proposal for setting mrls for deet residues in food · proposal for setting mrls for deet residues...
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Proposal for setting MRLs for DEET residues in food
1. Introduction In Germany DEET residues are regularly reported in some raw food commodities, e.g. in
chanterelles1, blueberries, herbal infusions and spices. Generally DEET is not applied to crops before
harvest or during storage or transport of harvested plant products. As the affected foods are
handpicked and DEET is commonly used in insect repellents it can reasonably be assumed that DEET
may be transferred from treated skin/hands to food during handling.
To date 16 DEET containing insect repellents have been authorized in Germany in the framework of
the Biocidal Product Regulation (EU) 528/2012 (see summary table published at
http://www.baua.de/de/Chemikaliengesetz-Biozidverfahren/Biozide/Produkt/Zugelassene-
Biozidprodukte.html;jsessionid=88D7D16739B4F5185A87060E15D17E4D.1_cid323,
date:10.08.2017). However in this context there has not been a quantitative assessment of DEET
residues in food. Instead the label restrictions “To prevent contamination of food, avoid contact of
treated skin with food.” and “Keep away from food, drinks and animal feeding stuff.” have been set in
order to avoid transfer of the active substance DEET to food.
In the context of an e-consultation recently initiated by the French Competent Authority (CA), the
Dutch CA also reported cases of DEET found on hand-picked food. Similar to the German CA, the
Dutch CA currently also uses label restrictions to exclude food contamination from insect repellents.
However, in the light of residue findings, they argued that a dietary risk assessment might become
necessary for the scenario. The French CA informed that they consider it necessary to conduct a
quantitative dietary risk assessment for insect repellents, because label restrictions are in their
opinion not sufficient to exclude a risk, in particular because some may not be realistic for the user
(e.g. a label restriction advising to wash hands after application is unrealistic if the hands are what
the user wants to protect from insects).
In Germany the following approach is currently in place to deal with DEET findings in food:
In these incidental cases risk assessment is performed and national provision special permits
(“Ausnahmegenehmigung”) according to § 68 of the German Food and Feed Act (LFGB) are issued
upon request (restricted to the requested commodity and the requested maximum allowable
content and to the company asking for the permit). In the years 2010-2017 more than 90
applications for special permits have been submitted and approved in Germany for DEET in various
food commodities. Several of these permits have been extended once or twice. The maximum
allowable contents applied for were in the range of 0.04 to 9.0 mg depending on the food
commodity.
The possibility of setting MRLs to deal with occasional DEET findings has not been pursued so far.
1 http://www.bfr.bund.de/cm/343/deet_rueckstaende_in_pfifferlingen_aus_osteuropa_sind_kein_gesundheitsr
isiko.pdf
English translation:
http://www.bfr.bund.de/cm/349/no_risk_to_health_from_deet_residues_in_chanterelle_mushrooms_from_e
astern_europe.pdf
2
2. Proposed way forward In order to avoid having to issue special permits and in order to give legal certainty to monitoring
agencies as well as to food producers and food trade, Germany proposes to set MRLs for DEET
residues in several food commodities.
In the context of establishing MRLs for biocide residues in food and feed an interim approach has
been proposed by COM. The approach has been discussed at several Competent Authority Meetings
and has finally been adopted in March 2017 (CA-March17-Doc.7.6.c-final.docx). The document states
that MRL setting for substances that are not covered by other legislation should be considered
“where (i) measurable residue levels in food would arise from the envisaged use (as indicator of
significant exposure) and (ii) the applicant fails to demonstrate that these residue levels do not pose
a risk to health” (point 45 of the COM paper). Furthermore if a Member State, based on collected
data, considers that a limit should be set, it should inform the Commission, who will then trigger the
appropriate procedure for setting limits (point 50 of the COM paper).
According to the interim approach, MRL setting is justified in the case of DEET residues in foods:
Reference to
COM Proposal
(CA-March17-
Doc.7.6.c-
final.docx)
Description of procedure proposed in
COM Proposal
Application of procedure to DEET
point (44)
Step 1
Active substance is not covered by
legislation on FCM, PPP or VMP
DEET is not covered by other
legislations.
point (45) Step 2
MRL setting should be considered
where
(i) measurable residue levels in food
arise from the envisaged use
(ii) and the applicant fails to
demonstrate that these residue levels
do not pose a risk to health
DEET residues above the LOQ do occur
as shown by German monitoring data
and data from applications for special
permits in Germany.
A consumer health risk from DEET
residues in food was not identified as
it was assumed that label restrictions
are in place preventing transfer of the
active substance DEET from treated
skin onto food.
point (49) Step 3
Member States and other parties to
collect occurrence data (applicant to
submit residue definition
and analytical methods)
COM proposal does not specify
whether occurrence data has to be
representative and how data should
be analysed.
Monitoring data and data from
applications for special permits
available in DE have been collected
and are presented in this paper (Annex
II and III).
point (50) Step 4
When a Member State, based on
collected data, considers that a limit
should be set, it should inform the
Commission. The Commission, based
on the provided information, may
decide to trigger the appropriate
Based on the available data, Germany
considers it necessary to set MRLs for
DEET. Although DEET residues have
been found in amounts that pose no
risk to human health (see Annex 1),
MRLs would support authorities when
dealing with findings of DEET residues
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procedure for setting limits (…). found in handpicked food
commodities. Moreover MRLs would
provide legal certainty to monitoring
agencies, food producers and trade.
3. MRL proposal for DEET residues Based on the available data, Germany considers it necessary to set MRLs for DEET for a number of
food commodities (see table below). The following values are proposed:
Food commodity (Code No. acc. to
Annex I of Reg. (EC) No. 396/2005)
Proposed MRL value
pine kernels (01120090) 0.5 mg/kg
berries and small fruits, except grapes
(01520000, 01530000, 01540000)
0.1 mg/kg
wild fungi (0280020) 1.0 mg/kg
herbal infusions from flowers, leaves and herbs
(0631000, 0632000)
0.1 mg/kg
spices (0800000) 0.5 mg/kg
honey (1040000) 0.15 mg/kg
The detailed derivation of these values can be found in Annex I.
For discussion: Open issues/data gaps with regard to dietary risk assessment
- Information on qualitative and quantitative changes of DEET residues during food processing
(e.g. cooking, baking, frying) is not available. Considering the very low estimated uptake of
DEET residues via food (TMDI = 0.5 % of the ADI) it is proposed to apply “DEET (parent only)”
as residue definition for monitoring and risk assessment.
- No ADI and ARfD have been derived during active substance approval for DEET. In the CAR an
AELacute (oral exposure) has been derived, that appears to be applicable for dietary risk
assessment (both acute and chronic).
- Validated analytical methods for residues in food were not described in the CAR. However
appropriate methods are available and were used for the collection of monitoring data.
