proposal for setting mrls for deet residues in food · proposal for setting mrls for deet residues...

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1 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 chanterelles 1 , 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

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Page 1: Proposal for setting MRLs for DEET residues in food · Proposal for setting MRLs for DEET residues in food 1. Introduction In Germany DEET residues are regularly reported in some

1

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

Page 2: Proposal for setting MRLs for DEET residues in food · Proposal for setting MRLs for DEET residues in food 1. Introduction In Germany DEET residues are regularly reported in some

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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

Page 3: Proposal for setting MRLs for DEET residues in food · Proposal for setting MRLs for DEET residues in food 1. Introduction In Germany DEET residues are regularly reported in some

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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.

Page 4: Proposal for setting MRLs for DEET residues in food · Proposal for setting MRLs for DEET residues in food 1. Introduction In Germany DEET residues are regularly reported in some

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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

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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).

Page 7: Proposal for setting MRLs for DEET residues in food · Proposal for setting MRLs for DEET residues in food 1. Introduction In Germany DEET residues are regularly reported in some

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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

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# 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,

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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

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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.

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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.

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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.

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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.

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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

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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

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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

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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

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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

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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 /

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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

Page 23: Proposal for setting MRLs for DEET residues in food · Proposal for setting MRLs for DEET residues in food 1. Introduction In Germany DEET residues are regularly reported in some

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

Page 24: Proposal for setting MRLs for DEET residues in food · Proposal for setting MRLs for DEET residues in food 1. Introduction In Germany DEET residues are regularly reported in some

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

Page 25: Proposal for setting MRLs for DEET residues in food · Proposal for setting MRLs for DEET residues in food 1. Introduction In Germany DEET residues are regularly reported in some

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)