EFSA Journal 2011;9(8):2348
REASONED OPINION
Review of the existing maximum residue levels (MRLs) for dimethomorph
according to Article 12 of Regulation (EC) No 396/2005 1
European Food Safety Authority
2, 3
European Food Safety Authority (EFSA), Parma, Italy
SUMMARY
Dimethomorph was included in Annex I to Directive 91/414/EEC on 01 October 2007, which is
before 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(2) of afore mentioned regulation. In order to collect the relevant pesticide
residues data, EFSA asked Germany, as the designated rapporteur Member State (RMS), to complete
the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA
on 18 December 2008 and, after having considered several comments made by EFSA, the RMS
provided on 05 November 2009 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 11 March 2011 a draft reasoned opinion that was circulated to Member State
experts for consultation. Comments received by 13 May 2011 were considered for finalisation of this
reasoned opinion. The following conclusions are derived.
The toxicological profile of dimethomorph was evaluated in the framework of Directive 91/414/EEC,
which resulted in an ADI of 0.05 mg/kg bw/d and an ARfD of 0.6 mg/kg bw.
Primary crop metabolism was investigated after foliar applications of dimethomorph in grapes (fruit
and fruiting vegetables), potatoes (root and tuber vegetables) and lettuce (leafy vegetables) and
following application through a hydroponic system in tomatoes. Metabolic patterns in the different
studies were shown to be similar and representative for all uses supported in the framework of this
review. Metabolism in lactating ruminants and laying hens was sufficiently investigated and findings
can be extrapolated to pigs as well. The relevant residue definition for both enforcement and risk
assessment in all plant commodities and in foods of animal origin was therefore defined as
dimethomorph.
Dimethomorph (sum of isomers) can be enforced in food of plant origin with an LOQ of 0.01 mg/kg
in high water content, dry and acidic commodities, 0.02 mg/kg in high fat content commodities and
1
2
3
On request from EFSA, Question No EFSA-Q-2008-528, issued on 26 August 2011.
Correspondence: [email protected]
Acknowledgement: EFSA wishes to thank the rapporteur Member State Germany for the preparatory work on this
scientific output.
Suggested citation: European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for
dimethomorph according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2011;9(8):2348. [64 pp.]
doi:10.2903/j.efsa.2011.2348. Available online: www.efsa.europa.eu/efsajournal
© European Food Safety Authority, 2011
Review of the existing MRLs for dimethomorph
0.2 mg/kg in hops as well as in food of animal origin with an LOQ of 0.01 mg/kg in milk, meat, fat,
kidney, liver and eggs.
Regarding the magnitude of residues in primary crops, the available residues data are considered
sufficient to derive adequate MRL proposals as well as adequate risk assessment values for most of
the commodities under evaluation, except for spinach where the MRL derived is tentative only and for
blackberries and raspberries, where the available data were insufficient to derive tentative MRLs. It
should also be noted that the MRL and risk assessment values derived for melons, cucurbits with
edible peel, peppers and poppy seed are resulting from one of the reported uses only while data
requirements may still apply to the remaining uses.
In processed commodities, dimethomorph was shown to be stable during pasteurisation, baking,
boiling, brewing and sterilisation. Studies investigating the magnitude of residues in some processed
products are also available but in most cases they only allowed EFSA to derive indicative processing
factors. For enforcement purposes, only the following robust processing factors could be derived:
Oranges, peeled:
0.13
Wine grapes, dry pomace:
2.6
Wine grapes, red wine (unheated):
0.31
Wine grapes, white wine:
0.30
Hops, beer:
0.002
Further processing studies are not required because they are not expected to affect the outcome of the
risk assessment. However, if there would be the intention from risk managers to derive more
processing factors for enforcement purposes, additional processing studies might be required.
The potential incorporation of soil residues into succeeding and rotational crops was investigated in
wheat, radishes, carrots, lettuce and soybean. These studies showed a comparable metabolism patterns
in primary and succeeding crops. However, occurrence of parent dimethomorph in dry beans or in
case of early harvest of carrots or spinach was demonstrated. A plant-back restriction at national level
when granting an authorization of dimethomorph is therefore recommended.
Based on the uses reported by the RMS, significant intakes were calculated for dairy ruminant, meat
ruminants and pigs. The RMS reported a livestock feeding study on dairy cows, which demonstrated
that residues of dimethomorph are not expected in significant amounts and MRLs in pigs and
ruminants can be set at the LOQ. For poultry products no MRLs are required because there is no
significant exposure of poultry to dimethomorph residues.
