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

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


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;


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)


EFSA Journal 2011;9(8):2335 5

Code

number

Commodity Existing

EU MRL

(mg/kg)

Existing

CXL

(mg/kg)


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)


EFSA Journal 2011;9(8):2335 6

Code

number

Commodity Existing

EU MRL

(mg/kg)

Existing

CXL

(mg/kg)


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)


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


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)


EFSA Journal 2011;9(8):2335 7

Code

number

Commodity Existing

EU MRL

(mg/kg)

Existing

CXL

(mg/kg)


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)


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)


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)


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)


EFSA Journal 2011;9(8):2335 8

Code

number

Commodity Existing

EU MRL

(mg/kg)

Existing

CXL

(mg/kg)


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


(*): 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.


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


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.


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.


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.


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.


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

<0.002 mg/kg in rice grain to 0.015 mg/kg in dry soybean seeds. Cleavage of the pyrrole ring results

in the formation of 2,2-difluoro-benzo[1,3]dioxole metabolites. The peer review concluded that the

metabolic pattern is qualitatively similar in all crop groups investigated, but in root vegetables (study

in spring onions) after foliar application higher rates of metabolites (but less than 7% of the TRR)

have been observed in whole plant, while parent fludioxonil remained the major residue (11.5 % to 31

% of the TRR).

Table 3-1: Summary of available metabolism studies in plants

Group Crop Label

position

Application and sampling details

Method,

F or G (a)

Rate No Sampling

(DAT)

Remarks

Fruits and

fruiting

vegetable Grape [pyrrole-4-14

C] Foliar, F 0.50 kg

a.s./ha 3

After 1st appl.:

0, 26

After 3rd

appl.:

0, 14 and at

maturity


EFSA Journal 2011;9(8):2335 15

Group Crop Label

position


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)


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


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.


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.


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


EFSA Journal 2011;9(8):2335 20


Outdoor

/Indoor


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


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.


EFSA Journal 2011;9(8):2335 21


Outdoor

/Indoor


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


cherries.

Rber= 0.34

Rmax= 0.36

SEU Outdoor 0.08; 0.09; 0.17;

0.18; 0.22; 0.36


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


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


EFSA Journal 2011;9(8):2335 22


Outdoor

/Indoor


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


plums.

Rber= 0.33

Rmax= 0.28

SEU Outdoor 0.02; 0.03; 0.05;

0.09; 0.11; 0.12


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


table grapes.

Rber= 4.39

Rmax= 5.38


EFSA Journal 2011;9(8):2335 23


Outdoor

/Indoor


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;


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


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



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



Rber= 2.33

Rmax= 3.26


EFSA Journal 2011;9(8):2335 24


Outdoor

/Indoor


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


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


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


EFSA Journal 2011;9(8):2335 25


Outdoor

/Indoor


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


mangoes.

Rber= 1.01

Rmax= 0.83

Pomegranate Import (US)

Indoor

(post-

harvest)

0.65; 0.92; 0.97;

1.21


pomegranates.

Rber= 2.30

Rmax= 2.12

Potatoes NEU Outdoor

(seed

treat.)

<0.01; 4x0.01;

0.02; 0.03


potatoes.

Rber= 0.04

Rmax= 0.04

SEU Outdoor

(seed

treat.)

2x <0.01; 0.01;

2x0.02; 2x 0.03;

0.04


potatoes.

Rber= 0.06

Rmax= 0.06

Sweet potatoes

Yams

Import (n.r.)

Indoor

(post-

harvest)

Sweet potatoes:

2.49; 2.81

Yams: 4.7; 5.7


sweet potates (2) and yams (2)

were combined.

Rber= 10.90

Rmax= 11.81


EFSA Journal 2011;9(8):2335 26


Outdoor

/Indoor


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


carrots.

Rber= 1.00

Rmax= 0.77

SEU Outdoor 0.04; 0.05; 2x0.06;

0.07; 0.09; 0.18; 0.3


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


EFSA Journal 2011;9(8):2335 27


Outdoor

/Indoor


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<0.02 - 0.02 0.02 0.02 2.80 GAP compliant residue trials on

bulb onions. Residue

extrapolation to garlic and

shallots supported.

SEU Outdoor 6x<0.02 - 0.02 0.02 0.02 2.80 GAP compliant residue trials on

bulb onions. Residue

extrapolation to garlic and

shallots supported.

Spring onions NEU Outdoor 0.11; 0.17; 0.2; 0.47 - 0.19 0.47 1 2.80 GAP compliant residue trials on

spring onions.

Rber= 0.81

Rmax= 1.06

SEU Outdoor 0.05; 0.1; 0.11; 0.35 - 0.11 0.35 1 2.80 GAP compliant residue trials on

spring onions.

Rber= 0.58

Rmax= 0.84

Tomatoes

NEU Outdoor 0.07; 0.30 - - - - 1.00 Insufficient number of trials.

SEU Outdoor 0.10; 0.28 - - - - 1.00 Insufficient number of trials.

EU Indoor 0.05; 0.09; 2x0.10;

2x0.13; 2x 0.15; 2x

0.16; 0.22; 0.24;

0.32; 0.37; 0.80


tomatoes (Germany, 2011).

Rber= 0.48

Rmax= 0.68

Import

(n.r.)

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


EFSA Journal 2011;9(8):2335 28


Outdoor

/Indoor


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.)


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


peppers.

Rber= 0.72

Rmax= 1.11

Import

(n.r.)



EFSA Journal 2011;9(8):2335 29


Outdoor

/Indoor


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


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<0.02 - <0.01 <0.01 0.01* 1.00 Residue data on immature maize

(from a more critical GAP).

SEU Outdoor

(seed

treat.)

3x<0.02 - <0.01 <0.01 0.01* 1.00 Residue data on immature maize

(from a more critical GAP).


EFSA Journal 2011;9(8):2335 30


Outdoor

/Indoor


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


lettuce.

Rber= 2.20

Rmax= 2.42

SEU Outdoor <0.02; 0.09; 0.31;

0.34; 0.8; 0.87;

1.46; 2.28; 2.5


lettuce.

Rber= 3.74

Rmax= 3.77

EU Indoor 1.6; 1.7; 1.74; 1.8;

3.23; 4.3; 4.3; 7;

8.63


lettuce.

Rber= 11.30

Rmax= 11.53

Scarole

(broad-leaf

endive)

NEU Outdoor 0.16; 0.17; 0.18;

0.64; 0.68; 0.79;

1.2; 1.68


outdoor GAP on lettuce.

SEU Outdoor 4x<0.02; 0.39;

0.42; 0.46; 1.24

- 0.21 1.24 2 1.00 Direct extrapolation from the

southern outdoor GAP on lettuce

is not possible (GAPs are

different) but trials on lettuce

compliant with scarole GAP are

available.

Rber= 0.90

Rmax= 1.67

EU Indoor 1.6; 1.7; 1.74; 1.8;

3.23; 4.3; 4.3; 7;

8.63

- 3.23 8.63 12 1.00 Extrapolation from the indoor

GAP on lettuce.


EFSA Journal 2011;9(8):2335 31


Outdoor

/Indoor


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


outdoor GAP on lettuce (The

United Kingdom, 2007 and 2010).

Spinach

Beet leaves

SEU Outdoor 3x<0.02; 0.04;

0.29; 2x1.2


southern outdoor GAP on lettuce

is not possible (GAPs are

different) but trials on lettuce

compliant with GAP for spinach

and beet leaves are available.

Rber= 1.95

Rmax= 2.05

EU Indoor 0.72; 0.98; 1.1; 2.4;

2.5; 2.7; 3.4; 3.4;

4.7; 6


indoor GAP on lettuce is not

possible (GAPs are different) but

trials on lettuce compliant with

GAP for spinach and beet leaves

are available.

Rber= 7.45

Rmax= 7.68

Witloof NEU Outdoor 4x<0.02 - 0.02 0.02 0.02 1.00 GAP compliant residue trials on

witloof (leaves).


EFSA Journal 2011;9(8):2335 32


Outdoor

/Indoor


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 <0.02; 0.13 - - - - 1.00 Insufficient number of trials.

SEU Outdoor <0.02; 0.02;

2x0.03; 0.04; 0.06;

3x0.09; 0.17; 0.2


beans with pods.

Rber= 0.18

Rmax= 0.25

EU Indoor 0.46; 2x0.48; 0.27;

0.49; 0.45; 0.86; 0.5


beans with pods.

Rber= 1.00

Rmax= 1.02

Beans (fresh,

without pods)

Peas (fresh,

without pods)

NEU Outdoor 11x<0.02; 0.05 - 0.02 0.05 0.05 1.00 GAP compliant residue trials on

peas without pods.

Rber= 0.04

Rmax= 0.05

SEU Outdoor 5x<0.02 - 0.02 0.02 0.02 1.00 GAP compliant residue trials on

peas without pods.

Lentils (fresh) NEU Outdoor 11x<0.02; 0.05 - 0.02 0.05 0.05 1.00 Extrapolation from the northern

outdoor GAP on fresh peas

without pods.


EFSA Journal 2011;9(8):2335 33


Outdoor

/Indoor


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 - - <0.01 <0.01 0.01* 1.00 Considering that the application is

made 6 months before harvest and

that fludioxonil is not a systemic

substance, residues exceeding the

enforcement LOQ of 0.01 mg/kg

are not expected.

SEU Outdoor - - <0.01 <0.01 0.01* 1.00

Celery NEU Outdoor 0.62 - - - - 1.00 Insufficient number of trials.

SEU Outdoor 0.53 - - - - 1.00 Insufficient number of trials.

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

SEU Outdoor 2x0.02; 2x0.03 - 0.03 0.03 0.05 1.00 GAP compliant residue trials on

fennel.

Rber= 0.06

Rmax= 0.05

Dry pulses NEU Outdoor Dry beans:

2x<0.02; 2x0.02

Dry peas: 2x0.02;

0.05; 0.08


beans (4) and peas (4) were

combined(France, 2011; The

Netherlands, 2011).

Rber= 0.09

Rmax= 0.10


EFSA Journal 2011;9(8):2335 34


Outdoor

/Indoor


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<0.02; 0.31;

Dry peas: 2x0.02;

0.05; 0.08


beans (4) and peas (4) were

combined. The highest value of

0.31 derived from mechanical

harvesting (France, 2011; The

Netherlands, 2011).

Rber= 0.15

Rmax= 0.39

Poppy seed

Sunflower

seed

Rape seed

Soya bean

Cotton seed

Gold of

pleasure

NEU Outdoor

(seed

treat.)

7x<0.02 - <0.01 <0.01 0.01* 1.00 GAP compliant residue trials on

rape seed.

SEU Outdoor

(seed

treat.)


rape seed. No authorized use on

gold of pleasure in SEU.

Barley grain

Oats grain

Rye grain

Wheat grain

NEU Outdoor

(seed

treat.)

21x<0.02;

19x<0.04

- <0.01 <0.01 0.01* 1.00 GAP compliant residue trials on

wheat.

SEU Outdoor

(seed

treat.)


wheat.


EFSA Journal 2011;9(8):2335 35


Outdoor

/Indoor


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.)


maize grain.

Based on the metabolism studies,

one residue trial (0.05 mg/kg) was

considered as an outlier.

SEU Outdoor

(seed

treat.)


maize grain.

Barley straw

Oats straw

Rye straw

Wheat straw

NEU Outdoor

(seed

treat.)

5x<0.02; 21x<0.04;

14x<0.05

- 0.04 0.05 0.05(e)


wheat.

SEU Outdoor

(seed

treat.)

3x<0.02; <0.04;

12x<0.05

- 0.05 0.05 0.05(e)


wheat.

Sugar beet

(roots)

NEU Outdoor

(seed

treat.)

- - <0.01 <0.01 0.01* 1.00 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

(Denmark, 2011).

Sugar beet

(tops)

NEU Outdoor

(seed

treat.)

- - <0.01 <0.01 0.01* 1.00

n.r.: not reported

(a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU.

(b): Median value of the individual trial results according to the enforcement residue definition.

(c): Highest value of the individual trial results according to the enforcement residue definition.


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.



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


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).


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.


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


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.


EFSA Journal 2011;9(8):2335 40

Crop group Crop Label

position


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 %

maturity

Cereals Winter

wheat

[pyrrole-14

C]

Soil

spraying,

F

0.750 140, 320,

345

25 %,

50 % and

100 %

maturity

Spring

wheat

[pyrrole-14

C]

Soil

spraying,

F

0.124 33, 90 25 % and

100 %

maturity

[pyrrole-14

C]

Soil

spraying,

F

0.062 32, 90 25 %,

50 % and

100 %

maturity

[phenyl-14

C]

Soil

spraying,

F

1.117 30, 90,

210

25 %,

50 % and

100 %

maturity

Corn [pyrrole-14

C]

Soil

spraying,

F

0.750 140, 320,

345

25 %,

50 % and

100 %

maturity

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

3.1.2.3. Magnitude of residues

Under the peer review one rotational crop study with non radiolabelled fludioxonil was submitted

(Denmark, 2005). Fludioxonil was applied 4 times at an application rate of 0.282 kg a.s./ha on bare

soil. No residues exceeding 0.01 mg/kg were found in any of the samples planted/sown at a 30d plant-

back interval.

Considering the fact that fludioxonil was applied to a bare soil (interception of fludioxonil by the

plants is expected in practice), it is expected that residues of fludioxonil resulting from soil uptake

will not exceed 0.01 mg/kg. Specific plant-back restrictions related to the use of fludioxonil are

therefore not required, provided that the active substance is applied in compliance with the GAPs

evaluated in the framework of this review (see Appendix A).

3.2. Nature and magnitude of residues in livestock

3.2.1. Dietary burden of livestock

Fludioxonil is authorised for use on several crops that might be fed to livestock. The median and

maximum dietary burdens were therefore calculated for different groups of livestock using the agreed

European methodology (EC, 1996). The input values for all relevant commodities have been selected


EFSA Journal 2011;9(8):2335 41

according to the recommendations of JMPR (FAO, 2009) and are summarized in Table 3-5. For citrus

pomace and apple pomace, the indicative processing factors derived in section 3.1.1.3 have been

included in the calculation in order to consider potential concentration of residues in these

commodities. Considering the results of available residues trials and primary crops metabolism

studies, the presence of residues in cereal grain and oilseeds following a seed treatment seems very

unlikely and concentration of residues in processed commodities thereof is not expected. Default

concentration factors in bran and oilseed cake were therefore not included.

Table 3-5: Input values for the dietary burden calculation

Commodity Median dietary burden Maximum dietary burden

Input value

(mg/kg)

Comment Input value

(mg/kg)

Comment

Risk assessment residue definition: sum of fludioxonil and its metabolites oxidized to metabolite 2,2-


Citrus, pomace 9.46 Median residue x PF 9.46 Median residue x PF

Apple, pomace 3.22 Median residue x PF 3.22 Median residue x PF

Wheat, rye grain 0.01 Median residue 0.01 Median residue

Barley, oat grain 0.01 Median residue 0.01 Median residue

Maize grain 0.01 Median residue 0.01 Median residue

Wheat, rye bran 0.01 Median residue 0.01 Median residue

Wheat, rye straw 0.04 Median residue 0.05 Highest residue

Barley, oat straw 0.04 Median residue 0.05 Highest residue

Peas, beans, lupins (dry) 0.02 Median residue 0.02 Median residue

Potatoes 0.02 Median residue 0.04 Highest residue

Rape seed

Cotton seed

Sunflower seed

Soya bean

0.01 Median residue 0.01 Median residue

Rape seed meal

Cotton seed meal

Sunflower seed meal

Soya bean meal

0.01 Median residue 0.01 Median residue

The results of the calculations are reported in Table 3-6. The calculated dietary burdens for ruminants

and pigs were found to exceed the trigger value of 0.1 mg/kg DM. Further investigation of residues is

therefore only required in these groups of livestock.


