the influence of industrial processing on federal...

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The influence of industrial processing on residue levels present in

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Michael Herrmann

Federal Institute for Risk Assessment, Berlin, Germany

European Pesticide Residue Workshop

May 25th, 2016

The influence of industrial processing on present in raw materials

Federal Institute for Risk Assessment, Berlin, Germany

European Pesticide Residue Workshop

o Part of agricultural commodities are not eaten raw, but subject to processing

operations prior to consumption

o Processing may modulate the pesticide residue level of commodities

Introductory remarks

o Processing may modulate the pesticide residue level of commodities

o Quantitative scale of such an effect is described by

Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016

Part of agricultural commodities are not eaten raw, but subject to processing

rocessing may modulate the pesticide residue level of commodities

Introductory remarks

rocessing may modulate the pesticide residue level of commodities

Quantitative scale of such an effect is described by ´processing factors´

o Food control services

monitoring for compliance of pesticide residues

Who is interested in processing factors ?

monitoring for compliance of pesticide residues in processed products against legal standards for the starting material (RAC)

o Dietary Risk Assessors

realistic estimate of dietary exposure of humans


realistic estimate of dietary exposure of humans and livestock to pesticide residues in processed (by)products

monitoring for compliance of pesticide residues

Who is interested in processing factors ?

monitoring for compliance of pesticide residues in processed products against legal standards

realistic estimate of dietary exposure of humans

© pixabay.com

realistic estimate of dietary exposure of humans and livestock to pesticide residues in processed

© bfr

Guidance in place

o Guideline on nature of the residue (qualitative manner)

� OECD Guideline 507

High temperature hydrolysis, simulating various conditions in pH, temperature regimeHigh temperature hydrolysis, simulating various conditions in pH, temperature regime

o Guideline/Guidance Document on magnitude of the residue

� OECD Guideline 508

� OECD Guidance Document ENV/JM/MONO(2008) on Magnitude of Pesticide Residues in Processed Commodities

• Information on processing types and extrapolations

• Simulation of processing steps on laboratory scale or (semi)technical


• Simulation of processing steps on laboratory scale or (semi)technical representative of conditions ´usually used in

Guidance in place

(qualitative manner)

High temperature hydrolysis, simulating various conditions in pH, temperature regimeHigh temperature hydrolysis, simulating various conditions in pH, temperature regime

magnitude of the residue (quantitative manner)

ENV/JM/MONO(2008) on Magnitude of Pesticide

Information on processing types and extrapolations

laboratory scale or (semi)technical scale

laboratory scale or (semi)technical scale used in practice´

o Maximum residue limits for pesticides (MRL) in EU residue legislation are exclusively

fixed for Raw Agricultural Products (RAC) in Annex I to Regulation (EC) No 396/2005

Legal surroundings

o ´Where MRLs are not set out for processed and/or composite food or

MRLs of the RAC do apply ´.. taking into account changes in the levels of pesticide

residues caused by processing ..´

o Legal requirement of article 20(2) of Regulation

processing information - Annex VI - has not yet


Maximum residue limits for pesticides (MRL) in EU residue legislation are exclusively

Annex I to Regulation (EC) No 396/2005

Legal surroundings

MRLs are not set out for processed and/or composite food or feed´ those

taking into account changes in the levels of pesticide

of article 20(2) of Regulation (EC) No 396/2005 of providing such

not yet been established

Where to get information about processing factors ?

o EFSA Reasoned opinions on the modification and/or

o Approval of pesticidal active substances under Reg. (EU) No 1107/2009

o Reports and evaluations by Joint FAO/WHO Meeting on pesticide residuesin food and some feed

Full processing study reports are proprietary information

reliability and applicability of a specific published P

� No insight in quality of underlying study

� lack in transparency on details of study design

The resulting data compilation includes the stock of processing study (ca. 2600 on 193 actives) submitted in the framework of various regulatory procedures, amongst those …

in food and some feed

�� ´historic´ BfR database versionshttp://www.bfr.bund.de/de/a-z_index/verarbeitungsfaktoren