Both chronic and acute consumer exposure resulting from the MRLs proposed in the framework of
this review were calculated and an exceedance of the ARfD was identified for scarole, representing
102.9 % of the ARfD. Considering the fall-back MRL for scarole resulting from the northern
European GAP, the highest chronic exposure represented 6.6 % of the ADI (WHO Cluster diet B) and
the highest acute exposure amounted to 31.7 % of the ARfD (lettuce).
Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs
have also been established for dimethomorph. Additional calculations of the consumer exposure,
including these CXLs, were therefore performed. The highest chronic exposure represented 8.8 % of
the ADI (WHO Cluster diet B) and the highest acute exposure amounted to 32.3 % of the ARfD
(lettuce).
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 as
‘Recommended’ in the table 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
EFSA Journal 2011;9(8):2348
2
Review of the existing MRLs for dimethomorph
for details). In particular, certain tentative MRLs and existing EU MRLs still need to be confirmed by
the following data:
4 trials complying with the northern outdoor GAP on blackberries or raspberries;
2 trials complying with the northern outdoor GAP on spinach;
It is highlighted that some of the recommended MRLs resulted 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 validity of the
recommended MRLs but which might have an impact on national authorisations:
8 trials complying with the indoor GAP on melons;
8 trials complying with the southern outdoor GAP on pepper unless it is demonstrated that the
outdoor use is less critical than the indoor use, then, the number of residues trials may be
reduced;
2 trials complying with the southern outdoor GAP on poppy seeds.
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 actions are therefore considered desirable but not essential:
a detailed review of the analytical method in commodities of animal origin.
Code
number
Commodity
Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
Enforcement residue definition: dimethomorph (sum of isomers)
0.8
-
0.8
Recommended(a)
Table grapes
3
2
3
Recommended(b)
0151020
Wine grapes
3
2
3
Recommended(b)
0152000
Strawberries
0.7
0.05
0.7
Recommended(b)
0153010
Blackberries
0.05*
-
0.05
Further consideration needed(c)
0153030
Raspberries
0.05*
-
0.05
Further consideration needed(c)
0163080
Pineapples
0.05*
0.01*
0.01*
Recommended(d)
0211000
Potatoes
0.5
0.05
0.05
Recommended(b)
0213080
Radishes
1
-
1.5
Recommended(a)
0220010
Garlic
0.15
-
0.15
Recommended(a)
0220020
Onions
0.15
-
0.15
Recommended(a)
0220030
Shallots
0.15
-
0.15
Recommended(a)
0220040
Spring onions
0.3
-
0.2
Recommended(a)
0110020
Oranges
0151010
EFSA Journal 2011;9(8):2348
3
Review of the existing MRLs for dimethomorph
Code
number
Commodity
Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
1
1
1
Recommended(b)
MRL
(mg/kg)
Comment
0231010
Tomatoes
0231020
Peppers
0.50
1
1
Recommended(e)
0231030
Aubergines (egg plants)
0.3
1
1
Recommended(e)
0231040
Okra, lady’s fingers
0.05*
1
1
Recommended(d)
0232010
Cucumbers
1
0.5
0.5
Recommended(b)
0232020
Gherkins
1
0.5
0.5
Recommended(b)
0232030
Courgettes
1
0.5
0.5
Recommended(b)
0233010
Melons
1
0.5
0.5
Recommended(e)
0233020
Pumpkins
0.05*
0.5
0.5
Recommended(d)
0233030
Watermelons
0.05*
0.5
0.5
Recommended(d)
0241010
Broccoli
0.05*
1
1
Recommended(e)
0241020
Cauliflower
0.05*
-
0.05
Recommended(a)
0242020
Head cabbage
0.05*
2
2
Recommended(d)
0244000
Kohlrabi
0.05*
0.02
0.02
Recommended(b)
0251010
Lamb's lettuce
10
10
10
Recommended(e)
0251020
Lettuce
10
10
10
Recommended(e)
0251030
Scarole (broad-leaf endive)
1
-
0.1
Recommended(a)
0251040
Cress
10
-
10
Recommended(a)
0251050
Land cress
10
-
10
Recommended(a)
0251060
Rocket, Rucola
10
-
10
Recommended(a)
0251070
Red mustard
10
-
10
Recommended(a)
0251080
Leaves and sprouts of
Brassica spp. including
turnip greens
10
-
10
Recommended(a)
0252010
Spinach
0.1
-
0.05
Further consideration needed(f)
0255000
Witloof
10
-
0.05
Recommended(a)
0256000
Herbs
10
-
10
Recommended(a)
0260020
Beans (fresh, without
pods)
0.05*
-
0.04
Recommended(a)
0260040
Peas (fresh, without pods)
0.1
-
0.1
Recommended(a)
0270050
Globe artichokes
2
-
2
Recommended(a)
0270060
Leek
1.5
-
1.5
Recommended(a)
0401030
Poppy seed
0.05*
-
0.02*
Recommended(a)
0401060
Rape seed
0.05*
-
0.02*
Recommended(a)
0700000
Hops (dried)
50
80
80
Recommended(e)
1011010
Swine meat
0.05*
0.01*
0.01*
Recommended(b)
1011020
Swine fat (free of lean
0.05*
0.01*
0.01*
Recommended(b)
EFSA Journal 2011;9(8):2348
4
Review of the existing MRLs for dimethomorph
Code
number
Commodity
Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