EFSA Journal 2011;9(8):2335 42

Table 3-6: Results of the dietary burden calculation

Maximum

dietary burden

(mg/kg bw/d)

Median dietary

burden

(mg/kg bw/d)

Highest

contributing

commodity

Max dietary

burden

(mg/kg DM)

Trigger

exceeded

(Y/N)



Dairy ruminants 0.188 0.186 Orange pomace 5.22 Y

Meat ruminants 0.659 0.655 Orange pomace 15.32 Y

Poultry 0.004 0.002 Potatoes 0.07 N

Pigs 0.007 0.004 Potatoes 0.18 Y

3.2.2. Nature of residues

The nature of fludioxonil residues in commodities of animal origin was investigated in the framework

of Directive 91/414/EEC (Denmark, 2005). Reported metabolism studies include one study in

lactating goats and one study in laying hens using 14

C-pyrrole labelled fludioxonil (see Table 3-7).

Table 3-7: Summary of available metabolism studies in livestock

Group Species Label

position

No of

animal

Application details Sample details

Rate

(mg/kg bw/d)

Duration

(days)

Commodity Time

Lactating

ruminants Goat

[pyrrole-

4-14C] 2 3.5 4

Milk Daily

Urine and faeces Daily

Tissues After

sacrifice

Laying

poultry Hens

[pyrrole-

4-14C] 5 6.3 8

Eggs Daily

Excreta Daily

Tissues After

sacrifice

Lactating goats were dosed with 3.5 mg/kg bw/d of 14

C-fludioxonil. The parent compound was

identified as the major component of the TRR in liver (13.9 %) and fat (82.6 %). In kidneys the major

components were identified as the glucuronide conjugate of mono-hydroxylated fludioxonil (37.7 %

of the TRR). Since metabolism in rats and ruminants was demonstrated to be similar, the findings in

ruminants can also be extrapolated to pigs.

For poultry there is in principle no necessity to establish a residue definition because the calculated

dietary burden of poultry amounted to less than 0.1 mg/kg DM. Nevertheless, a metabolism study

with laying hens is reported in the DAR. Laying hens were dosed with 6.3 mg/kg bw/d of 14

C-

fludioxonil. The sulphate conjugate of the N-hydroxylated fludioxonil was the major component of

the residue in egg yolks and thigh muscle. In egg whites and liver, the major metabolites resulted from

the opening of the oxidised pyrrole ring. Parent compound was major in breast muscle.


EFSA Journal 2011;9(8):2335 43

Identification of metabolites indicated that the major metabolic pathways were similar in both species;

this pathway proceeds through the hydroxylation of the pyrrole and benzodioxol rings followed by

conjugation reactions. In hens, further reactions involve the opening of the pyrrole ring. Hence the

relevant residue for enforcement and risk assessment in commodities of animal origin is defined 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. These conclusions reached by EFSA are

also in line with the findings of the JMPR (FAO, 2004) and validated analytical methods for

enforcement of the proposed residue definition are available (see also section 1.1).

In the framework of the peer review, parent compound fludioxonil was considered to be fat soluble

based on the fact that its log Po/w is higher than 3 (Denmark, 2005). EFSA therefore concludes that the

residue as defined for commodities of animal origin is fat soluble.

During the consultation of Member States, Germany expressed its disagreement with the enforcement

residue definitions proposed by EFSA and proposed to enforce only the parent compound in

commodities of animal origin. Regarding kidney and milk, EFSA does not agree with the German

proposal because parent fludioxonil was not identified in these commodities and would therefore not

be an appropriate indicator for enforcement. In muscle, fat and liver, EFSA agrees that parent

fludioxonil would be a good indicator compound for the total residue. However, analytical methods

and livestock feeding studies currently presented to EFSA include all metabolites containing the 2,2-

difluorobenzo [1,3]dioxole-4 carboxylic moiety (see also sections 1.2 and 3.2.3). Implementing the

residue definition proposed by Germany would require the rejection of data that were compliant with

the data requirements. EFSA therefore proposes to maintain the residue definition as initially

proposed but it is highlighted that for enforcement of muscle, fat and liver the residue would

preferably be defined as the parent compound only. For this purpose, it would be desirable to provide

EFSA with an analytical method for enforcement of parent fludioxonil only as well as a livestock

feeding study where fludioxonil and metabolites containing the 2,2-difluorobenzo [1,3]dioxole-4

carboxylic moiety are reported separately.

3.2.3. Magnitude of residues

During the peer review under Directive 91/414/EEC the magnitude of fludioxonil residues in

livestock was investigated in a feeding study with lactating cows (Denmark, 2005). Three groups of

lactating cows, each consisting of three animals, were dosed for 28-30 days with fludioxonil at levels

of 0.02, 0.06 and 0.20 mg fludioxonil/kg bw/day. The samples were analyzed for parent fludioxonil

and its metabolites determined as 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155)

and expressed as fludioxonil equivalents.

At the highest dose level, no residues above the LOQ (0.01 or 0.05 mg/kg) were observed in animal

tissues and further analysis was not carried out on the lower dose samples. Residues were found in six

out the eighteen milk samples obtained at the highest dose level. Residue concentrations ranged from

0.010 mg/kg to 0.019 mg/kg. The highest residue was observed 14 days after the first dose

administration. No residues (<0.01 mg/kg) were found in any milk samples from the two lower dose

levels. Results of the livestock feeding study are summarized in Table 3-8.

The demonstrated storage stability of fludioxonil in animal products was evaluated during the peer

review. Studies demonstrated storage stability of fludioxonil in milk, eggs, beef muscle and liver for

up to 12 months when stored deep frozen. Samples collected during the livestock feeding study were

stored for less than 12 months under freezer conditions. Storage stability of metabolites determined as

2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155) was not demonstrated but

considering that the residue definition is based on a common moiety obtained after oxidation of the

extracts, it is unlikely that the residue will hydrolyse even further.


EFSA Journal 2011;9(8):2335 44

Table 3-8: Overview of the values derived from the livestock feeding studies

Commodity Dietary burden Results of the livestock feeding study Median

residue

(mg/kg)

Highest

residue

(mg/kg)

MRL

proposal

(mg/kg)

CF for

RA Med.

(mg/kg

bw/d)

Max.

(mg/kg

bw/d)

Dose Level

(mg/kg

bw/d)

No Result for enf. Result for RA

Mean

(mg/kg)

Max.

(mg/kg)

Mean

(mg/kg)

Max.

(mg/kg)

Residue definition for enforcement and risk assessment: the sum of fludioxonil and all metabolites containing the 2,2-difluoro-benzo[1,3]dioxole-4-carboxylic

moiety, expressed as fludioxonil

Pig meat 0.004 0.007 0.02 3 n.a. n.a. See results for

enforcement residue

definition

0.01 0.01 0.05* (F)

1.00

0.06 3 n.a. n.a.

0.20 3 <0.01 <0.01

Pig fat 0.02 3 n.a. n.a. 0.05 0.05 0.05* 1.00

0.06 3 n.a. n.a.

0.20 3 <0.05 <0.05

Pig liver 0.02 3 n.a. n.a. 0.05 0.05 0.05* 1.00

0.06 3 n.a. n.a.

0.20 3 <0.05 <0.05

Pig kidney 0.02 3 n.a. n.a. 0.05 0.05 0.05* 1.00

0.06 3 n.a. n.a.

0.20 3 <0.05 <0.05

Ruminant meat 0.655 0.659 0.02 3 n.a. n.a. 0.15 0.15 0.2 (F)

(tentative)

1.00

0.06 3 n.a. n.a.

0.20 3 <0.01 <0.01

Ruminant fat 0.02 3 n.a. n.a. 0.15 0.15 0.2

(tentative)

1.00

0.06 3 n.a. n.a.


EFSA Journal 2011;9(8):2335 45

Commodity Dietary burden Results of the livestock feeding study Median

residue

(mg/kg)

Highest

residue

(mg/kg)

MRL

proposal

(mg/kg)

CF for

RA Med.

(mg/kg

bw/d)

Max.

(mg/kg

bw/d)

Dose Level

(mg/kg

bw/d)

No Result for enf. Result for RA

Mean

(mg/kg)

Max.

(mg/kg)

Mean

(mg/kg)

Max.

(mg/kg)

0.20 3 <0.05 <0.05 See results for

enforcement residue

definition Ruminant liver 0.655 0.659 0.02 3 n.a. n.a. 0.15 0.15 0.2

(tentative)

1.00

0.06 3 n.a. n.a.

0.20 3 <0.05 <0.05

Ruminant kidney 0.02 3 n.a. n.a. 0.15 0.15 0.2

(tentative)

1.00

0.06 3 n.a. n.a.

0.20 3 <0.05 <0.05

Milk 0.186 0.188 0.02 18 <0.01 (a)

<0.01 0.01 0.01 0.01* 1.00

0.06 18 <0.01 (a)

<0.01

0.20 18 0.01 (a)

0.02

n.a.: not analysed because residues at higher dosing level(s) were already demonstrated to be at or below the limit of quantification (LOQ).



(a): mean residue level from day 1 until day 28 (3 cows, 6 sampling days).


EFSA Journal 2011;9(8):2335 46

Based on the available livestock feeding study, MRLs and risk assessment values in ruminant and pig

products were calculated in compliance with the latest international recommendations on this matter

(FAO, 2009). Significant residues in milk or any edible matrix of pigs are not expected and MRLs for

these commodities can be established at the LOQ. However, livestock dietary intake for meat

ruminants exceeds the highest dose level of the feeding study. It can therefore not be ascertained that

residues in edible matrices of ruminants will be below the enforcement LOQ and tentative MRLs for

these commodities were calculated, based on extrapolation from the highest available dosing level.

EFSA notes that a feeding study including a higher dosing level was submitted to the RMS. However,

the data gap still remains as the study was not yet evaluated by the RMS.

MRLs for poultry products are not required because poultry is not expected to be exposed to

significant levels of fludioxonil residues.

4. Consumer risk assessment

In the framework of this review, only the uses of fludioxonil reported by the RMS in Appendix A

were considered but the use of fludioxonil was previously assessed by the JMPR (FAO, 2004, 2006).

The CXLs, resulting from these assessments by JMPR and adopted by the CAC, are now international

recommendations that need to be considered by European risk managers when establishing MRLs. In

order to facilitate consideration of these CXLs by risk managers, the consumer exposure was

calculated both with and without consideration of the existing CXLs (see Appendix C.2).

4.1. Consumer risk assessment without consideration of the existing CXLs

Chronic exposure calculations for all crops supported in the framework of this review were performed

using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) (EFSA, 2007a). Input values

for the intake calculations were derived in compliance with Appendix D and are summarized in Table

4-1. For cucurbits with inedible peel, asparagus and celery, residue trials were not sufficient to derive

reliable median residue values and existing EU MRLs are not sufficiently supported by data. In order

to investigate whether these EU MRLs could be maintained awaiting submission of additional

information, EFSA performed the exposure calculation using the existing MRL values for these crops.

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

active substance.

Table 4-1: Input values for the consumer risk assessment (without consideration of CXLs)

Commodity Chronic risk assessment

Input value

(mg/kg)

Comment



Citrus fruits 5.30 Median residue (a)

Pistachios 0.06 Median residue (tentative) (b)

Pome fruits 2.30 Median residue (a)

Apricots 1.06 Median residue (tentative) (b)

Cherries 1.29 Median residue (a)

Peaches 3.65 Median residue (a)

Plums 1.06 Median residue (tentative) (b)


EFSA Journal 2011;9(8):2335 47


Input value

(mg/kg)

Comment

Table grapes 0.38 Median residue (a)

Wine grapes 0.33 Median residue (a)

Strawberries 0.70 Median residue (tentative) (b)

Blackberries 0.53 Median residue (a)

Raspberries 0.53 Median residue (a)

Blueberries 0.37 Median residue (a)

Cranberries 0.37 Median residue (a)

Currants (red, black and white) 0.37 Median residue (a)

Gooseberries 0.37 Median residue (a)

Elderberries 0.24 Median residue (a)

Kiwi 7.30 Median residue (a)

Mangoes 0.02 Median residue x PF (a)

Pomegranate 0.95 Median residue (a)

Potatoes 0.02 Median residue (a)

Sweet potatoes 3.76 Median residue (a)

Yams 3.76 Median residue (a)

Beetroot 1.13 Median residue x CF(a)

Carrots 1.13 Median residue x CF(a)

Celeriac 0.21 Median residue x CF(a)

Horseradish 1.13 Median residue x CF(a)

Parsnips 1.13 Median residue x CF(a)

Parsley root 1.13 Median residue x CF(a)

Salsify 1.13 Median residue x CF(a)

Garlic 0.06 Median residue x CF(a)

Onions 0.06 Median residue x CF(a)

Shallots 0.06 Median residue x CF(a)

Spring onions 0.52 Median residue x CF(a)

Tomatoes 0.15 Median residue (a)

Peppers 0.21 Median residue (a)

Aubergines (egg plants) 0.12 Median residue (a)

Cucurbits with edible peel 0.10 Median residue (a)

Cucurbits with inedible peel 0.05 EU MRL (c)

Sweet corn 0.01 Median residue (=LOQ) (a)

Lamb’s lettuce 0.66 Median residue (a)

Lettuce 3.23 Median residue (a)

Scarole (broad-leaf endive) 3.23 Median residue (a)


EFSA Journal 2011;9(8):2335 48


Input value

(mg/kg)

Comment

Cress 0.66 Median residue (a)

Land cress 0.66 Median residue (a)

Rocket, Rucola 0.66 Median residue (a)

Red mustard 0.66 Median residue (a)

Leaves and sprouts of Brassica 0.66 Median residue (a)

Spinach 2.60 Median residue (a)

Beet leaves (chard) 2.60 Median residue (a)

Witloof 0.02 Median residue (a)

Chives 2.71 Median residue (a)

Basil 2.71 Median residue (a)

Beans (fresh, with pods) 0.48 Median residue (a)

Beans (fresh, without pods) 0.02 Median residue (a)

Peas (fresh, with pods) 0.48 Median residue (a)

Peas (fresh, without pods) 0.02 Median residue (a)

Lentils (fresh) 0.02 Median residue (a)

Asparagus 0.01 Median residue (=LOQ)(a)

Celery 0.05 EU MRL (c)

Fennel 0.03 Median residue (a)

Pulses, dry 0.02 Median residue (a)

Poppy seed 0.01 Median residue (=LOQ)(a)

Sunflower seed 0.01 Median residue (=LOQ)(a)

Rape seed 0.01 Median residue (=LOQ)(a)

Soya bean 0.01 Median residue (=LOQ)(a)

Cotton seed 0.01 Median residue (=LOQ)(a)

Barley grain 0.01 Median residue (=LOQ)(a)

Maize grain 0.01 Median residue (=LOQ)(a)

Oats grain 0.01 Median residue (=LOQ)(a)

Rye grain 0.01 Median residue (=LOQ)(a)

Wheat grain 0.01 Median residue (=LOQ)(a)

Herbal infusions (dried, roots) 1.13 Median residue x CF (a)

Spices (roots and rhizome) 1.13 Median residue x CF (a)

Sugar beet (roots) 0.01 Median residue (=LOQ)(a)

Swine meat 0.01 Median residue (d)

Swine fat (free of lean meat) 0.05 Median residue (d)

Swine liver 0.05 Median residue (d)

Swine kidney 0.05 Median residue (d)


EFSA Journal 2011;9(8):2335 49


Input value

(mg/kg)

Comment

Ruminant meat 0.15 Median residue (tentative) (b)

Ruminant fat 0.15 Median residue (tentative) (b)

Ruminant liver 0.15 Median residue (tentative) (b)

Ruminant kidney 0.15 Median residue (tentative) (b)

Ruminant milk 0.01 Median residue (d)

(a): At least one relevant GAP reported by the RMS is fully supported by data for this commodity; the risk assessment value

derived in section 3 is used for the exposure calculations.

