appendix 4 · web viewalso derivation of assessment end-points, reference values, mrls, and...

EUROPEAN COMMISSIONHEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Directorate E – Safety of the food chainUnit E.3 - Chemicals, contaminants, pesticides

SANCO/12592/2012 –rev. 0

November 2012

Template to be used for

Assessment Reports

This document was elaborated by representatives of some of the Member States. It does not represent the official position of the Commission. It does not intend to produce legally binding effects.

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Contents

Background 3

Implementation schedule 3

Volume 1 4

Volume 2 17

Volume 3 – Active Substance 18

Volume 3 – Plant Protection Product 26

Volume 4 33

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Background

This template is intended to align the current structure of the assessment report with the dossier as well as the revised data requirements. It also aims to reduce duplication of information in different parts of the assessment report and to separate out the active substance part from product related exposure and risk. In this way transparency and consistency in the documentation submitted and assessed in light of an application for an approval of an active substance will be increased.

Furthermore it is envisages that this structure will support the risk envelope approach for products and that it will facilitate the setting of Maximum Residue Levels (MRLs), the preparation of a "Conclusion on the peer review of the pesticide risk assessment of an active substance" as prepared by the European Food Safety Authority (EFSA), as well as a "Proposal for Harmonised Classification and Labelling" (CLH report) as prepared by the European Chemicals Agency (ECHA).

An Assessment Report shall consists of the following parts: Volume 1, Volume 2, Volume 3 Active Substance part, Volume 3 Plant Protection Product part(s), Volume 4, as well as a List of Endpoints as a stand-alone document separated in an Active Substance part and Plant Protection Product part(s). The template for the List of Endpoints is in preparation.

This template should be used in conjunction with the TEMPLATE TO BE USED FOR ASSESSMENT REPORTS REGARDING LEVEL 3 OF VOLUME 1 (SANCO/11114/2012).

Implementation schedule

This document has been finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012. This template should be used for assessment reports prepared for active substances covered by Commission Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and for active substances for which an application for the approval has been submitted as from 1 January 2014.

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TABLE OF CONTENTS - VOLUME 1

General guidance on content of Volume 1

Volume 1 should have a cover page, version history page (see guidance for version control – under development) and a table of content page.

Volume 1 contains an overall summary of the active substance assessment and concise view of the conclusions reached in relation to the risk posed by the representative product and uses. Coupled with a Level 3 addressing the approval criteria (as set out in Article 4 and Annex II of Regulation (EC) No 1107/2009) and proposed regulatory outcome, this allows both risk assessors and risk managers to more clearly identify the key areas for further consideration.

All section-wise summaries of study evaluations (e.g. summary of all metabolism data, summary of all data relevant for reproductive toxicity, summary of all degradation half-lives etc) are presented exclusively in Level 2 of this volume.Also derivation of assessment end-points, reference values, MRLs, and definition of the residues are presented exclusively in Level 2 of this volume. It should be clearly identified in the respective section of Level 2 whether or not an endpoint meets one of the approval criteria.Assessment end-points, in particular those established for environmental fate and behaviour and ecotoxicology, may occasionally be derived from both data on the active substance and data on formulated products. Therefore, Level 2 summaries needs to cover all study end-points - as presented in Volume 3 (AS) and Volume 3 (PPP) - relevant for the establishment of assessment end-points for the active substance. Level 3 provides a concise presentation of the outcome of the evaluation and consideration against the approval criteria including a proposal for the decision and any conditions or restrictions associated with it.

Since it needs to be established, in order to decide on the approval, that risks are acceptable under realistic conditions of use it is necessary to reflect also data on representative products and exposure and risk assessment for representative areas of use in Volume 1. However, these elements (in particular, the exposure and risk assessments) should be kept to the minimum necessary to allow conclusions relevant for the approval of the active substance. Brief summaries of the higher tiers of exposure and risk assessment are therefore expected under the relevant sections of Level 2.

Level 1

1 Statement of subject matter and purpose for which this report has been prepared and background information on the application

1.1 Context in which the draft assessment report was prepared

1.1.1 Purpose for which the draft assessment report was preparedInformation should be provided if the draft assessment report is prepared for a new active substance (NAS) or for the Renewal of the approval. It should also be indicated if a proposal for MRL-setting is included and/or a proposal for Classification & Labelling.

1.1.2 Arrangements between rapporteur Member State and co-rapporteur Member State

1.1.3 EU Regulatory history for use in Plant Protection ProductsIf applicable, information should be provided on the approval of the active substance and subsequent renewals. It should also be indicated if relevant Reasoned Opinions, EFSA-conclusions, MRL-proposals are available.For renewals the history should indicate where possible:

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- Whether the substance was first evaluated as part of a programme for Existing Active Substances (review list 1, 2, 3A, 3B, 4) or New Active Substance indicating specifically if an EFSA-conclusion is available;

- All decisions and review reports available for the respective active substance;- Any changes in RMS, Co-RMS, applicant; - If and when confirmatory data has been submitted and considered.

1.1.4 Evaluations carried out under other regulatory contextsInformation should be provided if there are any other relevant EU-evaluations of the active substance carried out in the framework of other relevant EU-legislation (e.g. biocides, flavourings, food additives, cosmetics). Also information should be provided on relevant and recent evaluations of countries other than EU (e.g. US-EPA, PMRA) and international organisations like JMPR, WHO/FAO as well as on information exchange within OECD.

1.2 Applicant(s) information

1.2.1 Name and address of applicant(s) for approval of the active substance

1.2.2 Producer or producers of the active substance

1.2.3 Information relating to the collective provision of dossiers Information should be provided related to (the forming of) Task Forces.

