EFSA Journal 2011;9(8):2335
Suggested citation: European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for fludioxonil
according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2011;9(8):2335. [86 pp.]
doi:10.2903/j.efsa.2011.2335. Available online: www.efsa.europa.eu/efsajournal
© European Food Safety Authority, 2011
REASONED OPINION
Review of the existing maximum residue levels (MRLs) for fludioxonil
according to Article 12 of Regulation (EC) No 396/20051
European Food Safety Authority2, 3
European Food Safety Authority (EFSA), Parma, Italy
SUMMARY
Fludioxonil was included in Annex I to Directive 91/414/EEC on 01 November 2008, which is after
the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore
required to provide a reasoned opinion on the review of the existing MRLs for that active substance in
compliance with Article 12(1) of afore mentioned regulation. In order to collect the relevant pesticide
residues data, EFSA asked Denmark, as the designated rapporteur Member State (RMS), to complete
the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The
requested information was submitted to EFSA on 02 March 2010 and, after having considered several
comments made by EFSA, the RMS provided on 14 January 2011 a revised PROFile.
Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs
established by the Codex Alimentarius Commission and the additional information provided by the
RMS, EFSA issued on 16 March 2011 a draft reasoned opinion that was circulated to Member State
experts for consultation. Comments received by 20 May 2011 were considered for finalisation of this
reasoned opinion. The following conclusions are derived.
The toxicological profile of fludioxonil was evaluated in the framework of Directive 91/414/EEC,
which resulted in an ADI of 0.37 mg/kg bw/d. No ARfD was deemed necessary.
Primary crop metabolism of fludioxonil was investigated in three different crop groups following
foliar applications, and in three different crop groups following seed applications. Metabolic patterns
in the different studies were shown to be similar and the relevant residue for enforcement in all crops
supported in the framework of this review is proposed as parent fludioxonil. For risk assessment, the
residue was defined as the sum of fludioxonil and its metabolites oxidized to metabolite 2,2-difluoro-
benzo[1,3]dioxole-4 carboxylic acid, expressed as fludioxonil. A conversion factor of 2.8 from
enforcement to risk assessment is proposed for root vegetables after foliar application. No studies
investigating the metabolism of fludioxonil following post-harvest treatment are available. However,
as a more extensive metabolism of the active substance is not expected in the post-harvest use, EFSA
concludes that the same residue definitions apply. Validated analytical methods for enforcement of
1 On request from EFSA, Question No EFSA-Q-2009-00024, issued on 22 August 2011. 2 Correspondence: [email protected] 3 Acknowledgement: EFSA wishes to thank the rapporteur Member State Denmark for the preparatory work on this
scientific output.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 2
the residue definition in foods of plant origin are available with a LOQ of 0.01 mg/kg in high water
content, high oil content, acidic and dry commodities.
Regarding the magnitude of residues in most crops reported by the RMS, at least one GAP or import
tolerance was supported by a sufficient number of supervised residue trials, which allowed EFSA to
estimate the expected residue concentrations in the relevant plant commodities and to derive
appropriate MRLs, except for citrus fruits, pistachios, stone fruits and strawberries where data were
sufficient to derive tentative MRLs only. For cucurbits with inedible peel and celery, the number of
residue trials was not compliant with the minimum data requirements defined by EU guidance
documents. EFSA was therefore not able to derive reliable MRL proposals in the above mentioned
crops and further residue trials are required.
In processed commodities, parent fludioxonil was shown to be stable during pasteurisation, cooking,
boiling/brewing/baking and sterilisation and no formation of toxicologically relevant metabolites
occurs. Magnitude of residues in processed commodities was also investigated and robust processing
factors could be derived for carrots (canned, cooked, juice), wine grapes (juice, must, wine), table
grapes (raisin) and peeled passion fruits. Further processing studies are not required as they are not
expected to affect the outcome of the risk assessment. However, if there would be the intention to
derive more robust processing factors, in particular for enforcement purposes, additional processing
studies would be required.
The potential incorporation of soil residues into succeeding and rotational crops was investigated in
lettuce, winter and spring wheat, sugar beets, corn, mustard, turnips and radishes. These studies
showed a comparable metabolism to the primary crops and significant residues in rotational crops are
not expected, provided that fludioxonil is applied according to the GAPs supported in the framework
of this review.
Based on the uses reported by the RMS, significant exposures to fludioxonil are expected for dairy
ruminants, meat ruminants and pigs. Metabolism in lactating ruminants and poultry was sufficiently
investigated and findings can be extrapolated to pigs as well. The relevant residue definition for
enforcement and risk assessment was defined as the sum of fludioxonil and its metabolites oxidized to
metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid, expressed as fludioxonil. A validated
analytical method for enforcement of the residue definition is also available with a LOQ of 0.01
mg/kg in milk and meat and a LOQ of 0.05 mg/kg in liver, kidney, fat and eggs. The available
livestock feeding study demonstrated that residues of fludioxonil are not expected in milk or in any
edible matrix of pigs and MRLs in these commodities can be set at the LOQ. Yet the livestock dietary
intake for meat ruminants exceeds the highest dose level of the feeding study. Tentative MRLs for
these commodities can be proposed, based on extrapolation from the highest available dosing level
but a new feeding study including a higher dosing level is still required. MRLs are not required for
poultry products because poultry is not expected to be exposed to significant levels of fludioxonil
residues.
Chronic consumer exposure resulting from the MRLs proposed in the framework of this review was
calculated. The highest chronic exposure represented 16.5 % of ADI (German child). Acute exposure
calculations were not carried out because an ARfD was not deemed necessary for this active
substance.
Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs
have also been established for fludioxonil. Additional calculations of the chronic consumer exposure,
including these CXLs, were therefore performed. The highest chronic exposure represented 15.8 % of
the ADI (German child).
Based on the above assessment, EFSA does not recommend inclusion of this active substance in
Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 3
the decision tree reported in Appendix D (see table below for a summary). All MRL values listed in
the table as ‘Recommended’ are sufficiently supported by data and therefore proposed for inclusion in
Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for
inclusion in Annex II because they require further consideration by risk managers (see table footnotes
for details). In particular, certain tentative MRLs and existing EU MRLs still need to be confirmed by
the following data:
6 additional residue trials supporting the northern outdoor GAP, 4 additional residue trials
supporting the southern outdoor GAP and 6 residue trials supporting the indoor GAP on
strawberries;
8 residue trials on melons supporting the import tolerance GAP on cucurbits with inedible
peel (currently ongoing);
3 additional residue trials supporting the northern outdoor GAP and 3 additional residue trials
supporting the southern outdoor GAP on celery (currently ongoing);
a livestock feeding study for meat ruminants at higher dose levels, taking into account the
calculated dietary burdens where levels of fludioxonil and metabolites containing the 2,2-
difluorobenzo [1,3]dioxole-4 carboxylic moiety are preferably reported separately (currently
ongoing).
It is highlighted, however, that some of the ‘Recommended’ MRLs result from a CXL or from a GAP
in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data.
EFSA therefore identified the following data gaps which are not expected to impact on the
recommended MRLs but which might have an impact on national authorisations:
2 additional residue trials on oranges supporting the post-harvest EU GAP on citrus fruits;
1 additional residue trial supporting the import tolerance GAP on pistachios;
1 additional residue trial on plums supporting the import tolerance GAP on apricots and
plums;
3 additional residue trials on raspberries complying with the southern outdoor GAP on
raspberries and blackberries;
8 residue trials on currants complying with the southern outdoor GAP on blueberries,
cranberries, currants and gooseberries;
6 additional residue trials on tomatoes supporting the northern outdoor GAP, 6 additional
residue trials on tomatoes supporting the southern outdoor GAP and 8 residue trials on
tomatoes supporting the import tolerance GAP on tomatoes and aubergines;
8 residue trials complying with the import tolerance GAP on peppers;
8 residue trials on cucumbers and/or courgettes supporting the northern outdoor GAP, 4
additional residue trials on cucumbers supporting the southern outdoor GAP and 8 residue
trials on cucumbers and/or courgettes supporting the import tolerance GAP on cucurbits with
edible peel;
6 additional residue trials on fresh beans with pods complying with the northern outdoor GAP
on fresh beans and fresh peas with pods;
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 4
4 residue trials complying with the northern outdoor GAP on fennel;
residue trials including both pre- and post-harvest treatments to assess the combined effect of
both treatments on the residue levels (pome fruits).
If the above reported data gaps are not addressed in the future, Member States are recommended to
withdraw or modify the relevant authorisations at national level.
Minor deficiencies were also identified in the assessment but these deficiencies are not expected to
impact either on the validity of the recommended MRLs or on the national authorisations. The
following data are therefore considered desirable but not essential:
development of a more efficient analytical method for enforcement of commodities of animal
origin, less laborious than the current one, and preferably analysing the for the parent
compound only in muscle, fat and liver;
1 additional residue trial complying with the northern outdoor GAP on potatoes;
2 trials complying with the northern outdoor GAP on sugar beet;
residues trials supporting the GAPs on bulb vegetables, witloof, fresh beans, fresh peas,
oilseeds, cereals grains and sweet corn carried out with analytical methods achieving a LOQ
of 0.01 mg/kg.
