378

Yes Add

OECD KIIA

6.3.1

Fuchsbichler, G. 1996 Determination of the residues of Metamitron and

Desomino-metamitron in sugar beets (4 trials in 1994)

HVA 8/95 ! GER 94400/1 ! 14185 ! 14186 ! 14187 !

14188

GLP: Yes Published: No

BVL-2206952,

ASB2011-14416

Yes FSG Add**

OECD KIIA

6.3.1

Hauck, E. J.;

Schulz, H.

2011 Study on the magnitude of residue of Metamitron and

its metabolite and Quimmerac and its metabolites in

sugar beets after one application of Goltix WG 70

formulation or three applications of Quinmerac and

Metamitron in Northern Europe 2010

RA-2131/01 ! IF-10/1539609


BVL-2203849,

ASB2011-14418

Yes FSG Add**

OECD KIIA

6.3.1

Hoenzelaers, R.;

Schulz, J.

1995 Final report about testing the residual behaviour of

AGH 211 (MAC 93 001 H) in sugar beet under field

conditions

AGR/RP-H 94/MAC 93 001 H


BVL-2206951,

ASB2011-14415

Yes FSG Add**



zRMS version

Page 10 / 24

Annex

point/

reference

No


Report-No.


Data

protection

claimed

Owner How

considered in

dRR *

KIIA 6.3 Simek, I. 2009 Determination of Quinmerac and Metamitron residues

in Sugar Beet (RAC) following treatment with the

formulated product MAF0617 under field conditions

in Northern France in 2007

R A7091 ! FR-qut-07-1


BVL-2757382, ASB2015-1088

Yes ADAMA Y

* Y: Yes, relied on

N: No, not relied on

Add: Relied on, study not submitted by applicant but necessary for evaluation

** Studies provided by the applicant for the main application procedure of GOLTIX TITAN (ZV1 007529-00/00)

Appendix 2 Detailed evaluation of the additional studies relied upon

A 2.1 Storage stability

A 2.1.1 Storage stability of residues in plant products

A new study was submitted by the applicant on storage stability of Quinmerac and its metabolites in

various wheat matrices.

Reference: KIIIA 8.1.1/01

Report Meyer, M. (2011) Determination of the Storage Stability of Quinmerac and

Metabolites in Plant Matrices; ASB2011-9249

Guideline(s): YES

Chemikaliengesetz der Bundesrepublik Deutschland (ChemG) §19, sowie der

Anhänge 1 und 2 in the valid form; OECD document OECD-DOC.

ENV/MC/CHEM(98)17, Paris 1998; Storage stability of Residue Samples, EC doc.

7032/VI/95-rev.5, dated 22/7/97

Deviations: No

GLP: Yes

Acceptability: Yes

Materials and methods

Untreated samples of wheat green matter, wheat grain, wheat straw, and carrot roots were fortified with

either Quinmerac or BH 518-2 and BH 518-4 at a fortification level of 0.5 mg/kg and stored deep-frozen

at ≤-18°C protected from light over a period of 12 months. Samples were analysed after immediately after

specimen preparation (day 0), 3 months, 11 months, and 12 months. On each day of analysis 1 control

specimen, 1 freshly prepared Quinmerac fortified specimen, 1 freshly prepared BH 518-2 and BH 518-4

fortified specimen, 2 storage stability specimens fortified with Quinmerac, and 2 storage stability

specimens fortified with BH 518-2 and BH 518-4 were analysed per matrix.

Samples were analysed using the method “Determination of Residues of Quinmerac and its metabolites

BH 518-2 and BH 518-4 in Plant Matrices” which was validated by M. Meyer, SGS Institut Fresenius

under the Project No. IF-09/01249451 in April 2010. Samples were extracted with methanol/0.4 M

hydrochloric acid (70/30; v/v) and partitioned with Extrelut comprising a washing step with cyclohexane

and elution with ethyl acetate/formic acid (99/1; v/v). The eluate was evaporated to dryness under

nitrogen. Residues were reconstituted in acetonitrile/water (4/6; v/v + 0.1% formic acid). Final

determination was performed with LC-MS/MS. The limit of quantification was 0.05 mg/kg for all

matrices.



zRMS version

Page 11 / 24

Results and discussions

The recovery values in percentage of quinmerac and its metabolites BH 518-2 and BH 518-4 over the

whole storage time period and for all matrices are given in the table below. They were not corrected by

the mean recovery values of the simultaneously analysed freshly fortified specimens

Table A 2: Summary of storage stability of quinmerac and its metabolites BH 518-2 and BH

518-4 in wheat green matter, wheat grain, wheat straw, and carrot roots at ≤-18°C

Time [months]

0 3 11 12 Wheat green matter, recovery values [%]

Quinmerac

mean 91; 94 88; 89 86; 118 82; 82

93 89 102 82

BH 518-2

mean 100; 102 92; 92 96; 94 102; 104

101 92 95 103

BH 518-4

mean 96; 98 79; 79 81; 80 83; 83

97 79 81 83

Wheat grain, recovery values [%] Quinmerac

mean 107; 93 89; 91 90; 88 92; 92

100 90 89 92

BH 518-2

mean 101; 99 95; 94 103; 95 98; 99

100 95 99 99

BH 518-4

mean 96; 93 77; 75 78; 79 78; 80

95 76 79 79

Wheat straw, recovery values [%] Quinmerac

mean 91; 93 86; 86 90; 87 90; 91

92 86 89 91

BH 518-2

mean 101; 99 93; 92 94; 98 94; 93

100 93 96 94

BH 518-4

mean 94; 94 77; 81 77; 86 77; 75

94 79 82 76

Carrot roots, recovery values [%] Quinmerac

mean 90; 88 88; 89 85; 87 87; 90

89 89 86 89

BH 518-2

mean 88; 93 90; 90 98; 102 100; 104

91 90 100 102

BH 518-4

mean 82; 85 77; 77 80; 83 88; 89

84 77 82 89

The accuracy of the analytical method was by simultaneous analysis of one freshly prepared fortified

specimen from each matrix on each date of analysis (same level as for storage stability specimens). The

results are shown in the following table.



zRMS version

Page 12 / 24

Table A 3: Summary of concurrent recoveries of quinmerac and its metabolites BH 518-2

and BH 518-4 from various wheat matrices and carrot roots

No. of fortified

specimens

Mean recovery

rates [%]

Standard deviation Relative standard

deviation [%]

Wheat green matter

Quinmerac 4 92 1.7 1.9

BH 518-2 4 98 2.5 2.6

BH 518-4 4 91 8.3 9.1

Wheat grain


BH 518-2 4 102 3.9 3.8

BH 518-4 4 90 8.4 9.3

Wheat straw


BH 518-2 4 102 3.7 3.6

BH 518-4 4 92 7.8 8.5

Carrot roots


BH 518-2 4 102 3.7 3.6

BH 518-4 4 92 7.8 8.5

Conclusion

Quinmerac and its metabolites BH 518-2 and BH 518-4 were found to be stable for at least 12 months

under deep freeze storage conditions in wheat green matter, wheat grain, wheat straw, and carrot roots.

Comments of zRMS: The study is acceptable to demonstrate stability of residues of quinmerac and its

metabolites over 12 months under deep freeze conditions in matrices of high water

content.

A 2.1.2 Storage stability of residues in animal products

No new studies were submitted on the storage stability of residues in animal products.

A 2.2 Residues in primary crops

A 2.2.1 Nature of residues

No further study was submitted on the nature of residues.



zRMS version

Page 13 / 24

A 2.2.2 Magnitude of residues in sugar beets

Reference: OECD KIIA 6.3

Report see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list)

Guideline(s): in accordance with agreed guidance unless stated otherwise in the commenting box

Deviations: no relevant deviations unless stated otherwise in the commenting box

GLP: see reference list

Acceptability: acceptable unless stated otherwise in the commenting box

Table A 4: Residues of metamitron in sugar beets

RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Metamitron

(Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet

Federal Institute for Risk Assessment, Berlin

Federal Republic of Germany Submission date : 2011-12-08

Content of a.i. (g/kg or g/l) : 710 g/kg Indoors / outdoors : Outdoors (European North)

Formulation (e.g. WP) : WG Other a.i. in formulation

Commercial product (name) : submitted to AG-QMM1-565 SC 007529-00

treated with MAC 93 001 H, WDG (710 g/kg Metamitron)

(content and common name) :

Applicant : Feinchemie Schwebda GmbH Residues calculated as : 8.1 Metamitron

8.2 Desaminometamitron

1 2 3 4 5 6 7 8.1 8.2 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1) Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage at last

treatment

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

AGR / RP-H 94 / MAC 93

001 H, GER 94 400/R,

trial MAK 12, 14185

Germany

47574 Goch

1994-01-31

sugar beet /

Sophie

1) 1994-04-04

2)

3) 1994-10-09

1.5

3.2

310

268

0.48

1.2

1994-05-19

1994-05-29

BBCH 19 plant

leaf

leaf

leaf

root

root

root

107

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

1.2

0.070

<0.050

<0.050

<0.050

<0.050

<0.050

0

16

30

120

16

30

120

(c) sprayings

analytical method: GC-NPD and GC-MSD

LOQ: 0.05 mg/kg,

max. sample storage: 16 months,

ASB2011-14415 (field part),

ASB2008-4378 (analytical part)

ASB2011-14416



zRMS version

Page 14 / 24

1 2 3 4 5 6 7 8.1 8.2 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1) Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage at last

treatment

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)


001 H, GER 94 400/R,

trial MAK 13, 14186

Germany

49685 Bühren

1994-01-31

sugar beet /

Meta

1) 1994-04-20

2)

3) 1994-10-06

1.4

3.7

287

315

0.47

1.2

1994-05-18

1994-05-28

BBCH 19

plant

leaf

leaf

leaf

root

root

root

278

0.050

0.090

<0.050

<0.050

<0.050

<0.050

4.9

0.13

<0.050

<0.050

<0.050

<0.050

<0.050

0

16

32

123

16

32

123

(c) sprayings


LOQ: 0.05 mg/kg,




ASB2011-14416


001 H, GER 94 400/R,

trial MAK 14, 14188

Germany

16278 Angermünde

1994-01-31

sugar beet /

Meta

1) 1994-04-24

2)

3) 1994-10-20

1.4

3.6

202

201

0.71

1.8

1994-05-26

1994-06-06

BBCH 19

plant

leaf

leaf

leaf

root

root

root

183

<0.050

<0.050

<0.050

0.0900

<0.050

<0.050

2.6

0.050

<0.050

<0.050

<0.050

<0.050

<0.050

0

16

32

135

16

32

135

(c) sprayings


LOQ: 0.05 mg/kg,




ASB2011-14416


001 H, GER 94 400/R,

trial MAK 15, 14187

Germany

67150 Niederkirchen

1994-01-31

sugar beet /

Kawe-Tuka

1) 1994-04-10

2)

3) 1994-10-18

1.5

3.6

206

200

0.71

1.8

1994-05-14

1994-05-24

BBCH 19

plant

leaf

leaf

leaf

root

root

root

2.6

0.10

<0.050

<0.050

<0.050

<0.050

<0.050

0.31

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

0

14

29

131

14

29

131

(c) sprayings


LOQ: 0.05 mg/kg,




ASB2011-14416

Remarks: (a) According to CODEX Classification / Guide

(b) Only if relevant

(c) Year must be indicated

(d) Days after last application (Label pre-harvest interval, PHI, underline)

(e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included

Note: All entries to be filled in as appropriate

Comments of zRMS: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet.



zRMS version

Page 15 / 24


RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Metamitron




Content of a.i. (g/kg or g/l) : 525 g/l / 700 g/kg Indoors / outdoors : Outdoors (European North)

Formulation (e.g. WP) : SC / WG Other a.i. in formulation

Commercial product (name) : AG-QMM1-565 SC / Goltix WG 700 (content and common name) : 40 g/l Quinmerac

Applicant : Feinchemie Schwebda GmbH Residues calculated as : 8.1 Metamitron

8.2 Desaminometamitron

1 2 3 4 5 6 7 8.1 8.2 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1) Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage at last

treatment

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

IF-10/01539609,

90012787,

trial 10-DE-001, plot 3

Germany

64584 Biebersheim

2011-02-24

sugar beet /

Pauletta

1) 2010-03-17

2)

3) 2010-09-27

1.1

1.1

1.1

204

208

216

0.51

0.53

0.53

2010-04-16

2010-04-29

2010-05-27

BBCH 19

plant

leaf with top

beet root

0.012

<0.010

<0.010

0.023

<0.010

<0.010

14

123

123

(c) spraying s

AG-QMM1-565 SC , 525 g/L

analytical methods: IF-10/01618813

(HPLC-MS/MS), LOQ 0.01 mg/kg,

max. sample storage: 8 months

ASB2011-14418

IF-10/01539609,

90012787,


Germany

64584 Biebersheim

2011-02-24

sugar beet /

Pauletta

1) 2010-03-17

2)

3) 2010-09-27

2.8 200 1.4 2010-06-10 BBCH 37 plant

leaf, with top

beet root

46.0

<0.010

<0.010

0.57

<0.010

<0.010

0

109

109

(c) spraying

Goltix WG 700 g/kg

analytical method: IF-10/01618813



ASB2011-14418

IF-10/01539609,

90012787,


Germany

68649 Groß-Rohrheim

2011-02-24

sugar beet /

Theresa

1) 2010-03-15

2)

3) 2010-10-30

1.0

1.0

1.0

193

193

190

0.53

0.53

0.53

2010-04-16

2010-04-29

2010-05-27

BBCH 19

plant

plant

plant

leaf with top

leaf with top

root

root

17.9

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

0.38

<0.010

<0.010

<0.010

<0.010

<0.010

<0.010

0

29

60

90

123

90

123

(c) spraying s

AG-QMM1-565 SC , 525 g/L



max. sample storage: 8.5 months

ASB2011-14418



zRMS version

Page 16 / 24

1 2 3 4 5 6 7 8.1 8.2 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1) Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage at last

treatment

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

IF-10/01539609,

90012787,


Germany

49685 Emstek

2011-02-24

sugar beet /

Ricada (KWS)

1) 2010-04-20

2)

3) 2010-11-20

0.99

1.1

0.98

284

300

280

0.35

0.35

0.35

2010-05-14

2010-05-27

2010-06-15

BBCH 19

plant

leaf with top

beet root

35.9

<0.010

<0.010

0.59

<0.010

<0.010

0

132

132

(c) spraying s

AG-QMM1-565 SC , 525 g/L




ASB2011-14418

IF-10/01539609,

90012787,


Germany

49685 Emstek

2011-02-24

sugar beet /

Ricada (KWS)

1) 2010-04-20

2)

3) 2010-11-20

1.1

1.0

1.0

322

288

286

0.35

0.35

0.35

2010-05-14

2010-05-27

2010-06-15

BBCH 19

plant

plant

plant

leaf with top

leaf with top

root

root

31.4

0.27

<0.010

<0.010

<0.010

<0.010

<0.010

0.47

0.28

<0.010

<0.010

<0.010

<0.010

<0.010

0

29

59

91

132

91

132

s(c) spraying s

AG-QMM1-565 SC , 525 g/L




ASB2011-14418

IF-10/01539609,

90012787,


Germany

49685 Emstek

2011-02-24

sugar beet /

Ricada (KWS)

1) 2010-04-20

2)

3) 2010-11-20

2.7 292 0.93 2010-06-28 BBCH 37 plant

leaf, with top

beet root

33.6

<0.010

<0.010

0.11

<0.010

<0.010

0

119

119

(c) spraying

Goltix WG 700 g/kg




ASB2011-14418






Comments of zRMS: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. It is noted however that plot 2 and plot 3 of trial 10-

DE-001 as well as plot 2 and plot 3 of trial 10-DE-003 including plot 2 of trial trial 10-DE-003were not sufficiently independend from one another



zRMS version

Page 17 / 24


RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : metamitron


Crop Code : BEAVA



Content of a.i. (g/kg or g/l) : 500 g/L Indoors / Outdoors : Outdoors (European North)

Formulation (e.g. WP) : SC Other a.i. in formulation

Commercial product (name) : MAF06017 (content and common name) : 150 g/L quinmerac

Applicant : ADAMA Deutschland GmbH Residues calculated as : metamitron

1 2 3 4 5 6 7 8 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1)Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage

at last

treatment

Portion

analysed

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study R A7091 trial

AN1,

France (north)

67160 Seebach

2009-03-11

sugar beet /

Nordika

1) 2007-04-11

2)

3) 2007-09-26

1.7 190 0.88 2007-05-03 BBCH 12 whole plant

leaf with top

root body

<0.050

<0.050

<0.050

92

146

146

(c) spraying

analytical method: Bayer 39/1986 (GC-MS)

LOQ: 0.05 mg/kg

max. sample storage 16 months

ASB2015-1088

study R A7091

trial BP1,

France (north)

45300 Engenville

2009-03-11

sugar beet /

Radar

1) 2007-03-16

2)

3) 2007-10-08

1.7 190 0.88 2007-05-21 BBCH 31 whole plant

leaf with top

root body

<0.050

<0.050

<0.050

91

140

140

(c) spraying


LOQ: 0.05 mg/kg


ASB2015-1088

study R A7091

trial BM1,

France (north)

72800 Thoree les Pins

2009-03-11

sugar beet /

Ardan

1) 2007-05-15

2)

3) 2007-10-09

1.9 220 0.87 2007-06-01 BBCH 11 whole plant

leaf with top

root body

<0.050

<0.050

<0.050

90

130

130

(c) spraying


LOQ: 0.05 mg/kg


ASB2015-1088



zRMS version

Page 18 / 24

1 2 3 4 5 6 7 8 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1)Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage

at last

treatment

Portion

analysed

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study R A7091

trial OB1,

France (north)

29830 Ploudalmezeau

2009-03-11

sugar beet /

Radar

1) 2007-04-20

2)

3) 2007-11-13

1.8 210 0.87 2007-05-17 BBCH 12 whole plant

leaf with top

root body

<0.050

<0.050

<0.050

103

180

180

(c) spraying


LOQ: 0.05 mg/kg


ASB2015-1088






Comments of zRMS: Not acceptable. The trials cannot be used to suport the intended use of the product on sugar/fodder beet for reasons of not addressing the critical GAP



zRMS version

Page 19 / 24

Table A 7: Residues of quinmerac in sugar beets

RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Quinmerac




Content of a.i. (g/kg or g/l) : 40 g/l Indoors / outdoors : Outdoors (European North)


Commercial product (name) : AG-QMM1-565 SC 007529-00 (content and common name) : 525 g/l Metamitron

Applicant : Feinchemie Schwebda GmbH All residues were calculated

as quinmerac equivalents

: 8.1 Quinmerac

8.2 BH 518-4 (7-chloro-3-hydroxymethyl-quinoline-8-carboxylic acid)

8.3 BH 518-2 (7-chloroquinoline-3,8-dicarboxylic acid)

1 2 3 4 5 6 7 8.1 8.2 8.3 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1) Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage at

last

treatment

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

IF-10/01539609,

90012787,


Germany

64584 Biebersheim

2011-02-24

sugar beet /

Pauletta

1) 2010-03-17

2)

3) 2010-09-27

0.080

0.084

0.086

204

208

216

0.039

0.040

0.040

2010-04-16

2010-04-29

2010-05-27

BBCH 11

BBCH 14

BBCH 19

plant

leaf with top

beet root

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

14

123

123

(c) sprayings


(HPLC-MS/MS), LOQ 0.05 mg/kg


ASB2011-14418

IF-10/01539609,

90012787,


Germany

68649 Groß-Rohrheim

2011-02-24

sugar beet /

Theresa

1) 2010-03-15

2)

3) 2010-10-30

0.077

0.077

0.076

193

193

190

0.040

0.040

0.040

2010-04-16

2010-04-29

2010-05-27

BBCH 10

BBCH 14

1BCH 19

plant

plant

plant

leaf, with top

leaf with top

root

root

1.7

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

0.089

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

0

29

60

90

123

90

123

(c) sprayings




ASB2011-14418

IF-10/01539609,

90012787,


Germany

49685 Emstek

2011-02-24

sugar beet /

Ricada (KWS)

1) 2010-04-20

2)

3) 2010-11-20

0.076

0.080

0.075

284

300

280

0.027

0.027

0.027

2010-05-14

2010-05-27

2010-06-15

BBCH 10

BBCH 14

BBCH 19

plant

leaf with top

beet root

3.0

<0.050

<0.050

0.084

<0.050

<0.050

<0.050

<0.050

<0.050

0

132

132

(c) sprayings




ASB2011-14418



zRMS version

Page 20 / 24

1 2 3 4 5 6 7 8.1 8.2 8.3 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1) Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage at

last

treatment

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

F-10/01539609,

90012787,


Germany

49685 Emstek

2011-02-24

sugar beet /

Ricada (KWS)

1) 2010-04-20

2)

3) 2010-11-20

0.086

0.077

0.076

322

288

286

0.027

0.027

0.027

2010-05-14

2010-05-27

2010-06-15

BBCH 10

BBCH 14

BBCH 19

plant

plant

plant

leaf with top

leaf with top

root

root

2.7

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

0.075

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

0

29

59

91

132

91

132

spraying

analytical method: F-09/01249451



ASB2011-14418






Comments of zRMS: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. However, two of the trials are not sufficiently

independent to present separate residue level figures (trial 10-DE-003 and 10-DE-004).



zRMS version

Page 21 / 24

Table A 8: Residues of quinmerac in sugar beets

RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS

(SUMMARY)

Active ingredient : quinmerac


Crop Code : BEAVA



Content of a.i. (g/kg or g/l) : 150 g/L Indoors / Outdoors : Outdoors (European North)


Commercial product (name) : MAF06017 (content and common name) : 500 g/L metamitron

Applicant : ADAMA Deutschland GmbH Residues calculated as : 8.1 Quinmerac

8.2 BH 518-4 (7-chloro-3-hydroxymethyl-quinoline-8-carboxylic acid)

8.3 BH 518-2 (7-chloroquinoline-3,8-dicarboxylic acid)

1 2 3 4 5 6 7 8.1 8.2 8.3 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1) Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage at last

treatment

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study R A7091,

trial AN1,

France (north)

67160 Seebach

2009-03-11

sugar beet /

Nordika

1) 2007-04-11

2)

3) 2007-09-26

0.50 190 0.26 2007-05-03 BBCH 12 whole plant

leaf with top

root

<0.010

<0.010

<0.010

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

92

146

146

(c) spraying

analytical method: CEN/TC 275

WG 4 (LC-MS/MS),

LOQ:

8.1: 0.01 mg/kg

8.2: 0.05 mg/kg

8.3: 0.05 mg/kg


ASB2015-1088

study R A7091,

trial BP1,

France (north)

45300

Engenville

2009-03-11

sugar beet /

Radar

1) 2007-03-16

2)

3) 2007-10-08

0.50 190 0.26 2007-05-21 BBCH 31 whole plant

leaf with top

root body

<0.010

<0.010

<0.010

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

91

140

140

(c) spraying


WG 4 (LC-MS/MS),

LOQ:

8.1: 0.01 mg/kg

8.2: 0.05 mg/kg

8.3: 0.05 mg/kg


ASB2015-1088



zRMS version

Page 22 / 24

1 2 3 4 5 6 7 8.1 8.2 8.3 9 10

Report-No.

Location

incl. postal code

and date

Commodity/

Variety

Date of

1) Sowing

2) Flowering

3) Harvest

Application

rate per treatment

Dates of

treatments

Growth

stage at last

treatment

Portion

analysed

Residues

(mg/kg)

Residues

(mg/kg)

Residues

(mg/kg)

PHI

(days)

Remarks

kg

a.i./ha

Water

l/ha

kg

a.i./hl

(a) (b) (c) (a) (d) (e)

study R A7091,

trial BM1,

harvest trial

France (north)

72800 Thoree les

Pins

2009-03-11

sugar beet /

Ardan

1) 2007-05-15

2)

3) 2007-10-09

0.56 220 0.26 2007-06-01 BBCH 11 whole plant

leaf with top

root body

<0.010

<0.010

<0.010

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

90

130

130

(c) spraying


WG 4 (LC-MS/MS),

LOQ:

8.1: 0.01 mg/kg

8.2: 0.05 mg/kg

8.3: 0.05 mg/kg


ASB2015-1088

study R A7091,

trial OB1,

France (north)

29830

Ploudalmezeau

2009-03-11

sugar beet /

Radar

1) 2007-04-20

2)

3) 2007-11-13

0.54 210 0.26 2007-05-17 BBCH 12 whole plant

leaf with top

root body

<0.010

<0.010

<0.010

<0.050

<0.050

<0.050

<0.050

<0.050

<0.050

103

180

180

(c) spraying


WG 4 (LC-MS/MS),

LOQ:

8.1: 0.01 mg/kg

8.2: 0.05 mg/kg

8.3: 0.05 mg/kg


ASB2015-1088






Comments of zRMS: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. Event though conducted considerably overdosed the

results clearly show a nil-residue situation.

It is however unclear, if the applicant has access to the storage stability study on sugar bee tmatrices (ASB2010-13949) demonstrating integrity of samples

over periods of at least 24 months. In its own study on wheat matrices stability was demonstrated for only 12 months.



zRMS version

Page 23 / 24

A 2.3 Residues in processed commodities

No new study on residues in processed commodities has been submitted and none is needed due to low

residues at harvest.

A 2.4 Residues in rotational crops

No new study on residues in rotational crops has been submitted.

A 2.5 Residues in livestock

No new study on residues in livestock has been submitted.

A 2.6 Other studies/information

None



zRMS version

Page 24 / 24

Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2)

Result of chronic risk assessment (EFSA PRIMo rev.2), based on input data as outlined in table 4.3-1

Result of chronic risk assessment (EFSA PRIMo rev.2), based on input data as outlined in table 4.3-3


Core Assessment

GOLTIX TITAN

Registration Report

Central Zone

Page 1 of 36

ADAMA Deutschland GmbH Evaluator: Germany

Date: Feb 2016

REGISTRATION REPORT

Part B

Section 5 Environmental Fate


Product code: GOLTIX TITAN

(AG-QMM1-565 SC)

Active Substance(s): metamitron 525 g/L

quinmerac 40 g/L

Central Zone


CORE ASSESSMENT


Date: Feb 2016


Core Assessment

GOLTIX TITAN

Registration Report

Central Zone

Page 2 of 36


Date: Feb 2016

Table of Contents TABLE OF CONTENTS ....................................................................................................................................... 2

FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) .................................................................... 3

5.1 GENERAL INFORMATION ON THE FORMULATION .................................................................................... 3 5.2 PROPOSED USE PATTERN ........................................................................................................................ 3 5.3 INFORMATION ON THE ACTIVE SUBSTANCES ........................................................................................... 4 5.4 SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ............................... 4 5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (PECSOIL) (KIIIA1 9.4) ......................................................... 5 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (PECSW/PECSED) (KIIIA1 9.7)

6 141/ 156 .......................................................................................................................................................... 8 75 .................................................................................................................................................................... 8

5.7 RISK ASSESSMENT GROUND WATER (KIIIA1 9.6) ................................................................................. 10 5.7.1 Predicted environmental concentration in groundwater (PECGW) calculation for active substances

and metabolites (Tier 1 and 2) ...................................................................................................................... 10 5.7.2 Higher tier leaching assessment ...................................................................................................... 14 5.7.3 Summary of risk assessment for ground water ................................................................................ 14

5.8 POTENTIAL OF ACTIVE SUBSTANCE FOR AERIAL TRANSPORT ................................................................ 15

APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION .......................... 17

APPENDIX 2 DETAILED EVALUATION OF STUDIES RELIED UPON .............................................. 19

KIIIA 9 FATE AND BEHAVIOUR IN THE ENVIRONMENT ..................................................................................... 19

APPENDIX 3 TABLE OF INTENDED USES JUSTIFICATION AND GAP TABLES ........................... 35


Core Assessment

GOLTIX TITAN

Registration Report

Central Zone

Page 3 of 36


Date: Feb 2016

FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9)

The product GOLTIX TITAN was already authorized in Germany (reg. No. 007529-00), Belgium

(reg. No. 1038P/B1) and the Netherlands (reg. No. 14298N) following a first original submission for

the use in beets (use no. 1 in the GAP table, see Appendix 3). This document comprises the risk

assessment for groundwater and the exposure assessment of surface water and soil for the plant

protection product GOLTIX TITAN for a label extension (use no. 2 in the GAP table, see

Appendix 3).

Within this document, the first Registration Report is cited in several chapters to avoid replication.

National Addenda are included containing country specific assessments for some annex points.

5.1 General Information on the formulation

Table 5.1-1: General information on the formulation GOLTIX TITAN

Code AG-QMM1-565 SC

Plant protection product GOLTIX TITAN


Date of application 30.01.2014

Formulation type

(WP, EC, SC, …; density)

SC

Active substance (s) metamitron quinmerac

Concentration of as (g/L) 525 40

5.2 Proposed use pattern

The GAP used for exposure assessment is presented in Table 5.2-1. Further details on the intended use

within the zone is given in Appendix 3.

Table 5.2-1: Critical use pattern of GOLTIX TITAN

Use Crop/growth

stage

Application

method /

Drift scenario

Number of applications,

Minimum application

interval, interception,

application time

(season)

Application rate,

cumulative

(g as/ha)

Soil effective

application rate

(g as/ha)

2 beets (sugar and

fodder) /

BBCH 0-19

Spraying /

arable crops

4 x, 5 d,

1. 0 %

2.-4. 20 %,

spring

metamitron

1 x 1575

3 x 525

quinmerac

1 x 120

3 x 40

metamitron

1 x 1575

3 x 420

quinmerac

1 x 84

3 x 32

1 Could not be checked by zRMS, might be different


Core Assessment

GOLTIX TITAN

Registration Report

Central Zone

Page 4 of 36


Date: Feb 2016

5.3 Information on the active substances

Please refer to the first Registration Report for GOLTIX TITAN that led to authorizations in Germany,

Belgium and the Netherlands.

As additional information, the RMS UK concluded in the draft addendum on confirmatory data in

2014 that the metamitron metabolite M3 was an experimental artifact. Therefore, the metabolite M3

has not to be considered in the groundwater assessment.

5.4 Summary on input parameters for environmental exposure assessment

Please refer to the first Registration Report for GOLTIX TITAN that led to authorizations in Germany,

Belgium and the Netherlands.





Core Assessment

GOLTIX TITAN

Registration Report

Central Zone

Page 5 of 36


Date: Feb 2016

5.5 Estimation of concentrations in soil (PECsoil) (KIIIA1 9.4)

PECsoil calculations are based on the recommendations of the FOCUS workgroup on degradation

kinetics. A soil bulk density of 1.5 g/cm3, a soil depth of 5 cm and a tillage depth of 20 cm (arable

crop)/5 cm (permanent crops) were assumed. The PECsoil calculations were performed with

ESCAPE 2.0 based on the input parameters as presented in tables below.

According to section 6 of the first Registration Report for GOLTIX TITAN the TER values in soil for

quinmerac and its soil metabolites were above the respective TER values for metamitron and far above

the trigger. Therefore it was concluded that no calculation of PECsoil for quinmerac and its soil

metabolites is necessary, as the risk is covered by the assessment of metamitron and the formulation.

Table 5.5-1: Application related input parameters for PECSoil calculations


Use No.: 2

Crop: beets (sugar and fodder)

Application rate: 6 L product/ha ( 3/ 1/ 1/ 1)

Number of applications/interval: 4x/ 5d

Crop interception: 0/ 20/ 20/ 20 %

Table 5.5-2: Substance related input parameters for PECsoil calculation

Active substance DT50

metamitron 22 d (Maximum Field studies, 1st

order)

metabolite Desamino-metamitron 39.7 d (Maximum Field studies, 1st

order)

Due to the fast degradation of metamitron in soil (DT90 <365 d, field data) the accumulation potential

of metamitron does not need to be considered. Besides PECact values also PECtwa, 21 d values are

required for risk assessment. PECtwa, 21 d values are also presented in Table 5.5-3.

Table 5.5-3: Results of PECsoil calculation for application of GOLTIX TITAN in beets (sugar

and fodder) (soil bulk density 1.5 g/cm-3, soil depth 5 cm)

active substance/

preparation

soil relevant

application rate

(g/ha)

PECact

(mg/kg)

PECtwa

21 d

(mg/kg)

tillage

depth

(cm)

PECbkgd

(mg/kg)

PECaccu =

PECact +

PECbkgd

(mg/kg)

GOLTIX TITAN 5400 (cummulative,

no degradation)

7.2000 - - - -

metamitron

molecular weight:

202.2 g/mol

1x 1575, 3x 420 2.7561

occurring

on day 15

1.422 - - -

metabolite Desamino-

metamitron

molecular weight:

187.2 g/mol

Formation fraction:

0.5

0.8395

occurring

on day 47

0.7683 20 0.0000 0.8403


Core Assessment

GOLTIX TITAN

Registration Report

Central Zone

Page 6 of 36


Date: Feb 2016

5.6 Estimation of concentrations in surface water and sediment

(PECsw/PECsed) (KIIIA1 9.7)

PECsw and PECsed calculations are provided according to the recommendations of the FOCUS working

group on surface water scenarios in a stepwise approach considering the pathways drainage and

runoff.

The relevant input parameters used for PEC calculation are summarized in the tables below.

Table 5.6-1: Input parameters for metamitron for PECsw/sed calculations

Parameter Endpoint used for

PECsw/sed calculation

Values in

accordance to

EU endpoint in

LoEP

Remarks

Active substance metamitron

Molecular weight (g/mol) 202.2 yes

Saturated vapour

pressure (Pa)

3.01x 10-7

yes

Water solubility (mg/L) 1680 yes

Kf,oc (mL g-1) 86.4 yes Arithmetic mean

Freundlich Exponent

1/n

0.78 Arithmetic mean

DT50,soil (d) 19.1

yes in Addendum 5 (August 2008) a

DT50 of 19 days was used (Q10 of

2.2 instead of Q10 of 2.58)

DT50,water (d) 1000 yes Default value

DT50,sed (d) 11.41 yes

DT50,whole system (d) 11.41


Core Assessment

GOLTIX TITAN

Registration Report

Central Zone

Page 7 of 36


Date: Feb 2016

Table 5.6-2: Input parameters for quinmerac for PECsw/sed calculations


PECsw/sed calculation

Values in

accordance to

EU endpoint in

LoEP

Remarks

Active substance quinmerac - -

Molecular weight (g/mol) 221.64 yes -

Water solubility (mg/L) 107000 (pH 7) yes -

Kf,oc (mL g-1) 35.1 yes Deviating from first Registration

Report, in accordance with LoEP

DT50,soil (d) 17.4 yes (degradation

in soil)

Geometric mean, normalised

(20 ºC, pF2), laboratory studies.

Deviating from first Registration

Report, in accordance with LoEP.

DT50,water (d) Step 1/2:

179.4

yes Geomean of whole system (SFO,

20°C)

DT50,sed (d) Step 1/2:

179.4


20°C)

DT50,whole system (d) 179.4


20°C)

As in STEPS 1-2 in FOCUS model there is no possibility to calculate PECs resulting from combined

different application rates, use No.2 was calculated separately for the 1st application and then for the

next three applications. Resulting concentrations in surface water and sediment resulting from use

No.2 are then considered as sum of both parts of the calculations as a conservative approach.

Table 5.6-3: Input parameters related to application for PECsw/sed calculations


Use No.

2

Crop: Sugar beet

Application rate: Metamitron: 1x 1575 g/ha, 3x 525 g/ha

Quinmerac: 1 x 120 g/ha, 3 x 40 g/ha

Number of applications/interval: 4 / 5 d

Season of application (step 2): Mar.-may

Crop interception (step 2): 1st: no interception, 2.-4.: minimal crop cover

Application method (step 3): ground spray


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Table 5.6-4: FOCUS Step 3 Scenario related input parameters for PECSW/sed calculations for

the application of GOLTIX TITAN

Crop / Use No Scenario Start of application

window

End of application

window

Single application/ 4

applications

Date of

applications*

Sugar beets/ No.2 D3 111 141/ 156

20.4./ 4.5./ 14.5./

19.5

D4 120 150/ 165

14.5./ 19.5./ 27.5/

4.6.

R1 102 132/ 147 26.4./ 1.5./ 8.5./ 15.5.