meat)
1011030
Swine liver
0.05*
0.01*
0.01*
Recommended(b)
1011040
Swine kidney
0.05*
0.01*
0.01*
Recommended(b)
1012010
Bovine meat
0.05*
0.01*
0.01*
Recommended(b)
1012020
Bovine fat
0.05*
0.01*
0.01*
Recommended(b)
1012030
Bovine liver
0.05*
0.01*
0.01*
Recommended(b)
1012040
Bovine kidney
0.05*
0.01*
0.01*
Recommended(b)
1013010
Sheep meat
0.05*
0.01*
0.01*
Recommended(b)
1013020
Sheep fat
0.05*
0.01*
0.01*
Recommended(b)
1013030
Sheep liver
0.05*
0.01*
0.01*
Recommended(b)
1013040
Sheep kidney
0.05*
0.01*
0.01*
Recommended(b)
1014010
Goat meat
0.05*
0.01*
0.01*
Recommended(b)
1014020
Goat fat
0.05*
0.01*
0.01*
Recommended(b)
1014030
Goat liver
0.05*
0.01*
0.01*
Recommended(b)
1014040
Goat kidney
0.05*
0.01*
0.01*
Recommended(b)
1016010
Poultry meat
0.05*
0.01*
0.01*
Recommended(d)
1016010
Poultry fat
0.05*
0.01*
0.01*
Recommended(d)
1016030
Poultry liver
0.05*
0.01*
0.01*
Recommended(d)
1020010
Cattle milk
0.05*
0.01*
0.01*
Recommended(b)
1020020
Sheep milk
0.05*
0.01*
0.01*
Recommended(b)
1020030
Goat milk
0.05*
0.01*
0.01*
Recommended(b)
1030000
Birds' eggs
0.05*
0.01*
0.01*
Recommended(d)
See App
C
-
-
Other products of plant
and animal origin
Further consideration needed(g)
(*): 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): 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).
(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): 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).
(e): 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 fully supported by data, leads to a lower MRL (combination G-VII 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; no CXL is available (combination E-I in Appendix D).
(g): 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).
EFSA Journal 2011;9(8):2348
5
Review of the existing MRLs for dimethomorph
KEY WORDS
Dimethomorph, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, morpholine fungicide.
EFSA Journal 2011;9(8):2348
6
Review of the existing MRLs for dimethomorph
TABLE OF CONTENTS
Summary .................................................................................................................................................. 1
Table of contents ...................................................................................................................................... 7
Background .............................................................................................................................................. 8
Terms of reference ................................................................................................................................... 9
The active substance and its use pattern .................................................................................................. 9
Assessment ............................................................................................................................................. 10
1. Methods of analysis ....................................................................................................................... 10
1.1.
Methods for enforcement of residues in food of plant origin ............................................... 10
1.2.
Methods for enforcement of residues in food of animal origin ............................................ 11
2. Mammalian toxicology .................................................................................................................. 11
3. Residues ......................................................................................................................................... 12
3.1.
Nature and magnitude of residues in plant ........................................................................... 12
3.1.1. Primary crops.................................................................................................................... 12
3.1.2. Rotational crops ................................................................................................................ 24
3.2.
Nature and magnitude of residues in livestock ..................................................................... 25
3.2.1. Dietary burden of livestock .............................................................................................. 25
3.2.2. Nature of residues ............................................................................................................. 26
3.2.3. Magnitude of residues ...................................................................................................... 27
4. Consumer risk assessment ............................................................................................................. 29
4.1.