1.3 Identity of the active substance The information under point 1.3.1 – 1.3.9 should be provided in a table compatible with Vol. 3 and LoEP.

1.3.1 Common name proposed or ISO-accepted and synonyms

1.3.2 Chemical name (IUPAC and CA nomenclature)

1.3.3 Producer's development code numbers This item should be included in the LoEP.

1.3.4 CAS, EC and CIPAC numbers

1.3.5 Molecular and structural formulae, molecular mass

1.3.6 Method of manufacture (synthesis pathway) of the active substance

1.3.7 Specification of purity of the active substance in g/kg

1.3.8 Identity and content of additives (such as stabilisers) and impuritiesIsomers not covered by the common name should be listed here, as impurities.

1.3.8.1 Additives

1.3.8.2 Significant impurities

1.3.8.3 Relevant impurities

1.3.9 Analytical profile of batches

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1.4 Information on the plant protection product The information under point 1.4.1 – 1.4.8 should be provided for all Plant Protection Products in an overview table.

1.4.1 Applicant

1.4.2 Producer of the plant protection product

1.4.3 Trade name or proposed trade name and producer's development code number of the plant protection product

1.4.4 Detailed quantitative and qualitative information on the composition of the plant protection product

1.4.4.1 Composition of the plant protection product

1.4.4.2 Information on the active substances

1.4.4.3 Information on safeners, synergists and co-formulants

1.4.5 Type and code of the plant protection product

1.4.6 Function E.g. herbicide, insecticide, fungicide, plant growth regulator.

1.4.7 Field of use envisagedE.g. crops, orchards, seed treatmen.t

1.4.8 Effects on harmful organisms E.g. systemic, protective or curative, mode of action, range of target organisms.

1.5 Detailed uses of the plant protection product (to be included for each preparation for which documentation was submitted)

1.5.1 Details of representative usesThe GAP table for the representative uses should be inserted here.

1.5.2 Further information on representative uses Information should be provided like:- Details on method of application for specialised applications e.g. soil fumigants; - Details on number and timing of applications and duration of protection, in case the GAP table gives ranges; - Necessary waiting period or other precautions to avoid phytotoxic effects on succeeding crops; - Proposed instructions for use.

1.5.3 Details of other uses applied for to support the setting of MRLs for uses beyond the representative uses

This information should also be provided in the format of a GAP table; however these uses should not be covered by the GAP table under 1.5.1.

1.5.4 Overview on authorisations in EU Member StatesThis would apply for renewal submissions and it is expected that information in line with the Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 Appendix II Point 5 would be included here.

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Level 2

2 Summary of active substance hazard and of product risk assessmentIn every section a conclusion should be drawn, deficiencies indicated and any problems together with their regulatory consequences listed.

2.1 Identity

2.1.1 Summary of identityAny issues related to e.g. impurities, isomers, pilot plant, full scale production should be listed here.

2.2 Physical and chemical properties

2.2.1 Summary of physical and chemical properties of the active substance

2.2.2 Summary of physical and chemical properties of the plant protection product

2.3 Data on application and efficacyFor efficacy it is intended that limited summary information is placed under each of the headings here to address the requirements of Article 4(3) of Regulation (EC) No 1107/2009. The information should be in line with the relevant guidance: – for new active substances “SANCO E3 WORKING DOCUMENT (Data requirements on efficacy

for the dossier to be submitted for the approval of new active substances as defined under Regulation (EC) No 1107/2009 contained in plant protection products)";

- for renewals - Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 Appendix II (SANCO/2012/11251).

2.3.1 Summary of effectiveness

2.3.2 Summary of information on the development of resistance

2.3.3 Summary of adverse effects on treated crops

2.3.4 Summary of observations on other undesirable or unintended side-effects

2.4 Further information

2.4.1 Summary of methods and precautions concerning handling, storage, transport or fire

2.4.2 Summary of procedures for destruction or decontamination

2.4.3 Summary of emergency measures in case of an accident

2.5 Methods of analysis

2.5.1 Methods used for the generation of pre-authorisation data

2.5.2 Methods for post control and monitoring purposes

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2.6 Effects on human and animal health

2.6.1 Summary of absorption, distribution, metabolism and excretion in mammals

2.6.2 Summary of acute toxicity

2.6.3 Summary of short-term toxicity

2.6.4 Summary of genotoxicity

2.6.5 Summary of long-term toxicity and carcinogenicity

2.6.6 Summary of reproductive toxicity

2.6.7 Summary of neurotoxicity

2.6.8 Summary of further toxicological studies on the active substanceWhere appropriate this will include a summary of:- toxicity studies of metabolites as referred to in the introduction; - supplementary studies on the active substance;- endocrine disrupting properties.

2.6.9 Summary of toxicological data on impurities and metabolites

2.6.10 Summary of medical data and information

2.6.11 Toxicological end point for assessment of risk following long-term dietary exposure - ADI

2.6.12 Toxicological end point for assessment of risk following acute dietary exposure - ARfD (acute reference dose)

2.6.13 Toxicological end point for assessment of occupational, bystander and residents risks – AOEL

2.6.14 Summary of product exposure and risk assessment A concise high level summary of exposure and risk assessment is expected here, with reference to the appropriate Volume(s) 3 (PPP) in which the complete calculations are presented. Sub-headings may be introduced as appropriate. Conclusions drawn regarding the anticipated risk should be clearly stated for each representative use. Any risk mitigation measure taken into account, such as personal protective equipment, waiting period for workers etc. should be clearly indicated for each representative use.