R3 75 105/ 120

28.3./ 4.4./ 11.4./

16.4

*determined by the Pesticide Application Timer (PAT) of FOCUS SW

Table 5.6-5: Maximum FOCUS Step 1 and Step 2 PECsw and PECsed of metamitron for the

application of GOLTIX TITAN in beets (sugar and fodder)

Metamitron 1x 1575 g/ha

no interception

FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg)

485.25 406.74


Europe North 94.78 77.53

Europe South 176.12 147.89

Metamitron

3x 525g/ha, 5d

interval

Minimal crop

cover


485.25 406.74




Metamitron

Sum of 1575

g/ha and 3x

525 g/ha


970.5 813.48





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Table 5.6-6: Maximum FOCUS Step 1 and Step 2 PECsw and PECsed of quinmerac for the

application of GOLTIX TITAN in beets (sugar and fodder) according to use No 2

Quinmerac

1x 120 g/ha

No

interception


39.32 13.69




Quinmerac

3x 40 g/ha

5d interval

Minimal crop

cover


39.32 13.69




Quinmerac

Sum

(conservative

approach)


78.64 27.38




Table 5.6-7: Global maximum FOCUS Step 3 PECsw and PECsed values for metamitron for

the application of GOLTIX TITAN in beets (sugar and fodder) according to use

No 2

FOCUS STEP 3

Scenario,

Single application 1.575 kg/ha

Water

Body

PECsw

global max (µg/L)

PECSED global max

(µg/kg)

D3 ditch 8.253 2.252

D4 pond 0.375 0.720

D4 stream 6.852 0.395

R1 pond 0.43 0.871

R1 stream 9.401 1.893

R3 stream 9.541 3.057

FOCUS STEP 3

Scenario,

1x 1575 g/ha, 3x 525g/ha, 5d interval

Water

Body

PECsw

global max (µg/L)

PECSED global max

(µg/kg)

D3 ditch 5.544 1.576

D4 pond 0.502 1.505

D4 stream 4.640 0.617

R1 pond 1.495 2.357

R1 stream 24.089 5.431

R3 stream 53.013 14.535


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5.7 Risk assessment ground water (KIIIA1 9.6)

5.7.1 Predicted environmental concentration in groundwater (PECGW)

calculation for active substances and metabolites (Tier 1 and 2)

Groundwater contamination by direct leaching of the active substance and its metabolites, degradation

or reaction products through soil is generally assessed by groundwater model calculations. The

applicant provided a calculation with PELMO 4.4.3 and PEARL 4.4.4 according to Stangelj (2011).

This study and its results are described in Appendix 2. The zRMS did not agree with all the input

parameters used and therefore did own calculations using FOCUS PELMO 5.5.3.

The study results of Stangelj (2011) show lower PECs compared to the calculations performed by the

zRMS. The main reason might be the different parametrisation of the plant uptake factor (Stangelj

(2011): 0.5, zRMS: 0).

In the following, the calculations of the zRMS are described, the calculation of Stangelj (2011) is

found in Appendix 2.

Table 5.7-1: Application related input parameters for PECGW modelling


Use No. 2

Application rate (kg as/ha) metamitron: 1.575/ 0.42/ 0.42/ 0.42 (interception considered)

quinmerac: 0.12 / 0.032 / 0.032 / 0.032 (interception considered)

Application mode yearly (no crop rotation considered)

Crop (crop rotation) sugar beets

Relative application date(s) 4d before, 1d after, 6d after, 11d after emergence

Interception (%) 0%/ 20% / 20%/ 20%

Soil moisture 100 % FC

Q10-factor 2.58

Moisture exponent 0.7

Simulation period (years) 26

Metamitron

The PEC of metamitron and its metabolites in ground water have been assessed with standard FOCUS

scenarios to obtain outputs from the FOCUS PELMO.

Table 5.7-2: Input parameters related to metamitron for PECGW modelling

Parent Metamitron Remarks/Reference

Molecular weight (g/mol) 202.2

DT50 in soil (d) 19.1 38.2 -> Desaminometamitron, 38.2 -> M3

Kfoc 86.4 (median LoEP)

1/n 0.78


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Table 5.7-3: Input parameters related to metabolites of metamitron for PECGW modelling

Metabolite A1 Desamino-

metamitron

Remarks/Reference

Molecular weight (g/mol) 187.2

Formation fraction 0.5 DAR

DT50 in soil (d) 30.5

Kfoc 102.5

1/n 0.78

Table 5.7-4: PECGW at 1 m soil depth for metamitron and its metabolites for the application of

GOLTIX TITAN in beets (sugar and fodder)

(based on geom. mean for DT50 value and arithm. mean for Kfoc)

Use No /crop Scenario 80th Percentile PECGW at 1 m Soil Depth (µg L-1)

groundwater model: FOCUS PELMO 5.5.3

Metamitron Metabolite

Desamino-metamitron

2 /sugar beets Châteaudun < 0.001 0.010

Hamburg 0.001 0.054

Jokioinen <0.001 <0.001

Kremsmünster <0.001 0.022

Okehampton 0.001 0.070

Piacenza 0.005 0.203

Porto <0.001 0.042

Sevilla <0.001 < 0.001

Thiva <0.001 <0.001

The PECGW values for Metamitron (80th percentile at 1.0 m depth) following consecutive yearly use

(for 26 years) were significantly below the acceptable concentration limit of 0.1 µg/L in all respective

scenarios and all crops using FOCUS PELMO 5.5.3. The PECGW values for the Metamitron metabolite

Desamino-metamitron was calculated to be below 0.1 µg/L in 8 of the 9 scenarios.


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Quinmerac

The PEC of quinmerac and its metabolites in ground water have been assessed with standard FOCUS

scenarios to obtain outputs from the FOCUS PELMO 5.5.3.

Table 5.7-5: Input parameters related to quinmerac for PECGW modelling


PECGW calculation

Remarks/Reference

Molecular weight (g/mol) 221.64 -

DT50 in soil (d) 17.4 Deviating from first Registration Report, in accordance with

LoEP (EFSA, 2010)

Geometric mean normalised lab studies.*

Kfoc 35.1 Deviating from first Registration Report, in accordance with

LoEP

1/n 0.86 Arithmetic mean soils with pH ≥ 6.5 Deviating from first Registration Report, in accordance with

LoEP

plant uptake factor 0 -

* Field studies were conducted by another study sponsor and can’t be used for this application.

Table 5.7-6: Input parameters related to metabolites of quinmerac for PECGW modelling


PECGW calculation

Remarks/Reference

Metabolite 1 BH 518-2


Formation fraction 0.490 (from parent) Arithmetic mean of formation fractions from laboratory

studies with Quinmerac, LoEP

DT50 in soil (d) 29.7 Deviating from first Registration Report, in accordance with

LoEP

Kfoc 28 Kfoc of the soil with lowest pH (worst case scenario), LoEP

1/n 0.88 1/n value of the soil with lowest pH (worst case scenario),

LoEP

plant uptake factor 0

Metabolite 2 BH 518-5


Formation fraction 0.234 (from parent) Arithmetic mean of formation fractions from laboratory

studies with Quinmerac, LoEP

DT50 in soil (d) 601.5 Deviating from first Registration Report,

in accordance with LoEP

geometric mean, normalised (20ºC, pF2), laboratory studies

Kfoc 73.5 Arithmetic mean, LoEP

1/n 0.80 Arithmetic mean (without 1/n values < 0.7), LoEP

plant uptake factor 0 -


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Table 5.7-7: PECGW at 1 m soil depth for quinmerac and its metabolites for the application of

GOLTIX TITAN in beets (sugar and fodder)

(based on geom. mean for DT50 value and arithm. mean for Kfoc)

Crop/ use No. Szenario 80th percentile PECGW at 1 m soil depth (µg L-1)


quinmerac metabolite

BH 518-2

metabolite

BH 518-5

sugar beets / 2 Châteaudun 0.062 2.036 14.269

Hamburg 0.050 2.304 11.598

Jokioinen 0.022 1.665 8.939

Kremsmünster 0.049 1.784 10.02

Okehampton 0.145 2.38 7.878

Piacenza 0.103 1.743 10.075

Porto 0.117 1.449 6.023

Sevilla 0.043 1.016 13.588

Thiva 0.003 0.634 18.476

According to the PECGW modelling with FOCUS PELMO a groundwater contamination of the active

substance quinmerac at a concentration of ≥ 0.1 µg/L is not expected for all of the FOCUS

groundwater scenarios.

For the metabolite BH 518-2 a groundwater concentration of ≥ 0.1 µg/L cannot be excluded in all of

the FOCUS groundwater scenarios exept Jokioinen.

For the metabolite BH 518-5 groundwater concentrations of ≥ 0.1 µg/L cannot be excluded in all of

the FOCUS groundwater scenarios.

In addition to the tier 1 PECGW modelling a higher tier leaching assessment using experimental data

from lysimeter studies/field leaching studies for the active substance quinmerac is performed.


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5.7.2 Higher tier leaching assessment

Two lysimeter studies with quinmerac were submitted for Annex I inclusion (see DAR, 2007 and

LoEP, 2010) as higher tier studies. Results of the lysimeter study in Jülich, Germany (Mittelstaedt and

Fuehr, 1993, study no. 1993/11386) with an application in spring of 224.6 g a.s./ha and sugar beets as

treated crops are considered relevant for this assessment. The study revealed no leaching water

concentrations of quinmerac and the metabolite BH 518-5 in concentrations > 0.1 µg/L. However, the

yearly annual concentration of metabolite BH 518-2 was 6.32 µg/L.

Results of the lysimeter study in Schmallenberg, Germany with an application in autumn of 240 g

a.s./ha and oilseed rape are considered is as of limited relevance with respect to the critical use. The

maximum yearly annual concentration in the leachate were 0.06 µg/L (quinmerac), 2.35 µg/L (BH

518-2) and 0.74 µg/L (BH 518-5).

One field leaching study (Krotzky and Hesse, 1992, study no. 1992/11923) with Quinmerac has been

submitted for Annex 1 inclusion (DAR, 2007) as higher tier study. This study is of limited relevance

with respect to the critical use pattern provided in Chapter 5.2, since Quinmerac was applied with a

greater application rate of 500 g a.s./ha. The field leaching study indicated no risk of a groundwater

contamination with quinmerac and the metabolite BH 518-5 in concentrations > 0.1 µg/L. Once again,

groundwater contamination with the metabolite BH 518-2 in concentrations > 0.1µg/L could not be

excluded.

5.7.3 Summary of risk assessment for ground water

Results of modelling show that the active substance metamitron is not expected to penetrate into

groundwater at concentrations of ≥ 0.1 µg/L in the intended uses in all of the scenarios.

For the metabolite Desamino-metamitron concentrations of ≥ 0.1 µg/L in groundwater cannot be

excluded in one out of nine FOCUS groundwater scenarios in the intended uses.

As assessment of metabolite regarding their relevance for groundwater is necessary (see Section 8).


groundwater at concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites

BH 518-2 and BH 518-5 concentrations of ≥ 0.1 µg/L in groundwater cannot be excluded in all of the

FOCUS groundwater scenarios in the intended use.

Higher tier leaching studies indicate a slightly higher leaching potential of metabolite BH 518-2 and a

lower leaching potential of metabolite BH 518-5 than expected from the lower tier modelling. It has to

be considererd that the degradation rate used for modeling of metabolite BH 518-5 of DT50 = 601.5 d

is a geomean that includes several default values of 1000 d.

Furthermore, according to usual crop rotation scemes yearly applications are not expected. In the

original DAR, calculations were performed for the use every three years. However, the active

ingredient is now registered not only for the use in rape on a national level, but also for beets, for

example. This would allow a crop rotation with for example two treatment years in four years.

As assessment of metabolites regarding their relevance for groundwater is necessary (see Section 8).


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5.8 Potential of active substance for aerial transport

The vapour pressure at 20 °C of the active substance metamitron is < 10-5 Pa. Hence the active

substance metamitron is regarded as non-volatile.

The vapour pressure at 20 °C of the active substance quinmerac is < 10-5 Pa. Hence the active

substance quinmerac is regarded as non-volatile.


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Appendix 1 List of data submitted in support of the evaluation

Table A 1: List of data submitted in support of the evaluation

Annex

point/referenc

e No



company)

Report-No.

GLP or GEP status (where

relevant),

Published or not


Data

protection

claimed

Owner How considered

in dRR

Study-

Status/Usage*

KIIIA 9.6.1/01

Barrada,

M.

2014a CALCULATION OF

PREDICTED

ENVIRONMENTAL

CONCENTRATIONS IN

GROUNDWATER (PECGW)

FOR METAMITRON AND

ITS SOIL METABOLITE

DESAMINO-METAMITRON

AND FOR QUINMERAC

AND ITS SOIL

METABOLITES BH 518-2

AND BH 518-5 USING THE

MODEL SOFTWARE

FOCUS PELMO 5.5.3 AND

FOCUS PEARL 4.4.4

GAB Consulting Agrociencias

S.L.U

Quena Plant Protection N.V.

Report-no. 501833-A3-

090601-03

GLP/GEP: no

Published: no

yes QUE 3) (own

calculation by

evaluator)

OECD:

KIIIA1

9.6.1/02

Stangelj, A 2011 Calculation of predicted

environmental concentrationin

groundwater (PECGW) for

Metamitron and its soil

metabolite Desamino-

Metamitron and for Quinmerac

and its soil metabolites BH

518-2 and BH 518-5 using the

model software Pelmo 4.4.3

and Pearl 4.4.4

Y FSG 4) (but

submitted in

dossier for other

GOLTIX

TITAN use)

KIIIA 9.7.1/01

Barrada,

M.

2014b CALCULATION OF

PREDICTED

ENVIRONMENTAL

CONCENTRATIONS IN

SURFACE WATER (PECSW)

AND SEDIMENT (PECSED)

yes QUE 3) (own

calculation by

evaluator)


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*

1) accepted (study valid and considered for evaluation)

2) not accepted (study not valid and not considered for evaluation)

3) not considered (study not relevant for evaluation)

4) not submitted but necessary (study not submitted by applicant but necessary for evaluation)

5) supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)

FOR THE ACTIVE

SUBSTANCES

METAMITRON AND

QUINMERAC AND MAJOR

METABOLITES USING

FOCUS SW MODELLING

SOFTWARE AND

SCENARIOS

GAB Consulting Agrociencias

S.L.U.

Quena Plant Protection N.V.

Report-no. 501833-A3-

090701-03

GLP/GEP: no

Published: no


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Appendix 2 Detailed evaluation of studies relied upon

KIIIA 9 Fate and Behaviour in the Environment

KIIIA 9.6 Stangelj (2011)

Reference: KIIIA1 9.6

Report Calculation of predicted environmental concentration in groundwater (PECGW) for

Metamitron and its soil metabolite Desamino-Metamitron and for Quinmerac and

its soil metabolites BH 518-2 and BH 518-5 using the model software Pelmo 4.4.3

and Pearl 4.4.4, Stangelj, A.

Guideline(s): FOCUS GW

Generic Guidance for Tier 1, FOCUS Ground Water Assessments Version 2.0,

January 2011

Deviations: -

GLP: -

Summary

The Predicted Environmental Concentrations in ground water (PECGW) of Metamitron and Quinmerac

and the major soil metabolites, after the application of the product in sugar or fodder beet were

determined using the model software FOCUS PELMO 5.5.3 and FOCUS PEARL 4.4.4.

The PEC values of Metamitron and Quinmerac, as well as major metabolites in groundwater (PECGW)

have been assessed with the endpoints established in the EU review. Furthermore, additional calculations

were performed for Quinmerac and metabolites with adsorption endpoints established in the EU review

along with new data submitted.

Metamitron

Table 9.6-1: Agreed EU End-points used in the Evaluation for Metamitron and metabolite

(EFSA Scientific Report (2008) 185, 1-95)

End-Point Metamitron Desamino-metamitron

Molecular mass

[g/mol]

202.2 187.2

Solubility in water (at 20°C)

[mg/L]

1680 n.r.

Vapour pressure (at 20°C)

[Pa]

3.01 × 10-7 n.r.

KOC

[L/kg]

86.4

(median, n = 15)

102.5

(arithmetic mean, n = 4)

KOM

[L/kg]

50.1

(KOC/1.724)

59.5

(KOC/1.724)

1/n, arithmetic mean 0.78

(median, n = 15)

0.7805

(arithmetic mean, n = 4)

DT50 lab

[days] normalised to 20°C and

pF2

19

(geometric mean, n = 27)

30.5

(geometric mean, n = 9)


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Formation fraction

[%] Not applicable

0.5

(highest calculated from lab aerobic

soil metabolism study)

Plant uptake 0.5

(Brigg calculation)

0.5

(Brigg calculation)

n.r. not reported

Quinmerac

Table 9.6-2: Agreed EU End-points used in the Evaluation for Quinmerac and metabolites

(EFSA Journal 2010, 8(3):1532)

End-Point Quinmerac BH 518-2 BH 518-5

Molecular mass

[g/mol]

221.64 251.63 237.64

Solubility in water (at

pH7, 20°C) [mg/L]

107,000 n.r. n.r.

Vapour pressure (at

20°C) [Pa]

1.0 × 10-10 0

(conservative default)

0

(conservative default)

KOC

[L/kg]

35.1

(arithmetic mean, n =

8, soil pH ≥ 6.5)

28

(worst case, n = 4)

73.5


4)

KOM

[L/kg]

20.4

(KOC/1.724)

16.2

(KOC/1.724)

42.6

(KOC/1.724)

1/n, arithmetic mean

0.86


8, soil pH ≥ 6.5)

0.88

(worst case)

0.81

(mean)

DT50 soil

[days] normalised to

20°C and pF2

10.4

(normalised field,

median, n = 8)

29.7

(normalised laboratory,

geometric mean, n = 4)

601.5

(normalised

laboratory, geometric

mean, n = 4)

Formation fraction

[%] Not applicable 0.49 0.234

Plant uptake 0.5

(default)

0.5

(default)

0.5

(default)

n.r. not reported


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Metamitron

Table 9.6-3: Summary of input parameters for Metamitron for the leaching simulation models

FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3

Parameter Value Remarks

Physical-Chemical parameters

Molecular weight [g mol-1] 202.2 LoE

Phys.-chem. properties

Water solubility [mg L-1] 1680

(20°C)

LoE


Molar enthalpy of dissolution [kJ mol-1] 27 FOCUS recommendation

Vapour pressure [Pa] 3.01 × 10-7

(20°C)

LoE


Molar enthalpy of vaporization [kJ mol-1] 95 FOCUS recommendation

Diffusion coefficient in water [m² d-1] 4.3 × 10-5 (20 °C)

(PEARL) FOCUS recommendation

Diffusion coefficient in gas [m² d-1] 0.43 (20 °C) FOCUS recommendation

Degradation in soil

Desamino-metamitron

formation fraction [ - ] 0.5

LoE

Worst case

DT50 soil [d] 19

LoE

geometric mean of laboratory studies

(n=27 , normalised to 20°C and pF2)

Temperature correction function

Reference temperature [°C]

PEARL: [kJ mol-1]

PELMO: Q10 [-]

20

65.4

2.58

FOCUS recommendation

EFSA recommendation

EFSA recommendation

Moisture correction function

Reference moisture [-]

PEARL / PELMO: moisture exponent [-]

pF 2

0.7


Sorption to soil

Kf,oc [mL g-1] 86.4 LoE

median (n = 15)


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Table 9.6-3: Summary of input parameters for Metamitron for the leaching simulation models



Kf,om [mL g-1] 50.1 calculated from Koc values

(Koc = Kom × 1.7242)

Freundlich exponent 1/n [-] 0.78 LoE

median (n = 15)

Method of sorption subroutine

description pH independent

Crop/ Management related parameters

Crop uptake factor [-] 0.5 Brigg calculation

LoE list of endpoints / EFSA report3

Metamitron major metabolite – Desamino-metamitron

Table 9.6-4: Summary of input parameters for Desamino-metamitron for the leaching

simulation models FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3




Water solubility [mg L-1] n.r. -


Vapour pressure [Pa] n.r. -


Diffusion coefficient in water [m² d-1] 4.3 × 10-5 (20 °C)


Diffusion coefficient in gas [m² d-1] 0.43 (20 °C) FOCUS recommendation

Degradation in soil

DT50 soil [d] 30.5

LoE

Geometric mean of laboratory studies

(n= 9 , normalised at 20°C, pF2)



20


EFSA recommendation

2 SANCO/321/2000 rev.2, 202 pp, 2000. FOCUS groundwater scenarios in the EU review of active substances”, EC Document

Reference SANCO/321/2000 rev.2, 202 pp, 2000. 3 EFSA Scientific Report (2008) 185, 1-95; Conclusions on the peer review of metamitron


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Table 9.6-4: Summary of input parameters for Desamino-metamitron for the leaching

simulation models FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3


PEARL: [kJ mol-1]

PELMO: Q10 [-]

65.4

2.58

EFSA recommendation




pF 2

0.7


Sorption to soil

Kf,oc [mL g-1] 102.5 LoE

arithmetic mean (n = 4)


(KOC = KOM × 1.7244)


arithmetic mean (n = 4)


description pH independent


Crop uptake factor [-] 0.5 Brigg Calculation


n.r. not relevant

Quinmerac

Table 9.6-5: Summary of input parameters for Quinmerac for the leaching simulation models






Water solubility [mg L-1] 107,000 (20°C) LoE



Vapour pressure [Pa] 1.0 × 10-10 (20°C) LoE


Reference SANCO/321/2000 rev.2, 202 pp, 2000. 5 EFSA Scientific Report (2008) 185, 1-95; Conclusions on the peer review of metamitron


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Diffusion coefficient in water [m² d-1] 4.3× 10-5 (20°C)


Diffusion coefficient in gas [m² d-1] 0.43 (20°C) FOCUS recommendation

Degradation in soil

518-2

formation fraction [ - ]

518-5

formation fraction [ - ]

0.490

0.234

LoE

DT50 soil [d] 10.4 median of field studies

(n= 8, normalised to 20°C and pF2)



PEARL: [kJ mol-1]

PELMO: Q10 [-]

20

65.4

2.58


EFSA recommendation

EFSA recommendation




pF 2

0.7


Sorption to soil

Kf,oc [mL g-1]

35.1 LoE

arithmetic mean, n = 8 (soil pH ≥ 6.5)

30.9

additional calculations LoE + new

studies

arithmetic mean, n=11 (soil pH ≥ 6.5)


(KOC = KOM × 1.7246) 17.9

Freundlich exponent 1/n [-]

0.86 LoE

arithmetic mean, n = 8 (pH ≥ 6.5)

0.82

additional calculations LoE + new

studies

arithmetic mean, n=11 (soil pH ≥ 6.5)


Reference SANCO/321/2000 rev.2, 202 pp, 2000.


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description pH dependent LoE


Crop uptake factor [-] 0.5 FOCUS recommendations a

LoE list of endpoints / EFSA report7 a FOCUS recommendation: default value for

systemic substances

Quinmerac major metabolites – BH 518-2 and BH 518-5

Table 9.6-6: Summary of input parameters for metabolites BH 518-2 and BH 518-5 for the

leaching simulation models FOCUS PELMO 4.4.3 or 5.5.3 and FOCUS PEARL 4.4.4

Parameter BH 518-2 Remarks BH 518-5 Remarks


Molecular weight [g mol-1] 251.63 LoE 237.64 LoE

Water solubility [mg L-1] 1000 * LoE 1000 * LoE

Molar enthalpy of dissolution [kJ

mol-1] 27

FOCUS

recommendation 27

FOCUS

recommendation

Vapour pressure [Pa] 1.0 × 10-10

** DAR

1.0 × 10-10

** DAR

Molar enthalpy of vaporization [kJ

mol-1] 95

FOCUS

recommendation 95

FOCUS

recommendation

Diffusion coefficient in water [m²

d-1]

4.3 × 10-5

(20 °C)

FOCUS

recommendation

4.3 × 10-5

(20 °C)

FOCUS

recommendation

Diffusion coefficient in gas [m² d-

1] 0.43 (20°C)

FOCUS

recommendation 0.43 (20°C)

FOCUS

recommendation

Degradation in soil

DT50 soil [d] 29.7

Normalised

geomean from lab

studies, n=4; 20°C

601.5

Normalised

geomean from lab

studies, n=4

Formation fraction [ - ] 0.49 a LoE 0.234 a LoE



PEARL: [kJ mol-1]

20 #

0.095 +

FOCUS

recommendation #

EFSA

recommendation +

20 #

0.095 +

FOCUS

recommendation #

EFSA

recommendation +

7 EFSA Journal 2010; 8(3): 1523; Conclusion on pesticide peer review – Conclusion on peer review of the pesticide risk

assessment of the active substance quinmerac


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Page 26 of 36


Date: Feb 2016

PELMO: Q10 [-] 2.58 + 2.58 +



PEARL / PELMO: moisture

exponent [-]

pF 2

0.7

FOCUS

recommendation

pF 2

0.7

FOCUS

recommendation

Sorption to soil

Kf,oc [mL g-1] 28 LoE

(lowest value) 73.5

LoE

(arithmetic mean,

n=4)

Kf,om [mL g-1] 16.2 b - 42.6 b -


(lowest Koc value) 0.81

LoE

(arithmetic mean,

n=4)


description

pH

dependent LoE

pH

independent -


Crop uptake factor [-] 0.5 default 0.5 Default)


a maximum occurrence in soil – BH 518-2 = 42.4% and BH 518-5 = 34.7%

b calculated from KOC values (KOC= KOM × 1.7248)

* no measured value available, worst case for leaching considered

** no measured value available, default value used


Reference SANCO/321/2000 rev.2, 202 pp, 2000.


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Page 27 of 36


Date: Feb 2016

The application rate and frequency correspond to the maximum recommended application rate and

number per year. The key application data used for the modelling are summarised in the following.

Table 9.6-7: Key application data used in the FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4

calculations

FOCUS

Scenario

FOCUS

Crop / no.

of

applications

/ scheme

Interval

between

applications

Mode of

application

/ plant

uptake

Plant

interception

Application

timing

(both

models)

Application

rate

PELMO 4.4.3

& PEARL

4.4.4

Châteaudun

Hamburg

Jokioinen

Kremsmünster

Okehampton

Piacenza

Porto

Sevilla

Thiva

Sugar beet /

4 /

application

scheme B

5

Downward

spraying

overall,

every year /

0.5

1st appl.: 0%

2-4th appl.: 20%

1st appl.

four days

before

emergence

1st appl.:

3.0 L/ha

product

Metamitron:

1.575

Quinmerac:

0.120

2nd to 4th appl.:

1.0 L/ha

product

Metamitron:

0.525

Quinmerac:

0.040

A summary of calculation results is presented below in the following tables. Additionally PECGW for

Quinmerac and metabolites was calculated considering KOC and 1/n endpoints established in the EU

review along with new data submitted.

Furthermore, sugar beet will be rotated with other crops and is typically grown every third year, therefore,

the PECGW calculations for metabolites were performed assuming application onto the same area every

third year for the scenarios where the PECGW is exceeding the limit of 0.1 µg/L.


Core Assessment

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Registration Report

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Page 28 of 36


Date: Feb 2016

Metamitron

Table 9.6-8: Predicted concentrations of Metamitron in groundwater (PECGW) following

application scheme B (one pre-emergence & three post-emergence applications of 3.0 or 1.0 L AG-

QMM1-565 SC, equivalent to 1.575 or 0.525 kg Metamitron/ha) per growing season every year for

26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4 (sugar beet)

FOCUS Scenario Application dates PECGW [µg a.s./L] (80th percentile at 1 m depth)

FOCUS PELMO 4.4.3 FOCUS PEARL 4.4.4

Châteaudun 12-Apr/17-Apr/22-Apr/27-Apr < 0.001 < 0.001

Hamburg 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 < 0.001

Jokioinen 21-May/26-May/31-May/05-

Jun < 0.001 < 0.001

Kremsmünster 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 < 0.001

Okehampton 21-Apr/26-Apr/01-May/06-

May < 0.001 < 0.001

Piacenza 16-Mar/21-Mar/26-Mar/31-

Mar 0.002 < 0.001

Porto 11-Mar/16-Mar/21-Mar/26-

Mar < 0.001 < 0.001

Sevilla 6-Nov/11-Nov/16-Nov/21-Nov < 0.001 < 0.001

Thiva 27-Apr/02-May/07-May/12-

May < 0.001 < 0.001

Metamitron metabolite – Desamino-metamitron

Table 9.6-9: Predicted concentrations of Desamino-metamitron in groundwater (PECGW)

following application scheme B (one pre-emergence & three post-emergence applications of 3.0 or

1.0 L AG-QMM1-565 SC, equivalent to 1.575 or 0.525 kg Metamitron/ha) per growing season every

year for 26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4

(sugar beet)

FOCUS Scenario Application dates

PECGW [µg/L] (80th percentile at 1 m depth)

FOCUS PELMO

4.4.3 FOCUS PEARL 4.4.4

Châteaudun 12-Apr/17-Apr/22-Apr/27-Apr 0.004 0.109

Hamburg 11-Apr/16-Apr/21-Apr/26-Apr 0.017 0.050


Jun < 0.001 < 0.001


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Date: Feb 2016

Kremsmünster 11-Apr/16-Apr/21-Apr/26-Apr 0.011 0.013

Okehampton 21-Apr/26-Apr/01-May/06-May 0.034 0.034

Piacenza 16-Mar/21-Mar/26-Mar/31-Mar 0.100 0.034

Porto 11-Mar/16-Mar/21-Mar/26-Mar 0.023 0.001



May < 0.001 < 0.001

Quinmerac

Table 9.6-10: Predicted concentrations of Quinmerac in groundwater (PECGW) following


QMM1-565 SC, equivalent to 0.120 or 0.040 kg Quinmerac/ha) per growing season every year for

26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4 (sugar beets)


PECGW [µg a.s./L] (80th percentile at 1 m

depth)


Châteaudun 12-Apr/17-Apr/22-Apr/27-Apr 0.001 0.002

Hamburg 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 0.001


Jun < 0.001 < 0.001

Kremsmünster 11-Apr/16-Apr/21-Apr/26-Apr 0.001 < 0.001


May 0.003 0.001

Piacenza 16-Mar/21-Mar/26-Mar/31-Mar 0.003 0.001

Porto 11-Mar/16-Mar/21-Mar/26-Mar 0.003 < 0.001

Sevilla 6-Nov/11-Nov/16-Nov/21-Nov 0.003 < 0.001


May < 0.001 < 0.001


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Date: Feb 2016

Quinmerac metabolites – BH 518-2 and BH 518-5

Table 9.6-11: Predicted concentrations of BH 518-2 and BH 518-5 in groundwater (PECGW)


1.0 L AG-QMM1-565 SC, equivalent to 0.120 or 0.040 kg Quinmerac/ha) per growing season every


(sugar beets)

FOCUS

Scenario Application dates


BH 518-2 BH 518-5

FOCUS

PELMO

4.4.3

FOCUS

PEARL

4.4.4

FOCUS

PELMO

4.4.3

FOCUS

PEARL

4.4.4

Châteaudun 12-Apr/17-Apr/22-Apr/27-

Apr 0.876

1.620 6.309

6.794

Hamburg 11-Apr/16-Apr/21-Apr/26-

Apr 0.790

1.445 5.608

8.057

Jokioinen 21-May/26-May/31-

May/05-Jun 0.867

0.977 5.736

6.925

Kremsmünster 11-Apr/16-Apr/21-Apr/26-

Apr 0.822

1.011 5.147

6.465


May 1.128

1.182 4.750

5.882


Mar 0.710

0.583 4.889

6.298


Mar 0.733

0.435 3.922

4.408

Sevilla 6-Nov/11-Nov/16-Nov/21-

Nov 0.660

0.391 5.812

5.088


May 0.154

0.287 5.878

8.053


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Registration Report

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Page 31 of 36


Date: Feb 2016

Additional calculations for Quinmerac and metabolites (new Koc and 1/n-endpoints)

Table 9.6-12: Predicted concentrations of Quinmerac in groundwater (PECGW) following


QMM1-565 SC, equivalent to 0.120 or 0.040 kg Quinmerac/ha) per growing season every year for

26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4 (sugar beets)


PECGW [µg a.s./L] (80th percentile at 1 m

depth)


Châteaudun 12-Apr/17-Apr/22-Apr/27-Apr < 0.001 < 0.001

Hamburg 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 < 0.001


Jun < 0.001 < 0.001

Kremsmünster 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 < 0.001


May 0.001 < 0.001

Piacenza 16-Mar/21-Mar/26-Mar/31-Mar 0.001 < 0.001

Porto 11-Mar/16-Mar/21-Mar/26-Mar 0.001 < 0.001



May < 0.001 < 0.001

Table 9.6-13: Predicted concentrations of BH 518-2 and BH 518-5 in groundwater (PECGW)


1.0 L AG-QMM1-565 SC, equivalent to 0.120 or 0.040 kg Quinmerac/ha) per growing season every


(sugar beets)

FOCUS

Scenario Application dates


BH 518-2 BH 518-5

FOCUS

PELMO

4.4.3

FOCUS

PEARL

4.4.4

FOCUS

PELMO

4.4.3

FOCUS

PEARL

4.4.4

Châteaudun 12-Apr/17-Apr/22-Apr/27-

Apr 0.866 1.608 6.292 6.783

Hamburg 11-Apr/16-Apr/21-Apr/26-

Apr 0.783 1.436 5.574 8.051

Jokioinen 21-May/26-May/31-

May/05-Jun 0.857 0.967 5.726 6.912


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Page 32 of 36


Date: Feb 2016

Kremsmünster 11-Apr/16-Apr/21-Apr/26-

Apr 0.816 1.004 5.134 6.460


May 1.113 1.174 4.744 5.876


Mar 0.703 0.582 4.881 6.298


Mar 0.722 0.433 3.919 4.407

Sevilla 6-Nov/11-Nov/16-Nov/21-

Nov 0.648 0.383 5.766 5.053


May 0.152 0.283 5.854 8.028

Table 9.6-14: Summary of predicted maximum 80th percentile PECGW values for metabolites

resulting from applications every third year to beets and for scenarios exceeding the trigger value

of 0.1 µg/L –result from application scheme B

Substance Maximum 80th percentile concentrations (µg/L) of all crop relevant scenarios


Desamino-

metamitron 0.024 a 0.015 b

BH 518-2 ≤ 0.429 / ≤ 0.423* ≤ 0.591 / ≤ 0.586*

BH 518-5 ≤ 1.945 / ≤ 1.937* ≤ 2.566 / ≤ 2.556*

a only Piacenza scenario

b only Châteaudun scenario

* additional calculations with new endpoint for Quinmerac

The PECGW values for Metamitron and Quinmerac (80th percentile at 1.0 m depth) following consecutive

yearly use (for 26 years) were significantly below the acceptable concentration limit of 0.1 µg/L in all

respective scenarios and all crops using FOCUS PELMO and FOCUS PEARL models. The PECGW

values for the Metamitron metabolite – Desamino-metamitron was calculated to be below 0.1 µg/L in 8

out of 9 scenarios. In one scenario (Châteaudun) the PECGW was calculated to be slightly above the limit.

However, assuming application onto the same area every third year the resulting PECGW for the

metabolite is below the trigger for this scenario.

The PECGW values for BH 518-2 and BH 518-5 are clearly above the groundwater trigger value of 0.1

µg/L or 0.75 µg/L. Assuming application onto the same area every third year the resulting PECGW for the

metabolites BH 518-2 and BH 518-5 are considerably lower. However, the concentrations are still above

the groundwater trigger value of 0.1 µg/L or 0.75 µg/L.


Core Assessment

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Registration Report

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Page 33 of 36


Date: Feb 2016

zRMS:

IIIA 9.6.1/01

The above summary was prepared by the applicant. Values reported were compared with

the original study corrected, were necessary.

The study results show lower PECs compared to the calculations performed by the zRMS

(see chapter 5.7), even mainly the same input parameters were used. The zRMS, however,

does not use a default value of 0.5 for the plant uptake factor, and uses a value of 0. This

might be the main reason for the differences.

A second application sceme (calles application sceme A) was modelled in the study. This is

not relevant for this assessment and was deleted in the summary in order to facilitate the

overview.

As PEARL-results form Kremsmünster are of special interest for NL but were not reported

in the above summary in Table 9.6-14 for the application every third year, these values are

summarized in the following.

Predicted maximum 80th percentile PECGW values for metabolites resulting from

applications every third year to beets and for scenarios calculated with application

scheme B and FOCUS PEARL 4.4.4 :

Desamino-metamitron: <0.001 µg/L

BH 518-2: 0.311 µg/L (LoEP), 0.275 µg/L (new endpoint)

BH 518-5: 2.052 µg/L (LoEP), 1.785 µg/L (new endpoint)


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Registration Report

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Page 35 of 36


Date: Feb 2016

Appendix 3 Table of Intended Uses justification and GAP tables





active substance

safener -

synergist -




Conc. of as:

Conc. of safener: -


Applicant: company

Zone(s): northern/central/southern/EU

professional use


Verified by MS: no

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I


controlled

(additionally:




(days) Remarks:


e.g. recommended or mandatory tank

mixtures

Method /

Kind Timing /

Growth stage of

crop & season

Max. number (min.

interval between

applications)

a) per use

b) per crop/ season

kg, L product / ha



crop/season

g as/ha

a) max. rate per

appl.

b) max. total rate

per crop/season

Water L/ha

min / max

1 NL, BE

Beets (sugar and

fodder) Use already

authorised

F

GALAP and other

annual

dicotyledonous weed

species

spraying BBCH 10-19 a) 1-3 (5)

b) 3

a) 2

b) 6

a) Metamitron:

1050

Quinmerac: 80

b) Metamitron:

3150

Quinmerac: 240

200 / 400 F

Max. 2.0 L product/ha per treatment


Max. once per three years on same

field


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Page 36 of 36


Date: Feb 2016

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I


controlled

(additionally:




(days) Remarks:



mixtures

Method /

Kind Timing /

Growth stage of

crop & season

Max. number (min.

interval between

applications)

a) per use

b) per crop/ season

kg, L product / ha



crop/season

g as/ha

a) max. rate per

appl.

b) max. total rate

per crop/season

Water L/ha

min / max

2 NL, BE Beets (sugar and

fodder) F

POAAN, GALAP

and other annual

dicotyledonous weed

species

spraying

BBCH 00-09 a) 1

b) 1

a) 3

b) 3

a) Metamitron:

1575

Quinmerac: 120

b) Metamitron:

1575

Quinmerac: 120

200 / 400 F



field

BBCH 10-19 a) 1-3 (5)

b) 3

a) 1

b) 3

a) Metamitron:

525 Quinmerac:

40

b) Metamitron:

1575

Quinmerac: 120

200 / 400 F

Use No. 1 is already authorized.