(b): Use reported by the RMS is not fully supported by data but the risk assessment value derived in section 3 is used for

indicative exposure calculations.

(c): Use reported by the RMS is not fully supported by data; the existing EU MRL is used for indicative exposure

calculations (also assuming the existing residue definition).

(d): Livestock dietary burden resulting from the GAPs reported by the RMS is fully supported by data for this commodity;

the risk assessment value derived in section 3 is used for the exposure calculations.

The calculated exposures were compared with the toxicological reference value derived for

fludioxonil (see Table 2-1); detailed results of the calculations are presented as the EU scenario in

Appendix B.1. The highest chronic exposure was calculated for the German child, representing

16.5 % of the ADI.

Based on the above calculations, EFSA concludes that the uses of fludioxonil on crops fully

supported by data (footnote a in Table 4-1), are acceptable with regard to consumer exposure. For all

remaining crops, major uncertainties remain due to the data gaps identified in section 3 but

considering tentative MRLs or the existing EU MRLs in the exposure calculation did not indicate a

risk to consumers.

4.2. Consumer risk assessment with consideration of the existing CXLs

In order to include the CXLs in the calculations of the consumer exposure, all data relevant to the

consumer exposure assessment have been collected from JMPR evaluations and reported in Appendix

C.2 to this document. These CXLs were compared with the EU MRL proposals in compliance with

Appendix D and input values resulting from this comparison are summarized in Table 4-2. For cereals

and oilseeds, CXLs are set at an LOQ of 0.05 mg/kg to accommodate for seed treatments while the

European LOQ for enforcement is determined at 0.01 mg/kg. Based on the available metabolism

studies for seed treatments, EFSA considers that these CXLs are covered by the enforcement LOQ of

0.01 mg/kg; the same value is used for risk assessment purposes.

For risk assessment purposes, all CXLs for fludioxonil have been established for parent compound

only in products of plant origin, and for the sum of fludioxonil and its metabolites oxidized to

metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid in products of animal origin. In order to

express the Codex risk assessment values according to the EU risk assessment definition, a conversion

factor of 2.8 was applied for root and tuber vegetables. For all other crops, a conversion factor of 1

was estimated.

At European level there are no agreed extrapolations for commodities of animal origin between

animals (from ruminants to horses and other farm animals ) and between commodities (from a single

offal to all edible offals). Therefore there is no need to consider the CXLs that have been established

in horses and other farm animals and in edible offals (other than liver and kidney).


EFSA Journal 2011;9(8):2335 50

Table 4-2: Input values for the consumer risk assessment (with consideration of CXLs)


Input value (mg/kg) Comment



Citrus fruits 5.30 Median residue (a)

Pistachios 0.06 Median residue (CXL) (e)

Pome fruits 2.10 Median residue (CXL) (e)

Apricots 1.06 Median residue (CXL) (e)

Cherries 0.80 Median residue (CXL) (e)

Peaches 3.65 Median residue (a)

Plums 1.06 Median residue (CXL) (e)

Table grapes 0.38 Median residue (a)

Wine grapes 0.33 Median residue (a)

Strawberries 0.70 Median residue (tentative) (b)

Cane fruits 1 Median residue (CXL) (e)

Blueberries 0.37 Median residue (a)

Cranberries 0.37 Median residue (a)

Currants (red, black and white) 0.37 Median residue (a)

Gooseberries 0.37 Median residue (a)

Elderberries 0.24 Median residue (a)

Kiwi 7.30 Median residue (a)

Mangoes 0.02 Median residue x PF (a)

Pomegranate 0.95 Median residue (a)

Potatoes 0.02 Median residue (a)

Sweet potatoes 3.76 Median residue (a)

Yams 3.76 Median residue (a)

Beetroot 1.13 Median residue x CF (a)

Carrots 1.13 Median residue x CF (a)

Celeriac 0.21 Median residue x CF (a)

Horseradish 1.13 Median residue x CF (a)

Parsnips 1.13 Median residue x CF (a)

Parsley root 1.13 Median residue x CF (a)

Salsify 1.13 Median residue x CF (a)

Garlic 0.06 Median residue x CF (a)

Onions 0.11 Median residue (CXL) x CF (e)

Shallots 0.06 Median residue x CF (a)

Spring onions 1.65 Median residue (CXL) x CF (e)


EFSA Journal 2011;9(8):2335 51



Tomatoes 0.15 Median residue (a)

Peppers 0.21 Median residue (a)

Aubergines (egg plants) 0.12 Median residue (a)

Cucurbits with edible peel 0.10 Median residue (a)

Cucurbits with inedible peel 0.05 EU MRL (c)

Sweet corn 0.01 Median residue (=LOQ) (a)

Broccoli 0.23 Median residue (CXL) (e)

Head cabbage 0.24 Median residue (CXL) (e)

Chinese cabbage 1.20 Median residue (CXL) (e)

Lamb’s lettuce 0.66 Median residue (a)

Lettuce 3.23 Median residue (a)

Scarole (broad-leaf endive) 3.23 Median residue (a)

Cress 0.66 Median residue (a)

Land cress 0.66 Median residue (a)

Rocket, Rucola 0.66 Median residue (a)

Red mustard 0.66 Median residue (a)

Leaves and sprouts of Brassica 0.66 Median residue (a)

Spinach 2.60 Median residue (a)

Beet leaves (chard) 2.60 Median residue (a)

Water cress 1.20 Median residue (CXL) (e)

Witloof 0.02 Median residue (a)

Chives 2.71 Median residue (a)

Basil 2.71 Median residue (a)

Beans (fresh, with pods) 0.48 Median residue (a)

Beans (fresh, without pods) 0.02 Median residue (a)

Peas (fresh, with pods) 0.48 Median residue (a)

Peas (fresh, without pods) 0.02 Median residue (a)

Lentils (fresh) 0.02 Median residue (a)

Asparagus 0.01 Median residue (=LOQ) (a)

Celery 0.05 EU MRL (c)

Fennel 0.03 Median residue (a)

Pulses, dry 0.02 Median residue (a)

Poppy seed 0.01 Median residue (=LOQ) (a)

Sunflower seed 0.01 Median residue (=LOQ) (a)

Rape seed 0.01 Median residue (=LOQ) (a)

Soya bean 0.01 Median residue (=LOQ) (a)


EFSA Journal 2011;9(8):2335 52



Cotton seed 0.02 Median residue (CXL=LOQ) (a)

Barley grain 0.01 Median residue (=LOQ) (a)

Buckwheat grain 0.01 Median residue (CXL/EU) (f)

Maize grain 0.01 Median residue (=LOQ) (a)

Millet grain 0.01 Median residue (CXL/EU) (f)

Oats grain 0.01 Median residue (=LOQ) (a)

Rice grain 0.01 Median residue (CXL/EU) (f)

Rye grain 0.01 Median residue (=LOQ) (a)

Sorghum grain 0.01 Median residue (CXL/EU) (f)

Wheat grain 0.01 Median residue (=LOQ) (a)

Herbal infusions (dried, roots) 1.13 Median residue x CF (a)

Spices (roots and rhizome) 1.13 Median residue x CF (a)

Sugar beet (roots) 0.01 Median residue (=LOQ) (a)

Swine meat 0.01 Median residue (d)

Swine fat (free of lean meat) 0.05 Median residue (d)

Swine liver 0.05 Median residue (d)

Swine kidney 0.05 Median residue (d)

Ruminant meat 0.15 Median residue (tentative) (b)

Ruminant fat 0.15 Median residue (tentative) (b)

Ruminant liver 0.15 Median residue (tentative) (b)

Ruminant kidney 0.15 Median residue (tentative) (b)

Poultry meat 0.01 CXL (=LOQ) (e)

Poultry liver 0.05 CXL (=LOQ) (e)

Poultry kidney 0.05 CXL (=LOQ) (e)

Ruminant milk 0.01 Median residue (d)

Birds’ eggs 0.05 CXL (=LOQ) (e)

(a): At least one relevant GAP reported by the RMS is fully supported by data for this commodity; the risk assessment value

derived in section 3 is used for the exposure calculations.

(b): Use reported by the RMS is not fully supported by data but the risk assessment value derived in section 3 is used for

indicative exposure calculations.

(c): Use reported by the RMS is not fully supported by data; the existing EU MRL is used for indicative exposure

calculations (also assuming the existing residue definition).

(d): Livestock dietary burden resulting from the GAPs reported by the RMS is fully supported by data for this commodity;

the risk assessment value derived in section 3 is used for the exposure calculations.

(e): CXL is supported by data; the corresponding risk assessment value is used for the exposure calculations.

(f): CXL is supported by data but assuming that the EU LOQ for enforcement is set at 0.01 mg/kg; this value is also used for

risk assessment purposes.

Chronic exposure calculation was also performed using revision 2 of the EFSA PRIMo and calculated

exposures were compared with the toxicological reference value derived for fludioxonil (see Table 2-

1); detailed results of the calculations are presented as the EU/Codex scenario in Appendix B.2. The

highest chronic exposure was calculated for German child, representing 15.8 % of the ADI.


EFSA Journal 2011;9(8):2335 53

Based on the above calculations, EFSA concludes that all CXLs, which are all supported by data, are

not expected to be of concern for European consumers. EFSA notes that the CXLs for pistachios,

apricots and plums are supported by the same data as those evaluated in section 3 and that a data gap

was identified for these three crops. However, as those CXLs are internationally agreed upon, also by

EU risk managers, EFSA considers that no further information is required to support these CXLs.

CONCLUSIONS AND RECOMMENDATIONS

CONCLUSIONS

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

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


EFSA Journal 2011;9(8):2335 54

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).

RECOMMENDATIONS

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

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:


EFSA Journal 2011;9(8):2335 55

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;

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.


EFSA Journal 2011;9(8):2335 56

Code

number

Commodity Existing

EU MRL

(mg/kg)

Existing

CXL

(mg/kg)


MRL

(mg/kg)

Comment


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)

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)


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)


EFSA Journal 2011;9(8):2335 57

Code

number

Commodity Existing

EU MRL

(mg/kg)

Existing

CXL

(mg/kg)


MRL

(mg/kg)

Comment

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)

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)


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


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)


EFSA Journal 2011;9(8):2335 58

Code

number

Commodity Existing

EU MRL

(mg/kg)

Existing

CXL

(mg/kg)


MRL

(mg/kg)

Comment

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)

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)


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


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


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)


EFSA Journal 2011;9(8):2335 59

Code

number

Commodity Existing

EU MRL

(mg/kg)

Existing

CXL

(mg/kg)


MRL

(mg/kg)

Comment

1012010 Bovine meat 0.05* 0.01* 0.2 (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)


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)


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)

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




(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).


EFSA Journal 2011;9(8):2335 60

(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).

DOCUMENTATION PROVIDED TO EFSA

1. Pesticide Residues Overview File (PROFile) on fludioxonil prepared by the rapporteur Member

State Denmark in the framework of Article 12 of Regulation (EC) No 396/2005. Submitted to

EFSA on 02 March 2010. Last updated on 14 January 2011.

REFERENCES

Austria, 2011. Evaluation report prepared under Article 12 of Regulation (EC) No 396/2005.

Authorised uses to be considered for the review of the existing MRLs for fludioxonil, March 2011.

Belgium, 2011. Evaluation report prepared under Article 12 of Regulation (EC) No 396/2005.

Authorised uses to be considered for the review of the existing MRLs for fludioxonil, May 2011.

CEN (European Committee for Standardization), 2008. Foods of plant origin - Determination of

pesticide residues using GC-MS and/or LC-MS/MS following acetonitrile extraction/partitioning

and clean-up by dispersive SPE. QuEChERS-method. EN 15662, November 2008.

Denmark, 2005. Draft assessment report on the active substance fludioxonil prepared by the

rapporteur Member State Denmark in the framework of Council Directive 91/414/EEC, June 2005.

Denmark, 2007. Final addendum to the draft assessment report on the active substance fludioxonil

prepared by the rapporteur Member State Denmark in the framework of Council Directive

91/414/EEC, compiled by EFSA, June 2007.

Denmark, 2010. Evaluation report on the review of the existing EU MRLs for fludioxonil prepared by

the rapporteur Member State Denmark in the framework of Article 12 of Regulation (EC) No

396/2005, March 2010.

Denmark, 2011. Evaluation report prepared under Article 12 of Regulation (EC) No 396/2005.


EC (European Commission), 1996. Appendix G. Livestock Feeding Studies. 7031/VI/95 rev.4.

Available online: http://ec.europa.eu/food/plant/protection/resources/publications_en.htm

EC (European Commission), 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-

rev.3. Available online: http://ec.europa.eu/food/plant/protection/resources/publications_en.htm

EC (European Commission), 1997b. Appendix B. General recommendations for the design,

preparation and realization of residue trials. Annex 2. Classification of (minor) crops not listed in

the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. Available online:

http://ec.europa.eu/food/plant/protection/resources/publications_en.htm

EC (European Commission), 1997c. Appendix C. Testing of plant protection products in rotational

crops. 7524/VI/95-rev.2. Available online:


EC (European Commission), 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. Available

online: http://ec.europa.eu/food/plant/protection/resources/publications_en.htm

EC (European Commission), 1997e. Appendix F. Metabolism and distribution in domestic animals.

7030/VI/95-rev.3. Available online:









EFSA Journal 2011;9(8):2335 61

EC (European Commission), 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-

rev.5. Available online: http://ec.europa.eu/food/plant/protection/resources/publications_en.htm

EC (European Commission), 1997g. Appendix I. Calculation of maximum residue level and safety

intervals. 7039/VI/95. As amended by the document: classes to be used for the setting of EU

pesticide maximum residue levels (MRLs). SANCO 10634/2010. Available online:


EC (European Commission), 2000. Residue analytical methods. For pre-registration data requirement

for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414.

SANCO/3029/99-rev.4. Available online:


EC (European Commission), 2004. Residue analytical methods. For post-registration control.

SANCO/825/00-rev.7. Available online:


EC (European Commission), 2010. Classes to be used for the setting of EU pesticide Maximum

Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalized in the Standing Committee on the

Food Chain and Animal Health at its meeting of 23-24 March 2010. Available online:


EC (European Commission), 2011. Appendix D. Guidelines on comparability, extrapolation, group

tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. Available online:


EFSA (European Food Safety Authority), 2007a. Reasoned opinion on the potential chronic and acute

risk to consumers’ health arising from proposed temporary EU MRLs according to Regulation

(EC) No 396/2005 on Maximum Residue Levels of Pesticides in Food and Feed of Plant and

Animal Origin. 15 March 2007.

EFSA (European Food Safety Authority), 2007b. Conclusion on the peer review of the pesticide risk

assessment of the active substance fludioxonil. EFSA Scientific Report (2007) 110, 1-85.

EFSA (European Food Safety Authority), 2008. Reasoned opinion on the setting of an import

tolerance for fludioxonil in pomegranates. EFSA Scientific Report (2008) 199, 1-19.

EFSA (European Food Safety Authority), 2009a. Reasoned opinion on the modification of the

existing MRLs for fludioxonil in various root vegetables. EFSA Scientific Report (2009) 238, 1-27.

