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  • EFSA Journal 2011;9(8):2335

    Suggested citation: European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for fludioxonil

    according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2011;9(8):2335. [86 pp.]

    doi:10.2903/j.efsa.2011.2335. Available online: www.efsa.europa.eu/efsajournal

    © European Food Safety Authority, 2011

    REASONED OPINION

    Review of the existing maximum residue levels (MRLs) for fludioxonil

    according to Article 12 of Regulation (EC) No 396/20051

    European Food Safety Authority2, 3

    European Food Safety Authority (EFSA), Parma, Italy

    SUMMARY

    Fludioxonil was included in Annex I to Directive 91/414/EEC on 01 November 2008, which is after

    the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore

    required to provide a reasoned opinion on the review of the existing MRLs for that active substance in

    compliance with Article 12(1) of afore mentioned regulation. In order to collect the relevant pesticide

    residues data, EFSA asked Denmark, as the designated rapporteur Member State (RMS), to complete

    the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The

    requested information was submitted to EFSA on 02 March 2010 and, after having considered several

    comments made by EFSA, the RMS provided on 14 January 2011 a revised PROFile.

    Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs

    established by the Codex Alimentarius Commission and the additional information provided by the

    RMS, EFSA issued on 16 March 2011 a draft reasoned opinion that was circulated to Member State

    experts for consultation. Comments received by 20 May 2011 were considered for finalisation of this

    reasoned opinion. The following conclusions are derived.

    The toxicological profile of fludioxonil was evaluated in the framework of Directive 91/414/EEC,

    which resulted in an ADI of 0.37 mg/kg bw/d. No ARfD was deemed necessary.

    Primary crop metabolism of fludioxonil was investigated in three different crop groups following

    foliar applications, and in three different crop groups following seed applications. Metabolic patterns

    in the different studies were shown to be similar and the relevant residue for enforcement in all crops

    supported in the framework of this review is proposed as parent fludioxonil. For risk assessment, the

    residue was defined as the sum of fludioxonil and its metabolites oxidized to metabolite 2,2-difluoro-

    benzo[1,3]dioxole-4 carboxylic acid, expressed as fludioxonil. A conversion factor of 2.8 from

    enforcement to risk assessment is proposed for root vegetables after foliar application. No studies

    investigating the metabolism of fludioxonil following post-harvest treatment are available. However,

    as a more extensive metabolism of the active substance is not expected in the post-harvest use, EFSA

    concludes that the same residue definitions apply. Validated analytical methods for enforcement of

    1 On request from EFSA, Question No EFSA-Q-2009-00024, issued on 22 August 2011. 2 Correspondence: [email protected] 3 Acknowledgement: EFSA wishes to thank the rapporteur Member State Denmark for the preparatory work on this

    scientific output.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 2

    the residue definition in foods of plant origin are available with a LOQ of 0.01 mg/kg in high water

    content, high oil content, acidic and dry commodities.

    Regarding the magnitude of residues in most crops reported by the RMS, at least one GAP or import

    tolerance was supported by a sufficient number of supervised residue trials, which allowed EFSA to

    estimate the expected residue concentrations in the relevant plant commodities and to derive

    appropriate MRLs, except for citrus fruits, pistachios, stone fruits and strawberries where data were

    sufficient to derive tentative MRLs only. For cucurbits with inedible peel and celery, the number of

    residue trials was not compliant with the minimum data requirements defined by EU guidance

    documents. EFSA was therefore not able to derive reliable MRL proposals in the above mentioned

    crops and further residue trials are required.

    In processed commodities, parent fludioxonil was shown to be stable during pasteurisation, cooking,

    boiling/brewing/baking and sterilisation and no formation of toxicologically relevant metabolites

    occurs. Magnitude of residues in processed commodities was also investigated and robust processing

    factors could be derived for carrots (canned, cooked, juice), wine grapes (juice, must, wine), table

    grapes (raisin) and peeled passion fruits. Further processing studies are not required as they are not

    expected to affect the outcome of the risk assessment. However, if there would be the intention to

    derive more robust processing factors, in particular for enforcement purposes, additional processing

    studies would be required.

    The potential incorporation of soil residues into succeeding and rotational crops was investigated in

    lettuce, winter and spring wheat, sugar beets, corn, mustard, turnips and radishes. These studies

    showed a comparable metabolism to the primary crops and significant residues in rotational crops are

    not expected, provided that fludioxonil is applied according to the GAPs supported in the framework

    of this review.

    Based on the uses reported by the RMS, significant exposures to fludioxonil are expected for dairy

    ruminants, meat ruminants and pigs. Metabolism in lactating ruminants and poultry was sufficiently

    investigated and findings can be extrapolated to pigs as well. The relevant residue definition for

    enforcement and risk assessment was defined as the sum of fludioxonil and its metabolites oxidized to

    metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid, expressed as fludioxonil. A validated

    analytical method for enforcement of the residue definition is also available with a LOQ of 0.01

    mg/kg in milk and meat and a LOQ of 0.05 mg/kg in liver, kidney, fat and eggs. The available

    livestock feeding study demonstrated that residues of fludioxonil are not expected in milk or in any

    edible matrix of pigs and MRLs in these commodities can be set at the LOQ. Yet the livestock dietary

    intake for meat ruminants exceeds the highest dose level of the feeding study. Tentative MRLs for

    these commodities can be proposed, based on extrapolation from the highest available dosing level

    but a new feeding study including a higher dosing level is still required. MRLs are not required for

    poultry products because poultry is not expected to be exposed to significant levels of fludioxonil

    residues.

    Chronic consumer exposure resulting from the MRLs proposed in the framework of this review was

    calculated. The highest chronic exposure represented 16.5 % of ADI (German child). Acute exposure

    calculations were not carried out because an ARfD was not deemed necessary for this active

    substance.

    Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs

    have also been established for fludioxonil. Additional calculations of the chronic consumer exposure,

    including these CXLs, were therefore performed. The highest chronic exposure represented 15.8 % of

    the ADI (German child).

    Based on the above assessment, EFSA does not recommend inclusion of this active substance in

    Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 3

    the decision tree reported in Appendix D (see table below for a summary). All MRL values listed in

    the table as ‘Recommended’ are sufficiently supported by data and therefore proposed for inclusion in

    Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for

    inclusion in Annex II because they require further consideration by risk managers (see table footnotes

    for details). In particular, certain tentative MRLs and existing EU MRLs still need to be confirmed by

    the following data:

    6 additional residue trials supporting the northern outdoor GAP, 4 additional residue trials

    supporting the southern outdoor GAP and 6 residue trials supporting the indoor GAP on

    strawberries;

    8 residue trials on melons supporting the import tolerance GAP on cucurbits with inedible

    peel (currently ongoing);

    3 additional residue trials supporting the northern outdoor GAP and 3 additional residue trials

    supporting the southern outdoor GAP on celery (currently ongoing);

    a livestock feeding study for meat ruminants at higher dose levels, taking into account the

    calculated dietary burdens where levels of fludioxonil and metabolites containing the 2,2-

    difluorobenzo [1,3]dioxole-4 carboxylic moiety are preferably reported separately (currently

    ongoing).

    It is highlighted, however, that some of the ‘Recommended’ MRLs result from a CXL or from a GAP

    in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data.

    EFSA therefore identified the following data gaps which are not expected to impact on the

    recommended MRLs but which might have an impact on national authorisations:

    2 additional residue trials on oranges supporting the post-harvest EU GAP on citrus fruits;

    1 additional residue trial supporting the import tolerance GAP on pistachios;

    1 additional residue trial on plums supporting the import tolerance GAP on apricots and

    plums;

    3 additional residue trials on raspberries complying with the southern outdoor GAP on

    raspberries and blackberries;

    8 residue trials on currants complying with the southern outdoor GAP on blueberries,

    cranberries, currants and gooseberries;

    6 additional residue trials on tomatoes supporting the northern outdoor GAP, 6 additional

    residue trials on tomatoes supporting the southern outdoor GAP and 8 residue trials on

    tomatoes supporting the import tolerance GAP on tomatoes and aubergines;

    8 residue trials complying with the import tolerance GAP on peppers;

    8 residue trials on cucumbers and/or courgettes supporting the northern outdoor GAP, 4

    additional residue trials on cucumbers supporting the southern outdoor GAP and 8 residue

    trials on cucumbers and/or courgettes supporting the import tolerance GAP on cucurbits with

    edible peel;

    6 additional residue trials on fresh beans with pods complying with the northern outdoor GAP

    on fresh beans and fresh peas with pods;

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 4

    4 residue trials complying with the northern outdoor GAP on fennel;

    residue trials including both pre- and post-harvest treatments to assess the combined effect of

    both treatments on the residue levels (pome fruits).

    If the above reported data gaps are not addressed in the future, Member States are recommended to

    withdraw or modify the relevant authorisations at national level.