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Annex I: Dietary exposure assessment for DEET and its biocidal use as PT19
repellent
Note:
Dietary exposure assessment has been based on information from CAR (DEET, PT19, eCA: SE, 20102),
German monitoring data 2005-2017 and applicant´s data provided in the context of German national
provision special permits according to § 68 of the German Food and Feed Act.
1. Representative dietary exposure scenarios
Intended use(s) (critical application with regard to dietary exposure)
Biocidal product OFF!TM
Aerosol
(representative biocidal product evaluated in CAR (DEET,
PT19, RMS: SE, 2010))
Active substance(s) DEET (N,N-diethyl-m-toluamide)
Type of formulation Alcohol-based, self-pressurized aerosol
Field(s) of use outdoor, indoor
Target organism(s) against biting flies, biting midges or black flies
(Ceratopogonidae, Simuliidae), chiggers, deer flies, no-
seeums, gnats, horse flies (Tabanidae), mosquitoes
(Culicidae), fleas, sand flies (Phlebotomidae), stable flies, ticks,
and small flying insects
Application rate(s) and frequency Direct dermal application of biocidal product with an aerosol
spray 1-2 times per day (aerosol contains 150 mg a.s./kg).
Category(ies) of users non-professional
Waiting periods after treatment /
Further information CAR (DEET, PT19, RMS: SE, 2010): Doc IIIB 6.6 (1)
Non-professional/general public exposure via food is “Not
applicable because during normal use in insect repellent
products applied directly to human skin, OFF!TM Aerosol
insect repellent will not be used where food for human
consumption is prepared, consumed or stored or where
feedingstuff for livestock is prepared, consumed or stored.”
In Germany currently 16 DEET containing repellents with uses similar to the CAR representative
biocidal product have been authorized (see summary table published at
http://www.baua.de/de/Chemikaliengesetz-
Biozidverfahren/Biozide/pdf/Repellentien.pdf?__blob=publicationFile&v=12, date 01.08.2017). For
all these products label restrictions apply in order to avoid contamination of food.
2 http://dissemination.echa.europa.eu/Biocides/ActiveSubstances/0023-19/0023-19_Assessment_Report.pdf
5
Summary table of main representative dietary exposure scenarios
Scenario
number
Type of use Description of scenario Subject of exposure
Transfer of biocidal active substances into foods as a result of non-professional use
1. non-
professional
Biocidal product is transferred from
treated human skin onto food items.
In the CAR it was concluded that the
use pattern of the representative
biocidal product does not result in any
contact with food and feeding stuffs
(AR 2010; section 2.1.1). Nevertheless
it is conceivable that transfer of the
biocidal product from treated skin onto
foods may occur, e.g. when picking
berries or collecting mushrooms. This
is supported by residues detected in
German food monitoring and data
submitted in the context of §68 LFBG
special permits.
food of plant and animal origin
(raw and processed)
2. Nature of residues
General information on active substance
Active substance (Common Name) DEET (N,N-diethyl-m-toluamide)
CAS number 134-62-3
Chemical structure
Molecular formula C12H17NO
Molar mass 191.27 g/mol
Log Po/w 2.4 at pH 6 and 22°C (99.2% pure), No pH dependency
expected as DEET cannot dissociate
Vapour pressure Extrapolated (99.4% pure):
0.11 Pa at 20°C
0.23 Pa at 25°C
Solubility in water 11.2 g/L with no pH control
Active substance approval PT: 19; RMS: SE
Restrictions /
Current regulations on MRLs EU regulations:
specific MRLs for DEET not available
National provision in DE:
special permits (“Ausnahmegenehmigung”) according to
§ 68 of the German Food and Feed Act (LFGB) are issued
upon request (restricted to the requested commodity
and residue level and to the company asking for the
permit). For more details see annex III.
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Non-biocidal uses of the
active substance
no uses in plant protection products, veterinary drugs,
food contact materials
Metabolism and degradation of active substance
Metabolism in plants no information available
Metabolism in animals − rat studies (CAR Doc IIA 3.1, DEET, PT19, eCA: SE,
2010): after oral administration 85-95% of DEET is
absorbed, extensively metabolized to m-[(N,N-
diethylamino) carbonyl] benzoic acid (metabolite A)
and m-[(ethylamino)carbonyl] benzoic acid (metabolite
B), and metabolites are excreted in the urine. No
bioaccumulation was noted.
− studies on metabolism in livestock animals not
available
Bioaccumulation DEET is considered to have little or no potential to
bioaccumulate in the aquatic or terrestrial environment
(log Po/w= 2.4, no experimental studies on accumulation)
(CAR Doc IIA 4.1.4, DEET, PT19, eCA: SE, 2010)
Hydrolysis of active substance and
relevant metabolites (DT50)
(state pH and temperature)
pH 4, 7, 9; 50°C: DT50 ≥ 1 year
(CAR Doc IIA 4.1.1.2, DEET, PT19, RMS: SE, 2010)
Photolytic / photo-oxidative
degradation of active substance and
resulting relevant metabolites
DEET is photolytically stable in sterile distilled water and
no degradation products were detected.
(CAR Doc IIA 4.1.1.2, DEET, PT19, eCA: SE, 2010)
Stability on human skin >80% of DEET applied to human skin is recovered in skin
wipes and rinses after 8 hours of exposure.
(CAR Doc IIA 3.1, DEET, PT19, eCA: SE, 2010)
Conclusion on nature of residues
Following application of the repellent to human skin, sufficient DEET will remain on treated skin, so
that contact with food may possibly lead to contamination of handled food items. As a targeted
treatment of food, feed and livestock animals is not foreseen and food commodities are presumably
contaminated at/after harvest of crops, relevant metabolism of DEET is not expected to occur.
Information on qualitative and quantitative changes of DEET residues during food processing (e.g.
cooking, baking, frying) is not available.
Considering the very low estimated uptake of DEET residues via food (TMDI <1 % of the AELoral, acute) it
is proposed to apply “DEET (parent only)” as residue definition for monitoring and risk assessment.
3. Toxicological reference values
In the context of active substance approval for DEET/PT19 it was not considered necessary to derive
an ADI and an ARfD since no exposure to DEET was expected via food or drinking water (CAR, PT19,
eCA: SE, 2010). The following toxicological reference values are reported in the CAR:
− AELacute (oral exposure): 0.75 mg/kg bw/d
(based on neurotoxicity in 8-week dog study: NOAEL: 75 mg/kg bw/d, AF 100)
− AELrepeated (dermal exposure): 8.2 mg/kg bw/d
(based on kidney lesions observed in 90-day-rat study: NOAEL > 1000 mg/kg bw/d, 82 %
dermal absorption, AF 100)
The derived AELacute for oral exposure of 0.75 mg/kg bw/d may also be considered as ADI and ARfD
and will be used for dietary risk assessment (both acute and chronic).
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4. Methods of analysis
Fully validated methods for analysis of DEET residues in food and feed have not been described in the
CAR. However appropriate methods are available and were used for the collection of monitoring
data for DEET residues in food. An overview of methods as described in the CAR and in §68 LFBG
applications is presented in the table below.