EFSA (European Food Safety Authority), 2009b. Reasoned opinion on the modification of the

existing MRLs for fludioxonil in spinach and beet leaves (chard). EFSA Scientific Report (2009)

244, 1-23.

EFSA (European Food Safety Authority), 2009c. Reasoned opinion on the modification of the

existing MRL for fludioxonil in celeriac. EFSA Journal 2009;7(10):1345. [22 pp.].

doi:10.2903/j.efsa.2009.1345. Available online: www.efsa.europa.eu/efsajournal.htm

EFSA (European Food Safety Authority), 2010. Reasoned opinion on the modification of the existing

MRLs for fludioxonil in sweet potatoes, yams and grapes. EFSA Journal 2010;8(11):1912. [25

pp.] doi:10.2903/j.efsa.2010.1912. Available online: www.efsa.europa.eu/efsajournal.htm

FAO (Food and Agriculture Organization of the United Nations), 2004. Fludioxonil. In: Pesticide

residues in food – 2004. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide

Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO

Plant Production and Protection Paper 178. Available online:

http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/jmpr/jmpr-rep/en/










http://www.efsa.europa.eu/efsajournal.htm

http://www.efsa.europa.eu/efsajournal.htm



EFSA Journal 2011;9(8):2335 62



FAO (Food and Agriculture Organization of the United Nations), 2009. Submission and evaluation of

pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide

Residues. 2nd

Ed. FAO Plant Production and Protection Paper 197, 264 pp.






Finland, 2011. Evaluation report prepared under Article 12 of Regulation (EC) No 396/2005.


France, 2011. Evaluation report prepared under Article 12 of Regulation (EC) No 396/2005.


Germany, 2011. Evaluation report prepared under Article 12 of Regulation (EC) No 396/2005.


The Netherlands, 2011. Evaluation report prepared under Article 12 of Regulation (EC) No 396/2005.


The United Kingdom, 2007. COP 2007/00218: D stream application for Switch (cyprodinil,

fludioxonil) for use as a fungicide on lettuce, leaf herbs, edible flowers, leafy brassicas (baby leaf),

spinach and beet leaves (chard). Residues filenote, June 2007.

The United Kingdom, 2010. COP 2010/00867: O/L stream application for Switch (Cyprodinil,

fludioxonil) for use as a fungicide on outdoor and protected lettuce and salad crops. Residues

filenote, December 2010.


http://www.fao.org/docrep/012/i1216e/i1216e00.htm

http://www.fao.org/docrep/012/i1216e/i1216e00.htm



EFSA Journal 2011;9(8):2335 63

APPENDIX A – GOOD AGRICULTURAL PRACTICES (GAPS)

Conc. UnitFrom

BBCH

Until

BBCHMin. Max. Min. Max.

Apples Malus domesticus NEU Outdoor NL WG 250.0 g/L Foliar treatment - spraying 3 10 14 0.30 kg a.i./ha 3

Pears Pyrus communis NEU Outdoor NL WG 250.0 g/L Foliar treatment - spraying 3 10 14 0.30 kg a.i./ha 3

Apricots Prunus armeniaca NEU Outdoor FR Foliar treatment - spraying 3 0.25 kg a.i./ha 7

CherriesPrunus cerasus,

Prunus aviumNEU Outdoor WG 250.0 g/L Foliar treatment - spraying 3 7 14 0.25 kg a.i./ha 7

Peaches Prunus persica NEU Outdoor Foliar treatment - spraying 3 0.25 kg a.i./ha 7

Plums Prunus domestica NEU Outdoor WG 250.0 g/L Foliar treatment - spraying 3 7 14 0.25 kg a.i./ha 7

Table grapes Vitis euvitis NEU Outdoor DE Foliar treatment - spraying 75 2 0.24 kg a.i./ha 35

Wine grapes Vitis euvitis NEU Outdoor FR WG 250.0 g/kg Foliar treatment - spraying 0 2 0.30 kg a.i./ha 21

Strawberries Fragaria x ananassa NEU Outdoor NL WG 250.0 g/kg Foliar treatment - spraying 3 10 14 0.25 kg a.i./ha 1

Blackberries Rubus fruticosus NEU Outdoor FR Foliar treatment - spraying 61 89 3 10 0.25 kg a.i./ha 7

Raspberries Rubus idaeus NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 61 89 3 10 0.25 kg a.i./ha 7

BlueberriesVaccinium

corymbosumNEU Outdoor BE, IE, FR WG 250.0 g/kg Foliar treatment - spraying 61 89 3 10 0.25 kg a.i./ha 7

CranberriesVaccinium

macrocarpon NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 10 0.25 kg a.i./ha 7

Currants (red, black and

white)Ribes nigrum, rubrum NEU Outdoor BE, IE, FR WG 250.0 g/kg Foliar treatment - spraying 3 10 0.25 kg a.i./ha 7

Gooseberries Ribes uva-crispa NEU Outdoor FR Foliar treatment - spraying 3 10 0.25 kg a.i./ha 7

Elderberries Sambucus nigra NEU Outdoor AT WG 250.0 g/kg Foliar treatment - spraying 3 14 21 0.25 kg a.i./ha 28

PotatoesTuber form Solanum

SppNEU Outdoor FS 100.0 g/L

Seed treatment - general (see also

comment field)0 0 1 25.00 g a.i./ton n.a. or 4 L/tonne

BeetrootBeta vulgaris subsp.

VulgarisNEU Outdoor WG 25.0 % (w/w) Foliar treatment - spraying 3 12 0.25 kg a.i./ha 7

Carrots Daucus carota NEU Outdoor WG 25.0 % (w/w) Foliar treatment - spraying 3 12 0.25 kg a.i./ha 7

CeleriacApium graveolens var.

rapaceum NEU Outdoor FR WG 250.0 g/kg Foliar treatment - spraying 2 14 0.25 kg a.i./ha 14

Horseradish Armoracia rusticana NEU Outdoor WG 25.0 % (w/w) Foliar treatment - spraying 3 12 0.25 kg a.i./ha 7

Parsnips Pastinaca sativa NEU Outdoor WG 25.0 % (w/w) Foliar treatment - spraying 3 12 0.25 kg a.i./ha 7

Parsley root Petroselinum crispum NEU Outdoor WG 25.0 % (w/w) Foliar treatment - spraying 3 12 0.25 kg a.i./ha 7

Salsify Tragopogon porrifolius NEU Outdoor WG 25.0 % (w/w) Foliar treatment - spraying 3 12 0.25 kg a.i./ha 7

Garlic Allium sativum NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 14 0.25 kg a.i./ha 14

Onions Allium cepa NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 14 0.25 kg a.i./ha 14

Shallots

Allium ascalonicum

(Allium cepa var.

aggregatum)

NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 14 0.25 kg a.i./ha 14

Spring onions Allium cepa NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 14 0.25 kg a.i./ha 7

TomatoesLycopersicum

esculentum NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 7 0.25 kg a.i./ha 3

Aubergines (egg plants) Solanum melongena NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 7 0.25 kg a.i./ha 3

Cucumbers Cucumis sativus NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 7 0.25 kg a.i./ha 3

Gherkins Cucumis sativus NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 7 0.25 kg a.i./ha 3

CourgettesCucurbita pepo var.

melopepo NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 7 0.25 kg a.i./ha 3

Sweet cornZea mays var.

sacharata NEU Outdoor FR


comment field)0 0 1 2.50

g a.i./100

kgn.a. spray

Lamb's lettuce Valerianella locusta NEU Outdoor UK WG 25.0 % (w/w) Foliar treatment - spraying 2 0.20 kg a.i./ha 7

Lettuce Lactuca sativa NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 10 0.18 kg a.i./ha 7

Scarole (broad-leaf

endive)Cichorium endiva NEU Outdoor NL WG 250.0 g/L Foliar treatment - spraying 3 0.15 kg a.i./ha 7

Cress Lepidium sativum NEU Outdoor UK WG 25.0 % (w/w) Foliar treatment - spraying 2 0.20 kg a.i./ha 7

Land cress Barbarea verna NEU Outdoor UK WG 25.0 % (w/w) Foliar treatment - spraying 2 0.20 kg a.i./ha 7

Rocket, RucolaEruca sativa (Diplotaxis

spec.)NEU Outdoor UK WG 25.0 % (w/w) Foliar treatment - spraying 2 0.20 kg a.i./ha 7

Max. rate Rate UnitComments (max. 250 charachters)

Common name Scientific name Type

Content

Method

Growth stage Number Interval (days)

Min. rate

Critical Outdoor GAPs for Northern Europe

Crop

RegionOutdoor/

Indoor

Member state or

CountryPests controlled

Formulation Application Application rate PHI or

wiaiting

period

(days)


EFSA Journal 2011;9(8):2335 64

Conc. UnitFrom

BBCH

Until


Red mustardBrassica juncea var.

rugosaNEU Outdoor UK WG 25.0 % (w/w) Foliar treatment - spraying 2 0.20 kg a.i./ha 7

Leaves and sprouts of

Brassica sppBrassica spp NEU Outdoor UK WG 25.0 % (w/w) Foliar treatment - spraying 2 0.20 kg a.i./ha 7

WitloofCichorium intybus. var.

Foliosum NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 1 25.00 g a.i./hL n.a. or 5 g a.s./tonne root

Beans (with pods) Phaseolus vulgaris, NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 10 0.25 kg a.i./ha 14

Beans (without pods) Phaseolus vulgaris NEU Outdoor NL WG 250.0 g/L Foliar treatment - spraying 2 0.25 kg a.i./ha 14

Peas (with pods) Pisum sativum NEU Outdoor FR Foliar treatment - spraying 3 0.25 kg a.i./ha 14

Peas (without pods) Pisum sativum NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 2 10 0.25 kg a.i./ha 14

Lentils (fresh)Lens culinaris syn. L.

esculentaNEU Outdoor NL Foliar treatment - spraying 60 71 2 10 14 0.25 kg a.i./ha 14

Asparagus Asparagus officinalis NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 3 14 0.30 kg a.i./ha n.a. PHI > 6 months

CeleryApium graveolens var.

dulceNEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 2 10 0.25 kg a.i./ha 14

Fennel Foeniculum vulgare NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 2 10 0.20 kg a.i./ha 7

Beans (dry) Phaseolus vulgaris NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 2 10 14 0.25 kg a.i./ha 28

Lentils (dry)Lens culinaris syn. L.

esculentaNEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 2 10 14 0.25 kg a.i./ha 28

Peas (dry) Pisum sativum NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 2 10 14 0.25 kg a.i./ha 28

Lupins Lupinus spp. NEU Outdoor WG 250.0 g/kg Foliar treatment - spraying 2 10 14 0.25 kg a.i./ha 28

Poppy seed Papaver somniferum NEU Outdoor FS 25.0 g/LSeed treatment - general (see also

comment field)0 0 1 12.00 15.00

g a.i./100

kgn.a.

Sunflower seed Helianthus annuus NEU Outdoor FS 25.0 g/LSeed treatment - general (see also

comment field)0 0 1 12.00 15.00

g a.i./100

kgn.a.

Rape seed Brassica napus NEU Outdoor FS 25.0 g/LSeed treatment - general (see also

comment field)0 0 1 12.00 15.00

g a.i./100

kgn.a.

Soya bean Glycine max NEU Outdoor FS 25.0 g/LSeed treatment - general (see also

comment field)0 0 1 12.00 15.00

g a.i./100

kgn.a.

Cotton seed Gossypium spp. NEU Outdoor FS 25.0 g/LSeed treatment - general (see also

comment field)0 0 1 12.00 15.00

g a.i./100

kgn.a.

Gold of pleasure Camelina sativa NEU Outdoor FIfusarium filt, downy

mildews, flea beatleFS 8.0 g/L


comment field)0 0 1 12.00 16.00

g a.i./100

kgn.a.

Barley Hordeum spp. NEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

Maize Zea mays NEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

Oats Avena fatua NEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

Rye Secale cereale NEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

Wheat Triticum aestivum NEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

Herbal infusions (roots) Not specified NEU Outdoor WG 25.0 % (w/w) Foliar treatment - spraying 3 12 0.25 kg a.i./ha 7

Spices (roots and

rhizome)Not specified NEU Outdoor WG 25.0 % (w/w) Foliar treatment - spraying 3 12 0.25 kg a.i./ha 7

Sugar beet Beta vulgaris NEU Outdoor DK 930.0 g/kgSeed treatment - general (see also

comment field)1 0.01 kg a.i./unit n.a.

Max. rate Rate UnitComments (max. 250 charachters)

Common name Scientific name Type

Content

Method


Min. rate

Critical Outdoor GAPs for Northern Europe

Crop

RegionOutdoor/

Indoor

Member state or



wiaiting

period

(days)


EFSA Journal 2011;9(8):2335 65

Conc. UnitFrom

BBCH

Until


Apples Malus domesticus SEU Outdoor Foliar treatment - spraying 3 6 14 0,25 kg a.i./ha 3

Pears Pyrus communis SEU Outdoor Foliar treatment - spraying 3 6 14 0,25 kg a.i./ha 3

Apricots Prunus armeniaca SEU Outdoor FR Foliar treatment - spraying 2 0,25 kg a.i./ha 7


Prunus aviumSEU Outdoor Foliar treatment - spraying 3 7 14 0,25 kg a.i./ha 7

Peaches Prunus persica SEU Outdoor Foliar treatment - spraying 2 0,25 kg a.i./ha 7

Plums Prunus domestica SEU Outdoor Foliar treatment - spraying 3 7 14 0,25 kg a.i./ha 7

Table grapes Vitis euvitis SEU Outdoor IT, ES, PT, FR WG 500,0 g/kg Foliar treatment - spraying 60 88 2 0,50 kg a.i./ha 7

Wine grapes Vitis euvitis SEU Outdoor IT, ES, PT, FR WG 500,0 g/kg Foliar treatment - spraying 60 88 2 0,50 kg a.i./ha 21

Strawberries Fragaria x ananassa SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 10 14 0,25 kg a.i./ha 1

Blackberries Rubus fruticosus SEU Outdoor FR Foliar treatment - spraying 3 10 0,25 kg a.i./ha 7

Raspberries Rubus idaeus SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 10 0,25 kg a.i./ha 7

BlueberriesVaccinium

corymbosumSEU Outdoor FR Foliar treatment - spraying 61 89 3 10 0,25 kg a.i./ha 7

CranberriesVaccinium

macrocarpon SEU Outdoor FR Foliar treatment - spraying 61 89 3 10 0,25 kg a.i./ha 7

Currants (red, black and

white)Ribes nigrum, rubrum SEU Outdoor FR Foliar treatment - spraying 61 89 3 10 0,25 kg a.i./ha 7

Gooseberries Ribes uva-crispa SEU Outdoor FR Foliar treatment - spraying 61 89 3 10 0,25 kg a.i./ha 7

PotatoesTuber form Solanum

SppSEU Outdoor FS 100,0 g/L


comment field)0 0 1 25,00 g a.i./ton n.a. or 4 L/tonne

Carrots Daucus carota SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 12 0,25 kg a.i./ha 7

Garlic Allium sativum SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 14 0,25 kg a.i./ha 7

Onions Allium cepa SEU Outdoor FR WG 250,0 g/kg Foliar treatment - spraying 3 14 0,25 kg a.i./ha 7

Shallots

Allium ascalonicum

(Allium cepa var.

aggregatum)

SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 14 0,25 kg a.i./ha 7

Spring onions Allium cepa SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 14 0,25 kg a.i./ha 7


esculentum SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 7 0,25 kg a.i./ha 3

Aubergines (egg plants) Solanum melongena SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 7 0,25 kg a.i./ha 3