    Minor deficiencies were also identified in the assessment but these deficiencies are not expected to

    impact either on the validity of the recommended MRLs or on the national authorisations. The

    following data are therefore considered desirable but not essential:

    development of a more efficient analytical method for enforcement of commodities of animal

    origin, less laborious than the current one, and preferably analysing the for the parent

    compound only in muscle, fat and liver;

    1 additional residue trial complying with the northern outdoor GAP on potatoes;

    2 trials complying with the northern outdoor GAP on sugar beet;

    residues trials supporting the GAPs on bulb vegetables, witloof, fresh beans, fresh peas,

    oilseeds, cereals grains and sweet corn carried out with analytical methods achieving a LOQ

    of 0.01 mg/kg.

    Code

    number

    Commodity Existing

    EU MRL

    (mg/kg)

    Existing

    CXL

    (mg/kg)

    Outcome of the review

    MRL

    (mg/kg)

    Comment

    Enforcement residue definition: fludioxonil

    110010 Grapefruit 10 10 10 Recommended (e)

    110020 Oranges 7 10 10 Recommended (e)

    110030 Lemons 7 10 10 Recommended (e)

    110040 Limes 7 10 10 Recommended (e)

    110050 Mandarins 7 10 10 Recommended (e)

    120100 Pistachios 0.05* 0.2 0.2 Recommended (i)

    130000 Pome fruit 5 5 5 Recommended (h)

    140010 Apricots 5 5 5 Recommended (i)

    140020 Cherries 5 5 5 Recommended (h)

    140030 Peaches 7 5 10 Recommended (e)

    140040 Plums 0.5 5 5 Recommended (i)

    151010 Table grapes 2 2 5 Recommended (e)

    151020 Wine grapes 2 2 4 Recommended (e)

    152000 Strawberries 3 3 4 Further consideration needed (f)

    153010 Blackberries 5 5 5 Recommended (h)

    153020 Dewberries 0.05* 5 5 Recommended (j)

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 5

    Code

    number

    Commodity Existing

    EU MRL

    (mg/kg)

    Existing

    CXL

    (mg/kg)

    Outcome of the review

    MRL

    (mg/kg)

    Comment

    153030 Raspberries 5 5 5 Recommended (h)

    154010 Blueberries 3 2 2 Recommended (e)

    154020 Cranberries 1 - 2 Recommended (a)

    154030 Currants (red, black and

    white)

    3 - 2 Recommended (a)

    154080 Elderberries 2 - 0.8 Recommended (a)

    154040 Gooseberries 3 - 2 Recommended (a)

    162010 Kiwi 20 15 15 Recommended (e)

    163030 Mangoes 0.05* - 1 Recommended (a)

    163050 Pomegranate 3 2 3 Recommended (e)

    211000 Potatoes 1 0.02 0.06 Recommended (e)

    212020 Sweet potatoes 0.05* 10 10 Recommended (e)

    212030 Yams 0.05* 10 10 Recommended (e)

    213010 Beetroot 1 - 1 Recommended (a)

    213020 Carrots 1 0.7 1 Recommended (e)

    213030 Celeriac 0.2 - 0.2 Recommended (a)

    213040 Horseradish 1 - 1 Recommended (a)

    213060 Parsnips 1 - 1 Recommended (a)

    213070 Parsley root 1 - 1 Recommended (a)

    213090 Salsify 1 - 1 Recommended (a)

    220010 Garlic 0.05* - 0.02 Recommended (a)

    220020 Onions 0.1 0.5 0.5 Recommended (h)

    220030 Shallots 0.05* - 0.02 Recommended (a)

    220040 Spring onions 0.3 5 5 Recommended (h)

    231010 Tomatoes 1 0.5 0.9 Recommended (e)

    231020 Peppers 2 1 1 Recommended (e)

    231030 Aubergines (egg plants) 1 0.3 0.4 Recommended (e)

    232010 Cucumbers 1 0.3 0.4 Recommended (e)

    232020 Gherkins 0.5 - 0.4 Recommended (a)

    232030 Courgettes 1 0.3 0.4 Recommended (e)

    233010 Melons 0.05* 0.03 0.05 Further consideration needed (g)

    233020 Pumpkins 0.05* - 0.05 Further consideration needed (c)

    233030 Watermelons 0.05* - 0.05 Further consideration needed (c)

    234000 Sweet corn 0.05* 0.01* 0.01* Recommended (e)

    241010 Broccoli 0.05* 0.7 0.7 Recommended (j)

    242020 Head cabbage 0.05* 2 2 Recommended (j)

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 6

    Code

    number

    Commodity Existing

    EU MRL

    (mg/kg)

    Existing

    CXL

    (mg/kg)

    Outcome of the review

    MRL

    (mg/kg)

    Comment

    243010 Chinese cabbage 0.05* 10 10 Recommended (j)

    0251010 Lamb’s lettuce 10 - 3 Recommended (a)

    251020 Lettuce 10 10 12 Recommended (e)

    251030 Scarole (broad-leaf

    endive)

    10 - 12 Recommended (a)

    0251040 Cress 10 - 3 Recommended (a)

    0251050 Land cress 10 - 3 Recommended (a)

    0251060 Rocket, rucola 10 - 3 Recommended (a)

    0251070 Red mustard 10 - 3 Recommended (a)

    0251080 Leaves and sprout of

    brassica spp

    10 - 3 Recommended (a)

    252010 Spinach 7 - 8 Recommended (a)

    252030 Beet leaves (chard) 7 - 8 Recommended (a)

    254000 Water cress 0.05* 10 10 Recommended (j)

    255000 Witloof 0.05* - 0.02 Recommended (a)

    256020 Chives 1 10 10 Recommended (e)

    256080 Basil 1 10 10 Recommended (e)

    260010 Beans (fresh, with pods) 1 0.3 1 Recommended (e)

    260020 Beans (fresh, without

    pods)

    0.2 0.03 0.05 Recommended (e)

    260030 Peas (fresh, with pods) 0.2 0.3 1 Recommended (e)

    260040 Peas (fresh, without pods) 0.05* 0.03 0.05 Recommended (e)

    260050 Lentils (fresh) 0.05* - 0.05 Recommended (a)

    270010 Asparagus 0.05* - 0.01* Recommended (a)

    270030 Celery 0.05* - 0.05 Further consideration needed (c)

    270040 Fennel 0.1 - 0.05 Recommended (a)

    300010 Beans (dry) 0.05* 0.07 0.4 Recommended

    (k)

    300020 Lentils (dry) 0.05* - 0.4 Recommended

    (a)

    300030 Peas (dry) 0.05* 0.07 0.4 Recommended (k)

    300040 Lupins (dry) 0.05* - 0.4 Recommended (a)

    401030 Poppy seed 0.05* - 0.01* Recommended (a)

    401050 Sunflower seed 0.05* - 0.01* Recommended (a)

    401060 Rape seed 0.05* 0.02* 0.01* Recommended (k)

    401070 Soya bean 0.05* - 0.01* Recommended (a)

    401090 Cotton seed 0.05* 0.05* 0.01* Recommended (k)

    500010 Barley grain 0.05* 0.05* 0.01* Recommended (k)

    500020 Buckwheat grain 0.05* 0.05* 0.01* Recommended (l)

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 7

    Code

    number

    Commodity Existing

    EU MRL

    (mg/kg)

    Existing

    CXL

    (mg/kg)

    Outcome of the review

    MRL

    (mg/kg)

    Comment

    500030 Maize grain 0.1 0.05* 0.01* Recommended (k)

    500040 Millet grain 0.05* 0.05* 0.01* Recommended (l)

    500050 Oats grain 0.05* 0.05* 0.01* Recommended (k)

    500060 Rice grain 0.05* 0.05* 0.01* Recommended (l)

    500070 Rye grain 0.05* 0.05* 0.01* Recommended (k)

    500080 Sorghum grain 0.05* 0.05* 0.01* Recommended (l)

    500090 Wheat grain 0.2 0.05* 0.01* Recommended (k)

    633000 Herbal infusions (dried,

    roots)

    1 - 1 Recommended (a)

    840000 Spices (roots and rhizome) 1 - 1 Recommended (a)

    900010 Sugar beet (roots) 0.05* 0.01* Recommended (a)

    - Others products of plant

    origin

    See App.