Analytical methods for detecting DEET residues in various matrices
Matrix Principle of method and LOQ Reference
Methods reported for active substance approval (DEET, PT19)
Soil DEET: LC-MS/MS with 1 transition (LOQ:
0.01 mg/kg)
LoEP, CAR DEET, PT19,
eCA: SE, 2010
Air No method required based on the use
pattern and properties of DEET and the
representative product.
A method might be required at the
product-authorisation stage
LoEP, CAR DEET, PT19,
eCA: SE, 2010
Water An LC-MS/MS method taken from the
open literature is proposed with a
Method Reporting Limit of 0.1 ng/L.
However, further validation data is
needed to verify the usefulness of the
method for the natural water
compartment.
LoEP, CAR DEET, PT19,
eCA: SE, 2010
Body fluids and tissues DEET in blood plasma:
HPLC-UV (LOQ 49.4μg/L)
No confirmatory method provided. No
further data required as DEET is not
classified as toxic or highly toxic
LoEP, CAR DEET, PT19,
eCA: SE, 2010
Food/feed of plant origin
Not required as the use pattern of DEET
will not result in any contact with food or
feeding stuffs
LoEP, CAR DEET, PT19,
eCA: SE, 2010
Food/feed of animal origin
Not required as the use pattern of DEET
will not result in any contact with food or
feeding stuffs
LoEP, CAR DEET, PT19,
eCA: SE, 2010
Methods reported with applications for §68 LFGB special permits
Chanterelles, Herbal
infusions, blueberries
pine kernels, spices, cocoa
QuEChERS GC-TOF/MS, LC-MS/MS or GC-
MS/MS
LOQ 0.01 mg/kg
Applicant´s information
provided in various
applications
Methods reported by EU Reference Laboratories
Plant matrices QuEChERS LC-MS/MS
validated LOQs in the range of 0.02 to
0.05 mg/kg (depending on matrix)
EURL Data Pool*
* http://www.eurl-pesticides-test.eu
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5. Residue data
Residues in pine nut kernels
Food
commodity
(Code No.)#
Data source No. of samples Residues (mg/kg)
pine nut
kernels
(0120090)
monitoring
(DE, 2005-2017)
total 65 range: <LOQ to 0.355
97.5th
percentile: 0.174
(no individual values reported, LOQ variable)
n > 0.01 30
pine nut
kernels
(0120090)
§68 LFGB
special permits
total 24 0.013, 0.021, 0.023 (2), 0.026, 0.027, 0.035,
0.037, 0.039, 0.040, 0.042, 0.043, 0.045,
0.060, 0.076, 0.080, 0.082, 0.100, 0.110 (2),
0.150 (2), 0.18, 0.36
(reported LOQ: 0.01 or 0.02 mg/kg) # Code No. acc. to Annex I of Reg. (EC) No. 396/2005
Residues in berries (except grapes)
Food
commodity
(Code No.)#
Data source No. of samples Residues (mg/kg)
strawberries
(0152000)
cane fruits
(0153000)
other small
fruits and
berries
(0154000)
monitoring
(DE, 2005-2017)
total 10408 fresh and frozen berries
range: <LOQ to 0.12
97.5th
percentile ≤ LOQ
(no individual values reported, LOQ variable)
n > 0.01
mg/kg
21
blueberries
(0154010)
§68 LFGB
special permits
total 11 fresh and frozen blueberries
0.010, 0.012, 0.014, 0.015, 0.019, 0.020 (2),
0.031, 0.032, 0.04, 0.067
(reported LOQ: 0.01 mg/kg or LOQ not
specified)
blueberries
(0154010)
§68 LFGB
special permits
total 18 dried blueberries (whole, pieces, powder)
0.016, 0.029, 0.034 (2), 0.046, 0.098, 0.122,
0.191
(= calculated residues considering a
processing factor* of 5.2 for drying:
0.003, 0.006, 0.007 (2), 0.009, 0.019, 0.023,
0.037
blueberry fraction of fruit mixtures
(assuming that DEET residues originate from
blueberries only)
< LOQ (2), 0.028, 0.039, 0.042, 0.095, 0.126,
0.132, 0.217, 0.264
(= calculated residues considering a
processing factor* of 5.2 for drying:
< LOQ (2), 0.005, 0.008 (2), 0.018, 0.024,
0.025, 0.042, 0.051
(LOQ not specified)
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Summarized
data
§68 LFGB
special permits
total 29 blueberries, fresh, frozen, dried (calculated
back to consider drying process)
< LOQ (2), 0.003, 0.005, 0.006, 0.007 (2),
0.008 (2), 0.009, 0.010, 0.012, 0.014, 0.015,
0.018, 0.019, 0.019, 0.020 (2), 0.023, 0.024,
0.025, 0.031, 0.032, 0.037, 0.04, 0.042,
0.051, 0.067 # Code No. acc. to Annex I of Reg. (EC) No. 396/2005
* For dried blueberries a processing factor of 5.2 was considered based on water content of fresh
(81.1 %) and dried (15.7%) grapes (Souci, Fachmann, Kraut (2008) Die Zusammensetzung der
Lebensmittel, 7. Auflage 2008, Wissenschaftliche Verlagsgesellschaft, Stuttgart).
Residues in wild fungi
Food
commodity
(Code No.)#
Data source No. of samples Residues (mg/kg)
wild fungi
(280000)
monitoring
(DE, 2005-2017)
total 572 range: <LOQ to 1.5
97.5th
percentile: 0.532 mg/kg
(no individual values reported, LOQ variable)
n > 0.01
mg/kg
230
chanterelle,
fresh or
frozen
(0280020)
§68 LFGB
special permits
total 112 <0.005 (2), <0.01 (58), 0.01 (3), 0.016,
0.02 (3), 0.021, 0.027, 0.028 (2), 0.03, 0.035,
0.039, 0.040 (2), 0.05 (2), 0.051, 0.06, 0.061,
0.064, 0.066, 0.10 (3), 0.12, 0.13 (2), 0.14,
0.15 (2), 0.18, 0.19, 0.23, 0.24 (2), 0.25, 0.28,
0.34, 0.35, 0.42, 0.43, 0.49, 0.51, 0.53 (2),
0.54, 0.85, 0.98, 1.77, 1.93
(reported LOQ 0.01 mg/kg or LOQ not
specified)
chanterelle,
dried
§68 LFGB
special permits
total 5 0.012, 0.035, 0.39, 0.78, 8.8
(= calculated residues considering a
processing factor* of 9.2 for drying:
0.001, 0.004 (2), 0.08, 0.96)
(reported LOQ 0.01 mg/kg or LOQ not
specified)
chanterelle,
pickled
§68 LFGB
special permits
total 4 <0.01, 0.057, 0.09, 0.156
(reported LOQ 0.01 mg/kg)
porcini,
dried
§68 LFGB
special permits
total 1 0.24
(LOQ not specified)
morels,
dried
§68 LFGB
special permits
total 4 0.026; 0.073; 0.29; 0.32
(LOQ not specified)
Summarized
data
§68 LFGB
special permits
total 117 wild fungi, fresh, frozen, dried (calculated
back to consider drying process)
0.001, 0.004 (2), <0.005 (2), <0.01 (58),
0.01 (3), 0.016, 0.02 (3), 0.021, 0.027, 0.028
(2), 0.03, 0.035, 0.039, 0.040 (2), 0.05 (2),
0.051, 0.06, 0.061, 0.064, 0.066, 0.08, 0.10
(3), 0.12, 0.13 (2), 0.14, 0.15 (2), 0.18, 0.19,
0.23, 0.24 (2), 0.25, 0.28, 0.34, 0.35, 0.42,
0.43, 0.49, 0.51, 0.53 (2), 0.54, 0.85, 0.96,
0.98, 1.77, 1.93
10
# Code No. acc. to Annex I of Reg. (EC) No. 396/2005
* For dried chanterelles a processing factor of 9.2 was considered based on water content of fresh
(91.5 %) and dried (10.0%) chanterelles (Souci, Fachmann, Kraut (2008) Die Zusammensetzung der
Lebensmittel, 7. Auflage 2008, Wissenschaftliche Verlagsgesellschaft, Stuttgart).