Cucumbers Cucumis sativus SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 7 0,25 kg a.i./ha 3

Gherkins Cucumis sativus SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 7 0,25 kg a.i./ha 3


melopepo SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 7 0,25 kg a.i./ha 3

Sweet cornZea mays var.

sacharata SEU Outdoor FR


comment field)0 0 1 2,50

g a.i./100

kgn.a. spray

Max. rate Rate Unit

Application rate PHI or

wiaiting

period

(days)

Comments (max. 250 charachters)Common name Scientific name Type

Content

Method


Min. rate

Critical Outdoor GAPs for Southern Europe

Crop

RegionOutdoor/

Indoor

Member state or


Formulation Application


EFSA Journal 2011;9(8):2335 66

Lettuce Lactuca sativa SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 10 0,18 kg a.i./ha 7

Scarole (broad-leaf

endive)Cichorium endiva SEU Outdoor FR Foliar treatment - spraying 3 0,15 kg a.i./ha 14

Spinach Spinacia oleracea SEU Outdoor PT WG 250,0 g/kg Foliar treatment - spraying 2 10 0,15 kg a.i./ha 14GAP as reported by Portugal in

EFSA RO (No.244; 2009)

Beet leaves (chard) Beta vulgaris SEU Outdoor PT WG 250,0 g/kg Foliar treatment - spraying 2 10 0,15 kg a.i./ha 14GAP as reported by Portugal in

EFSA RO (No.244; 2009)

Beans (with pods) Phaseolus vulgaris, SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 10 0,25 kg a.i./ha 14

Beans (without pods) Phaseolus vulgaris SEU Outdoor FR Foliar treatment - spraying 2 0,25 kg a.i./ha 14

Peas (with pods) Pisum sativum SEU Outdoor FR Foliar treatment - spraying 3 0,25 kg a.i./ha 14

Peas (without pods) Pisum sativum SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 2 10 0,25 kg a.i./ha 14

Asparagus Asparagus officinalis SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 3 10 0,25 kg a.i./ha n.a. PHI > 6 months

CeleryApium graveolens var.

dulceSEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 2 10 0,25 kg a.i./ha 14

Fennel Foeniculum vulgare SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 2 10 0,20 kg a.i./ha 7

Beans (dry) Phaseolus vulgaris SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 2 10 0,25 kg a.i./ha 28

Lentils (dry)Lens culinaris syn. L.

esculentaSEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 2 10 0,25 g a.i./ha 28

Peas (dry) Pisum sativum SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 2 10 0,25 kg a.i./ha 28

Lupins Lupinus spp. SEU Outdoor WG 250,0 g/kg Foliar treatment - spraying 2 10 0,25 kg a.i./ha 28

Poppy seed Papaver somniferum SEU Outdoor FS 25,0 g/LSeed treatment - general (see also

comment field)0 0 1 12,00 15,00

g a.i./100

kgn.a.

Sunflower seed Helianthus annuus SEU Outdoor FS 25,0 g/LSeed treatment - general (see also

comment field)0 0 1 12,00 15,00

g a.i./100

kgn.a.

Rape seed Brassica napus SEU Outdoor FS 25,0 g/LSeed treatment - general (see also

comment field)0 0 1 12,00 15,00

g a.i./100

kgn.a.

Soya bean Glycine max SEU Outdoor FS 25,0 g/LSeed treatment - general (see also

comment field)0 0 1 12,00 15,00

g a.i./100

kgn.a.

Cotton seed Gossypium spp. SEU Outdoor FS 25,0 g/LSeed treatment - general (see also

comment field)0 0 1 12,00 15,00

g a.i./100

kgn.a.

Barley Hordeum spp. SEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

Maize Zea mays SEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

Oats Avena fatua SEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

Rye Secale cereale SEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

Wheat Triticum aestivum SEU OutdoorSeed treatment - general (see also


g a.i./100

kgn.a.

n.a.: not applicable


EFSA Journal 2011;9(8):2335 67

Conc. UnitFrom

BBCH

Until


Grapefruit Citrus paradisi NEU/SEU Indoor SC 200,0 g/L Post-harvest - spraying 99 99 2 0,06 kg a.i./hL n.a.drench or drip application + low

volume spray at 0.24 kg a.s./hL

Oranges Citrus sinensis NEU/SEU Indoor SC 200,0 g/L Post-harvest - spraying 99 99 2 0,06 kg a.i./hL n.a.drench or drip application + low


Lemons Citrus limon NEU/SEU Indoor SC 200,0 g/L Post-harvest - spraying 99 99 2 0,06 kg a.i./hL n.a.drench or drip application + low


Limes Citrus aurantifolia NEU/SEU Indoor SC 200,0 g/L Post-harvest - spraying 99 99 2 0,06 kg a.i./hL n.a.drench or drip application + low


Mandarins Citrus reticulata NEU/SEU Indoor SC 200,0 g/L Post-harvest - spraying 99 99 2 0,06 kg a.i./hL n.a.drench or drip application + low


Apples Malus domesticus NEU/SEU Indoor SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.

dip/drench application plus 2.5 g

a.s./t fruits as a low volume spray

application

Pears Pyrus communis NEU/SEU Indoor SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Quinces Cydonia oblonga NEU/SEU Indoor SC Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Medlar Mespilus germanica NEU/SEU Indoor SC Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Loquat Eriobotrya japonica NEU/SEU Indoor SC Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Strawberries Fragaria x ananassa NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 10 14 0,25 kg a.i./ha 1

Blackberries Rubus fruticosus NEU/SEU Indoor FR WG 250,0 g/kg Foliar treatment - spraying 61 89 3 10 0,25 kg a.i./ha 7

Raspberries Rubus idaeus NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 10 0,25 kg a.i./ha 7


esculentum NEU/SEU Indoor BE WG 250,0 g/kg Foliar treatment - spraying 3 10 14 0,29 kg a.i./ha 3

Peppers

Capsicum annuum, var

grossum and var.

longum

NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 10 0,25 kg a.i./ha 3

Aubergines (egg plants) Solanum melongena NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 7 0,25 kg a.i./ha 3

Cucumbers Cucumis sativus NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 7 0,25 kg a.i./ha 3

Gherkins Cucumis sativus NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 7 0,25 kg a.i./ha 3


melopepo NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 7 0,25 kg a.i./ha 3

Lettuce Lactuca sativa NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 10 0,18 kg a.i./ha 7

Scarole (broad-leaf

endive)Cichorium endiva NEU/SEU Indoor NL WG 250,0 g/L Foliar treatment - spraying 3 0,15 kg a.i./ha 7

Spinach Spinacia oleracea NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 2 0,15 kg a.i./ha 14GAP as reported by Portugal in

EFSA RO (No.244; 2009)

Beet leaves (chard) Beta vulgaris NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 2 0,15 kg a.i./ha 14GAP as reported by Portugal in

EFSA RO (No.244; 2009)

Beans (with pods) Phaseolus vulgaris, NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 10 0,25 kg a.i./ha 3

Peas (with pods) Pisum sativum NEU/SEU Indoor WG 250,0 g/kg Foliar treatment - spraying 3 10 0,25 kg a.i./ha 3



Min. rate Max. rate Rate Unit


wiaiting

period

(days)

Comments (max. 250 charachters)Common name Scientific name Type

Content

Method

Critical Indoor GAPs for Northern and Southern Europe (incl. post-harvest treatments)

Crop

RegionOutdoor/

Indoor

Member state or



EFSA Journal 2011;9(8):2335 68

Conc. UnitFrom

BBCH

Until


Grapefruit Citrus paradisi non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.

dip or drench application plus 5 g


application; 1 appl.prior storage, 1

appl.prior marketing

Oranges Citrus sinensis non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.





Lemons Citrus limon non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.





Limes Citrus aurantifolia non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.





Mandarins Citrus reticulata non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.





Pistachios Pistachia vera non-EU Outdoor US WG 250,0 g/kg Foliar treatment - spraying 4 14 0,25 kg a.i./ha 7

Apples Malus domesticus non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Pears Pyrus communis non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Quinces Cydonia oblonga non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Medlar Mespilus germanica non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Loquat Eriobotrya japonica non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Apricots Prunus armeniaca non-EU JP, AUT, CL, US SC 230,0 g/L Post-harvest treatment - drenching 99 99 1 2,50 g a.i./ton n.a.


Prunus aviumnon-EU US SC 230,0 g/L Post-harvest treatment - drenching 99 99 1 0,06 kg a.i./hL n.a. plus finishing wax

Peaches Prunus persica non-EU US SC 230,0 g/L Post-harvest treatment - drenching 99 99 1 2,50 g a.i./ton n.a. plus finishing wax

Plums Prunus domestica non-EU US SC 230,0 g/L Post-harvest treatment - drenching 99 99 1 2,50 g a.i./ton n.a.

KiwiActinidia deliciosa syn.

A. chinensis non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.

or application of 2.5 g a.s./t fruits as

low volume spray.

Mangoes Mangifera indica non-EU ZA SC 200,0 g/L Post-harvest treatment - dipping 99 99 1 0,03 kg a.i./hL n.a.

or drenching, with application of

finishing wax post treatment or at

the time of the treatment.

Pomegranate Punica granatum non-EU US SC 200,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.

Sweet potatoes Ipomoea batatas non-EU Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.

Yams Dioscorea sp. non-EU Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.


esculentum non-EU Foliar treatment - spraying 3 0,20 kg a.i./ha 7 oudoor protected

Peppers


grossum and var.

longum

non-EU Foliar treatment - spraying 3 0,25 kg a.i./ha 7

Aubergines (egg plants) Solanum melongena non-EU Foliar treatment - spraying 3 0,25 kg a.i./ha 7 oudoor protected

Cucumbers Cucumis sativus non-EU Foliar treatment - spraying 3 0,20 kg a.i./ha 7


melopepo non-EU Foliar treatment - spraying 3 0,20 kg a.i./ha 7

Melons Cucumis melo non-EU Outdoor US WP 500,0 g/kg Foliar treatment - spraying 3 6 14 21 0,56 kg a.i./ha 14(pre or post transplanting); drip-

irrigation soil drench

Pumpkins Cucurbita maxima non-EU Outdoor US WP 500,0 g/kg Foliar treatment - spraying 3 6 14 21 0,56 kg a.i./ha 14(pre or post transplanting); drip-


Watermelons Citrullus lanatus non-EU Outdoor US WP 500,0 g/kg Foliar treatment - spraying 3 6 14 21 0,56 kg a.i./ha 14(pre or post transplanting); drip-


Chives Allium schoenoprasum non-EU Outdoor US WG 250,0 g/kg Foliar treatment - spraying 4 10 14 0,25 kg a.i./ha 7

Basil Ocimum basilicum non-EU Outdoor US WG 250,0 g/kg Foliar treatment - spraying 4 10 14 0,25 kg a.i./ha 7


Interval (days)



wiaiting

period

(days)Scientific name Type

Content

Method

Growth stage Number

Critical GAPs for Import Tolerances (non-European indoor, outdoor or post-harvest treatments)

Crop

RegionOutdoor/

Indoor

Member state or



Comments (max. 250 charachters)Common name


EFSA Journal 2011;9(8):2335 69

Conc. UnitFrom

BBCH

Until


Grapefruit Citrus paradisi non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.





Oranges Citrus sinensis non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.





Lemons Citrus limon non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.





Limes Citrus aurantifolia non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.





Mandarins Citrus reticulata non-EU US, CAN WP 500,0 g/kg Post-harvest - spraying 99 99 2 0,12 kg a.i./hL n.a.





Pistachios Pistachia vera non-EU Outdoor US WG 250,0 g/kg Foliar treatment - spraying 4 14 0,25 kg a.i./ha 7

Apples Malus domesticus non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Pears Pyrus communis non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Quinces Cydonia oblonga non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Medlar Mespilus germanica non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Loquat Eriobotrya japonica non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.



application

Apricots Prunus armeniaca non-EU JP, AUT, CL, US SC 230,0 g/L Post-harvest treatment - drenching 99 99 1 2,50 g a.i./ton n.a.


Prunus aviumnon-EU US SC 230,0 g/L Post-harvest treatment - drenching 99 99 1 0,06 kg a.i./hL n.a. plus finishing wax

Peaches Prunus persica non-EU US SC 230,0 g/L Post-harvest treatment - drenching 99 99 1 2,50 g a.i./ton n.a. plus finishing wax

Plums Prunus domestica non-EU US SC 230,0 g/L Post-harvest treatment - drenching 99 99 1 2,50 g a.i./ton n.a.

KiwiActinidia deliciosa syn.

A. chinensis non-EU US SC 230,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.

or application of 2.5 g a.s./t fruits as

low volume spray.

Mangoes Mangifera indica non-EU ZA SC 200,0 g/L Post-harvest treatment - dipping 99 99 1 0,03 kg a.i./hL n.a.

or drenching, with application of

finishing wax post treatment or at

the time of the treatment.

Pomegranate Punica granatum non-EU US SC 200,0 g/L Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.

Sweet potatoes Ipomoea batatas non-EU Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.

Yams Dioscorea sp. non-EU Post-harvest treatment - dipping 99 99 1 0,06 kg a.i./hL n.a.


esculentum non-EU Foliar treatment - spraying 3 0,20 kg a.i./ha 7 oudoor protected

Peppers


grossum and var.

longum

non-EU Foliar treatment - spraying 3 0,25 kg a.i./ha 7

Aubergines (egg plants) Solanum melongena non-EU Foliar treatment - spraying 3 0,25 kg a.i./ha 7 oudoor protected

Cucumbers Cucumis sativus non-EU Foliar treatment - spraying 3 0,20 kg a.i./ha 7


melopepo non-EU Foliar treatment - spraying 3 0,20 kg a.i./ha 7

Melons Cucumis melo non-EU Outdoor US WP 500,0 g/kg Foliar treatment - spraying 3 6 14 21 0,56 kg a.i./ha 14(pre or post transplanting); drip-


Pumpkins Cucurbita maxima non-EU Outdoor US WP 500,0 g/kg Foliar treatment - spraying 3 6 14 21 0,56 kg a.i./ha 14(pre or post transplanting); drip-


Watermelons Citrullus lanatus non-EU Outdoor US WP 500,0 g/kg Foliar treatment - spraying 3 6 14 21 0,56 kg a.i./ha 14(pre or post transplanting); drip-


Chives Allium schoenoprasum non-EU Outdoor US WG 250,0 g/kg Foliar treatment - spraying 4 10 14 0,25 kg a.i./ha 7

Basil Ocimum basilicum non-EU Outdoor US WG 250,0 g/kg Foliar treatment - spraying 4 10 14 0,25 kg a.i./ha 7


Interval (days)



wiaiting

period

(days)Scientific name Type

Content

Method

Growth stage Number

Critical GAPs for Import Tolerances (non-European indoor, outdoor or post-harvest treatments)

Crop

RegionOutdoor/

Indoor

Member state or



Comments (max. 250 charachters)Common name


EFSA Journal 2011;9(8):2335 70

APPENDIX B – PESTICIDE RESIDUES INTAKE MODEL (PRIMO)

Appendix B.1 – EU scenario including all EU MRL proposals resulting from the GAPs reported by the RMS

Appendix B.2 – EU/Codex scenario including demonstrated safe EU MRL proposals and all CXLs


EFSA Journal 2011;9(8):2335 71

APPENDIX B.1 – EU SCENARIO INCLUDING ALL EU MRL PROPOSALS RESULTING FROM THE GAPS REPORTED BY THE RMS

Status of the active substance: Included Code no.

LOQ (mg/kg bw): 0.01 proposed LOQ:

ADI (mg/kg bw/day): 0.37 ARfD (mg/kg bw): n.n.