2.7 Residues

2.7.1 Summary of storage stability of residues

2.7.2 Summary of metabolism, distribution and expression of residues in plants, poultry, lactating ruminants, pigs and fish

2.7.3 Definition of the residue

2.7.4 Summary of residue trials in plants and identification of critical GAP

2.7.5 Summary of feeding studies in poultry, ruminants, pigs and fish

2.7.6 Summary of effects of processing

2.7.7 Summary of residues in rotational crops2.7.8 Summary of other studies

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2.7.9 Estimation of the potential and actual exposure through diet and other sources

2.7.10 Proposed MRLs and compliance with existing MRLs

2.7.11 Proposed import tolerances and compliance with existing import tolerances

2.8 Fate and behaviour in the environment

2.8.1 Summary of fate and behaviour in soil

2.8.2 Summary of fate and behaviour in water and sediment

2.8.3 Summary of fate and behaviour in air

2.8.4 Summary of monitoring data concerning fate and behaviour of the active substance, metabolites, degradation and reaction products

2.8.5 Definition of the residues in the environment requiring further assessment

2.8.6 Summary of exposure calculations and product assessment

For each compartment (soil, groundwater, etc) provide a summary of the exposure assessments done for each representative use, with reference to the appropriate Volume(s) 3 (PPP) in which the complete calculations are presented. Sub-headings may be introduced for each compartment. For soil, surface water and sediment, the PEC values should be presented together with the corresponding TER in section 2.9.9. For these compartments it would therefore not be necessary to present any PEC values here.Soil: For each representative use, the method (tier) used to estimate the exposure and any risk mitigation measure taken into account should be stated. Whether or not PECplateau was triggered should be indicated. Groundwater: For each representative use, the method (tier) used to estimate the exposure and any risk mitigation measure taken into account should be stated. Conclusions on the risk for exceedence of the 0.1 µg/l limit value should be clearly stated. The need for an assessment of the relevance of metabolites should be clearly indicated, with reference to section 2.11. Individual PECgw (for active substance and metabolites) needs to be presented for each FOCUS scenario only in case the estimated PECgw is > 0.001 µg/l for any of the scenarios.Surface water and sediment: For each representative use, the method (tier) used to estimate the exposure and any risk mitigation measure taken into account should be stated.Air: For the case exposure via air has been estimated, state method used and the estimated values. Other routes of exposure: State whether or not it has been shown that exposure via other routes (e.g., by deposition of dust; indirect exposure of surface water from Sewage Treatment Plant; from amenity use) can be excluded. If this has not been shown, state the method used to estimate the exposure and any risk mitigation measure taken into account. Since the estimated levels of exposure are expected to be presented in the risk assessment (i.e., under 2.9.9) there would be no need to repeat the values here.

2.9 Effects on non-target species

2.9.1 Summary of effects on birds and other terrestrial vertebrates

2.9.2 Summary of effects on aquatic organisms

2.9.3 Summary of effects on arthropods

2.9.4 Summary of effects on non-target soil meso- and macrofauna

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2.9.5 Summary of effects on soil nitrogen transformation

2.9.6 Summary of effects on terrestrial non-target higher plants

2.9.7 Summary of effects on other terrestrial organisms (flora and fauna)

2.9.8 Summary of effects on biological methods for sewage treatment

2.9.9 Summary of product exposure and risk assessment For each group of organisms (terrestrial vertebrates, aquatic organisms etc) provide a summary of the risk assessment done for each representative use, with reference to the appropriate Volume(s) 3 (PPP) in which the complete calculations are presented. Sub-headings may be introduced for each group of organisms. Conclusions drawn regarding the anticipated risk should be clearly stated for each representative use. State clearly the method (guidance and tier) used for risk assessment, method and assumptions used for refinements, and any risk mitigation measures taken into account. For each use representations of risk (TER values, HQ etc.) together with the corresponding PEC values or other expressions of exposure should be presented for: - one standard calculation without refinement or risk mitigation (eg Step 3 for aquatic organisms);- one calculation for the highest Tier necessary to draw conclusions for the most sensitive organism within each

group of organisms.

2.10 Classification and labellingThe following structured tables - in line with the ECHA-report- should be included here.

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Proposed classification according to Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures

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CLP Annex I

ref

Hazard class Proposed classification

Proposed SCLs and/or M-factors

Current classification 1)

Reason for no classification 2)

2.1. Explosives

2.2. Flammable gases

2.3. Flammable aerosols

2.4. Oxidising gases

2.5. Gases under pressure

2.6. Flammable liquids

2.7. Flammable solids

2.8. Self-reactive substances and mixtures

2.9. Pyrophoric liquids

2.10. Pyrophoric solids

2.11. Self-heating substances and mixtures

2.12. Substances and mixtures which in contact with water emit flammable gases

2.13. Oxidising liquids

2.14. Oxidising solids

2.15. Organic peroxides

2.16. Substance and mixtures corrosive to metals

3.1. Acute toxicity - oral

Acute toxicity - dermal

Acute toxicity - inhalation

3.2. Skin corrosion / irritation

3.3. Serious eye damage / eye irritation

3.4. Respiratory sensitisation

3.4. Skin sensitisation

3.5. Germ cell mutagenicity

3.6. Carcinogenicity

3.7. Reproductive toxicity

3.8. Specific target organ toxicity –single exposure

3.9. Specific target organ toxicity – repeated exposure

3.10. Aspiration hazard

4.1. Hazardous to the aquatic

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environment

5.1. Hazardous to the ozone layer1) Including specific concentration limits (SCLs) and M-factors2) Data lacking, inconclusive, or conclusive but not sufficient for classification