Consumer risk assessment without consideration of the existing CXLs .............................. 29
4.2.
Consumer risk assessment with consideration of the existing CXLs ................................... 31
Conclusions and recommendations ........................................................................................................ 34
Documentation provided to EFSA ......................................................................................................... 38
References .............................................................................................................................................. 38
Appendix A – Good Agricultural Practices (GAPs) .............................................................................. 41
Appendix B – Pesticide Residues Intake Model (PRIMo) ..................................................................... 46
Appendix C – Existing EU maximum residue limits (MRLs) and Codex Limits (CXLs) .................... 53
Appendix D – Decision tree for deriving MRL recommendations ........................................................ 59
Appendix E – List of metabolites and related structural formula .......................................................... 61
Abbreviations ......................................................................................................................................... 63
EFSA Journal 2011;9(8):2348
7
Review of the existing MRLs for dimethomorph
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(2) of that regulation lays down that EFSA shall
provide by 01 September 2009 a reasoned opinion on the review of the existing MRLs for all active
substances included in Annex I to Directive 91/414/EEC5 before 02 September 2008. As
dimethomorph was included in Annex I to the above mentioned directive on 01 October 2007, EFSA
initiated the review of all existing MRLs for that active substance and a task with the reference
number EFSA-Q-2008-528 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.
Germany, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC,
was asked to complete the PROFile for dimethomorph. The requested information was submitted to
EFSA on 18 December 2008 and subsequently checked for completeness. On 05 November 2009,
after having clarified some issues with EFSA, the RMS provided a revised PROFile.
A draft reasoned opinion was issued by EFSA on 11 March 2011 and submitted to Member States
(MS) for commenting. All MS comments received by 13 May 2011 were considered by EFSA for
finalization of the reasoned opinion.
4
5
Commission Regulation (EC) No 396/2005 of 23 February 2005. OJ L 70, 16.3.2005, p. 1-16.
Council Directive 91/414/EEC of 15 July 1991, OJ L 230, 19.8.1991, p. 1-32.
EFSA Journal 2011;9(8):2348
8
Review of the existing MRLs for dimethomorph
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
Dimethomorph is the ISO common name for (E,Z)-4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)
acryloyl]morpholine (IUPAC).
Cl
Cl
O
N
O
O
O
O
E-Isomer
N
O
O
O
Z-Isomer
Dimethomorph belongs to the class of morpholine fungicides such as tridemorph and fenpropimorph.
Dimethomorph is active against fungi in the family of Peronosporaceae and the genus Phytophthora
by inhibiting the formation of the fungal cell wall. When applied to foliage, dimethomorph penetrates
leaf surfaces and is translocated within the leaf by diffusion. When applied to the roots, the compound
is systemically translocated acropetally in the plant.
Dimethomorph was evaluated in the framework of Directive 91/414/EEC with Germany being the
designated rapporteur Member State (RMS). The representative use supported for the peer review
process included outdoor treatment of potatoes at a rate of 0.180 kg a.s./ha both in northern and
southern Europe. Following the peer review, a decision on inclusion of the active substance in Annex
I to Directive 91/414/EEC was published by means of Commission Directive 2007/25/EC, entering
into force on 01 October 2007. According to Regulation (EU) No 540/20116, dimethomorph is
deemed to have been approved under Regulation (EC) No 1107/20097 as well. This approval is
restricted to uses as a fungicide only.
EU MRLs for dimethomorph in products of plant and animal origin have been set for the first time in
2008 by means of Commission Regulation (EC) No 149/20088 establishing Annexes II, III and IV of
Regulation (EC) No 396/2005. This regulation established EU MRLs on the basis of those established
by former EU directives (Annexe II) and national MRLs (Annexe III). Since the entry into force of that
regulation, EFSA recommended the modification of the existing MRLs for peas without pods, leek and
other various crops (EFSA, 2009, 2010) which was legally implemented in Regulation (EC) No
6
Regulation (EU) No 540/2011 of 25 May 2011, OJ L 153, 11.6.2011, p. 1-186.
Regulation (EC) No 1107/2009 of 21 October 2009, OJ 309, 24.11.2009, p. 1–50.
8
Commission Regulation (EC) No 149/2008 of 29 January 2008. OJ L 58, 1.3.2008, p. 1-398.