Source of ADI: EFSA Source of ARfD: EFSA

Year of evaluation: 2007 Year of evaluation: 2007

2 17

No of diets exceeding ADI: ---

Highest calculated

TMDI values in %

of ADI MS Diet

Highest contributor

to MS diet

(in % of ADI)

2nd contributor to

MS diet

(in % of ADI)

3rd contributor to

MS diet

(in % of ADI)

Commodity /

group of commodities

pTMRLs at

LOQ

(in % of ADI)

16.5 DE child 7.5 5.5 0.6 Mandarins 0.1

11.9 NL child 4.5 3.9 1.1 Mandarins 0.1

10.5 IE adult 3.6 1.5 1.0 Grapefruit 0.0

7.0 FR toddler 2.9 1.6 0.7 Carrots 0.0

5.5 ES child 3.1 0.7 0.4 Lettuce 0.1

5.1 WHO Cluster diet B 1.2 0.6 0.5 Mandarins 0.1

5.1 UK Toddler 2.8 1.1 0.4 Mandarins 0.1

4.9 FR infant 1.6 1.3 0.8 Carrots 0.1

4.3 NL general 2.1 0.7 0.3 Mandarins 0.0

4.1 ES adult 1.9 0.5 0.5 Lettuce 0.0

3.9 SE general population 90th percentile 1.1 0.7 0.6 Mandarins 0.0

3.7 UK Infant 1.9 1.0 0.4 Carrots 0.0

3.4 DK child 1.4 0.4 0.4 Carrots 0.0

3.0 PT General population 0.9 0.7 0.4 Peaches 0.0

2.9 WHO Cluster diet F 1.2 0.4 0.3 Mandarins 0.0

2.9 IT kids/toddler 0.7 0.6 0.3 Peaches 0.0

2.8 WHO cluster diet E 0.6 0.5 0.2 Mandarins 0.0

2.7 WHO regional European diet 0.7 0.4 0.3 Lettuce 0.0

2.6 IT adult 0.5 0.5 0.4 Peaches 0.0

2.4 UK vegetarian 1.2 0.4 0.2 Grapefruit 0.0

2.3 FR all population 0.4 0.4 0.3 Apples 0.0

2.2 FI adult 1.4 0.3 0.2 Mandarins 0.0

2.1 PL general population 1.3 0.2 0.1 Carrots 0.0

1.7 UK Adult 0.8 0.3 0.1 Lettuce 0.0

1.7 WHO cluster diet D 0.4 0.3 0.2 Limes 0.0

1.7 LT adult 1.2 0.1 0.1 Pears 0.0

1.5 DK adult 0.5 0.2 0.1 Carrots 0.0

Apples

Wine grapes

Apples Oranges

Oranges

Apples

Pears

Apples

Oranges

Apples

Apples

Apples

Apples

Apples

Apples

Apples

Oranges

Apples

Apples

Apples

Apples

Oranges

Apples

Oranges

Apples

Apples

Apples

Commodity /


Commodity /


Apples

Oranges

FLUDIOXONIL

Toxicological end points

TMDI (range) in % of ADI

minimum - maximum

Chronic risk assessment - refined calculations

Conclusion:The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI.

A long-term intake of residues of FLUDIOXONIL is unlikely to present a public health concern.

Oranges

Apples

Oranges

Oranges

Sweet potatoes

Oranges

Oranges

Oranges

Oranges

Oranges

Oranges

Oranges

Oranges

Oranges

Apples

Oranges

Pears

Apples

Oranges

Apples

Apples

Oranges

Oranges

Oranges

Oranges


EFSA Journal 2011;9(8):2335 72

APPENDIX B.2 – EU/CODEX SCENARIO INCLUDING DEMONSTRATED SAFE EU MRL PROPOSALS AND ALL CXLS

Status of the active substance: Included Code no.

LOQ (mg/kg bw): 0.01 proposed LOQ:

ADI (mg/kg bw/day): 0.37 ARfD (mg/kg bw): n.n.

Source of ADI: EFSA Source of ARfD: EFSA

Year of evaluation: 2007 Year of evaluation: 2007

2 16

No of diets exceeding ADI: ---

Highest calculated

TMDI values in %

of ADI MS Diet

Highest contributor

to MS diet

(in % of ADI)

2nd contributor to

MS diet

(in % of ADI)

3rd contributor to

MS diet

(in % of ADI)

Commodity /


pTMRLs at

LOQ

(in % of ADI)

15.8 DE child 6.8 5.5 0.6 Mandarins 0.1

11.6 NL child 4.5 3.6 1.1 Mandarins 0.1

10.4 IE adult 3.6 1.5 1.0 Grapefruit 0.0

6.9 FR toddler 2.9 1.5 0.7 Carrots 0.0

5.4 ES child 3.1 0.6 0.4 Lettuce 0.1

5.1 WHO Cluster diet B 1.2 0.6 0.5 Mandarins 0.0

5.0 UK Toddler 2.8 1.0 0.4 Mandarins 0.1

4.8 FR infant 1.4 1.3 0.8 Carrots 0.1

4.3 NL general 2.1 0.7 0.3 Mandarins 0.0

4.0 ES adult 1.9 0.5 0.4 Apples 0.0

4.0 SE general population 90th percentile 1.1 0.6 0.6 Apples 0.0

3.7 UK Infant 1.9 0.9 0.4 Carrots 0.0

3.2 DK child 1.3 0.4 0.4 Pears 0.0

2.9 WHO Cluster diet F 1.2 0.4 0.3 Mandarins 0.0

2.9 PT General population 0.9 0.6 0.4 Peaches 0.0

2.8 IT kids/toddler 0.7 0.5 0.3 Peaches 0.0

2.8 WHO cluster diet E 0.6 0.5 0.2 Mandarins 0.0

2.7 WHO regional European diet 0.7 0.4 0.3 Lettuce 0.0

2.6 IT adult 0.5 0.5 0.4 Peaches 0.0

2.4 UK vegetarian 1.2 0.3 0.2 Grapefruit 0.0

2.3 FR all population 0.4 0.4 0.3 Mandarins 0.0

2.2 FI adult 1.4 0.2 0.2 Mandarins 0.0

2.0 PL general population 1.2 0.2 0.1 Carrots 0.0

1.8 WHO cluster diet D 0.4 0.3 0.2 Limes 0.0

1.7 UK Adult 0.8 0.2 0.1 Lettuce 0.0

1.6 LT adult 1.1 0.1 0.1 Pears 0.0

1.5 DK adult 0.4 0.2 0.1 Carrots 0.0

Carrots

Apples

Apples

Oranges

Apples

Oranges

Oranges

Oranges

Oranges

Oranges

Oranges

Oranges

Oranges

Oranges

Oranges

Apples

Oranges

Oranges

Apples

Oranges

Oranges

Sweet potatoes

Oranges

Oranges

Oranges

Conclusion:The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI.

A long-term intake of residues of FLUDIOXONIL is unlikely to present a public health concern.

FLUDIOXONIL

Toxicological end points

TMDI (range) in % of ADI

minimum - maximum

Chronic risk assessment - refined calculations

Commodity /


Commodity /


Apples

Oranges

Oranges

Apples

Oranges

Apples

Apples

Apples

Apples

Oranges

Apples

Lettuce

Mandarins

Apples

Apples

Apples

Apples

Apples

Apples

Apples

Apples

Wine grapes

Apples Oranges

Oranges

Apples

Pears

Oranges

Apples


EFSA Journal 2011;9(8):2335 73

APPENDIX C – EXISTING EU MAXIMUM RESIDUE LIMITS (MRLS) AND CODEX LIMITS (CXLS)

Appendix C.1 – Existing EU MRLs

Appendix C.2 – Existing CXLs


EFSA Journal 2011;9(8):2335 74

APPENDIX C.1 – EXISTING EU MRLS

(Pesticides - Web Version - EU MRLs (File created on 14/01/2011 14:16)

Code

number

Groups and examples of

individual products to which

the MRLs apply (a)

Fludioxonil

100000 1. FRUIT FRESH OR

FROZEN; NUTS

110000 (i) Citrus fruit

110010 Grapefruit (Shaddocks, pomelos,

sweeties, tangelo, ugli and other

hybrids) 10

110020 Oranges (Bergamot, bitter orange,

chinotto and other hybrids) 7

110030 Lemons (Citron, lemon ) 7

110040 Limes 7

110050 Mandarins (Clementine, tangerine

and other hybrids) 7

110990 Others 7

120000 (ii) Tree nuts (shelled or

unshelled) 0,05*

120010 Almonds 0,05*

120020 Brazil nuts 0,05*

120030 Cashew nuts 0,05*

120040 Chestnuts 0,05*

120050 Coconuts 0,05*

120060 Hazelnuts (Filbert) 0,05*

120070 Macadamia 0,05*

120080 Pecans 0,05*

120090 Pine nuts 0,05*

120100 Pistachios 0,05*

120110 Walnuts 0,05*

120990 Others 0,05*

130000 (iii) Pome fruit 5

130010 Apples (Crab apple) 5

130020 Pears (Oriental pear) 5

130030 Quinces 5

130040 Medlar 5

130050 Loquat 5

130990 Others 5

140000 (iv) Stone fruit

140010 Apricots 5

140020 Cherries (sweet cherries, sour

cherries) 5

140030 Peaches (Nectarines and similar

hybrids) 7

140040 Plums (Damson, greengage,

mirabelle) 0,5

Code

number



the MRLs apply (a)

Fludioxonil

140990 Others 0,05*

150000 (v) Berries & small fruit

151000 (a) Table and wine grapes 2

151010 Table grapes 2

151020 Wine grapes 2

152000 (b) Strawberries 3

153000 (c) Cane fruit

153010 Blackberries 5

153020 Dewberries (Loganberries,

Boysenberries, and cloudberries) 0,05*

153030 Raspberries (Wineberries ) 5

153990 Others 0,05*

154000 (d) Other small fruit & berries

154010 Blueberries (Bilberries cowberries

(red bilberries)) 3

154020 Cranberries 1

154030 Currants (red, black and white) 3

154040 Gooseberries (Including hybrids

with other ribes species) 3

154050 Rose hips 1

154060 Mulberries (arbutus berry) 1

154070 Azarole (mediteranean medlar) 1

154080 Elderberries (Black chokeberry

(appleberry), mountain ash,

azarole, buckthorn (sea

sallowthorn), hawthorn, service

berries, and other treeberries) 2

154990 Others 1

160000 (vi) Miscellaneous fruit

161000 (a) Edible peel 0,05*

161010 Dates 0,05*

161020 Figs 0,05*

161030 Table olives 0,05*

161040 Kumquats (Marumi kumquats,

nagami kumquats) 0,05*

161050 Carambola (Bilimbi) 0,05*

161060 Persimmon 0,05*

161070 Jambolan (java plum) (Java apple

(water apple), pomerac, rose

apple, Brazilean cherry

(grumichama), Surinam cherry) 0,05*

161990 Others 0,05*

Code

number



the MRLs apply (a)

Fludioxonil

162000 (b) Inedible peel, small

162010 Kiwi 20

162020 Lychee (Litchi) (Pulasan,

rambutan (hairy litchi)) 0,05*

162030 Passion fruit 0,05*

162040 Prickly pear (cactus fruit) 0,05*

162050 Star apple 0,05*

162060 American persimmon (Virginia

kaki) (Black sapote, white sapote,

green sapote, canistel (yellow

sapote), and mammey sapote) 0,05*

162990 Others 0,05*

163000 (c) Inedible peel, large

163010 Avocados 0,05*

163020 Bananas (Dwarf banana, plantain,

apple banana) 0,05*

163030 Mangoes 0,05*

163040 Papaya 0,05*

163050 Pomegranate 3

163060 Cherimoya (Custard apple, sugar

apple (sweetsop) , llama and other

medium sized Annonaceae) 0,05*

163070 Guava 0,05*

163080 Pineapples 0,05*

163090 Bread fruit (Jackfruit) 0,05*

163100 Durian 0,05*

163110 Soursop (guanabana) 0,05*

163990 Others 0,05*

200000 2. VEGETABLES FRESH OR

FROZEN

210000 (i) Root and tuber vegetables

211000 (a) Potatoes 1

212000 (b) Tropical root and tuber

vegetables 0,05*

212010 Cassava (Dasheen, eddoe

(Japanese taro), tannia) 0,05*

212020 Sweet potatoes 0,05*

212030 Yams (Potato bean (yam bean),

Mexican yam bean) 0,05*

212040 Arrowroot 0,05*

212990 Others 0,05*

213000 (c) Other root and tuber

vegetables except sugar beet

Code

number



the MRLs apply (a)

Fludioxonil

213010 Beetroot 1

213020 Carrots 1

213030 Celeriac 0,2

213040 Horseradish 1

213050 Jerusalem artichokes 0,05*

213060 Parsnips 1

213070 Parsley root 1

213080 Radishes (Black radish, Japanese

radish, small radish and similar

varieties) 0,05*

213090 Salsify (Scorzonera, Spanish

salsify (Spanish oysterplant)) 1

213100 Swedes 0,05*

213110 Turnips 0,05*

213990 Others 0,05*

220000 (ii) Bulb vegetables

220010 Garlic 0,05*

220020 Onions (Silverskin onions) 0,1

220030 Shallots 0,05*

220040 Spring onions (Welsh onion and

similar varieties) 0,3

220990 Others 0,05*

230000 (iii) Fruiting vegetables

231000 (a) Solanacea

231010 Tomatoes (Cherry tomatoes, ) 1

231020 Peppers (Chilli peppers) 2

231030 Aubergines (egg plants) (Pepino) 1

231040 Okra, lady’s fingers 0,5

231990 Others 0,5

232000 (b) Cucurbits - edible peel

232010 Cucumbers 1

232020 Gherkins 0,5

232030 Courgettes (Summer squash,

marrow (patisson)) 1

232990 Others 0,5

233000 (c) Cucurbits-inedible peel 0,05*

233010 Melons (Kiwano ) 0,05*

233020 Pumpkins (Winter squash) 0,05*

233030 Watermelons 0,05*

233990 Others 0,05*

234000 (d) Sweet corn 0,05*

239000 (e) Other fruiting vegetables 0,05*


EFSA Journal 2011;9(8):2335 75

Code

number



the MRLs apply (a)

Fludioxonil

240000 (iv) Brassica vegetables 0,05*

241000 (a) Flowering brassica 0,05*

241010 Broccoli (Calabrese, Chinese

broccoli, Broccoli raab) 0,05*

241020 Cauliflower 0,05*

241990 Others 0,05*

242000 (b) Head brassica 0,05*

242010 Brussels sprouts 0,05*

242020 Head cabbage (Pointed head

cabbage, red cabbage, savoy

cabbage, white cabbage) 0,05*

242990 Others 0,05*

243000 (c) Leafy brassica 0,05*

243010 Chinese cabbage (Indian

(Chinese) mustard, pak choi,

Chinese flat cabbage (tai goo

choi), peking cabbage (pe-tsai),

cow cabbage) 0,05*

243020 Kale (Borecole (curly kale),

collards) 0,05*

243990 Others 0,05*

244000 (d) Kohlrabi 0,05*

250000 (v) Leaf vegetables & fresh herbs

251000 (a) Lettuce and other salad plants

including Brassicacea 10

251010 Lamb s lettuce (Italian cornsalad) 10

251020 Lettuce (Head lettuce, lollo rosso

(cutting lettuce), iceberg lettuce,

romaine (cos) lettuce) 10

251030 Scarole (broad-leaf endive) (Wild

chicory, red-leaved chicory,

radicchio, curld leave endive,

sugar loaf) 10

251040 Cress 10

251050 Land cress 10

251060 Rocket, Rucola (Wild rocket) 10

251070 Red mustard 10

251080 Leaves and sprouts of Brassica

spp (Mizuna) 10

251990 Others 10

252000 (b) Spinach & similar (leaves)