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use




(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989

(f) All abbreviations used must be explained

(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of


(i) g/kg or g/l

(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,


application

(k) The minimum and maximum number of application possible under practical conditions of use

must be provided

(l) PHI - minimum pre-harvest interval

(m) Remarks may include: Extent of use/economic importance/restrictions


National Addendum– Germany

GOLTIX TITAN Registration Report

Central Zone

zRMS: Germany

Page 1 of 20

ADAMA Deutschland GmbH Evaluator: Germany (UBA)

Feb 2016

REGISTRATION REPORT

Part B

Section 5 Environmental Fate



(AG-QMM1-565 SC)

Active Substance(s): metamitron 525 g/L

quinmerac 40 g/L

Central Zone


NATIONAL ADDENDUM – Germany


Date: Feb 2016




Central Zone

zRMS: Germany

Page 2 of 20


Feb 2016


SEC 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ........................................ 3

5.1 GENERAL INFORMATION ON THE FORMULATION .................................................................................... 3 5.2 PROPOSED USE PATTERN ........................................................................................................................ 4 5.3 INFORMATION ON THE ACTIVE SUBSTANCES ........................................................................................... 5 5.4 SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ............................... 5 5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4) ........................................................................ 6 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7) ............................ 8

5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent deposition .......................... 8 5.6.2 PECSW after exposure by surface run-off and drainage ..................................................................... 9

5.7 RISK ASSESSMENT FOR GROUNDWATER (KIIIA1 9.6) ........................................................................... 10 5.7.1 Direct leaching into groundwater .................................................................................................... 11 5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and

drainage ........................................................................................................................................................ 15

APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION .......................... 17

APPENDIX 2 TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL 2014-04-14) ... 19




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zRMS: Germany

Page 3 of 20


Feb 2016

Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT

(KIIIA 9)

The exposure assessment of the plant protection product GOLTIX TITAN in its intended uses in beets

(sugar and fodder) is documented in detail in the core assessment of the plant protection product

GOLTIX TITAN dated from Feb 2016 performed by Germany.

This document comprises the risk assessment for groundwater and the exposure assessment of surface

water and soil for authorization of the plant protection product GOLTIX TITAN in Germany

according to uses listed in Appendix 2.

Regarding PECgw relevant risk mitigation measures, if necessary, are documented in this document.

PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary

(see National addendum Germany, part B, section 6 and part A).

The plant protection product GOLTIX TITAN has already been authorized in Germany in beets (sugar

and fodder) (Reg No. 007529-00-00). Therefore the exposure assessment of the intended use of

GOLTIX TITAN in beets (sugar and fodder) according to use No. 1 refers also to the German national

addendum dated from June 2012. This application is an application for label extension.

5.1 General Information on the formulation

Table 5.1-1: General information on the formulation GOLTIX TITAN

Code AG-QMM1-565 SC



Date of application 30.01.2014

Formulation type

(WP, EC, SC, …; density)

SC

Active substances (as) metamitron quinmerac -

Concentration of as (g/L) 525 40 -




Central Zone

zRMS: Germany

Page 4 of 20


Feb 2016

5.2 Proposed use pattern

The intended uses in Germany classified according the soil effective application rate (cumulative,

disregarding degradation in soil) is presented in Table 5.2-1. Full details of the proposed uses that will

be assessed is included in Appendix 2.

The intended uses in Germany (use No. 1) are covered by the core assessment performed by Germany.

Table 5.2-1: Classification of intended uses in Germany for GOLTIX TITAN

Use No* Crop/growth

stage

Application

method

Drift scenario


Minimum application

interval, application

time, interception

Application rate,

cumulative

(g as/ha)

Soil effective

application rate

(g as/ha)

00-001 beets (sugar and

fodder) /

BBCH 0-19

Spraying /

arable crops

4 x, 5 d, 11.04, 16.04,

21.04, 26.04

1. 0 %

2.-4. 20 %

metamitron

1 x 1575

3 x 525

quinmerac

1 x 120

3 x 40

metamitron

1 x 1575

3 x 420

quinmerac

1 x 120

3 x 32

* For administrative purposes, each intended use of a plant protection product in Germany is assigned with an

individual use number from the German Federal Office of Consumer Protection and Food Safety (BVL). A

complete list of the individual GAPs in Germany together with their assigned use numbers is given in Appendix

2 of this Addendum.




Central Zone

zRMS: Germany

Page 5 of 20


Feb 2016

5.3 Information on the active substances

Please refer to the German national addendum of GOLTIX TITAN (Reg No. 007529-00-00) dated

from June 2012.




5.4 Summary on input parameters for environmental exposure assessment

Please refer to the German national addendum of GOLTIX TITAN (Reg No. 007529-00-00) dated

from June 2012.







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Feb 2016

5.5 Estimation of concentrations in soil (KIIIA1 9.4)

Results of PECsoil calculation for GOLTIX TITAN according to EU assessment considering 5 cm soil

depth are given in the core assessment, part B, section 5, chapter 5.5.

According to section 6 of the first Registration Report for GOLTIX TITAN the TER values in soil for

quinmerac and its soil metabolites were above the respective TER values for metamitron and far above

the trigger. Therefore it was concluded that no calculation of PECsoil for quinmerac and its soil

metabolites is necessary, as the risk is covered by the assessment of metamitron and the formulation.

For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler,

Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittel-

wirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben

FKZ 360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of

2.5 cm is applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. As

soil bulk density 1.5 g cm-3 is assumed.

Due to the fast degradation of the active substance metamitron in soil (DT90 < 365 d) the accumulation

potential of Metamitron does not need to be considered.

The PECsoil calculations were performed with ESCAPE 2.0 based on the input parameters as presented

in Table 5.5-1.

Table 5.5-1: Input parameters for GOLTIX TITAN for PECsoil calculation

Active substance DT50

metamitron 22 d (Maximum Field studies, 1st order)

Metabolite Desamino-

metamitron

39.7 d (Maximum Field studies, 1st order)

Additional PECsoil,act was calculated for the formulation GOLTIX TITAN for a soil depth of 2.5 cm.

No short-term and long-term PECsoil were calculated for the formulation since PECsoil,act is considered

sufficient for German risk assessment.




Central Zone

zRMS: Germany

Page 7 of 20


Feb 2016

The calculated PECsoil used for German risk assessment for metamitron and quinmerac as well as for

the formulation GOLTIX TITAN are summarized in Table 5.5-2.

Table 5.5-2: Results of PECsoil calculation for the intended use in beets used for German risk

assessment

plant protection product: GOLTIX TITAN

use: 01-001

Number of applications/intervall 4x, interval 5d

application rate: 6L product/ha ( 3/ 1/ 1/ 1)

crop interception: 0% / 20/ 20/ 20 %

active substance/

formulation

soil relevant

application rate

(g/ha)

soil depthact

(cm)

PECact

(mg/kg)

tillage

depth (cm)

PECbkgd

(mg/kg)

PECaccu =

PECact +

PECbkgd

(mg/kg)

GOLTIX TITAN 5400

(cummulative, no

degradation)

2.5 14.4000 - - -

Metamitron 1x 1575, 3x 420 2.5 5.5123 on

d 15

- - -

Metabolit Desamino-

metamitron

Formation

fraction: 0.5

2.5 1.6790

occurring

on day 47

20 0.0007 1.6798




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5.6 Estimation of concentrations in surface water and sediment (KIIIA1 9.7)

Results of PECsw calculation of metamitron and quinmerac for the intended uses of GOLTIX TITAN

in beets (sugar and fodder) using FOCUS Surface Water are given in the core assessment, part B,

section 5, chapter 5.6.

For authorization in Germany, exposure assessment of surface water considers the two routes of entry

(i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in

order to allow risk mitigation measures separately for each entry route.

Surface water exposure via spray drift and volatilization with subsequent deposition is estimated with

the model EVA 2.1. Surface water exposure via surface run-off and drainage is estimated using the

model EXPOSIT 3.0.

The aquiatic toxicity of the formulated product GOLTIX TITAN (AG-QMM1-565 SC) is mainly

driven by the active substance metamitron, as an evaluation of the toxicity per fraction under

consideration of the respective endpoints for quinmerac and metamitron show (please refer to the core

assessement of the first application (Reg No. 007529-00-00), Sect. 6, point 6.16.1). Therfore, no

aquatic PEC values for quinmerac were calculated.

The German surface water exposure assessment is outlined in the following chapters.

5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent

deposition

The calculation of concentrations in surface water is based on spray drift data by Rautmann and

Ganzelmeier. The vapour pressure at 20 °C of the active substance metamitron is < 10-5 Pa. Hence the

active substance metamitron is regarded as non-volatile. Therefore exposure of surface water by the

active substance metamitron due to deposition following volatilization does not need to be considered.

The calculation of PECsw after exposure via spray drift and volatilization with subsequent deposition

is performed using the model EVA 3. For a single application, the exposure assessment via spray drift

is based on the application rate in conjunction with the 90th percentile of the drift values. For multiple

applications, lower percentiles of the drift values for each application are applied, resulting in an

overall 90th percentile of drift probabilities. Only one volatilization event following the last use of

pesticide is generally considered.

The endpoints used for modelling of surface water exposure via spray drift and volatilization with

subsequent deposition with EVA 3 are summarized below.

Table 5.6-1: Endpoints of metamitron used for the PECSW calculations with EVA 3

Parameter Metamitron Reference

vapour pressure (Pa) not required since no v/d See core assessment,

Solubility in (mg/L) not required since no v/d

DissT50 water (d) 11.55 SFO (worst case) see CA 7529

DegT50 water/sediment study,

total system (d)

only water phase is considered




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Feb 2016

The calculated PECsw values after exposure via spray drift for metamitron for the intended use of

GOLTIX TITAN in beets (sugar and fodder) according to use No 001 are presented in the National

addendum Germany, part B, section 6, chapter 6.5 considering the following input parameters related

to the application.

Table 5.6-2: Input parameters for GOLTIX TITAN used for PECSW calculations with EVA 3

Use No.: 001

Number of applications/ interval 4 x/ 5d

Application rate

Metamitron: 1575 g/ha/ 525 g/ha/ 525 g/ha/ 525 g/ha

Drift scenario Arable crops

5.6.2 PECSW after exposure by surface run-off and drainage

The concentration of the active substance metamitron in adjacent ditch due to surface runoff and

drainage is calculated using the model EXPOSIT 3.01.

The substance specific input parameters used for modelling surface water exposure via run-off and

drainage in an adjacent ditch with EXPOSIT 3.01 are summarized in chapter 5.7.2 of this document.

The calculated PECSW in an adjacent ditch due to surface run-off and drainage for the active substance

metamitron for the intended use of GOLTIX TITAN in beets (sugar and fodder) according to use No.

1 are presented in the National addendum Germany, part B, section 6, chapter 6.5 considering the

following input parameters related to the application.

Table 5.6-3: Input parameters related to the application for PECsw calculations with Exposit

3.01

Use No.: 001

Number of applications/ interval: 4, interval of 5d

Application rate

(g a.s./ha)

Metamitron: 1x 1575 g/ha, 3x 525g/ha

Crop interception: 0%/ 20% /20% /20%




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Feb 2016

5.7 Risk assessment for groundwater (KIIIA1 9.6)

Results of the PECgw calculation of metamitron and quinmerac for the intended uses of GOLTIX

TITAN in beets (sugar and fodder) according to EU assessment using FOCUS PELMO are given in

the core assessment, part B, section 5, chapter 5.7.

For authorization in Germany, risk assessment for groundwater considers two pathways, (i) direct

leaching of the active substance into the groundwater after soil passage and (ii) surface run-off and

drainage of the active substance into an adjacent ditch with subsequent bank filtration into the

groundwater.

Direct leaching after soil passage is assessed following the recommendations of the publication of

Holdt et al. 2011 (Holdt et al: Recommendations for simulations to predict environmental

concentrations of active substances of plant protection products and their metabolites in groundwater

(PECGW) in the National assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011)

for tier 1 and tier 2 risk assessment. According to Hold et al, 2011, endpoints for groundwater

modelling are derived with the program INPUT DECISION 3.1 and subsequent simulations are

performed for the groundwater scenarios “Hamburg” or with the scenarios “Hamburg” and

“Kremsmünster” of FOCUS PELMO.

In tier 3 risk assessment, results of experimental studies (lysimeter studies and/or field leaching

studies) can also be considered in German groundwater risk assessment.

Surface run-off and drainage into an adjacent ditch with subsequent bank filtration into the

groundwater are estimated using the model EXPOSIT 3.

The German risk assessment for groundwater is given in the following chapters.




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Feb 2016

5.7.1 Direct leaching into groundwater

5.7.1.1 PECGW modelling

The worst case scenario used for PECgw modelling is summarized in Fehler! Verweisquelle konnte

nicht gefunden werden. following table. It covers the intended uses of GOLTIX TITAN in beets

according to Table 5.2-1 (see also Appendix 2).

Table 5.7-1: Input parameters related to application for PECGW modelling with FOCUS

PELMO 5.5.3

use evaluated 00-001

application rate (kg as/ha) Metamitron: 1x 1.575 , 3x 0.42 ( interception considered)

crop (crop rotation) Sugar beet

date of application 11.4./ 16.4./ 21.4./ 26.4

interception (%) 0/ 20/20/20 %

soil moisture 100 % FC

Q10-factor 2.58

moisture exponent 0.7

plant uptake Quinmerac: 0*,

Metamitron: 0.5 and for the metabolites : 0**

simulation period (years) 26

* The plant uptake factor for Quinmerac and its soil metabolites BH 518-2 and BH 518-5 was set to 0 in

order to simulate a worst case scenario in tier 1 modelling as proposed in Holdt et al. (2011). In tier 2

modelling the PECgw can be refined by experimental determination of the substance specific plant

uptake factor (FOCUS 2009). This approach should be developed in close collaboration between the

notifier and the responsible authority (Holdt et al., 2011).

** The use of the plant uptake factor 0 for the metabolites deviates from the input parameters in

the core assessment where a plant uptake factor of 0.5 was used.




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Feb 2016

Metamitron

The endpoints used for groundwater modelling for Metamitron and its metabolites Desamino-

metamitron and M3 according to INPUT DECISION 3.1 are summarized in the following table.

Table 5.7-2: Input parameters related to Metamitron for PECGW modelling

Parent Metamitron Remarks/Reference to Part B, Section 5,

Core assessment

molecular mass 202.2


Kfoc Kf: 1.45/ 1.45/ 1.45/ 0 /0

/0

Deviation from the input parameters in the

core assessment: Use of horizon specific

Kf-values for Metamitron according to

Input_Decision_3_2 instead of the median

KOC value 86.4 used in the LoEP.

1/n 0.77

Metabolite Desamino-metamitron A1 in metabolism schema

molecular mass 187.2

Formation fraction 0.5


Kfoc 102.5

1/n 0.78

The results of the groundwater simulation are presented in Table 5.7-3.

Table 5.7-3: PECGW at 1 m soil depth of Metamitron and its metabolites Desamino-

metamitron considered relevant for German exposure assessment

Use No. Szenario

80th Percentile PECGW at 1 m Soil Depth (µg L-1) modeled by FOCUS

PELMO 5.5.3

Metamitron Metabolite Desamino-metamitron

001 Hamburg <0.001 0.032

According to the results of the groundwater simulation with FOCUS-PELMO 5.5.3, a groundwater

contamination of the active substance Metamitron in concentrations of ≥ 0.1 µg/L is not expected for

the intended use in sugar beet.

For the metabolite Desamino-metamitron a groundwater concentration of ≥ 0.1 µg/L can be excluded

for the application in sugar beet according to the results of the groundwater simulation with FOCUS-

PELMO 5.5.3.




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Feb 2016

Quinmerac

The endpoints used for groundwater modelling for quinmerac and its metabolites in the core

assessment are regarded as worst case endpoints, that would be also used for national assessment.

Therefore no additional calculation with national endpoints is considererd necessary.

The results of the groundwater simulation are presented in Table 5.7-4. As a pH-dependency was

stated for the sortion behavior, the scenario Kremsmünster is relevant additionally to Hamburg.

Table 5.7-4: PECGW at 1 m soil depth of quinmerac and its metabolites considered relevant for

German exposure assessment (yearly application assumed for modelling)

Use No. Szenario

80th Percentile PECGW at 1 m soil depth (µg L-1) modeled by FOCUS

PELMO 5.5.3

quinmerac Metabolite BH 518-2 Metabolite BH 518-5

001 Hamburg 0.050 2.304 11.598


In addition to the PECgw modelling experimental data from lysimeter studies/ field leaching studies

are used to assess the leaching behaviour of the active substance quinmerac.

5.7.1.2 Experimental data to the leaching behaviour

Quinmerac

Two lysimeter studies with quinmerac were submitted for Annex I inclusion (see DAR, 2007 and

LoEP, 2010) as higher tier studies. Results of the lysimeter study in Jülich, Germany (Mittelstaedt and

Fuehr, 1993, study no. 1993/11386) with an application in spring of 224.6 g a.s./ha and sugar beets as

treated crops are considered relevant for this assessment. The study revealed no leaching water

concentrations of quinmerac and the metabolite BH 518-5 in concentrations > 0.1 µg/L. However, the

yearly annual concentration of metabolite BH 518-2 was 6.32 µg/L.

Results of the lysimeter study in Schmallenberg, Germany with an application in autumn of 240 g

a.s./ha and oilseed rape are considered is as of limited relevance with respect to the critical use. The

maximum yearly annual concentration in the leachate were 0.06 µg/L (quinmerac), 2.35 µg/L (BH

518-2) and 0.74 µg/L (BH 518-5).

One field leaching study (Krotzky and Hesse, 1992, study no. 1992/11923) with Quinmerac has been

submitted for Annex 1 inclusion (DAR, 2007) as higher tier study. This study is of limited relevance

with respect to the critical use pattern provided in Chapter 5.2, since Quinmerac was applied with a

greater application rate of 500 g a.s./ha. The field leaching study indicated no risk of a groundwater

contamination with quinmerac and the metabolite BH 518-5 in concentrations > 0.1 µg/L. Once again,

groundwater contamination with the metabolite BH 518-2 in concentrations > 0.1µg/L could not be

excluded.




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Feb 2016

5.7.1.3 Summary on risk assessment for groundwater after direct leaching

Results of modelling show that the active substance metamitron is not expected to penetrate into

groundwater at concentrations of ≥ 0.1µg/L is not expected to penetrate into groundwater at

concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolite Desamino-metamitron

concentrations of ≥ 0.1µg/L in groundwater can be excluded.


groundwater at concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites

BH 518-2 and BH 518-5 concentrations of ≥ 0.1 µg/L in groundwater cannot be excluded in all of the

FOCUS groundwater scenarios in the intended use.

Higher tier leaching studies indicate a slightly higher leaching potential of metabolite BH 518-2 and a

lower leaching potential of metabolite BH 518-5 than expected from the lower tier modeling. It has to

be considererd that the degradation rate used for modeling of metabolite BH 518-5 of DT50 = 601.5 d

is a geomean that includes several default values of 1000 d.

Furthermore, according to usual crop rotation scemes yearly applications (as assumed in modeling) are

not expected. In the original DAR, calculations were performed for the use every three years.

However, the active ingredient is now registered not only for the use in rape on a national level, but

also for beets, for example. This would allow a crop rotation with for example two treatment years in

four years.

As a result, the active substance quinmerac is not expected to penetrate into groundwater at

concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites BH 518-2 and

BH 518-5 concentrations of ≥ 0.1 µg/L cannot be excluded, but it is expected that concentrations

remain below 10 µg/L.


none




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Feb 2016

5.7.2 Ground water contamination by bank filtration due to surface water

exposure via run-off and drainage

Metamitron

The input parameters for metamitron used for modelling surface water exposure via run-off and

drainage in an adjacent ditch with subsequent bank filtration into the groundwater with EXPOSIT 3.0

are summarized in Table 5.7-5.

Table 5.7-5: Input parameters for Metamitron used for PECGW calculations with EXPOSIT

3.01

Parameter Metamitron

K foc, Runoff 122

Kfoc, mobility class 37

DT50 soil (d) 22

Solubility in water (mg/L) 1680

Mobility class 3

Reduction by bank filtration 90%

The calculated PECgw for Metamitron after surface run-off and drainage with subsequent bank

filtration are summarized in Table 5.7-6.

Table 5.7-6: PECgw for Metamitron after surface run-off and drainage with subsequent bank

filtration (modelled with EXPOSIT 3.01 )


Use No. application

rate

interception

PECgw due to

run-off drainage

vegetated buffer

strip

(m)

bank filtrate

(µg/L)

Time of

application

bank filtrate

(µg/L)

001 1x 1575, 3x

525g/ha with

an interval of

5d,

interception:

0/ 20/20/20%

0 0.144 autumn/winter/

early spring Not relevant

5 0.124

10 0.107 spring/summer 0.047

20 0.075

required labelling yes

According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L

by the active substance Metamitron due to surface run-off and drainage into the adjacent ditch with

subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of

20 m) are applied




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Feb 2016

Quinmerac

It can be concluded from the original Registration Report (reg. no. 007529-00-00) that the calculated

PECs of quinmerac and its metabolites are far below the trigger of 0.1 µg/L in a comparable use.

Therefore, a calculation for this use is not necessary.


The authorization of the plant protection product GOLTIX TITAN is linked with following labeling:

Use No. 001 NG 404




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Feb 2016


No additional data for national assessment submitted.



GOLTIX TITAN Tstst Registration Report

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Page 19 of 20


Feb 2016

Appendix 2 Table of Intended Uses in Germany (according to BVL 2014-04-14)








Zone(s): central/EU

professional use X


Verified by MS: yes

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I


controlled

(additionally:




(days) Remarks:


e.g. recommended or


Method /


stage of crop &

season

Max. number

(min. interval

between

applications)

a) per use

b) per crop/

season

kg, L product /

ha

a) max. rate per

appl.

b) max. total rate

per crop/season

g, kg as/ha

a) max. rate

per appl.

b) max. total

rate per

crop/season

Water L/ha

min / max

001 DE Sugar beet

BEAVA

fodder beet

BEAVC

F TTTMS

TTTDS

Spraying

splitting 4

applications

Spring

BBCH 00 – 19


emergence


after emergence

a) 4

b) 4

the 2nd to 4th

treatment with

an interval of 5

to 10 days

a)

timing 1:

3 L/ha

timing 2-4:

1 L/ha

a)

timing 1:

Metamitron

1575 g as/ha

Quinmerac

120 g as/ha

timing 2-4:

Metamitron

525 g as/ha

Quinmerac

40 g as/ha

200 - 400 *XF



GOLTIX TITAN Tstst Registration Report

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Page 20 of 20


Feb 2016

b) 6 L/ha

maximum

application rate

for the intented

crop per year

b)

Metamitron

3150 g as/ha

Quinmerac

240 g as/ha

maximum

application rate

for the intented

crop per year

*The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in

days is not required resp.












application









(L/ha)




Core Assessment

GOLTIX TITAN Draft Registration Report

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Page 1 of 55

Applicant: ADAMA Evaluator: zRMS DE

Date May 2015

REGISTRATION REPORT

Part B

Section 6: Ecotoxicological studies



(AG-QMM1-565 SC)

Active Substances: Metamitron 525 g/L

Quinmerac 40 g/L

Central Zone


CORE ASSESSMENT

Applicant: ADAMA

Date: May 2015


Core Assessment


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Page 2 of 55


Date May 2015

Table of Contents SEC 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)............................................................ 5

6.1 GAP AND OVERALL CONCLUSIONS .................................................................................................. 6

6.1.1 Table of intended uses ............................................................................................................ 6

6.1.2 Grouping of intended uses for risk assessment ...................................................................... 7

6.1.3 Consideration of metabolites .................................................................................................. 8

6.2 EFFECTS ON BIRDS (MIIIA 10.1, KPC 10.1, KPC 10.1.1) ................................................................. 9

6.2.1 Justification for new endpoints ............................................................................................ 10

6.2.2 Risk assessment (MIIIA 10.1.1, MIIIA 10.1.2) for spray applications ................................ 10

6.2.3 Biomagnification in terrestrial food chains .......................................................................... 18

6.2.4 Risk assessment (MIIIA 10.1.3, MIIIA 10.1.4, MIIIA 10.1.5) for baits, pellets, granules,

prills or treated seed ............................................................................................................. 18

6.2.5 Overall conclusions .............................................................................................................. 18

6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC

10.1.2) .................................................................................................................................................... 18


6.3.2 Risk assessment (MIIIA 10.3.1) for spray applications ....................................................... 19

6.3.3 Biomagnification in terrestrial food chains .......................................................................... 28

6.3.4 Risk assessment (MIIIA 10.3.1) for baits, pellets, granules, prills or treated seed .............. 28


6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC

10.1.3) .................................................................................................................................................... 28

6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1) ...................................... 29


6.5.2 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) ........................................... 33


6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1) .................................................................................. 38

6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ..................................... 38


6.7.2 Risk assessment .................................................................................................................... 38


6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1,

KPC 10.4.2) ............................................................................................................................................ 44


6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna, TERA and

TERLT (MIIIA 10.6.1) .......................................................................................................... 46

6.8.3 Higher tier risk assessment ................................................................................................... 47


6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) .................................................. 47


6.9.2 Risk assessment .................................................................................................................... 49


6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) .......................................................... 50

6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) ........................................................ 50


6.11 EFFECTS ON OTHER TERRESTRIAL ORGANISMS (FLORA AND FAUNA) (KPC 10.7) ......................... 53

6.12 MONITORING DATA (KPC 10.8) ..................................................................................................... 53

6.13 AVAILABLE PRELIMINARY DATA (IIIA 10.9) .................................................................................. 53

6.14 OTHER/SPECIAL STUDIES (IIIA 10.10) ............................................................................................ 53

APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ................. 54

APPENDIX 2 DETAILED EVALUATION OF THE NEW STUDIES .............................................. 55


Core Assessment


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Page 3 of 55


Date May 2015


Core Assessment


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Page 5 of 55


Date May 2015

Sec 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)

This document reviews the ecotoxicological studies for the product GOLTIX TITAN containing the active

substances Quinmerac and Metamitron, which is currently approved under Reg. (EC) No 1107/2009

(repealing Directive 91/414/EEC) and fulfils the criteria according to commission implementing regulation

(EU) No 546/2011, Annex, Part I C , 2.

GOLTIX TITAN (AG-QMM1-565 SC) was not the representative formulation considered in the EU review

process as part of Annex I inclusion. The studies with the relevant endpoints for each non-target organism

group were agreed during EU review process and are used for the risk assessment. Reference is made to

the following documents, if not otherwise labelled with an asterisk:

Quinmerac: EFSA Conclusion: EFSA Journal 2010; 8(3):1523

Metamitron: EFSA Conclusion: EFSA Scientific Report (2008) 185, 1-95

Full details of toxicity studies are provided in the respective EU DAR. The applicant provides further

studies with the formulation GOLTIX TITAN and for the active substances Quinmerac, Metamitron and

its major metabolites. This Registration Report 007529-00-01 is a label extension to Registration Report

007529-00-00. Detailed study summaries for the studies performed with the formulated product GOLTIX

TITAN and for other new studies are presented in Registration Report 007529-00-00 GOLTIX TITAN.


Core Assessment

GOLTIX TITAN

Draft Registration Report

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Page 6 of 55


Date April 2015

6.1 GAP and overall conclusions

6.1.1 Table of intended uses

Table 6.1-1: GAP and overall conclusions

Intended

use F/G

Timing

(months,

BBCH)

Max number

appl. (interval

in days)

Application per treatment Overall conclusions

kg a.s./ha

max

Rate/season

[kg a.s./ha]

max

Birds Aquatic

organisms Mammals Bees

Non-target

arthropods

Soil

organisms

Non-target

plants

2 (sugar- and

fodder beets) F

BBCH 0-

19 4

Metamitron:

3150

Quinmerac

240

6.0 L prod./ha,

max. once per

three years on

same field

X X X1

Please refer

to the risk

assessemnt

outcome as

provided by

JKI

X X X

F: Field use; G: Glasshouse use

Remarks:

Safe use identified

Further refinement and/or risk mitigation measures are needed

No safe use identified and considered possible

Explanations:

The colours in the Table 6-1 are intended to reflect the outcome of the assessments including the available and valid refinement steps and risk mitigations measures.

Remarks “X1”: acceptability criteria TER>5 is not total reached for focal species “woodmouse” Apodemus sylvaticus, further refinement on national level is

necessary


Core Assessment


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Page 7 of 55


Date May 2015

6.1.2 Grouping of intended uses for risk assessment

The following table lists the grouping of the intended uses in order to perform a risk envelope approach.

Please not: provided Registration Report 00759-00-01 is a label extension of product GOLTIX TITAN

007529-00-00.

Table 6.1-2: Critical use pattern of GOLTIX TITAN (label extension)

Use Crop/growth

stage

Application

method /

Drift scenario


Minimum application

interval, interception,

application time

(season)

Application rate,

cumulative

(g as/ha)

Soil effective

application rate

(g as/ha)

2 beets (sugar and

fodder) /

BBCH 0-19

Spraying /

arable crops

4 x, 5 d,

1. 0 %

2.-4. 20 %,

Spring,

1x 3L prod./ha +

3x 1L prod./ha

metamitron

1 x 1575

3 x 525

quinmerac

1 x 120

3 x 40

metamitron

1 x 1575

3 x 420

quinmerac

1 x 120

3 x 32

Table 6.1-3: Critical use pattern of GOLTIX TITAN grouped according to soil relevance, drift scenario and crop scenario

Groups – Soil relevance

Group Intended uses Application rate (Interception) Soil relevant effective appl. rate, cumulative

[g/ha] [g/ha]

B01 2 Metamitron: 1 x 1575

3 x 525

Quinmerac: 1 x 120

3 x 40

Application:

4 x, 5 d,

1. 0 %

2.-4. 20 %,

spring

Metamitron: 1 x 1575

3 x 420

Quinmerac: 1 x 120

3 x 32

Groups – Drift szenario

Group Intended uses Application rate Drift scenario

[g/ha]

D01 2 Metamitron: 1 x 1575

3 x 525

Quinmerac: 1 x 120

3 x 40

74th percentile

Groups – Birds and mammals

Group Intended uses Application rate Crop scenario [g/ha]

V01S01 2 Metamitron: 1 x 1575 Bare soil,


Core Assessment


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Page 8 of 55


Date May 2015

3 x 525

Quinmerac: 1 x 120

3 x 40

Root and stem vegetables

6.1.3 Consideration of metabolites

The metabolites which require an ecotoxicological assessment according to the endpoint list are given

below.

Copy the following tables from section 5.

Table 6.1-4: Metabolites of active substance Metamitron potentially relevant for exposure

assessment (> 10 % of as or > 5 % of as in 2 sequential measurements or > 5 % of a.s. and maximum of formation not yet reached at the end of the study)

Metabolite Structural formula/Molecular

formula

occurrence in compartments (Max. at day/

Status of Relevance (EFSA Conclusion: EFSA

Scientific Report (2008) 185,

1-95)

Metamitron

Desamino-

metamitron

C10H9N3O

Soil: max. 17.1% on day 30

Surface water: max. 54% on

day 58

Sediment: max. 27.5% on day

58

No

M3, not

identified

Soil: Transient, 2x>5% No information available,

assessment of confirmatory

data pending

1) According to Guidance Document on the assessment of the relevance of metabolites in groundwater of substances regulated

under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25 February 2003)

Table 6.1-5: Metabolites of active Quinmerac potentially relevant for exposure assessment

(> 10 % of as or > 5 % of as in 2 sequential measurements or > 5 % of a.s. and maximum of formation not yet reached at the end of the study)

Metabolite Structural

formula/Molecular

formula

occurrence in compartments

(Max. at day/

Status of Relevance

(EFSA Conclusion: EFSA

Journal 2010; 8(3):1523)

N

NH

N

O

Me


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BH 518-2

N

COOH

Cl

O OH

C11H6ClNO4

Soil:

Aerobic degradation:

Max. 29.1 % TAR after 30 d

(at 20 °C and 40 % MWHC)


(at 5 °C and 60 % FC)

Anaerobic degradation:


Field studies:

73.1 % max. TAR after 98 d

Surface water:


(at the end of the study)

Risk to soil and aquatic

organisms assessed as low.

BH 518-5

NCl

O OH

OH

C11H8ClNO3

Soil:

Aerobic degradation:


(20 °C and 50 % MWHC)


(10 °C and 60 %FC)

Anaerobic degradation:


(at the end of study)

Field studies:

76.4 % TAR max. after 30 d

EFSA conclusion:

Acute risk to soil organisms

assessed as low

Long-term risk to earthworms

needs to be adressed further .

Risk to aquatic organisms

assessed as low.

1) According to Guidance Document on the assessment of the relevance of metabolites in groundwater of substances

regulated under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25 February 2003)

6.2 Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1)

Table 6.2-1: Endpoints used for risk assessment for birds

Species Substance Exposure

System

Results Reference Internal

code

Colinus virgianus Quinmerac Acute LD50 > 2000 mg

a.s./kg bw/d

XXX

1987

Project

No.11W0100/8633

28982

Coturnix coturnix

japonica

Quinmerac Long-term NOEL = 173 mg

a.s./kg bw/d

XXX

1999

147-180

49934

Coturnix coturnix

japonica

Quinmerac Long-term LOAEL = 11 mg

a.s./kg bw/d*

(=100 ppm)

XXX

2010

25301

76731

Coturnix coturnix

japonica

Metamitron acute LD50 = 1302 mg/kg

bw/d (female)

XXX

07.02.1992

90 10 42 250

29712

Colinus

virginianus

Metamitron Long-term NOAEL = 81.5

mg/kg bw/day

XXX

28.02.1992

VB-015

38429


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* New study submitted by applicant in core assessment of GOLTIX titan and already evaluated by RMS. Please refer to the

Registration Report for Goltix titan, part B, Section 6 of the core assessment for Central Zone Dec. 2012.

6.2.1 Justification for new endpoints

A new long term study with Coturnix coturnix japonica using Quinmerac (XXX 2010) was submitted by

applicant in core assessment of GOLTIX titan and already evaluated by RMS. Please refer to the

Registration Report for Goltix titan, part B, Section 6 of the core assessment for Central Zone Dec. 2012.

6.2.2 Risk assessment (MIIIA 10.1.1, MIIIA 10.1.2) for spray applications

The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for

Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438).

Exposure to standard generic focal species was estimated according to the Guidance Document on Risk

Assessment for Birds and Mammals (EFSA Journal 2009; 7(12): 1438)

∑

∑

×××=

××××

=

i

i

i

totali

PTARRUDbw

FIR

PTARRUDbw

FIRPDDDD

where:

DDD = Daily dietary dose (mg/kg bw/day)

PDi = composition of diet obtained from treated area

FIRi = Food intake rate of indicator species i (g fresh weight/d)

bw = Body weight (g)

RUD = Residue per unit dose, bases on an application rate of 1 kg a.s./ha and assuming

broadcast seedling

AR = Application rate (kg/ha)

PT = Proportion of diet obtained in the treated area (0…1)

In a first approach, it is assumed that birds do not avoid contaminated food items, that they feed exclusively

in the treated area and on a single food type. Factors PT and PD are therefore equal to 1.

The risk assessment procedure follows a stepwise approach. A first screening step involves standard

scenarios and default values for the exposure estimate, representing a “reasonable worst case”. If a risk is

indicated in the screening step, then one or several refinement steps (Tier 1, Tier2) may follow. According

to the Guidance Document, no further assessment is required if all uses are safe in the screening step.

Mixture toxicity

According to Appendix B to the Guidance Document on the Risk assessment for birds and mammals

(EFSA, 1438/2009), the basic concept of the risk assessment is that animals are exposed to residues of the

active substances in the environment. Thus, the assessment for GOLTIX TITAN does not evaluate the

formulation toxicity as such, but the effects of an exposure to a mixture of active substances in the

environment, resulting from the use of the formulation. Toxicity studies for birds with formulated products

are typically not available. For the assessment of acute effects, a surrogate LD50 is calculated. Sublethal


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effects and effects on reproduction are assessed on a case-by-case basis. A model often used to estimate the

toxicity of mixtures is the assumption of dose/concentration additivity of toxicity (Finney approach of

concentration additivity of toxicity; Finney 1948 and 1971).

The following formula is used to derive a surrogate LD50 for the mixture of active substances with known

toxicity assuming dose additivity:

( )( )

( )

1

50

50..

..−

= ∑

i i

i

saLC

saXmixLD

where:

X(a.s. i) = fraction of active substance (i) in the mixture expressed as:

X(Metamitron) = 525 g a.s./kg / (525 g Metamitron/kg + 40 g Quinmerac/kg) = 0,93

X(Quinmerac) = 40 g a.s./kg / (525 g Metamitron/kg + 40 g Quinmerac/kg) = 0,07

LD50(a.s. i) = acute toxicity value for active substance (i)

Because of the direct proportionality of the calculated TER to the LD50, it is possible to calculate a

TER(mix) with the following formula:

1

)TER(a.s.