7
EFSA Journal 2011;9(8):2348
9
Review of the existing MRLs for dimethomorph
750/20109 and Regulation (EU) No 508/201110. EFSA also recommended the modification of the
existing MRLs for strawberries, lamb’s lettuce, oranges and various leafy crops (EFSA, 2011a, 2011b)
which was already approved by the meeting of the Standing Committee on the Food Chain and Animal
Health held on 23-24 March 2011 and 16-17 June 2011 but not yet legally implemented. All existing
EU MRLs for dimethomorph are summarized in Appendix C.1 to this document. CXLs for
dimethomorph have been established by the Codex Alimentarius Commission and are reported in
Appendix C.2 to this reasoned opinion.
For the purpose of this MRL review, the critical uses of dimethomorph 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). According to
the reported GAPs, dimethomorph is applied on a wide range of crops as both indoor and outdoor
foliar treatment. A drenching treatment on strawberries, blackberries and raspberries and a seed
treatment on rape seed are also reported.
ASSESSMENT
EFSA bases its assessment on the PROFile, the Draft Assessment Report (DAR) prepared under
Council Directive 91/414/EEC (Germany, 2004), the conclusion on the peer review of the pesticide
risk assessment of the active substance dimethomorph (EFSA, 2006), the JMPR Evaluation report
(FAO, 2007) as well as the previous reasoned opinions on dimethomorph (EFSA, 2009, 2010, 2011a
and 2011b) and the German, French and British evaluation reports submitted during the Member
States consultation (Germany, 2011; France, 2011 and United Kingdom, 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
and 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, the multi-residue analytical method DFG S19
using GC-NPD confirmed by GC-MSD and its ILV were evaluated and adequately validated for the
determination of dimethomorph (sum of isomers) in plant matrices with an LOQ of 0.02 mg/kg in
high water content (onions), acidic (wine grapes) and high fat content (rape seed) commodities, and
0.2 mg/kg in hops (Germany, 2004; EFSA 2006).
An additional method using GC-NPD was evaluated and adequately validated for the determination of
dimethomorph (sum of isomers) in plant matrices with an LOQ of 0.05 mg/kg in high water content
(potatoes) and acidic (grapes) commodities (Germany, 2004).
A method using HPLC-UV was also evaluated and adequately validated for the determination of
dimethomorph (sum of isomers) in plant matrices with an LOQ of 0.01 mg/kg in high water content
commodities (potatoes) (Germany, 2004).
9
Regulation (EC) 750/2010 of 07 July 2010, OJ L 220, 21.8.2010, p. 1–56.
Regulation (EU) 508/2011 of 24 May 2011, OJ L 137, 25.5.2011, p. 3–52.
11
Regulation (EU) No 546/2011 of 10 June 2011. OJ L 155, 11.06.2011, p. 127-175.
10
EFSA Journal 2011;9(8):2348
10
Review of the existing MRLs for dimethomorph
In addition, a method using GC-NPD confirmed by HPLC-MS/MS was evaluated and adequately
validated for the determination of dimethomorph (sum of isomers) in plant matrices with an LOQ of
0.05 mg/kg in high water content (potatoes) and acidic (grapes) commodities. (Germany, 2004; EFSA
2006)
The multi-residue QuEChERS method using HPLC-MS/MS described in the European Standard EN
15662:2008 for the determination of parent compound in high water content, acidic and dry
commodities is also applicable.
Hence it is concluded that dimethomorph (sum of isomers) can be enforced in food of plant origin
with an LOQ of 0.01 mg/kg in high water content, dry and acidic commodities, 0.02 mg/kg in high fat
content commodities and 0.2 mg/kg in hops.
Table 1-1: Recovery data for the analysis of of dimethomorph in different crop groups using the
QuEChERS method in combination with LC-MS/MS (CEN, 2008)
Commodity group
1.2.
Spiking levels
(mg/kg)
Recoveries
Mean (%)
RSD (%)
n
No of
labs
Acidic
0.01
0.1
94
97
7
5
25
24
5
5
Dry (cereals)
0.01
0.1
102
102
7
6
20
20
4
4
High water
0.01
0.1
96
99
8
5
25
25
5
5
Methods for enforcement of residues in food of animal origin
During the peer review under Directive 91/414/EEC, the multi-residue analytical method DFG S19
using GC-NPD confirmed by GC-MSD and its ILV were evaluated and adequately validated for the
determination of dimethomorph (sum of isomers) in food of animal origin with an LOQ of 0.01 mg/kg
in milk, meat and eggs and with an LOQ of 0.1 mg/kg in fat (Germany, 2004; EFSA 2006).