Residues in herbal infusions
Food
commodity
(Code No.)#,*
Data source No. of samples Residues (mg/kg)
herbal
infusions
(0630000)
monitoring
(DE, 2005-2017)
total 396 range: <LOQ to 0.08
97.5th
percentile ≤ LOQ
(no individual values reported, LOQ variable)
n > 0.01
mg/kg
5
Rose
flowers,
petals or
buds, dried
(0631030)
§68 LFGB
special permits
total 26 dried rose flowers, petals, buds
0.010 (2), 0.012, 0.013, 0.016, 0.018, 0.020,
0.021, 0.022, 0.023, 0.029, 0.032, 0.034 (2),
0.037, 0.045, 0.047, 0.059, 0.065, 0.066,
0.067, 0.072, 0.14
tea mix
0.007, 0.009, 0.020
(reported LOQ: 0.01 mg/kg)
Lime/linden
flowers,
dried
(0631050)
§68 LFGB
special permits
total 105 lime/linden flowers
<0.01 (53), 0.010 (4), 0.011 (2), 0.012 (4),
0.013, 0.015 (3), 0.016 (4), 0.017, 0.018,
0.019 (2), 0.021 (3), 0.024, 0.027, 0.028 (2),
0.030 (3), 0.031, 0.035 (2), 0.040, 0.041, 043,
0.045, 0.050, 0.053, 0.059, 0.060 (3), 0.063,
0.083, 0.089, 0.093, 0.094, 0.230, 0.390
(reported LOQ: 0.01 mg/kg)
Blue hibiscus
flowers,
dried
(0631020)
§68 LFGB
special permits
total 4 blue hibiscus flowers
0.012, 0.03, 0.037, 0.05
(reported LOQ: 0.01 mg/kg)
Elder
flowers,
dried
(0631030)
§68 LFGB
special permits
total 5 elder flowers
<0.01 (2), 0.03, 0.04, 0.05
(reported LOQ: 0.01 mg/kg)
Chamomile
(leaves,
flowers,
petals),
dried
(0631010)
§68 LFGB
special permits
total 7 chamomile, fine-cut
<0.01 (2), 0.011 (2), 0.013, 0.035, 0.037
(reported LOQ: 0.01 mg/kg)
Summarized
data for MRL
derivation
§68 LFGB
special permits
total 147 rose (flowers, petals, buds), lime/linden
(flowers), blue hibiscus (flowers), elder
(flowers), chamomile (fine-cut)
0.007, 0.009, <0.01 (57), 0.010 (6), 0.011 (4),
0.012 (6), 0.013 (3), 0.015 (3), 0.016 (5),
0.017, 0.018 (2), 0.019 (2), 0.020 (2), 0.021
(4), 0.022, 0.023, 0.024, 0.027, 0.028 (2),
0.029, 0.030 (5), 0.031, 0.032, 0.034 (2),
0.035 (3), 0.037 (3), 0.040 (2), 0.041, 0.043,
11
0.045 (2), 0.047, 0.050 (3), 0.053, 0.059 (2),
0.060 (3), 0.063, 0.065, 0.066, 0.067, 0.072,
0.083, 0.089, 0.093, 0.094, 0.14, 0.230, 0.390 # Code No. acc. to Annex I of Reg. (EC) No. 396/2005
* Code No. applies to dried products
Residues in spices
Food
commodity
(Code No.)#
Data source No. of samples Residues (mg/kg)
Spices
(0800000)
monitoring
(DE 2005-2017)
total 588 range: <LOQ to 0.1
97.5th
: percentile: not reported
(no individual values reported, LOQ variable)
n > 0.01
mg/kg
2
nutmeg
(0810090)
§68 LFGB
special permits
total 5 ground nutmeg
0.036, 0.052
nutmeg oil
0.16, 2.6, 2.7, 3.5, 8.3
(reported LOQ 0.01 mg/kg)
mace
(0870010)
§68 LFGB
special permits
total 14 whole and ground mace
0.029, 0.046, 0.062, 0.065, 0.077, 0.10, 0.12,
0.13, 0.131, 0.14, 0.16, 0.35, 0.39, 0.86
(reported LOQ 0.01 mg/kg)
cloves
(0850010)
§68 LFGB
special permits
total 4 <0.01, 0.017, 0.031, 0.042
(reported LOQ 0.01 mg/kg)
cinnamon
(0830010)
§68 LFGB
special permits
total 6 ground cinnamon
0.008, 0.021, 0.022, 0.029 (2), 0.025,
0.030,0.033, 0.034, 0.067, 0.074, 0.08, 0.09
(LOQ not specified)
pepper
(0820060)
§68 LFGB
special permits
total 5 whole pepper
0.011, 0.015, 0.016, 0.019 (2)
(LOQ not specified)
chilies
§68 LFGB
special permits
total 3 ground
0.013, 0.027, 0.12
(LOQ not specified)
Summarized
data
§68 LFGB
special permits
total 41 whole and ground spices (nutmeg, mace,
cloves, cinnamon, pepper, chilies)
0.008, <0.01, 0.011, 0.12, 0.013, 0.015,
0.016, 0.017, 0.019 (2), 0.021, 0.022, 0.025,
0.027, 0.029 (3), 0.030, 0.031, 0.033, 0.034,
0.036, 0.042, 0.046, 0.052, 0.062, 0.065,
0.067, 0.074, 0.077, 0.08, 0.09, 0.10, 0.12,
0.13, 0.131, 0.14, 0.16, 0.35, 0.39, 0.86 # Code No. acc. to Annex I of Reg. (EC) No. 396/2005
Residues in honey
Food
commodity
(Code No.)#
Data source No. of samples Residues (mg/kg)
honey
(1040000)
monitoring
(DE, 2005-2017)
total 1879 range: <LOQ to 0.15
97.5th
percentile ≤ LOQ
(no individual values reported, LOQ variable)
n > 0.01
mg/kg
33
# Code No. acc. to Annex I of Reg. (EC) No. 396/2005
12
6. Conclusion on residues/ MRL proposal
Representative German monitoring data from 2005-2017 (see Annex II) indicate that DEET residues
are usually below the LOQ in the majority of food commodities (total of 106793 samples of fresh and
frozen commodities analysed with 361 samples containing residues > LOQ). Samples with residues
exceeding the LOQ mostly belong to handpicked commodities of plant origin such as wild fungi (230
out of 572 analysed samples), pine nut kernels (30 out of 65 analysed samples) and berries (21 out of
10408 analysed samples). Out of the total number of samples analysed only about 5849 belong to
commodities that are usually not harvested by hand, such as cereals or potatoes.
