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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

  • 3

    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.

  • 4

    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 applicants 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 22C (99.2% pure), No pH dependency

    expected as DEET cannot dissociate

    Vapour pressure Extrapolated (99.4% pure):

    0.11 Pa at 20C

    0.23 Pa at 25C

    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.

  • 6

    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; 50C: 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 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).

  • 7

    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 49.4g/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

    Applicants 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

  • 8

    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: 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: 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)

  • 9

    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: 0.01

    mg/kg

    230

    chanterelle,

    fresh or

    frozen

    (0280020)

    68 LFGB

    special permits

    total 112

  • 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: 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

  • 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: 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

  • 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 fr Bienenkunde der Universitt Hohenheim fr 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

  • 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

    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

  • 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:

  • 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

  • 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

  • 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)

of 25/25
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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