    C.1

    - - Further consideration needed (d)

    Enforcement residue definition: the sum of fludioxonil and its metabolites oxidized to metabolite 2,2-

    difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as fludioxonil

    1011010 Swine meat 0.05* 0.01* 0.05*(F)

    Recommended (e)

    1011020 Swine fat (free of lean

    meat)

    0.05* - 0.05* Recommended (a)

    1011030 Swine liver 0.05* 0.05* 0.05* Recommended (e)

    1011040 Swine kidney 0.05* 0.05* 0.05* Recommended (e)

    1012010 Bovine meat 0.05* 0.01* 0.2 (F)

    Further consideration needed (f)

    1012020 Bovine fat 0.05* - 0.2 Further consideration needed (b)

    1012030 Bovine liver 0.05* 0.05* 0.2 Further consideration needed (f)

    1012040 Bovine kidney 0.05* 0.05* 0.2 Further consideration needed (f)

    1013010 Sheep meat 0.05* 0.01* 0.2 (F)

    Further consideration needed (f)

    1013020 Sheep fat 0.05* - 0.2 Further consideration needed (b)

    1013030 Sheep liver 0.05* 0.05* 0.2 Further consideration needed (f)

    1013040 Sheep kidney 0.05* 0.05* 0.2 Further consideration needed (f)

    1014010 Goat meat 0.05* 0.01* 0.2 (F)

    Further consideration needed (f)

    1014020 Goat fat 0.05* - 0.2 Further consideration needed (b)

    1014030 Goat liver 0.05* 0.05* 0.2 Further consideration needed (f)

    1014040 Goat kidney 0.05* 0.05* 0.2 Further consideration needed (f)

    1016010 Poultry meat 0.05* 0.01* 0.01* Recommended (j)

    1016030 Poultry liver 0.05* 0.05* 0.05* Recommended (j)

    1016040 Poultry kidney 0.05* 0.05* 0.05* Recommended (j)

    1020010 Cattle milk 0.05* 0.01 0.01 Recommended (e)

    1020020 Sheep milk 0.05* 0.01 0.01 Recommended (e)

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 8

    Code

    number

    Commodity Existing

    EU MRL

    (mg/kg)

    Existing

    CXL

    (mg/kg)

    Outcome of the review

    MRL

    (mg/kg)

    Comment

    1020030 Goat milk 0.05* 0.01 0.01 Recommended (e)

    1030000 Birds' eggs 0.05* 0.05* 0.05* Recommended (j)

    - Others products of animal

    origin

    See App.

    C.1

    - - Further consideration needed (d)

    (*): Indicates that the MRL is set at the limit of analytical quantification.

    (F): MRL is expressed as mg/kg of fat contained in the whole product.

    (a): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to

    consumers is identified; no CXL is available (combination G-I in Appendix D).

    (b): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk

    to consumers could be identified; no CXL is available (combination E-I in Appendix D).

    (c): GAP evaluated at EU level is not supported by data but no risk to consumers could be identified for the existing EU

    MRL; no CXL is available (combination C-I in Appendix D).

    (d): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either the specific

    LOQ or the default MRL of 0.01 mg/kg may be considered (combination A-I in Appendix D).

    (e): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to

    consumers is identified; existing CXL is covered by the recommended MRL (combination G-III in Appendix D).

    (f): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk

    to consumers could be identified; existing CXL is covered by the tentative MRL (combination E-III in Appendix D).

    (g): GAP evaluated at EU level is not supported by data but no risk to consumers could be identified for the existing EU

    MRL; existing CXL is covered by the existing EU MRL (combination C-III in Appendix D).

    (h): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified;

    GAP evaluated at EU level, which is also fully supported by data, leads to a lower MRL (combination G-VII in

    Appendix D).

    (i): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified;

    GAP evaluated at EU level, which is not fully supported by data, leads to a lower tentative MRL (combination E-VII in

    Appendix D).

    (j): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified;

    there are no relevant authorisations or import tolerances reported at EU level (combination A-VII in Appendix D).

    (k): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to

    consumers is identified; existing CXL is covered by the recommended MRL when the European enforcement LOQ of

    0.01 mg/kg is assumed (combination G-III in Appendix D).

    (l): MRL is derived from the existing CXL but considering the European enforcement LOQ of 0.01 mg/kg (supported by

    data and no risk to consumers identified); there are no relevant authorisations or import tolerances reported at EU level

    (combination A-VII in Appendix D).

    KEY WORDS

    Fludioxonil, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, phenylpyrrole, fungicide,

    2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 9

    TABLE OF CONTENTS

    Summary .................................................................................................................................................. 1 Table of contents ...................................................................................................................................... 9 Background ............................................................................................................................................ 10 Terms of reference ................................................................................................................................. 11 The active substance and its use pattern ................................................................................................ 11 Assessment ............................................................................................................................................. 12 1. Methods of analysis ....................................................................................................................... 12

    1.1. Methods for enforcement of residues in food of plant origin ............................................... 12 1.2. Methods for enforcement of residues in food of animal origin ............................................ 13

    2. Mammalian toxicology .................................................................................................................. 13 3. Residues ......................................................................................................................................... 14

    3.1. Nature and magnitude of residues in plant ........................................................................... 14 3.1.1. Primary crops .................................................................................................................... 14 3.1.2. Rotational crops ................................................................................................................ 38

    3.2. Nature and magnitude of residues in livestock ..................................................................... 40 3.2.1. Dietary burden of livestock .............................................................................................. 40 3.2.2. Nature of residues ............................................................................................................. 42 3.2.3. Magnitude of residues ...................................................................................................... 43

    4. Consumer risk assessment ............................................................................................................. 46 4.1. Consumer risk assessment without consideration of the existing CXLs .............................. 46 4.2. Consumer risk assessment with consideration of the existing CXLs ................................... 49

    Conclusions and recommendations ........................................................................................................ 53 Documentation provided to EFSA ......................................................................................................... 60 References .............................................................................................................................................. 60 Appendix A – Good Agricultural Practices (GAPs) .............................................................................. 63 Appendix B – Pesticide Residues Intake Model (PRIMo) ..................................................................... 70 Appendix C – Existing EU maximum residue limits (MRLs) and Codex Limits (CXLs) .................... 73 Appendix D – Decision tree for deriving MRL recommendations ........................................................ 82 Appendix E – List of metabolites and related structural formula .......................................................... 84 Abbreviations ......................................................................................................................................... 85

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 10

    BACKGROUND

    Regulation (EC) No 396/20054 establishes the rules governing the setting as well as the review of

    pesticide MRLs at Community level. Article 12(1) of that regulation lays down that EFSA shall

    provide within 12 months from the date of the inclusion or non-inclusion of an active substance in

    Annex I to Directive 91/414/EEC5 a reasoned opinion on the review of the existing MRLs for that

    active substance. As fludioxonil was included in Annex I to the above mentioned directive on

    01 November 2008, EFSA initiated the review of all existing MRLs for that active substance and a

    task with the reference number EFSA-Q-2009-00024 was included in the EFSA Register of

    Questions.

    According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant

    assessment report prepared under Directive 91/414/EEC. It should be noted, however, that in the

    framework of Directive 91/414/EEC only a few representative uses are evaluated while MRLs set out

    in Regulation (EC) No 396/2005 should accommodate for all uses authorised within the EC as well as

    uses authorised in third countries having a significant impact on international trade. The information

    included in the assessment report prepared under Directive 91/414/EEC is therefore insufficient for

    the assessment of all existing MRLs for a given active substance.

    In order to have an overview on the pesticide residues data that have been considered for the setting of

    the existing MRLs, EFSA developed the Pesticide Residue Overview File (PROFile). The PROFile is

    an electronic inventory of all pesticide residues data relevant to the risk assessment as well as the

    MRL setting for a given active substance. This includes data on:

    the nature and magnitude of residues in primary crops;

    the nature and magnitude of residues in processed commodities;

    the nature and magnitude of residues in rotational crops;

    the nature and magnitude of residues in livestock commodities and;

    the analytical methods for enforcement of the proposed MRLs.

    Denmark, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC,

    was asked to complete the PROFile for fludioxonil and to prepare a supporting evaluation report. The

    requested information was submitted to EFSA on 02 March 2010 and subsequently checked for

    completeness. On 14 January 2011, after having clarified some issues with EFSA, the RMS provided

    a revised PROFile.

    A draft reasoned opinion was issued by EFSA on 16 March 2011 and submitted to Member States

    (MS) for commenting. All MS comments received by 20 May 2011 were considered by EFSA for

    finalization of the reasoned opinion.

    4 Commission Regulation (EC) No 396/2005 of 23 February 2005. OJ L 70, 16.3.2005, p. 1-16. 5 Council Directive 91/414/EEC of 15 July 1991, OJ L 230, 19.8.1991, p. 1-32.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 11

    TERMS OF REFERENCE

    According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on:

    the inclusion of the active substance in Annex IV to the Regulation, when appropriate;

    the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs

    set out in Annex II or III of the Regulation;

    the inclusion of the recommended MRLs in Annex II or III to the Regulation;

    the setting of specific processing factors as referred to in Article 20(2) of the Regulation.

    THE ACTIVE SUBSTANCE AND ITS USE PATTERN

    Fludioxonil is the ISO common name for 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-pyrrole-3-carbonitrile

    (IUPAC).

    OO

    FF

    N

    N

    Fludioxonil belongs to the group of phenylpyrrole compounds which are used as fungicide. Its mode

    of action is the inhibition of a mitogen-activated protein (MAP) kinase in signal transduction of osmo-

    regulation (glycerol synthesis). Fludioxonil is used as foliar and seed treatment applications to control

    diseases caused by fungi in the class of Ascomycetes, Basidiomycetes and Fungi imperfecti.

    Fludioxonil was evaluated in the framework of Directive 91/414/EEC with Denmark being the

    designated rapporteur Member State (RMS). The representative uses supported for the peer review

    process cover foliar applications on wine and table grapes and seed treatment of wheat grain.