Additional residue data provided in the framework of national provision of special permits
(“Ausnahmegenehmigung” according to § 68 of the German Food and Feed Act (LFGB)) confirms that
residues above the LOQ are intermittently observed in certain hand-picked commodities such as
chanterelles, herbal infusions, blueberries, and spices. It should be noted that these data focus on
contaminated lots of food and are not representative.
In the table below MRL proposals are given for pine nut kernels, berries (except grapes), wild fungi,
herbal infusions, spices and honey. The values were derived based on the available residue data in
the framework of monitoring programs and, if available, §68 LFGB special permits.
For cocoa the available residue data is not considered sufficient to derive an MRL (8 monitoring
samples, 12 samples from §68 LFGB special permit applications).
No MRLs are proposed for citrus fruits, pome fruits, stone fruits, grapes, root and tuber vegetables,
bulb vegetables, leafy vegetables, stem vegetables, and legume vegetables. For these commodities
large numbers of monitoring samples were analysed with only occasional findings of DEET residues
below or around 0.05 mg/kg.
For fruiting vegetables residues were only found in 2 samples of chilies. As residues in chilies may be
covered by the MRL proposed for spices, no specific MRL for fruiting vegetables is derived.
For all additional food items of plant origin no MRLs are proposed, as monitoring results show
residue levels below the LOQ in all samples.
For food items of animal origin no MRLs are proposed as DEET residues were below the LOQ in nearly
all monitoring samples and exposure of livestock and wild animals is not plausible. The single
observation of high residues in a sample of boar meat is considered incidental.
13
Food commodity
(Code No.)
Proposed MRL
(mg/kg)
Remarks
pine nut kernels
(0120090)
0.5 German monitoring data
65 samples of pine nut kernels have been analysed with 30
samples containing residues >LOQ. The maximal residue level
detected was 0.355 mg/kg, the 97.5th
percentile 0.174 mg/kg.
Data from §68 LFGB national provision special permits
In Germany currently §68 LFGB two special permits have been
issued in order to deal with occasional DEET findings in pine
nut kernels. The residue data submitted with the applications
is not representative for the general residue situation but
rather reflects a selection of food lots with high residues, i.e.
can be considered worst case. In all of the analysed 24
samples DEET residues exceeded 0.01 mg/kg with maximal
residues detected at 0.36 mg/kg.
Overall conclusion
Transfer of DEET residues onto pine nut kernels may arise
from contact with treated skin during and after harvest. Based
on monitoring data and data submitted in the context of §68
LFGB special permits an MRL of 0.5 mg/kg is proposed for pine
nut kernels. This is in line with values accepted for current §68
LFGB special permits issued in Germany.
Berries except
grapes:
strawberries
(0152000)
cane fruits
(0153000)
other small fruits
and berries
(0154000)
0.1 German monitoring data
10408 samples of berries (except grapes) have been analysed
with 21 samples (including strawberries, raspberries,
blueberries and currants) containing residues >LOQ. The
maximal residue level detected was 0.12 mg/kg, the 97.5th
percentile is ≤ LOQ.
Data from §68 LFGB national provision special permits
In Germany currently four §68 LFGB special permits have been
issued in order to deal with occasional DEET findings in
blueberries. The residue data submitted with the applications
is not representative for the general residue situation but
rather reflects a selection of food lots with high residues, i.e.
can be considered worst case. In about one third of the
analysed 29 samples DEET residues did not exceed
0.01 mg/kg. Maximal residues were detected at 0.067 mg/kg.
Overall conclusion
Transfer of DEET residues onto berries may arise from contact
with treated skin by handpicking during harvest. Based on
monitoring data and data submitted in the context of §68
LFGB special permits an MRL of 0.1 mg/kg is proposed for
berries (except grapes). This is in line with the value accepted
for current §68 LFGB special permits issued in Germany.
Wild fungi,
fresh or frozen
(0280000)
1.0 German monitoring data
572 samples of wild fungi have been analysed with 230
samples containing residues > LOQ. The maximal residue level
detected was 1.5 mg/kg, the 97.5th
percentile 0.532 mg/kg.
14
Food commodity
(Code No.)
Proposed MRL
(mg/kg)
Remarks
Data from §68 LFGB national provision special permits
In Germany currently §68 LFGB special permits have been
issued in order to deal with occasional DEET findings in
chanterelles, porcini and morels. Considering the numerous
permits over the last years (more than 40 applications and
extensions since 2010) an MRL is proposed to handle findings
of DEET residues and achieve legal certainty.
The residue data submitted with the applications is not
representative for the general residue situation but rather
reflects a selection of food lots with high residues, i.e. can be
considered worst case. In about 50 % of the analysed 117
samples DEET residues did not exceed 0.01 mg/kg. The 97.5th
percentile was calculated as 0.96 mg/kg.
Overall conclusion
Transfer of DEET residues onto wild fungi may arise from
contact with treated skin by handpicking during harvest.
Based on monitoring data and data submitted in the context
of §68 LFGB special permits an MRL of 1.0 mg/kg is proposed
for wild fungi. This is in line with values accepted for current
§68 LFGB special permits issued in Germany.
15
Food commodity
(Code No.)
Proposed MRL
(mg/kg)
Remarks
herbal infusions
from flowers and
leaves
(0630000)
0.1 German monitoring data
396 samples of herbal infusions, both flowers and leaves have
been analysed with 5 samples containing residues > LOQ.
Maximal residues detected were 0.08 mg/kg the 97.5th
percentile is ≤ LOQ.
Data from §68 LFGB special permits
In Germany currently §68 LFGB special permits have been
issued in order to deal with occasional DEET findings in herbal
infusions from flowers (chamomile, rose flowers/petals/buds,
lime/linden, hibiscus flowers, elder flowers). Since 2011, 13
permits and 1 extension have been applied for. With these
applications residue data for an overall of 147 samples has
been submitted.