1TER(mix)

−

= ∑

i i

where:

TER(a.s.i)= calculated TER for the active substance i

6.2.2.1 Screening assessment

In the screening step, the risk to indicator bird species from an exposure to GOLTIX TITAN is assessed.

These indicators are considered to have highest exposure in a specific crop at a particular time due to their

size and feeding habits and represent a worst case scenario.

To estimate the daily dietary doses, following equations were used:

Daily dietary dose (DDD):

DDDsingle application = application rate [kg a.s./ha] × shortcut value1

1 see section 4.1 of EFSA/2009/1438

In case of multiple applications, the daily dietary dose for a single application is multiplied with an

appropriate multiple application factor for 90th percentile residue data (MAF90; see Table 7 of

EFSA/2009/1438 ).A specific MAF90 may be calculated according to Appendix H of EFSA/2009/1438 for

non-standard application intervals.

DDDmultiple application = DDDsingle application × MAF901


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Toxicity exposure ratio (acute):

bw/day) (mg/kg DDD Acute

bw/day) mg/kg(LD=TER 50

A

The results of the acute and reproductive screening risk assessments are summarized in the following tables.

Table 6.1.2.1-1: Acute screening assessment for birds

Intended use Indicator species Endpoint SV MAF90 DDD TER

[g/ha] [mg/kg bw] (GD)

Combined toxicity, TER mix

Intended use 2 (1 x 1575 g

Metamitron./ha +

3 x 525 g Metamitro./ha

and 1 x 120 g

Quinmerac/ha +

3 x 40 g Quinmerac/ha)

Bare soil

Small granivorous

bird

17.7


Metamitron./ha +


and 1 x 120 g

Quinmerac/ha +


Sugar beet

Small omnivorous

bird

2.7

Metamitron


a.s./ha +

3 x 525 g a.s./ha)

Bare soil

Small granivorous

bird

1302 24.7 1.8 70.025 18.6


a.s./ha +

3 x 525 g a.s./ha)

Sugar beet

Small omnivorous

bird

1302 158.8 1.8 450.198 2.9

Quinmerac


a.s./ha +

3 x 40 g a.s./ha)

Bare soil

Small granivorous

bird

>2000 24.7 1.8 5.335 375


a.s./ha +

3 x 40 g a.s./ha)

Sugar beet

Small omnivorous

bird

>2000 158.8 1.8 34.301 58

SV: shortcut value; MAF90: multiple application factor (90th percentile); DDD: daily dietary dose; TER: toxicity to exposure

ratio. TER values shown in bold fall below the relevant trigger.


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Table 6.2-2: Reproductive screening assessment for birds

Intended use Indicator species Endpoint SV MAFm DDD TER

[g/ha] [mg/kg bw/d]



Metamitron./ha +


and 1 x 120 g

Quinmerac/ha +


Bare soil

Small granivorous

bird

2.5


Metamitron./ha +


and 1 x 120 g

Quinmerac/ha +


Sugar beet

Small omnivorous

bird

0.4

Metamitron


a.s./ha +

3 x 525 g a.s./ha)

Bare soil

Small granivorous

bird

81.5 11.4 2.2x0.53 20.936 3.9


a.s./ha +

3 x 525 g a.s./ha)

Sugar beet

Small omnivorous

bird

81.5 64.8 2.2x0.53 119.0 0.7

Quinmerac


a.s./ha +

3 x 40 g a.s./ha)

Bare soil

Small granivorous

bird

11 11.4 2.2x0.53 1.595 6.9


a.s./ha +

3 x 40 g a.s./ha)

Sugar beet

Small omnivorous

bird

11 64.8 2.2x0.53 9.067 1.2



According to EFSA/2009/1438, the calculation of a combined toxicity is not applicable to the risk

assessment of reproductive effects. Due to differences in evaluated endpoints and the dependency of the

derived NOEL of the test design, any calculated TERmix value can only be used for illustrating purposes.

Hence, in the case of an unacceptable TERmix, it has to be discussed if the results of the toxicity studies

present any evidence for a possible concentration additivity of the effects and risks.

6.2.2.2 Tier 1 risk assessment

In the Tier 1 risk assessment step, the defined daily dietary doses and TER values were calculated for so-

called generic focal species (see EFSA 1438/2009, Annex I). As for the indicator species, the generic focal


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species are considered to be representative for all species potentially at risk. In the Tier 1 assessment, a

mixed diet approach is followed when appropriate and interception of the spray by the crop is taken into

account for the calculation of residue levels for different food types.

If more than one generic focal species is relevant for the crop, the one that is relevant in terms of time of

application or growth stage should be selected. If more than one generic focal species is relevant in terms

of application time and growth stage, then the risk should be assessed for all relevant generic focal species.

If the same generic focal species is relevant for several application times according to the BBCH growth

stages, the risk assessment for this generic focal species is conducted once using the highest mean short-

cut value, since this mirrors a realistic worst case scenario.

For Metamitron, the TERA was below the trigger of 10 in the screening step for the intended uses in sugar

beets. Therefore, a Tier 1 risk assessment step will be performed for these uses.

The results of the acute and reproductive Tier 1 risk assessments are summarized in the following tables.

For acute risk assessment in “bare soil” screening step was sufficient for assessement. Higher tier

assessment is needed for “sugar beet” growth stage.

Table 6.2-3: Acute tier 1 risk assessment for birds for the GOLTIX TITAN/Combined risk, Metamitron and Quinmerac

Intended use Generic focal

species

Generic diet

composition

Endpoint SV MAF90 DDDA TER

[mg/kg bw/d] [mg/kg bw/d]

Intended use 2 Combined toxicity (1 x 1575 g Metamitron./ha + 3 x 525 g Metamitro./ha and 1 x 120 g

Quinmerac/ha + 3 x 40 g Quinmerac/ha), sugar beet

Early spring

BBCH 10 - 19

Small

omnivorous

bird “lark”

18.2

BBCH 10 - 19 Small

omnivorous

bird “wagtail”

40.1

Intended use 2 (1 x 1575 g Metamitron./ha + 3 x 525 g Metamitron/ha), sugar beet

Early spring

BBCH 10 - 19

Small

omnivorous

bird “lark”

1302 10.9 1.8 68.040 19.1

BBCH 10 - 19 Small

omnivorous

bird “wagtail”

1302 5.9 1.8 30.902 42.1

Intended use 2 (1 x 120 g Quinmerac/ha + 3 x 40 g Quinmerac/ha), sugar beet

Early spring

BBCH 10 - 19

Small

omnivorous

bird “lark”

2000 24 1.8 5.184 385.8

BBCH 10 - 19 Small

omnivorous

bird “wagtail”

2000 10.9 1.8 2.354 849.5


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For reproductive risk assessment refinement is needed for “bare soil” and “sugar beet” stage.

Table 6.2-4: Reproductive Tier-1 risk assessment for birds for Metamitron


species

Generic diet

composition

Endpoint SV MAFx

twa

DDDA TER


Intended use 2 (1 x 1575 g a.s./ha + 3 x 525 g a.s./ha), bare soil and sugar beet

Bare soil

BBCH <10

Sugar beet

BBCH 10 19

Small

granivorous

bird “lark”

81.5 Worst

case

10.9

2.2x0.53 20.017 4.1

Bare soil

BBCH 10- 19

Sugar beet

BBCH 10- 19

Small

insectivorous

bird “wagtail”

81.5 5.9

5.9

2.2x0.53 10.835 7.5

Bare soil

BBCH <10

Small

granivorous

bird “finch”

81.5 11.4 Worst

case

2.2x0.53

21.007 3.9

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values

shown in bold fall below the relevant trigger.

Refinement needed for Metamirton for small granivorous bird “lark”on bare soil and in sugar beet and for

small granivorous bird “finch” in bare soil.

Table 6.2-5: Reproductive Tier-1 risk assessment for birds for Quinmerac


species

Generic diet

composition

Endpoint SV MAFx

twa

DDDA TER


Intended use 2 (1 x 120 g Quinmerac/ha + 3 x 40 g Quinmerac/ha), bare soil and sugar beet)

Bare soil

BBCH <10

Sugar beet

BBCH 10 19

Small

granivorous

bird “lark”

11.0 Worst

case

10.9

2.2x0.53 1.530 7.2

Bare soil

BBCH 10- 19

Sugar beet

BBCH 10- 19

Small

insectivorous

bird “wagtail”

11.0 5.9

5.9

2.2x0.53 0.828 13.3


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Bare soil

BBCH <10

Small

granivorous

bird “finch”

81.5 11.4 Worst

case

2.2x0.53

0.725 15.2

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values


6.2.2.3 Higher tier risk assessment for Metamitron in agriculture

Table 6.2-6: Refinement of reproductive risk assessment for lark exposed to Metamitron according to EFSA Journal (2009) in intended use 2. For details see text

Intended use Generic focal species

Generic diet composition

Endpoint SV MAFx twa

DDDA TER



Bare soil

BBCH <10

Sugar beet

BBCH 10 19

Small

granivorous

bird “lark”

81.5 Worst

case

10.9

2.2x0.53 20.017 4.1

Refinement: more realistic application scenario: lark is focal species for bare soil stages BBCH <10 and

for sugar beet scenarios BBCH 10- 19 1x 1575 g Metamitron./ha in bare soil BBCH <10, SV “lark”= 8.2,

and 3x 525 g Metamitron/ha on sugar beet BBCH 10-19, SV “lark” = 10.9.

For each application date a DDD will be calculated without residue dynamic. Residue dynamic is

considered in twa calculation DT50 (default)= 10d, twa-intervall: 21 d

Bare soil

BBCH <10

Sugar beet

BBCH 10 19

Small

granivorous

bird “lark”

81.5 8.2

10.9

Overall DDD

12.915

6.33

Table 6.2-7: Refinement of reproductive risk assessment for finch exposed to Metamitron

according to EFSA Journal (2009) in intended use 2. For details see text


species

Generic diet

composition

Endpoint SV MAFx

twa

DDDA TER




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Bare soil

BBCH <10

Small

granivorous

bird “finch”

81.5 11.4 Worst

case

applica-

tion

2.2x0.53

21.007 3.9

Refinement: finch is focal species for bare soil stages BBCH < 10 but not for sugar beet scenarios BBCH 10- 19,

no MAF will be used for application design, more realistic application rate: 1x 1575 g Metamitron/ha

Bare soil

BBCH <10

Small

granivorous

bird “finch”

81.5 11.4 1x0.53 9.516 8.6

6.2.2.4 Drinking water exposure

Due to the characteristics of the exposure scenario in connection with the standard assumptions for water

uptake by animals (see below), no specific calculations of exposure and TER are necessary when the ratio

of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case

of less sorptive substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500

L/kg). The puddle scenario has been taken into account to calculate the exposure concentration of GOLTIX

TITAN (AG-QMM1-565 SC) formed on a field after rainfall. The ratios do not exceed the value of 50 for

Metamitron (Koc = 122.3 L/kg) and Quinmerac (Koc = 35.1 L/kg), thus it is not necessary to conduct a

drinking water risk assessment for birds.

A comparison of the relevant endpoints with the effective application rates for Metamitron and Quinmerac

is presented below.

Table 6.2-8: Application rate to endpoint ratios for birds exposed to Metamitron and Quinmerac

Intended

use

Exposure

Scenario

Effective

application rate*

Koc LD50/NOEL Ratio

Application Rate :

endpoint

[g a.s./ha]* [L/kg] [mg a.s./kg bw]

Metamitron

Intended

use 2

Acute Total:

3150

122.3 1302 <50

Long-term 81.5 <50

Quinmerac

Intended

use 2

Acute Total:

240

35.1 >2000 <50

Long-term 11 <50

* effective application rate = application rate multiplied by mean MAF

6.2.2.5 Effects of secondary poisoning (MIIIA 10.1.9)

The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a

log Kow ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6


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"Bioaccumulation and food chain behaviour"). ). Since the log Kow values of Quinmerac. and Metamitron

are 1.41 (pH=7) and 0.85 respectively, these active substances are deemed to have a negligible potential to

bioaccumulate in animal tissues. No formal risk assessment from secondary poisoning is therefore required.

6.2.3 Biomagnification in terrestrial food chains

Not relevant.

6.2.4 Risk assessment (MIIIA 10.1.3, MIIIA 10.1.4, MIIIA 10.1.5) for baits, pellets,

granules, prills or treated seed

Not relevant.

6.2.5 Overall conclusions

Dietary risk assessment

Based on tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from

an exposure of birds to Metamitron and Quinmerac (oral exposure and exposure via drinking water and

secondary poisoning) according to the GAP of the formulation GOLTIX TITAN achieve the acceptability

criteria TER ≥ 10 resp. TER ≥ 5, according to commission implementing regulation (EU) No 546/2011,

Annex, Part I C, 2. Specific principles, point 2.5.2. for acute effects. The results of the assessment indicate

an acceptable acute and long-term risk for birds due to the intended use of GOLTIX TITAN in agriculture

according to the label.

Risk assessment for exposure via drinking water

Based on the calculation of the risk arising from the uptake of Metamitron and Quinmerac via drinking

water , the calculated TER values for birds exposed to the active substances Metamitron and Quinmerac

according to the GAP of the formulation GOLTIX TITAN achieve the acceptability criteria TER ≥ 5,

according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific

principles, point 2.5.2. for long-term effects.

Risk assessment for exposure via secondary poisoning

Since the log Kow values of Quinmerac. and Metamitron are 1.41 (pH=7) and 0.85 respectively, these active

substances are deemed to have a negligible potential to bioaccumulate in animal tissues. No formal risk

assessment from secondary poisoning is therefore required.


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6.3 Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1,

KPC 10.1.2)

Table 6.3-1: EU agreed endpoints and new endpoints


System


code

Rat Quinmerac Acute oral

toxicity

LD50 >5000 mg

a.i./kg bw/d

XXX

1987

1987/040

76812

Mouse Metamitron Acute oral

toxicity

LD50 = 644 mg

a.i./kg bw/d

XXX

30.10.1996

25596 /T

8060723

77874

Rabbit Quinmerac Long-term

toxicity and

reproduction

NOAEL = 30

mg/kg a.s./kg bw /d

LOAEL = 100

mg/kg a.s./kg bw/d

XXX

1987

BASF RegDoc

1988/0506

76867

Rat Metamitron Long-term

toxicity and

reproduction

NOAEL = 36.4 mg

a.s/kg bw/d (male)

NOAEL = 53.8 mg

a.s/kg bw/d (female)

XXX

08.11.1993

TOXI.ES-991-

RP-G2

76422

Rat GOLTIX TITAN

(AG-QMM1-565)

Acute oral

toxicity

LD50 > 2000 mg

prod./ kg bw/day

XXX

02.07.2010

25392

77820


Not necessary.

6.3.2 Risk assessment (MIIIA 10.3.1) for spray applications

The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for

Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438). Please see 6.2.2 for detailed

information on the estimation of daily intake rates and the assessment of mixture toxicity.

6.3.2.1 Screening assessment

For the estimation of Daily dietary doses (DDD) and the calculation of TER values, please see 6.2.2.1.

The results of the acute and reproductive screening risk assessments are summarized in the following tables.

Table 6.3-2: Acute screening assessment for mammals

Intended use Indicator species Endpoint SV MAF90 DDD TER



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Metamitron./ha +


and 1 x 120 g

Quinmerac/ha +


Bare soil

Small granivorous

mammal

15.64


Metamitron./ha +


and 1 x 120 g

Quinmerac/ha +


Sugar beet

Small herbivorous

mammal

1.89

Metamitron


a.s./ha +

3 x 525 g a.s./ha)

Bare soil

Small granivorous

mammal

644 14.4 1.8 18.711 15.8


a.s./ha +

3 x 525 g a.s./ha)

Sugar beet

Small herbivorous

mammal

644 118.4 1.8 335.664 1.9

Quinmerac


a.s./ha +

3 x 40 g a.s./ha)

Bare soil

Small granivorous

mammal

>5000 14.4 1.8 3.110 1607


a.s./ha +

3 x 40 g a.s./ha)

Sugar beet

Small herbivorous

mammal

>5000 118.4 1.8 25.574 965.5



Table 6.3-3: Reproductive screening assessment for mammals

Intended use Indicator species Endpoint SV MAFm DDD TER

[g/ha] [mg/kg bw/d] [mg/kg

bw/d]



Metamitron./ha +

3 x 525 g Metamitro./ha and

1 x 120 g Quinmerac/ha +


Bare soil

Small granivorous

mammal

2.92


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Metamitron./ha +

3 x 525 g Metamitro./ha and

1 x 120 g Quinmerac/ha +


Sugar beet

Small herbivorous

mammal

0.39

Metamitron


a.s./ha +

3 x 525 g a.s./ha)

Bare soil

Small granivorous

mammal

36.4 6.6 2.2x0.53 12.121 3.0


a.s./ha +

3 x 525 g a.s./ha)

Sugar beet

Small herbivorous

mammal

36.4 48.3 2.2x0.53 88.701 0.4

Quinmerac


a.s./ha +

3 x 40 g a.s./ha)

Bare soil

Small granivorous

mammal

100 6.6 2.2x0.53 0.923 108.3


a.s./ha +

3 x 40 g a.s./ha)

Sugar beet

Small herbivorous

mammal

100 48.3 2.2x0.53 6.758 14.8

SV: shortcut value; MAFm: multiple application factor (mean); DDD: daily dietary dose; TER: toxicity to exposure ratio. TER

values shown in bold fall below the relevant trigger.

According to EFSA/2009/1438, the calculation of a combined toxicity is not applicable to the risk

assessment for reproductive effect. Due to differences in evaluated endpoints and the dependency of the

derived NOEL of the test design, any calculated TERmix value can only be used for illustrating purposes.

Hence, in the case of an unacceptable TERmix, it has to be discussed if the results of the toxicity studies

present any evidence for a possible concentration additivity of the effects and risks.

6.3.2.2 Tier-1 risk assessment

For the estimation of Daily dietary doses (DDD) and the calculation of TER values, please see 6.2.2.2.

The results of the acute and reproductive Tier 1 risk assessments are summarized in the following tables.

Table 6.3-4: Acute tier 1 risk assessment for birds for the GOLTIX TITAN/Combined risk,

Metamitron and Quinmerac


species

Generic diet

composition


[mg/kg

bw/d]

[mg/kg

bw/d]



BBCH 10 - 19 Small

insectivorous

mammal “shrew”

29.61


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BBCH 10 – 39 Large herbivorous

mammal

“lagomorph””

6.43

BBCH 10- 39 Small omnivorous

mammal “mouse”

13.07


BBCH 10 - 19 Small

insectivorous

mammal “shrew”

644 7.6 1.8 21.546 29.9


mammal

“lagomorph””

644 35.1 1.8 99.509 6.5


mammal “mouse”

644 17.2 1.8 48.762 13.2


BBCH 10 - 19 Small

insectivorous

mammal “shrew”

>5000 7.6 1.8 1.642 3045.

8


mammal

“lagomorph””

>5000 35.1 1.8 7.582 659.5


mammal “mouse”

>5000 17.2 1.8 3.715 1345.

8



Further refinement for acute risk assessment for product GOLTIX TITAN and active substance Metamitron

for large herbivorous mammal “lagomorphs” is needed.

Table 6.3-5: Reproductive Tier-1 risk assessment for terrestrial vertebrates other than birds for Metamitron


species

Generic diet

composition

Endpoint SV MAF DDDLT TER

[g/ha] [mg/kg

bw/d]


Bare Soil

BBCH 10 - 19 Small

omnivorous

mammal

“mouse”

Small omnivorous

mammal “mouse”

36.4 5.7 2.2x0.5

3

10.504 3.5

Sugar beet

BBCH 10 – 39

Small

insectivorous

mammal “shrew”

36.4 4.2 2.2x0.

53

7.740 4.7

BBCH 10- 39 Large

herbivorous

36.4 14.3 2.2x0.

53

26.351 1.4


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mammal

“lagomorph”

BBCH 10- 39 Small

omnivorous

mammal

“mouse”

36.4 7.8 2.2x0.

53

14.373 2.5

SV: shortcut value; MAF: multiple application factor. DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values


Further refinement for reproductive risk assessment for active substance Metamitron for small omnivorous

mammal “mouse” in bare soil is needed and for small insectivorous mammal “shrew”, large herbivorous

mammal “lagomorphs” and small omnivorous mammal “mouse” in sugar beet.

6.3.2.3 Higher tier risk assessment for GOLTIX TITAN/ combined risk and for

Metamitron in sugar beets (KPC 10.1.2.2)

Table 6.3-6: Refinement of acute risk assessment for large herbivorous mammals “lagomorphs” exposed to Metamitron according to EFSA Journal (2009) in sugar beets. For details see text

Intended use Generic focal species

Generic diet composition


[mg/kg

bw/d]

[mg/kg

bw/d]




mammal

“lagomorph””

6.43

Using refined values for Metamitron for focal species “Lagomorph”( Refinement: lagomorph is focal species for

sugar beet stages BBCH 10-39 but not for bare soil scenarios BBCH <10, MAF for 3x application = 1.6,

application rate: 3x 525 g Metamitron/ha)


mammal

“lagomorph””

Metamitron:

644

Quinmerac:

>5000

35.1

35.1

1.6

1.8

29.484

7.582

21.8

659.5

Combi

ned

Tox.

Result

=

21.1



mammal

“lagomorph””

644 35.1 1.8 99.509 6.5


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Refinement: lagomorph is focal species for sugar beet stages BBCH 10-39 but not for bare soil scenarios BBCH

<10, MAF for 3x application = 1.6, application rate: 3x 525 g Metamitron/ha


mammal

“lagomorph””

644 35.1 1.6 29.484 21.8



mammal

“lagomorph””

>5000 35.1 1.8 7.582 659.5

No further refinement for acute risk assessment for product GOLTIX TITAN and active substances

Metamitron ans Quinmerac for mammals is needed.

Further refinement for reproductive risk assessment for active substance Metamitron for small

omnivorous mammal “mouse” in bare soil is needed and for small insectivorous mammal “shrew, large

herbivorous mammal “lagomorphs” and small omnivorous mammal in sugar beet.

Table 6.3-7: Refinement of reproductive risk assessment for small omnivorous mammals “mouse”, small insectivorous mammal “shrew” and large herbivorous mammals

“lagomorphs” exposed to Metamitron according to EFSA Journal (2009) in sugar beets. For details see text

Intended use

Species/BBCH stage

Diet composition

MAFx twa

FIR/ bw

PD RUD PT DDD Endpoint TER

[mg/kg

bw/d]

[mg/kg

bw/d]

Wood mouse, Intended use 2 (1 x 1575 g a.s./ha + 3 x 525 g a.s./ha),

02 Sugar beet

BBCH 10-

39

Apodemus

sylvaticus

25% non-

grass herbs

2.2x0.

53

0.07 1 28.7 1 3.518 36.4

2.6

25% ground

arthropods

(with

interception)

2.2x0.

53

0.07 1 3.5 1 0.429

50%weed

seeds 2.2x0.

53

0.13 1 40.2 1 9.854

Wood mouse

Early stages of beet fields do not provide sufficient plant cover for small mammals. Studies estimating the reaction

of wood mice to fields with sparse vegetation will help to estimate the exposure more realistically.

In the study conducted by Todd et al. (2000)1 23 wood mice were radio tracked in winter and spring (November –

March) and 56 in summer (June – August) in arable habitat. The preferred macrohabitat of the wood mouse in arable

land were hedgerows. In the study conducted by Tew et al. (2000)2 48 wood mice were radio tracked and

1 Todd I.A., Tew T.E. and Macdonald D.W. (2000): Arable habitat use by wood mice (Apodemus sylvaticus). 1.

MacrohabitatJ.Zoo., Lond. 250, 299-303 2 Tew, T. E., Todd, I. A. & Macdonald, D. W. (2000): Arable habitat use by wood mice (Apodemus sylvaticus). 2. Microhabitat.

Journal of Zoology (London), 250, 305-311.


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microhabitats were recorded. In their study they found that wood mice avoided foraging in areas with a high

abundance of bare earth. On such fields, predatory risk to feeding mice is high. This finding is also confirmed by

Green (1979)3, who showed that fields with bare soil surface are not attractive feeding areas for mammals.

The predominant feeding habitats of a wood mouse are thick grass, woodland, arable land, heather and sand dunes

(Mammals Bible4). They need cover protection for themselves and their offspring such as stone walls, hedgerows,

gardens and even buildings if unoccupied. Beet fields at early BBCH stages do not provide such cover. Due to the

absence of cover protections, it is unlikely that wood mouse will exclusively forage in beet fields in early BBCH

stages. Thus a reduced PT value of 0.8 is much more realistic and will be considered in a refined risk assessment.

02

Sugar beet

BBCH 10-

39

Apodemus

sylvaticus

25% non-

grass herbs

2.2x0.

13*

(refer

to

refine

ment

of

rabbit)

0.07 1 28.7 0.8 0.690 4.1

25% ground

arthropods

(with

interception)

2.2x0.

53

0.07 1 3.5 0.8 0.343

50%weed

seeds 2.2x0.

53

0.13 1 40.2 0.8 7.883

Rabbit

02

Sugar beet

BBCH 10-

39

Rabbit

Oryctolagus

cuniculus

100% non-

grass herbs

2.2x0.

53

0.50 1 28.7 1 26.327 36.4 1.4

3 Green, R. 1979. The ecology of Wood mice (Apodemus sylvaticus) on arable farmland. Journal of Zoology, 188: 357–377. 4 Gurney, J. E., Perett, J., Crocker, D. R. & Pascual, J. A. (1998): Mammal bible. Mammals and farming: information for risk

assessment. Contract PN0910/PN0919. pp. 2-223. York: Central Science Laboratory; Project No. M37


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Refinement for rabbit:

Refinement of ftwa: The use of the same time window (21 days), and a DT50 value from the residue studies (please

refer to EFSA Report (2008)) resulted in a refined ftwa for Metamitron. For a refined exposure assessment, initial

residue levels on beets and their time-dependent decrease were calculated by use of measured residue levels

determined in residue studies with Metamitron. A twa-value of 0.13 was considered in the following risk

assessment which was calculated using a DT50 value of 1.9 days (based on residue decline studies; please refer to

EFSA Report (2008) List of Endpoints) for foliar residues. According to EFSA Report (2008) of Metamitron the

apparent short foliar half-life of Metamitron is also supported by the results of four German residue field studies in

which, following spray applications of formulated Metamitron, the high initial measured residues of Metamitron

were found to be reduced to non-significant level. The evidence is considered sufficient to support use of a DT50 of

1.9 days for foliar residues in the refined risk assessment.

02

Sugar beet

BBCH 10-

39

Rabbit

Oryctolagus

cuniculus

100% non-

grass herbs

2.2x0.

13

0.50 1 28.7 1 6.457 36.4 5.6

Shrew: no further refinement was provided by applicant. There is still a light undercut of acceptability criteria

TER >5 for focal species “common shrew”. No refined assessment was done until that point. A light

refinement of PD (composition of diet obtained from treated area) or PT (proportion of an animal´s diet

obtained in habitat treated with pesticide) would reach TER >5. As presented in CRD Mammals Bible

(2007) feeding habitat for Sorex araneus is wher low vegetation provides cover, particularly in thick

grass and scrub, hedgerows and deciduous woodland. Thus the shrew will not stay total searching for

food on treated area. Also as presented in Mammal bible food of Sorex araneus do not consist of 100%

ground arthropods, but particulary also on earthworms and snails. In total the risk for common shrew

should be acceptable, also with a light undercut of acceptability criteria.

02

Sugar beet

BBCH 10-

19

Common

shrew

Sorex

araneus

100%

ground

arthropods

without

interception

2.2x0.

53

0.55 1 7.5 1 7.623 36.4 4.8

SV: shortcut value; MAF: multiple application factor. DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values


There is still a very light undercut of acceptability criteria TER >5 for focal species common shrew caused

by active substance Metamitron. As shown in refinement there are different possibilities in further

refinement options (for instance according to information in frequency of feeding habitat use and food

consumption).

There is still a light undercut of acceptability criteria TER >5 for focal species woodmouse Apodemus

sylvaticus caused by active substance Metiram. On the ZONAL HARMONISATION WORKSHOP

HIGHER TIER BIRDS AND MAMMALS in Wageningen, June 2014 there were a discussion about

changing trigger values for vole and mouse, but majority of MS were not willing to change trigger values

of vole and mouse.

In higher tier assessment approaches, member states might check refinement options considering their

national environmental conditions and agricultural sceneries to reach a save use for wood mouse too.


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6.3.2.4 Drinking water exposure

Due to the characteristics of the exposure scenario in connection with the standard assumptions for water

uptake by animals (see below), no specific calculations of exposure and TER are necessary when the ratio

of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case

of less sorptive substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500

L/kg). The puddle scenario has been taken into account to calculate the exposure concentration of GOLTIX

TITAN (AG-QMM1-565 SC) formed on a field after rainfall. The ratios do not exceed the value of 50 for

Metamitron (Koc = 122.3 L/kg) and Quinmerac (Koc = 35.1 L/kg), thus it is not necessary to conduct a

drinking water risk assessment for birds.

A comparison of the relevant endpoints with the effective application rates for Metamitron and Quinmerac

is presented below.

Table 6.3-8: Application rate to endpoint ratios for mammals exposed to Metamitron and Quinmerac

Intended

use

Exposure

Scenario

Effective

application rate*

Koc LD50/NOEL Ratio

Application Rate :

endpoint

[g a.s./ha]* [L/kg] [mg a.s./kg bw]

Metamitron

Intended

use 2

Acute Total:

3150

122.3 644 <50

Long-term 36.4 >50 refinement needed

(puddle scenario)

Quinmerac

Intended

use 2

Acute Total:

240

35.1 >5000 <50

Long-term 100 <50

* effective application rate = application rate multiplied by mean MAF

Puddle scenario

Table 6.3-9: Exposure of mammals to the active substance Metamitron via contaminated drinking water in puddles and calculated toxicity exposure ratio

Substance Crop Time

scale

Indicator

species

Endpoint

Concentration

in runoff/

puddles

KFOC

PEC

puddle

TER

[mg a.s./kg bw/d]

[mg/L] [ml/g] [mg/L]

Metamitron

acute Apodemus

sylvaticus

644

787.5 122.3 0.77

3466.2

long-

term 36.4 195.9


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6.3.2.5 Effects of secondary poisoning (MIIIA 10.3.2.3)

The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a

log Kow ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6

"Bioaccumulation and food chain behaviour"). ). Since the log Kow values of Quinmerac. and Metamitron

are 1.41 (pH=7) and 0.85 respectively, these active substances are deemed to have a negligible potential to

bioaccumulate in animal tissues. No formal risk assessment from secondary poisoning is therefore required.

6.3.3 Biomagnification in terrestrial food chains

Not relevant.

6.3.4 Risk assessment (MIIIA 10.3.1) for baits, pellets, granules, prills or treated seed

Not relevant.


Dietary risk assessment

Based on higher tier assessment step, the calculated TER values for the acute and long-term risk resulting

from an exposure of mammals to Quinmerac and Metamitron (oral exposure and exposure via drinking

water and secondary poisoning) according to the GAP of the formulation GOLTIX TITAN achieve the

acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission implementing regulation (EU) No

546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute effects. The results of the assessment

indicate an acceptable acute and long-term risk for mammals due to the intended use of GOLTIX TITAN

in beets according to the label. Further refinement for long-term risk for woodmouse Apodemus sylvaticus

may be needed on national level.

Risk assessment for exposure via drinking water

Based on the calculation of the risk arising from the uptake of Quinmerac and Metamitron via drinking

water , the calculated TER values for mammals exposed to the active substances Quinmerac and

Metamitron according to the GAP of the formulation GOLTIX TITAN achieve the acceptability criteria

TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific

principles, point 2.5.2. for long-term effects.

6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC

10.1.3)

Not yet considered.


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6.5 Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1)

Table 6.5-1: Endpoints used for risk assessment for aquatic organisms for Quinmerac and its relevant metabolites


System


code

[mg a.s./L]

Oncorhynchus

mykiss

Quinmerac 96 h LC50 = 86.8 mg

a.s./L

XXX

1987

Report No.12F100/86

28978

Oncorhynchus

mykiss

Quinmerac 28 d NOEC = 3.16 mg

a.s./L

XXX

1990

Project

No.42F0100/865133

28979

Daphnia magna Quinmerac 48 h EC50 > 100 mg

a.s./L

Jatzek, H.-J.

2000

99/0703/50/1

49764

Daphnia magna Quinmerac 48 h EC50 > 100 mg

a.s./L

Kuhl, R., Deierling, T.

2009

49684220

76753

Daphnia magna Quinmerac 21 d NOEC ≥ 100 mg

a.s./L

Jatzek H.-J.

2003

02/0103/51/1

49770

Daphnia magna Quinmerac 21 d NOEC = 10 mg

a.s./L

Kuhl, R., Wydra, V.

2010

49686221

76763

Anabaena flos-

aquae

Quinmerac 72 h EbC50 > 100 mg

a.s./L

ErC50 > 100 mg

a.s./L

Kubitza, J.

2000

58020

49765

Anabaena flos-

aquae

Quinmerac 72 h EbC50 > 100 mg

a.s./L

ErC50 > 100 mg

a.s./L

Kuhl, R., Deierling, T.

2010

49682210

76765

Lemna gibba Quinmerac 7 d EbC50 = 96 mg

a.s./L

ErC50 > 100 mg

a.s./L

Dohmen, G.P.

1996

36449

49769

Lemna gibba Quinmerac 7 d EbC50 = 16 mg

a.s./L

ErC50 > 32 mg

a.s./L

Kuhl, R. Deierling, T.

2009

49685240

76772

Metabolites of Quinmerac

Oncorhynchus

mykiss

BH 518-2 96 d LC50 (96h) >

100 mg/L

XXX

1992

Report

No.12F0516/915092

28990

Oncorhynchus

mykiss

BH 518-5 96 h LC50 (96h) >

100 mg/L

XXX

2000

49781


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12F0305/995040

Oncorhynchus

mykiss

BH 518-5 96 d LC50 (96h) > 100

mg/L

XXX

2010

49704230

76752

Oncorhynchus

mykiss

BH 518-2 28 d NOEC = 0.32

mg/L (no study,

assumption: 10

times higher

toxicity of parent)

- -

Oncorhynchus

mykiss

BH 518-5 28 d NOEC (28d) = 5

mg/L

XXX

1993

42F0514/915142//93/1

0798

28997

Daphnia magna BH 518-2 48 h EC50 > 100 mg/L Dohmen, G.P.

1992

P92-E015 3425

28987

Daphnia magna BH 518-5 48 h EC50 > 100 mg/L Dohmen, G.P.

1992

P92-E016 3427

64695

Daphnia

magna

BH 518-2 21 d NOEC = 25

mg/L

Jatzek, H.-J.

1993

93/1051/51/1

28989

Daphnia

magna

BH 518-5 21 d NOEC = 25

mg/L

Jatzek, H.-J.

1993

93/1052/51/1

28995

P. subcapitata BH 518-2 72 h EbC50 = 700

mg/L

Dohmen, G.P.

1992

P92-E018, 3431

28986

P. subcapitata BH 518-5 72 h EbC50 = 160

mg/L

Dohmen, G.P.

1992

P92-E017, 3432

28993

Lemna gibba BH 518-2 7 d EbC50 > 100

mg/L

ErC50 > 100

mg/L

Dohmen, G.P.

1996

36452

49773


mg/L

ErC50 > 100

mg/L


2010

49691240

76771


mg/L

ErC50 > 100

mg/L

Dohmen, G.P.

1996

36453

49782


mg/L

ErC50 > 100

mg/L


2010

49702240

76770


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Table 6.5-2: Endpoints used for risk assessment for aquatic organisms for Metamitron and its

relevant metabolites


System


code

[mg a.s./L]

Oncorhynchus

mykiss

Metamitron 96 h, static EC50 > 190 mg

a.s./L

XXX

1991

80-91-0131-03-91

27758

Oncorhynchus

mykiss

Metamitron 21 d semi-static NOEC (growth) =

7.0 mg a.s./L

XXX

1991

80-91-0131-04-91

27759

Daphnia magna Metamitron 48 h static EC50

(immobility) =

5.7 mg/L

Bell, G.

1995

AGM 13(b)/941205

68002

Daphnia magna Metamitron 21 d semi-static NOEC

(reproduction) =

10 mg a.s./L

Peither, A.

1999

732688

68005

Pseudo-

kirchneriella

subcapitata

Metamitron 72 h static

EbC50 = 0.4 mg

a.s./L

ErC50 = 1.8 mg

a.s./L

Anderson, J.P.E.

1993

AJO/110193

38233

Lemna gibba Metamitron 7 d semi-static

EbC50 = 0.4 mg

a.s./L

ErC50 = 0.8 mg

a.s./L

Dengler, G.

1998

98063/01-AALg

38534

Lemna gibba Metamitron 14 d semi-static

EbC50 = 0.38 mg

a.s./L

EC50 = 0.45 mg

a.s./L

Scheerbaum, D.