�� RIVM databasehttps:// chemkap.rivm.nl/groente-fruit/processing

� lack in transparency on details of study design

� risk of misinterpretation due to inconsistent terms for processed food items

� Review of each individual processing study

robustness and reliability (pre-defined by BfR)


procedures, amongst those …

� approval of active substances (DAR, RAR) � applications for setting of MRLs� national PPP authorisations

+ data from food business operators on

Where to get information about processing factors ?

EFSA Reasoned opinions on the modification and/or review of existing MRLs

active substances under Reg. (EU) No 1107/2009

by Joint FAO/WHO Meeting on pesticide residues

information, impeding to judge

reliability and applicability of a specific published Pf figure, because of …

No insight in quality of underlying study

ack in transparency on details of study design

The resulting data compilation includes the stock of processing study reports framework of various regulatory

z_index/verarbeitungsfaktoren-8400.html

fruit/processing-factors/

ack in transparency on details of study design

isk of misinterpretation due to inconsistent terms for processed food items

eview of each individual processing study by scrutinizing against criteria of

defined by BfR)

(DAR, RAR)

on peel/pulp in citrus fruits

New BfR database – elements of interest

residue

definition

main crop

group

sub crop

group

commodity processed

matrix

OECD

procedure

code

individual

Pf

median

Pf

number

of trials

boscalid cereals barley pot/ pearl

barley

XI 0.22 - 0.37 0.33 4

boscalid cereals barley malt V 0.37 - 0.58 0.49 4

boscalid cereals barley malt V 0.53 - 1.10 0.93 4 boscalid cereals barley malt

sprouts

V 0.53 - 1.10 0.93 4

boscalid cereals barley beer V 0.01 - 0.02 0.02 4

boscalid vegetables fruity

vegetables

tomatoes fruit,

washed

VI 1.00 1.00 4


vegetables

tomatoes juice,

pasteurised

VII 0.09 - 0.27 0.15 4


vegetables

tomatoes puree VII 0.19 - 0.73 0.24 4


vegetables

tomatoes paste VII 0.53 - 2.24 0.73 4



vegetables

tomatoes fruit,

peeled

VI 0.03 - 0.07 0.05 3


vegetables

tomatoes fruit,

canned

VIII 0.03 - 0.12 0.05 3

boscalid fruits pome

fruits

apples fruit,

washed

IV 0.4 - 1.00 0.65 4


fruits

apples pomace,

wet

II 5.8 - 8.2 6.55 4


fruits

apples juice II 0.05 - 0.10 0.08 4

elements of interest

number

of trials

acceptability

of study

GLP storage

conditions

analytical

method

procedural

recovery

further

comments

reference EFSA regards

yes yes stability in

watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799

yes yes stability in BASF 92%, [2] EFSA Journal yes yes stability in

watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

stable D9908

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

BASF

method

92.1%,

SD 10.9,

[16] EFSA Journal

2014;12(7):3799

Residue definition

o residue definition for

preferably simple

� fixed in Annexes II and III to Reg. (EC) No 396/2005

o residue definition for o residue definition for

frequently encompassing further component(s) besides

parent (metabolites, breakdown or reaction products)

� not infrequently

� no enacted legislation to look up for

The BfR data compilation is focusing on the definition


The BfR data compilation is focusing on the definition

for future extension(s)

� EFSA forthcoming grant call for drawing up a

processing factors compatible with the EFSA food classification and description system