    Following the peer review, which was carried out by EFSA, a decision on inclusion of the active

    substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive

    2007/76/EC6, entering into force on 01 November 2008. The Annex I inclusion of fludioxonil is

    restricted to uses as fungicide only.

    EU MRLs for fludioxonil in products of plant and animal origin have been set for the first time in

    2008 by means of Commission Regulation (EC) No 149/20087 establishing Annexes II, III and IV of

    Regulation (EC) No 396/2005. These temporary MRLs were derived from the MRLs that have been

    set at national level before Regulation (EC) No 396/2005 entered into force. EFSA recently

    recommended the modification of existing MRLs for pomegranates, spinach and beet leaves, celeriac

    as well as for various root vegetables (carrots, beetroots, salsify, horseradish, parsnips, parsley roots,

    roots of herbal infusions and roots of spices) (EFSA, 2008, 2009a, 2009b, 2009c) which were legally

    implemented in Regulations 2009/256/EC8, 2009/822/EC

    9 and 2010/750/EC

    10, and for sweet potatoes,

    yams, table and wine grapes (EFSA, 2010) which were already approved by the meeting of the

    Standing Committee on the Food Chain and Animal Health held on 23-24 March 2011 but which are

    not yet legally implemented. All existing EU MRLs, which are established for the parent compound

    6 Commission Directive 2007/76/EC of 20 December 2007, OJ L 337, 21.2.2007, p. 100-104.

    7 Commission Regulation (EC) No 149/2008 of 29 January 2008. OJ L 58, 1.3.2008, p. 1-398.

    8 Commission Regulation 2009/256/EC of 23 March 2009, OJ L 81, 27.3.2009, p. 3-14

    9 Commission Regulation 2009/822/EC of 27 August 2009, OJ L 239, 10.9.2009, p. 5-45

    10 Commission Regulation (EU) No750/2010 of 7 July 2010. OJ L 220, 21.08.2010, p. 1-56.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 12

    only, are summarized in Appendix C.1 to this document. CXLs for fludioxonil were also established

    by the Codex Alimentarius Commission (CAC) and are reported in Appendix C.2 to this reasoned

    opinion. These CXLs refer to parent compound only for products of plant origin, and to the sum of

    fludioxonil and its benzopyrrole metabolites, determined as 2,2-difluoro-benzo[1,3]dioxide-4-

    carboxylic acid and expressed as fludioxonil, for products of animal origin.

    For the purpose of this MRL review, the critical uses of fludioxonil currently authorized within the

    EU as well as uses authorised in third countries that might have a significant impact on international

    trade, have been collected by the RMS and reported in the PROFile (see Appendix A). Uses of

    fludioxonil previously evaluated by EFSA were also considered (EFSA, 2008, 2009a, 2009b, 2009c,

    2010). According to the reported GAPs, fludioxonil is applied on a wide range of crops either by

    foliar spraying, seed treatment or post-harvest treatment, both indoor and outdoor. PHIs may vary

    between 1 and 28 days.

    ASSESSMENT

    EFSA bases its assessment on the PROFile submitted by the RMS, the evaluation report

    accompanying the PROFile (Denmark, 2010), the Draft Assessment Report (DAR) and its addenda

    prepared under Council Directive 91/414/EEC (Denmark, 2005, 2007), the conclusion on the peer

    review of the pesticide risk assessment of the active substance fludioxonil (EFSA, 2007), the JMPR

    Evaluation report (FAO, 2004, 2006, 2010), the previous reasoned opinions on fludioxonil (EFSA,

    2008, 2009a, 2009b, 2009c, 2010) and the evaluation reports submitted during the Member States

    consultation (Austria, 2001; Belgium, 2011; Denmark, 2011; Finland, 2011; France, 2011; Germany,

    2011; The Netherlands, 2011; The United Kingdom, 2007 and 2010). The assessment is performed in

    accordance with the legal provisions of the Uniform Principles for the Evaluation of the Authorization

    of Plant Protection Products adopted by Commission Regulation (EU) No 546/201111

    and the

    currently applicable guidance documents relevant for the consumer risk assessment of pesticide

    residues (EC, 1996, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2004, 2010, 2011).

    1. Methods of analysis

    1.1. Methods for enforcement of residues in food of plant origin

    During the peer review under Directive 91/414/EEC, an analytical method using HPLC-UV was

    evaluated and validated for the determination of parent fludioxonil with a LOQ of 0.02 mg/kg in high

    water content (strawberries), high acid content (grapes, apples) and dry (wheat grain) commodities

    and a LOQ of 0.05 mg/kg in wine (Denmark, 2005). A confirmatory method was not available.

    Additionally, the multi-residue analytical method DFG S19 using HPLC-MS/MS and its ILV were

    evaluated and validated for the determination of parent fludioxonil with a LOQ of 0.01 mg/kg in high

    oil content (avocados), acidic (kiwi, citrus) and dry (wheat) commodities (Denmark, 2005; EFSA,

    2007b).

    The multi-residue QuEChERS method using HPLC-MS/MS described in the European Standard

    EN 15662:2008 validated with a LOQ of 0.01 mg/kg for the determination of residues in high water

    content and acidic commodities is also applicable.

    11

    Regulation (EU) No 546/2011 of 10 June 2011. OJ L 155, 11.06.2011, p. 127-175.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 13

    Table 1-1: Recovery data for the analysis of fludioxonil in different crop groups using the

    QuEChERS method in combination with LC-MS/MS (CEN, 2008)

    Commodity group Spiking levels

    (mg/kg)

    Recoveries No of

    labs Mean (%) RSD (%) n

    Acidic

    0.01

    0.025

    0.1

    0.25

    98

    104

    100

    102

    7

    10

    7

    10

    15

    20

    14

    25

    3

    4

    3

    5

    Watery 0.01

    0.025

    0.1

    0.25

    96

    97

    97

    103

    4

    5

    6

    8

    15

    40

    15

    55

    3

    5

    3

    6

    Hence, according to the peer review and the CEN, it is concluded that parent fludioxonil can be

    enforced in food of plant origin with a LOQ of 0.01 mg/kg in high water content, high oil content,

    acidic and dry commodities.

    1.2. Methods for enforcement of residues in food of animal origin

    During the peer review under Directive 91/414/EEC, an analytical method using HPLC-UV,

    confirmed by the use of an alternative column in the HPLC system, and its ILV were evaluated and

    validated for the determination of the sum of fludioxonil and its metabolites that can be oxidised to

    metabolite CGA 19215512

    , expressed as fludioxonil, with a LOQ of 0.01 mg/kg in milk and meat and

    a LOQ of 0.05 mg/kg in liver, kidney, fat and eggs (FAO, 2004; Denmark, 2005). However, as the

    method is very complex, involving a laborious extraction method, the development of a more efficient

    method is still desirable.

    Hence, it is concluded that the sum of fludioxonil and its metabolites that can oxidised to metabolite

    CGA 192155, expressed as fludioxonil, can be enforced in products of animal origin with a LOQ of

    0.01 mg/kg in milk and meat and a LOQ of 0.05 mg/kg in liver, kidney, fat and eggs.

    2. Mammalian toxicology

    The toxicological assessment of fludioxonil was peer reviewed under Directive 91/414/EEC and

    toxicological reference values were established by EFSA (2007b). These toxicological reference

    values are summarized in Table 2-1.

    12

    CGA 192155: 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid. See Appendix E.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 14

    Table 2-1: Overview of the toxicological reference values

    Source Year Value Study relied upon Safety

    factor

    Fludioxonil

    ADI EFSA 2007 0.37 mg/kg bw/d Rat, acute neurotoxicity 100

    ARfD EFSA 2007 Not necessary

    3. Residues

    3.1. Nature and magnitude of residues in plant

    3.1.1. Primary crops

    3.1.1.1. Nature of residues

    Metabolism of fludioxonil was investigated for foliar application on fruits and fruiting vegetables

    (grape, peach, tomato), on leafy vegetables (lettuce) and on root and tuber vegetables (spring onion)

    as well as for seed treatment on root and tuber vegetables (potato), pulses and oilseeds (cotton,

    soybean) and cereals (wheat, rice) using both pyrrole-4-14

    C labelled and phenyl-U-14

    C labelled

    fludioxonil (Denmark, 2005). Available studies are summarized in table 3-1.

    When applied on leaves or on seeds, fludioxonil is metabolised mainly through oxidation followed by

    conjugation of metabolites with sugars. Following foliar application, the major component was parent

    fludioxonil, accounting for 22 % of the TRR in peach and up to 73.2 % of the TRR in tomatoes.