1998

980219FC

39029

Metabolites of Metamitron

Oncorhynchus

mykiss Desamino-

Metamitron

96 h, static EC50 > 1000 mg

a.s./L

XXX

1994

FAR42441

31364

Daphnia magna Desamino-

Metamitron

48 h static EC50 (mortality)

= 745 mg a.s./L

Noack, M.

1994

DAI42441

31363

Chironomus

riparius

Desamino-

Metamitron

28 d static NOEC > 100 mg

a.s./L

Heimbach, F.

1999

E 416 1705-4

68010

Pseudo-

kirchneriella

subcapitata

Desamino-

Metamitron

72 h static

EbC50 = 25.1 mg

a.s./L

ErC50 = 73.5 mg

a.s./L

Dorgerloh, M.

1999

DOM 99085

43659


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Table 6.5-3: Endpoints used for risk assessment for aquatic organismsfor GOLTIX TITAN


System


code

[mg a.s./L]

Oncorhynchus

mykiss

GOLTIX TITAN

(AG-QMM1-565

SC)

96 h, static EC50 > 100 mg/L XXX

2010

S10-00592

77803

Daphnia magna GOLTIX TITAN

(AG-QMM1-565

SC)

48 h static EC50 (mortality)

> 100 mg/L

Borrmann, K.

2010

S10-00593

77801

Pseudokirchneri

ella subcapitata GOLTIX TITAN

(AG- QMM1-565

SC)

72 h, static EbC50 = 2,09

mg/L

EyC50 = 1,99

mg/L

ErC50 = 3,77

mg/L

von Seydlitz-

Kurzbach, J.

2010

S10-00594

77794

Lemna gibba GOLTIX TITAN

(AG- QMM1-565

SC)

7 d semi-static

EbC50 = 0.86

mg/L (frond area)

EyC50 = 1.50

mg/L (frond

yield)

EbC50 = 1.55

mg/L (frond No.)

ErC50 = 3.66

mg/L (growth

rate)

Borrmann, K.

2010

S10-00593

77795

Higher tier tests

Goltix SC 700 Phyto-plankton,

Zooplank-ton and

macrophyte

communi-ties

NOEAEC = 1.12

mg a.s./L

(Assessment

factor: 3)

Heimbach, F. et

al.

1999

HBF/Mt 07

43664 Goltix

SC 700


EU Peer review on mesocosms data:

After a single application of ‘Goltix SC 700’ (containing 700 g/L Metamitron) to outdoor mesocosm

enclosures containing phytoplankton, zooplankton and macrophyte communities, significant treatment

related effects were observed at the 2 highest test concentrations (i.e. 1120 and 4480 µg a.s./L), but only

for physical-chemical endpoints related to the community metabolism (pH and dissolved oxygen

concentration), with these effects at 1120 µg a.s./L being slight and transient (day 2 reductions of 0.5 in pH

& of 30% in oxygen levels, with no effects when next assessed on day 5). No consistent treatment related

effects on structural endpoints of phytoplankton (species composition, densities, chlorophyll-a level),

periphyton (chlorophyll-a level) and macrophytes (% cover, final biomass, growth of Myriophyllum

spicatum in in situ bioassays) were obtained at up to the highest test concentration. In addition, densities of

the major zooplankton groups appeared to be unaffected.


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Only the more pronounced effects on oxygen and pH levels at 4480 µg a.s./L (i.e. reductions on day 2

compared with day 0 in oxygen levels by 80% and a pH drop from 9.2. to 7.5, with recovery by day 15) are

considered to be ecologically relevant, and on this basis the study NOAEC is 1120 µg a.s./L or 1.12 mg

a.s./L (nominal value).

Given the low level and rapid reversibility of effects at the NOAEC, the effects of Metamitron exposure at

or below this concentration are considered to be unlikely to increase significantly by repeated exposure.

Although effects on a wide range of aquatic invertebrates and algae species were assessed in the study,

effects on only three species of higher aquatic plants were assessed – which may not be fully representative

of the range of sensitivity of higher aquatic plants to Metamitron. To take account of the uncertainty

involved in extrapolating the results of the mesocosm study to the field situation, an uncertainty factor of 3

has been proposed by the RMS to the study NOAEC during Annex I inclusion of Metamitron to regulation

91/414/EEC.

The regulatory endpoint derived from the mesocosm study on the solo formulation Goltix SC 700

containing 700 g Metamitron/L is also applicable for risk assessments for the preparation GOLTIX TITAN

(AG-QMM1-565 SC) because Metamitron is by a factor of > 1000 more toxic to aquatic organisms than

the other active substance (Quinmerac) in the product (see also the comparison of toxicity per fraction

below). The contribution of Quinmerac to the aquatic toxicity of the product in an aquatic environment is

therefore considered as negligible. This is confirmed by the laboratory study endpoints for the most

sensitive aquatic species showing a comparable toxicity for the mixture formulation as for the active

ingredient Metamitron. For more detailed explanations see below.

6.5.2 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1)

The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with

the recommendations of the “Guidance Document on Aquatic Ecotoxicology”, as provided by the

Commission Services (SANCO/3268/2001 rev.4 (final), 17 October 2002).

Mixture Toxicity

According to EFSA conclusion report on the active substance Quinmerac, the active substance MEtamitron

in the formulation GOLTIX TITAN can be considered to drive the toxicity of the formulation for aquatic

organisms. A model often used to estimate the toxicity of mixtures is the assumption of dose/concentration

additivity of toxicity (Finney approach of concentration additivity of toxicity; Finney, D.J., 1948 and 1971).

Toxicity studies on acute and chronic effects of the active substances and GOLTIX TITAN to aquatic

organisms are available. For a more detailed assessment of mixture toxicity, a surrogate LC50 or EC50 can

be calculated. However, reliable results can only be expected for combinations of ECX values for the same

biological endpoint. Moreover, the use of NOEC values, which are strongly depending on dose-spacing,

would introduce additional bias in the calculations.

The following formula is used to derive a surrogate LC50 or EC50 for the mixture of active substances with

known toxicity assuming concentration additivity:


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( )( )

( )

1

50

50

−

= ∑

i i

i

.s.aLC

.s.aXmixLC

where:

X(a.s.i) = fraction of active substance (i) in the mixture expressed as:

X(Metamitron) = 525 g a.s./kg / (525 g Metamitron/kg + 40 g Quinmerac/kg) = 0.93

X(Quinmerac) = 40 g a.s./kg / (525 g Metamitron /kg + 40 g Quinmerac/kg) = 0.07

LC50(a.s .i) = toxicity value for active substance (i)

Because of the direct proportionality of the calculated TER to the LC50, it is possible to calculate a


1

)TER(a.s.

1TER(mix)

−

= ∑

i i

where:


The relevant global maximum FOCUS Step 1, 2 and 3 PECSW for risk assessments covering the proposed

use pattern and the resulting TER values are presented in the following table.


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6.5.2.1 Toxicity to exposure ratio for the active substances

In the following table the TER values for each FOCUS scenario for each organisms group are given.

Table 6.5-4: Aquatic organisms: PECsw for Metamitron and relevant ecotoxicological endpoints for each organism’ group.

Scenario PECSW

global

max

Fish

acute

Fish

prolonged

Invertebrates

acute

Invertebrates

prolonged

Algae Aquatic

plant

Mesocosm

O. mykiss O. mykiss D. magna D. magna P.

subcapitata

L. gibba Invertebrates

FOCUS LC50 NOEC EC50 NOEC EbC50 NOEC NOEC

190000 70000 5700 10000 400 380 1120

[µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L]

Focus Step 1

970.5 195.8 7.2 5.9 10.3 0.4 0.4 1.2

Focus Step 2

N.Europe 159.2 1193.5 44 35.8 62.8 2.5 2.4 7

S.Europe 295.48 643 23.7 19.3 33.8 1.4 1.3 3.8

Focus Step 3

D3/ditch 5.544 34271.3 1262.6 1028.1 1803.8 72.2 68.5 202

D4/pond 0.502 378486.1 13944.2 11354.6 19920.3 796.8 757 2231.1

D4/stream 4.64 40948.3 1508.6 1228.4 2155.2 86.2 81.9 241.4

R1/pond 1.495 127090.3 468.,3 3812.7 6689 267.6 254.2 749.2

R1/stream 24.089 7887.4 290.6 236.6 415.1 16.6 15.8 46.5

R3/stream 53.013 3584 132 107.5 188.6 7.5 7.2 21.1

TER

criterion

100 10 100 10 10 10 3

TER values shown in bold fall below the relevant trigger.


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Table 6.5-5: Aquatic organisms: PECsw for Quinmerac and it´s metabolites and relevant ecotoxicological endpoints for long time effects in fish with Pecsw values for

Quinmerac (worst case value).

Substance Endpoint

(µg/L)

Focus Scenario Pecsw global

max (µg/L)

TER TER

criterion

Quinmerac

Oncorhynchus mykiss NOEC = 3160 Step 1 - 78.64 40.2 10

BH 518-2

Oncorhynchus mykiss NOEC = 320 Step 1 - 78.64 4.07 10

Step

2


Step 2 Europe South 23.39 13.7

BH 518-5

Oncorhynchus mykiss NOEC = 5000 Step1 - 78.64 63.6 10

The TER values for all scenarios for acive substance Metamitron and Quinmerac are above the Annex VI

trigger value of 100 or 10, except of the TERLT value for the R3 Stream scenario of Metamitron, which is

below the Annex VI trigger value of 10. Thus, a further risk refinement is required for Metamitron, R3

Stream scenario for algae and aquatic plants.

Refined risk assessment for Metamitron

As written in beginning of that chapter a mesocosm study was performed with Goltix SC 700, a formulation

containing 700 g/L Metamitron. The results of this field mesocosm study indicate an NOAEC of 1120 µg

a.s./L. The NOAEC of 1120 µg a.s./L has been used for further refinement of the risk assessment of

Metamitron. A comparison of this NOAEC with the FOCUS Step 3 PECsw values (worst-case) for the

relevant scenario has been performed in table obove.

Based on the mesocosm study and on the FOCUS Step 3 PECsw, the TERLT value for Metamitron for the

R3 Stream scenario is above the trigger value of 3 for algae and aquatic plants. This indicates that the active

substances Metamitron and Quinmerac contained in GOLTIX TITAN pose a low long-term risk to algae

and aquatic plants following application of GOLTIX TITAN at the proposed application rates.

6.5.2.2 Consideration of Metabolites

Metamitron forms one major metabolite in surface water: Desamino-Metamitron (54 % after 58 d). This

metabolite is also formed in sediment (27.5 % after 58 d). Moreover Desamino-Metamitron is a major

metabolite in soil (17.1 % after 30 d). Contamination of surface waters via run-off and drainage can not be

excluded. Ecotoxicological studies on the metabolite Desamino-Metamitron are available with fish (acute),

daphnids (acute) and algae.

The comparison of the study results for the metabolite Desamino-Metamitron with the study results of the

parent compound Metamitron show a higher sensitivity of aquatic organisms towards the active ingredient


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Metamitron. Since risk assessment gives indication that the use of Metamitron as intended in GOLTIX

TITAN poses low risks to aquatic organisms, also the environmental risk arising from the metabolite

Desamino-Metamitron is considered to be low.

Metamitron forms the unidentified major metabolite M3 in soil. The metabolite M3 was found in amounts

of > 5% AR on two consecutive sample points (day 1 and day 2) in one soil. Therefore, contamination of

surface waters via run-off and drainage can not be excluded. As no ecotoxicological studies are available

for the metabolite M3, an environmental risk assessment can not be performed quantitatively. The Inclusion

Directive for Metamitron lists as confirmatory data to be delivered to the Commission till August 2011

requirements for further studies with the metabolite M3. However, subject to the provisions of the results

of the confirmatory data evaluation, the risk for organisms exposed via run-off and drainage is expected to

be low. It is not expected that the metabolite M3 reaches surface waters before it is degradaded (transient

metabolite detected in one soil only at day 1 and 2).

Quinmerac forms one major metabolite in surface water: BH 518-2 (9.5 % after 100 d). In soil the

metabolites BH 518-2 and BH 518-5 are formed (BH 518-2 = 29.1 % after 30 d and 42.2 % after 224 d;

and BH 518-5 = 34.7 % after 91 d and 30.1 % after 120 d). Contamination of surface waters via run-off and

drainage can not be excluded. Ecotoxicological studies for the metabolites BH 518-2 and BH 518-5 are

available with fish, daphnids, algae and aquatic plants.

The comparison of the studies for the metabolites BH 518-2 and BH 518-5 with the studies of Quinmerac

show that the sensitivity of aquatic organisms towards the active ingredient Quinmerac and the metabolites

are comparable, with the exception of long-term toxicity for fish for BH 518-2. As no long-term study with

BH 518-2 was conducted the EC50 of Quinmerac is assumed as surrogate for the aquatic risk assessment.

Therefore a TERLT for fish was calculated for BH 518-2 but for the other groups of aquatic organisms the

risk assessment of the metabolites is covered by that of the active substance Quinmerac.

6.5.2.3 Accumulation in aquatic non-target organisms

Bioaccumulation of any of the active substances under natural conditions is not expected to occur and a

study is not necessary to determine bioaccumulation in aquatic non-target organisms.


Based on the calculated concentrations of active substances Metamitron and Quinmerac in surface water

(PECSW FOCUS Step 3), the calculated TER values for the acute and long-term risk resulting from an

exposure of aquatic organisms to active substance Metamitron and Quinmerac according to the GAP of the

formulation GOLTIX TITAN achieve the acceptability criteria TER ≥ 100, TER ≥ 10 and TER ≥ 3,


principles, point 2.5.2. for long-term effects. The results of the assessment indicate an acceptable risk for

aquatic organisms due to the intended use of GOLTIX TITAN in beets according to the label.


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6.6 Effects on bees (MIIIA 10.4, KPC 10.3.1)

In the the honey bee risk assessment for the main application it was concluded that the risk to bees is

acceptable when GOLTIX TITAN (AG-QMM1-565 SC) is used up to 6 L product/ha in pre-emergence

or early post-emergence fodder and sugar beet fields. Since the recommended application rate does not

exceed this rate no further risk assessment is required.

Labelling phrase NB6641 shall be applied.

6.7 Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2)

Table 6.7-1: Toxicity of the product GOLTIX TITAN (AG-QMM1-565 SC) to non-target arthropods


System

Results

Reference Internal

code

Aphidius

rhopalosiphi

FSG 02122 H

(40g/L Quinmerac

+ 525g/L

Metamitron

nominal

2 d,

Extended

Laboratory study

3D: barley

plants, mortality

and reproduction

capability

LR50 >

6000 mL

Prod../ha

Stevens, J.

27.04.2010

FSG-10-1

77797

Typhlodromus pyri FSG 02122 H (40

G/L Quinmerac +

525 g/L Metamitron

nominal)

7 d

Extended

laboratory study,

2D: bean leaves,

mortality and

reproduction

capability

LR50 >

6000 mL

Prod./ha

Fallowfield, L.

27.04.2010

FSG-10-2

77798

* Endpoint differing from LoEP / New study submitted


Not necessary.

6.7.2 Risk assessment

The evaluation of the risk for non-target arthropods was performed in accordance with the

recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the

Commission Services (SANCO/10329/2002 rev.2 (final), October 17, 2002), and in consideration of the

recommendations of the guidance document ESCORT 2.


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6.7.2.1 Risk assessment for in-field exposure

Exposure

The in-field exposure, given as predicted environmental rates, PER, for non-target arthropods resulting

from the intended uses of GOLTIX TITAN is calculated according to published agreement after ESCORT

2 workshop (Candolfi et al. 20015 -hereafter referred to as ‘Guidance Document’) using the following

equation:

Application rate (g a.s./ha) MAFin field

PER−

= ×

where:

MAF = generic multiple application factor used to take into account the potential build-up of

applied substances between applications. This factor integrates number of applications,

application interval and degradation kinetics of the active substance

Default MAF values for given numbers of applications are listed in the Guidance Document.

Application scheme in use 02: 1x 3.0 L prod./ha + 3x 1 L prod./ha (equivalent to total 6.0 L prod./ha

per season). Maximum application rate of 6.0 L prod./ha is used (without MAF) as a worst case

application rate in PER calculation.

Table 6.7-2: Predicted in-field environmental rates (PER) (worst case)

Intended use Exposure Max. appl. rate MAF PERin-field

[L Prod./ha] (worst

case)

[L Prod/ha]

02 In-field 6 - 6

02 refinement In-field 1x 3.0 L prod./ha + 3x 1

L prod./ha

2.3 5.3

MAF: Multiple application factor; fdrift: Drift factor; fveg: Vegetation distribution factor; PER: Predicted environmental rates

Tier 1 risk assessment for in-field exposure

The risk for non-target arthropods exposed in-field to GOLTIX TITAN was assessed by calculating the

hazard quotient (HQ = exposure/toxicity) as the ratio of the predicted environmental rate (PER) and the

lowest lethal rate (LR50) estimated in standard toxicity tests with non-target arthropods according to the

formula:

5 Candolfi, M.P.; Barrett, K.L.; Campbell, P.; Forster, R.; Grandy, N.; Huet, M.C.; Lewis. G.; Oomen, P.A.; Schmuck, R.; Vogt,

H. (2001): Guidance document on regulatory testing and risk assessment procedures for plant protection products with

non-target arthropods. ESCORT2 Workshop European Standard Characteristics of Non-Target Arthropod Regulatory

Testing. Wageningen, The Netherlands, 46 pp.


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50LR

PER field-InHQ fieldIn =

The resulting HQ in-field values for the standard species are presented in the following table.

It is noted that the tier 1 HQ trigger criterion has been calibrated using laboratory LR50s from glass plate

studies on the standard tier 1 indicator species. However, according to the ESCORT II report, “for products

where effects on reproduction are expected, sub-lethal parameters (e.g. oviposition) should also be

evaluated” in tier 1. Effects on reproduction should be assessed if detected in tier 1 studies. Considering the

worst-case character of the exposure conditions in standard tier 1 studies it is considered appropriate to set

the tier 1 acceptability criterion for reproductive effects for T. pyri and A. rhopalosiphi at an HQ of 2 in

line with the mortality assessment. Therefore, the tier 1 risk assessment uses the ER50 for the most sensitive

parameter (mortality or reproduction) in HQ calculations.

Table 6.7-3: HQ values for non-target arthropods (Tier-1) for in-field exposure

Intended use Species L/ER50 Exposure PER HQ

[L prod./ha] [L prod./ha]]

Use 02 A. rhopalosiphi >6 in-field 6 1

T. pyri >6 in-field 6 1

PER: Predicted environmental rates ; HQ: Hazard quotient

Higher tier risk assessment for in-field exposure

The risk for non-target arthropods exposed in-field to GOLTIX TITAN was assessed by comparing the

environmental rate (PERin-field) to the lowest lethal rate (LR50) estimated in toxicity tests with non-target

arthropods. With regard to extended laboratory tests and semi-field tests, lethal and sublethal effects of less

than 50 % are considered acceptable, provided that the tests covered the appropriate field rate.

Table 6.7-4: Predicted in-field environmental rates (PER) – Higher tier

Intended use Exposure Single appl. rate MAF PERin-field

[L prod./ha] [L prod./ha]

Use 02 In-field 6 - 6

MAF: Multiple application factor; fveg: Vegetation distribution factor; PER: Predicted environmental rates

The results of the risk assessment are summarised in the following table.


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Table 6.7-5: Risk assessment for non-target arthropods (Higher tier) for in-field exposure

Intended use LR50/ER50 PER Risk acceptable

[g a.s./ha] [g a.s./ha] [yes/no]

Use 02 >6 6 yes

PER: Predicted environmental rates

6.7.2.2 Risk assessment for off-field exposure

Exposure

Exposure of non-target arthropods living in non-target off-field areas to GOLTIX TITAN will mainly be

due to spray drift from field applications. Off-field predicted environmental rates (PER-values) were

calculated from in-field PERs in conjunction with drift values published by the BBA (20006) as shown in

the following equation:

)(

100

vdffactorondistributivegetation

percentiledriftxPERfieldinMaximum

PERfieldOff

−

=−

where:

vdf = vegetation distribution factor used in combination with test results derived from 2-dimensional

exposure set-ups

To account for interception and dilution by three-dimensional vegetation in off-crop areas, a vegetation

distribution or dilution factor (vdf, see above) is incorporated into the equation when calculating off-field

exposure in conjunction with toxicity endpoints derived from two-dimensional studies (e.g. glass plate or

leaf discs). A vdf of 10 is recommended in the ESCORT 2 report when the off-field risk assessment is based

on toxicity endpoints obtained in a test design with two-dimensional exposure but has been questioned.

Germany considers a vdf of five as a more reliable value to extrapolate from a two dimensional exposure

situation to the exposure situation in the field. The exposure estimation was based mainly on the ‘Retention

Area Index’ (RAI) characterizing the total retention area of sprayed plant protection products in a canopy

per base area. As a ‘realistic worst case scenario, meadow canopies < 20 cm height was chosen (Koch and

Weisser, 20047; German Federal Environment Agency UBA, 20068). The derived vdf of 5 agrees well with

6 BBA (Biologische Bundesanstalt für Land- und Forstwirtschaft) (2000): Abdrifteckwerte für Flächen- und Raumkulturen sowie

für den gewerblichen Gemüse-, Zierpflanzen- und Beerenobstanbau. Bundesanzeiger 100, 26. Mai 2000, Köln, pp.

9879.

7 Koch H and Weisser P, 2004. Die Gesamtoberflaeche in Saumstrukturen als potentielle Retentionsflaeche fuer Driftpartikel,

Retention Area Index (RAI). Nachrichtenblatt des Deutschen Pflanzenschutzdienstes, 56, 65-69.

8 German Federal Environment Agency (UBA), 2006. Exposure calculation for arthropods in field border structures - selection

of an appropriate ‘vegetation distribution factor’. Parma.


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field data by Koch et al. (2003)9, who compared measured residues of plant protection products on two

dimensional surfaces with the measured residues on meadows next to a treated area (factor of 4.4 to 6.5

between median spray residues on leaves when a standard nozzle was used for spray application). For

endpoints resulting from 3-dimensional studies, i.e. where spray treatment is applied onto whole plants, the

vdf is not used.

Active substances Metamitron and Quinmerac have a vapour pressure of < 10-5 Pa and is therefore classified

as non-volatile. Hence, deposition following volatilization has not to be considered.

Maximum application rate of 6.0 L prod./ha is used (without MAF) as a worst case application rate

in PER calculation.

The drift rate at 1 m distance is 2.77% of the application rate (90th percentile drift). It has to be noted that

this value is a worst case assumption.

The resulting PERoff-field value is shown in the following table:

Table 6.7-6: Predicted off-field environmental rates (PER) for GOLTIX TITAN

Intended use Exposure Single appl.

rate

MAF Drift

scenario

fdrift vdf PERoff-field

[L prod./ha] [L

prod./ha]

Use 02 Off-field 6 - 90th 2.77 1 (3D) 0.1662

Use 02 Off-field 6 - 90th 2.77 5 (2D) 0.0332

Use 02 refinement Off-field 5.3 2.3 74th 1.85 1 (3D) 0.0981

Use 02 refinement Off-field 5.3 2.3 74th 1.85 5 (2D) 0.0196

MAF: Multiple application factor; fdrift: Drift factor; vdf: Vegetation distribution factor; PER: Predicted environmental rates

Higher tier risk assessment for off-field exposure

For the results of study with T. pyri exposed to GOLTIX TITAN (AG-QMM1-565 SC), a vegetation

distribution factor has to be considered (study conducted in 2D environment). Regarding the results of the

study with A. rhopalosiphi exposed to GOLTIX TITAN (AG-QMM1-565 SC), the vegetation distribution

factor does not have to be considered since it was conducted in 3D environment.

According to ESCORT II , lethal and sublethal effects less than 50 % at the calculated deposition rates

including the correction factor are considered acceptable. The correction factor can be lowered to 5 if higher

9 Koch H, Weisser P and Landfried M, 2003. Effect of drift potential on drift exposure in terrestrial habitats. Nachrichtenblatt des

Deutschen Pflanzenschutzdienstes, 55, 181-188.


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tier tests with the more sensitive of the species affected in tier I and ‘two additional species with different

biology’ were submitted (please refer to European Commission 2002)10

Additionally the assessment of the risk to non-target arthropods due to an exposure to GOLTIX TITAN

was performed on basis of the calculation of toxicity-exposure ratios (TER values) according the following

formula:

)/(

)/(50)(

haproductLPERfieldOff

haproductLRELTER

−=

The risk is considered acceptable if the values obtained are TER off-field > 10 when the ecotoxicological

data resulted from tier 1 tests on glass plates or TER off-field > 5 if higher tier tests with the more sensitive

of the species affected in tier I and ‘two additional species with different biology’ were submitted (please

refer to European Commission, 2002)11.

The results of the risk assessment are summarized in the following table.

Table 6.7-7: Risk assessment for non-target arthropods (Tier 2) for off-field exposure

Intended

use

Species Test type LR50/ER50 PERoff-field TER Risk acceptable

[L

prod./ha]

[L prod./ha] [yes/no]

02 Aphidius

rhopalosiphi

Lab. 3D >6 0.1662 >36.1 Yes

02 Typhlodromus

pyri

Lab. 2D >6 0.0332 >180.7 Yes

PER: Predicted environmental rates; TER: Toxicity to ecposure ratio. TER values shown in bold fall below the relevant trigger.

6.7.2.3 Risk mitigation measures

No risk mitigation needed.


In-field

Based on the calculated rates of GOLTIX TITAN in in-field areas, the calculated HQ and TER values

describing the risk resulting from an exposure of non-target arthropods to GOLTIX TITAN with active

10 European Commission (2002): Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC:

Directorate E - Food Safety: plant health, animal health and welfare, international questions; E1 - Plant health.

11 European Commission. 2002. Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC:

Directorate E - Food Safety: plant health, animal health and welfare, international questions; E1 - Plant health.


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substances Metamitron and Quinmerac according to the GAP of the formulation GOLTIX TITAN achieves

the acceptability criteria HQ ≤ 2 (Tier 1) of TER ≥ 10 (Tier 1) resp. 5 (Higher tier), according to commission

implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results

of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of GOLTIX

TITAN in agriculture according to the label.

Off-field

Based on the calculated rates of formulation GOLTIX TITAN in off-field areas the calculated HQ and TER

values describing the risk resulting from an exposure of non-target arthropods to active substances

Metamitron and Quinmerac in the formulation GOLTIX TITAN according to the GAP of the formulation

GOLTIX TITAN achieve the acceptability criteria HQ ≤ 2 (Tier 1) and of TER ≥ 10 (Tier 1) resp. 5 (Higher

tier), according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific

principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods

due to the intended use of GOLTIX TITAN in beets according to the label.

6.8 Effects on non-target soil meso- and macrofauna (MIIIA 10.6, KPC 10.4, KPC

10.4.1, KPC 10.4.2)

Table 6.8-1: EU agreed endpoints and new endpoints for earthworms and other soil macro- and

mesofauna


System


code

Eisenia

fetida

Quinmerac

BAS 518 H

14 d

akut

LC50 >1000

mg/kg

Mortality

Lührs, U.

24.08.2001

10481021

49849

Eisenia

foetida

Quinmerac

Metabolit

Dicarbonsäuremetabolit

BH518-2

14 d

akut

LC50 >1000

mg/kg TS

Dohmen, G.P.

1992

P92-E008 // 3438

28984

Eisenia

foetida

Quinmerac

Metabolit

BH518-5

14 d

akut

LC50 >1000

mg/kg TS

Mortality

Dohmen, G.P.

1992

P92-E009 // 3439

28991

Eisenia

foetida

Quinmerac

Metabolit

BH518-5

chronic NOEC = 0.775

mg a.s./kg soil

Luehrs 2003 LOEP

Eisenia

foetida

Quinmerac

Metabolit

BH518-5

chronic

56 d

NOEC = 20 mg

a.s./kg soil**

Witte, B.

21.01.2010

49703022

76783

Folsomia

candida

Quinmerac

Metabolit

BH518-5

Chronic

56 d

NOEC = 1000 mg

a.s./kg soil

Witte, B.

20.01.2010

49705016

76784

Eisenia

foetida

Metamitron 14 d

akut

LC50 = 914 mg

a.s./kg dw soil

Heimbach, F.

06.07.1999

HBF/Rg 307

68019


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Date May 2015

Eisenia

foetida

Metamitron

Metabolit

Desamino-Metamitron

14 d

akut

LC50 > 1000 mg

a.s./kg dw soil

LC50 corr > 500

mg a.s./kg dw soil

Meisner, P.

28.05.2001

MPE/Rg 372/01

68020

Eisenia

foetida

Metamitron chronic NOER = 21 kg

a.s./ha

NOEC = 28 mg

a.s./kg soil*

= NOEC = 28.36

mg ai/kg -

Calculated

considering a soil

depth of 5 cm and

a density of 1.5

g/cm3 (aus LoEP)

Winkelmann, G.

16.03.2007

RRR112401

68022

Folsomia

candida

Metamitron

Metabolit

Desamino-Metamitron

chronic NOEC = 100 mg

a.s./kg soil

EFSA 2008 -

Eisenia

foetida

GOLTIX TITAN (AG-

QMM1-565 SC)

acut

14 d

NOEC = 1000 mg

product/kg

(at 10% peat

content)

Krome, K.**

20.05.2010

OFC00018409

77827

Eisenia

foetida

GOLTIX TITAN (AG-

QMM1-565 SC)

chronic

56 d

NOEC = 100 mg

product/kg

(at 10% peat

content)

Krome, K.**

08.06.2010

RRA13609

77826

* endpoint considering a soil depth of 5 cm

**New studies, submitted by the applicant in application report 007529-00-00 (GOLTIX TITAN), detailed

information about study can be found in Appendix 3 of first GOLTIX TITAN application (007529-00-00).

According to EFSA Journal 2010; 8(3):1523 no chronic study required for Quinmerac or BH 518-2 – DT50 >

100 and < 365 days, one application proposed.

Metabolite studies of the applicant used for risk assessments:

The results of the chronic earthworm study on the major soil metabolite of Quinmerac, BH 518-5 (Luehrs

2003), were equivocal. Some statistically significant effect on adult mortality was observed at the highest

test concentration of 1.25 mg/kg. However, as there was no clear dose-response, the rapporteur considered

this effect not treatment-related and proposed 1.25 mg/kg, i.e. the highest concentration tested as endpoint.

The effects seen in the chronic worm study only concerned adult survival with no impairment on

reproductive parameters. Nevertheless, EFSA did not agree to this proposal resulting in the lower endpoint

of 0.775 mg/kg as the relevant figure included in the list of endpoints. However, in agreement with the

original interpretation of the rapporteur, that effects in the study by Luehrs were not treatment-related, a

NOEC of 20 mg BH 518-5/kg (again the highest concentration tested) in a new study of the applicant

(Witte 2010c) indicates a low chronic toxicity of this metabolite towards earthworms. For these reasons, in

the risk assessment it is referred to the endpoint of the new study of the applicant (Witte 2010c).


Core Assessment


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Page 46 of 55


Date May 2015


Justification of new studies on Quinmerac metabolites were done in application report 007529-00-00

(GOLTIX TITAN), detailed information about study can be found there in Appendix 3.

6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna,

TERA and TERLT (MIIIA 10.6.1)

The evaluation of the risk for earthworms and other soil macro-organisms was performed in accordance

with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the

Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).

For the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the

environmental fate section (Part B, Section 5) of this submission.

The acute risk for earthworms and other non-target soil macro- and mesofauna resulting from an exposure

to GOLTIX TITAN and active substances Metamitron and Quinmerac as well as the major soil degradation

products of Metamitron and Quinmerac was assessed by comparing the maximum PECSOIL with the 14-day

LC50 value to generate acute TER values. The TERA was calculated as follows:

The chronic risk for earthworms, other non-target soil macro- and mesofauna and organic matter breakdown

resulting from an exposure to GOLTIX TITAN and active substances Metamitron and Quinmerac as well

as the major soil degradation product of Quinmerac BH 518-5 was assessed by comparing the maximum

PECSOIL with the NOEC value to generate chronic TER values. The TERLT was calculated as follows:


As written in Sec. 5 core assessment chapter 5.5 no Pec Soil calcualton s for Quinmerac were carried out.

Explanation: according to section 6 of the first Registration Report for GOLTIX TITAN the TER values in

soil for quinmerac and its soil metabolites were above the respective TER values for metamitron and far

above the trigger. Therefore it was concluded that no calculation of PECsoil for quinmerac and its soil

metabolites is necessary, as the risk is covered by the assessment of metamitron and the formulation. Results

from first Registration Report for GOLTIX TITAN for Quinmaerc and its metabolites for use 01 are

presented for information.

Table 6.8-2: TER values for earthworms and other soil macro- and mesofauna (Tier-1), use 02, application rate: 1 x 1575 g Metamitron/ha +3 x 420 Metamitron/ha and 1x 120 g

Quinmerac/ha + 3 x 32 g Quinmerac/ha, 5 d interval

Species Test item Time scale Endpoint Max. PECact

worst case

TER

[mg/kg soil dw] [mg/kg soil dw]

(mg/kg) PEC

(mg/kg) LC=TER

soil

50

A

(mg/kg) PEC

(mg/kg) NOEC=TER

soil

LT


Core Assessment


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Page 47 of 55


Date May 2015

Eisenia fetida Metamitron Acute 914 2.7561 331.6

Chronic 28 2.7561 10.2

Desamino-

Metamitron

Acute >500 corr. 0.8395 595.6

GOLTIX TITAN Acute 1000 7.200 138.8

Chronic 100 7.200 13.8

Folsomia

candida

Desamino-

Metamitron

Chronic 100 0.8395 119.1

TER values for earthworm for Quinmerac and its metabolites for use 01 of GOLTIX TITAN for information

Folsomia

candida

Quinmerac Acute 1000 0.2414 4143

BH 518-2 Acute 1000 0.1215 8230

BH 518-5 Acute 1000 0.0939 10649


6.8.3 Higher tier risk assessment

Not relevant.


Based on the predicted concentrations of Metamitron and Quinmerac and their metabolites in soils, the TER

values describing the acute and long-term risk for earthworms and other non-target soil organisms following

exposure to active substances Metamitron, Quinmerac and formulation GOLTIX TITAN according to the

GAP of the formulation GOLTIX TITAN achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5


principles, point 2.5.2. The results of the assessment indicate an acceptable risk for soil organisms due to

the intended use of GOLTIX TITAN in beetsaccording to the label.

6.9 Effects on soil microbial activity (MIIIA 10.7, KPC 10.5)

Effects on soil micro-organisms for GOLTIX TITAN (AG-QMM1-565 SC) were not evaluated as part of

the EU review of either Quinmerac or Metamitron. Therefore, all relevant data and assessments are

provided here and are considered adequate.

Table 6.9-1: EU agreed endpoints and new endpoints for soil microorganisms

Test design Substance Results Source Internal code


Core Assessment


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Page 48 of 55


Date May 2015

CO2-Development Quinmerac 30 d

aerob

Effect < 25 %

1 kg ai/ha (3.3

mg ai/kg dw)

Effect <25 %

5 kg ai/ha (16.5

mg ai/kg dw)

Hamm, R.T.

1987

2417

70752

Nitrate-turnover Quinmerac 28 d

aearob

Effect : 11 %

at 3.3 mg ai/kg

dw

Effect : 12 %

at 16.5 mg ai/kg

dw

Hamm, R.T.

1987

P86-E021

70753

Nitrate-turnover BH 518-2 28 d

Effect : < 10

%

0.625 kg ai/ha

(0.83 mg ai/kg

dw Effect : <

10 %

0.125 kg ai/ha

(0.17 mg ai/kg

dw)

Gerhardt, R.

1992

P92-E003

70913

CO2-Development

BH 518-2 28 d

aerob

Effect : < 25

difference to

control

0.83 mg ai/kg

dw + 0.17 mg

ai/kg dw

Gerhardt, R.

1992

P92-E002

70916

Nitrate-turnover

BH 518-5 28 d

aerob

Effect <10 %

At 0.3125 kg

ai/ha (0.42 mg

ai/kg dw)

Effect <10 % at

0.0625 kg ai/ha

(0.083 mg ai/kg

dw)

Gerhardt, R.

1992

P92-E005

70912

CO2-Development

BH 518-5 28 d

aerob

Effect < 10 %

At 0.3125 kg

ai/ha (0.42 mg

ai/kg dw) and at

0.0625 kg ai/ha

(0.083 mg ai/kg

dw)

Gerhardt, R.

1992

P92-E004

70914

CO2-Development GOLTIX SC 700

containing 690 g/L

Metamitron

28 d

aerob

Effects at 19.5

mg a.s./kg d.w.

soil throughout

the study <

±25% of the

control

Schulz, L.

03.05.2007

07 10 48 008 C

76445

Nitrate-turnover GOLTIX SC 700

containing 690 g/L

Metamitron

28 d

aerob

Effects by day

28 at 19.5 mg

a.s./kg d.w.

Schulz, L.

03.05.2007

07 10 48 008 N

68111


Core Assessment


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Page 49 of 55


Date May 2015

soil < ±25% of

the control

Nitrate-turnover Desamino-

Metamitron

42 d Effects by day

42 at 21.73 mg

/kg d.w.

soil < ±25% of

the control

Anderson, J.P.E.