252010 Spinach (New Zealand spinach,

turnip greens (turnip tops)) 7

252020 Purslane (Winter purslane

(miner’s lettuce), garden purslane,

common purslane, sorrel,

glassworth) 10

252030 Beet leaves (chard) (Leaves of

beetroot) 7

Code

number



the MRLs apply (a)

Fludioxonil

252990 Others 0,05*

253000 (c) Vine leaves (grape leaves) 0,05*

254000 (d) Water cress 0,05*

255000 (e) Witloof 0,05*

256000 (f) Herbs 1

256010 Chervil 1

256020 Chives 1

256030 Celery leaves (fennel leaves ,

Coriander leaves, dill leaves,

Caraway leaves, lovage, angelica,

sweet cisely and other Apiacea) 1

256040 Parsley 1

256050 Sage (Winter savory, summer

savory, ) 1

256060 Rosemary 1

256070 Thyme ( marjoram, oregano) 1

256080 Basil (Balm leaves, mint,

peppermint) 1

256090 Bay leaves (laurel) 1

256100 Tarragon (Hyssop) 1

256990 Others 1

260000 (vi) Legume vegetables (fresh)

260010 Beans (with pods) (Green bean

(french beans, snap beans), scarlet

runner bean, slicing bean,

yardlong beans) 1

260020 Beans (without pods) (Broad

beans, Flageolets, jack bean, lima

bean, cowpea) 0,2

260030 Peas (with pods) (Mangetout

(sugar peas)) 0,2

260040 Peas (without pods) (Garden pea,

green pea, chickpea) 0,05*

260050 Lentils 0,05*

260990 Others 0,05*

270000 (vii) Stem vegetables (fresh)

270010 Asparagus 0,05*

270020 Cardoons 0,05*

270030 Celery 0,05*

270040 Fennel 0,1

270050 Globe artichokes 0,05*

270060 Leek 0,05*

270070 Rhubarb 0,05*

270080 Bamboo shoots 0,05*

270090 Palm hearts 0,05*

270990 Others 0,05*

280000 (viii) Fungi 0,05*

280010 Cultivated (Common mushroom,

Oyster mushroom, Shi-take) 0,05*

Code

number



the MRLs apply (a)

Fludioxonil

280020 Wild (Chanterelle, Truffle, Morel

,) 0,05*

280990 Others 0,05*

290000 (ix) Sea weeds 0,05*

300000 3. PULSES, DRY 0,05*

300010 Beans (Broad beans, navy beans,

flageolets, jack beans, lima beans,

field beans, cowpeas) 0,05*

300020 Lentils 0,05*

300030 Peas (Chickpeas, field peas,

chickling vetch) 0,05*

300040 Lupins 0,05*

300990 Others 0,05*

400000 4. OILSEEDS AND

OILFRUITS 0,05*

401000 (i) Oilseeds 0,05*

401010 Linseed 0,05*

401020 Peanuts 0,05*

401030 Poppy seed 0,05*

401040 Sesame seed 0,05*

401050 Sunflower seed 0,05*

401060 Rape seed (Bird rapeseed, turnip

rape) 0,05*

401070 Soya bean 0,05*

401080 Mustard seed 0,05*

401090 Cotton seed 0,05*

401100 Pumpkin seeds 0,05*

401110 Safflower 0,05*

401120 Borage 0,05*

401130 Gold of pleasure 0,05*

401140 Hempseed 0,05*

401150 Castor bean 0,05*

401990 Others 0,05*

402000 (ii) Oilfruits 0,05*

402010 Olives for oil production 0,05*

402020 Palm nuts (palmoil kernels) 0,05*

402030 Palmfruit 0,05*

402040 Kapok 0,05*

402990 Others 0,05*

500000 5. CEREALS

500010 Barley 0,05*

500020 Buckwheat 0,05*

500030 Maize 0,1

500040 Millet (Foxtail millet, teff) 0,05*

500050 Oats 0,05*

500060 Rice 0,05*

500070 Rye 0,05*

500080 Sorghum 0,05*

Code

number



the MRLs apply (a)

Fludioxonil

500090 Wheat (Spelt Triticale) 0,2

500990 Others 0,05*

600000 6. TEA, COFFEE, HERBAL

INFUSIONS AND COCOA

610000 (i) Tea (dried leaves and stalks,

fermented or otherwise of

Camellia sinensis) 0,05*

620000 (ii) Coffee beans 0,05*

630000 (iii) Herbal infusions (dried)

631000 (a) Flowers 0,05*

631010 Camomille flowers 0,05*

631020 Hybiscus flowers 0,05*

631030 Rose petals 0,05*

631040 Jasmine flowers 0,05*

631050 Lime (linden) 0,05*

631990 Others 0,05*

632000 (b) Leaves 0,05*

632010 Strawberry leaves 0,05*

632020 Rooibos leaves 0,05*

632030 Maté 0,05*

632990 Others 0,05*

633000 (c) Roots 1

633010 Valerian root 1

633020 Ginseng root 1

633990 Others 1

639000 (d) Other herbal infusions 0,05*

640000 (iv) Cocoa (fermented beans) 0,05*

650000 (v) Carob (st johns bread) 0,05*

700000 7. HOPS (dried) , including hop

pellets and unconcentrated

powder 0,05*

800000 8. SPICES

810000 (i) Seeds 0,05*

810010 Anise 0,05*

810020 Black caraway 0,05*

810030 Celery seed (Lovage seed) 0,05*

810040 Coriander seed 0,05*

810050 Cumin seed 0,05*

810060 Dill seed 0,05*

810070 Fennel seed 0,05*

810080 Fenugreek 0,05*

810090 Nutmeg 0,05*

810990 Others 0,05*

820000 (ii) Fruits and berries 0,05*

820010 Allspice 0,05*

820020 Anise pepper (Japan pepper) 0,05*

820030 Caraway 0,05*

820040 Cardamom 0,05*


EFSA Journal 2011;9(8):2335 76

Code

number



the MRLs apply (a)

Fludioxonil

820050 Juniper berries 0,05*

820060 Pepper, black and white (Long

pepper, pink pepper) 0,05*

820070 Vanilla pods 0,05*

820080 Tamarind 0,05*

820990 Others 0,05*

830000 (iii) Bark 0,05*

830010 Cinnamon (Cassia ) 0,05*

830990 Others 0,05*

840000 (iv) Roots or rhizome 1

840010 Liquorice 1

840020 Ginger 1

840030 Turmeric (Curcuma) 1

840040 Horseradish 1

840990 Others 1

850000 (v) Buds 0,05*

850010 Cloves 0,05*

850020 Capers 0,05*

850990 Others 0,05*

860000 (vi) Flower stigma 0,05*

860010 Saffron 0,05*

860990 Others 0,05*

870000 (vii) Aril 0,05*

870010 Mace 0,05*

870990 Others 0,05*

900000 9. SUGAR PLANTS 0,05*

900010 Sugar beet (root) 0,05*

900020 Sugar cane 0,05*

900030 Chicory roots 0,05*

900990 Others 0,05*

1000000 10. PRODUCTS OF ANIMAL 0,05*

Code

number



the MRLs apply (a)

Fludioxonil

ORIGIN-TERRESTRIAL

ANIMALS

1010000 (i) Meat, preparations of meat,

offals, blood, animal fats fresh

chilled or frozen, salted, in brine,

dried or smoked or processed as

flours or meals other processed

products such as sausages and

food preparations based on these 0,05*

1011000 (a) Swine 0,05*

1011010 Meat 0,05*

1011020 Fat free of lean meat 0,05*

1011030 Liver 0,05*

1011040 Kidney 0,05*

1011050 Edible offal 0,05*

1011990 Others 0,05*

1012000 (b) Bovine 0,05*

1012010 Meat 0,05*

1012020 Fat 0,05*

1012030 Liver 0,05*

1012040 Kidney 0,05*


1012990 Others 0,05*

1013000 (c) Sheep 0,05*

1013010 Meat 0,05*

1013020 Fat 0,05*

1013030 Liver 0,05*

1013040 Kidney 0,05*


1013990 Others 0,05*

1014000 (d) Goat 0,05*

Code

number



the MRLs apply (a)

Fludioxonil

1014010 Meat 0,05*

1014020 Fat 0,05*

1014030 Liver 0,05*

1014040 Kidney 0,05*


1014990 Others 0,05*

1015000 (e) Horses, asses, mules or hinnies 0,05*

1015010 Meat 0,05*

1015020 Fat 0,05*

1015030 Liver 0,05*

1015040 Kidney 0,05*


1015990 Others 0,05*

1016000 (f) Poultry -chicken, geese, duck,

turkey and Guinea fowl-, ostrich,

pigeon 0,05*

1016010 Meat 0,05*

1016020 Fat 0,05*

1016030 Liver 0,05*

1016040 Kidney 0,05*


1016990 Others 0,05*

1017000 (g) Other farm animals (Rabbit,

Kangaroo) 0,05*

1017010 Meat 0,05*

1017020 Fat 0,05*

1017030 Liver 0,05*

1017040 Kidney 0,05*


1017990 Others 0,05*

1020000 (ii) Milk and cream, not 0,05*

Code

number



the MRLs apply (a)

Fludioxonil

concentrated, nor containing

added sugar or sweetening matter,

butter and other fats derived from

milk, cheese and curd

1020010 Cattle 0,05*

1020020 Sheep 0,05*

1020030 Goat 0,05*

1020040 Horse 0,05*

1020990 Others 0,05*

1030000 (iii) Birds’ eggs, fresh preserved

or cooked Shelled eggs and egg

yolks fresh, dried, cooked by

steaming or boiling in water,

moulded, frozen or otherwise

preserved whether or not

containing added sugar or

sweetening matter 0,05*

1030010 Chicken 0,05*

1030020 Duck 0,05*

1030030 Goose 0,05*

1030040 Quail 0,05*

1030990 Others 0,05*

1040000 (iv) Honey (Royal jelly, pollen) 0,05*

1050000 (v) Amphibians and reptiles (Frog

legs, crocodiles) 0,05*

1060000 (vi) Snails 0,05*

1070000 (vii) Other terrestrial animal

products 0,05*

(*) Indicates lower limit of analytical determination


EFSA Journal 2011;9(8):2335 77

APPENDIX C.2 – EXISTING CXLS

Residue definition Residue definitionSTMR (-P)

(mg/kg)HR (-P) (mg/kg)

Default

variability

factor

Reduced

variability

factor

STMR (mg/kg) HR (mg/kg)Median peeling

factor

Median

conversion

factor

YearBased on EU

GAP only?Other comments

110010 Grapefruit Fludioxonil 10 Fludioxonil 0.4 n.c. 1 n.c. 5.3 7.8 0.07 1 2010 no

110020 Oranges Fludioxonil 10 Fludioxonil 0.4 n.c. 1 n.c. 5.3 7.8 0.07 1 2010 no

110030 Lemons Fludioxonil 10 Fludioxonil 0.4 n.c. 1 n.c. 5.3 7.8 0.07 1 2010 no

110040 Limes Fludioxonil 10 Fludioxonil 0.4 n.c. 1 n.c. 5.3 7.8 0.07 1 2010 no

110050 Mandarins Fludioxonil 10 Fludioxonil 0.4 n.c. 1 n.c. 5.3 7.8 0.07 1 2010 no

120100 Pistachios Fludioxonil 0.2 Fludioxonil 0.05 n.c. 1 n.c. 0.05 0.08 n.a. 1 2004 no Interim CXL (2005-2009). Trials were

conducted in the USA according to

GAP.

130010 Apples Fludioxonil 5 Fludioxonil 2.1 n.c. 1 n.c. 2.1 2.8 n.a. 1 2006 no

130020 Pears Fludioxonil 5 Fludioxonil 2.1 n.c. 1 n.c. 2.1 2.8 n.a. 1 2006 no

130030 Quinces Fludioxonil 5 Fludioxonil 2.1 n.c. 1 n.c. 2.1 2.8 n.a. 1 2006 no

130040 Medlar Fludioxonil 5 Fludioxonil 2.1 n.c. 1 n.c. 2.1 2.8 n.a. 1 2006 no

130050 Loquat Fludioxonil 5 Fludioxonil 2.1 n.c. 1 n.c. 2.1 2.8 n.a. 1 2006 no

140010 Apricots Fludioxonil 5 Fludioxonil 0.8 n.c. 1 n.c. 0.8 3.6 n.a. 1 2004 no

140020 Cherries Fludioxonil 5 Fludioxonil 0.8 n.c. 1 n.c. 0.8 3.6 n.a. 1 2004 no

140030 Peaches Fludioxonil 5 Fludioxonil 0.8 n.c. 1 n.c. 0.8 3.6 n.a. 1 2004 no

140040 Plums Fludioxonil 5 Fludioxonil 0.8 n.c. 1 n.c. 0.8 3.6 n.a. 1 2004 no

151010 Table grapes Fludioxonil 2 Fludioxonil 0.28 n.c. 1 n.c. 0.28 1.6 n.a. 1 2004 no

151020 Wine grapes Fludioxonil 2 Fludioxonil 0.28 n.c. 1 n.c. 0.28 1.6 n.a. 1 2004 no

152000 Strawberries Fludioxonil 3 Fludioxonil 0.27 n.c. 1 n.c. 0.27 1.9 n.a. 1 2004 no Interim CXL (2005-2009). Trials were

conducted in both the EU and USA

according to GAP.

153010 Blackberries Fludioxonil 5 Fludioxonil 1 n.c. 1 n.c. 1 3.6 n.a. 1 2004 no

153020 Dewberries Fludioxonil 5 Fludioxonil 1 n.c. 1 n.c. 1 3.6 n.a. 1 2004 no

153030 Raspberries Fludioxonil 5 Fludioxonil 1 n.c. 1 n.c. 1 3.6 n.a. 1 2004 no

154010 Blueberries Fludioxonil 2 Fludioxonil 0.6 n.c. 1 n.c. 0.6 1.4 n.a. 1 2004 no Interim CXL (2005-2009). Based on

the USA GAP.

162010 Kiwi Fludioxonil 15 Fludioxonil 7.2 n.c. 1 n.c. 7.2 9 n.a. 1 2004 no Post harvest use. Trials were


GAP.

163050 Pomegranate Fludioxonil 2 Fludioxonil 1.000 n.c. 1 n.c. 1.000 1.300 n.a. 1 2010 no

211000 Potatoes Fludioxonil 0.02 Fludioxonil 0.01 n.c. 1 n.c. 0.01 0.01 n.a. 1 2004 no Interim CXL (2005-2009). Trials were


GAP.

212020 Sweet potatoes Fludioxonil 10 Fludioxonil 3.500 n.c. 1 n.c. 3.500 5.700 n.a. 1 2010 no

212030 Yams Fludioxonil 10 Fludioxonil 3.500 n.c. 1 n.c. 3.500 5.700 n.a. 1 2010 no

213020 Carrots Fludioxonil 0.7 Fludioxonil 0.2 n.c. 1 n.c. 0.2 0.42 n.a. 1 2004 no Interim CXL (2005-2009). Trials were


GAP.

220020 Onions Fludioxonil 0.5 Fludioxonil 0.04 n.c. 1 n.c. 0.04 0.34 n.a. 1 2004 no Interim CXL (2005-2009). Trials were

conducted in the EU and USA

according to GAP.