Code
number
Commodity Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
Enforcement residue definition: fludioxonil
110010 Grapefruit 10 10 10 Recommended (e)
110020 Oranges 7 10 10 Recommended (e)
110030 Lemons 7 10 10 Recommended (e)
110040 Limes 7 10 10 Recommended (e)
110050 Mandarins 7 10 10 Recommended (e)
120100 Pistachios 0.05* 0.2 0.2 Recommended (i)
130000 Pome fruit 5 5 5 Recommended (h)
140010 Apricots 5 5 5 Recommended (i)
140020 Cherries 5 5 5 Recommended (h)
140030 Peaches 7 5 10 Recommended (e)
140040 Plums 0.5 5 5 Recommended (i)
151010 Table grapes 2 2 5 Recommended (e)
151020 Wine grapes 2 2 4 Recommended (e)
152000 Strawberries 3 3 4 Further consideration needed (f)
153010 Blackberries 5 5 5 Recommended (h)
153020 Dewberries 0.05* 5 5 Recommended (j)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 5
Code
number
Commodity Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
153030 Raspberries 5 5 5 Recommended (h)
154010 Blueberries 3 2 2 Recommended (e)
154020 Cranberries 1 - 2 Recommended (a)
154030 Currants (red, black and
white)
3 - 2 Recommended (a)
154080 Elderberries 2 - 0.8 Recommended (a)
154040 Gooseberries 3 - 2 Recommended (a)
162010 Kiwi 20 15 15 Recommended (e)
163030 Mangoes 0.05* - 1 Recommended (a)
163050 Pomegranate 3 2 3 Recommended (e)
211000 Potatoes 1 0.02 0.06 Recommended (e)
212020 Sweet potatoes 0.05* 10 10 Recommended (e)
212030 Yams 0.05* 10 10 Recommended (e)
213010 Beetroot 1 - 1 Recommended (a)
213020 Carrots 1 0.7 1 Recommended (e)
213030 Celeriac 0.2 - 0.2 Recommended (a)
213040 Horseradish 1 - 1 Recommended (a)
213060 Parsnips 1 - 1 Recommended (a)
213070 Parsley root 1 - 1 Recommended (a)
213090 Salsify 1 - 1 Recommended (a)
220010 Garlic 0.05* - 0.02 Recommended (a)
220020 Onions 0.1 0.5 0.5 Recommended (h)
220030 Shallots 0.05* - 0.02 Recommended (a)
220040 Spring onions 0.3 5 5 Recommended (h)
231010 Tomatoes 1 0.5 0.9 Recommended (e)
231020 Peppers 2 1 1 Recommended (e)
231030 Aubergines (egg plants) 1 0.3 0.4 Recommended (e)
232010 Cucumbers 1 0.3 0.4 Recommended (e)
232020 Gherkins 0.5 - 0.4 Recommended (a)
232030 Courgettes 1 0.3 0.4 Recommended (e)
233010 Melons 0.05* 0.03 0.05 Further consideration needed (g)
233020 Pumpkins 0.05* - 0.05 Further consideration needed (c)
233030 Watermelons 0.05* - 0.05 Further consideration needed (c)
234000 Sweet corn 0.05* 0.01* 0.01* Recommended (e)
241010 Broccoli 0.05* 0.7 0.7 Recommended (j)
242020 Head cabbage 0.05* 2 2 Recommended (j)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 6
Code
number
Commodity Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
243010 Chinese cabbage 0.05* 10 10 Recommended (j)
0251010 Lamb’s lettuce 10 - 3 Recommended (a)
251020 Lettuce 10 10 12 Recommended (e)
251030 Scarole (broad-leaf
endive)
10 - 12 Recommended (a)
0251040 Cress 10 - 3 Recommended (a)
0251050 Land cress 10 - 3 Recommended (a)
0251060 Rocket, rucola 10 - 3 Recommended (a)
0251070 Red mustard 10 - 3 Recommended (a)
0251080 Leaves and sprout of
brassica spp
10 - 3 Recommended (a)
252010 Spinach 7 - 8 Recommended (a)
252030 Beet leaves (chard) 7 - 8 Recommended (a)
254000 Water cress 0.05* 10 10 Recommended (j)
255000 Witloof 0.05* - 0.02 Recommended (a)
256020 Chives 1 10 10 Recommended (e)
256080 Basil 1 10 10 Recommended (e)
260010 Beans (fresh, with pods) 1 0.3 1 Recommended (e)
260020 Beans (fresh, without
pods)
0.2 0.03 0.05 Recommended (e)
260030 Peas (fresh, with pods) 0.2 0.3 1 Recommended (e)
260040 Peas (fresh, without pods) 0.05* 0.03 0.05 Recommended (e)
260050 Lentils (fresh) 0.05* - 0.05 Recommended (a)
270010 Asparagus 0.05* - 0.01* Recommended (a)
270030 Celery 0.05* - 0.05 Further consideration needed (c)
270040 Fennel 0.1 - 0.05 Recommended (a)
300010 Beans (dry) 0.05* 0.07 0.4 Recommended
(k)
300020 Lentils (dry) 0.05* - 0.4 Recommended
(a)
300030 Peas (dry) 0.05* 0.07 0.4 Recommended (k)
300040 Lupins (dry) 0.05* - 0.4 Recommended (a)
401030 Poppy seed 0.05* - 0.01* Recommended (a)
401050 Sunflower seed 0.05* - 0.01* Recommended (a)
401060 Rape seed 0.05* 0.02* 0.01* Recommended (k)
401070 Soya bean 0.05* - 0.01* Recommended (a)
401090 Cotton seed 0.05* 0.05* 0.01* Recommended (k)
500010 Barley grain 0.05* 0.05* 0.01* Recommended (k)
500020 Buckwheat grain 0.05* 0.05* 0.01* Recommended (l)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 7
Code
number
Commodity Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
500030 Maize grain 0.1 0.05* 0.01* Recommended (k)
500040 Millet grain 0.05* 0.05* 0.01* Recommended (l)
500050 Oats grain 0.05* 0.05* 0.01* Recommended (k)
500060 Rice grain 0.05* 0.05* 0.01* Recommended (l)
500070 Rye grain 0.05* 0.05* 0.01* Recommended (k)
500080 Sorghum grain 0.05* 0.05* 0.01* Recommended (l)
500090 Wheat grain 0.2 0.05* 0.01* Recommended (k)
633000 Herbal infusions (dried,
roots)
1 - 1 Recommended (a)
840000 Spices (roots and rhizome) 1 - 1 Recommended (a)
900010 Sugar beet (roots) 0.05* 0.01* Recommended (a)
- Others products of plant
origin
See App.
C.1
- - Further consideration needed (d)
Enforcement residue definition: the sum of fludioxonil and its metabolites oxidized to metabolite 2,2-
difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as fludioxonil
1011010 Swine meat 0.05* 0.01* 0.05*(F)
Recommended (e)
1011020 Swine fat (free of lean
meat)
0.05* - 0.05* Recommended (a)
1011030 Swine liver 0.05* 0.05* 0.05* Recommended (e)
1011040 Swine kidney 0.05* 0.05* 0.05* Recommended (e)
1012010 Bovine meat 0.05* 0.01* 0.2 (F)
Further consideration needed (f)
1012020 Bovine fat 0.05* - 0.2 Further consideration needed (b)
1012030 Bovine liver 0.05* 0.05* 0.2 Further consideration needed (f)
1012040 Bovine kidney 0.05* 0.05* 0.2 Further consideration needed (f)
1013010 Sheep meat 0.05* 0.01* 0.2 (F)
Further consideration needed (f)
1013020 Sheep fat 0.05* - 0.2 Further consideration needed (b)
1013030 Sheep liver 0.05* 0.05* 0.2 Further consideration needed (f)
1013040 Sheep kidney 0.05* 0.05* 0.2 Further consideration needed (f)
1014010 Goat meat 0.05* 0.01* 0.2 (F)
Further consideration needed (f)
1014020 Goat fat 0.05* - 0.2 Further consideration needed (b)
1014030 Goat liver 0.05* 0.05* 0.2 Further consideration needed (f)
1014040 Goat kidney 0.05* 0.05* 0.2 Further consideration needed (f)
1016010 Poultry meat 0.05* 0.01* 0.01* Recommended (j)
1016030 Poultry liver 0.05* 0.05* 0.05* Recommended (j)
1016040 Poultry kidney 0.05* 0.05* 0.05* Recommended (j)
1020010 Cattle milk 0.05* 0.01 0.01 Recommended (e)
1020020 Sheep milk 0.05* 0.01 0.01 Recommended (e)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 8
Code
number
Commodity Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
1020030 Goat milk 0.05* 0.01 0.01 Recommended (e)
1030000 Birds' eggs 0.05* 0.05* 0.05* Recommended (j)
- Others products of animal
origin
See App.
C.1
- - Further consideration needed (d)
(*): Indicates that the MRL is set at the limit of analytical quantification.
(F): MRL is expressed as mg/kg of fat contained in the whole product.
(a): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to
consumers is identified; no CXL is available (combination G-I in Appendix D).
(b): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk
to consumers could be identified; no CXL is available (combination E-I in Appendix D).
(c): GAP evaluated at EU level is not supported by data but no risk to consumers could be identified for the existing EU
MRL; no CXL is available (combination C-I in Appendix D).
(d): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either the specific
LOQ or the default MRL of 0.01 mg/kg may be considered (combination A-I in Appendix D).
(e): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to
consumers is identified; existing CXL is covered by the recommended MRL (combination G-III in Appendix D).
(f): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk
to consumers could be identified; existing CXL is covered by the tentative MRL (combination E-III in Appendix D).
(g): GAP evaluated at EU level is not supported by data but no risk to consumers could be identified for the existing EU
MRL; existing CXL is covered by the existing EU MRL (combination C-III in Appendix D).
(h): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified;
GAP evaluated at EU level, which is also fully supported by data, leads to a lower MRL (combination G-VII in
Appendix D).
(i): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified;
GAP evaluated at EU level, which is not fully supported by data, leads to a lower tentative MRL (combination E-VII in
Appendix D).
(j): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified;
there are no relevant authorisations or import tolerances reported at EU level (combination A-VII in Appendix D).
(k): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to
consumers is identified; existing CXL is covered by the recommended MRL when the European enforcement LOQ of
0.01 mg/kg is assumed (combination G-III in Appendix D).
(l): MRL is derived from the existing CXL but considering the European enforcement LOQ of 0.01 mg/kg (supported by
data and no risk to consumers identified); there are no relevant authorisations or import tolerances reported at EU level
(combination A-VII in Appendix D).
KEY WORDS
Fludioxonil, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, phenylpyrrole, fungicide,
2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 9
TABLE OF CONTENTS
Summary .................................................................................................................................................. 1 Table of contents ...................................................................................................................................... 9 Background ............................................................................................................................................ 10 Terms of reference ................................................................................................................................. 11 The active substance and its use pattern ................................................................................................ 11 Assessment ............................................................................................................................................. 12 1. Methods of analysis ....................................................................................................................... 12
1.1. Methods for enforcement of residues in food of plant origin ............................................... 12 1.2. Methods for enforcement of residues in food of animal origin ............................................ 13
2. Mammalian toxicology .................................................................................................................. 13 3. Residues ......................................................................................................................................... 14
3.1. Nature and magnitude of residues in plant ........................................................................... 14 3.1.1. Primary crops .................................................................................................................... 14 3.1.2. Rotational crops ................................................................................................................ 38
3.2. Nature and magnitude of residues in livestock ..................................................................... 40 3.2.1. Dietary burden of livestock .............................................................................................. 40 3.2.2. Nature of residues ............................................................................................................. 42 3.2.3. Magnitude of residues ...................................................................................................... 43
4. Consumer risk assessment ............................................................................................................. 46 4.1. Consumer risk assessment without consideration of the existing CXLs .............................. 46 4.2. Consumer risk assessment with consideration of the existing CXLs ................................... 49
Conclusions and recommendations ........................................................................................................ 53 Documentation provided to EFSA ......................................................................................................... 60 References .............................................................................................................................................. 60 Appendix A – Good Agricultural Practices (GAPs) .............................................................................. 63 Appendix B – Pesticide Residues Intake Model (PRIMo) ..................................................................... 70 Appendix C – Existing EU maximum residue limits (MRLs) and Codex Limits (CXLs) .................... 73 Appendix D – Decision tree for deriving MRL recommendations ........................................................ 82 Appendix E – List of metabolites and related structural formula .......................................................... 84 Abbreviations ......................................................................................................................................... 85
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 10
BACKGROUND
Regulation (EC) No 396/20054 establishes the rules governing the setting as well as the review of
pesticide MRLs at Community level. Article 12(1) of that regulation lays down that EFSA shall
provide within 12 months from the date of the inclusion or non-inclusion of an active substance in
Annex I to Directive 91/414/EEC5 a reasoned opinion on the review of the existing MRLs for that
active substance. As fludioxonil was included in Annex I to the above mentioned directive on
01 November 2008, EFSA initiated the review of all existing MRLs for that active substance and a
task with the reference number EFSA-Q-2009-00024 was included in the EFSA Register of
Questions.