    Following seed application, uptake and translocation of fludioxonil was low, TRR ranged from

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 15

    Group Crop Label

    position

    Application and sampling details

    Method,

    F or G (a)

    Rate No Sampling

    (DAT)

    Remarks

    Peach [phenyl-U-14

    C] Foliar, F

    0.84 or

    8.40 kg

    a.s./ha

    (total)

    8.40 kg

    a.s./ha

    (total)

    3

    2

    28

    30, 114

    Tomato [pyrrole-4-14

    C] Foliar, G 0.75 kg

    a.s./ha 3

    After 1st appl.: 0

    After 3rd

    appl.:

    0, 40

    Leafy

    vegetables

    Lettuce [pyrrole-4-14

    C] Foliar, F

    0.20 kg

    a.s./ha

    or

    0.60 kg

    a.s./ha

    3 0, 6, 13

    Root and tuber

    vegetables

    Spring

    onion

    [phenyl-U-14

    C] Foliar

    0.12 kg

    a.s./ha

    (total)

    or

    6.17 kg

    a.s./ha

    (total)

    2 0, 7, 14, 28

    Potato [pyrrole-4-14

    C] Seed, F

    2.50 g

    a.s./100 kg

    seed

    1 0, 40, 71, 95

    Pulses and

    oilseeds

    Cotton [pyrrole-4-14

    C] Seed, G

    2.50 g

    a.s./100 kg

    5.0 g

    a.s./100kg

    seed

    1 186

    Soybean [pyrrole-4-14

    C] Seed, G

    5.00 g

    a.s./100 kg

    seed

    1 28, 38, 133

    Cereals

    Wheat [pyrrole-4-14

    C] Seed, G,

    F

    6.40 g

    a.s./100 kg

    seed (G)

    7.30 g

    a.s./100 kg

    seed (F)

    1

    11, 18, 25, 32,

    39, 46, 53

    48, 83, 106

    Rice [pyrrole-4-14

    C] Seed

    6.50 g

    a.s./100 kg

    seed

    1 38, 76, 152

    (a): Outdoor/field application (F) or glasshouse/protected/indoor application (G)

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 16

    Consequently, the residue definition for enforcement is set as fludioxonil for all plant commodities.

    The risk assessment residue definition was set as the sum of fludioxonil and its metabolites oxidized

    to metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as

    fludioxonil (EFSA, 2007b). Validated analytical methods for enforcement of the proposed residue

    definition are available (see also section 1.1).

    For cereals (seed treatment), fruits and leafy vegetables, pulses and oilseeds, the conversion factor of

    1 between residue definitions for enforcement and risk assessment was derived which reflects the fact

    that no significant concentrations of metabolites containing the 2,2-difluoro-benzo[1,3]dioxole-4

    carboxylic moiety are expected. For root vegetables after foliar application the conversion factor of

    2.8 (derived from the metabolism study on spring onions) from enforcement to risk assessment

    residue definition is proposed (EFSA, 2009a).

    No studies investigating the metabolism of fludioxonil following post-harvest treatment are available.

    However, as a more extensive metabolism of the active substance is not expected in the post-harvest

    use, EFSA concludes that for all plant commodities and all types of application, the same residue

    definition as established by the peer review should apply.

    It is noted that the JMPR has established both the risk assessment and enforcement residue definitions

    for plant commodities as parent fludioxonil only (FAO, 2004) but according to EFSA the residue

    definition derived by JMPR will underestimate the toxicological burden of fludioxonil residues, in

    root and tuber vegetables in particular.

    3.1.1.2. Magnitude of residues

    According to the RMS, the active substance fludioxonil is authorised for foliar and seed treatments in

    northern and southern Europe on a large number of crops, both under outdoor and indoor conditions

    (see Appendix A). To assess the magnitude of fludioxonil residues resulting from these GAPs, EFSA

    considered all residues trials reported in the PROFile (Denmark, 2010), including residues trials

    evaluated in the framework of the peer review (Denmark, 2005) or in the framework of MRLs

    applications (EFSA, 2008, 2009a, 2009b, 2009c, 2010) and additional data submitted during the

    Member State consultation (Austria, 2011; Denmark, 2011; Finland, 2011; France, 2011; Germany,

    2011; The Netherlands, 2011; The United Kingdom, 2007 and 2010). All available residue trials that

    comply with the authorised GAPs, are summarized in Table 3-2.

    The number of residues trials and extrapolations were evaluated in view of the European guidelines

    on comparability, extrapolation, group tolerances and data requirements for setting MRLs (EC, 2011).

    A sufficient number of trials complying with the GAP was reported by the RMS for all crops under

    assessment, except in the following cases:

    Citrus fruit: the number of residues trials compliant with the post-harvest uses of fludioxonil

    in southern Europe is not compliant with the data requirements for these crops. Although

    appropriate MRL and risk assessment values can be derived from the import tolerance data, 2

    additional trials on oranges for the post-harvest use in the EU are still required.

    Pistachios: the number of residue trials compliant with the import tolerance of fludioxonil is

    not compliant with the data requirements for this crop. Tentative MRL and risk assessment

    values can be derived from the import tolerance data but 1 additional trial is still required.

    Apricots and plums: the number of residues trials supporting the import tolerance (post-

    harvest uses) of fludioxonil is not compliant with the data requirements for these crops.

    Tentative MRL and risk assessment values can be derived but 1 additional residue trial on

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 17

    plums is still required to support the import tolerance in plums as well as the extrapolation to

    apricots.

    Strawberries: the number of residue trials supporting the northern, southern and indoor uses

    of fludioxonil is not compliant with the data requirements for this crop. EFSA used values

    from 0 d PHI or 3 d PHI to derive tentative MRLs. However, considering that interpolations

    are not supported, additional residue trials representing the residue situation at the PHI of 1

    day are still required for each area: 6 for the northern use, 4 for the southern use and 6 for the

    indoor use.

    Blackberries and raspberries: the number of residues trials supporting the southern use of

    fludioxonil is not compliant with the data requirements for these crops. Although appropriate

    MRL and risk assessment values can be derived from the northern outdoor data, 3 additional

    residues trials on raspberries complying with the southern GAP for these two crops are still

    required.

    Blueberries, cranberries, currants and gooseberries: no trials are available to support the

    southern use of fludioxonil. Although appropriate MRL and risk assessment values can be

    derived from the northern outdoor data, 8 trials complying with the southern GAP for these

    crops are still required, with a minimum of 4 trials on currants.

    Elderberries: trials were carried out with a PHI of 14 days while a PHI of 21 days is

    authorised in Austria. Although only deviations of 25% are normally allowed, this deviation

    of 33 % is accepted in this case because elderberries are classified a very minor crop, because

    fludioxonil has a low acute toxicity (no ARfD was established) and because this deviation is

    expected to overestimate residues and risk to consumers.

    Potatoes: no sufficient trials are available to support the northern use of fludioxonil. Although

    appropriate MRL and risk assessment values can be derived from the southern outdoor data, 1

    additional trial complying with the northern GAPs would be desirable.

    Tomatoes and aubergines: the number of residues trials supporting the northern, southern and

    import tolerance uses of fludioxonil is not compliant with the data requirements for these

    crops. Although appropriate MRL and risk assessment values can be derived from the indoor

    data, additional residue trials on tomatoes complying with the GAPs for these two crops are

    still required for each area: 6 for northern use, 6 for southern use and 8 for import tolerance.

    Peppers: no trials are available to support the import tolerance of fludioxonil. Although

    appropriate MRL and risk assessment values can be derived from the indoor data, 8 trials

    complying with the import tolerance GAP are still required.

    Cucurbits with edible peel: the number of residues trials supporting the northern, southern

    and import tolerance uses of fludioxonil is not compliant with the data requirements for these

    crops. Although appropriate MRL and risk assessment values can be derived from the indoor

    data, residue trials on cucumbers and/or courgettes complying with the GAPs for these crops

    are still required for each area: 8 for northern use, 4 for southern use and 8 for import

    tolerance.

    Cucurbits with inedible peel: no trials are available to support the import tolerance of

    fludioxonil. At least 8 representative trials on melons would have to be submitted to support a

    group tolerance; no MRL is proposed due to the insufficient dataset. The RMS highlighted

    that residues trials are ongoing but these trials cannot be considered by EFSA as long as they

    are not finalised.

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    EFSA Journal 2011;9(8):2335 18

    Sweet corn: a data requirement of 4 residue trials normally applies while only 3 trials on

    immature maize are available in each area. Considering however that all residue levels are

    below the LOQ, indicating a no residue situation, further residue trials are not required.

    Fresh beans and fresh peas with pods: the number of residues trials supporting the northern

    use of fludioxonil is not compliant with the data requirements for these crop. Although

    appropriate MRL and risk assessment values can be derived from the indoor data, 6 additional

    trials on fresh beans with pods complying with the northern GAP for these two crops are still

    required.

    Celery: available trials are not sufficient to support the northern and southern outdoor uses of

    fludioxonil. At least 3 representative trials on celery are required for each area; no MRL is

    proposed due to the insufficient dataset. The RMS highlighted that residues trials are ongoing

    but these trials cannot be considered by EFSA as long as they are not finalised.

    Fennel: no trials are available to support the northern use of fludioxonil. Although appropriate

    MRL and risk assessment values can be derived from the southern outdoor data, 4 trials on

    fennel complying with the northern GAP are still required.

