The influence of industrial processing on FEDERAL...
Transcript of The influence of industrial processing on FEDERAL...
FE
DE
RA
L IN
ST
ITU
TE
F
OR
RIS
K A
SS
ES
SM
EN
T
The influence of industrial processing on residue levels present in
FE
DE
RA
L IN
ST
ITU
TE
F
OR
RIS
K A
SS
ES
SM
EN
T
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´
Page 2
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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
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
Page 3
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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
• 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
Page 4
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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
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
Page 5
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)
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
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)
Page 6
(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
boscalid vegetables fruity
vegetables
tomatoes juice,
pasteurised
VII 0.09 - 0.27 0.15 4
boscalid vegetables fruity
vegetables
tomatoes puree VII 0.19 - 0.73 0.24 4
boscalid vegetables fruity
vegetables
tomatoes paste VII 0.53 - 2.24 0.73 4
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
boscalid vegetables fruity
vegetables
tomatoes fruit,
peeled
VI 0.03 - 0.07 0.05 3
boscalid vegetables fruity
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
boscalid fruits pome
fruits
apples pomace,
wet
II 5.8 - 8.2 6.55 4
boscalid fruits pome
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
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
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
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
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
Page 7
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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
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
Page 8
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
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
boscalid vegetables fruity
vegetables
tomatoes juice,
pasteurised
VII 0.09 - 0.27 0.15 4
boscalid vegetables fruity
vegetables
tomatoes puree VII 0.19 - 0.73 0.24 4
boscalid vegetables fruity
vegetables
tomatoes paste VII 0.53 - 2.24 0.73 4
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
boscalid vegetables fruity
vegetables
tomatoes fruit,
peeled
VI 0.03 - 0.07 0.05 3
boscalid vegetables fruity
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
boscalid fruits pome
fruits
apples pomace,
wet
II 5.8 - 8.2 6.55 4
boscalid fruits pome
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
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
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
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
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
Page 9
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. ´canola seed´ was replaced by e.g. ´canola seed´ was replaced by
e.g. ´corn´ (AE) was replaced by
o Distinction between red and white varieties for
Main crop group Sub crop groupfruits citrus fruits
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
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
Page 10
pome fruits apples
pears
stone fruits apricots
cherries
peaches
plums
berries and small fruits grapes, red
grapes, white
black currants
strawberries
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
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
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
boscalid vegetables fruity
vegetables
tomatoes juice,
pasteurised
VII 0.09 - 0.27 0.15 4
boscalid vegetables fruity
vegetables
tomatoes puree VII 0.19 - 0.73 0.24 4
boscalid vegetables fruity
vegetables
tomatoes paste VII 0.53 - 2.24 0.73 4
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
boscalid vegetables fruity
vegetables
tomatoes fruit,
peeled
VI 0.03 - 0.07 0.05 3
boscalid vegetables fruity
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
boscalid fruits pome
fruits
apples pomace,
wet
II 5.8 - 8.2 6.55 4
boscalid fruits pome
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
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
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
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
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
Page 11
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 ´e.g. ´ young beer´ ,´cooled beer
commodity processed
matrix
OECD
procedure
code
individual
pot/ pearl
barley
XI 0.22
e.g. ´ young beer´ ,´cooled beer
combined into a common matrix term
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
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 grain´cooled beer´ and simply ´beer´ were cooled beer´ and simply ´beer´ were
combined into a common matrix term ´beer´
Page 12
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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
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
Matrices and matrices grouping
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
Page 13
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
Matrices and matrices grouping
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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
Matrices and matrices grouping
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
Page 14
© publicdomainvectors.org
Matrices and matrices groupings
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
Matrices and matrices groupings
Page 15
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
individual
Pf
median
Pf
0.22 - 0.37 0.33
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
boscalid vegetables fruity
vegetables
tomatoes juice,
pasteurised
VII 0.09 - 0.27 0.15 4
boscalid vegetables fruity
vegetables
tomatoes puree VII 0.19 - 0.73 0.24 4
boscalid vegetables fruity
vegetables
tomatoes paste VII 0.53 - 2.24 0.73 4
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
boscalid vegetables fruity
vegetables
tomatoes fruit,
peeled
VI 0.03 - 0.07 0.05 3
boscalid vegetables fruity
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
boscalid fruits pome
fruits
apples pomace,
wet
II 5.8 - 8.2 6.55 4
boscalid fruits pome
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
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
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
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
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
Page 16
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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
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
Page 17
currently populated with about 6300 median Pf values
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
boscalid vegetables fruity
vegetables
tomatoes juice,
pasteurised
VII 0.09 - 0.27 0.15 4
boscalid vegetables fruity
vegetables
tomatoes puree VII 0.19 - 0.73 0.24 4
boscalid vegetables fruity
vegetables
tomatoes paste VII 0.53 - 2.24 0.73 4
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
boscalid vegetables fruity
vegetables
tomatoes fruit,
peeled
VI 0.03 - 0.07 0.05 3
boscalid vegetables fruity
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
boscalid fruits pome
fruits
apples pomace,
wet
II 5.8 - 8.2 6.55 4
boscalid fruits pome
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
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
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
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
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
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
Page 18
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
´Eligibility´o 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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
� 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
´acceptable´,
Page 19
sample storage conditions
onducted to GLP standards
residue level of RAC > LOQ
indicative
nonsatisfying
performance of a ca. 11 %
share is earmarked as
´nonsatisfying´
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
boscalid vegetables fruity
vegetables
tomatoes juice,
pasteurised
VII 0.09 - 0.27 0.15 4
boscalid vegetables fruity
vegetables
tomatoes puree VII 0.19 - 0.73 0.24 4
boscalid vegetables fruity
vegetables
tomatoes paste VII 0.53 - 2.24 0.73 4
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
boscalid vegetables fruity
vegetables
tomatoes fruit,
peeled
VI 0.03 - 0.07 0.05 3
boscalid vegetables fruity
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
boscalid fruits pome
fruits
apples pomace,
wet
II 5.8 - 8.2 6.55 4
boscalid fruits pome
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
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
yes yes stability in BASF 92%, [2] EFSA Journal
further
comments
reference EFSA regards
[2] EFSA Journal
2014;12(7):3799
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
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
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
Page 20
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
reference EFSA regards
[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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
� 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
Page 21
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)
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
modes of rosé wines)
Persisting limitations and uncertainties
Limited to simply processed commodities (basically staple food)
Uncertainties about representativeness of processing procedures
Page 22
´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
Michael Herrmann, 11th EPR, Limassol, Cyprus, 24-27 May 2016
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
Page 23
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
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