According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant
assessment report prepared under Directive 91/414/EEC. It should be noted, however, that in the
framework of Directive 91/414/EEC only a few representative uses are evaluated while MRLs set out
in Regulation (EC) No 396/2005 should accommodate for all uses authorised within the EC as well as
uses authorised in third countries having a significant impact on international trade. The information
included in the assessment report prepared under Directive 91/414/EEC is therefore insufficient for
the assessment of all existing MRLs for a given active substance.
In order to have an overview on the pesticide residues data that have been considered for the setting of
the existing MRLs, EFSA developed the Pesticide Residue Overview File (PROFile). The PROFile is
an electronic inventory of all pesticide residues data relevant to the risk assessment as well as the
MRL setting for a given active substance. This includes data on:
the nature and magnitude of residues in primary crops;
the nature and magnitude of residues in processed commodities;
the nature and magnitude of residues in rotational crops;
the nature and magnitude of residues in livestock commodities and;
the analytical methods for enforcement of the proposed MRLs.
Denmark, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC,
was asked to complete the PROFile for fludioxonil and to prepare a supporting evaluation report. The
requested information was submitted to EFSA on 02 March 2010 and subsequently checked for
completeness. On 14 January 2011, after having clarified some issues with EFSA, the RMS provided
a revised PROFile.
A draft reasoned opinion was issued by EFSA on 16 March 2011 and submitted to Member States
(MS) for commenting. All MS comments received by 20 May 2011 were considered by EFSA for
finalization of the reasoned opinion.
4 Commission Regulation (EC) No 396/2005 of 23 February 2005. OJ L 70, 16.3.2005, p. 1-16. 5 Council Directive 91/414/EEC of 15 July 1991, OJ L 230, 19.8.1991, p. 1-32.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 11
TERMS OF REFERENCE
According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on:
the inclusion of the active substance in Annex IV to the Regulation, when appropriate;
the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs
set out in Annex II or III of the Regulation;
the inclusion of the recommended MRLs in Annex II or III to the Regulation;
the setting of specific processing factors as referred to in Article 20(2) of the Regulation.
THE ACTIVE SUBSTANCE AND ITS USE PATTERN
Fludioxonil is the ISO common name for 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-pyrrole-3-carbonitrile
(IUPAC).
OO
FF
N
N
Fludioxonil belongs to the group of phenylpyrrole compounds which are used as fungicide. Its mode
of action is the inhibition of a mitogen-activated protein (MAP) kinase in signal transduction of osmo-
regulation (glycerol synthesis). Fludioxonil is used as foliar and seed treatment applications to control
diseases caused by fungi in the class of Ascomycetes, Basidiomycetes and Fungi imperfecti.
Fludioxonil was evaluated in the framework of Directive 91/414/EEC with Denmark being the
designated rapporteur Member State (RMS). The representative uses supported for the peer review
process cover foliar applications on wine and table grapes and seed treatment of wheat grain.
Following the peer review, which was carried out by EFSA, a decision on inclusion of the active
substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive
2007/76/EC6, entering into force on 01 November 2008. The Annex I inclusion of fludioxonil is
restricted to uses as fungicide only.
EU MRLs for fludioxonil in products of plant and animal origin have been set for the first time in
2008 by means of Commission Regulation (EC) No 149/20087 establishing Annexes II, III and IV of
Regulation (EC) No 396/2005. These temporary MRLs were derived from the MRLs that have been
set at national level before Regulation (EC) No 396/2005 entered into force. EFSA recently
recommended the modification of existing MRLs for pomegranates, spinach and beet leaves, celeriac
as well as for various root vegetables (carrots, beetroots, salsify, horseradish, parsnips, parsley roots,
roots of herbal infusions and roots of spices) (EFSA, 2008, 2009a, 2009b, 2009c) which were legally
implemented in Regulations 2009/256/EC8, 2009/822/EC
9 and 2010/750/EC
10, and for sweet potatoes,
yams, table and wine grapes (EFSA, 2010) which were already approved by the meeting of the
Standing Committee on the Food Chain and Animal Health held on 23-24 March 2011 but which are
not yet legally implemented. All existing EU MRLs, which are established for the parent compound
6 Commission Directive 2007/76/EC of 20 December 2007, OJ L 337, 21.2.2007, p. 100-104.
7 Commission Regulation (EC) No 149/2008 of 29 January 2008. OJ L 58, 1.3.2008, p. 1-398.
8 Commission Regulation 2009/256/EC of 23 March 2009, OJ L 81, 27.3.2009, p. 3-14
9 Commission Regulation 2009/822/EC of 27 August 2009, OJ L 239, 10.9.2009, p. 5-45
10 Commission Regulation (EU) No750/2010 of 7 July 2010. OJ L 220, 21.08.2010, p. 1-56.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 12
only, are summarized in Appendix C.1 to this document. CXLs for fludioxonil were also established
by the Codex Alimentarius Commission (CAC) and are reported in Appendix C.2 to this reasoned
opinion. These CXLs refer to parent compound only for products of plant origin, and to the sum of
fludioxonil and its benzopyrrole metabolites, determined as 2,2-difluoro-benzo[1,3]dioxide-4-
carboxylic acid and expressed as fludioxonil, for products of animal origin.
For the purpose of this MRL review, the critical uses of fludioxonil currently authorized within the
EU as well as uses authorised in third countries that might have a significant impact on international
trade, have been collected by the RMS and reported in the PROFile (see Appendix A). Uses of
fludioxonil previously evaluated by EFSA were also considered (EFSA, 2008, 2009a, 2009b, 2009c,
2010). According to the reported GAPs, fludioxonil is applied on a wide range of crops either by
foliar spraying, seed treatment or post-harvest treatment, both indoor and outdoor. PHIs may vary
between 1 and 28 days.
ASSESSMENT
EFSA bases its assessment on the PROFile submitted by the RMS, the evaluation report
accompanying the PROFile (Denmark, 2010), the Draft Assessment Report (DAR) and its addenda
prepared under Council Directive 91/414/EEC (Denmark, 2005, 2007), the conclusion on the peer
review of the pesticide risk assessment of the active substance fludioxonil (EFSA, 2007), the JMPR
Evaluation report (FAO, 2004, 2006, 2010), the previous reasoned opinions on fludioxonil (EFSA,
2008, 2009a, 2009b, 2009c, 2010) and the evaluation reports submitted during the Member States
consultation (Austria, 2001; Belgium, 2011; Denmark, 2011; Finland, 2011; France, 2011; Germany,
2011; The Netherlands, 2011; The United Kingdom, 2007 and 2010). The assessment is performed in
accordance with the legal provisions of the Uniform Principles for the Evaluation of the Authorization
of Plant Protection Products adopted by Commission Regulation (EU) No 546/201111
and the
currently applicable guidance documents relevant for the consumer risk assessment of pesticide
residues (EC, 1996, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2004, 2010, 2011).
1. Methods of analysis
1.1. Methods for enforcement of residues in food of plant origin
During the peer review under Directive 91/414/EEC, an analytical method using HPLC-UV was
evaluated and validated for the determination of parent fludioxonil with a LOQ of 0.02 mg/kg in high
water content (strawberries), high acid content (grapes, apples) and dry (wheat grain) commodities
and a LOQ of 0.05 mg/kg in wine (Denmark, 2005). A confirmatory method was not available.
Additionally, the multi-residue analytical method DFG S19 using HPLC-MS/MS and its ILV were
evaluated and validated for the determination of parent fludioxonil with a LOQ of 0.01 mg/kg in high
oil content (avocados), acidic (kiwi, citrus) and dry (wheat) commodities (Denmark, 2005; EFSA,
2007b).
The multi-residue QuEChERS method using HPLC-MS/MS described in the European Standard
EN 15662:2008 validated with a LOQ of 0.01 mg/kg for the determination of residues in high water
content and acidic commodities is also applicable.
11
Regulation (EU) No 546/2011 of 10 June 2011. OJ L 155, 11.06.2011, p. 127-175.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 13
Table 1-1: Recovery data for the analysis of fludioxonil in different crop groups using the
QuEChERS method in combination with LC-MS/MS (CEN, 2008)
Commodity group Spiking levels
(mg/kg)
Recoveries No of
labs Mean (%) RSD (%) n
Acidic
0.01
0.025
0.1
0.25
98
104
100
102
7
10
7
10
15
20
14
25
3
4
3
5
Watery 0.01
0.025
0.1
0.25
96
97
97
103
4
5
6
8
15
40
15
55
3
5
3
6
Hence, according to the peer review and the CEN, it is concluded that parent fludioxonil can be
enforced in food of plant origin with a LOQ of 0.01 mg/kg in high water content, high oil content,
acidic and dry commodities.
1.2. Methods for enforcement of residues in food of animal origin
During the peer review under Directive 91/414/EEC, an analytical method using HPLC-UV,
confirmed by the use of an alternative column in the HPLC system, and its ILV were evaluated and
validated for the determination of the sum of fludioxonil and its metabolites that can be oxidised to
metabolite CGA 19215512
, expressed as fludioxonil, with a LOQ of 0.01 mg/kg in milk and meat and
a LOQ of 0.05 mg/kg in liver, kidney, fat and eggs (FAO, 2004; Denmark, 2005). However, as the
method is very complex, involving a laborious extraction method, the development of a more efficient
method is still desirable.
Hence, it is concluded that the sum of fludioxonil and its metabolites that can oxidised to metabolite
CGA 192155, expressed as fludioxonil, can be enforced in products of animal origin with a LOQ of
0.01 mg/kg in milk and meat and a LOQ of 0.05 mg/kg in liver, kidney, fat and eggs.
2. Mammalian toxicology
The toxicological assessment of fludioxonil was peer reviewed under Directive 91/414/EEC and
toxicological reference values were established by EFSA (2007b). These toxicological reference
values are summarized in Table 2-1.
12
CGA 192155: 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid. See Appendix E.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 14
Table 2-1: Overview of the toxicological reference values
Source Year Value Study relied upon Safety
factor
Fludioxonil
ADI EFSA 2007 0.37 mg/kg bw/d Rat, acute neurotoxicity 100
ARfD EFSA 2007 Not necessary
3. Residues
3.1. Nature and magnitude of residues in plant
3.1.1. Primary crops
3.1.1.1. Nature of residues
Metabolism of fludioxonil was investigated for foliar application on fruits and fruiting vegetables
(grape, peach, tomato), on leafy vegetables (lettuce) and on root and tuber vegetables (spring onion)
as well as for seed treatment on root and tuber vegetables (potato), pulses and oilseeds (cotton,
soybean) and cereals (wheat, rice) using both pyrrole-4-14
C labelled and phenyl-U-14
C labelled
fludioxonil (Denmark, 2005). Available studies are summarized in table 3-1.