FoodEx 2´

Residue definition

residue definition for monitoring:

preferably simple marker amenable to MRM (e.g. parent),

fixed in Annexes II and III to Reg. (EC) No 396/2005

residue definition for risk assessment:residue definition for risk assessment:

frequently encompassing further component(s) besides

parent (metabolites, breakdown or reaction products)

infrequently amended

no enacted legislation to look up for

definition for monitoring - with an option

definition for monitoring - with an option

call for drawing up a ´Database of processing types and

processing factors compatible with the EFSA food classification and description system


residue

definition

main crop

group

sub crop

group

commodity processed

matrix

OECD

procedure

code

individual

Pf

median

Pf

number

of trials


barley

XI 0.22 - 0.37 0.33 4



sprouts

V 0.53 - 1.10 0.93 4



vegetables

tomatoes fruit,

washed

VI 1.00 1.00 4


vegetables

tomatoes juice,

pasteurised

VII 0.09 - 0.27 0.15 4


vegetables



vegetables




vegetables

tomatoes fruit,

peeled

VI 0.03 - 0.07 0.05 3


vegetables

tomatoes fruit,

canned

VIII 0.03 - 0.12 0.05 3


fruits

apples fruit,

washed

IV 0.4 - 1.00 0.65 4


fruits

apples pomace,

wet

II 5.8 - 8.2 6.55 4


fruits

apples juice II 0.05 - 0.10 0.08 4


number

of trials

acceptability

of study

GLP storage

conditions

analytical

method

procedural

recovery

further

comments



watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

stable D9908

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

BASF

method

92.1%,

SD 10.9,

[16] EFSA Journal

2014;12(7):3799

Main/sub crop groups and commodities

o Alignment of RACs to those food categories of Annex I

to Reg. (EC) No 396/2005

o Standardization of terminology in case of diverging terms

employed for identical RACs

e.g. ćanola seed´ was replaced by e.g. ćanola seed´ was replaced by

e.g. ćorn´ (AE) was replaced by

o Distinction between red and white varieties for

Main crop group Sub crop groupfruits citrus fruits


pome fruits

stone fruits

berries and small fruits

Main/sub crop groups and commodities

Alignment of RACs to those food categories of Annex I

to Reg. (EC) No 396/2005

Standardization of terminology in case of diverging terms

employed for identical RACs

was replaced by rape seed´´was replaced by rape seed´´) was replaced by ´maize´ (BE)

istinction between red and white varieties for vinification

crop group Commodity

citrus fruits grapefruit

lemons

limes

mandarins

oranges

pome fruits apples

pears

stone fruits apricots

cherries

peaches

plums

berries and small fruits grapes, red

grapes, white

black currants

strawberries


residue

definition

main crop

group

sub crop

group

commodity processed

matrix

OECD

procedure

code

individual

Pf

median

Pf

number

of trials


barley

XI 0.22 - 0.37 0.33 4



commodity processed

matrix

OECD

procedure

code

individual

pot/ pearl

barley

XI 0.22

boscalid cereals barley malt

sprouts

V 0.53 - 1.10 0.93 4



vegetables

tomatoes fruit,

washed

VI 1.00 1.00 4


vegetables

tomatoes juice,

pasteurised

VII 0.09 - 0.27 0.15 4


vegetables



vegetables




vegetables

tomatoes fruit,

peeled

VI 0.03 - 0.07 0.05 3


vegetables

tomatoes fruit,

canned

VIII 0.03 - 0.12 0.05 3


fruits

apples fruit,

washed

IV 0.4 - 1.00 0.65 4


fruits

apples pomace,

wet

II 5.8 - 8.2 6.55 4


fruits

apples juice II 0.05 - 0.10 0.08 4


number

of trials

acceptability

of study

GLP storage

conditions

analytical

method

procedural

recovery

further

comments



watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

stable D9908

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

BASF

method

92.1%,

SD 10.9,

[16] EFSA Journal

2014;12(7):3799

Matrices and matrix grouping

o Nomenclature of processed fractions (matrix) are found

different in different studies

e.g. ´spent grain´ and é.g. ´ young beer´ ,ćooled beer

commodity processed

matrix

OECD

procedure

code

individual

pot/ pearl

barley

XI 0.22

e.g. ´ young beer´ ,ćooled beer

combined into a common matrix term


Altogether,

ca. 800 denotations for processed fractions housed by the inventory

were narrowed down into a total of 175 consolidated descriptors

Matrices and matrix grouping

Nomenclature of processed fractions (matrix) are found

different studies

´brewer‘s grainćooled beer´ and simply ´beer´ were cooled beer´ and simply ´beer´ were