Labelling: Signal word: Hazard statements: Precautionary statements:

Proposed notes assigned to an entry:Notes in accordance with CLP Regulation, Annex VI, Section 1.1.3

Proposed classification according to Dangerous Substances Directive (Directive 67/548/EEC)Hazardous property Proposed

classificationProposed SCLs Current

classification 1)Reason for no classification 2)

Explosiveness

Oxidising properties

Flammability

Other physico-chemical properties

[Add rows when relevant]

Thermal stability

Acute toxicity

Acute toxicity – irreversible damage after single exposure

Repeated dose toxicity

Irritation / Corrosion

Sensitisation

Carcinogenicity

Mutagenicity – Genetic toxicity

Toxicity to reproduction – fertility

Toxicity to reproduction – development

Toxicity to reproduction – breastfed babies. Effects on or via lactation

Environment1) Including SCLs 2) Data lacking, inconclusive, or conclusive but not sufficient for classification

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Labelling: Indication of danger: R-phrases: S-phrases:

2.11 Relevance of metabolites in groundwater

2.11.1 STEP 1: Exclusion of degradation products of no concern

2.11.2 STEP 2: Quantification of potential groundwater contamination

2.11.3 STEP 3: Hazard assessment – identification of relevant metabolites

2.11.3.1 STEP 3, Stage 1: screening for biological activity

2.11.3.2 STEP 3, Stage 2: screening for genotoxicity

2.11.3.3 STEP 3, Stage 3: screening for toxicity

2.11.4 STEP 4: Exposure assessment – threshold of concern approach

2.11.5 STEP 5: Refined risk assessment

2.11.6 Overall conclusion

2.12 Consideration of isomeric composition in the risk assessment

2.12.1 Identity and physical chemical properties

2.12.2 Methods of analysis

2.12.3 Mammalian toxicity

2.12.4 Operator, Worker, Bystander and Resident exposure

2.12.5 Residues and Consumer risk assessment

2.12.6 Environmental fate

2.12.7 Ecotoxciology

2.13 Residue definitions

2.13.1 Definition of residues for exposure/risk assessmentTo be specified for the following matrices:Food of plant origin: [insert name of active substance, metabolites etc as appropriate]

Food of animal origin: [insert name of active substance, metabolites etc as appropriate]

Soil: [insert name of active substance, metabolites etc as appropriate]

Groundwater: [insert name of active substance, metabolites etc as appropriate]

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Surface water: [insert name of active substance, metabolites etc as appropriate]

Sediment: [insert name of active substance, metabolites etc as appropriate]

Air: [insert name of active substance, metabolites etc as appropriate]

2.13.2 Definition of residues for monitoringTo be specified for the following matrices:Food of plant origin: [insert name of active substance, metabolites etc as appropriate]

Food of animal origin: [insert name of active substance, metabolites etc as appropriate]

Soil: [insert name of active substance, metabolites etc as appropriate]

Groundwater: [insert name of active substance, metabolites etc as appropriate]

Surface water: [insert name of active substance, metabolites etc as appropriate]

Sediment: [insert name of active substance, metabolites etc as appropriate]

Air: [insert name of active substance, metabolites etc as appropriate]

Level 3

3 Proposed decision with respect to the application

3.1 Background to the proposed decision

3.1.1 Proposal on acceptability against the approval criteria – Article 4 and Annex II of Regulation (EC) No 1107/2009

3.1.2 Proposal - Candidate for substitution

3.1.3 Proposal – Low risk active substance

3.1.4 List of studies to be generated, still ongoing or available but not evaluated

3.1.4.1 Identity of the active substance or formulation

3.1.4.2 Physical and chemical properties of the active substance and physical, chemical and technical properties of the formulation

3.1.4.3 Data on uses and efficacy

3.1.4.4 Data on handling, storage, transport, packaging and labelling

3.1.4.5 Methods of analysis

3.1.4.6 Toxicology and metabolism

3.1.4.7 Residue data

3.1.4.8 Environmental fate and behaviour

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3.1.4.9 Ecotoxicology

3.1.5 Issues that could not be finalised

3.1.6 Critical areas of concern

3.1.7 Overview table of the concerns identified for each representative use considered

3.1.8 Area(s) where expert consultation is considered necessary

3.1.9 Critical issues on which the Co-RMS did not agree with the assessment by the RMS

3.2 Proposed decision

3.3 Rational for the conditions and restrictions to be associated with any approval or authorisation(s), as appropriate

3.3.1 Particular conditions proposed to be take into account to manage the risks identified

APPENDICES

Appendix 1 Guidance documents used in this assessment

Appendix 2 Reference list References should be listed here which are not listed in Volume 2, 3 and/or 4 (references underpinning documents such as PPR-panel opinions, EFSA conclusions, national documents).

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The list of references , alphabetically by first author, includes all study reports, documents, and published articles submitted, by the applicant or any other parties, or included in the DAR by the RMS, and whether relied upon or not. This should include references on the active substance as well as references on product(s).

References identified in literature search in accordance with Article 8(5) of Regulation (EC) No 1107/2009 and not submitted or requested should not be listed here. The full outcome of the literature search is presented in the summary dossier which is available on the EFSA website.

For draft renewal assessment reports the reference lists for each section should include also those studies that were submitted to support the approval or subsequent renewals.