The residue data submitted with the applications is not
representative for the general residue situation but rather
reflects a selection of food lots with high residues, i.e. can be
considered worst case. In about 40 % of the analysed 147
samples DEET residues did not exceed 0.01 mg/kg. The 97.5th
percentile was calculated as 0.093 mg/kg.
Overall conclusion
Transfer of DEET residues onto flowers and leaves may arise
from contact with treated skin by handpicking during harvest.
Based on monitoring data and data submitted in the context
of §68 LFGB special permits an MRL of 0.1 mg/kg is proposed
for herbal infusions from flowers and leaves. This is in line
with values accepted for current §68 LFGB special permits
issued in Germany.
16
Food commodity
(Code No.)
Proposed MRL
(mg/kg)
Remarks
spices
(0800000)
0.5 German monitoring data
588 samples of spices have been analysed with 2 samples
containing residues >LOQ. The maximal residue level detected
was 0.1 mg/kg.
Data from §68 LFGB national provision special permits
In Germany currently more than 10 §68 LFGB special permits
have been issued in order to deal with occasional DEET
findings in various spices. The residue data submitted with the
applications is not representative for the general residue
situation but rather reflects a selection of food lots with high
residues, i.e. can be considered worst case. In all but two of
the analysed 41 samples (whole and ground spices) DEET
residues exceeded 0.01 mg/kg. Maximal residues were
detected at 0.86 mg/kg, the next highest value of 0.39 mg/kg
was more than 2-fold lower.
Overall conclusion
As exposure of food commodities occurs during or after
harvest there is no need to distinguish MRLs for spices from
different plant parts (e.g. seed, fruit, bark etc). Based on
monitoring data and data submitted in the context of §68
LFGB special permits an MRL of 0.5 mg/kg is proposed for
whole and ground spices. This is in line with values accepted
for current §68 LFGB special permits issued in Germany.
This value would also covers DEET residues observed in
nutmeg oil considering a fat content of ca. 30% for nutmeg.3
honey
(1040000)
0.15 German monitoring data
1879 samples of honey have been analysed with 33 samples
containing residues > LOQ. Maximal residues detected were
0.15 mg/kg.
Overall conclusion
DEET residues in honey may originate from the former use of
a DEET containing repellent (Fabi-Spray) applied in bee-
keeping.4 Based on available monitoring data an MRL at the
maximally observed level of 0.15 mg/kg is proposed for
honey.
3 Franke, W., Nutzpflanzenkunde, 5. Auflage, 1992, Georg Thieme Verlag, Stuttgart
4 Rosenkranz et al, Bericht der Landesanstalt für Bienenkunde der Universität Hohenheim für das Jahr 2016,
https://bienenkunde.uni-
hohenheim.de/fileadmin/einrichtungen/bienenkunde/Downloads/Jahresbericht/Bericht_der_Landesanstalt_fu
er_Bienenkunde_2016.pdf
17
7. Consumer exposure assessment (acute and chronic)
7.1 Input values
For acute and chronic exposure assessment German monitoring data as well as residue data
submitted in the context of special permits according to § 68 of the German Food and Feed Act
(LFGB) were considered as described in the table below:
- For pine nut kernels, berries (except grapes), wild fungi, herbal infusions, spices ,and honey:
proposed MRL (acute and chronic)
- For other food commodities with §68 special permits (i.e. cocoa beans): the highest
approved limit (chronic only)
- For further commodities with residues < LOQ in all monitoring samples: highest reported
LOQ of 0.05 mg/kg (chronic only)
Justification: In the context of active substance approval, analytical methods for DEET
residues in food have not been assessed. According to EURL-DataPool (http://www.eurl-
pesticides-datapool.eu/) an LOQ of 0.02 to 0.05 mg/kg is feasible, while occasionally LOQs as
low as 0.01 mg/kg were reported. Residue data submitted in the context of §68 LFGB special
permits frequently refer to an LOQ of 0.01 mg/kg. The highest reported LOQ of 0.05 mg/kg
has been included in the consumer risk assessment to cover the worst case.
- For further commodities with residues > LOQ in few monitoring samples: mean residue, but
under consideration of validated LOQ (chronic only).
Justification: The mean residue did not exceed 0.05 mg/kg for any of these food categories.
As it is not clear if lower LOQs than 0.05 mg/kg were sufficiently validated, mean values <
0.05 mg/kg were replaced by the highest validated LOQ of 0.05 mg/kg.
The key data for consumer intake assessment are summarized in the table below:
Table: Input values for consumer risk assessment
Commodity
Chronic risk assessment Acute risk assessment
Input
value
(mg/kg)
Comment
Input
value
(mg/kg)
Comment
Definition of residue: DEET
Citrus fruits
(0110000)
0.05 mean residue DE monitoring
data, replaced by LOQ
18
Commodity
Chronic risk assessment Acute risk assessment
Input
value
(mg/kg)
Comment
Input
value
(mg/kg)
Comment
Tree nuts except pine nut
kernels
(0120000)
0.05 LOQ
Pine nut kernels
(0120090)
0.5 proposed MRL 0.5 proposed MRL
Pome fruits
(0130000)
0.05 mean residue DE monitoring
data, replaced by LOQ
Stone fruits
(0140000)
0.05 mean residue DE monitoring
data, replaced by LOQ
Grapes
(0151000) 0.05 mean residue DE monitoring
data, replaced by LOQ
Berries and small fruits,
grapes
(0150000)
0.1 proposed MRL 0.1 proposed MRL
Miscellaneous fruits
(0160000)
0.05 LOQ
Root and tuber vegetables
(0210000)
0.05 mean residue DE monitoring
data, replaced by LOQ
Bulb vegetables
(0220000)
0.05 mean residue DE monitoring
data, replaced by LOQ
Fruiting vegetables
(0230000)
0.05 mean residue DE monitoring
data, replaced by LOQ
Brassica vegetables
(excluding brassica roots
and brassica baby leaf
crops)
(0240000)
0.05 LOQ
Leaf vegetables, herbs and
edible flowers
(0250000)
0.05 mean residue DE monitoring
data, replaced by LOQ
Legume vegetables
(0260000)
0.05 mean residue DE monitoring
data, replaced by LOQ
19
Commodity
Chronic risk assessment Acute risk assessment
Input
value
(mg/kg)
Comment
Input
value
(mg/kg)
Comment
Stem vegetables
(0270000)
0.05 mean residue DE monitoring
data, replaced by LOQ
wild fungi
(0280020)
1.0 proposed MRL 1.0 proposed MRL
cultivated fungi
(0280010)
0.05 LOQ
Pulses
(0300000) 0.05 LOQ
Oilseeds and oil fruits
(0400000) 0.05 LOQ
Cereals (0500000) 0.05 LOQ
Coffee (0620000) 0.05 LOQ
Herbal infusions
(0630000) 0.1 proposed MRL 0.1 proposed MRL
Cocoa beans
(0640000) 0.1 Special permit according to
§ 68 German LFGB for
cocoa butter and nibs
Spices
(0800000) 0.5 proposed MRL 0.5 proposed MRL
Products of animal origin
(1000000) other than
honey and products from
wild terrestrial vertebrates
0.05 LOQ
Honey
(1040000) 0.15 proposed MRL 0.15 proposed MRL
Tissues from wild
terrestrial vertebrates
(1070000)
0.05 mean residue DE monitoring
data, replaced by LOQ
7.2 Consumer exposure assessment/ Dietary risk assessment
Chronic and acute exposure of consumers via DEET residues in food has been estimated using EFSA
PRIMo (revision 2)5.