combined into a common matrix term ´beer´

800 denotations for processed fractions housed by the inventory

were narrowed down into a total of 175 consolidated descriptors

Matrices and matrices grouping

commodity processed

matrix

OECD

procedure

code

individual

pot/ pearl

barley

XI 0.22

I

II

III

IV

V

VI

o To unequivocally classify the processing

type each processing operation was

VI

VII

VIII

IX

X

XI

XII

XIII

XIV


type each processing operation was

assigned one of the processing codes

outlined in OECD Guidance Document

ENV/JM/MONO(2008)23

XIV

XV

XVI

XVII

XVIII

XIX


distribution in the edible/ non edible portion

preparation of fruit juice

preparation of canned fruit

preparation of other fruit products

preparation of alcoholic beverages (fermentation,

distillation)

cooking vegetables, pulses and grains in water cooking vegetables, pulses and grains in water

(including steaming)

VII preparation of vegetable juice

VIII preparation of canned vegetable

miscellaneous preparation of other vegetable

products

preparation of oil (extraction, pressing, milling in case

of maize)

Xa belongs to extraction, Xb belongs to pressing, Xc

belongs to maize milling

distribution on milling

XII preparation of sugar

XIII infusions and extractions

XIV silage production

XIV silage production

XV processing of products of animal origin including

preparation of meat and fish (poaching,

frying, baking, boiling)

XVI dehydration

XVII fermentation of soybeans, rice and others (except

alcoholic beverages)

XVIII microwaving vegetable

XIX pickling


o For illustrative assistance a total of 34 processing maps

(standardized flow charts) were drawn up, showing affiliated

products and co-products which may be yielded from a

processed commodity

commodity processed

matrix

OECD

procedure

code

individual

pot/ pearl

barley

XI 0.22



illustrative assistance a total of 34 processing maps

(standardized flow charts) were drawn up, showing affiliated

products which may be yielded from a

© publicdomainpictures.net

© publicdomainvectors.org

Matrices and matrices groupings


Matrices and matrices groupings


residue

definition

main crop

group

sub crop

group

commodity processed

matrix

OECD

procedure

code

individual

Pf

median

Pf

number

of trials


barley

XI 0.22 - 0.37 0.33 4



individual

Pf

median

Pf

0.22 - 0.37 0.33

boscalid cereals barley malt

sprouts

V 0.53 - 1.10 0.93 4



vegetables

tomatoes fruit,

washed

VI 1.00 1.00 4


vegetables

tomatoes juice,

pasteurised

VII 0.09 - 0.27 0.15 4


vegetables



vegetables




vegetables

tomatoes fruit,

peeled

VI 0.03 - 0.07 0.05 3


vegetables

tomatoes fruit,

canned

VIII 0.03 - 0.12 0.05 3


fruits

apples fruit,

washed

IV 0.4 - 1.00 0.65 4


fruits

apples pomace,

wet

II 5.8 - 8.2 6.55 4


fruits

apples juice II 0.05 - 0.10 0.08 4


number

of trials

acceptability

of study

GLP storage

conditions

analytical

method

procedural

recovery

further

comments



watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

stable D9908

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

BASF

method

92.1%,

SD 10.9,

[16] EFSA Journal

2014;12(7):3799

Processing factors

individual

Pf

median

Pf

0.22 - 0.37 0.33

o range of Pf -

o median Pf - in case of more than one processing factor

been specified for a processed fraction in the study been specified for a processed fraction in the study