When applied on leaves or on seeds, fludioxonil is metabolised mainly through oxidation followed by
conjugation of metabolites with sugars. Following foliar application, the major component was parent
fludioxonil, accounting for 22 % of the TRR in peach and up to 73.2 % of the TRR in tomatoes.
Following seed application, uptake and translocation of fludioxonil was low, TRR ranged from
<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
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 15
Group Crop Label
position
Application and sampling details
Method,
F or G (a)
Rate No Sampling
(DAT)
Remarks
Peach [phenyl-U-14
C] Foliar, F
0.84 or
8.40 kg
a.s./ha
(total)
8.40 kg
a.s./ha
(total)
3
2
28
30, 114
Tomato [pyrrole-4-14
C] Foliar, G 0.75 kg
a.s./ha 3
After 1st appl.: 0
After 3rd
appl.:
0, 40
Leafy
vegetables
Lettuce [pyrrole-4-14
C] Foliar, F
0.20 kg
a.s./ha
or
0.60 kg
a.s./ha
3 0, 6, 13
Root and tuber
vegetables
Spring
onion
[phenyl-U-14
C] Foliar
0.12 kg
a.s./ha
(total)
or
6.17 kg
a.s./ha
(total)
2 0, 7, 14, 28
Potato [pyrrole-4-14
C] Seed, F
2.50 g
a.s./100 kg
seed
1 0, 40, 71, 95
Pulses and
oilseeds
Cotton [pyrrole-4-14
C] Seed, G
2.50 g
a.s./100 kg
5.0 g
a.s./100kg
seed
1 186
Soybean [pyrrole-4-14
C] Seed, G
5.00 g
a.s./100 kg
seed
1 28, 38, 133
Cereals
Wheat [pyrrole-4-14
C] Seed, G,
F
6.40 g
a.s./100 kg
seed (G)
7.30 g
a.s./100 kg
seed (F)
1
11, 18, 25, 32,
39, 46, 53
48, 83, 106
Rice [pyrrole-4-14
C] Seed
6.50 g
a.s./100 kg
seed
1 38, 76, 152
(a): Outdoor/field application (F) or glasshouse/protected/indoor application (G)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 16
Consequently, the residue definition for enforcement is set as fludioxonil for all plant commodities.
The risk assessment residue definition was set as the sum of fludioxonil and its metabolites oxidized
to metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as
fludioxonil (EFSA, 2007b). Validated analytical methods for enforcement of the proposed residue
definition are available (see also section 1.1).
For cereals (seed treatment), fruits and leafy vegetables, pulses and oilseeds, the conversion factor of
1 between residue definitions for enforcement and risk assessment was derived which reflects the fact
that no significant concentrations of metabolites containing the 2,2-difluoro-benzo[1,3]dioxole-4
carboxylic moiety are expected. For root vegetables after foliar application the conversion factor of
2.8 (derived from the metabolism study on spring onions) from enforcement to risk assessment
residue definition is proposed (EFSA, 2009a).
No studies investigating the metabolism of fludioxonil following post-harvest treatment are available.
However, as a more extensive metabolism of the active substance is not expected in the post-harvest
use, EFSA concludes that for all plant commodities and all types of application, the same residue
definition as established by the peer review should apply.
It is noted that the JMPR has established both the risk assessment and enforcement residue definitions
for plant commodities as parent fludioxonil only (FAO, 2004) but according to EFSA the residue
definition derived by JMPR will underestimate the toxicological burden of fludioxonil residues, in
root and tuber vegetables in particular.
3.1.1.2. Magnitude of residues
According to the RMS, the active substance fludioxonil is authorised for foliar and seed treatments in
northern and southern Europe on a large number of crops, both under outdoor and indoor conditions
(see Appendix A). To assess the magnitude of fludioxonil residues resulting from these GAPs, EFSA
considered all residues trials reported in the PROFile (Denmark, 2010), including residues trials
evaluated in the framework of the peer review (Denmark, 2005) or in the framework of MRLs
applications (EFSA, 2008, 2009a, 2009b, 2009c, 2010) and additional data submitted during the
Member State consultation (Austria, 2011; Denmark, 2011; Finland, 2011; France, 2011; Germany,
2011; The Netherlands, 2011; The United Kingdom, 2007 and 2010). All available residue trials that
comply with the authorised GAPs, are summarized in Table 3-2.
The number of residues trials and extrapolations were evaluated in view of the European guidelines
on comparability, extrapolation, group tolerances and data requirements for setting MRLs (EC, 2011).
A sufficient number of trials complying with the GAP was reported by the RMS for all crops under
assessment, except in the following cases:
Citrus fruit: the number of residues trials compliant with the post-harvest uses of fludioxonil
in southern Europe is not compliant with the data requirements for these crops. Although
appropriate MRL and risk assessment values can be derived from the import tolerance data, 2
additional trials on oranges for the post-harvest use in the EU are still required.
Pistachios: the number of residue trials compliant with the import tolerance of fludioxonil is
not compliant with the data requirements for this crop. Tentative MRL and risk assessment
values can be derived from the import tolerance data but 1 additional trial is still required.
Apricots and plums: the number of residues trials supporting the import tolerance (post-
harvest uses) of fludioxonil is not compliant with the data requirements for these crops.
Tentative MRL and risk assessment values can be derived but 1 additional residue trial on
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 17
plums is still required to support the import tolerance in plums as well as the extrapolation to
apricots.
Strawberries: the number of residue trials supporting the northern, southern and indoor uses
of fludioxonil is not compliant with the data requirements for this crop. EFSA used values
from 0 d PHI or 3 d PHI to derive tentative MRLs. However, considering that interpolations
are not supported, additional residue trials representing the residue situation at the PHI of 1
day are still required for each area: 6 for the northern use, 4 for the southern use and 6 for the
indoor use.
Blackberries and raspberries: the number of residues trials supporting the southern use of
fludioxonil is not compliant with the data requirements for these crops. Although appropriate
MRL and risk assessment values can be derived from the northern outdoor data, 3 additional
residues trials on raspberries complying with the southern GAP for these two crops are still
required.
Blueberries, cranberries, currants and gooseberries: no trials are available to support the
southern use of fludioxonil. Although appropriate MRL and risk assessment values can be
derived from the northern outdoor data, 8 trials complying with the southern GAP for these
crops are still required, with a minimum of 4 trials on currants.
Elderberries: trials were carried out with a PHI of 14 days while a PHI of 21 days is
authorised in Austria. Although only deviations of 25% are normally allowed, this deviation
of 33 % is accepted in this case because elderberries are classified a very minor crop, because
fludioxonil has a low acute toxicity (no ARfD was established) and because this deviation is
expected to overestimate residues and risk to consumers.
Potatoes: no sufficient trials are available to support the northern use of fludioxonil. Although
appropriate MRL and risk assessment values can be derived from the southern outdoor data, 1
additional trial complying with the northern GAPs would be desirable.
Tomatoes and aubergines: the number of residues trials supporting the northern, southern and
import tolerance uses of fludioxonil is not compliant with the data requirements for these
crops. Although appropriate MRL and risk assessment values can be derived from the indoor
data, additional residue trials on tomatoes complying with the GAPs for these two crops are
still required for each area: 6 for northern use, 6 for southern use and 8 for import tolerance.
Peppers: no trials are available to support the import tolerance of fludioxonil. Although
appropriate MRL and risk assessment values can be derived from the indoor data, 8 trials
complying with the import tolerance GAP are still required.
Cucurbits with edible peel: the number of residues trials supporting the northern, southern
and import tolerance uses of fludioxonil is not compliant with the data requirements for these
crops. Although appropriate MRL and risk assessment values can be derived from the indoor
data, residue trials on cucumbers and/or courgettes complying with the GAPs for these crops
are still required for each area: 8 for northern use, 4 for southern use and 8 for import
tolerance.
Cucurbits with inedible peel: no trials are available to support the import tolerance of
fludioxonil. At least 8 representative trials on melons would have to be submitted to support a
group tolerance; no MRL is proposed due to the insufficient dataset. The RMS highlighted
that residues trials are ongoing but these trials cannot be considered by EFSA as long as they
are not finalised.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 18
Sweet corn: a data requirement of 4 residue trials normally applies while only 3 trials on
immature maize are available in each area. Considering however that all residue levels are
below the LOQ, indicating a no residue situation, further residue trials are not required.
Fresh beans and fresh peas with pods: the number of residues trials supporting the northern
use of fludioxonil is not compliant with the data requirements for these crop. Although
appropriate MRL and risk assessment values can be derived from the indoor data, 6 additional
trials on fresh beans with pods complying with the northern GAP for these two crops are still
required.
Celery: available trials are not sufficient to support the northern and southern outdoor uses of
fludioxonil. At least 3 representative trials on celery are required for each area; no MRL is
proposed due to the insufficient dataset. The RMS highlighted that residues trials are ongoing
but these trials cannot be considered by EFSA as long as they are not finalised.
Fennel: no trials are available to support the northern use of fludioxonil. Although appropriate
MRL and risk assessment values can be derived from the southern outdoor data, 4 trials on
fennel complying with the northern GAP are still required.
Oilseeds: the number of residues trials in each area is not compliant with the data
requirements for these crops but the reduced number of trials was considered acceptable by
EFSA because residues levels after the seed treatment were demonstrated to be below the
LOQ.
Maize: the value of 0.05 mg/kg would be identified as an outlier according to the Dixon Q
test. Based on the metabolism studies and residue trials on cereals, this value was excluded
from the MRL calculation.
Bulb vegetables, wiltoof, fresh beans and peas (without pods): a MRL of 0.02 mg/kg is
proposed because all residue levels were found to be below the LOQ of 0.02 mg/kg that was
used in the residues trials. Considering however that a LOQ of 0.01 mg/kg can be achieved
for enforcement purposes (see also section 1.1), the elaboration of residues trials with a LOQ
of 0.01 mg/kg is desirable.
Oilseeds, cereals grains and sweet corn: there is a lack of residues trials compliant with the
LOQ for enforcement (0.01 mg/kg). However, residues resulting from the seed treatment are
expected to be below this LOQ (supported by the metabolism studies). In these cases MRLs
are set at 0.01* mg/kg.
Sugar beet: considering that it is a seed treatment, that fludioxonil is not a systemic substance,
and that no residues are expected in succeeding crops, residues exceeding the enforcement
LOQ of 0.01 mg/kg are not expected. However, at least 2 residues trials demonstrating that
residue levels are below the LOQ are desirable.
The combined effect of a pre-harvest and a post-harvest treatment on the total residue in a
given crop could not be assessed by EFSA as there are no residue trials available combining
both modes of application. Member States are therefore recommended to take the appropriate
measures for avoiding this kind of combined treatments.