Lists of studies should be prepared according to the "Guidance Document on preparing list of tests and study reports according to Article 60 of Regulation (EC) No 1107/2009" (in preparation).

A List of the tests, studies and information submitted

A.1 Identity

A.2 Physical and chemical properties

A.3 Data on application and efficacy

A.4 Further information

A.5 Methods of analysis

A.6 Toxicology and metabolism data

A.7 Residue data

A.8 Environmental fate and behaviour

A.9 Ecotoxicology data

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Volume 3- Annex B (AS)

General guidance on content of Volume 3 – Annex B (AS)

This Volume is structured following the order of the "new" data requirements, detailed till one sublevel.

Every chapter (B.1, B.2, etc.) should have a cover page, version history page (see guidance for version control – under development) and a table of content page. Each chapter should be paginated in its own right.

For draft renewal assessment reports the reference lists at the end of each section (sorted by data requirement) should include the newly submitted data relied upon as well as the original submitted tests and studies that are still considered valid and therefore used to support the application for renewal. However these studies should be clearly identified in the reference list as well as in the individual study sections. This could be done by consistent use of a statement for each study:

Previous evaluation: responded “Submitted for the purpose of renewal”, or“In DAR (year)”, “In Addendum to DAR (year)” or any other appropriate information

In every chapter (B.1, B.2, etc.) in Volume 3 (AS) the reference relied on heading should start with a paragraph indicating how the literature search was carried out and if this is considered acceptable. It should also be indicated if the RMS can agree with the justifications given by the notifier (especially for non-relevant literature).This is not expected to be a detailed study-by-study consideration. Relevant literature would be evaluated and assessed in the normal way within each section.

For each individual study, comments and conclusions of the RMS should be clearly identified and separated from the conclusions of the study author or applicant.It should be clearly indicated whether the RMS’s conclusion deviates from conclusion of the applicant or the study author.

It is recommended that the RMS indicates, for each individual study, whether the study is considered as “relevant”, “supplementary” etc… Same terminology as developed by dRR-group should be used.

This volume contains the evaluation of the study reports on the active substance with derivation of the appropriate study end-point from each individual study. This volume focuses only on active substance hazard evaluation.

For all sections (except B.7 Residue data) this volume does not contain any evaluations of studies on formulated products. These studies are instead evaluated in Volume 3 (PPP), regardless of the potential use of the study endpoint for the assessment of the active substance (as can be the case, e.g. for field dissipation studies and for ecotox studies). Volume 3 AS should then include a good cross reference to the corresponding product section.

No summaries of the different areas of evaluations, nor the derivation of assessment end-points, definition of residues, reference values, proposed MRLs etc. are presented in this volume. These parts of the evaluation are instead exclusively presented in Volume 1.

In Volume 1, Level 2, all study endpoints for the active substance and the product(s) are considered for the derivation of the appropriate assessment end-points (e.g. the appropriate input value for PEC modelling, or the appropriate aquatic NOEC to use for ecotoxicological risk assessment).

For B.7 Residue data, all individual studies, whether performed on the active substance or on formulated products, are evaluated in this Volume, i.e. Volume 3 (AS). The main reason to handle residue data different than data for the other sections is that the revised data requirements do not specify requirements for residue data on the formulated products. Additionally (and in contrast to other sections of the evaluation) there is no expected benefit for the product authorisation step to have residue data presented as per product.

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Studies related to the isomeric composition should be reported under the respective heading of the active substance in Volume 3. The consideration on the risk assessment should be reported in Volume 1, Level 2, point 2.12.

B Summary of the data and information

B.1 Identity

B.1.1 Identity of the active substance Same table as used in Volume 1 with the information under 1.3.1 – 1.3.9 should be inserted here.

B.1.2 References relied on

B.2 Physical and chemical properties of the active substance Data under 2.1-2.13 should be reported in the standard table.

B.2.1. Melting point and boiling point

B.2.2. Vapour pressure, volatility

B.2.3. Appearance (physical state, colour)

B.2.4. Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity

B.2.5. Solubility in water

B.2.6. Solubility in organic solvents

B.2.7. Partition coefficient n-octanol/water

B.2.8. Dissociation in water

B.2.9. Flammability and self-heating

B.2.10. Flash point

B.2.11. Explosive properties

B.2.12. Surface tension

B.2.13. Oxidising properties

B.2.14 Other studies


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B.3 Data on application

B.3.1. Use of the active substance

B.3.2. Function

B.3.3. Effects on harmful organisms

B.3.4. Field of use envisaged

B.3.5. Harmful organisms controlled and crops or products protected or treated

B.3.6. Mode of action

B.3.7. Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies


B.4 Further information

B.4.1 Methods and precautions concerning handling, storage, transport or fire

B.4.2 Procedures for destruction or decontamination

B.4.3 Emergency measures in case of an accident


B.5 Methods of analysis

B.5.1 Methods used for the generation of pre-approval data

B.5.1.1 Methods for the analysis of the active substance as manufactured

B.5.1.2 Methods for risk assessment

Add additional subheadings according to matrices, if appropriate.