o number of replicates in a study per processed fraction


The data pool is currently populated with about

Processing factors

in case of replicate trials in a single study

in case of more than one processing factor

been specified for a processed fraction in the study been specified for a processed fraction in the study

number of replicates in a study per processed fraction

currently populated with about 6300 median Pf values


residue

definition

main crop

group

sub crop

group

commodity processed

matrix

OECD

procedure

code

individual

Pf

median

Pf

number

of trials


barley

XI 0.22 - 0.37 0.33 4



sprouts

V 0.53 - 1.10 0.93 4



vegetables

tomatoes fruit,

washed

VI 1.00 1.00 4


vegetables

tomatoes juice,

pasteurised

VII 0.09 - 0.27 0.15 4


vegetables



vegetables




vegetables

tomatoes fruit,

peeled

VI 0.03 - 0.07 0.05 3


vegetables

tomatoes fruit,

canned

VIII 0.03 - 0.12 0.05 3


fruits

apples fruit,

washed

IV 0.4 - 1.00 0.65 4


fruits

apples pomace,

wet

II 5.8 - 8.2 6.55 4


fruits

apples juice II 0.05 - 0.10 0.08 4


number

of trials

acceptability

of study

GLP storage

conditions

analytical

method

procedural

recovery

further

comments



watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799

yes yes stability in BASF 92%, [2] EFSA Journal

GLP storage

conditions

analytical

method

yes stability in

watery

matrices >

24 months

BASF

method

no. 514/0


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

stable D9908

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

BASF

method

92.1%,

SD 10.9,

[16] EFSA Journal

2014;12(7):3799

Éligibilityó processing factors used

enforcement of legal standards

minimum of quality criteria, as regulatory decisions may

largely depend on that piece of

o the following requirements

GLP storage

conditions

analytical

method

yes stability in

watery

matrices >

24 months

BASF

method

no. 514/0

� minimum

� validity

� sample

o the following requirements

as a prerequisite for acceptability and reliability of study

results

Acceptability of a study

all criteria satisfactory addressed ……. acceptable

one of key criteria not fulfilled ………… indicative


� sample

� conducted

� residue

one of key criteria not fulfilled ………… indicative

more than one criterion not fulfilled .. nonsatisfying

criteria

processing factors used in either risk assessment or

enforcement of legal standards should comply with a

minimum of quality criteria, as regulatory decisions may

largely depend on that piece of information.