    Oilseeds: the number of residues trials in each area is not compliant with the data

    requirements for these crops but the reduced number of trials was considered acceptable by

    EFSA because residues levels after the seed treatment were demonstrated to be below the

    LOQ.

    Maize: the value of 0.05 mg/kg would be identified as an outlier according to the Dixon Q

    test. Based on the metabolism studies and residue trials on cereals, this value was excluded

    from the MRL calculation.

    Bulb vegetables, wiltoof, fresh beans and peas (without pods): a MRL of 0.02 mg/kg is

    proposed because all residue levels were found to be below the LOQ of 0.02 mg/kg that was

    used in the residues trials. Considering however that a LOQ of 0.01 mg/kg can be achieved

    for enforcement purposes (see also section 1.1), the elaboration of residues trials with a LOQ

    of 0.01 mg/kg is desirable.

    Oilseeds, cereals grains and sweet corn: there is a lack of residues trials compliant with the

    LOQ for enforcement (0.01 mg/kg). However, residues resulting from the seed treatment are

    expected to be below this LOQ (supported by the metabolism studies). In these cases MRLs

    are set at 0.01* mg/kg.

    Sugar beet: considering that it is a seed treatment, that fludioxonil is not a systemic substance,

    and that no residues are expected in succeeding crops, residues exceeding the enforcement

    LOQ of 0.01 mg/kg are not expected. However, at least 2 residues trials demonstrating that

    residue levels are below the LOQ are desirable.

    The combined effect of a pre-harvest and a post-harvest treatment on the total residue in a

    given crop could not be assessed by EFSA as there are no residue trials available combining

    both modes of application. Member States are therefore recommended to take the appropriate

    measures for avoiding this kind of combined treatments.

    The demonstrated storage stability of fludioxonil in treated crops was evaluated under the peer review

    of Directive 91/414/EEC (Denmark, 2005). Studies demonstrated storage stability of fludioxonil in

    commodities with high water, high acid, high oil and dry content for up to 24 months when stored

    deep frozen. All available residue trials samples were stored for not more than 24 months.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 19

    Table 3-2: Overview of the available residues trials data

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Citrus fruits EU Indoor

    (post-

    harvest)

    Oranges: 1.5; 1.26

    Mandarins: 1.84;

    2.23; 1.91; 1.46

    - 1.67 2.23 4 1.00 EU GAP compliant residue trials

    on oranges (2) and mandarins (4).

    Rber= 3.98

    Rmax= 3.02

    Import (US,

    CA)

    Indoor

    (post-

    harvest)

    Oranges: 2.9; 3.5;

    4; 4.4; 4.6; 5; 7.2

    Mandarins: 2.9;

    2x5.6; 5.8; 7; 2x7.8

    - 5.30 7.80 10 1.00 US GAP compliant residue trials

    on oranges (7) and mandarins (7)

    (FAO, 2010).

    Rber= 14.10

    Rmax= 9.72

    Pistachios Import (US)

    Outdoor 0.04; 0.06; 0.08 - 0.06 0.08 0.2

    (tentative)

    1.00 GAP compliant residue trials on

    pistachios.

    Rber= -

    Rmax= 0.21

    Pome fruits NEU Outdoor 0.45; 0.19; 0.33;

    0.26; 0.18; 0.16;

    0.6; 0.18; 0.19; 0.11

    - 0.19 0.60 0.8 1.00 GAP compliant residue trials on

    apples (7) and pears (3) were

    combined. Only authorised for use

    on apples and pears.

    Rber= 0.72

    Rmax= 0.71

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    EFSA Journal 2011;9(8):2335 20

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    SEU Outdoor 0.35; 0.14; 0.15;

    0.19; 0.22; 0.23;

    0.24; 0.29; 0.39;

    0.42

    - 0.24 0.42 0.8 1.00 GAP compliant residue trials on

    pears (2) and apples (8) were

    combined. Only authorised for use

    on apples and pears.

    Rber= 0.72

    Rmax= 0.55

    EU Indoor

    (post-

    harvest)

    - - 2.30 2.80 4 1.00 GAP compliant residue trials on

    pears (4) and apples (4) carried

    out in the US can be used for the

    EU GAP as well (one worldwide

    zone for post-harvest

    applications).

    Rber= 5.10

    Rmax= 4.11

    Import (US)

    Indoor

    (post-

    harvest)

    1.1; 1.2; 1.6; 2.8;

    2.2; 2.4; 2.4; 2.6

    -

    Apricots NEU Outdoor 0.15; 0.48; 0.17;

    0.33

    - 0.25 0.48 1 1.00 Extrapolation from the northern

    outdoor GAP on peaches.

    SEU Outdoor 0.06; 0.08; 0.11;

    0.19; 0.31; 0.36;

    0.37; 0.5

    - 0.25 0.50 0.8 1.00 Extrapolation from the northern

    outdoor GAP on peaches.

    Import (JP, AU,

    CL, US)

    Indoor

    (post-

    harvest)

    0.4; 1.06;1.90 - 1.06 1.90 5

    (tentative)

    1.00 Extrapolation from the post

    harvest use on plums.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 21

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Cherries NEU Outdoor 0.07; 2x0.08; 0.14;

    0.16; 0.17; 0.25

    - 0.14 0.25 0.4 1.00 GAP compliant residue trials on

    cherries.

    Rber= 0.34

    Rmax= 0.36

    SEU Outdoor 0.08; 0.09; 0.17;

    0.18; 0.22; 0.36

    - 0.18 0.36 0.5 1.00 GAP compliant residue trials on

    cherries.

    Rber= 0.51

    Rmax= 0.56

    Import (US)

    Indoor

    (post-

    harvest)

    0.27; 0.78; 1.8; 1.9 - 1.29 1.90 4 1.00 GAP compliant residue trials on

    cherries.

    Rber= 3.75

    Rmax= 5.27

    Peaches NEU Outdoor 0.15; 0.48; 0.17;

    0.33

    - 0.25 0.48 1 1.00 GAP compliant residue trials on

    peaches.

    Rber= 0.89

    Rmax= 1.08

    SEU Outdoor 0.06; 0.08; 0.11;

    0.19; 0.31; 0.36;

    0.37; 0.5

    - 0.25 0.50 0.8 1.00 GAP compliant residue trials on

    peaches.

    Rber= 0.74

    Rmax= 0.76

    Import (US)

    Indoor

    (post-

    harvest)

    1.9; 2.8; 4.5; 5.5 - 3.65 5.50 10 1.00 GAP compliant residue trials on

    peaches.

    Rber= 10.50

    Rmax= 12.04

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 22

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Plums NEU Outdoor 2x0.02; 0.04; 0.05;

    0.1; 0.11; 0.13;

    0.16; 0.17; 0.18

    - 0.11 0.18 0.3 1.00 GAP compliant residue trials on

    plums.

    Rber= 0.33

    Rmax= 0.28

    SEU Outdoor 0.02; 0.03; 0.05;

    0.09; 0.11; 0.12

    - 0.07 0.12 0.3 1.00 GAP compliant residue trials on

    plums.

    Rber= 0.23

    Rmax= 0.23

    Import (US)

    Indoor

    (post-

    harvest)

    0.4; 1.06;1.90 - 1.06 1.90 5

    (tentative)

    1.00 3 GAP compliant trials on plums.

    Rber= -

    Rmax= 6.88

    Table grapes NEU Outdoor 0.06; 0.1; 0.19;

    0.21; 0.21; 0.31;

    0.75; 1.18; 1.64;

    - 0.21 1.64 3 1.00 Although GAP on table grapes is

    less critical, extrapolation from

    the northern outdoor GAP on

    wine grapes is considered

    sufficient to demonstrate that

    northern GAP is not more critical

    than southern GAP.

    SEU Outdoor 0.21; 0.22; 0.27;

    0.3; 0.45; 0.82;

    2.65; 3.73

    - 0.38 3.73 5 1.00 GAP compliant residue trials on

    table grapes.

    Rber= 4.39

    Rmax= 5.38

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 23

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Wine grapes NEU Outdoor 0.06; 0.1; 0.19;

    0.21; 0.21; 0.31;

    0.75; 1.18; 1.64;

    - 0.21 1.64 3 1.00 GAP compliant residue trials on

    wine grapes.

    Rber= 1.93

    Rmax= 2.20

    SEU Outdoor 0.15; 0.2; 0.26;

    0.27; 0.38; 0.49;

    1.95; 2.65

    - 0.33 2.65 4 1.00 GAP compliant residue trials on

    wine grapes.

    Rber= 3.17

    Rmax= 3.84

    Strawberries NEU Outdoor 0d PHI: 0.83; 0.3;

    0.21; 0.61; 0.15;

    0.23;

    1d PHI: 0.24; 0.54

    - 0.27 0.83 1.5 1.00 Interpolated values for PHI 1 d

    were excluded, instead values of 0

    d PHI was chosen for 6 trials.

    Rber= 1.19

    Rmax= 1.16

    SEU Outdoor 0d PHI: 0.94; 0.31;

    0.31

    1d PHI:0.31; 0.77;

    0.87; 0.7

    - 0.70 0.94 2 1.00 Interpolated values for PHI 1 d

    were excluded, instead values of 0

    d PHI was chosen for 3 trials.