05.07.2001

AJO/220701

68112

CO2-Development GOLTIX TITAN

(AG-QMM1-565

SC)

*

At 20.0 L

product/ha

(31.04 mg/kg

soil dry

weight): no

adverse effects

on carbon

turnover in soil,

no difference to

control < 25 %.

Schulz, L.

22.09.2010

101048022 C7N*

77819

Nitrate-turnover GOLTIX TITAN

(AG-QMM1-565

SC)

*

At 20.0 L

product/ha

(31.04 mg/kg

soil dry

weight): no

adverse effects

on nitrogen

turnover in soil,

no difference to

control < 25 %.

Schulz, L.

22.09.2010

101048022 C7N*

77819

* New study submitted by applicant

However, as the actual preparation contains two active substances, the data on the formulated product are

most relevant for the risk assessments.


Summaries of new submitted studies by applicant were evaluated in main application proposal GOLTIX

TITAN (007529-00-00).


The evaluation of the risk for earthworms was performed in accordance with the recommendations of the

“Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services

(SANCO/10329/2002 rev 2 (final), October 17, 2002).

Please refer to above for the predicted environmental concentrations in soil (PECSOIL) of Metamitron,

Quinmerac and GOLTIX TITAN.



Core Assessment


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Date May 2015

Table 6.9-2: Risk assessment for effects on soil micro-organisms

Test substance Test concentration

(adverse effects < 25%)

PECSOIL Risk acceptable

[mg /kg] [mg/kg] [yes/no]

GOLTIX TITAN (AG-

QMM1-565 SC)

31.04 mg prep./kg soil = 20 L

prod./ha

7.2 Yes

Quinmerac 16.5 mg a.s./kg soil 0.2414* Yes

Metamitron 19.5 mg a.s./kg soil 2.7561 Yes

BH 518-2 0.83 mg a.s./kg soil 0.1215* Yes


Desamino-Metamitron 21.73 mg a.s./kg soil 0.8395 Yes

*Pecsoil values for Quinmerac and its metabolites from main application proposal GOLTIX TITAN

(007529-00-00) Core assessment


Based on the predicted concentrations of Metamitron, Quinmerac and GOLTIX TITAN in soils, the risk to

soil microbial processes following exposure to Metamitron, Quinmerac according to the GAP of the

formulation GOLTIX TITANis considered to be acceptable according to commission implementing

regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2.

6.10 Effects on non-target plants (MIIIA 10.8, KPC 10.6)

6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1)

Table 6.10-1: EU-agreed endpoints and new endpoints for non-target terrestrial plants


System

Results

Reference Internal

code

Rape (Brassica

napus), Sunflower

(Helianthus annuus),

Flax (Linum

usitatissimum),

Tomato (Solanum

lycopersicum), Soya

bean (Glycine max),

Carrot (Daucus

carota), Onion

(Allium cepa), Oats

(Avena sativa), Rye

gras (Lolium

AG-QMM1- 565

SC (40 g/L

Quinmerac + 525

g/L Metamitron)

Seedling

emergence

ER50 >

1116 mL

Präp./ha

oilseed

rape, flax,

tomato,

carrot

Minarski, A.,

Marquardt, J.

04.08.2010

AS150

77821


Core Assessment


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Page 51 of 55


Date May 2015

mulltiflorum), Corn

(Zea mays)

Rape (Brassica

napus), Sunflower

(Helanthus annuus),

Flax (Linum

usitisimum), Tomato

(Solanum

lycopersicum), Soya

bean (Glycine max),

Carrot (Daucus

carota), Onion

(Allium capa), Oats

(Avena sativa), Rye

grass (Lolium

multiflorum), Corn

(Zea mays)

AG-QMM1- 565

SC (40 g/L

Quinmerac + 525

g/L Metamitron)

Vegetative

vigour

ER50 >

1116 mL

Präp./ha

flax, tomato

Minarski, A.,

Marquardt, J.

30.07.2010

AS151

77822



TITAN (007529-00-00).

6.10.2.1 Risk assessment

The risk assessment is based on the “Guidance Document on Terrestrial Ecotoxicology”,

(SANCO/10329/2002 rev.2 final, 2002). It is restricted to off-field situations, as non-target plants are non-

crop plants located outside the treated area. Spray drift from the treated areas may lead to residues of a

product in off-crop areas.

Exposure

Effects on non-target plants are of concern in the off-field environment, where they may be exposed to

spray drift. The amount of spray drift reaching off-crop habitats is calculated using the 90th percentile

estimates derived by the BBA (2000) from the spray-drift predictions of Ganzelmeier & Rautmann (2000).

Any dilution over the 3-dimensional vegetation surface is accounted for in the study design. Therefore, in

contrast to the assessment of risks to arthropods from standard laboratory tests, no vegetation distribution

factor is considered here.

PERoff-field= Maximum PERin-field (including MAF) x %drift

Active substances Metamitron and Quinmerac have a vapour pressure of < 10-5 Pa and is therefore classified

as non-volatile. Hence, deposition following volatilization has not to be considered.

For calculation of PERin-field, please refer to 6.7.2.1.


Core Assessment


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Date May 2015

Table 6.10-2: Predicted off-field environmental rates (PER) for GOLTIX TITAN, use 02, 74th drift percentile, MAF: 2.3

Intended use Exposure Single appl. rate MAF Drift scenario fdrift PERoff-field

[L prod./ha] [L prod./ha]

Use 02 Off-field 1x 3.0 L

prod./ha+ 3x 1.0

L prod./ha

= 5.30 L prod./ha

2.3 74 1.85 0.098

MAF: Multiple application factor; fdrift: Drift factor; PER: Predicted environmental rates

Screening assessment

The risk is considered acceptable if at the intended application rate no significant effects occur.

Tier 1 assessment

The assessment of the risk to non-target arthropods due to an exposure to GOLTIX TITAN is performed

on basis of the calculation of toxicity-exposure ratios (TER values) according the following formula:

)/(

)/(50

haproductLPERfieldOff

haproductLERTER

−=


Table 6.10-3: Risk assessment for non-target terrestrial plants exposed to GOLTIX TITAN

for intended use 2

Intended use ER50 PER TER

[L prod./ha] [g/ha]

Use 2 > 1.116 0.098 >11.39

Risk mitigation measures

No risk mitigation needed.

6.10.2.2 Higher tier risk assessment (quantitative risk assessment)

Not relevant.


Core Assessment


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Page 53 of 55


Date May 2015

6.10.2.3 Overall conclusions

Based on the predicted rates of GOLTIX TITAN with active substances Quinmerac and Metamitron in off-

field areas, the TER values describing the risk for non-target plants following exposure to Quinmaerac and

Metamitron according to the GAP of the formulation GOLTIX TITAN achieve the acceptability criteria

TER ≥ 10 resp. ≥ 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C

, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target

terrestrial plants due to the intended use of GOLTIX TITAN in beets according to the label.

6.11 Effects on other terrestrial organisms (flora and fauna) (KPC 10.7)

6.12 Monitoring data (KPC 10.8)

6.13 Available preliminary data (IIIA 10.9)

6.14 Other/special studies (IIIA 10.10)


Core Assessment


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Date May 2015


Please refer to main application proposal GOLTIX TITAN (007529-00-00).


Core Assessment


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Date May 2015

Appendix 2 Detailed evaluation of the new studies


TITAN (007529-00-00).


National Addendum – DE

GOLTIX TITAN


Central Zone

Page 1 of 17


Date May 2015

REGISTRATION REPORT

Part B

Section 6: Ecotoxicological studies



(AG-QMM1-565 SC)

Active Substance: Metamitron g/L

Quinmerac 40 g/L

Central Zone


NATIONAL ADDENDUM

Applicant: ADAMA

Date: May 2015



GOLTIX TITAN


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Date May 2015

Table of Contents

SEC 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)............................................................ 3

6.1 PROPOSED USE PATTERN AND CONSIDERED METABOLITES .............................................................. 4

6.1.1 Grouping of intended uses for risk assessment ...................................................................... 4

6.1.2 Consideration of metabolites .................................................................................................. 5

6.2 EFFECTS ON BIRDS (MIIIA 10.1, KPC 10.1, KPC 10.1.1) ................................................................. 6

6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC

10.1.2) ...................................................................................................................................................... 6

6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC

10.1.3) ...................................................................................................................................................... 7

6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1) ........................................ 8

6.5.1 Overview ................................................................................................................................ 8

6.5.2 Toxicity .................................................................................................................................. 8

6.5.3 Justification for new endpoints .............................................................................................. 8

6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) ............................................. 8


6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1) .................................................................................. 12

6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ..................................... 12

6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1,

KPC 10.4.2) ............................................................................................................................................ 12


6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna, TERA and

TERLT (MIIIA 10.6.1) .......................................................................................................... 12

6.8.3 Higher tier risk assessment ................................................................................................... 14


6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) .................................................. 14


6.9.2 Risk assessment .................................................................................................................... 14


6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) .......................................................... 15

6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) ........................................................ 15

APPENDIX 1 TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL 2014-04-

14) 16



GOLTIX TITAN


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Sec 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)

A full risk assessment according to Uniform Principles for the plant protection product GOLTIX TITAN

in its intended uses in beets is documented in detail in the core assessment of the plant protection product

GOLTIX TITAN dated from May 2015 performed by zRMS Germany.

This document comprises specific risk assessment for some annex points for authorization of the plant

protection product GOLTIX TITAN in Germany according to the uses listed in Appendix 2.

General information on the formulation GOLTIX TITAN can be found in Table 5.1-1of Section 5 of the

National addendum Germany (May 2015).



GOLTIX TITAN


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6.1 Proposed use pattern and considered metabolites

6.1.1 Grouping of intended uses for risk assessment

Full details of the proposed use pattern of the formulation GOLTIX TITAN that will be assessed are pre-

sented in Appendix 1 and summarized in the table below. The intended uses in Germany are covered by

the core assessment performed by zRMS Germany.

The following table lists the grouping of the intended uses in order to perform a risk envelope approach.

Table 6.1-1: Critical use pattern of GOLTIX TITAN

Use No* Crop/growth

stage

Application

method

Drift scenario


Minimum application

interval, application

time, interception

Application rate,

cumulative

(g as/ha)

Soil effective

application rate

(g as/ha)

00-001 beets (sugar and

fodder) /

BBCH 0-19

Spraying /

arable crops

4 x, 5 d, 11.04, 16.04,

21.04, 26.04

1. 0 %

2.-4. 20 %

metamitron

1 x 1575

3 x 525

quinmerac

1 x 120

3 x 40

metamitron

1 x 1575

3 x 420

quinmerac

1 x 120

3 x 32

* For administrative purposes, each intended use of a plant protection product in Germany is assigned with an indi-

vidual use number from the German Federal Office of Consumer Protection and Food Safety (BVL). A complete list

of the individual GAPs in Germany together with their assigned use numbers is given in Appendix 2 of this Addendum.

Table 6.1-2: Critical use pattern of GOLTIX TITAN grouped according to soil relevance, drift

scenario and crop scenario

Groups – Soil relevance

Group Intended uses Application rate (Interception) Soil relevant effective appl.

rate, cumulative

[g/ha] [g/ha]

B01 1 Metamitron: 1 x 1575

3 x 525

Quinmerac: 1 x 120

3 x 40

Application:

4 x, 5 d,

1. 0 %

2.-4. 20 %,

spring

Metamitron: 1 x 1575

3 x 420

Quinmerac: 1 x 120

3 x 32

Groups – Drift szenario

Group Intended uses Application rate Drift scenario

[g/ha]



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D01 2 Metamitron: 1 x 1575

3 x 525

Quinmerac: 1 x 120

3 x 40

Groups – Birds and mammals

Group Intended uses Application rate Crop scenario

[g/ha]

V01S01 2 Metamitron: 1 x 1575

3 x 525

Quinmerac: 1 x 120

3 x 40

Bare soil,

Root and stem vegetables

6.1.2 Consideration of metabolites

Please refer to the core assessment.



GOLTIX TITAN


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Date May 2015

6.2 Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1)



none

6.3 Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1,

KPC 10.1.2)

For all other focal species please refer to the core assessment. For refinement of woodmouse Apodemus

sylvaticus please refer to table beneath.

Table 6.3-1: Refinement of reproductive risk assessment for small omnivorous mammals

“mouse”, small insectivorous mammal “shrew” and large herbivorous mammals

“lagomorphs” exposed to Metamitron according to EFSA Journal (2009) in sugar

beets. For details see text

Intended

use

Species/BB

CH stage

Diet

composition

MAF

x twa

FIR/

bw

PD RUD PT DDD Endpoint TER

[mg/kg

bw/d]

[mg/kg

bw/d]

Wood mouse, Intended use 2 (1 x 1575 g a.s./ha + 3 x 525 g a.s./ha),

01 Sugar beet

BBCH 10-

39

Apodemus

sylvaticus

25% non-

grass herbs

2.2x0.

53

0.07 1 28.7 1 3.518 36.4

2.6

25% ground

arthropods

(with

interception)

2.2x0.

53

0.07 1 3.5 1 0.429

50%weed

seeds 2.2x0.

53

0.13 1 40.2 1 9.854

Wood mouse

Early stages of beet fields do not provide sufficient plant cover for small mammals. Studies estimating the reaction

of wood mice to fields with sparse vegetation will help to estimate the exposure more realistically.

In the study conducted by Todd et al. (2000)1 23 wood mice were radio tracked in winter and spring (November –

March) and 56 in summer (June – August) in arable habitat. The preferred macrohabitat of the wood mouse in arable

land were hedgerows. In the study conducted by Tew et al. (2000)2 48 wood mice were radio tracked and microhab-

itats were recorded. In their study they found that wood mice avoided foraging in areas with a high abundance of

bare earth. On such fields, predatory risk to feeding mice is high. This finding is also confirmed by Green (1979)3,

who showed that fields with bare soil surface are not attractive feeding areas for mammals.

1 Todd I.A., Tew T.E. and Macdonald D.W. (2000): Arable habitat use by wood mice (Apodemus sylvaticus). 1. Macrohabi-

tatJ.Zoo., Lond. 250, 299-303 2 Tew, T. E., Todd, I. A. & Macdonald, D. W. (2000): Arable habitat use by wood mice (Apodemus sylvaticus). 2. Microhabitat.

Journal of Zoology (London), 250, 305-311. 3 Green, R. 1979. The ecology of Wood mice (Apodemus sylvaticus) on arable farmland. Journal of Zoology, 188: 357–377.



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The predominant feeding habitats of a wood mouse are thick grass, woodland, arable land, heather and sand dunes

(Mammals Bible4). They need cover protection for themselves and their offspring such as stone walls, hedgerows,

gardens and even buildings if unoccupied. Beet fields at early BBCH stages do not provide such cover. Due to the

absence of cover protections, it is unlikely that wood mouse will exclusively forage in beet fields in early BBCH

stages. Thus a reduced PT value of 0.8 is much more realistic and will be considered in a refined risk assessment.

01

Sugar beet

BBCH 10-

39

Apodemus

sylvaticus

25% non-

grass herbs

2.2x0.

13*

(refert

to

refine

ment

of

rabbit)

0.07 1 28.7 0.8 0.690 4.1

25% ground

arthropods

(with

interception)

2.2x0.

53

0.07 1 3.5 0.8 0.343

50%weed

seeds 2.2x0.

53

0.13 1 40.2 0.8 7.883

In cases where the relevant model species for assessment of the risk from the intended uses of Metamitron

is a mouse (e.g. Apodemus sylvaticus) or a vole, the TER acceptability criterion may be modified. In terms

of size and potential exposure, mice and voles already represent the ‘worst case’ for agricultural areas in

Europes' central zone. Furthermore, the toxicological endpoints and effect values for the assessment are

determined on phylogenetically closely related species. Hence, a TER ≥ 5 in the acute exposure scenario

and a TER ≥ 2 in the long-term exposure scenario may be accepted as sufficient. It should additionally be

noted that there are currently no indications for a significant impact of pesticides on the population dynam-

ics of mice or voles in the agricultural landscape, which are apparently determined by other biological

factors (e.g. periodical increases in vole populations creating the necessity for control measures).

The results of the assessment indicate an acceptable acute and long-term risk for mammals due to the in-

tended use of GOLTIX TITAN in beets according to the label.


none

6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC

10.1.3)


4 Gurney, J. E., Perett, J., Crocker, D. R. & Pascual, J. A. (1998): Mammal bible. Mammals and farming: information for risk

assessment. Contract PN0910/PN0919. pp. 2-223. York: Central Science Laboratory; Project No. M37



GOLTIX TITAN


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Date May 2015


none

6.5 Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1)

6.5.1 Overview

Results of aquatic risk assessment for the intended for uses of GOLTIX TITAN in beets based on FOCUS

Surface Water PEC values is presented in the Core assessment, Part B, Section 6, chapter 6.5

For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i)

spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order to

allow risk mitigation measures separately for each entry route. Hence, aquatic risk assessment differs from

those in the core assessment.

The risk assessment for aquatic organism for authorization of GOLTIX TITAN is outlined in the following

chapters.

6.5.2 Toxicity




6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1)

The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with

the recommendations of the “Guidance Document on Aquatic Ecotoxicology”, as provided by the Com-

mission Services (SANCO/3268/2001 rev.4 (final), 17 October 2002).

Mixture Toxicity

According to EFSA conclusion report on the active substance Quinmerac, the active substance Metamitron

in the formulation GOLTIX TITAN can be considered to drive the toxicity of the formulation for aquatic

organisms. A model often used to estimate the toxicity of mixtures is the assumption of dose/concentration

additivity of toxicity (Finney approach of concentration additivity of toxicity; Finney, D.J., 1948 and 1971).

Toxicity studies on acute and chronic effects of the active substances and GOLTIX TITAN to aquatic or-

ganisms are available. For a more detailed assessment of mixture toxicity, a surrogate LC50 or EC50 can be

calculated. However, reliable results can only be expected for combinations of ECX values for the same

biological endpoint. Moreover, the use of NOEC values, which are strongly depending on dose-spacing,

would introduce additional bias in the calculations.

The following formula is used to derive a surrogate LC50 or EC50 for the mixture of active substances with

known toxicity assuming concentration additivity:



GOLTIX TITAN


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Date May 2015

( )( )

( )

1

50

50

−

= ∑

i i

i

.s.aLC

.s.aXmixLC

where:

X(a.s. i) = fraction of active substance (i) in the mixture expressed as:

X(Metamitron) = 525 g a.s./kg / (525 g Metamitron/kg + 40 g Quinmerac/kg) = 0.93

X(Quinmerac) = 40 g a.s./kg / (525 g Metamitron /kg + 40 g Quinmerac/kg) = 0.07

LC50(a.s. i) = acute toxicity value for active substance (i)

Because of the direct proportionality of the calculated TER to the LC50, it is possible to calculate a


1

)TER(a.s.

1TER(mix)

−

= ∑

i i

where:


6.5.4.1 TER values for the entry into surface water via spraydrift and deposition

following volatilization

The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzel-

meier. Active substance Metamitron and Quinmerac have a vapour pressure of < 10-5 Pa and are therefore

classified as non-volatile. Hence, deposition following volatilization has not been considered. The input

parameters for Metamitron and Quinmerac are given in Section 5.5.6

Several ecotoxicological endpoints are available to assess the risk of the active substances Metamitron,

Quinmerac and the formulation GOLTIX TITAN (see chapter 6.5.2). The choice of the relevant scenario

is based on the ratio of endpoint to the highest PEC for each active substance and the formulation, related

to the relevant trigger TER value.

Table 6.5-1: Decision making of the relevant scenario for risk assessment of aquatic organisms

based on the lowest ratio of TER to safety factor

Substance Max.

application rate

Drift factor Max. PEC

(act)

Endpoint,

Species, safety

factor

TER TER/SF

[g/ha] % [µg/L] [µg/L]

Quinmerac 1 x 120 +

3 x 40

74th 1.470 3160

Oncorhynchus

mykiss

SF= 10

2150 215

Metamitron 1 x 1575 +

3 x 525

74th 19.291 1.12

Mesocosm

58.1 19.4



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SF=3

PEC: predicted environmenral concentration; TER: Toxicity exposure ratio; SF: Safety factor

Based on the table above, endpoint from Mesocosm study provides for Metamitron the lowest TER/SF ratio

and is therefore the relevant scenario for risk assessment.

Table 6.5-2: Risk assessment for Metamitron for aquatic organisms for the entry route via spray-

drift and deposition following volatilization under the implementation of different

risk mitigation measures

Compound: Metamitron

Crop/Application rate: 1 x 1575 +3 x 525 g a.i./ha

Growth stage and season 0-19 BBCH

Intended use group: 1

DT50 water (SFO): 1000 (default)

PEC-selection: actual

Drift-Percentile: 74th

Buffer

zone

Entry via

spraydrift

Entry via

deposition

following

volatilization

PECsw; conventional and drift reducing technique

0% conv. 50% red. 75% red. 90% red.

[m] [%] [µg/ha] [%] [µg/L] [µg /L]

1 1.85 1.470 1.470 0.735 0.367 0.147

5 0.38 0.302 0.302 0.151 0.075 0.030

10 0.19 0.151 0.151 0.075 0.038 0.015

15 0.13 0.103 0.103 0.052 0.026 0.010

20 0.10 0.079 0.079 0.040 0.020 0.008

Relevant toxicity endpoint: NOEAEC = 1.12 mg a.s./L, multispecies mesocosm

Relevant TER: 3

Buffer zone [m] TER

1 2150.0 4299.9 8599.9 21499,7

Risk mitigation measures none

PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.

6.5.4.2 TER values for the entry into surface water via run-off and drainage

The concentration of the active substance Metamitron in adjacent ditch due to surface runoff and drainage

is calculated using the model EXPOSIT 3.01. The input parameters for Metamitron for exposure modelling

with EXPOSIT 3.01 are given in the German National Addendum Section 5, chapter 5.6.2.

Table 6.5-3: Risk assessment for Metamitron for aquatic organisms for the entry route via run-

off and drainage under the implementation of different risk mitigation measures

Compound: Metamitron



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Application rate: 1 x 1575 +3 x 525 g a.i./ha

Intended use 1

Relevant toxicity endpoint: NOEAEC = 1.12 mg a.s./L, multispecies mesocosm

Relevant TER: 3

Run-off

Buffer zone

[m]

PEC

[µg/L]

TER

0 17.94 62.4

5 15.55 72.0

10 13.33 84.1

20 9.33 120.1

Drainage

Time of application PEC TER

[µg/L]

Autumn/winter/early spring 18.08 61.94

Spring/summer 5.88 190.6

Risk mitigation measures -none

PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.

6.5.4.3 Consideration of Metabolites



Based on the calculated concentrations of Metamitron and Quinmerac in surface water (EVA 2.1, EXPOSIT

3.0.1), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic

organisms to Metamitron according to the GAP of the formulation GOLTIX TITAN achieve the accepta-

bility criteria TER ≥ 3 (multispecies mesocosm), according to commission implementing regulation (EU)

No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects. The results of the

assessment indicate an acceptable risk for aquatic organisms due to the intended use of GOLTIX TITAN

in beets according to the label.


For the authorization of the plant protection product GOLTIX TITAN following labeling and conditions

of use are mandatory:

Required Labelling

NW 262 EbC50Metamitron = 0.4 mg/L (P. subcapitata; EC50Goltix Titan = 2.0 mg/L (P.

subcapitata)



GOLTIX TITAN


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NW 263 LC50Metamitron = 5.7 mg/L (D. magna)

NW 265

EbC50Metamitron = 0.4 mg/L (L. gibba); ErC50Goltix Titan = 3.66 mg/L (L.

gibba)

Conditions for use

GOLTIX TITAN NW 468

use No. 2 NW 642

6.6 Effects on bees (MIIIA 10.4, KPC 10.3.1)

Please refer to the core assessment and the risk assessment outcome as provided by JKI.


none

6.7 Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2)



None

6.8 Effects on non-target soil meso- and macrofauna (MIIIA 10.6, KPC 10.4, KPC

10.4.1, KPC 10.4.2)




6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna,

TERA and TERLT (MIIIA 10.6.1)

The evaluation of the risk for earthworms and other soil macro-organisms was performed in accordance

with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the

Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).

For the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the

environmental fate section (Part B, Section 5) of this submission. The resulting maximum PECsoil values



GOLTIX TITAN


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Date May 2015

for the active substances Metamitron and the major soil degradation products are presented in the table

below.

As written in Sec. 5 core assessment chapter 5.5 no Pec Soil calcualton s for Quinmerac were carried out.

Explanation: according to section 6 of the first Registration Report for GOLTIX TITAN the TER values in

soil for quinmerac and its soil metabolites were above the respective TER values for metamitron and far

above the trigger. Therefore it was concluded that no calculation of PECsoil for quinmerac and its soil me-

tabolites is necessary, as the risk is covered by the assessment of metamitron and the formulation.

For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Ku-

biak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirk-

stoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ

360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of 2.5 cm is

applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. As soil bulk density

1.5 g cm-3is assumed.

The acute risk for earthworms and other non-target soil macro- and mesofauna resulting from an exposure

to Metamitron as well as the major soil degradation products of Metamitron was assessed by comparing

the maximum PECSOIL with the 14-day LC50 value to generate acute TER values. The TERA was calculated

as follows:

The chronic risk for earthworms, other non-target soil macro- and mesofauna and organic matter breack-

down resulting from an exposure to GOLTIX TITAN and Metamitron as well as the major soil degradation

products of Metamitron was assessed by comparing the maximum PECSOIL with the NOEC value to gener-

ate chronic TER values. The TERLT was calculated as follows:


Table 6.8-1: TER values for earthworms and other soil macro- and mesofauna (Tier-1) for Met-

amitron for the use in beets


Species Test item Time scale Endpoint Max. PECact

worst case

TER

[mg/kg soil dw] [mg/kg soil dw]

Eisenia fetida Metamitron Acute 914 5.5123 165.8

Chronic 28 5.5123 5.1

Desamino-

Metamitron

Acute >500 corr. 1.6790 297.8

(mg/kg) PEC

(mg/kg) LC=TER

soil

50

A

(mg/kg) PEC

(mg/kg) NOEC=TER

soil

LT



GOLTIX TITAN


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Date May 2015

GOLTIX TITAN Acute 1000 14.400 69.4

Chronic 100 14.400 6.94

Folsomia

candida

Desamino-

Metamitron

Chronic 100 1.6790 59.8

6.8.3 Higher tier risk assessment

Not relevant.


Based on the predicted concentrations of Metamitron/ GOLTIX TITAN in soils, the TER values describing

the acute and longterm risk for earthworms and other non-target soil organisms following exposure to Met-

amitron/ GOLTIX TITAN according to the GAP of the formulation GOLTIX TITAN achieves the accept-

ability criteria TER ≥ 10 resp. TER ≥ 5 according to commission implementing regulation (EU) No

546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an

acceptable risk for soil organisms due to the intended use of GOLTIX TITAN in beets according to the

label.


none

6.9 Effects on soil microbial activity (MIIIA 10.7, KPC 10.5)





The evaluation of the risk for earthworms was performed in accordance with the recommendations of the

“Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services

(SANCO/10329/2002 rev 2 (final), October 17, 2002).

Please refer to above for the predicted environmental concentrations in soil (PECSOIL) of Metamitron, Quin-

merac and GOLTIX TITAN.




GOLTIX TITAN


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Table 6.9-1: Risk assessment for effects on soil micro-organisms

Test substance Test concentration

(adverse effects < 25%)

PECSOIL Risk acceptable

GOLTIX TITAN (AG-

QMM1-565 SC) 31.04 mg prep./kg soil

14.40 Yes

Quinmerac 16.5 mg a.s./kg soil 0.4829* Yes

Metamitron 19.5 mg a.s./kg soil 5.5123 Yes



Desamino-Metamitron 21.73 mg a.s./kg soil 1.6790 Yes

*Pecsoil values for Quinmerac and its metabolites from main application proposal GOLTIX TITAN

(007529-00-00) National assessment


Based on the predicted concentrations of Metamitron, Quinmerac and GOLTIX TITAN in soils, the risk to

soil microbial processes following exposure to Metamitron, Quinmerac and GOLTIX TITAN according to

the GAP of the formulation GOLTIX TITAN is considered to be acceptable/ not acceptable according to

commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point

2.5.2.


none

6.10 Effects on non-target plants (MIIIA 10.8, KPC 10.6)

6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1)



None



GOLTIX TITAN


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Appendix 1 Table of Intended Uses in Germany (according to BVL 2014-04-14)







Applicant: ADAMA

Zone(s): central/EU

professional use X


Verified by MS: yes

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination / pur-

pose of crop)

F

G

or

I


controlled

(additionally: developmen-

tal stages of the pest or

pest group)


(days)

Remarks:


e.g. recommended or manda-

tory tank mixtures

Method /

Kind

Timing / Growth

stage of crop & sea-

son

Max. number

(min. interval

between appli-

cations)

a) per use

b) per crop/

season

kg, L product /

ha

a) max. rate per

appl.

b) max. total rate

per crop/season

g, kg as/ha

a) max. rate

per appl.

b) max. total

rate per

crop/season

Water L/ha

min / max

001 DE Sugar beet

BEAVA

fodder beet

BEAVC

F TTTMS

TTTDS

Spraying

splitting 4

applications

Spring

BBCH 00 – 19


emergence


after emergence

a) 4

b) 4

the 2nd to 4th

treatment with

an interval of 5

to 10 days

a)

timing 1:

3 L/ha

timing 2-4:

1 L/ha

a)

timing 1:

Metamitron

1575 g as/ha

Quinmerac

120 g as/ha

timing 2-4:

Metamitron

525 g as/ha

200 - 400 *XF



GOLTIX TITAN


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Date April 2015

b) 6 L/ha

maximum appli-

cation rate for

the intented crop

per year

Quinmerac

40 g as/ha

b)

Metamitron

3150 g as/ha

Quinmerac

240 g as/ha

maximum ap-

plication rate

for the intented

crop per year

*The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in

days is not required resp.



(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use sit-

uation should be described (e.g. fumigation of a structure)






(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, Black-

well, ISBN 3-8263-3152-4), including where relevant, information on season at time of applica-

tion









(L/ha)



Part B – Section 7 Core Assessment

Goltix Titan / AG-QMM1-565 SC 007529-00/01

Registration Report Central ZonePage 1 of 31

Julius Kühn-Institut 2015-02-06

REGISTRATION REPORT

Part B

Section 7: Efficacy Data and Information

Detailed Summary

Product Code: Goltix Titan / AG-QMM1-565 SC

Reg. No.: 007529-00/01

Active Substance: metamitron 525 g/L +

quinmerac 40 g/L

Central Zone


CORE ASSESSMENT

Applicant: Applicant: ADAMA Deutschland GmbH

Date: January 2014 (Label Extension)

Evaluator: Julius Kühn-Institut

Date: 2015-02-06





Table of Contents

IIIA1 6 Efficacy Data and Information on the Plant Protection Product ............................ 3

General information ............................................................................................. 3

Recent registration situation/history of the PPP ................................................... 3

Information on the active ingredients (Uptake and mode of action) ..................... 3

Information on crops and pests ........................................................................... 4

Information on the intended uses for Germany .................................................... 4

IIIA1 6.1 Efficacy data........................................................................................................ 5

IIIA1 6.1.1 Preliminary range-finding tests ............................................................................ 5

IIIA1 6.1.2 Minimum effective dose tests .............................................................................. 5

IIIA1 6.1.3 Efficacy tests ....................................................................................................... 6

IIIA1 6.1.4 Effects on yield and quality .................................................................................. 8

IIIA1 6.1.4.1 Impact on the quality of plants and plant products ............................................... 8

IIIA1 6.1.4.2 Effects on the processing procedure ................................................................... 9

IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products ...................................... 9

IIIA1 6.2 Adverse effects ................................................................................................... 9

IIIA1 6.2.1 Phytotoxicity to host crop..................................................................................... 9

IIIA1 6.2.2 Adverse effects on health of host animals ......................................................... 10

IIIA1 6.2.3 Adverse effects on site of application ................................................................ 10

IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) ................................ 10

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ...................... 11

IIIA1 6.2.6 Impact on succeeding crops .............................................................................. 11

IIIA1 6.2.7 Impact on other plants including adjacent crops ................................................ 12

IIIA1 6.2.8 Possible development of resistance or cross-resistance ................................... 12

IIIA1 6.3 Economics ........................................................................................................ 14

IIIA1 6.4 Benefits ............................................................................................................. 14

IIIA1 6.4.1 Survey of alternative pest control measures ...................................................... 14

IIIA1 6.4.2 Compatibility with current management practices including IPM........................ 14

IIIA1 6.4.3 Contribution to risk reduction ............................................................................. 15

IIIA1 6.5 Other/special studies ......................................................................................... 15

IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 ...................... 15

IIIA1 6.7 List of test facilities including the corresponding certificates .............................. 16

Appendix 1: List of data submitted in support of the evaluation ............................................. 17

Appendix 2: GAP Table ........................................................................................................ 27





IIIA1 6 Efficacy Data and Information on the Plant Protection Product

General information

This document summarises the information related to the efficacy data for a label extension of the plant protection product AG-QMM1-565 SC (in Germany: Goltix Titan). AG-QMM1-565 SC is a herbicide for the control of annual weeds in fodder- and sugar beet. It contains the active ingre-dients metamitron and quinmerac. AG-QMM1-565 SC (Goltix Titan) was authorised in Germany on December 20th, 2012 for the post-emergence control of annual dicotyledonous weeds in fod-der- and sugar beets (Registration N°: 007529-00). Further authorisations for this indication cur-rently exist in Belgium (GOLTIX QUEEN: Registration N° 10238P/B) and the Netherlands (GOLTIX QUEEN: Registration N° 14298 authorised on Dec. 6th, 2013). Metamitron was added to the list of approved active substances contained in Commission Imple-menting Regulation (EU) No 540/2011 (date of approval 01/09/2009). The inclusion expires on 31/08/2019. Rapporteur Member State is Great Britain. Quinmerac was added to the list of approved active substances contained in Commission Imple-menting Regulation (EU) No 540/2011 (date of approval 01/05/2011). The inclusion expires on 30/04/2021. Rapporteur Member State is UK. According to the EPPO standard PP1/241 (zones of comparable climate in the EPPO region) Germany, Belgium and the Netherlands are part of the maritime EPPO zone.

Zonal rapporteur member state (zRMS) and concerned member states (cMS).

zRMS Germany DE

cMS Belgium, Netherlands BE, NL

Recent registration situation/history of the PPP

Both active substances are registered in Germany and in countries of zone B in different herbicidal products. Metamitron is presently registered as a component of several other herbicides for the control of annual weeds in sugar- and fodder beet. Examples from Germany are: Reg.-No.: 006470-00 [Goltix Gold], 024081-00 [Tornado], 005338-00 [Beetix SC], 024169-00 [Completto], 005428-00 [Betanal Quattro]. The active ingredient Quinmerac is presently authorised for weed control in sugar beet as a com-ponent of the herbicide Rebell (Reg.-No.: 024105-00 [Germany]). The test product AG-QMM1-565 SC is not registered in any country of the EU yet.

Information on the active ingredients (Uptake and mode of action)

Metamitron belongs to the chemical group of triazinones. Metamitron is a selective herbicide to be used in fodder- and sugar beets for the control of mono- and dicotyledonous weeds. Primarily it is taken up by plant roots and shoots and is translocated acropetally to the chloroplasts. Also a plant uptake through the leaves is possible. Like other triazinones, metamitron acts as an inhibitor of photosynthetic electron transport at the photosystem II receptor site (Hill-reaction). Plant uptake is influenced by many factors: temperature, humidity, soil moisture and sorption properties of the soil. Selectivity of weeds is based on different metabolisation. Susceptible weed seedlings be-come chlorotic, exhibit yellowed and cleared discolouration and finally get withered. Metamitron is highly selective in fodder and sugar beets. Metamitron is readily degraded by aqueous photol-ysis. The major metabolite in sugar beet is deaminated metamitron. The further degradation takes





place by opening of the heterocyclic ring. A main metabolite in sugar beet is 3-methyl-6-phenyl-1,2,4-triazin-5(4H)-on. Site of action (HRAC-group): C1 Quinmerac belongs to the chemical group of quinolinecarboxylic acids. Quinmerac is absorbed primarily via the root system but can also be absorbed from the foliage. Adequate soil moisture supports the uptake by roots and the onset of activity. Uptake by leaves depends on the concen-tration of the active ingredient and time. Light increases the uptake rate. In contrast dependence on temperature is slight. Its mode of action has been proposed as root growth inhibition which exhibits auxin type effects (similar to phenoxycarboxylic acids). Based on the auxin effects quin-merac stimulates the formation of the phytohormone ethylene in sensitive plants, leading to epi-nasty, altered uptake and other effects. In the biosynthesis the enzymatic activity of 1-aminocy-clopropane-1-carboxylic-acid synthase will be induced. As a result an accumulation of abscisic acid (ABA) in the plant tissue occurs. The consequences are: deformation of plants, occlusion of stomata, inhibition of transpiration, CO2-assimilation and growth as well as the death of plant cells. The selective effect is based on plant tissue/target location selectivity in crop plants. In sugar beet the tolerance is supported by a faster degradation. Uptake and translocation has no great signif-icance for herbicide efficacy. Plant metabolism studies showed that hydroxylation of the quinoline ring and hydroxylation/car-boxylation of the 3-methyl-quinoline moiety and subsequent carbohydrate conjugation are the primary metabolic pathways of quinmerac. Major metabolites identified were 7-chloro-3-hy-droxymethyl quinoline-8.carboxylic acid and 7-chloro-quinoline-3,8-dicarboxylic acid. Site of ac-tion (HRAC-group): O

Information on crops and pests

According to the importance (occurrence, cultivation) in the member states (MS) the intended target/crop can be classified in Germany as follows: Table 6.0-1: Importance of intended target/crop in Germany

target/crop EPPO Country Classification

target

annual dicotyledonous weeds

TTTDD Germany major

annual monocotyledonous weeds

TTTMS Germany major

Crop

Sugar beet BEAVA Germany major

Fodder beet BEAVC Germany minor

Information on the importance of crops and pests for Belgium and the Netherlands is not reported sufficiently by the applicant.