The demonstrated storage stability of fludioxonil in treated crops was evaluated under the peer review
of Directive 91/414/EEC (Denmark, 2005). Studies demonstrated storage stability of fludioxonil in
commodities with high water, high acid, high oil and dry content for up to 24 months when stored
deep frozen. All available residue trials samples were stored for not more than 24 months.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 19
Table 3-2: Overview of the available residues trials data
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Citrus fruits EU Indoor
(post-
harvest)
Oranges: 1.5; 1.26
Mandarins: 1.84;
2.23; 1.91; 1.46
- 1.67 2.23 4 1.00 EU GAP compliant residue trials
on oranges (2) and mandarins (4).
Rber= 3.98
Rmax= 3.02
Import (US,
CA)
Indoor
(post-
harvest)
Oranges: 2.9; 3.5;
4; 4.4; 4.6; 5; 7.2
Mandarins: 2.9;
2x5.6; 5.8; 7; 2x7.8
- 5.30 7.80 10 1.00 US GAP compliant residue trials
on oranges (7) and mandarins (7)
(FAO, 2010).
Rber= 14.10
Rmax= 9.72
Pistachios Import (US)
Outdoor 0.04; 0.06; 0.08 - 0.06 0.08 0.2
(tentative)
1.00 GAP compliant residue trials on
pistachios.
Rber= -
Rmax= 0.21
Pome fruits NEU Outdoor 0.45; 0.19; 0.33;
0.26; 0.18; 0.16;
0.6; 0.18; 0.19; 0.11
- 0.19 0.60 0.8 1.00 GAP compliant residue trials on
apples (7) and pears (3) were
combined. Only authorised for use
on apples and pears.
Rber= 0.72
Rmax= 0.71
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 20
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
SEU Outdoor 0.35; 0.14; 0.15;
0.19; 0.22; 0.23;
0.24; 0.29; 0.39;
0.42
- 0.24 0.42 0.8 1.00 GAP compliant residue trials on
pears (2) and apples (8) were
combined. Only authorised for use
on apples and pears.
Rber= 0.72
Rmax= 0.55
EU Indoor
(post-
harvest)
- - 2.30 2.80 4 1.00 GAP compliant residue trials on
pears (4) and apples (4) carried
out in the US can be used for the
EU GAP as well (one worldwide
zone for post-harvest
applications).
Rber= 5.10
Rmax= 4.11
Import (US)
Indoor
(post-
harvest)
1.1; 1.2; 1.6; 2.8;
2.2; 2.4; 2.4; 2.6
-
Apricots NEU Outdoor 0.15; 0.48; 0.17;
0.33
- 0.25 0.48 1 1.00 Extrapolation from the northern
outdoor GAP on peaches.
SEU Outdoor 0.06; 0.08; 0.11;
0.19; 0.31; 0.36;
0.37; 0.5
- 0.25 0.50 0.8 1.00 Extrapolation from the northern
outdoor GAP on peaches.
Import (JP, AU,
CL, US)
Indoor
(post-
harvest)
0.4; 1.06;1.90 - 1.06 1.90 5
(tentative)
1.00 Extrapolation from the post
harvest use on plums.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 21
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Cherries NEU Outdoor 0.07; 2x0.08; 0.14;
0.16; 0.17; 0.25
- 0.14 0.25 0.4 1.00 GAP compliant residue trials on
cherries.
Rber= 0.34
Rmax= 0.36
SEU Outdoor 0.08; 0.09; 0.17;
0.18; 0.22; 0.36
- 0.18 0.36 0.5 1.00 GAP compliant residue trials on
cherries.
Rber= 0.51
Rmax= 0.56
Import (US)
Indoor
(post-
harvest)
0.27; 0.78; 1.8; 1.9 - 1.29 1.90 4 1.00 GAP compliant residue trials on
cherries.
Rber= 3.75
Rmax= 5.27
Peaches NEU Outdoor 0.15; 0.48; 0.17;
0.33
- 0.25 0.48 1 1.00 GAP compliant residue trials on
peaches.
Rber= 0.89
Rmax= 1.08
SEU Outdoor 0.06; 0.08; 0.11;
0.19; 0.31; 0.36;
0.37; 0.5
- 0.25 0.50 0.8 1.00 GAP compliant residue trials on
peaches.
Rber= 0.74
Rmax= 0.76
Import (US)
Indoor
(post-
harvest)
1.9; 2.8; 4.5; 5.5 - 3.65 5.50 10 1.00 GAP compliant residue trials on
peaches.
Rber= 10.50
Rmax= 12.04
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 22
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Plums NEU Outdoor 2x0.02; 0.04; 0.05;
0.1; 0.11; 0.13;
0.16; 0.17; 0.18
- 0.11 0.18 0.3 1.00 GAP compliant residue trials on
plums.
Rber= 0.33
Rmax= 0.28
SEU Outdoor 0.02; 0.03; 0.05;
0.09; 0.11; 0.12
- 0.07 0.12 0.3 1.00 GAP compliant residue trials on
plums.
Rber= 0.23
Rmax= 0.23
Import (US)
Indoor
(post-
harvest)
0.4; 1.06;1.90 - 1.06 1.90 5
(tentative)
1.00 3 GAP compliant trials on plums.
Rber= -
Rmax= 6.88
Table grapes NEU Outdoor 0.06; 0.1; 0.19;
0.21; 0.21; 0.31;
0.75; 1.18; 1.64;
- 0.21 1.64 3 1.00 Although GAP on table grapes is
less critical, extrapolation from
the northern outdoor GAP on
wine grapes is considered
sufficient to demonstrate that
northern GAP is not more critical
than southern GAP.
SEU Outdoor 0.21; 0.22; 0.27;
0.3; 0.45; 0.82;
2.65; 3.73
- 0.38 3.73 5 1.00 GAP compliant residue trials on
table grapes.
Rber= 4.39
Rmax= 5.38
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 23
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Wine grapes NEU Outdoor 0.06; 0.1; 0.19;
0.21; 0.21; 0.31;
0.75; 1.18; 1.64;
- 0.21 1.64 3 1.00 GAP compliant residue trials on
wine grapes.
Rber= 1.93
Rmax= 2.20
SEU Outdoor 0.15; 0.2; 0.26;
0.27; 0.38; 0.49;
1.95; 2.65
- 0.33 2.65 4 1.00 GAP compliant residue trials on
wine grapes.
Rber= 3.17
Rmax= 3.84
Strawberries NEU Outdoor 0d PHI: 0.83; 0.3;
0.21; 0.61; 0.15;
0.23;
1d PHI: 0.24; 0.54
- 0.27 0.83 1.5 1.00 Interpolated values for PHI 1 d
were excluded, instead values of 0
d PHI was chosen for 6 trials.
Rber= 1.19
Rmax= 1.16
SEU Outdoor 0d PHI: 0.94; 0.31;
0.31
1d PHI:0.31; 0.77;
0.87; 0.7
- 0.70 0.94 2 1.00 Interpolated values for PHI 1 d
were excluded, instead values of 0
d PHI was chosen for 3 trials.
Rber= 1.74
Rmax= 1.56
EU Indoor 0d PHI: 0.36; 1;
0.26; 0.25; 2.72;
1.33; 0.57
1d PHI: 0.78; 0.26
- 0.57 2.72 4
(tentative)
1.00 Interpolated values for PHI 1 d
were excluded, instead values of 0
d PHI was chosen for 7 trials.
Rber= 2.33
Rmax= 3.26
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 24
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Blackberries
Raspberries
NEU Outdoor 0.36; 0.5; 0.51;
0.54; 0.61; 0.98
- 0.53 0.98 1.5 1.00 GAP compliant residue trials on
raspberries.
Rber= 1.41
Rmax= 1.37
SEU Outdoor 0.98 - - - - 1.00 Insufficient number of trials.
EU Indoor 0.32; 0.37; 0.2; 0.33 - 0.33 0.37 0.8 1.00 Residues trials on raspberries
compliant with GAP on
raspberries and blackberries
(France, 2011).
Rber= 0.68
Rmax= 0.72
Blueberries
Cranberries
Currants (red,
black and
white)
Gooseberries
NEU Outdoor Blueberries: 0.15;
0.31; 0.31; 0.37
Currants: 0.26; 0.6;
0.62; 0.63; 1.44
- 0.37 1.44 2 1.00 GAP compliant residue trials on
blueberries (4) and currants (5)
were combined.
Rber= 1.25
Rmax= 1.69
SEU Outdoor - - - - - 1.00 No residue trials available
Elderberries NEU Outdoor Blueberries: 0.04;
0.08; 0.12; 0.24
Currants: 0.16;
0.30; 0.33; 0.45;
0.56
- 0.24 0.56 0.8 1.00 Residue trials on blueberries (4)
and currants (5) more critical than
GAP on elderberries (PHI of 14d
instead of 21d, other parameters
compliant with GAP) (Austria,
2011).
Rber= 0.78
Rmax= 0.78
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 25
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Kiwi Import (US)
Indoor
(post-
harvest)
5.4; 6.6; 7.3; 8; 9.5 - 7.30 9.50 15 1.00 GAP compliant residue trials on
kiwi.
Rber= 17.50
Rmax= 13.82
Mangoes Import (ZA)
Indoor
(post-
harvest)
0.28; 0.31; 0.32;
0.34; 0.37; 0.49;
0.51; 0.66
- 0.36 0.66 1 1.00 GAP compliant residue trials on
mangoes.
Rber= 1.01
Rmax= 0.83
Pomegranate Import (US)
Indoor
(post-
harvest)
0.65; 0.92; 0.97;
1.21
- 0.95 1.21 3 1.00 GAP compliant residue trials on
pomegranates.
Rber= 2.30
Rmax= 2.12
Potatoes NEU Outdoor
(seed
treat.)
<0.01; 4x0.01;
0.02; 0.03
- 0.01 0.03 0.04 1.00 GAP compliant residue trials on
potatoes.
Rber= 0.04
Rmax= 0.04
SEU Outdoor
(seed
treat.)
2x <0.01; 0.01;
2x0.02; 2x 0.03;
0.04
- 0.02 0.04 0.06 1.00 GAP compliant residue trials on
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
- 3.76 5.70 10 1.00 GAP compliant residue trials on
sweet potates (2) and yams (2)
were combined.
Rber= 10.90
Rmax= 11.81
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 26
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Carrots NEU Outdoor 0.19; 2x0.29; 0.4;
0.41; 0.44; 0.52;
0.54
- 0.41 0.54 1 2.80 GAP compliant residue trials on
carrots.
Rber= 1.00
Rmax= 0.77
SEU Outdoor 0.04; 0.05; 2x0.06;
0.07; 0.09; 0.18; 0.3
- 0.07 0.30 0.4 2.80 GAP compliant residue trials on
carrots.
Rber= 0.32
Rmax= 0.39
Celeriac NEU Outdoor 0.06; 0.07; 0.08; 0.1 - 0.07 0.10 0.2 2.80 GAP compliant residue trials on
celeriac.