    Rber= 1.74

    Rmax= 1.56

    EU Indoor 0d PHI: 0.36; 1;

    0.26; 0.25; 2.72;

    1.33; 0.57

    1d PHI: 0.78; 0.26

    - 0.57 2.72 4

    (tentative)

    1.00 Interpolated values for PHI 1 d

    were excluded, instead values of 0

    d PHI was chosen for 7 trials.

    Rber= 2.33

    Rmax= 3.26

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 24

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Blackberries

    Raspberries

    NEU Outdoor 0.36; 0.5; 0.51;

    0.54; 0.61; 0.98

    - 0.53 0.98 1.5 1.00 GAP compliant residue trials on

    raspberries.

    Rber= 1.41

    Rmax= 1.37

    SEU Outdoor 0.98 - - - - 1.00 Insufficient number of trials.

    EU Indoor 0.32; 0.37; 0.2; 0.33 - 0.33 0.37 0.8 1.00 Residues trials on raspberries

    compliant with GAP on

    raspberries and blackberries

    (France, 2011).

    Rber= 0.68

    Rmax= 0.72

    Blueberries

    Cranberries

    Currants (red,

    black and

    white)

    Gooseberries

    NEU Outdoor Blueberries: 0.15;

    0.31; 0.31; 0.37

    Currants: 0.26; 0.6;

    0.62; 0.63; 1.44

    - 0.37 1.44 2 1.00 GAP compliant residue trials on

    blueberries (4) and currants (5)

    were combined.

    Rber= 1.25

    Rmax= 1.69

    SEU Outdoor - - - - - 1.00 No residue trials available

    Elderberries NEU Outdoor Blueberries: 0.04;

    0.08; 0.12; 0.24

    Currants: 0.16;

    0.30; 0.33; 0.45;

    0.56

    - 0.24 0.56 0.8 1.00 Residue trials on blueberries (4)

    and currants (5) more critical than

    GAP on elderberries (PHI of 14d

    instead of 21d, other parameters

    compliant with GAP) (Austria,

    2011).

    Rber= 0.78

    Rmax= 0.78

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 25

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Kiwi Import (US)

    Indoor

    (post-

    harvest)

    5.4; 6.6; 7.3; 8; 9.5 - 7.30 9.50 15 1.00 GAP compliant residue trials on

    kiwi.

    Rber= 17.50

    Rmax= 13.82

    Mangoes Import (ZA)

    Indoor

    (post-

    harvest)

    0.28; 0.31; 0.32;

    0.34; 0.37; 0.49;

    0.51; 0.66

    - 0.36 0.66 1 1.00 GAP compliant residue trials on

    mangoes.

    Rber= 1.01

    Rmax= 0.83

    Pomegranate Import (US)

    Indoor

    (post-

    harvest)

    0.65; 0.92; 0.97;

    1.21

    - 0.95 1.21 3 1.00 GAP compliant residue trials on

    pomegranates.

    Rber= 2.30

    Rmax= 2.12

    Potatoes NEU Outdoor

    (seed

    treat.)

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 26

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Carrots NEU Outdoor 0.19; 2x0.29; 0.4;

    0.41; 0.44; 0.52;

    0.54

    - 0.41 0.54 1 2.80 GAP compliant residue trials on

    carrots.

    Rber= 1.00

    Rmax= 0.77

    SEU Outdoor 0.04; 0.05; 2x0.06;

    0.07; 0.09; 0.18; 0.3

    - 0.07 0.30 0.4 2.80 GAP compliant residue trials on

    carrots.

    Rber= 0.32

    Rmax= 0.39

    Celeriac NEU Outdoor 0.06; 0.07; 0.08; 0.1 - 0.07 0.10 0.2 2.80 GAP compliant residue trials on

    celeriac.

    Rber= 0.19

    Rmax= 0.16

    Beetroot

    Horseradish

    Parsnips

    Parsley root

    Salsify

    Herbal

    infusions

    (dried, roots)

    Spices (roots

    and rhizome)

    NEU Outdoor 0.19; 2x0.29; 0.4;

    0.41; 0.44; 0.52;

    0.54

    - 0.41 0.54 1 2.80 Direct extrapolation from carrots

    is not possible because GAPs are

    different but residue trials on

    carrots are available compliant

    with GAP on beetroot, parsnips,

    horseradish, parsley roots, salsify,

    roots of herbal infusions and roots

    of spices.

    Rber= 1.00

    Rmax= 0.77

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 27

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Garlic

    Onions

    Shallots

    NEU Outdoor 8x

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 28

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Aubergines

    (egg plant)

    NEU Outdoor - - - - - 1.00 No residue trials available

    SEU Outdoor - - - - - 1.00 No residue trials available

    EU Indoor 0.05; 0.10; 0.13;

    0.15

    - 0.12 0.15 0.4 1.00 Direct extrapolation from

    tomatoes is not possible (different

    GAPs) but GAP compliant

    residue trials on aubergines are

    available.

    Rber= 0.29

    Rmax= 0.33

    Import

    (n.r.)

    n.r. - - - - - 1.00 No residue trials available

    Peppers EU Indoor 0.09; 0.1; 0.15;

    0.17; 0.19; 0.21;

    0.26; 0.35; 0.36;

    0.78; 0.93

    - 0.21 0.93 1 1.00 GAP compliant residue trials on

    peppers.

    Rber= 0.72

    Rmax= 1.11

    Import

    (n.r.)

    n.r. - - - - - 1.00 No residue trials available

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 29

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Cucumbers

    Gherkins

    Courgettes

    NEU Outdoor - - - - - 1.00 No residue trials available

    SEU Outdoor 0.04; 0.05; 0.08;

    0.11

    - 0.07 0.11 0.3 1.00 GAP compliant residue trials on

    cucumbers.

    Rber= 0.21

    Rmax= 0.23

    EU Indoor Cucumbers: 0.03;

    2x0.05; 3x0.09;

    0.16; 0.17; 0.27;

    Courgettes: 0.07;

    0.09; 2x0.1; 0.14;

    2x0.17; 0.28

    - 0.10 0.28 0.4 1.00 GAP compliant residue data on

    cucumbers (9) and courgettes (8)

    were combined. Data

    extrapolation to gherkins and

    courgettes is supported.

    Rber= 0.34

    Rmax= 0.30

    Import

    (n.r.)

    n.r. - - - - - 1.00 No residue trials available. This

    import tolerance is not requested

    for gherkins.

    Melons

    Pumpkins

    Watermelons

    Import

    (US)

    Outdoor - - - - - 1.00 No residue trials available.

    Sweet corn NEU Outdoor

    (seed

    treat.)

    3x

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 30

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Lettuce NEU Outdoor 0.16; 0.17; 0.18;

    0.64; 0.68; 0.79;

    1.2; 1.68

    - 0.66 1.68 3 1.00 GAP compliant residue trials on

    lettuce.

    Rber= 2.20

    Rmax= 2.42

    SEU Outdoor

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 31

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Lamb’s lettuce

    Cress

    Land cress

    Rocket, rucola

    Red mustard

    Leaves and

    sprouts of

    Brassica

    NEU Outdoor 0.16; 0.17; 0.18;

    0.64; 0.68; 0.79;

    1.2; 1.68

    - 0.66 1.68 3 1.00 Extrapolation from the northern

    outdoor GAP on lettuce (The

    United Kingdom, 2007 and 2010).

    Spinach

    Beet leaves

    SEU Outdoor 3x

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 32

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Chives

    Basil

    Import

    (US)

    Outdoor 2; 3.42; 1.8; 4.54 - 2.71 4.54 10 1.00 GAP compliant residue trials on

    basil (2) and chives (2) combined.

    Rber= 8.52

    Rmax= 9.56

    Beans (fresh,

    with pods)

    Peas (fresh,

    with pods)

    NEU Outdoor

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 33

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Asparagus NEU Outdoor - -

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 34

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    SEU Outdoor Dry beans:

    3x

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 35

    Commodity Region (a)

    Outdoor

    /Indoor

    Individual trial results (mg/kg) Median

    residue

    (mg/kg) (b)

    Highest

    residue

    (mg/kg) (c)

    MRL

    proposal

    (mg/kg)

    Median

    CF (d)

    Comments

    Enforcement

    (fludioxonil)

    Risk assessment

    (sum of fludioxonil

    and its metabolites

    oxidized to

    metabolite CGA

    192155, expressed

    as fludioxonil) (f)

    Maize grain NEU Outdoor

    (seed

    treat.)

    10x

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 36

    (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial.

    (e): Indicates that no limit of analytical quantification is available for the commodity.

    (f): Residues are not reported, CF for risk assessment is derived from metabolism studies.