B.5.2 Methods for post-approval control and monitoring purposes


B.6 Toxicology and metabolism data

B.6.1 Absorption, distribution, metabolism and excretion in mammals

B.6.1.1 Absorption, distribution, metabolism and excretion by oral route

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B.6.1.2 Absorption, distribution, metabolism and excretion by other routes

B.6.2 Acute toxicity

B.6.2.1 Oral

B.6.2.2 Dermal

B.6.2.3 Inhalation

B.6.2.4 Skin irritation

B.6.2.5 Eye irritation

B.6.2.6 Skin sensitisation

B.6.2.7 Phototoxicity

B.6.3 Short-term toxicity

B.6.3.1 Oral 28-day study

B.6.3.2 Oral 90-day study

B.6.3.3 Other routes

B.6.4 Genotoxicity

B.6.4.1 In vitro studies

B.6.4.2 In vivo studies in somatic cells

B.6.4.3 In vivo studies in germ cells

B.6.5 Long-term toxicity and carcinogenicity

B.6.6 Reproductive toxicity

B.6.6.1 Generational studies

B.6.6.2 Developmental toxicity studies

B.6.7 Neurotoxicity

B.6.7.1 Neurotoxicity studies in rodents

B.6.7.2 Delayed polyneuropathy studies

B.6.8 Other toxicological studies

B.6.8.1 Toxicity studies of metabolites and relevant impurities

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B.6.8.2 Supplementary studies on the active substance

B.6.8.3 Studies on endocrine disruption

B.6.9 Medical data and information

B.6.9.1 Medical surveillance on manufacturing plant personnel and monitoring studies

B.6.9.2 Data collected on humans

B.6.9.3 Direct observations

B.6.9.4 Epidemiological studies

B.6.9.5 Diagnosis of poisoning (determination of active substance, metabolites), specific signs of poisoning, clinical tests

B.6.9.6 Proposed treatment: first aid measures, antidotes, medical treatment

B.6.9.7 Expected effects of poisoning


B.7 Residue data1

B.7.1 Storage stability of residues

B.7.2 Metabolism, distribution and expression of residues

B.7.2.1 Plants

B.7.2.2 Poultry

B.7.2.3 Lactating ruminants

B.7.2.4 Pigs

B.7.2.5 Fish

B.7.3 Magnitude of residue trials in plants

B.7.4 Feeding studies

B.7.4.1 Poultry

B.7.4.2 Ruminants

B.7.4.3 Pigs

1 Uses applied for to support the setting of MRLs for uses beyond the representative uses(s) should be clearly identified.

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B.7.4.4 Fish

B.7.5 Effects of processing

B.7.5.1 Nature of the residue

B.7.5.2 Distribution of the residue in peel and pulp

B.7.5.3 Magnitude of residues in processed commodities

B.7.6 Residues in rotational crops

B.7.6.1. Metabolism in rotational crops

B.7.6.2. Magnitude of residues in rotational crops

B.7.7 Other studies

B.7.7.1 Effect on the residue level in pollen and bee products


B.8 Environmental fate and behaviour

B.8.1 Fate and behaviour in soil

B.8.1.1 Route and rate of degradation in soil

B.8.1.2 Adsorption and desorption in soil

B.8.1.3 Mobility in soil

B.8.2 Fate and behaviour in water and sediment

B.8.2.1 Route and rate of degradation in aquatic systems (chemical and photochemical degradation)

B.8.2.2 Route and rate of biological degradation in aquatic systems

B.8.2.3 Degradation in the saturated zone

B.8.3 Fate and behaviour in air

B.8.3.1 Route and rate of degradation in air

B.8.3.2 Transport via air

B.8.3.3 Local and global effects

B.8.4 Monitoring data concerning fate and behaviour of the active substance, metabolites, degradation and reaction products

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Data generated in e.g., local/regional monitoring programmes for pesticides should be presented here – but not specific studies such as e.g., field leaching studies, these should instead be presented under the appropriate sub-heading for study evaluation.


B.9 Ecotoxicology data

B.9.1 Effects on birds and other terrestrial vertebrates

B.9.1.1 Effects on Birds

B.9.1.1.1 Acute oral toxicity to birds

B.9.1.1.2 Short-term dietary toxicity to birds

B.9.1.1.3 Sub-chronic toxicity and reproduction to birds

B.9.1.2 Effects on terrestrial vertebrates other than birds

B.9.1.2.1 Acute oral toxicity to mammals

B.9.1.2.2 Long-term and reproduction toxicity to mammals

B.9.1.3 Active substance bioconcentration in prey of birds and mammals

B.9.1.4 Other data on effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)

B.9.1.5 Potential for endocrine disruption

B.9.2 Effects on aquatic organisms

B.9.2.1 Acute toxicity to fish

B.9.2.2 Long-term and chronic toxicity to fish

B.9.2.3 Potential for endocrine disruption

B.9.2.4 Acute toxicity to aquatic invertebrates

B.9.2.5 Long-term and chronic toxicity to aquatic invertebrates

B.9.2.6 Effects on algal growth

B.9.2.7 Effects on aquatic macrophytes

B.9.2.8 Further testing on aquatic organisms

B.9.3 Effects on arthropods

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B.9.3.1 Effects on bees

B.9.3.2 Effects on non-target arthropods other than bees

B.9.4 Effects on non-target soil meso- and macrofauna

B.9.4.1 Earthworm – sub-lethal effects

B.9.4.2 Effects on non-target soil meso- and macrofauna (other than earthworms)

B.9.5 Effects on soil nitrogen transformation

B.9.6 Effects on terrestrial non-target higher plants

B.9.6.1 Summary of screening data

B.9.6.2 Testing on non-target plants

B.9.7 Effects on other terrestrial organisms (flora and fauna)

B.9.8 Effects on biological methods for sewage treatment

B.9.9 Monitoring data

B.9.10 Biological activity of metabolites potentially occurring in groundwater


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Volume 3 - Annex B (PPP)

General guidance on content of Volume 3 – Annex B (PPP)

One Volume 3 (PPP) should be presented for each unique product.