Information on the intended uses for Germany

2014-06-24 Goltix Titan Use No. 007529-00/01-001 Field of use Agriculture (field crops) Crop(s)/object(s) fodder beet (BEAVC), sugar beet (BEAVA) Crop stage(s) (BBCH) 00 to 19

Formatiert: Links

Formatiert: Links





Pest(s)/target(s) annual monocotyledonous weeds (TTTMS)*, annual dicotyle-donous weeds (TTTDS)

Area of application Outdoors Timing of application Spring, before emergence (1st treatment), after emergence (2nd to

4th treatment) Notes on time of treat-ment

the 2nd to 4th treatment with an interval of 5 to 10 days

Max. number of treat-ments for the use

4

Max. number of treat-ments per crop or sea-son

4

Application method/kind of treat-ment

spraying

Remarks on application method

splitting (4 applications)

Application rate(s) timing 1: 3 L/ha in 200 to 400 L water/ha timing 2: 1 L/ha in 200 to 400 L water/ha timing 3: 1 L/ha in 200 to 400 L water/ha timing 4: 1 L/ha in 200 to 400 L water/ha

Notes on application rate

maximum application rate for the intended crop per year 6 L/ha

*withdrawn by letter of applicant from 2015-01-13. The new indication No. 002 (label extension) in the GAP list in App. 2 for AG-QMM1-565 SC is intended for Belgium and the Netherlands.

IIIA1 6.1 Efficacy data

IIIA1 6.1.1 Preliminary range-finding tests

The applicant indicates that the active substances of AG-QMM1-565 SC, metamitron and quin-

merac, are authorised and widely used for weed control in many countries inside and outside of

Europe. It is therefore not deemed necessary to provide results from preliminary range finding

tests.

IIIA1 6.1.2 Minimum effective dose tests

An overview of trials presented for the purpose ‘minimum effective dose’ is given in Table 6.1.2-1. Table 6.1.2-1: Overview and distribution of field trials carried out to determine the minimum effec-tive dose EU zone EPPO zone Country Year: 2012 Central Maritime BE 2 DE 4 NL 4 Sum 10





In 10 trials carried out in 2012 AG-QMM1-565 SC was tested to determine the minimum effective dose. The reduced tested rates of AG-QMM1-565 SC were 2.4+3x0.8 L/ha and 1.5+3x0.5 L/ha. The rate range reflects 60%, 80% and 100% of the full recommended application rate of AG-QMM1-565 SC, in accordance with the EPPO standard PP1/225(1) “Minimum effective dose”. Efficacy is tested under a range of environmental conditions to fully challenge the product. The trials were carried out in Germany, Belgium and the Netherlands (all EC Central zone; maritime EPPO zone). They were of a randomised block design with four replicates and a minimum plot size of 17.5 m2. Reference products were Goltix Gold (Goltix SC) either as single product splitting applications or as pre-emergence applications followed by common spraying sequences at au-thorised rates. The dose response results against some target weed species show that there is a trend that for most of the weed species the efficacy is reduced and the variability of the level of control is increased, if rates lower than 3+3x1 L/ha of AG-QMM1-565 SC are applied (table 6.1.2-2). Table 6.1.2-2: Efficacy (% control) of different rates of AG-QMM1-565 SC against target weed species in 2012

EPPO code

Scientific Name

n

1.5+3x0.5 L/ha (50%)

2.4+3x0.8 L/ha (80%) 3+3x1 L/ha (100%)

Ø Med Min Max Ø Med Min Max Ø Med Min Max

POAAN Poa annua 2 100 100 100 100 100 100 100 100 100

CHEAL Chenopodium album

5 68 69 29 96 79 87 53 99 91 95 79 100

POLPE Polygonum persicaria

4 94 96 85 99 96 96 93 100 92 97 74 99

VIOAR Viola arvensis 4 80 88 54 91 87 92 64 99 94 94 90 99

AETCY Aethusa cynapium

3 85 99 55 100 97 99 91 100 100 100 99 100

CAPBP Capsella bursa-pastoris

3 100 100 99 100 100 100 99 100 100 100 100 100

FUMOF Fumaria offici-nalis

3 36 18 0 91 65 93 10 93 72 91 26 98

GALAP Galium apa-rine

3 80 75 66 100 84 76 75 100 89 91 75 100

STEME Stellaria media 3 95 99 85 100 94 99 84 100 93 100 78 100

Conclusion The dose response results against some target weed species show that there is a trend that for most of the weed species the efficacy is reduced and the variability of the level of control is in-creased, if rates lower than 3+3x1 L/ha of AG-QMM1-565 SC are applied.

IIIA1 6.1.3 Efficacy tests

A total of 17 trials were carried out in 2010, 2011, and 2012 to evaluate the efficacy of AG-QMM1-565 SC for the control of the target weed species in fodder- and sugar beet. All of them were conducted to GEP and followed the appropriate EPPO standards (PP1/52 “Weeds in sugar and fodder beet”, PP1/152 “Design and Analysis of Efficacy Evaluation Trials”, PP1/181 “Conduct and Reporting of Efficacy Evaluation Trials”). The field trials were of a random-ized complete block design with four replicates and a minimum plot size of 17.5 m2. Trials included





a range of locations to determine efficacy against the target weed species on a number of com-mercially grown varieties of the target crops under a range of conditions. All the trials were placed within regions where fodder- and sugar beets are commonly grown. The trials presented in this dossier for the European Central regulatory zone have been carried out in Belgium, Germany and the Netherlands in the maritime EPPO zone (according to EPPO standard PP1/241(1) “Guidance on comparable climates”. Table 6.1.3-1 presents the distribution of the trials over years and countries. Table 6.1.3-1: Overview and distribution of field trials carried out to determine the efficacy of AG-QMM1-565 SC on target weeds species in fodder- and sugar beet

EU zone EPPO zone Country Year

Sum 2010 2011 2012

Central Maritime BE 2 2 DE 4 4 NL 4 3 4 11 Sum 4 3 10 17

The applied application rate of AG-QMM1-565 SC was 3 L/ha pre-emergence followed by up to 3 post-emergence splitting applications of 1 L/ha each. Reference products were Goltix Gold, Goltix 700 SC and application sequences consisting of different products used in practice com-monly. In all GEP compliant efficacy trials weed control was assessed according to EPPO standards, with a series of visual assessments of % control in relation to an untreated plot. Either weed cover was recorded as plants/m2 or populations were recorded using a % ground cover score. Across the trials visual weed assessments were done up to 4 times. A summary of the results from tests carried out in 2010, 2011, and 2012 is presented in Table 6.1.3-2. Table 6.1.3-2: Efficacy (% control) of AG-QMM1-565 SC against target weed species

Weed Species n

AG-QMM1-565 SC Reference Product(s)

EPPO Code

Scientific Name Ø Med Min Max Ø Med Min Max

POAAN Poa annua 2 100 100 100 100 100 100

ECHCG Echinochloa crus-galli 2 28 0 56 99 98 100

CHEAL Chenopodium album 8 85 85 71 100 97 98.5 88 100

VIOAR Viola arvensis 5 92 92 86 99 95 94 89 100

POLPE Polygonum persicaria 5 87 97 68 99 94 99 76 100

STEME Stellaria media 5 86 78 29 100 96 100 86 100

AETCY Aethusa cynapium 3 100 100 99 100 79 93 43 100

CAPBP Capsella bursa-pastoris 3 100 100 100 100 100 100 100 100

LAMPU Lamium purpureum 3 98 100 94 100 98 100 95 100

GALAP Galium aparine 3 89 91 75 100 88 91 75 97

FUMOF Fumaria officinalis 3 72 90.8 26 98 70 100 11 100

POLCO Fallopia convolvulus 3 71 67 50 96 65 78 17 100

POLAV Polygonum aviculare 3 59 60 43 75 82 81 65 100

MATCH Matricaria chamomilla 2 100 100 100 100 99 100

VERSS Veronica 2 100 100 100 97 94 100

LAMAM Lamium amplexicaule 2 89 83 95 99 98 100

SOLNI Solanum nigrum 2 74 71 77 100 100 100





Weed Species n

AG-QMM1-565 SC Reference Product(s)

EPPO Code

Scientific Name Ø Med Min Max Ø Med Min Max

MERAN Mercurialis annua 2 58 18 99 96 93 100

MATSS Matricaria 1 100 100

AMARE Amaranthus retroflexus 1 100 100

SENVU Senecio vulgaris 1 100 100

SSYOF Sisymbrium officinale 1 100 100

GASPA Galinsoga parviflora 1 98 100

URTUR Urtica urens 1 98 100

ATXPA Atriplex patula 1 90 100

POLTO Polygonum tomentosum 1 50 81

SINAR Sinapis arvensis 1 43 95

Conclusion Based on the results it can be concluded AG-QMM1-565 SC provides sufficient control of a num-ber of annual dicotyledonous weed species in fodder and sugar beets. POAAN and ECHCG are documented only in 2 trials. More annual monocotyledonous species didn´t occur in the efficacy trials. So a final evaluation for annual monocotyledonous species is not possible. Member States should consider the levels of control achieved according to National conventions.

IIIA1 6.1.4 Effects on yield and quality

To evaluate the effects of AG-QMM1-565 SC on yield and quality it is focused on the specific weed free yield trials.

IIIA1 6.1.4.1 Impact on the quality of plants and plant products

Quality parameters being determined in the tests are the sugar content and the components so-dium, potassium and amino-N. The adjusted sugar content is presented in this report as the result of these parameters. The sugar content and the components sodium, potassium and α-amino-N were determined in 8 selectivity trials. The adjusted sugar content was calculated by the author using the 'Braunschwei-ger formula'. The results are presented in Table 6.1.4-1. They demonstrate that there is no influ-ence on the sugar content or the adjusted sugar content of beets by AG-QMM1-565 SC, even if the product is applied at double rate. Table 6.1.4-1: Influence of AG-QMM1-565 SC applied at target rate (3 L/ha pre- + 3x1 L/ha post-emergence) and double rates on the sugar content of sugar beets

No.

Sugar content [%] Adjusted sugar content [%]

Con- trol

AG-QMM1-565 SC

Ref. Prod. Con- trol

AG-QMM1-565 SC

Ref. Prod.

3+3x 1 L/ha

6+3x 2 L/ha

X-rate 2X-rate 3+3x

1 L/ha 6+3x

2 L/ha X-rate 2X-rate

1 18.14 17.76 18.08 18.52 16.10 15.75 16.00 16.20 2 18.52 19.12 19.22 19.06 16.72 17.29 17.39 17.18 3 16.57 16.68 17.15 16.73 14.82 14.94 15.38 14.96 4 14.21 14.17 14.16 14.14 12.12 12.06 12.07 12.01 5 15.36 15.10 15.81 15.33 13.63 13.37 14.05 13.59 6 15.32 15.69 15.40 15.39 15.68 13.20 13.53 13.27 13.27 13.50





7 16.19 16.16 16.21 16.18 16.36 13.94 13.92 13.92 13.94 14.10 8 15.30 15.29 15.00 14.91 15.25 13.46 13.46 13.15 13.07 13.40 Ø 16.20 16.24 16.38 16.28 15.76 14.25 14.29 14.40 14.28 13.67

Conclusion: Based on the results of 8 trials carried out in sugar beets in Germany and the Netherlands during the cropping season 2013 it can be concluded that there are no indications for a negative impact on quality of plants and plant products in sugar or fodder beets if AG-QMM1-565 SC is applied at the intended target application rates. Even at the double rates there is no substantial risk for an impact on plant or plant products.

IIIA1 6.1.4.2 Effects on the processing procedure

Since the market introduction of the active ingredients metamitron and quinmerac no cases of negative influences on parameters influencing the processing procedure of sugar- or fodder beets were reported, neither from practical use nor from trial experience. Thus, no special trials were carried out for the assessment of this criterion.

IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products

Yield was taken in 8 selectivity trials carried out under almost weed free conditions. The results are presented in Table 6.1.4.3-1. Table 6.1.4.3-1: Influence of AG-QMM1-565 SC on yield quantity (relative to control) of sugar beets

No. Cultivar Control

AG-QMM1-565 SC Reference product(s) 3-3x1 L/ha 6+3x2 L/ha X-rate 2X-rate

t/ha t/ha rel t/ha rel t/ha rel t/ha rel

1 Sporta 52.3 52.4 100 52.2 100 52.4 100 2 Emilia 55.4 55.6 101 55.6 100 55.4 100

3 Schubert 99.5 98.2 99 99.6 100 96.3 97 4 Hella 61.7 62.2 101 62.3 101 62.0 100

5 Christarina 74.6 70.1 94 80.6 108 74.6 100 6 Isabella 115.1 115.7 101 112.9 98 114.5 100 111.2 97 7 Isabella 94.9 94.6 100 88.3 93 91.6 97 94.1 99

8 Fernanda 95.0 92.9 98 88.9 94 84.2 89 91.4 96 Ø 81.1 80.2 99 80.0 99 78.9 97 98.9 97

Conclusion The results demonstrate that there are no indications for a negative impact on quantity of yield in sugar- or fodder beets if AG-QMM1-565 SC is applied at the intended target application rates. Even at the double rate there is no substantial risk for an impact on yield quantity.

IIIA1 6.2 Adverse effects

IIIA1 6.2.1 Phytotoxicity to host crop

The effects AG-QMM1-565 SC applied in splitting applications (3 L/ha pre-emergence + 3x1 L/ha post-emergence) on the target crop were rated in a total of 25 trials (17 efficacy trials and 8 se-lectivity trials). In Table 6.2.1-1 the frequency and the magnitude of observations of phytotoxic symptoms are presented.



Registration Report Central Zone

Page 10 of 31


Table 6.2.1-1: Crop tolerance (Phyto*[%]) of AG-QMM1-565 SC applied POST emergence at the target rates in sugar beets

AG-QMM1-565 SC / 3+3x1 L/ha Reference product(s)

Eff. trials Sel. trials All trials Eff. trials Sel. trials All trials

across the whole test pe-riod

Mean** 0.22 0 0.15 1.5 0 0.82

Maximum 3.75 0 3.75 10 0 10

N° of tests: 0% 16 8 24 14 8 22

N° of tests: >0-5% 1 0 1 1 0 1

N° of tests: >5-15% 0 0 0 2 0 2

N° of tests: >15% 0 0 0 0 0 0

N° of tests 17 8 25 17 8 25 *) phyto = general phytotoxicity or maximum value of symptoms **) averaged maximum crop injury values within the evaluation period

Conclusion The results show that AG-QMM1-565 SC is tolerated well by sugar beets. For this indication only one year results are available from trials carried out with the double rate included under almost weed free conditions (2013). So Therefore a label warning (Damage is possible to the crop.) should be considered.

IIIA1 6.2.2 Adverse effects on health of host animals

This is not an EC data requirement.

IIIA1 6.2.3 Adverse effects on site of application


IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees)

The herbicide Goltix Titan has been proposed for split applications in sugar and fodder beets with a total application rate of 6 L/ha. Taking into account the potential dissipation of the active ingre-dients between applications, the worst case application rate can be calculated to be approximately 5.4 L/ha.

The evaluation of adverse effects of the proposed use of the test product on beneficial organisms (other than bees) is covered by the assessment in the main application (007529-00/00). Conclusion At the proposed application rate of 6 L/ha and year, Goltix Titan was harmless for Aphidius rhopalosiphi and Typhlodromus pyri with effects < 25%. The two indicator species are no relevant antagonists for the proposed crops, hence no classification is proposed for them. The results for the sensitive indicator species Typhlodromus pyri and the results for spiders of the genus Pardosa with metamitron indicate that the test product will not be harmful for other, relevant predatory mites and spiders. Besides the two indicator species, only the rove beetle Aleochara bilineata was tested with SC-formulations of the both active ingredients of the test product, metamitron and quinmerac. Met-amitron was shown to be slightly harmful with an effect between 30 – 80% under worst case conditions. No effects occurred in a laboratory study with the combination product AG-QM2-500 SC and in an extended laboratory study with metamitron, but the latter test did not fulfil the validity

Formatiert: Deutsch (Deutschland)




Page 11 of 31


criteria. Thus it could not be excluded, that the test product can be slightly harmful for Aleochara bilineata. On the basis of the results of an extended laboratory study with Metamitron, the test product has to be considered as slightly harmful for the ladybird beetle Coccinella septempunctata. Classification according to IOBC: Laboratory tests on artificial substrates

< 30% = not harmful 30 – 79% = slightly harmful ≥ 80% = harmful

Extended laboratory tests on natural substrates < 25% = not harmful 25 - 50% = slightly harmful > 50% = harmful

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes

Neither from the agricultural use of metamitron or quinmerac during the past years, nor from field trials there is any information that the application of products containing these active ingredients has any influence on the propagation behaviour of sugar beet.

IIIA1 6.2.6 Impact on succeeding crops

EC10-values of AG-QMM1-565 SC are determined. The results are demonstrated in Table 6.2-6.-1. Table 6.2.6-1: EC10-values of AG-QMM1-565 SC for the parameter fresh weight (AG-QMM1-565 SC mg/kg dry soil)

Crops

BRSNN BEAVA PIBSA TRFPR HORVS ZEAMX

EC10-value (mg/kg) 0.129 1.752 3.158 0.077 3.158 1.225

The TER-values are calculated as a quotient of the EC10-values and PECsoil. TER-values >1 indi-cate no unacceptable risk for the following crop. The results show that there is no indication by the TER-values for an unacceptable risk for all succeeding crops in common crop rotations. Out of the tested crops, red clover is the most sensitive crop to AG-QMM1-565 SC available in soil. It is followed by oil seed rape. Maize is moderately sensitive and barley, peas and sugar beets showed to be tolerant even at the highest rates tested. Table 6.2.6-2: TER- values of AG-QMM1-565 SC (3x2030 g AI/ha) for different crops at different DAAs

Days After Application (DAA)

0 10 30 60 90 120 150 240 360 Mixing Depth in soil: 5 cm

PECsoil MMN 2.739 1.999 1.064 0.414 0.161 0.062 0.024 0.001 0.000 PECsoil QMC 0.236 0.209 0.165 0.115 0.081 0.056 0.039 0.013 0.003 PECsoil Total 2.975 2.208 1.229 0.529 0.241 0.119 0.064 0.015 0.003

HORVS 1.06 1.43 2.57 6.0 13 26 49 212 978 PIBSA 1.06 1.43 2.57 6.0 13 26 49 212 978 BEAVA 0.59 0.79 1.43 3.31 7.2 14 27 118 542 ZEAMX 0.41 0.55 1.00 2.32 5.1 10 19 82 379 BRSNN 0.04 0.06 0.10 0.24 0.53 1.1 2.03 8.7 39




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TRFPR 0.03 0.03 0.06 0.15 0.32 0.65 1.21 5.2 23

Conclusion Potential impacts on succeeding crops have to be analysed on the basis of the EPPO standard PP1/207. The results show that there is no unacceptable risk for all succeeding crops in common crop rotations.

IIIA1 6.2.7 Impact on other plants including adjacent crops

The risk assessment for higher plants came to the conclusion, that the risk for all 10 species investigated following an application of AG-QMM1-565 SC is low (table 6.2.7-1). Table 6.2.7-1: Initial predicted environmental concentrations (PECini) in L/ha for the evaluation of the risk to non-target plants (use 001)

L/ha Distance

(m)

Drift values [90th percen-

tile] (%)

PECini (L/ha) Conventional

nozzles Drift reducing nozzles

50% 75% 90%

3 1 2.77 0.0831 0.04155 0.020775 0.00831 5 0.57 0.0171 0.00855 0.004275 0.00171

To assess the risk to emerged and non emerged adjacent crops, the phytotoxicity of AG-QMM1-565 SC was determined for 10 terrestrial plant species. Table 6.2.7-2: ED50-values (L/ha) of crops based on plant fresh weight

AVESA ZEAMX LOLPE ALLCE BRSNN HELAN LINUS LYCES DAUCA GLXMA

non-emer-ged plants

>2.009 >3.616 >2.009 >2.009 >1.116 >2.009 >1.116 >1.116 >1.116 >2.009

Emer-ged plants

>2.009 >3.616 >2.009 >2.009 >2.009 >3.616 >1.116 >1.116 >2.009 >3.616

Conclusion The comparison indicates that there is no risk of spray drift damage for the tested crops. Following the principles of good agriculture practice during the application, no effects on adjacent crops are expected.

IIIA1 6.2.8 Possible development of resistance or cross-resistance

Mechanism of resistance The herbicide Goltix Titan contains the active substances metamitron and quinmerac. Metamitron inhibits the photosynthesis by the inhibition of the electron transport in photosystem II. Due to this primary target site and the chemical subgroup, metamitron is classified as a HRAC group C1 herbicide (inhibition of photosynthesis at photo-system II). The other chemical groups in HRAC group C1 are: triazines, triazolinones, uracils, pyridazi-nones and phenyl-carbamates. The major reason for the reduced sensitivity of resistant weed biotypes against HRAC group C1 herbicides is a changed receptor protein psbA caused by a single SNP (Ser264Gly). The mecha-nism of resistance inherited maternal is well characterised with respect to physiological, biochem-ical and molecular processes. In addition, as it has been found in Amaranthus tuberculatus re-cently a second, nuclear inherited mechanism of resistance to triazines might exist in exceptional cases. However, plants being resistant to triazines by this mechanism are not cross resistant to




Page 13 of 31


triazinones (in this case metribuzin). Recently a new mutation has been described (Leu218Val) in Chenopodium album inducing resistance to metamitron, metribuzin and chloridazone, but not to triazines. Quinmerac belongs to the chemical group of the quinolinecarboxylic acids. Due to its primary target site and its chemical family, in the HRAC mode of action classification quinmerac is classi-fied as group O. Although the mechanism of resistance of group O herbicides has not been determined, resistance may be due to an insensitive target site.

Evidence of resistance and cross resistance HRAC group C1 herbicides are used for weed control in agricultural crops for about 50 years. Since the first observations of weeds becoming resistant to this group of herbicides in the early 1970s, worldwide further reports followed continuously until today with a peak during the 1980s and the early 1990s. In the global database of Ian Heap, 72 weed species with resistance to at least one active substance of the HRAC group C1 are listed (www.weedscience.org, accessed July 2014). In the predominant majority the cases are based on the development of weeds being resistant to triazines, but recently also some cases of metamitron resistant Chenopodium album biotypes were reported from Belgium and Germany and in Germany it was shown that Matricaria species collected from areas treated with metamitron for several years were less susceptible to this substance than species from areas that have never been treated with metamitron. Based on the HRAC resistance classification, cross resistance should be expected to be likely between metamitron (triazinones) and the other HRAC group C1 herbicides and was approved recently for metamitron, lenacil (uracil) and chloridazone (pyridazinone), all of them being HRAC Group C1 herbicides that inhibit photosynthesis at PS II. The metamitron-resistant C. album pop-ulations examined showed negative cross-resistance to S-metolachlor (HRAC Group K3: inhibi-tion of cell division), prosulfocarb (Group N: lipid synthesis, not ACCase, inhibition), aclonifen and clomazone (both Group F3: inhibition of carotenoid biosynthesis). Based on the HRAC database no case of cross resistance to herbicides belonging to different HRAC groups is reported. Cases of multiple resistance including HRAC group C1 herbicides are reported for biotypes of Amaran-thus species (mainly at oversea locations, 1 case in Germany 1980), Bidens subalternans, Kochia species, Portulaca oleracea (all on oversea locations) and Alopecurus myosuroides (Belgium 1996). In the global database of Ian Heap, 31 weed species with resistance to at least one active sub-stance of the HRAC group O are listed (www.weedscience.org, accessed July 2014). There are no known cases of resistance to quinmerac. However, based on HRAC resistance classification, cross resistance should be expected to be likely between quinmerac and other HRAC group O herbicides. In Europe cases of multiple resistance including HRAC group O herbicides are re-ported for biotypes of Papaver rhoeas. Analysis of the inherent risk Major weed species concerned by the intended indication for Goltix Titan are Poa annua, Cheno-podium album, Stellaria media, Polygonum species, Capsella bursa pastoris, Galinsoga parvi-flora, Matricaria species, Mercurialis annua, Viola species, Veronica species, Thlaspi arvensis, Lamium species and Solanum nigrum. Based on the reported cases of resistance the inherent risk to develop resistance against metamitron in Europe is considered high for Poa annua, Ama-ranthus retroflexus, Chenopodium album, Senecio vulgaris and Solanum nigrum. These weeds show the highest frequency of resistance development. Due to a presently increasing number of reported resistances and the generally high inherent risk, Matricaria species are considered as high risk weed species as well. With respect to quinmerac in general the frequency of the occur-rence of resistance against HRAC group O herbicides is very low, especially when only the Eu-ropean observations are taken into consideration. The applicant has not provided baseline sensitivity data but has reported on a monitoring study conducted on Chenopodium album in Germany during 2007 to 2009 to determine the actual sen-sitivity status of Chenopodium album to this active substance. 25 Chenopodium album sources from 25 German locations (sugar beet production areas) were compared to a known resistant




Page 14 of 31


Belgium source (Outgaarden). 24 sources showed to be sensitive to metamitron with ED50 - val-ues ranging from 0.16 to 0.76 L/ha of Goltix Gold, while Chenopodium album from 1 location (near Hannover) was resistant (ED50: 2.4 L/ha; resistant standard Outgaarden: ED50 = 1.93 L/ha). Based on the averaged sensitivity of the sensitive Chenopodium album sources the resistance factor (diversity factor) of this resistant source is calculated to be 4.52 (resistant standard Outgaarden: 3.98). Analysis of the agronomic risk The herbicide Goltix Titan is aimed at being applied for control of annual monocotyledonous weeds, GALAP and other annual dicotyledonous weeds in sugar and fodder beets. Sugar beets are planted exclusively in crop rotations with an interval of at least 3 years and it is not common practice to plant sugar beets in crop rotation with maize. They are typically rotated with cereals and in Germany and Benelux almost all available cereal herbicides have modes of action (A, B, C2, C3, E, F1, K1, K3, N, O) different from metamitron. Under many situations, the herbicide will be applied in tank mixtures or sequences with other active substances or MoA. Some of the target species of Goltix Titan may therefore also be con-trolled by other substances so that the selection pressure and resistance risk is slightly reduced. The herbicide contains two active ingredients providing different modes of action. The design of the respective crop rotations and the associated frequency of application of Goltix Titan may differ in the various Member States in the EU and a national-specific assessment of the agronomic risk is therefore recommended. Summary and conclusion The applicant claims that the risk for the development of resistant weed biotypes in major sugar beet production areas is considered medium because of the fact that despite many years of in-tensive use of metamitron only very occasional proven problems with weed resistance are re-ported in Europe, and that no proven problems of quinmerac with this active ingredient are re-ported. This conclusion cannot be fully followed. As the number of metamitron resistance cases reported for Chenopodium album has substantially increased in the last years, the resistance risk for metamitron has to be rated as high especially for Germany and Belgium. As the spectrum of weed species controlled by metamitron on and quinmerac is not overlapping and because the above mentioned high risk weed species (especially Chenopodium album) are nor controlled by quinmerac, the resistance risk of the herbicide has to be rated a medium to high. Management strategy Due to the medium to high resistance risk, management strategies are required. The applicant claims that basic recommendations for resistance risk management will be clearly recommended on the label.

IIIA1 6.3 Economics


IIIA1 6.4 Benefits

IIIA1 6.4.1 Survey of alternative pest control measures


IIIA1 6.4.2 Compatibility with current management practices including IPM





Page 15 of 31


IIIA1 6.4.3 Contribution to risk reduction


IIIA1 6.5 Other/special studies

None.

IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5

AG-QMM1-565 SC is a herbicide for the control of annual weeds in fodder- and sugar beet. It contains the active ingredients metamitron and quinmerac. The dose response results against some target weed species show that there is a trend that for most of the weed species the efficacy is reduced and the variability of the level of control is in-creased, if rates lower than 3+3x1 L/ha of AG-QMM1-565 SC are applied. Based on the efficacy results it can be concluded AG-QMM1-565 SC provides sufficient control of a number of annual dicotyledonous weed species in fodder and sugar beets. POAAN and ECHCG are documented only in 2 trials. More annual monocotyledonous species didn´t occur in the efficacy trials. So a final evaluation for annual monocotyledonous species is not possible. Member States should consider the levels of control achieved according to National conventions. Based on the results of 8 trials carried out in sugar beets in Germany and the Netherlands during the cropping season 2013 it can be concluded that there are no indications for a negative impact on quality of plants and plant products in sugar or fodder beets if AG-QMM1-565 SC is applied at the intended target application rates. Even at the double rates there is no substantial risk for an impact on plant or plant products. The yield results demonstrate that there are no indications for a negative impact on quantity of yield in sugar- or fodder beets if AG-QMM1-565 SC is applied at the intended target application rates. Even at the double rate there is no substantial risk for an impact on yield quantity. The crop tolerance results show that AG-QMM1-565 SC is tolerated well by sugar beets. For this indication only one year results are available from trials carried out with the double rate included under almost weed free conditions (2013). So Therefore a label warning (Damage is possible to the crop.) should be considered. The test product is classified as not harmful for populations of relevant predatory mites and spi-ders. The test product can be slightly harmful for populations of the species Coccinella sep-tempunctata (seven-spotted ladybird) and Aleochara bilineata (rove beetle). Potential impacts on succeeding crops have to be analysed on the basis of the EPPO standard PP1/207. The results show that there is no unacceptable risk for all succeeding crops in common crop rotations. There is no risk of spray drift damage for the tested crops. Following the principles of good agri-culture practice during the application, no effects on adjacent crops are expected. Due to the medium to high resistance risk, management strategies are required. The applicant claims that basic recommendations for resistance risk management will be clearly recommended on the label.




Page 16 of 31


IIIA1 6.7 List of test facilities including the corresponding certificates

ID Trial Unit Countr Address Phone GE

ATT Agrartest GmbH DE Palmbachstraße 37 65326 Aarbergen-Panrod

XXX Y

AGA Agricola DE Ruselweg 6b 94330 Salching

XXX Y

BCA BioChem Agrar Labor für biologische und chemische Analytik GmbH

DE Kupferstraße 6 04827 Machern

XXX Y

DBR De Bredelaar B.V. Research Company for Plant Protection

NL Breedlerdestraat 7 6662 NP Elst

XXX Y

FRS Field Research Support DE Potts Kamp 8 31515 Wunstorf

XXX Y

AH Hetterich Fieldworks Ingenieurbüro für landwirtschaftliche Feldversuche

DE Bambergerstraße 50 97359 Schwarzach

XXX Y

GO Landwirtschaftskammer Nordrhein-Westfalen Pflanzenschutzamt

DE Siebengebirgsstr. 200 53229 Bonn

XXX Y

RDB Redebel s.a. - n.v. BE Rue de Chassart 4 6221 Saint-Amand

XXX Y




Page 17 of 31


Appendix 1: List of data submitted in support of the evaluation

Annex Point

Author

Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.

Data pro-tection claimed (J=Yes O=Open N=No)

Owner How consid-ered in

dRR Study-Status / Usage

MIIIA1 Sec 6

Feinchemie Schwebda GmbH

2014 dRR - B6 - core assess. - DE - 007529-00/01 - Goltix Titan O/O N 2574121/349275

O FSG Y

MIIIA1 Sec 6



O FSG Y

MIIIA1 Sec 7



O FSG Y

MIIIA1 Sec 7



O FSG Y

MIIIA1 Sec 6


2014 dRR - B6 - nat. add. - DE - 007529-00/01 - Goltix Titan O/O N 2574184/349290

O FSG Y

MIIIA1 Sec 6


2014 dRR - B6 - nat. add. - DE - 007529-00/01 - Goltix Titan O/O N 2574185/349291

O FSG Y




Page 18 of 31


Annex Point

Author





KIIIA1 6


2014 dRR (BAD) - B7 - core assess. - DE - 007529-00/01 - Goltix Titan (vertraulich) O/O N 2574409/349297

O FSG Y

KIIIA1 6


2014 dRR (BAD) - B7 - core assess. - DE - 007529-00/01 - Goltix Titan (vertraulich) O/O N 2574417/349299

O FSG Y

KIIIA1 6.1.1

Minarski, A. 2010 AG-QMM1-565SC (40g/L Quinmerac+525 g/L Metamitron) standardized bioassay for the determination of EC10-(NOEC) and EC50-values for herbicides and selected following crops in soil AG-QMM1-565SC N/J N 2594007/349305

J FSG Y

KIIIA1 6.1.2

van de Ven, W. 2013 Evaluate the efficacy of AG-QMM1-565 SC for the control of dicotyledonous weeds and Poa annua in sugar beet 11200612 N/J N 2594008/349307

J FSG Y

KIIIA1 6.1.2

Rohr, J. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E01 N/J N 2594009/349309

J FSG Y

KIIIA1 6.1.2

Dissemond 2012 ACETY, GALAP, LAMPU-Z.-Rüben VA, NA 2012 FCS12-1621-E03 N/J N 2594010/349311

J FSG Y

Feldfunktion geändert





























Page 19 of 31


Annex Point

Author





KIIIA1 6.1.2

Labusch, U. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E04 N/J N 2594098/349314

J FSG Y

KIIIA1 6.1.2

Wolf, P. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E05 N/J N 2594100/349317

J FSG Y

KIIIA1 6.1.2

Reynens, P. 2013 Sugarbeet-Efficacy of AG-QMM1-565 SC R090-12H N/J N 2594104/349320

J FSG Y

KIIIA1 6.1.2


J FSG Y

KIIIA1 6.1.3

van de Ven, W. 2011 Crop safety and control of dicotyledonous weeds in sugar beet by AG-QMM1-565 SC and Goltix of 2010-the Netherlands H-10-2105 N/J N 2594108/349325

J FSG Y

KIIIA1 6.1.3

van de Ven, W. 2011 Crop safety and control of dicotyledonous weeds in sugar beet by AG-QMM1-565 SC and Fiesta new of 2011-the Netherlands H-11-2101 N/J N 2594114/349328

J FSG Y




Page 20 of 31


Annex Point

Author





KIIIA1 6.1.3


J FSG Y

KIIIA1 6.1.3


J FSG Y

KIIIA1 6.1.3


J FSG Y

KIIIA1 6.1.3


J FSG Y

KIIIA1 6.1.3


J FSG Y

KIIIA1 6.1.3


J FSG Y












Page 21 of 31


Annex Point

Author





KIIIA1 6.1.3


J FSG Y

KIIIA1 6.1.4

Zickart, U. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550B N/J N 2594162/349352

J FSG Y

KIIIA1 6.1.4

Zickart, U. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550A N/J N 2594164/349355

J FSG Y

KIIIA1 6.1.4

Hetterich, A. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550C N/J N 2594166/349358

J FSG Y

KIIIA1 6.1.4

Hetterich, A. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550D N/J N 2594167/349360

J FSG Y

KIIIA1 6.1.4

Franke, K. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550E N/J N 2594168/349363

J FSG Y




Page 22 of 31


Annex Point

Author





KIIIA1 6.1.4

van de Ven, W. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in 2013 NL13HSBEAVA001 N/J N 2594169/349366

J FSG Y

KIIIA1 6.2.1

van de Ven, W. 2011 Crop safety and control of dicotyledonous weeds in sugar beet by AG-QMM1-565 SC and Goltix of 2010-the Netherlands H-10-2105 N/J N 2594173/349368

J FSG Y

KIIIA1 6.2.1

van de Ven, W. 2011 Crop safety and control of dicotyledonous weeds in sugar beet by AG-QMM1-565 SC and Fiesta new of 2011-the Netherlands H-11-2101 N/J N 2594174/349371

J FSG Y

KIIIA1 6.2.1


J FSG Y

KIIIA1 6.2.1


J FSG Y

KIIIA1 6.2.1


J FSG Y Feldfunktion geändert











Page 23 of 31


Annex Point

Author





KIIIA1 6.2.1


J FSG Y

KIIIA1 6.2.1


J FSG Y

KIIIA1 6.2.1


J FSG Y

KIIIA1 6.2.1


J FSG Y

KIIIA1 6.2.1

Zickart, U. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550B N/J N 2594185/349394

J FSG Y

KIIIA1 6.2.1

Zickart, U. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550A N/J N 2594186/349397

J FSG Y




Page 24 of 31


Annex Point

Author





KIIIA1 6.2.1

Hetterich, A. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550C N/J N 2594187/349399

J FSG Y

KIIIA1 6.2.1

Hetterich, A. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550D N/J N 2594189/349402

J FSG Y

KIIIA1 6.2.1

Franke, K. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550E N/J N 2594192/349404

J FSG Y

KIIIA1 6.2.1

van de Ven, W. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in 2013 NL13HSBEAVA001 N/J N 2594193/349407

J FSG Y

KIIIA1 6.2.6

Minarski, A. 2010 AG-QMM1-565SC (40g/L Quinmerac+525 g/L Metamitron) standardized bioassay for the determination of EC10-(NOEC) and EC50-values for herbicides and selected following crops in soil AG-QMM1-565SC N/J N 2594198/349410

J FSG Y

KIIIA1 6.2.7

Minarski, A. 2010 Effect of AG-QMM1-565SC (40g/L Quinmerac+525 g/L Metamitron) on vegetative vigour of terrestrial plants AS150 N/J N 2594199/349413

J FSG Y






















Page 25 of 31


Annex Point

Author





KIIIA1 6.2.7

Minarski, A. 2010 Effect of AG-QMM1-565SC (40g/L Quinmerac+525 g/L Metamitron) on vegetative vigour of terrestrial plants AS151 N/J N 2594202/349416

J FSG Y

KIIIA1 6.2.8

Heimbach, U., Kral, G., Niemann, P.