Rber= 0.19
Rmax= 0.16
Beetroot
Horseradish
Parsnips
Parsley root
Salsify
Herbal
infusions
(dried, roots)
Spices (roots
and rhizome)
NEU Outdoor 0.19; 2x0.29; 0.4;
0.41; 0.44; 0.52;
0.54
- 0.41 0.54 1 2.80 Direct extrapolation from carrots
is not possible because GAPs are
different but residue trials on
carrots are available compliant
with GAP on beetroot, parsnips,
horseradish, parsley roots, salsify,
roots of herbal infusions and roots
of spices.
Rber= 1.00
Rmax= 0.77
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 27
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Garlic
Onions
Shallots
NEU Outdoor 8x<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
- 0.15 0.80 0.9 1.00 GAP compliant residue trials on
tomatoes (Germany, 2011).
Rber= 0.48
Rmax= 0.68
Import
(n.r.)
n.r. - - - - - 1.00 No residue trials available
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 28
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Aubergines
(egg plant)
NEU Outdoor - - - - - 1.00 No residue trials available
SEU Outdoor - - - - - 1.00 No residue trials available
EU Indoor 0.05; 0.10; 0.13;
0.15
- 0.12 0.15 0.4 1.00 Direct extrapolation from
tomatoes is not possible (different
GAPs) but GAP compliant
residue trials on aubergines are
available.
Rber= 0.29
Rmax= 0.33
Import
(n.r.)
n.r. - - - - - 1.00 No residue trials available
Peppers EU Indoor 0.09; 0.1; 0.15;
0.17; 0.19; 0.21;
0.26; 0.35; 0.36;
0.78; 0.93
- 0.21 0.93 1 1.00 GAP compliant residue trials on
peppers.
Rber= 0.72
Rmax= 1.11
Import
(n.r.)
n.r. - - - - - 1.00 No residue trials available
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 29
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Cucumbers
Gherkins
Courgettes
NEU Outdoor - - - - - 1.00 No residue trials available
SEU Outdoor 0.04; 0.05; 0.08;
0.11
- 0.07 0.11 0.3 1.00 GAP compliant residue trials on
cucumbers.
Rber= 0.21
Rmax= 0.23
EU Indoor Cucumbers: 0.03;
2x0.05; 3x0.09;
0.16; 0.17; 0.27;
Courgettes: 0.07;
0.09; 2x0.1; 0.14;
2x0.17; 0.28
- 0.10 0.28 0.4 1.00 GAP compliant residue data on
cucumbers (9) and courgettes (8)
were combined. Data
extrapolation to gherkins and
courgettes is supported.
Rber= 0.34
Rmax= 0.30
Import
(n.r.)
n.r. - - - - - 1.00 No residue trials available. This
import tolerance is not requested
for gherkins.
Melons
Pumpkins
Watermelons
Import
(US)
Outdoor - - - - - 1.00 No residue trials available.
Sweet corn NEU Outdoor
(seed
treat.)
3x<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).
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 30
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Lettuce NEU Outdoor 0.16; 0.17; 0.18;
0.64; 0.68; 0.79;
1.2; 1.68
- 0.66 1.68 3 1.00 GAP compliant residue trials on
lettuce.
Rber= 2.20
Rmax= 2.42
SEU Outdoor <0.02; 0.09; 0.31;
0.34; 0.8; 0.87;
1.46; 2.28; 2.5
- 0.80 2.50 4 1.00 GAP compliant residue trials on
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
- 3.23 8.63 12 1.00 GAP compliant residue trials on
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
- 0.66 1.68 3 1.00 Extrapolation from the northern
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.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 31
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Lamb’s lettuce
Cress
Land cress
Rocket, rucola
Red mustard
Leaves and
sprouts of
Brassica
NEU Outdoor 0.16; 0.17; 0.18;
0.64; 0.68; 0.79;
1.2; 1.68
- 0.66 1.68 3 1.00 Extrapolation from the northern
outdoor GAP on lettuce (The
United Kingdom, 2007 and 2010).
Spinach
Beet leaves
SEU Outdoor 3x<0.02; 0.04;
0.29; 2x1.2
- 0.03 1.20 4 1.00 Direct extrapolation from the
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
- 2.60 6.00 8 1.00 Direct extrapolation from the
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).
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 32
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Chives
Basil
Import
(US)
Outdoor 2; 3.42; 1.8; 4.54 - 2.71 4.54 10 1.00 GAP compliant residue trials on
basil (2) and chives (2) combined.
Rber= 8.52
Rmax= 9.56
Beans (fresh,
with pods)
Peas (fresh,
with pods)
NEU Outdoor <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
- 0.06 0.20 0.3 1.00 GAP compliant residue trials on
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
- 0.48 0.86 1 1.00 GAP compliant residue trials on
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.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 33
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Asparagus NEU Outdoor - - <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
- 0.02 0.08 0.1 1.00 GAP compliant residue trials on
beans (4) and peas (4) were
combined(France, 2011; The
Netherlands, 2011).
Rber= 0.09
Rmax= 0.10
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 34
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
SEU Outdoor Dry beans:
3x<0.02; 0.31;
Dry peas: 2x0.02;
0.05; 0.08
- 0.02 0.31 0.4 1.00 GAP compliant residue trials on
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.)
5x<0.02 - <0.01 <0.01 0.01* 1.00 GAP compliant residue trials on
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.)
16x<0.02 - <0.01 <0.01 0.01* 1.00 GAP compliant residue trials on
wheat.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 35
Commodity Region (a)
Outdoor
/Indoor
Individual trial results (mg/kg) Median
residue
(mg/kg) (b)
Highest
residue
(mg/kg) (c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(fludioxonil)
Risk assessment
(sum of fludioxonil
and its metabolites
oxidized to
metabolite CGA
192155, expressed
as fludioxonil) (f)
Maize grain NEU Outdoor
(seed
treat.)
10x<0.02 - <0.01 <0.01 0.01* 1.00 GAP compliant residue trials on
maize grain.
Based on the metabolism studies,
one residue trial (0.05 mg/kg) was
considered as an outlier.
SEU Outdoor
(seed
treat.)
4x<0.02 - <0.01 <0.01 0.01* 1.00 GAP compliant residue trials on
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)
1.00 GAP compliant residue trials on
wheat.
SEU Outdoor
(seed
treat.)
3x<0.02; <0.04;
12x<0.05
- 0.05 0.05 0.05(e)
1.00 GAP compliant residue trials on
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.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 36
(d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial.
(e): Indicates that no limit of analytical quantification is available for the commodity.
(f): Residues are not reported, CF for risk assessment is derived from metabolism studies.
(*): Indicates that the MRL is set at the limit of analytical quantification.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 37
The available residues data are considered acceptable to derive adequate MRL proposals and risk
assessment values for all commodities under evaluation, except for citrus fruits, pistachios, stone
fruits and strawberries where data gaps were identified and only a tentative MRL is calculated (see
also Table 3-2). For cucurbits with inedible peel and celery, available datasets were insufficient to
derive tentative MRLs. For cereals straws (except maize), tentative MRLs are derived in view of the
future need to set MRLs in feed items. In case several uses are supported for one commodity, the final
MRL proposal was derived from the most critical use and indicated in bold in Table 3-2.
3.1.1.3. Effect of industrial processing and/or household preparation
The effect of processing on the nature of fludioxonil was investigated in the framework of the peer
review. A study was conducted simulating representative hydrolytic conditions for pasteurisation (20
minutes at 90 C, pH 4), boiling/brewing/baking (60 minutes at 100 C pH 5) and sterilisation (20
minutes at 120 C, pH 6). This study showed that fludioxonil is stable under these conditions and that
no formation of toxicologically relevant metabolites occurs (Denmark, 2005). Thus, for processed
commodities the same enforcement residue definition as for raw agricultural commodities (RAC) is
applicable. Also for risk assessment, considering that all metabolites are oxidized to a common
moiety, it is unlikely that new metabolites will occur.
Studies investigating the magnitude of residues in processed commodities of table and wine grapes
were also reported in the framework of the peer review (Denmark, 2005). After fludioxonil was
included in Annex I to Directive 91/414/EEC, studies investigating the magnitude of residues in
processed commodities of mangoes, carrots, citrus, apples, plums, strawberries, tomatoes and fresh
beans were evaluated by EFSA or by the RMS. An overview of all available processing studies is
available in Table 3-3. Robust processing factors for enforcement and risk assessment purposes could
only be derived for carrots, mangoes, table and wine grapes. The processing factors reported for the
remaining commodities should be considered indicative as they are not sufficiently supported by
studies; a minimum of 3 processing studies is normally required.
Further processing studies are not required as they are not expected to affect the outcome of the risk
assessment. However, if there would be the intention to derive more robust processing factors, in
particular for enforcement purposes, additional processing studies would be required.
Table 3-3: Overview of the available processing studies
Processed commodity Number
of studies
Median
PF (a)
Median
CF (b)
Comments
Enforcement residue definition: fludioxonil
Recommended rrocessing factors (sufficiently supported by data)
Table grapes, dried (raisins) 15 1.08 1.00 Denmark, 2005
Wine grapes, juice 18 0.80 1.00 The PF for juice is an average PF.
No information available if wine
was red or white (Denmark, 2005). Wine grapes, must 10 0.37 1.00
Wine grapes, wine 12 0.03 1.00
Mangoes, peeled 8 0.06 1.00 Data obtained from the supervised
residue trials. In the pulp, residues
in all samples were below the LOQ
of 0.02 mg/kg (Denmark, 2010).
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 38
Processed commodity Number
of studies
Median
PF (a)
Median
CF (b)
Comments
Carrots, canned 4 0.19 2.80 In the absence of data on the
magnitude of fludioxonil
metabolites in processed carrots, it
is assumed that the CF is the same
as for raw commodities (EFSA,
2009a).
Carrots, cooked 4 0.11 2.80
Carrots, juice 4 0.20 2.80
Indicative processing factors (limited dataset)
Citrus, juice 2 0.13 1.00 PF derived from a processing study
on lemons (1 study) and oranges (1
study). Citrus, dry pomace 2 7.54 1.00
Citrus, wet pomace 2 2.20 1.00
Oranges, marmalade 2 0.47 1.00
Apples, juice 1 0.20 1.00 Denmark, 2010
Apples, wet pomace 1 5.30 1.00
Apples, dry pomace 1 1.40 1.00
Plums, canned 1 0.50 1.00 Denmark, 2010
Plums, dried (prunes) 1 2.60 1.00 Denmark, 2010
Plums, jam 1 0.66 1.00 Denmark, 2010
Strawberries, jam 1 0.33 1.00 Denmark, 2010
Strawberries, canned 1 0.57 1.00 Denmark, 2010
Tomatoes, peeled and
canned
1 0.20 1.00 Denmark, 2010
Tomatoes, juice 1 0.20 1.00
Beans (fresh with pods),
cooked
1 0.46 1.00 Denmark, 2010
(a): The median processing factor is obtained by calculating the median of the individual processing factors of each
processing study.
(b): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual
conversion factors of each processing study.