5 EFSA Pesticide Residue Intake Model (PRIMo, rev. 2),
https://www.efsa.europa.eu/de/applications/pesticides/tools
20
For acute exposure via herbal infusions consumption data from the German NVS II model6 has been
considered. For children (2-4 years) the model contains data for mate leaves (1 person-day) and elder
flowers (7 person-days). For the general population (14-80 years) consumption data for hibiscus
flowers (2979 person-days), rooibos (783 person-days) and mate (27 person-days) leaves are
included. Consumption data for herbal infusions from other European countries, e.g. from the EFSA
PRIMo model is not available.
The residue data considered in the calculations is summarized in section 7.1. The results of the TMDI
(chronic) and IESTI/NESTI calculations (acute) are shown in the table below. To illustrate the results
of the chronic risk assessment, a screenshot of the TMDI result obtained is pictured in Annex IV.
Risk for consumers via DEET residues in food
Scenario Tox. ref.
value
mg/kg
bw/d
Critical
consumer
group
Estimated
uptake
mg/kg bw/d
Estimated
uptake/Tox.
ref. value (%)
Acceptable
(yes/no)
Chronic consumer
exposure via
residues in food
(TMDI)
0.75#
NL child
0.0034
0.5
yes
Acute consumer
exposure via
residues in pine
nut kernels (IESTI)
0.75#
DE children
0.0003
<0.1
yes
Acute consumer
exposure via
residues in
berries (except
grapes) (IESTI)
0.75#
DE children
strawberries
0.0016
0.2
yes
Acute consumer
exposure via
residues in wild
fungi (IESTI)
0.75#
DE children
NL adult
0.0018
0.0053
0.2*
0.7
yes
yes
Acute consumer
exposure via
residues in herbal
infusions
(NESTI)
0.75#
DE children
elder flowers
mate leaves
general
population
hibiscus flowers
rooibos leaves
mate leaves
0.000488
0.000015
0.0000224
0.0000376
0.0000339
<0.1
<0.1
<0.1
<0.1
<0.1
yes
Acute consumer
exposure via
residues in spices
(IESTI)
0.75#
DE children
fennel seed
0.0004
<0.1
yes
6 BfR-Modell für die deutsche Bevölkerung im Alter von 14 bis 80 Jahren zur Berechnung der Aufnahme von
Pflanzenschutzmittel-Rückständen mit der Nahrung; BfR Stellungnahme Nr. 046/2011,
http://www.bfr.bund.de/cm/343/neues-bfr-modell-fuer-die-deutsche-bevoelkerung-im-altervon-14-bis-80-
jahren-nvs-2.pdf
21
Risk for consumers via DEET residues in food
Scenario Tox. ref.
value
mg/kg
bw/d
Critical
consumer
group
Estimated
uptake
mg/kg bw/d
Estimated
uptake/Tox.
ref. value (%)
Acceptable
(yes/no)
Acute consumer
exposure via
residues in honey
(IESTI)
0.75#
DE children
0.0002
<0.1
yes
# based on AELacute (oral exposure) derived in CAR (DEET, PT19, RMS: SE, 2010);
* Deviating from the EFSA PRIMo calculations (that include a factor of 7) a variability factor of 1 has
been applied as for chanterelles (assuming a unit weight below 25 g)
7.3 Overall conclusion on dietary risk assessment
The following proposed MRLs are acceptable:
0.5 mg/kg for pine nut kernels
0.1 mg/kg for berries except grapes
1.0 mg/kg for wild fungi
0.1 mg/kg for herbal infusions
0.5 mg/kg for spices
0.15 mg/kg for honey
Annex II: Monitoring data
German monitoring data 2005-2017: DEET residues in fresh and frozen food commodities
(http://www.bvl.bund.de/DE/01_Lebensmittel/01_Aufgaben/02_AmtlicheLebensmittelueberwachung/04_Mo
nitoring/lm_monitoring_node.html)
Summary according to food commodity groups
(Note: Individual residue values are not reported, the LOQ is variable and not specified.) a Monitoring Data, April 2017,
b Monitoring Data, Juli 2017
Food commodity group
(Code No.)
Sample analysis mean and 97.5th
percentile if appropriate;
Concerned commodities
n
(total)
n > LOQ max.
(mg/kg)
Citrus fruits (0110000) 5944 a 7 0.053 clementine
Tree nuts except pine nut kernels
(0120000)
137 b
0 /
Pine nut kernels (0120090) 65 b
30 0.355 mean <0.05 mg/kg
97.5th
perc: 0.174 mg/kg
Pome fruits (0130000) 6030 a 6 0.035 apple, pear
Stone fruits (0140000) 6380 a 10 0.055 peach, apricot, plum,
nectarine, cherry
Grapes (0151000) 3633 a 3 0.025 white grape
Strawberries (0152000)
Cane fruit (0153000)
Other small fruits and berries
(0154000)
10408 b
21 0.12 mean and 97.5th perc:
<0.05 mg/kg;
strawberry, raspberry,
blueberry, currant
Miscellaneous fruits (0160000) 7562 b
0 /
22
Summary according to food commodity groups
(Note: Individual residue values are not reported, the LOQ is variable and not specified.) a Monitoring Data, April 2017,
b Monitoring Data, Juli 2017
Food commodity group
(Code No.)
Sample analysis mean and 97.5th
percentile if appropriate;
Concerned commodities
n
(total)
n > LOQ max.