This Volume is structured following the order of the "new" data requirements, detailed till one sublevel.

Every chapter (B.1, B.2, etc.) should have a cover page, version history page (see guidance for version control – under development) and a table of content page. Each chapter should be paginated in its own right.

For draft renewal assessment reports the reference lists at the end of each section (sorted by data requirement) should include the newly submitted data relied upon as well as the original submitted tests and studies that are still considered valid and therefore used to support the application for renewal. However these studies should be clearly identified in the reference list as well as in the individual study sections. This could be done by consistent use of a statement for each study:

Previous evaluation: responded “Submitted for the purpose of renewal”, or“In DAR (year)”, “In Addendum to DAR (year)” or any other appropriate information

In every chapter (B.1, B.2, etc) in Volume 3 (PPP) the reference relied on heading should start with a cross reference to the corresponding heading in Volume 3 (AS) where it is indicated how the literature search was carried out and if this is considered acceptable. It is not considered necessary to duplicate that information in this volume However if there are specific remarks related to the way PPPs were handled in the literature search these should be made in this volume Relevant literature would be evaluated and assessed in the normal way within each section.

For each individual study, comments and conclusions of the RMS should be clearly identified and separated from the conclusions of the study author or applicant.It should be clearly indicated whether the RMS’s conclusion deviates from conclusion of the applicant or the study author.

It is recommended that the RMS indicates, for each individual study, whether the study is considered as “relevant”, “supplementary” etc… Same terminology as developed by dRR-group should be used.

Volume 3 (PPP) focuses on exposure and risk assessments relevant for the product. In addition, it contains the evaluation of the study reports on the formulated product with derivation of the appropriate study end-point from each individual study (i.e., product hazard evaluation). All studies conducted on formulated products should be evaluated in Volume 3 (PPP) despite the potential use of the study endpoint for the assessment of the active substance (as can be the case, e.g. for field dissipation studies and for ecotox studies). Studies carried out on a formulation which is not identical to the representative formulation should be reported in Volume 3 (PPP) together with a justification for their relevance.

As an exception all data for the residue section should be evaluated in Volume 3 (AS). The main reason is that the revised data requirements do not specify requirements for the formulated products. Volume 3 PPP should then include a good cross reference to the corresponding AS section.

Derivation of assessment end-points, definition of residues, or reference values etc. are presented exclusively in Volume 1. In the derivation of assessment end-points the study end-points from all relevant studies (i.e. on the active substance and the formulated product) are considered. The assessment study endpoints and reference values established in Volume 1 are used in exposure and risk assessment in this Volume 3 (PPP), as appropriate (e.g., input values in PEC modelling).

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B Summary, evaluation and assessment of the data and information

B.1 Identity

B.1.1 Identity of the plant protection product Same table as used in Volume 1 with the information under 1.4.1 – 1.4.8 should be inserted here.


B.2 Physical and chemical properties Data reported under 2.1-2.11 should be presented in the standard table.

B.2.1 Appearance

B.2.2 Explosive and oxidising properties

B.2.3 Flammability and auto-flammabillity

B.2.4 Acidity/alkalinity and pH value

B.2.5 Viscosity and surface tension

B.2.6 Relative density and bulk density

B.2.7 Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product

B.2.8 Technical characteristics of the plant protection product

B.2.8.1 Wettability

B.2.8.2 Persistent foaming

B.2.8.3 Suspensibility, spontaneity and dispersion stability

B.2.8.4 Degree of dissolution and dilution stability

B.2.8.5 Particle size distribution, dust content, attrition and mechanical stability

B.2.8.6 Emulsifiability, re-emulsifiability, emulsion stability

B.2.8.7 Flowability, pourability and dustability

B.2.9 Physical compatibility with other products including plant protection products with which its use is to be authorised

B.2.10 Adherence and distribution to seeds

B.2.11 Other studies


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B.3 Data on application and efficacy

The headings in this section are aligned with the revised data requirements for PPP. However, for efficacy related elements, it is envisaged that only limited information will be provided to address the requirements of Article 4(3) of Regulation (EC) No 1107/2009. Detailed consideration of efficacy will occur in the subsequent product authorisation process when a full biological assessment dossier will be required. Therefore only limited efficacy information is required under the appropriate headings in line with the relevant guidance: – for new active substances “SANCO E3 WORKING DOCUMENT (Data requirements on efficacy for

the dossier to be submitted for the approval of new active substances as defined under Regulation (EC) No 1107/2009 contained in plant protection products)";

- for renewals - Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012 Appendix II (SANCO/2012/11251).

The GAP table will cover elements of B.3.3 to B3.7 and, under some headings, it may be appropriate to:− simply cross-refer to consideration of information in Volume 3 active substance and Volume 1 as

appropriate (for example in relation to information on occurrence or possible occurrence of resistance)

− state that more detailed consideration of a particular aspect will be fully assessed in the context of subsequent applications for products authorisation.

B.3.1 Field of use envisaged

B.3.2 Effects on harmful organisms

B.3.3 Details of intended useThe GAP table for the intended uses should be inserted here.