3.1.2. Rotational crops
3.1.2.1. Preliminary considerations
The use of fludioxonil in permanent crops or in third countries is not considered relevant with regard
to the potential occurrence of residues in rotational crops. Within Europe, however, some crops
evaluated in the framework of this MRL review might be grown in rotation with other crops. During
the peer review under Directive 91/414/EEC, the degradation of fludioxonil in soil was investigated in
laboratory and field studies (Denmark, 2005). The most critical DT90 value (28-142 d) of fludioxonil
was obtained based on a field study performed in Germany. Since it exceeds 100 days, investigation
on the occurrence of fludioxonil residues in rotational crops is considered relevant.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 39
3.1.2.2. Nature of residues
Under the peer review, four metabolism studies in rotational crop studies were submitted on lettuce,
winter and spring wheat, sugar beets, corn, mustard, turnips, radishes (Denmark, 2005). The available
studies are summarized in Table 3-4.
Significant TRR levels were only identified in radish samples (30 DAT, 1.117 kg a.s./ha) and in
wheat samples (30 DAT, 0.124 and 1.117 kg a.s./ha); in all other crops TRR levels never exceeded
0.01 mg/kg. The highest TRR levels were observed in wheat straw (0.355 mg/kg) and radish tuber
(0.135 mg/kg). Parent fludioxonil accounted for 0.016 mg/kg in radish tubers and CGA 192155
accounted for 0.015 mg/kg in wheat straw. Other metabolites were tentatively identified as CGA
26537813
, CGA 30810314
, CGA 34035115
, CGA 22773116
and CGA 26076617
, none of which
accounted for more than 0.05 mg/kg each.
EFSA concluded in the framework of the peer review that the metabolic pathway of fludioxonil in
rotational crops is similar to that in primary crops and no formation of new metabolites was observed
(EFSA, 2007b). Hence the same residue definition of as for primary crops applies to the rotational
crops.
Table 3-4: Summary of available metabolism studies in rotational crops
Crop group Crop Label
position
Application and sampling details
Method,
F or G (a)
Rate
(kg a.i./ha)
Sowing
intervals
(DAT)
Harvest
Intervals
Remarks
Leafy vegetables Lettuce [pyrrole-14
C]
Soil
spraying,
F
0.750 90 50 % and
100 %
maturity
Root and tuber
vegetables
Sugar
beets
[pyrrole-14
C]
Soil
spraying,
F
0.750 140, 320,
345
25 %,
50 % and
100 %
maturity
Turnips [pyrrole-14
C]
Soil
spraying,
F
0.124 33, 90 100 %
maturity
Radishes [pyrrole-14
C]
Soil
spraying,
F
0.062 32, 90 100 %
maturity
[phenyl-14
C]
Soil
spraying,
F
1.117 30, 90,
210
100 %
maturity
Pulses and
oilseeds
Mustard [pyrrole-14
C]
Soil
spraying,
F
0.124 33, 90 100 %
maturity
13
CGA 265378: 4-(2,2-difluoro-benzol[1,3]dioxol-4-yl)-2,5-dioxo-2,5-dihydro-1H-pyrrole-3-carbonitrile. See
Appendix E. 14
CGA 308103: 2-(2,2-difluoro-benzol[1,3]dioxol-4-yl)-2-hydroxy-acetamide. See Appendix E. 15
CGA 340351: 2,2-difluorobenzol[1,3]dioxole-4-carboxylic acid amide. See Appendix E. 16
CGA 227731:6-hydroxy-2H-chromeno[3,4-c]pyrrol-4-one. See Appendix E. 17
CGA 260766: 3-(2,2-difluorobenzo[1,2]dioxol-4-yl)-4-hydroxy-pyrrole-2,5-dione. See Appendix E.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 40
Crop group Crop Label
position
Application and sampling details
Method,
F or G (a)
Rate
(kg a.i./ha)
Sowing
intervals
(DAT)
Harvest
Intervals
Remarks
[pyrrole-14
C]
Soil
spraying,
F
0.062 32, 90 100 %
maturity
[phenyl-14
C]
Soil
spraying,
F
1.117 30, 90,
210
100 %
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
Review of the existing MRLs for fludioxonil
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-
difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as fludioxonil
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.
Review of the existing MRLs for fludioxonil
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)
Risk assessment residue definition: sum of fludioxonil and its metabolites oxidized to metabolite 2,2-
difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as fludioxonil
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.
Review of the existing MRLs for fludioxonil
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.
Review of the existing MRLs for fludioxonil
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.
Review of the existing MRLs for fludioxonil
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).
(*): 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): mean residue level from day 1 until day 28 (3 cows, 6 sampling days).
Review of the existing MRLs for fludioxonil
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
Risk assessment residue definition: sum of fludioxonil and its metabolites oxidized to metabolite 2,2-
difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as fludioxonil
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)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 47
Commodity Chronic risk assessment
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)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 48
Commodity Chronic risk assessment
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)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 49
Commodity Chronic risk assessment
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).
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 50
Table 4-2: Input values for the consumer risk assessment (with consideration of CXLs)
Commodity Chronic risk assessment
Input value (mg/kg) Comment
Risk assessment residue definition: sum of fludioxonil and its metabolites oxidized to metabolite 2,2-
difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as fludioxonil
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)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 51
Commodity Chronic risk assessment
Input value (mg/kg) Comment
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)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 52
Commodity Chronic risk assessment
Input value (mg/kg) Comment
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.
Review of the existing MRLs for fludioxonil
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
Review of the existing MRLs for fludioxonil
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:
Review of the existing MRLs for fludioxonil
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.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 56
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)
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)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 57
Code
number
Commodity Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
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)
10 - 12 Recommended (a)
0251040 Cress 10 - 3 Recommended (a)
0251050 Land cress 10 - 3 Recommended (a)
0251060 Rocket, rucola 10 - 3 Recommended (a)
0251070 Red mustard 10 - 3 Recommended (a)
0251080 Leaves and sprout of
brassica spp
10 - 3 Recommended (a)
252010 Spinach 7 - 8 Recommended (a)
252030 Beet leaves (chard) 7 - 8 Recommended (a)
254000 Water cress 0.05* 10 10 Recommended (j)
255000 Witloof 0.05* - 0.02 Recommended (a)
256020 Chives 1 10 10 Recommended (e)
256080 Basil 1 10 10 Recommended (e)
260010 Beans (fresh, with pods) 1 0.3 1 Recommended (e)
260020 Beans (fresh, without
pods)
0.2 0.03 0.05 Recommended (e)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 58
Code
number
Commodity Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
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)
1 - 1 Recommended (a)
840000 Spices (roots and rhizome) 1 - 1 Recommended (a)
900010 Sugar beet (roots) 0.05* 0.01* Recommended (a)
- Others products of plant
origin
See App.
C.1
- - Further consideration needed (d)
Enforcement residue definition: the sum of fludioxonil and its metabolites oxidized to metabolite 2,2-
difluoro-benzo[1,3]dioxole-4 carboxylic acid (CGA 192155), expressed as fludioxonil
1011010 Swine meat 0.05* 0.01* 0.05*(F)
Recommended (e)
1011020 Swine fat (free of lean
meat)
0.05* - 0.05* Recommended (a)
1011030 Swine liver 0.05* 0.05* 0.05* Recommended (e)
1011040 Swine kidney 0.05* 0.05* 0.05* Recommended (e)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 59
Code
number
Commodity Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
1012010 Bovine meat 0.05* 0.01* 0.2 (F)
Further consideration needed (f)
1012020 Bovine fat 0.05* - 0.2 Further consideration needed (b)
1012030 Bovine liver 0.05* 0.05* 0.2 Further consideration needed (f)
1012040 Bovine kidney 0.05* 0.05* 0.2 Further consideration needed (f)
1013010 Sheep meat 0.05* 0.01* 0.2 (F)
Further consideration needed (f)
1013020 Sheep fat 0.05* - 0.2 Further consideration needed (b)
1013030 Sheep liver 0.05* 0.05* 0.2 Further consideration needed (f)
1013040 Sheep kidney 0.05* 0.05* 0.2 Further consideration needed (f)
1014010 Goat meat 0.05* 0.01* 0.2 (F)
Further consideration needed (f)
1014020 Goat fat 0.05* - 0.2 Further consideration needed (b)
1014030 Goat liver 0.05* 0.05* 0.2 Further consideration needed (f)
1014040 Goat kidney 0.05* 0.05* 0.2 Further consideration needed (f)
1016010 Poultry meat 0.05* 0.01* 0.01* Recommended (j)
1016030 Poultry liver 0.05* 0.05* 0.05* Recommended (j)
1016040 Poultry kidney 0.05* 0.05* 0.05* Recommended (j)
1020010 Cattle milk 0.05* 0.01 0.01 Recommended (e)
1020020 Sheep milk 0.05* 0.01 0.01 Recommended (e)
1020030 Goat milk 0.05* 0.01 0.01 Recommended (e)
1030000 Birds' eggs 0.05* 0.05* 0.05* Recommended (j)
- Others products of animal
origin
See App.
C.1
- - Further consideration needed (d)
(*): Indicates that the MRL is set at the limit of analytical quantification.
(F): MRL is expressed as mg/kg of fat contained in the whole product.
(a): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to
consumers is identified; no CXL is available (combination G-I in Appendix D).
(b): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk
to consumers could be identified; no CXL is available (combination E-I in Appendix D).
(c): GAP evaluated at EU level is not supported by data but no risk to consumers could be identified for the existing EU
MRL; no CXL is available (combination C-I in Appendix D).
(d): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either the specific
LOQ or the default MRL of 0.01 mg/kg may be considered (combination A-I in Appendix D).
(e): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to
consumers is identified; existing CXL is covered by the recommended MRL (combination G-III in Appendix D).
(f): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk
to consumers could be identified; existing CXL is covered by the tentative MRL (combination E-III in Appendix D).
(g): GAP evaluated at EU level is not supported by data but no risk to consumers could be identified for the existing EU
MRL; existing CXL is covered by the existing EU MRL (combination C-III in Appendix D).
(h): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified;
GAP evaluated at EU level, which is also fully supported by data, leads to a lower MRL (combination G-VII in
Appendix D).
(i): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified;
GAP evaluated at EU level, which is not fully supported by data, leads to a lower tentative MRL (combination E-VII in
Appendix D).
(j): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified;
there are no relevant authorisations or import tolerances reported at EU level (combination A-VII in Appendix D).
Review of the existing MRLs for fludioxonil
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.
Authorised uses to be considered for the review of the existing MRLs for fludioxonil, May 2011.
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:
http://ec.europa.eu/food/plant/protection/resources/publications_en.htm
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:
http://ec.europa.eu/food/plant/protection/resources/publications_en.htm
Review of the existing MRLs for fludioxonil
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:
http://ec.europa.eu/food/plant/protection/resources/publications_en.htm
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:
http://ec.europa.eu/food/plant/protection/resources/publications_en.htm
EC (European Commission), 2004. Residue analytical methods. For post-registration control.