(mg/kg)
Potatoes (0211000) 3707 b
0 /
Root and tuber vegetables, except
potatoes (0210000)
4215 b
1 0.048
Bulb vegetables (0220000) 1470 a,b
1 0.047 spring onion
Fruiting vegetables (0230000) 12960 b
2 0.12 chili
Brassica vegetables (excluding
brassica roots and brassica baby leaf
crops) (0240000)
5391 b
0 /
Leaf vegetables, herbs and edible
flowers (0250000)
10099 b
8 0.13 mean and 97.5th perc:
<0.05 mg/kg;
lettuce, basil, cilantro,
water cress
Legume vegetables (0260000) 5457 b
1 0.014
Stem vegetables (0270000) not
reported
1 0.014 asparagus
Cultivated fungi (0280010) 1843 b
0 /
Wild fungi (0280020) 572 b
230 1.5 mean 0.065 mg/kg
97.5th
perc: 0.532;
mostly chanterelle
Pulses (0300000) 501 b
0 /
Oilseeds and oil fruits (0400000) 255 b
0 /
Cereals (0500000) 2142 a 0 /
Coffee (0620000) 20 a 0 /
Herbal infusions (0630000) 396 b
5 0.08 mean and 97.5th perc:
<0.05 mg/kg;
flowers, leaves
Cocoa beans (0640000) 8 b
0 /
Spices (0800000) 588 b
2 0.1 mean and 97.5th perc:
<0.05 mg/kg;
fruit, root, herbs
Tissues from terrestrial animals
(1010000)
and wild terrestrial vertebrates
(1070000)
249 a 1 2.8 boar meat
Milk (1020000) 135 a 0 /
Eggs (1030000) 145 a 0 /
Honey (1040000) 1879 b
33 0.15 mean and 97.5th perc:
<0.05 mg/kg;
mainly rape honey,
polyfloral honey
23
Annex III: Information on §68 LFGB special permits
Overview on §68 LFGB special permits
Food commodity Approved
residue
level
(mg/kg)
Applications
since 2010
(+ extension of
permits)
Residues (mg/kg)
Chanterelles,
fresh, frozen, dried
1.0 approx. 40
(29)
fresh and frozen chanterelles
<0.005 (2), <0.01 (58), 0.01 (3),
0.016, 0.02 (3), 0.021, 0.027, 0.028
(2), 0.03, 0.035, 0.039, 0.040 (2), 0.05
(2), 0.051, 0.06, 0.061, 0.064, 0.066,
0.10 (3), 0.12, 0.13 (2), 0.14, 0.15 (2),
0.18, 0.19, 0.23, 0.24 (2), 0.25, 0.28,
0.34, 0.35, 0.42, 0.43, 0.49, 0.51, 0.53
(2), 0.54, 0.85, 0.98, 1.77, 1.93
dried chanterelles
0.012, 0.035, 0.39, 0.78, 8.8
[calculated residues considering a
processing factor# of 9.2 for drying:
0.001, 0.004 (2), 0.08, 0.96]
pickled chanterelles
<0.01, 0.057, 0.09, 0.156
Porcini,
dried
1.0 1 dried porcini
0.24
Morels,
dried
1.0 1 dried morels
0.026; 0.073; 0.29; 0.32
Rose
flowers, petals or buds,
dried
0.05
0.07
0.1
0.14
5
(1)
dried rose flowers, petals, buds
0.010 (2), 0.012, 0.013, 0.016, 0.018,
0.020, 0.021, 0.022, 0.023, 0.029,
0.032, 0.034 (2), 0.037, 0.045, 0.047,
0.059, 0.065, 0.066, 0.067, 0.072,
0.14
tea mix
0.007, 0.009, 0.020
Lime/linden flowers,
dried
0.1 5 lime/linden flowers
<0.01 (53), 0.010 (4), 0.011 (2), 0.012
(4), 0.013, 0.015 (3), 0.016 (4), 0.017,
0.018, 0.019 (2), 0.021 (3), 0.024,
0.027, 0.028 (2), 0.030 (3), 0.031,
0.035 (2), 0.040, 0.041, 043, 0.045,
0.050, 0.053, 0.059, 0.060 (3), 0.063,
0.083, 0.089, 0.093, 0.094, 0.230,
0.390,
Blue hibiscus flowers,
dried
0.1 1 blue hibiscus flowers
0.012, 0.03, 0.037, 0.05
Elder flowers,
dried
0.1 1 elder flowers
<0.01 (2), 0.03, 0.04, 0.05
24
Overview on §68 LFGB special permits
Food commodity Approved
residue
level
(mg/kg)
Applications
since 2010
(+ extension of
permits)
Residues (mg/kg)
Chamomile (leaves,
flowers, petals),
dried
0.05 1 chamomile, fine-cut
<0.01 (2), 0.011 (2), 0.013, 0.035,
0.037
Pine nut kernels,
dried
0.5 2
(2)
pine kernels
0.013, 0.021, 0.023 (2), 0.026, 0.027,
0.035, 0.037, 0.039, 0.04, 0.042,
0.06, 0.043, 0.045, 0.076, 0.080,
0.082, 0.100, 0.11 (2), 0.150, 0.15,
0.18, 0.36
Blueberries,
fresh, frozen, dried
0.1 4 fresh and frozen blueberries
0.010, 0.012, 0.014, 0.015, 0.019,
0.020 (2), 0.031, 0.032, 0.04, 0.067
dried blueberries
<LOQ (2), 0.016, 0.028, 0.029, 0.034
(2), 0.039, 0.042, 0.046, 0.095, 0.098,
0.122, 0.126, 0.132, 0.191, 0.200,
0.217
[calculated residues considering a
processing factor##
of 5.2 for drying:
<LOQ (2), 0.003, 0.005, 0.006, 0.007
(2), 0.008 (2), 0.009, 0.018, 0.019,
0.023, 0.024, 0.025, 0.037, 0.038,
0.042]
Cocoa (powder, mass) 0.05 2 cocoa powder
0.017, 0.026, 0.028
cocoa mass
0.031, 0.032
Cocoa (butter, nibs) 0.1 2 cocoa butter
0.035, 0.072, 0.076
cocoa nibs
0.018, 0.029, 0.049, 0.062
Nutmeg, oil 15 1 0.16, 2.6, 2.7, 3.5, 8.3
Nutmeg, dried 0.15 1 0.036, 0.052
Mace,
dried, ground
0.2
0.9
5 mace, ground or whole
0.015, 0.029, 0.046, 0.062, 0.065,
0.069, 0.077, 0.10, 0.11, 0.12, 0.13,
0.131, 0.14, 0.16, 0.35, 0.39, 0.86
Cinnamon (Cassia) 0.06
0.15
2 cinnamon, ground
0.025, 0.029, 0.030,0.033, 0.034,
0.08
Pepper, black,
whole, ground, crushed
0.03 1 black pepper, whole, steam treated
0.011, 0.015, 0.016, 0.019 (2),
Cloves 0.1 1 cloves
<0.01, 0.017, 0.031, 0.042
Chilies,
dried, ground
0.3 1 chilies, ground
0.013, 0.027, 0.12
25
# For dried chanterelles a processing factor of 9.2 was considered based on water content of fresh
(91.5 %) and dried (10.0 %) chanterelles (Souci, Fachmann, Kraut (2008) Die Zusammensetzung der
Lebensmittel, 7. Auflage 2008, Wissenschaftliche Verlagsgesellschaft, Stuttgart). ##
For dried blueberries a processing factor of 5.2 was considered based on water content of fresh
(81.1 %) and dried (15.7 %) grapes (Souci, Fachmann, Kraut (2008) Die Zusammensetzung der
Lebensmittel, 7. Auflage 2008, Wissenschaftliche Verlagsgesellschaft, Stuttgart).
Annex IV: Pesticide Residue Intake Model (PRIMo rev.2)