requirements should be adequately satisfied

minimum number of trials

validity of the analytical method

sample storage conditions

requirements should be adequately satisfied

as a prerequisite for acceptability and reliability of study

acceptable

indicative

out of the ca. 6300 factors

ca. 2700 were tagged fully

ácceptable´,

sample storage conditions

onducted to GLP standards

residue level of RAC > LOQ

indicative

nonsatisfying

performance of a ca. 11 %

share is earmarked as

ńonsatisfying´


residue

definition

main crop

group

sub crop

group

commodity processed

matrix

OECD

procedure

code

individual

Pf

median

Pf

number

of trials


barley

XI 0.22 - 0.37 0.33 4



sprouts

V 0.53 - 1.10 0.93 4



vegetables

tomatoes fruit,

washed

VI 1.00 1.00 4


vegetables

tomatoes juice,

pasteurised

VII 0.09 - 0.27 0.15 4


vegetables



vegetables




vegetables

tomatoes fruit,

peeled

VI 0.03 - 0.07 0.05 3


vegetables

tomatoes fruit,

canned

VIII 0.03 - 0.12 0.05 3


fruits

apples fruit,

washed

IV 0.4 - 1.00 0.65 4


fruits

apples pomace,

wet

II 5.8 - 8.2 6.55 4


fruits

apples juice II 0.05 - 0.10 0.08 4


number

of trials

acceptability

of study

GLP storage

conditions

analytical

method

procedural

recovery

further

comments



watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799

yes yes stability in BASF 92%, [2] EFSA Journal

further

comments


[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799


watery

matrices >

24 months

BASF

method

no. 514/0

92%,

SD 12.2,

CV 13.4%

[2] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

stable D9908

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

10°C for 5

months,

stable

BASF

method

number

D9908

86.7%,

SD 11.0

[8] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

months

BASF

method

no. 445/0

92.1%,

SD 10.9,

CV 11.8%

[16] EFSA Journal

2014;12(7):3799

yes yes stored at -

18°C for 5

BASF

method

92.1%,

SD 10.9,

[16] EFSA Journal

2014;12(7):3799

References and further information

further

comments


[2] EFSA Journal

2014;12(7):3799

o References

bibliographic information on

o EFSA evaluationso EFSA evaluations

indicates whether there is a Reasoned Opinion available

on the review of existing MRLs for the active substance

o Further Comments

miscellaneous information, e.g. on …

� metabolites / isomers

� residue in RAC < LOQ (

� deviations from the published analytical method

� particularities of processing conditions


� particularities of processing conditions

� any other irregularities

References and further information

bibliographic information on studies

evaluationsevaluations

indicates whether there is a Reasoned Opinion available

of existing MRLs for the active substance

Further Comments

iscellaneous information, e.g. on …

metabolites / isomers

RAC < LOQ (ca. 900 in 6300 factors)

deviations from the published analytical method

particularities of processing conditions

particularities of processing conditions

any other irregularities

Persisting limitations and uncertainties

o Limited to simply processed commodities (basically staple food)

o Uncertainties about representativeness of processing procedures

o Laboratory scale vs. industry scale� can there an 1:1 extrapolation be assumed?

o Lacking of important details in study reports

� e.g. duration of fermentation (winemaking)

� e.g. thickness of removed peel (potatoes)

� e.g. extraction procedures (oil processing)

� e.g. ratio of pulp/juice (apple juice)

o Inconsistencies of matrix terms� e.g. flour types

� e.g. beer brewing

� e.g. vinification (production

modes of rosé wines)


modes of rosé wines)

Persisting limitations and uncertainties

Limited to simply processed commodities (basically staple food)

Uncertainties about representativeness of processing procedures

´Take home messages

o The outcome of the data gathering project

customized search capabilities across a huge number of processing factors

along with information on key parameters of underlying studies

o The added value promotes confidence and allows for building of more

robust decisions on whether processed food

in compliance with legal standards

o The database is accessible to the general public (BfR homepage)

o Publication of the project description in a scientific journal is underway

o It is intended to future develop the database by


o It is intended to future develop the database by

- populating with input from upcoming new processing studies

- creating new features for data users

- foster co-operations and partnerships with other scientific institutions

Take home messages´

project provides for comprehensive,

customized search capabilities across a huge number of processing factors -

along with information on key parameters of underlying studies

The added value promotes confidence and allows for building of more

food has been manufactured

general public (BfR homepage)

Publication of the project description in a scientific journal is underway

It is intended to future develop the database by

It is intended to future develop the database by

populating with input from upcoming new processing studies

operations and partnerships with other scientific institutions

FE

DE

RA

L IN

ST

ITU

TE

F

OR

RIS

K A

SS

ES

SM

EN

T

Thank you for your kind attention

… and many thanks to myhaving undertaken all of the

FE

DE

RA

L IN

ST

ITU

TE

F

OR

RIS

K A

SS

ES

SM

EN

T

Dr. Michael Herrmann

Federal Institute for Risk Assessment

Max-Dohrn-Straße 8-10 / D-10589 Berlin / Germany

[email protected]

Thank you for your kind attention

my colleague, Rebekka Scholz, the complex compilation work !

Federal Institute for Risk Assessment

10589 Berlin / Germany

[email protected] � www.bfr.bund.de

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