SANCO/825/00-rev.7. Available online:
http://ec.europa.eu/food/plant/protection/resources/publications_en.htm
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:
http://ec.europa.eu/food/plant/protection/resources/publications_en.htm
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:
http://ec.europa.eu/food/plant/protection/resources/publications_en.htm
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/
FAO (Food and Agriculture Organization of the United Nations), 2006. Fludioxonil. In: Pesticide
residues in food – 2006. 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
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 62
Plant Production and Protection Paper 187. Available online:
http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/jmpr/jmpr-rep/en/
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.
FAO (Food and Agriculture Organization of the United Nations), 2010. Fludioxonil. In: Pesticide
residues in food – 2010. 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 200. Available online:
http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/jmpr/jmpr-rep/en/
Finland, 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.
France, 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.
Germany, 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.
The Netherlands, 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.
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.
Review of the existing MRLs for fludioxonil
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
Seed treatment - general (see also
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)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 64
Conc. UnitFrom
BBCH
Until
BBCHMin. Max. Min. Max.
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
Seed treatment - general (see also
comment field)0 0 1 12.00 16.00
g a.i./100
kgn.a.
Barley Hordeum spp. NEU OutdoorSeed treatment - general (see also
comment field)0 0 1 5.00
g a.i./100
kgn.a.
Maize Zea mays NEU OutdoorSeed treatment - general (see also
comment field)0 0 1 5.00
g a.i./100
kgn.a.
Oats Avena fatua NEU OutdoorSeed treatment - general (see also
comment field)0 0 1 5.00
g a.i./100
kgn.a.
Rye Secale cereale NEU OutdoorSeed treatment - general (see also
comment field)0 0 1 5.00
g a.i./100
kgn.a.
Wheat Triticum aestivum NEU OutdoorSeed treatment - general (see also
comment field)0 0 1 5.00
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
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)
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 65
Conc. UnitFrom
BBCH
Until
BBCHMin. Max. Min. Max.
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
CherriesPrunus cerasus,
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
Seed treatment - general (see also
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
TomatoesLycopersicum
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
CourgettesCucurbita pepo var.
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
Seed treatment - general (see also
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
Growth stage Number Interval (days)
Min. rate
Critical Outdoor GAPs for Southern Europe
Crop
RegionOutdoor/
Indoor
Member state or
CountryPests controlled
Formulation Application
Review of the existing MRLs for fludioxonil
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
comment field)0 0 1 5,00
g a.i./100
kgn.a.
Maize Zea mays SEU OutdoorSeed treatment - general (see also
comment field)0 0 1 5,00
g a.i./100
kgn.a.
Oats Avena fatua SEU OutdoorSeed treatment - general (see also
comment field)0 0 1 5,00
g a.i./100
kgn.a.
Rye Secale cereale SEU OutdoorSeed treatment - general (see also
comment field)0 0 1 5,00
g a.i./100
kgn.a.
Wheat Triticum aestivum SEU OutdoorSeed treatment - general (see also
comment field)0 0 1 5,00
g a.i./100
kgn.a.
n.a.: not applicable
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 67
Conc. UnitFrom
BBCH
Until
BBCHMin. Max. Min. Max.
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
volume spray at 0.24 kg a.s./hL
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
volume spray at 0.24 kg a.s./hL
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
volume spray at 0.24 kg a.s./hL
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
volume spray at 0.24 kg a.s./hL
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
application
Quinces Cydonia oblonga NEU/SEU Indoor SC 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
Medlar Mespilus germanica NEU/SEU Indoor SC 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
Loquat Eriobotrya japonica NEU/SEU Indoor SC 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
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
TomatoesLycopersicum
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
CourgettesCucurbita pepo var.
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
n.a.: not applicable
Growth stage Number Interval (days)
Min. rate Max. rate Rate Unit
Formulation Application Application rate PHI or
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
CountryPests controlled
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 68
Conc. UnitFrom
BBCH
Until
BBCHMin. Max. Min. Max.
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
a.s./t fruits as a low volume spray
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.
dip or drench application plus 5 g
a.s./t fruits as a low volume spray
application; 1 appl.prior storage, 1
appl.prior marketing
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.
dip or drench application plus 5 g
a.s./t fruits as a low volume spray
application; 1 appl.prior storage, 1
appl.prior marketing
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.
dip or drench application plus 5 g
a.s./t fruits as a low volume spray
application; 1 appl.prior storage, 1
appl.prior marketing
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.
dip or drench application plus 5 g
a.s./t fruits as a low volume spray
application; 1 appl.prior storage, 1
appl.prior marketing
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
CherriesPrunus cerasus,
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.
TomatoesLycopersicum
esculentum non-EU Foliar treatment - spraying 3 0,20 kg a.i./ha 7 oudoor protected
Peppers
Capsicum annuum, var
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
CourgettesCucurbita pepo var.
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-
irrigation soil drench
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-
irrigation soil drench
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
n.a.: not applicable
Interval (days)
Min. rate Max. rate Rate Unit
Application rate PHI or
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
CountryPests controlled
Formulation Application
Comments (max. 250 charachters)Common name
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 69
Conc. UnitFrom
BBCH
Until
BBCHMin. Max. Min. Max.
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
a.s./t fruits as a low volume spray
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.
dip or drench application plus 5 g
a.s./t fruits as a low volume spray
application; 1 appl.prior storage, 1
appl.prior marketing
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.
dip or drench application plus 5 g
a.s./t fruits as a low volume spray
application; 1 appl.prior storage, 1
appl.prior marketing
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.
dip or drench application plus 5 g
a.s./t fruits as a low volume spray
application; 1 appl.prior storage, 1
appl.prior marketing
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.
dip or drench application plus 5 g
a.s./t fruits as a low volume spray
application; 1 appl.prior storage, 1
appl.prior marketing
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
dip/drench application plus 2.5 g
a.s./t fruits as a low volume spray
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.
CherriesPrunus cerasus,
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.
TomatoesLycopersicum
esculentum non-EU Foliar treatment - spraying 3 0,20 kg a.i./ha 7 oudoor protected
Peppers
Capsicum annuum, var
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
CourgettesCucurbita pepo var.
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-
irrigation soil drench
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-
irrigation soil drench
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
n.a.: not applicable
Interval (days)
Min. rate Max. rate Rate Unit
Application rate PHI or
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
CountryPests controlled
Formulation Application
Comments (max. 250 charachters)Common name
Review of the existing MRLs for fludioxonil
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
Review of the existing MRLs for fludioxonil
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 /
group of commodities
Commodity /
group of commodities
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
Review of the existing MRLs for fludioxonil
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 /
group of commodities
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 /
group of commodities
Commodity /
group of commodities
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
Review of the existing MRLs for fludioxonil
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
Review of the existing MRLs for fludioxonil
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
Groups and examples of
individual products to which
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
Groups and examples of
individual products to which
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
Groups and examples of
individual products to which
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*
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 75
Code
number
Groups and examples of
individual products to which
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
Groups and examples of
individual products to which
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
Groups and examples of
individual products to which
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
Groups and examples of
individual products to which
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*
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 76
Code
number
Groups and examples of
individual products to which
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
Groups and examples of
individual products to which
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*
1012050 Edible offal 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*
1013050 Edible offal 0,05*
1013990 Others 0,05*
1014000 (d) Goat 0,05*
Code
number
Groups and examples of
individual products to which
the MRLs apply (a)
Fludioxonil
1014010 Meat 0,05*
1014020 Fat 0,05*
1014030 Liver 0,05*
1014040 Kidney 0,05*
1014050 Edible offal 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*
1015050 Edible offal 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*
1016050 Edible offal 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*
1017050 Edible offal 0,05*
1017990 Others 0,05*
1020000 (ii) Milk and cream, not 0,05*
Code
number
Groups and examples of
individual products to which
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
Review of the existing MRLs for fludioxonil
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
conducted in the USA according to
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
conducted in the USA according to
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
conducted in the USA according to
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
conducted in the USA according to
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
in accordance with GAP.
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
in accordance with GAP.
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
according to GAP. Treatment is
post-harvest.
Trials were conducted in the USA
according to GAP. Treatment is
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.
Review of the existing MRLs for fludioxonil
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
GAP only?Other comments
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
conducted in the USA according to
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
conducted in the USA according to
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
conducted in the USA according to
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
conducted in the USA according to
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
conducted in the USA according to
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
conducted in the USA according to
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.a.: not applicable
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
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 EU
according to GAP.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 79
Residue definitionExpressed
as fat?Residue definition STMR (mg/kg) HR (mg/kg) Year
Based on EU
GAP only?Other comments
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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1011030 Swine liver Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1011040 Swine kidney Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1011050 Swine edible offal Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1012010 Bovine 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1012030 Bovine liver Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1012040 Bovine kidney Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1012050 Bovine edible offal Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1013010 Sheep 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1013030 Sheep liver Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1013040 Sheep kidney Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1013050 Sheep edible offal Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
Interim CXL (2005-2009). Based on
a maximum dietary burden of 3.0
ppm for beef cattle.
Interim CXL (2005-2009). Based on
a maximum dietary burden of 3.0
ppm for beef cattle.
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
Values adopted by the CCPR
CXL (mg/kg)
Critical values of the JMPR evaluation Comment on the JMPR evaluation
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 80
1014010 Goat 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1014030 Goat liver Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1014040 Goat kidney Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1014050 Goat edible offal Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1015010 Horses, asses, mules or
hinnies 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1015030 Horses, asses, mules or
hinnies liver
Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1015040 Horses, asses, mules or
hinnies kidney
Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1015050 Horses, asses, mules or
hinnies edible offal
Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1016010 Poultry 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1016030 Poultry liver Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1016040 Poultry kidney Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1016050 Poultry edible offal Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
Interim CXL (2005-2009). Based on
a maximum dietary burden of 3.0
ppm for beef cattle.
Interim CXL (2005-2009). Based on
a maximum dietary burden of 3.0
ppm for beef cattle.
Interim CXLs (2005-2009). Based on
a maximum dietary burden of 0.07
ppm for poultry.
Review of the existing MRLs for fludioxonil
EFSA Journal 2011;9(8):2335 81
1017010 Other farm animals 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1017030 Other farm animals liver Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1017040 Other farm animals kidney Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1017050 Other farm animals edible offal Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1020010 Cattle milk 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1020020 Sheep milk 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1020030 Goat milk 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1020040 Horse milk 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
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no
1030000 Birds' eggs Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
n.a. 0.05 * Sum of fludioxonil and its
benzopyrrole metabolites,
determined as 2,2-difluoro-
benzo[1,3]dioxide-4-carboxylic acid
and expressed as fludioxonil
0 n.c. 2006 no Interim CXL (2005-2009)
(*) Indicates the lower limit of analytical quantification.
n.a.: not applicable
n.c.: not considered
n.k.: not known
Interim CXL (2005-2009). Based on
a maximum dietary burden of 1.7
ppm for dairy cattle.
Interim CXL (2005-2009). Based on
a maximum dietary burden of 3.0
ppm for beef cattle.
Review of the existing MRLs for fludioxonil
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
Review of the existing MRLs for fludioxonil
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
Review of the existing MRLs for fludioxonil
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
Review of the existing MRLs for fludioxonil
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
Review of the existing MRLs for fludioxonil
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