    (*): Indicates that the MRL is set at the limit of analytical quantification.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 37

    The available residues data are considered acceptable to derive adequate MRL proposals and risk

    assessment values for all commodities under evaluation, except for citrus fruits, pistachios, stone

    fruits and strawberries where data gaps were identified and only a tentative MRL is calculated (see

    also Table 3-2). For cucurbits with inedible peel and celery, available datasets were insufficient to

    derive tentative MRLs. For cereals straws (except maize), tentative MRLs are derived in view of the

    future need to set MRLs in feed items. In case several uses are supported for one commodity, the final

    MRL proposal was derived from the most critical use and indicated in bold in Table 3-2.

    3.1.1.3. Effect of industrial processing and/or household preparation

    The effect of processing on the nature of fludioxonil was investigated in the framework of the peer

    review. A study was conducted simulating representative hydrolytic conditions for pasteurisation (20

    minutes at 90 C, pH 4), boiling/brewing/baking (60 minutes at 100 C pH 5) and sterilisation (20

    minutes at 120 C, pH 6). This study showed that fludioxonil is stable under these conditions and that

    no formation of toxicologically relevant metabolites occurs (Denmark, 2005). Thus, for processed

    commodities the same enforcement residue definition as for raw agricultural commodities (RAC) is

    applicable. Also for risk assessment, considering that all metabolites are oxidized to a common

    moiety, it is unlikely that new metabolites will occur.

    Studies investigating the magnitude of residues in processed commodities of table and wine grapes

    were also reported in the framework of the peer review (Denmark, 2005). After fludioxonil was

    included in Annex I to Directive 91/414/EEC, studies investigating the magnitude of residues in

    processed commodities of mangoes, carrots, citrus, apples, plums, strawberries, tomatoes and fresh

    beans were evaluated by EFSA or by the RMS. An overview of all available processing studies is

    available in Table 3-3. Robust processing factors for enforcement and risk assessment purposes could

    only be derived for carrots, mangoes, table and wine grapes. The processing factors reported for the

    remaining commodities should be considered indicative as they are not sufficiently supported by

    studies; a minimum of 3 processing studies is normally required.

    Further processing studies are not required as they are not expected to affect the outcome of the risk

    assessment. However, if there would be the intention to derive more robust processing factors, in

    particular for enforcement purposes, additional processing studies would be required.

    Table 3-3: Overview of the available processing studies

    Processed commodity Number

    of studies

    Median

    PF (a)

    Median

    CF (b)

    Comments

    Enforcement residue definition: fludioxonil

    Recommended rrocessing factors (sufficiently supported by data)

    Table grapes, dried (raisins) 15 1.08 1.00 Denmark, 2005

    Wine grapes, juice 18 0.80 1.00 The PF for juice is an average PF.

    No information available if wine

    was red or white (Denmark, 2005). Wine grapes, must 10 0.37 1.00

    Wine grapes, wine 12 0.03 1.00

    Mangoes, peeled 8 0.06 1.00 Data obtained from the supervised

    residue trials. In the pulp, residues

    in all samples were below the LOQ

    of 0.02 mg/kg (Denmark, 2010).

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 38

    Processed commodity Number

    of studies

    Median

    PF (a)

    Median

    CF (b)

    Comments

    Carrots, canned 4 0.19 2.80 In the absence of data on the

    magnitude of fludioxonil

    metabolites in processed carrots, it

    is assumed that the CF is the same

    as for raw commodities (EFSA,

    2009a).

    Carrots, cooked 4 0.11 2.80

    Carrots, juice 4 0.20 2.80

    Indicative processing factors (limited dataset)

    Citrus, juice 2 0.13 1.00 PF derived from a processing study

    on lemons (1 study) and oranges (1

    study). Citrus, dry pomace 2 7.54 1.00

    Citrus, wet pomace 2 2.20 1.00

    Oranges, marmalade 2 0.47 1.00

    Apples, juice 1 0.20 1.00 Denmark, 2010

    Apples, wet pomace 1 5.30 1.00

    Apples, dry pomace 1 1.40 1.00

    Plums, canned 1 0.50 1.00 Denmark, 2010

    Plums, dried (prunes) 1 2.60 1.00 Denmark, 2010

    Plums, jam 1 0.66 1.00 Denmark, 2010

    Strawberries, jam 1 0.33 1.00 Denmark, 2010

    Strawberries, canned 1 0.57 1.00 Denmark, 2010

    Tomatoes, peeled and

    canned

    1 0.20 1.00 Denmark, 2010

    Tomatoes, juice 1 0.20 1.00

    Beans (fresh with pods),

    cooked

    1 0.46 1.00 Denmark, 2010

    (a): The median processing factor is obtained by calculating the median of the individual processing factors of each

    processing study.

    (b): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual

    conversion factors of each processing study.

    3.1.2. Rotational crops

    3.1.2.1. Preliminary considerations

    The use of fludioxonil in permanent crops or in third countries is not considered relevant with regard

    to the potential occurrence of residues in rotational crops. Within Europe, however, some crops

    evaluated in the framework of this MRL review might be grown in rotation with other crops. During

    the peer review under Directive 91/414/EEC, the degradation of fludioxonil in soil was investigated in

    laboratory and field studies (Denmark, 2005). The most critical DT90 value (28-142 d) of fludioxonil

    was obtained based on a field study performed in Germany. Since it exceeds 100 days, investigation

    on the occurrence of fludioxonil residues in rotational crops is considered relevant.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 39

    3.1.2.2. Nature of residues

    Under the peer review, four metabolism studies in rotational crop studies were submitted on lettuce,

    winter and spring wheat, sugar beets, corn, mustard, turnips, radishes (Denmark, 2005). The available

    studies are summarized in Table 3-4.

    Significant TRR levels were only identified in radish samples (30 DAT, 1.117 kg a.s./ha) and in

    wheat samples (30 DAT, 0.124 and 1.117 kg a.s./ha); in all other crops TRR levels never exceeded

    0.01 mg/kg. The highest TRR levels were observed in wheat straw (0.355 mg/kg) and radish tuber

    (0.135 mg/kg). Parent fludioxonil accounted for 0.016 mg/kg in radish tubers and CGA 192155

    accounted for 0.015 mg/kg in wheat straw. Other metabolites were tentatively identified as CGA

    26537813

    , CGA 30810314

    , CGA 34035115

    , CGA 22773116

    and CGA 26076617

    , none of which

    accounted for more than 0.05 mg/kg each.

    EFSA concluded in the framework of the peer review that the metabolic pathway of fludioxonil in

    rotational crops is similar to that in primary crops and no formation of new metabolites was observed

    (EFSA, 2007b). Hence the same residue definition of as for primary crops applies to the rotational

    crops.

    Table 3-4: Summary of available metabolism studies in rotational crops

    Crop group Crop Label

    position

    Application and sampling details

    Method,

    F or G (a)

    Rate

    (kg a.i./ha)

    Sowing

    intervals

    (DAT)

    Harvest

    Intervals

    Remarks

    Leafy vegetables Lettuce [pyrrole-14

    C]

    Soil

    spraying,

    F

    0.750 90 50 % and

    100 %

    maturity

    Root and tuber

    vegetables

    Sugar

    beets

    [pyrrole-14

    C]

    Soil

    spraying,

    F

    0.750 140, 320,

    345

    25 %,

    50 % and

    100 %

    maturity

    Turnips [pyrrole-14

    C]

    Soil

    spraying,

    F

    0.124 33, 90 100 %

    maturity

    Radishes [pyrrole-14

    C]

    Soil

    spraying,

    F

    0.062 32, 90 100 %

    maturity

    [phenyl-14

    C]

    Soil

    spraying,

    F

    1.117 30, 90,

    210

    100 %

    maturity

    Pulses and

    oilseeds

    Mustard [pyrrole-14

    C]

    Soil

    spraying,

    F

    0.124 33, 90 100 %

    maturity

    13

    CGA 265378: 4-(2,2-difluoro-benzol[1,3]dioxol-4-yl)-2,5-dioxo-2,5-dihydro-1H-pyrrole-3-carbonitrile. See

    Appendix E. 14

    CGA 308103: 2-(2,2-difluoro-benzol[1,3]dioxol-4-yl)-2-hydroxy-acetamide. See Appendix E. 15

    CGA 340351: 2,2-difluorobenzol[1,3]dioxole-4-carboxylic acid amide. See Appendix E. 16

    CGA 227731:6-hydroxy-2H-chromeno[3,4-c]pyrrol-4-one. See Appendix E. 17

    CGA 260766: 3-(2,2-difluorobenzo[1,2]dioxol-4-yl)-4-hydroxy-pyrrole-2,5-dione. See Appendix E.

  • Review of the existing MRLs for fludioxonil

    EFSA Journal 2011;9(8):2335 40

    Crop group Crop Label

    position

    Application and sampling details

    Method,

    F or G (a)

    Rate

    (kg a.i./ha)

    Sowing

    intervals

    (DAT)

    Harvest

    Intervals

    Remarks

    [pyrrole-14

    C]

    Soil

    spraying,

    F

    0.062 32, 90 100 %

    maturity

    [phenyl-14

    C]

    Soil

    spraying,

    F

    1.117 30, 90,

    210

    100 %

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