220040 Spring onions Fludioxonil 5 Fludioxonil 0.59 n.c. 1 n.c. 0.59 3 n.a. 1 2004 no Interim CXL (2005-2009). Trials were


GAP.

231010 Tomatoes Fludioxonil 0.5 Fludioxonil 0.12 n.c. 1 n.c. 0.12 0.32 n.a. 1 2004 yes All trials were conducted in the EU

in accordance with GAP.

231020 Peppers Fludioxonil 1 Fludioxonil 0.18 n.c. 1 n.c. 0.18 0.6 n.a. 1 2004 yes All trials were conducted in the EU


231030 Aubergines (egg plants) Fludioxonil 0.3 Fludioxonil 0.06 n.c. 1 n.c. 0.06 0.08 n.a. 1 2004 yes All trials were conducted in the EU


232010 Cucumbers Fludioxonil 0.3 Fludioxonil 0.06 n.c. 1 n.c. 0.06 0.14 n.a. 1 2004 yes

232030 Courgettes Fludioxonil 0.3 Fludioxonil 0.06 n.c. 1 n.c. 0.06 0.14 n.a. 1 2004 yes

Interim CXL (2005-2009). Trials were

conducted in both the EU and Chile

according to GAP.

Interim CXLs (2005-2009). Trials

were conducted in the USA

according to GAP. Treatment is

post-harvest. Data on peach, plum

and cherry were combined.

Summary of CXLs for fludioxonil in plant commodities

Commodity

codeCommodity name

Values adopted by the CCPR

CXL (mg/kg)

Critical values of the JMPR evaluation Comments on the JMPR evaluationRisk assessment values as calculated by EFSA

Trials were conducted in the USA


post-harvest.

Trials were conducted in the USA


post-harvest. Data on orange and

mandarins were combined to derive

the CXL. JMPR STMR relates to the

fruit pulp.

Interim CXL (2005-2009). Trials were

conducted in both the EU and USA

according to GAP. Data on

raspberry were extrapolated to

blackberry and dewberry.

All trials were conducted in the EU

in accordance with GAP. Data on

cucumber and courgette were

combined.


EFSA Journal 2011;9(8):2335 78

Residue definition Residue definitionSTMR (-P)

(mg/kg)HR (-P) (mg/kg)

Default

variability

factor

Reduced

variability

factor

STMR (mg/kg) HR (mg/kg)Median peeling

factor

Median

conversion

factor

YearBased on EU


233010 Melons Fludioxonil 0.03 Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.02 n.k. 1 2004 no Trials were conducted in the USA

according to GAP. No data were

available on the edible portion.

234000 Sweet corn Fludioxonil 0.01 * Fludioxonil 0.01 n.c. 1 n.c. 0.01 0.01 n.a. 1 2004 no Interim CXL (2005-2009). Trials were


GAP.

241010 Broccoli Fludioxonil 0.7 Fludioxonil 0.23 n.c. 1 n.c. 0.23 0.36 n.a. 1 2004 no Interim CXL (2005-2009). Trials were


GAP.

242020 Head cabbage Fludioxonil 2 Fludioxonil 0.24 n.c. 1 n.c. 0.24 1.2 n.a. 1 2004 no Interim CXL (2005-2009). Trials were


GAP.

243010 Chinese cabbage Fludioxonil 10 Fludioxonil 1.2 n.c. 1 n.c. 1.2 7.1 n.a. 1 2004 no Interim CXL (2005-2009). Trials were


GAP. Data on mustard greens and

watercress were combined.

251020 Lettuce Fludioxonil 10 Fludioxonil 2.7 n.c. 1 n.c. 2.7 6 n.a. 1 2004 yes All trials were conducted in the EU

(indoor) according to GAP.

254000 Water cress Fludioxonil 10 Fludioxonil 1.2 n.c. 1 n.c. 1.2 7.1 n.a. 1 2004 no Interim CXL (2005-2009). See

comment for chinese cabbage.

256020 Chives Fludioxonil 10 Fludioxonil 2.8 n.c. 1 n.c. 2.8 3.9 n.a. 1 2005 no Interim CXL (2005-2009). Trials were


GAP.

256080 Basil Fludioxonil 10 Fludioxonil 2.4 n.c. 1 n.c. 2.4 3 n.a. 1 2004 no Interim CXL (2005-2009). Trials were


GAP.

260010 Beans (fresh, with pods) Fludioxonil 0.3 Fludioxonil 0.04 n.c. 1 n.c. 0.04 0.2 n.a. 1 2004 yes Trials were conducted in the EU

according to GAP.

260020 Beans (fresh, without pods) Fludioxonil 0.03 Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.02 n.a. 1 2004 yes Extrapolated from pea without pod.

260030 Peas (fresh, with pods) Fludioxonil 0.3 Fludioxonil 0.04 n.c. 1 n.c. 0.04 0.2 n.a. 1 2004 yes Extrapolated from bean with pod.

260040 Peas (fresh, without pods) Fludioxonil 0.03 Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.02 n.a. 1 2004 yes Trials were conducted in the EU

according to GAP.

300010 Beans (dry) Fludioxonil 0.07 Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

300030 Peas (dry) Fludioxonil 0.07 Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

401060 Rape seed Fludioxonil 0.02 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.02 n.a. 1 2004 yes Interim CXL (2005-2009). Trials were

conducted in the EU according to

GAP.

401090 Cotton seed Fludioxonil 0.05 * Fludioxonil 0.05 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 no Interim CXL (2005-2009). Trials were

conducted according to USA GAP.

500010 Barley grain Fludioxonil 0.05 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

500020 Buckwheat grain Fludioxonil 0.05 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

500030 Maize grain Fludioxonil 0.05 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

500040 Millet grain Fludioxonil 0.05 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

500050 Oats grain Fludioxonil 0.05 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

500060 Rice grain Fludioxonil 0.05 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

500070 Rye grain Fludioxonil 0.05 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

500080 Sorghum grain Fludioxonil 0.05 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

500090 Wheat grain Fludioxonil 0.05 * Fludioxonil 0.02 n.c. 1 n.c. 0.02 0.05 n.a. 1 2004 yes

(*) Indicates the lower limit of analytical quantification.


n.c.: not considered

n.k.: not known

Interim CXLs (2005-2009). Trials

were conducted in the EU according

to GAP. Data on various cereal

grains were combined.

Summary of CXLs for fludioxonil in plant commodities

Commodity

codeCommodity name


CXL (mg/kg)

Critical values of the JMPR evaluation Comments on the JMPR evaluationRisk assessment values as calculated by EFSA

Trials were conducted in the EU

according to GAP.


EFSA Journal 2011;9(8):2335 79

Residue definitionExpressed

as fat?Residue definition STMR (mg/kg) HR (mg/kg) Year

Based on EU


1011010 Swine meat Sum of fludioxonil and its

benzopyrrole metabolites,

determined as 2,2-difluoro-

benzo[1,3]dioxide-4-carboxylic acid

and expressed as fludioxonil

no 0.01 * Sum of fludioxonil and its





0 n.c. 2006 no

1011030 Swine liver Sum of fludioxonil and its





n.a. 0.05 * Sum of fludioxonil and its





0 n.c. 2006 no

1011040 Swine kidney Sum of fludioxonil and its










0 n.c. 2006 no

1011050 Swine edible offal Sum of fludioxonil and its










0 n.c. 2006 no

1012010 Bovine meat Sum of fludioxonil and its










0 n.c. 2006 no

1012030 Bovine liver Sum of fludioxonil and its










0 n.c. 2006 no

1012040 Bovine kidney Sum of fludioxonil and its










0 n.c. 2006 no

1012050 Bovine edible offal Sum of fludioxonil and its










0 n.c. 2006 no

1013010 Sheep meat Sum of fludioxonil and its










0 n.c. 2006 no

1013030 Sheep liver Sum of fludioxonil and its










0 n.c. 2006 no

1013040 Sheep kidney Sum of fludioxonil and its










0 n.c. 2006 no

1013050 Sheep edible offal Sum of fludioxonil and its










0 n.c. 2006 no

Interim CXL (2005-2009). Based on

a maximum dietary burden of 3.0

ppm for beef cattle.







Summary of CXLs for fludioxonil in livestock commodities

Commodity

codeCommodity name


CXL (mg/kg)

Critical values of the JMPR evaluation Comment on the JMPR evaluation


EFSA Journal 2011;9(8):2335 80

1014010 Goat meat Sum of fludioxonil and its










0 n.c. 2006 no

1014030 Goat liver Sum of fludioxonil and its










0 n.c. 2006 no

1014040 Goat kidney Sum of fludioxonil and its










0 n.c. 2006 no

1014050 Goat edible offal Sum of fludioxonil and its










0 n.c. 2006 no

1015010 Horses, asses, mules or

hinnies meat

Sum of fludioxonil and its










0 n.c. 2006 no


hinnies liver











0 n.c. 2006 no


hinnies kidney











0 n.c. 2006 no


hinnies edible offal











0 n.c. 2006 no

1016010 Poultry meat Sum of fludioxonil and its










0 n.c. 2006 no

1016030 Poultry liver Sum of fludioxonil and its










0 n.c. 2006 no

1016040 Poultry kidney Sum of fludioxonil and its










0 n.c. 2006 no

1016050 Poultry edible offal Sum of fludioxonil and its










0 n.c. 2006 no







Interim CXLs (2005-2009). Based on


ppm for poultry.


EFSA Journal 2011;9(8):2335 81

1017010 Other farm animals meat Sum of fludioxonil and its










0 n.c. 2006 no

1017030 Other farm animals liver Sum of fludioxonil and its










0 n.c. 2006 no

1017040 Other farm animals kidney Sum of fludioxonil and its










0 n.c. 2006 no

1017050 Other farm animals edible offal Sum of fludioxonil and its










0 n.c. 2006 no

1020010 Cattle milk Sum of fludioxonil and its





no 0.01 Sum of fludioxonil and its





0 n.c. 2006 no

1020020 Sheep milk Sum of fludioxonil and its










0 n.c. 2006 no

1020030 Goat milk Sum of fludioxonil and its










0 n.c. 2006 no

1020040 Horse milk Sum of fludioxonil and its










0 n.c. 2006 no

1030000 Birds' eggs Sum of fludioxonil and its










0 n.c. 2006 no Interim CXL (2005-2009)

(*) Indicates the lower limit of analytical quantification.


n.c.: not considered

n.k.: not known



ppm for dairy cattle.





EFSA Journal 2011;9(8):2335 82

APPENDIX D – DECISION TREE FOR DERIVING MRL RECOMMENDATIONS

(A)

Specific LOQ or

default MRL?

(B)

Specific LOQ or

default MRL?

(C)

Maintain current

EU MRL?

(D)

Specific LOQ or

default MRL?

(E)

Establish tentative

EU MRL?

(F)

Specific LOQ or

default MRL?

(G)

MRL is

recommended.

GAP or

DB >0.1 mg/kg

DM in EU?

MRL derived

in section 3?

MRL fully

supported by

data?

Risk identified? Risk identified? Risk identified?

Median/highest

values are

included in the

RA.

Tentative median/

highest values are

included in the

RA.

Current EU MRL

is included in the

RA.

Fal-back MRL

available?

Fal-back MRL

available?

Not considered

for the RA

No Yes

Yes

No

Yes

No

NoYes

Yes

No

No

Yes

No

Yes

No

Recommendations resulting from EU authorisations and import tolerances

Evaluation of the GAPs and available residues data at EU level

Consumer risk assessment for GAPs evaluated at EU level - EU scenarios

Comparison

with CXLs


EFSA Journal 2011;9(8):2335 83

No

Yes

(I)

Maintain EU

recommendation

indicating that no

CXL is available.

(II)

Maintain EU

recommendation

indicating CXL is

not compatible.

(III)

Maintain EU

recommendation

indicating that

CXL is covered.

(IV)

Maintain EU

recommendation;

higher CXL is not

safe for consumer.

(V)

Maintain current

CXL or EU

recommendation?

(VI)

Maintain EU

recommendation;

higher CXL is not

safe for consumer.

(VII)

CXL is

recommended; EU

recommendation

is covered as well.

CXL available?

RD

comparable?

CXL fully

supported by

data?

Risk identified? Risk identified?

Codex median/

highest residues

are included in the

RA.

CXL is included in

the RA.

Input values for

the RA remain

unchanged.

Input values for

the RA remain

unchanged.

No Yes

Yes

No

Yes

No

Yes No Yes No

Recommendations with consideration of the existing CXL

Comparison of the EU recommendation with the existing CXL

Consumer risk assessment with consideration of the existing CXL

Input values for

the RA remain

unchanged.

CXL higher?

Result EU

assessment


EFSA Journal 2011;9(8):2335 84

APPENDIX E – LIST OF METABOLITES AND RELATED STRUCTURAL FORMULA

Common name IUPAC name Structural formula

CGA 192155 2,2-difluoro-benzo[1,3]dioxole-4

carboxylic acid

O

OF

F

OH

O

CGA 265378 4-(2,2-difluoro-benzol[1,3]dioxol-4-yl)-

2,5-dioxo-2,5-dihydro-1H-pyrrole-3-

carbonitrile O

OF

F

CN

NH

O

O

CGA 308103 2-(2,2-difluoro-benzol[1,3]dioxol-4-yl)-

2-hydroxy-acetamide OH

O

OF

FO NH

2

CGA 340351 2,2-difluorobenzol[1,3]dioxole-4-

carboxylic acid amide

O

OF

F

O

NH2

CGA 227731 6-hydroxy-2H-chromeno[3,4-c]pyrrol-4-

one

NH

O O

OH

CGA 260766 3-(2,2-difluorobenzo[1,2]dioxol-4-yl)-4-

hydroxy-pyrrole-2,5-dione

O

OF

F

NH

O

O

OH


EFSA Journal 2011;9(8):2335 85

ABBREVIATIONS

a.s. active substance

ADI acceptable daily intake

ARfD acute reference dose

BBCH growth stages of mono- and dicotyledonous plants

bw body weight

CAC Codex Alimentarius Commission

CF conversion factor for enforcement residue definition to risk assessment

residue definition

CXL codex maximum residue limit

d day

DAR Draft Assessment Report (prepared under Council Directive 91/414/EEC)

DAT days after treatment

DB dietary burden

DFG Deutsche Forschungsgemeinschaft German

DM dry matter

DT90 period required for 90 percent dissipation (define method of estimation)

EC European Commission

EFSA European Food Safety Authority

EU European Union

FAO Food and Agriculture Organisation of the United Nations

FS flowable suspension

GAP good agricultural practice

ha hectare

HPLC-MS/MS high performance liquid chromatography coupled with tandem mass

spectrometry

HPLC-UV high performance liquid chromatography coupled with ultra-violet detection

ILV independent laboratory validation


EFSA Journal 2011;9(8):2335 86

ISO International Organization for Standardization

IUPAC International Union of Pure and Applied Chemistry

JMPR Joint FAO/WHO Meeting on Pesticide Residues

L litre

LOQ limit of quantification

MAP mitogen-activated protein

MRL maximum residue limit

MS Member States

NEU northern European Union

PF processing factor

PHI pre-harvest interval

Pow partition coefficient n-octanol/water

PRIMo (EFSA) Pesticide Residues Intake Model

PROFile (EFSA) Pesticide Residues Overview File

QuEChERS Quick, Easy, Cheap, Effective, Rugged, and Safe (method)

Rber statistical calculation of the MRL by using a non-parametric method

Rmax statistical calculation of the MRL by using a parametric method

RA risk assessment

RAC raw agricultural commodity

RD residue definition

RMS rapporteur Member State

RSD relative standard deviation

SC suspension concentrate

SEU Southern European Union

TRR total radioactive residue

WG water dispersible granule

WP wettable powder

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