2000 Implementation of resistance risk analysis of plant protection products in the German authorisation procedure Proceedings of the Brighton Crop Protection- Pests and Diseases N/N J 2594204/349419

N LIT Y

KIIIA1 6.2.8

Petersen, J. 2003 Sensitivität verschiedener herkünfte von Matricaria inodora und Matricaria chamomilla gegenüber Metamitron Gesunde Pflanzen N/N J 2594205/349421

N LIT Y

KIIIA1 6.2.8

William, L., Patzoldt, Bradley, S., Dixon, Patrick, J., Tranel

2003 Abstract of: Triazine resistance in Amaranthus tuberculatus (Moq) Sauer that is not site-of-action mediated Pest Management Science N/N J 2594207/349424

N LIT Y

KIIIA1 6.2.8

Mechant, E., Bulcke, R.

2006 Cross-resistance profile of Metamitron-resistant Chenopodium album L. biotypes from sugar beet Zeitschrift für Pflanzenkrankheiten und Pflanzenschutz N/N J 2594212/349427

N LIT Y

KIIIA1 6.2.8

Petersen, J. 2010 Ein neuer Gänsefuß-Biotyp mit resistenz gegenüber Metribuzin und Metamitron Fachhochschule Bingen, Institut für Zuckerrübenforschung N/N J 2594215/349430

N LIT Y

Feldfunktion geändert ... [1]

Formatiert ... [2]

Formatiert ... [3]


Formatiert ... [5]

Formatiert ... [6]


Formatiert ... [8]

Formatiert ... [9]


Formatiert ... [11]


Formatiert ... [13]

Formatiert ... [14]


Formatiert ... [16]

Formatiert ... [17]


Formatiert ... [19]

Formatiert ... [20]


Formatiert ... [22]

Formatiert ... [23]


Formatiert ... [25]

Formatiert ... [26]


Formatiert ... [28]

Formatiert ... [29]


Formatiert ... [31]


Formatiert ... [33]

Formatiert ... [34]


Formatiert ... [36]

Formatiert ... [37]


Formatiert ... [39]

Formatiert ... [40]


Formatiert ... [42]

Formatiert ... [43]


Formatiert ... [45]


Formatiert ... [47]

Formatiert ... [48]


Formatiert ... [50]

Formatiert ... [51]




Page 26 of 31


Annex Point

Author





KIIIA1 6.2.8

Petersen, J. 2010 Sensitivitätsanalyse verschiedener Chenopodium album-Herkünfte gegen Metamitron (Goltix Gold) ITB GmbH an der Fachhochschule Bingen N/N J 2594216/349432

N LIT Y

KIIIA1 6.2.8

Thiel, H., Varrelmann, M.

2012 Identification of a new PSII target site psbA mutation leading to D1 amino acid Leu 218Val exchange in the Chenopodium album D1 protein and comparison to cross-resistance profiles of known modifications at positions 251 and 264 Society of Chemical Industry N/N J 2594225/349435

N LIT Y

KIIIA1 3.9

Anonymous 2014 Gebrauchsanleitung N/N N 2594255/349438

J FSG Y












Page 27 of 31


Appendix 2: GAP Table

GAP- Table of intended uses for Germany GAP rev. (No), date: 2014-04-14

PPP (product name/code) Goltix Titan active substance 1 Metamitron active substance 2 Quinmerac

Formulation type: SC Conc. of as 1: 525 g/L Conc. of as 2: 40 g/L

Applicant: Feinchemie Schwebda GmbH Zone(s): central/EU

professional use X non professional use

Verified by MS: yes

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-No.

Mem-ber state(s)

Crop and/ or situation (crop destination / purpose of crop)

F G or I

Pests or Group of pests controlled (additionally: devel-opmental stages of the pest or pest group)


Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mix-tures

Method / Kind

Timing / Growth stage of crop & season

Max. num-ber (min. in-terval be-tween appli-cations)

a) per use

b) per crop/ season

kg, L product / ha


b) max. total rate per crop/season

g, kg as/ha



Water L/ha min / max

001 DE Sugar beet

BEAVA

fodder beet

BEAVC

F annual monocotyle-donous weeds (TTTMS)*, annual di-cotyledonous weeds (TTTDS)

Spraying

splitting 4 applica-tions

Spring

BBCH 00 – 19

1st treatment before-emer-gence

2nd to 4th treat-ment after emergence

a) 4

b) 4

the 2nd to 4th treatment with an inter-val of 5 to 10 days

a)

timing 1: 3 L/ha

timing 2: 1 L/ha

timing 3: 1 L/ha

timing 4: 1 L/ha

a)

timing 1:

Metamitron

1575 g as/ha

Quinmerac

120 g as/ha

timing 2:

Metamitron

200 - 400 **XF




Page 28 of 31


b) 6 L/ha

maximum ap-plication rate for the in-tentedin-tended crop per year

525 g as/ha

Quinmerac

40 g as/ha

timing 3:

Metamitron

525 g as/ha

Quinmerac

40 g as/ha

timing 4:

Metamitron

525 g as/ha

Quinmerac

40 g as/ha

b)

Metamitron

3150 g as/ha

Quinmerac

240 g as/ha

maximum application rate for the intentedin-tended crop per year

*withdrawn by letter of applicant from 2015-01-13 **The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in days is not required resp.




Page 29 of 31


GAP- Table of intended uses for all cMS (without Germany), not verified by zRMS PPP (product name/code) AG-QMM1-565 SC active substance 1 Metamitron active substance 2 Quinmerac active substance safener - synergist -

Formulation type: SC (suspension concentrate) Conc. of as 1: 525 g/L Conc. of as 2: 40 g/L Conc. of as: Conc. of safener: - Conc. of synergist: -

Applicant: Feinchemie Schwebda GmbH Zone(s): central/EU

professional use non professional use

Verified by MS: no

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-No.

Mem-ber state(s)

Crop and/ or situation (crop destina-tion / purpose of crop)

F G or I

Pests or Group of pests con-trolled (additionally: de-velopmental stages of the pest or pest group)


Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures

Method / Kind

Timing / Growth stage of crop & sea-son

Max. number (min. interval be-tween applica-tions)

a) per use

b) per crop/ sea-son

kg, L product / ha



g as/ha




1 NL, BE

Beets (sugar and fodder) Use already au-thorised

F

GALAP and other annual dicotyle-donous weed species

spraying BBCH 10-19

a) 1-3 (5)

b) 3

a) 2

b) 6

a) Metamitron: 1050 Quin-merac: 80

b) Metamitron: 3150 Quin-merac: 240

200 / 400

F



Max. once per three years on same field

2 NL, BE Beets (sugar and fodder)

F

Poa annua POAAN, Galium aparine GALAP ,

spraying BBCH 00-09

a) 1

b) 1

a) 3

b) 3



200 / 400

F


Max. once per three years on same field




Page 30 of 31


1 2 3 4 5 6 7 8 10 11 12 13 14

Use-No.

Mem-ber state(s)


F G or I




Method / Kind



a) per use


kg, L product / ha



g as/ha




annual dicotyle-donous weeds (TTTDS) BBCH 10-

19

a) 1-3 (5)

b) 3

a) 1

b) 3



200 / 400

F

3 NL, BE

Beets (sugar and fodder) withdrawn by applicant on 14 February 2014

F

POAAN, GALAP and other annual dicotyledonous weed species

spraying

BBCH 00-09

a) 1

b) 1

a) 3

b) 3



200 / 400

F

Pre-emergence: 1 × 3.0 L fp/ha

Post-emergence: Max. individual applica-

tion rate: 3.0 L fp/ha,

E.g. 1× 3.0 L;

1 × 1.25 L + 1 × 1.0 L + 1 × 1.0 L;

1 × 1.5 L + 1 x 1.75 L fp/ha;

or combinations of other uses with 0.75 L/ha min).

Max. total post-emer-gence applied of 3.25 L

fp/ha

Max use rate of 250 g/ha Quinmerac is restricted

BBCH 10-19

a) 1-4 (5)

b) 4

a) 1,25

b) 3,25



200 / 400

F

BBCH 10-19



200 / 400

F




Page 31 of 31


1 2 3 4 5 6 7 8 10 11 12 13 14

Use-No.

Mem-ber state(s)


F G or I




Method / Kind



a) per use


kg, L product / ha



g as/ha




on the same field per year.

withdrawn by applicant on 14 February 2014

4 NL, BE

Beets (sugar and fodder) withdrawn by applicant on 14 February 2014

F

POAAN, GALAP and other annual dicotyledonous weed species

spraying BBCH 10-19

a) 1 (5)

b) 6

a) 0,75

b) 1,25


b Metamitron: 656 Quin-merac: 50

200 / 400

F

Max. individual applica-tion rate: 1.25 L fp/ha,

e.g. 5 × 1.25 L fp/ha or uses in

between

Max use rate of 250 g/ha Quinmerac is restricted on the same field per year.

withdrawn by applicant on 14 February 2014

Indication 1 is already authorised

Indication 3 and 4 only as national addendum – withdrawn by applicant on 14 February 2014

Seite 25: [1] Ändern Unknown


Seite 25: [2] Formatiert Holzmann, Dr. Achim 11.05.2016 06:48:00

Deutsch (Deutschland)










































Core Assessment /

Natioanl Addendum

GOLTIX TITAN

Draft Registration Report –

Central Zone

Page 1 of 16

Feinchemie Schwebda GmbH Evaluator: zRMS Germany

May 2015

Draft REGISTRATION REPORT

Part B

Section 8 Assessment of the relevance of

metabolites in groundwater



Active Substance: Metamitron 525 g/L

Quinmerac 40 g/L

Central Zone


CORE ASSESSMENT / NATIONAL

ADDENDUM GERMANY


Date: May 2015


Core Assessment /

Natioanl Addendum

GOLTIX TITAN


Central Zone

Page 2 of 16


May 2015


SEC 8 ASSESSMENT OF THE RELEVANCE OF METABOLITES IN GROUNDWATER ..... 3

8.1 EXCLUSION OF DEGRADATION PRODUCTS OF NO CONCERN .......................................................................... 3

8.2 QUANTIFICATION OF POTENTIAL GROUNDWATER CONTAMINATION ............................................................. 4

8.2.1 Metamitron .............................................................................................................................................. 4

8.2.2 Quinmerac ............................................................................................................................................... 5

8.3 HAZARD ASSESSMENT: IDENTIFICATION OF RELEVANT METABOLITES ......................................................... 7

8.3.1 Screening for biological activity ............................................................................................................. 7

8.3.2 Screening for genotoxicity ...................................................................................................................... 7

8.3.3 Screening for toxicity .............................................................................................................................. 7

8.4 EXPOSURE ASSESSMENT – THRESHOLD OF CONCERN APPROACH .................................................................. 7

8.5 REFINED RISK ASSESSMENT FOR NON-RELEVANT METABOLITES .................................................................. 8

8.5.1 Refined toxicological risk assessment for non-relevant metabolites ....................................................... 8

8.5.2 Refined ecotoxicological risk assessment for non-relevant metabolites ............................................... 11

APPENDIX 1 GAP TABLE ............................................................................................................................ 12

APPENDIX II REFERENCE LIST ........................................................................................................................... 14


Core Assessment /

Natioanl Addendum

GOLTIX TITAN


Central Zone

Page 3 of 16


May 2015

Sec 8 ASSESSMENT OF THE RELEVANCE OF METABOLITES IN

GROUNDWATER

Metamitron


active substance Metamitron, and in particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In the Inclusion Directive of Metamitron (2008/125/EC resp. regulation 540/2011) under Part B it is stated

that the concerned Member States shall request the submission of further data, in particular information as

regards the impact of soil metabolite M3 on groundwater, information as regards residues in rotational

crops and information to further address the long term risk to insectivorous birds, and the specific risk to

birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the

applicant provides such confirmatory data and information to the Commission by 31 August 2011.

The RMS UK concluded in the draft addendum on confirmatory data in 2014 that the metamitron metabolite

M3 was an experimental artifact. Therefore, the metabolite M3 has not to be considered in the groundwater

assessment.

Quinmerac


active substance Quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In the Inclusion Directive of Quinmerac (2010/89/EC resp. regulation 540/2011) under Part B it is stated

that the Member States concerned shall request the submission of information as regards to the potential of

plant metabolism to result in an opening of the quinolone ring and the residues in rotational crops and the

long term risk for earthworms due to the metabolite BH 518-5. They shall ensure that the applicant provides

such confirmatory data and information to the Commission by 30 April 2013.

8.1 Exclusion of degradation products of no concern

None.


Core Assessment /

Natioanl Addendum

GOLTIX TITAN


Central Zone

Page 4 of 16


May 2015

8.2 Quantification of potential groundwater contamination

8.2.1 Metamitron

8.2.1.1 Exposure assessment for the Central Zone

PECGW calculations after leaching from soil for the active substance Metamitron and its metabolites were

performed using the simulation model FOCUS PELMO 5.5.3 (see Section 5).

The results of the simulations for the scenarios "sugar beet" are as follows.

Table 8.2-1: PECGW at 1 m soil depth for Metamitron and its metabolites

Use No /crop Scenario 80th Percentile PECGW at 1 m Soil Depth (µg L-1)

groundwater model: FOCUS PELMO 5.5.3.

Metamitron Metabolite

Desamino-metamitron

2 /sugar beets Châteaudun < 0.001 0.010

Hamburg 0.001 0.054

Jokioinen <0.001 <0.001

Kremsmünster <0.001 0.022

Okehampton 0.001 0.070

Piacenza 0.005 0.203

Porto <0.001 0.042

Sevilla <0.001 < 0.001

Thiva <0.001 <0.001

Concentrations >0.1 µg/L are printed bold.

The PECGW values for the Metamitron metabolite Desamino-metamitron wer calculated to be below

0.1 µg/L except for the scenario Piacenza. A relevance assessment for the metabolite is triggered only in

case Piacenza is regarded as a relevant scenario by the respective MS for the national assessment (not the

case for DE).

The relevance of the groundwater metabolite Desamino-metamitron has already been assessed at EU level

(EFSA Scientific Report (2008) 185, 1-95. The metabolite is reagarded as of no toxicological relevance

up to 10 µg/L.

8.2.1.2 Exposure assessment for Germany

The PECGW values for the metabolite Desamino-metamitron were calculated to be below 0.1 µg/L in the

national assessment for Germany.


Core Assessment /

Natioanl Addendum

GOLTIX TITAN


Central Zone

Page 5 of 16


May 2015

8.2.2 Quinmerac

8.2.2.1 Exposure assessment for the Central Zone

PECGW calculations after leaching from soil for the active substance Quinmerac and its metabolites were

performed using the simulation model FOCUS PELMO 5.5.3 (see Section 5).


Table 8.2-2: PECGW at 1 m soil depth for Quinmerac and its metabolites

Use-No. Scenario 80th Percentile PECGW at 1 m Soil Depth (µg L-1)


Quinmerac Metabolite

BH 518-2

Metabolite

BH 518-5

2 Châteaudun 0.062 2.036 14.269

Hamburg 0.050 2.304 11.598

Jokioinen 0.022 1.665 8.939


Okehampton 0.145 2.38 7.878

Piacenza 0.103 1.743 10.075

Porto 0.117 1.449 6.023

Sevilla 0.043 1.016 13.588

Thiva 0.003 0.634 18.476

Yearly applications were assumed as worst case.

For the metabolites BH 518-2 and BH 518-5, a groundwater concentration of ≥ 0.1 µg/L cannot be excluded

regarding all applicable model scenarios.

In addition to the Tier 1 PECGW modeling, a higher tier leaching assessment using experimental data from

lysimeter studies and a field leaching study for the active substance Quinmerac is performed. Higher tier

leaching studies indicate a slightly higher leaching potential of metabolite BH 518-2 and a lower leaching

potential of metabolite BH 518-5 than expected from the lower tier modelling.

Furthermore, according to usual crop rotation scemes yearly applications are not expected. In the original

DAR, calculations were performed for the use every three years. However, the active ingredient is now

registered not only for the use in rape on a national level, but also for beets, for example. This would allow

a crop rotation with for example two treatment years in four years.

An assessment of the relevance of the metabolites BH 518-2 and BH 518-5 for groundwater is necessary.


Core Assessment /

Natioanl Addendum

GOLTIX TITAN


Central Zone

Page 6 of 16


May 2015

8.2.2.2 Exposure assessment for Germany

PECgw calculations after leaching from soil for the active substance Quinmerac and metabolites were

perfoGWrmed using the simulation model FOCUS PELMO 5.5.3 (see Section 5).


Table 8.2-3: PECGW at 1 m soil depth of Quinmerac and its metabolites BH 518-2 and BH 518-5

considered relevant for German exposure assessment, Concentrations >0.1 µg/L are

printed bold.

Use No. Scenario 80th Percentile PECGW at 1 m Soil Depth (µg L-1) modelled by FOCUS

PELMO 4.4.3

Quinmerac Metabolite BH 518-2 Metabolite BH 518-5

00-001 Hamburg 0.050 2.304 11.598


For the metabolites BH 518-2 and BH 518-5, a groundwater concentration of ≥ 0.1 µg/L cannot be

excluded.

In addition to the Tier 1 PECGW modeling, a higher tier leaching assessment using experimental data from

lysimeter studies and a field leaching study for the active substance Quinmerac is performed. Higher tier

leaching studies indicate a slightly higher leaching potential of metabolite BH 518-2 and a lower leaching

potential of metabolite BH 518-5 than expected from the lower tier modelling.

Furthermore, according to usual crop rotation scemes yearly applications (as assumed in modeling) are not

expected. In the original DAR, calculations were performed for the use every three years. However, the

active ingredient is now registered not only for the use in rape on a national level, but also for beets, for

example. This would allow a crop rotation with for example two treatment years in four years.

As a result, the active substance quinmerac is not expected to penetrate into groundwater at concentrations

of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites BH 518-2 and

BH 518-5 concentrations of ≥ 0.1 µg/L cannot be excluded, but it is expected that concentrations remain

below 10 µg/L.

An assessment of the relevance of the metabolites BH 518-2 and BH 518-5 for groundwater is necessary.


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8.3 Hazard Assessment: Identification of relevant metabolites

8.3.1 Screening for biological activity

8.3.1.1 Metamitron-Metabolite

A relevance assessment for the metabolite desamino-metamitron is triggered only in case Piacenza is

regarded as a relevant scenario by the respective MS for the national assessment (not the case for DE). The

metabolite desamino-metamitron was found to have no biological activity as compared to the parent

compound in the EU assessment (EFSA Scientific Report (2008) 185).

8.3.1.2 Quinmerac-Metabolites

The metabolites BH 518-2 and BH 518-5 have been evaluated in the peer review in view of the Annex I

inclusion of Quinmerac. The metabolites BH 518-2 and BH 518-5 have no biological activity as compared

to the parent compound (EFSA Conclusion Quinmerac EFSA Journal 2010: 8(3), 1523).

8.3.2 Screening for genotoxicity



regarded as a relevant scenario by the respective MS for the national assessment (not the case for DE).

The metabolite desamino-metamitron was found to be not toxicologically relevant in the EU assessment

(EFSA Scientific Report (2008) 185, 1-95).



inclusion of Quinmerac (EFSA Conclusion Quinmerac EFSA Journal 2010: 8(3), 1523). Please refer 8.5.1.

8.3.3 Screening for toxicity



regarded as a relevant scenario by the respective MS for the national assessment (not the case for DE). The

metabolite desamino-metamitron was found to be not toxicologically relevant in the EU assessment (EFSA

Scientific Report (2008) 185, 1-95).



inclusion of Quinmerac (EFSA Conclusion Quinmerac EFSA Journal 2010: 8(3), 1523). Please refer to

8.5.1.

8.4 Exposure assessment – threshold of concern approach

Please refer to 8.5.1.


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8.5 Refined risk assessment for non-relevant metabolites

8.5.1 Refined toxicological risk assessment for non-relevant metabolites

The quinmerac-metabolites BH518-02 and BH518-05 are predicted to occur in groundwater at

concentrations above 0.1 µg/L. An assessment of the relevance of these metabolites according to the

stepwise procedure of the EC guidance document SANCO/221/2000 –rev.10 is therefore required.

8.5.1.1 Relevance assessment of BH518-02

A summary of the relevance assessment is given in Table 8.5.1-4.

Table 8.5.1-4 Summary of the relevance assessment for BH518-02

Assessment step Result of assessment

STEP 1 Metabolite of no concern? no

Qu

an

ti

fica

tio

n o

f

gro

un STEP 2

Max PECgw See above

Based on

Ha

zard

ass

essm

ent

STEP 3 Stage 1 Biological activity comparable

to the parent?

no

Stage 2 Genotoxic properties of

metabolite

pass

Stage 3 Toxic properties of metabolite;

Classification of parent pass

Classification of metabolite pass

Co

nsu

mer

hea

lth

ris

k

ass

essm

ent

STEP 4 Estimated consumer exposure

via drinking water and other

sources; threshold of concern

approach

Exposure > TTC

STEP 5 Refined risk assessment pass

Predicted exposure Exposure < ADI

Summary concerning the toxicological relevance:

The relevance of the groundwater metabolite BH518-02 has already been assessed and accepted at EU

level (EFSA Journal 2010; 8(3):1523, 1-68 (2010-02-26) [ASB2012-3439]).

Metabolite BH518-2 was evaluated as part of the EU peer-review. Available studies are summarised in

Table 8.5.1-5. According to the background documents to the EU procedure (e.g., EFSA Journal 2010;

8(3):1523, 1-68 (2010-02-26) [ASB2012-3439]) this metabolite passed stage 2 and stage 3 of step 3.

However, PECgw is above 0.75 µg/l. Hence, a refined risk assessment is needed.

Taking into account, the default exposure assumptions (2 L/day, 60 kg bw), predicted exposure through

drinking water (0.058 µg/kg bw per day) is below the ADI for quinmerac (0.08 mg/kg bw) which was

considered applicable to BH518-2 during the EU peer review (EFSA Journal 2010; 8(3):1523, 1-68

(2010-02-26) [ASB2012-3439]).


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Table 8.5.1-5 Summary of the results of toxicity studies with BH518-2

Type of test Result Reference*

Ames test negative with S-9 mix,

positive in TA 100, TA

1537 and TA 98 in the

pre-incubation test

(without metabolic

activation)

ASB2007-809,

ASB2007-810*

Ames test negative ASB2011-9361

In vitro HPRT Inconclusive ASB2007-811,

ASB2007-812*

In vitro MLA negative ASB2009-10949,

ASB2009-10950,

ASB2009-10951*

In vitro MLA negative (several positive

control cultures show no

dose-response)

ASB2011-9362,

ASB2011-9371

In vitro CA negative ASB2007-813,

ASB2007-814*

In vitro CA negative ASB2011-9363

In vivo MN negative (no signs of

toxicity, no indication

that bone marrow was

exposed)

ASB2007-815*

*indicates that a study was reviewed at EU level; considering that the additional studies submitted for this application corroborate

the results of the studies submitted for the EU peer-review procedure, no detailed evaluations are prepared (SANCO/10328/2004

– rev. 8, 2012-01-24).

8.5.1.2 Relevance assessment of BH518-05

A summary of the relevance assessment is given in Table 8.5.1-3.


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Table 8.5.1-6 Summary of the relevance assessment forBH518-5

Assessment step Result of assessment

STEP 1 Metabolite of no concern? no

Qu

an

ti

fica

tio

n o

f

gro

un STEP 2

Max PECgw See above

Based on

Ha

zard

ass

essm

ent

STEP 3 Stage 1 Biological activity comparable

to the parent?

no

Stage 2 Genotoxic properties of

metabolite

pass

Stage 3 Toxic properties of metabolite;

Classification of parent pass

Classification of metabolite pass

Co

nsu

mer

hea

lth

ris

k

ass

essm

ent

STEP 4 Estimated consumer exposure

via drinking water and other

sources; threshold of concern

approach

Exposure > TTC

STEP 5 Refined risk assessment pass

Predicted exposure Exposure < ADI

Summary concerning the toxicological relevance:

The relevance of the groundwater metabolite BH518-05 has already been assessed and accepted at EU

level (EFSA Journal 2010; 8(3):1523, 1-68 (2010-02-26) [ASB2012-3439]).

Metabolite BH518-5 was evaluated as part of the EU peer-review. Available studies are summarised in

Table 8.5.1-7. According to the background documents to the EU procedure (e.g., EFSA Journal 2010;

8(3):1523, 1-68 (2010-02-26) [ASB2012-3439]) this metabolite passed stage 2 and stage 3 of step 3.

However, PECgw is above 0.75 µg/l. Hence, a refined risk assessment is needed.

Taking into account, the default exposure assumptions (2 L/day, 60 kg bw), predicted exposure through

drinking water (0.379 µg/kg bw per day) is below the ADI for quinmerac (0.08 mg/kg bw) which was

considered applicable to BH518-5 during the EU peer review (EFSA Journal 2010; 8(3):1523, 1-68

(2010-02-26) [ASB2012-3439]). It is noted, that GD SANCO/221/2000 does not allow metabolite

concentrations above 10 µg/L groundwater.

Table 8.5.1-7 Summary of the results of toxicity studies with BH518-5

Type of test Result Reference*

Rat LD50 oral > 2200 mg/kg bw TOX2003-1899*

Ames test negative TOX2003-1901*

In vitro HPRT inconclusive TOX2003-1904*

In vivo MN negative TOX2003-1903*

90-d, rat water consumption ↑;

urea levels ↑; kidney

(histopathological

changes)

TOX9300119*


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NOAEL: 216 mg/kg

bw/d (3000 ppm)

dev tox,rat feed consumption ↓, bw

and bw gain ↓ (early

phase of test substance

administration)

NOAEL(mat): < 1000

mg/kg bw/d

NOAEL(dev): 1000

mg/kg bw/d

TOX2003-1905,

ASB2009-11228*

*indicates that a study was reviewed at EU level

8.5.2 Refined ecotoxicological risk assessment for non-relevant metabolites

Not applicable.


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Applicant: Feinchemie Schwebda Evaluator: zRMS Germany

Section 8 Date May 2015

Appendix 1 GAP table





active substance

safener -

synergist -




Conc. of as:

Conc. of safener: -


Applicant: company

Zone(s): northern/central/southern/EU

professional use


Verified by MS: no

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I


controlled

(additionally:




(days)

Remarks:



mixtures

Method /

Kind

Timing /

Growth stage of

crop & season

Max. number (min.

interval between

applications)

a) per use

b) per crop/ season

kg, L product / ha



crop/season

g as/ha

a) max. rate per

appl.

b) max. total rate

per crop/season

Water L/ha

min / max

1 NL, BE

Beets (sugar and

fodder)

Use already

authorised

F

GALAP and other

annual

dicotyledonous weed

species

spraying BBCH 10-19 a) 1-3 (5)

b) 3

a) 2

b) 6

a) Metamitron:

1050

Quinmerac: 80

b) Metamitron:

3150

Quinmerac: 240

200 / 400 F




field


National Addendum – Germany

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Page 13 of 16

Applicant: Feinchemie Schwebda Evaluator: zRMS Germany

Section 8 Date May 2015

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I


controlled

(additionally:




(days)

Remarks:



mixtures

Method /

Kind

Timing /

Growth stage of

crop & season

Max. number (min.

interval between

applications)

a) per use

b) per crop/ season

kg, L product / ha



crop/season

g as/ha

a) max. rate per

appl.

b) max. total rate

per crop/season

Water L/ha

min / max

2 NL, BE Beets (sugar and

fodder) F

POAAN, GALAP

and other annual

dicotyledonous weed

species

spraying

BBCH 00-09 a) 1

b) 1

a) 3

b) 3

a) Metamitron:

1575

Quinmerac: 120

b) Metamitron:

1575

Quinmerac: 120

200 / 400 F



field

BBCH 10-19 a) 1-3 (5)

b) 3

a) 1

b) 3

a) Metamitron:

525 Quinmerac:

40

b) Metamitron:

1575

Quinmerac: 120

200 / 400 F

Use No. 1 is already authorized.

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use




(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989

(f) All abbreviations used must be explained

(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of


(i) g/kg or g/l

(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,


application

(k) The minimum and maximum number of application possible under practical conditions of use

must be provided

(l) PHI - minimum pre-harvest interval

(m) Remarks may include: Extent of use/economic importance/restrictions


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Page 14 of 16

Appendix II Reference list

Annex point/

reference No


Report-No.


Data

protection

claimed

Owner How

considered in

dRR #

KIIA 5.4.1.3,

KIIA 5.8.1.

Brosius, S. 2006 Quinmerac (BAS 518 H): Response to

questions raised by the rapporteur

member state UK on January 26, 2006

2006/1009969

ASB2009-11228

Open BASF Add*

KIIA 5.8. Engelhardt, G. 2004 Amendment No. 1 to the report: In vitro

chromosome aberration assay with Reg.

No. 176326 (metabolite of BAS 518 H,

Quinmerac) in V79 cells

2004/1010810 ! 32M0150/034019


BVL-1007257, BVL-1850068, BVL-

1946278, BVL-1984452, BVL-

2033007, ASB2007-814

Yes BAS N*

KIIA 5.8. Engelhardt, G. 2004 Amendment No. 1 to the report: In vitro

gene mutation test with Reg. No.

176326 (metabolite of BAS 518 H,

Quinmerac) in CHO cells (HPRT locus

assay)

2004/1010811 ! 50M0150/034018


BVL-1007312, BVL-1850088, BVL-

1946298, BVL-1984482, BVL-

2033027, ASB2007-812

Yes BAS N*

KIIA 5.8. Engelhardt, G. 2004 Amendment No. 1 to the report:

Salmonella typhimurium / Escherichia

coli reverse mutation assay (standard

plate test and preincubation test) with

Reg. No. 176326 (Metabolite of BAS

518 H, Quinmerac)

2004/1010812 ! 40M0150/034014


BVL-1007310, BVL-1850086, BVL-

1946296, BVL-1984480, BVL-

2033025, ASB2007-810

Yes BAS N*

KIIA 5.8 Engelhardt, G.; Leibold, E. 2003 Salmonella typhimurium / Escherichia

coli reverse mutation assay (standard

plate test and preincubation test) with

Reg. No. 176326 (Metabolite of BAS

518 H, Quinmerac)

2003/1014012 ! 40M0150/034014


BVL-1007309, BVL-1850085, BVL-

1946295, BVL-1984479, BVL-

2033024, ASB2007-809

Yes BAS N*

KIIA 5.8 Engelhardt, G.; Leibold, E. 2003 In vitro chromosome aberration assay

with Reg. No. 176326 (metabolite of

BAS 518 H, Quinmerac) in V79 cells

2003/1018219 ! 32M0150/034019


BVL-1007313, BVL-1850089, BVL-

1946299, BVL-1984483, BVL-

2033028, ASB2007-813

Yes BAS N*

KIIA 5.8 Engelhardt, G.; Leibold, E. 2004 In vitro gene mutation test with Reg.

No. 176326 (metabolite of BAS 518 H,

Quinmerac) in CHO cells (HPRT locus

assay)

2004/1004526 ! 50M0150/034018


BVL-1007311, BVL-1850087, BVL-

1946297, BVL-1984481, BVL-

2033026, ASB2007-811

Yes BAS N*


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Annex point/

reference No


Report-No.


Data

protection

claimed

Owner How

considered in

dRR #

KIIA 5.8 XXXXX. 2004 Cytogenetic study in vivo with Reg. No.

176326 (metabolite of BAS 518 H,

Quinmerac) in the mouse micronucleus

test after two oral administrations

2004/1009125 ! 26M0150/034112


BVL-1007258, BVL-1850069, BVL-

1946279, BVL-1984453, BVL-

2033008, ASB2007-815

Yes BAS N*

KIIA 5.8 Wollny, H.-E. 2000 Gene mutation assay in Chinese hamster

V79 cells in vitro (V79 / HPRT) with

Reg.-No. 230 089

2000/1000183 ! 50M0305/999038 !

647603


BVL-1007307, BVL-1850083, BVL-

1946293, BVL-1984477, BVL-

2033022, TOX2003-1904

Yes BAS Add*

KIIA 5.8 Wollny, H.-E. 2007 Cell mutation assay at the thymidine

kinase locus (TK+/-) in mouse

lymphoma L5178Y cells with Reg. No.

176326 (Metabolite of BAS 518 H,

Quinmerac)

2007/1020127 ! 1082802 !

52M0150/039024


BVL-1852342, BVL-1946325, BVL-

1995257, BVL-2033054, ASB2009-

10949

Yes BAS N*





Quinmerac) - First amendment

2007/1048088 ! 1082802 !

52M0150/039024


BVL-1852348, BVL-1946326, BVL-

1995258, BVL-2033055, ASB2009-

10950

Yes BAS N*





Quinmerac) - Second amendment

2007/1049350 ! 1082802 !

52M0150/039024


BVL-1852354, BVL-1946327, BVL-

1995259, BVL-2033056, ASB2009-

10951

Yes BAS N*

KIIA 5.10 Flügge, C. 2010 Mutagenicity study of BH 518-2 in the

mouse lymphoma forward mutation

assay - in vitro

24050


BVL-2200800, ASB2011-9371

Yes FSG Y

KIIA 5.10, KIIA

5.8, KIIIA1 7.11

Flügge C. 2010 In vitro assessment of the clastogenic

activity of BH 518-2 in cultured human

peripheral lymphocytes

LPT 25223


BVL-2200799, BVL-2200807, BVL-

2203829, ASB2011-9363

Yes FSG Y


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Annex point/

reference No


Report-No.


Data

protection

claimed

Owner How

considered in

dRR #

KIIA 5.10, KIIA

5.8, KIIIA1 7.11

Flügge, C. 2010 Mutagenicity study of BH 518-2 in the

salmonella typhimurium reverse

mutation Assay (in vitro)

LPT 24049


BVL-2200797, BVL-2200805, BVL-

2203827, ASB2011-9361

Yes FSG Y

KIIA 5.10, KIIA

5.8, KIIIA1 7.11

Flügge, C. 2010 Mutagenicity study of BH 518-2 in the

mouse lymphoma forward mutation

assay - in vitro - Amendment No. 1

LPT 24050


BVL-2200798, BVL-2200806, BVL-

2203828, ASB2011-9362

Yes FSG Y

KIIA 5.8 Engelhardt, G.; Hoffmann,

H. D.

1988 Report on the study of Reg.No. 230

089/02 in the AMES test (standard plate

test and preincubation test with

Salmonella typhimurium)

88/0507 ! 40M0220/884057


BVL-2200819, TOX2003-1901

No BAS Y

KIIA 5.8 XXXXX. 1988 Report on the study of acute oral

toxicity on the rat based on OECD and

EPA (FIFRA) of Reg.No. 230 089/02

88/0397 ! 10A0220/881064


BVL-2200817, TOX2003-1899

No BAS Y

KIIA 5.8 XXXXX. 1990 Report on the study of the prenatal

toxicity of Reg.No. 230 089/02 in rats

after oral administration (gavage),

LIMIT-test, based on OECD Guideline

90/0028 ! 34R0220/88024


BVL-2200821, TOX2003-1905

No BAS Y

KIIA 5.8 XXXXX. 1990 Report on the study to evaluate the

potential of Reg.No. 230 089 to induce

micronuclei in the polychromatic

erythrocytes of CD-1 mice, based on

OECD and JMAFF Guidelines

90/0074 ! 31MREBLG.003 ! BLG

3/MNT ! 26M0220/889020


BVL-2200820, TOX2003-1903

No BAS Y

KIIA 5.8 XXXXX. 1993 Report on the study of the oral toxicity

with Reg. No. 230 089 in Wistar rats -

Administration in the diet over 3 months

93/10972 ! 31S0514/91069


BVL-2200818, TOX9300119

No BAS Y

# Y: Yes, relied on

N*: Studies from EU peer-review were included here in terms of completeness, transparency and consistency, c.f., SANCO/10328/2004

– rev. 8 (2012-01-24)

Add*: Studies from EU peer-review were included here in terms of completeness, transparency and consistency, c.f., SANCO/10328/2004

– rev. 8 (2012-01-24), study not submitted by applicant but necessary for evaluation

registration report part a extension of uses risk

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