B.3.4 Application rate and concentration of the active substance

B.3.5 Method of application

B.3.6 Number and timing of applications and duration of protection

B.3.7 Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops

B.3.8 Proposed instructions for use

B.3.9 Effectiveness

B.3.10 Information on the development of resistance

B.3.11 Adverse effects on treated crops

B.3.12 Observations on other undesirable or unintended side-effects


B.4 Further information

B.4.1 Safety intervals and other precautions to protect humans, animals and the environment

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B.4.2 Recommended methods and precautions

B.4.3 Emergency measures in case of an accident

B.4.4 Packaging, compatibility of the plant protection product with proposed packaging materials

B.4.5 Procedures for destruction or decontamination of the plant protection product and its packaging4.5.1 Neutralisation procedure4.5.2 Controlled incineration


B.5 Methods of analysis

B.5.1 Methods used for the generation of pre-authorisation data

B.5.1.1 Analysis of the plant protection product

B.5.1.2 Methods for the determination of residues

Add additional subheadings according to matrices, if appropriate. Cross reference as appropriate to the AS section.

B.5.2 Methods for post-authorisation control and monitoring purposes


B.6 Toxicology and metabolism data and assessment of risks for humans

B.6.1 Acute toxicity of plant protection product

B.6.1.1 Oral toxicity

B.6.1.2 Dermal toxicity

B.6.1.3 Inhalation toxicity

B.6.1.4 Skin irritation

B.6.1.5 Eye irritation

B.6.1.6 Skin sensitisation

B.6.1.7 Supplementary studies on the plant protection product

B.6.1.8 Supplementary studies for combinations of plant protection products

B.6.2 Dermal absorption

B.6.3 Available toxicological data relating to co-formulants

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B.6.4 Exposure data

B.6.4.1 Operator exposure

B.6.4.2 Bystander and resident exposure

B.6.4.3 Worker exposure

B.6.5 Exposure and risk assessment


B.7 Residue data

-

All data for the residue section should be evaluated in Volume 3 (AS). The main reason is that the revised data requirements do not specify requirements for the formulated products. Volume 3 PPP should then include a good cross reference to the corresponding AS section.

B.8 Environmental fate and behaviour and environmental exposure assessment

B.8.1 Fate and behaviour in soil

B.8.1.1 Rate of degradation in soil

B.8.1.2 Mobility in the soil

B.8.2 Predicted environmental concentrations in soil (PECS)

B.8.3 Predicted environmental concentrations in ground water (PECGW)

B.8.4 Fate and behaviour in water and sediment

B.8.4.1 Aerobic mineralisation in surface water

B.8.4.2 Water/sediment study

B.8.4.3 Irradiated water/sediment study

B.8.5 Predicted environmental concentrations in surface water and sediment (PECSW, PECSD)

B.8.6 Fate and behaviour in air

B.8.6.1 Route and rate of degradation in air and transport via air

B.8.6.2 Predicted environmental concentrations from airborne transport

B.8.7 Predicted environmental concentrations from other routes of exposure


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B.9 Ecotoxicology data and assessment of risks for non-target species

B.9.1 Effects on birds and other terrestrial vertebrates

B.9.1.1 Effects on birds

B.9.1.2 Effects on terrestrial vertebrates other than birds

B.9.2 Risk assessment for birds and other terrestrial vertebrates

B.9.3 Effects on aquatic organisms

B.9.3.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes

B.9.3.2 Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms

B.9.3.3 Further testing on aquatic organisms

B.9.4 Risk assessment for aquatic organisms

B.9.5 Effects on arthropods

B.9.5.1 Effects on bees

B.9.5.2. Effects on non-target arthropods other than bees

B.9.6 Risk assessment for arthropods B.9.7 Effects on non-target soil meso- and macrofauna

B.9.7.1 Earthworms

B.9.7.2 Effects on non-target soil meso- and macrofauna (other than earthworms)

B.9.8 Risk assessment for non-target soil meso- and macrofauna

B.9.9 Effects on soil nitrogen transformation

B.9.10 Risk assessment for soil nitrogen transformation

B.9.11 Effects on terrestrial non-target higher plants

B.9.11.1 Summary of screening data

B.9.11.2 Testing on non-target plants

B.9.11.3 Extended laboratory studies on non-target plants

B.9.11.4 Semi-field and field tests on non-target plants

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B.9.12 Risk assessment for terrestrial non-target higher plants

B.9.13 Effects on other terrestrial organisms (flora and fauna)

B.9.14 Risk assessment for other terrestrial organisms (flora and fauna)


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In case there is more than one applicant, it is necessary to produce separate versions of Vol 4 for each applicant or member of a task force, to make sure that documents can be distributed to each individual data submitter without the need to first sanitise the document. If the applicant obtains the active substance from more than one source it should be clarified what is the reference source and subsequently for the other sources the technical equivalence should be established.

C Confidential information and, where relevant, details of any task force formed for the purposes of generating tests and studies submitted

C.1 Confidential information

C.1.1 Detailed information on the manufacturing process or processes for the active substance

C.1.2 Detailed specification of the active substance

C.1.3 Detailed specification of the preparations

C.1.4 Information on the batches used for the mammalian toxicity and ecotoxicity testsThis information should be provided in a standard tabular format.

C.1.5 Other confidential information

C.2 Summary of information relating to any task forces that submitted tests and study reports

C.2.1 Membership of each task force and contact pointNo information is needed here if data can be presented in Volume 1, Level and/or Volume 3, section 1.

C.2.2 Contact point for each member of the task forceNo information is needed here if data can be presented in Volume 1, Level and/or Volume 3, section 1.

C.2.3 Reasonable steps undertaken to form task force

C.3 Summary of information relating to avoidance of duplicative testing and sharing of tests and studies involving vertebrate animals

C.3.1 Detailed information on the avoidance of duplicative testing

C.3.2 Detailed information on sharing tests and studies involving vertebrate animals

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appendix 4 · web viewalso derivation of assessment end-points, reference values, mrls, and...

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