In addition, an analytical method using HPLC-MS/MS and its ILV were evaluated by the RMS after
Annex I inclusion and adequately validated for determination of dimethomorph (sum of isomers) in
food of animal origin with an LOQ of 0.01 mg/kg in muscle, fat, liver, kidney, milk and eggs.
However, this method was not reported in detail and a detailed peer review of this method is therefore
still desirable.
Hence it is concluded that dimethomorph (sum of isomers) can be enforced in food of animal origin
with an LOQ of 0.01 mg/kg in milk, fat, liver, kidney, meat and eggs.
2.
Mammalian toxicology
The toxicological assessment of dimethomorph was peer reviewed under Directive 91/414/EEC and
toxicological reference values were published by EFSA (2006). These toxicological reference values
are summarized in Table 2-1.
EFSA Journal 2011;9(8):2348
11
Review of the existing MRLs for dimethomorph
Table 2-1: Table 2-1. Overview of the toxicological reference values
Source
Year
Value
Study relied upon
Safety
factor
Parent compound
ADI
EFSA
2006
0.05 mg/kg bw/d
Dog, 1 year study
100
ARfD
EFSA
2006
0.6 mg/kg bw
Rat, developmental study
100
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 dimethomorph was investigated for foliar application on three different crop groups:
fruits and fruiting vegetables (grapes), root and tuber vegetables (potatoes) and leafy vegetables
(lettuce) (EFSA, 2006). Data are summarized in table 3-1.
Metabolism of dimethomorph was investigated with 14C-labelled compound in the chlorophenyl ring
and the morpholine ring (used in one of the studies with potatoes) (Germany, 2004). The degradation
of dimethomorph was limited. At harvest, the unchanged parent compound represented the major
portion of the radioactive residues in all investigated plant parts (86.5 % – 83 % of the TRR in grapes
and grape leaves, respectively; 93 % of the TRR in lettuce; 70.5 % of the TRR in potatoes green
matter with very low TRR in potatoes tubers: 0.056 mg/kg and 0.003 mg/kg in tuber peels and peeled
tubers, respectively). Only relatively small amounts of metabolites were detected; none of them is
expected to contribute significantly to the toxicological burden. The metabolic pathway was similar in
all crop groups and involved the demethylation of the two methoxy groups of the dimethoxyphenyl
ring to produce the metabolites Z6712 and Z6913 with further conjugation to glucose, the hydrolysis of
dimethomorph to form the metabolite Z714 and the oxidation of the morpholine ring to lead to the
metabolite Z3715. Based on the above finding, EFSA already concluded that following foliar
application the residue definition proposed for monitoring and risk assessment is parent compound
dimethomorph (EFSA, 2006).
Dimethomorph is also authorized for other types of application such as seed treatments and drenching
at planting. An additional metabolism study on tomatoes in a hydroponic system was therefore
considered. This study indicates that the compound can be taken up by the roots and translocated to
the fruits. Dimethomorph was the predominant residue, but was reduced with time under formation of
the metabolites Z69 (including conjugates), Z9316, Z9517 and Z9818. Two of them (Z69 and Z93) were
present at levels similar to that of the parent compound. However, the RMS noted that these
metabolites are more polar than dimethomorph and were also identified in rat metabolism (Germany,
12
Z67: 4-[(E)-and(Z)-beta-(p-chlorophenyl)-3-hydroxy-4-methoxycinnamoyl]morpholine (see Appendix E)
Z69: 4-[(E)-and(Z)-beta-(p-chlorophenyl)-4-hydroxy-3-methoxycinnamoyl]morpholine (see Appendix E)
14
Z7: 4-chloro-3’,4’-dimethoxy-benzophenone (see Appendix E)
15
Z37: 4-[3-(4-chlorophenyl)-3-3,4-dimethoxy-phenyl)-1-oxo-2-propenyl]-2-oxo-morpholine (see Appendix E)
16
Z93 : 3-(4-chlorophenyl)-3-(3,4-dimethoxy-phenyl)-N,N-bis-(2-hydroxyethyl) acrylamide (see Appendix E)
17
Z95 : N-[3-(4-chlorophenyl)-3-3,4-dimethoxyphenyl)-1-oxo-2-propenyl-ethanolamine (see Appendix E)
18
Z98 : 3-(4-chlorophenyl)-3-(3,4-dimethoxy-phenyl)-acrylamide (see Appendix E)
13
EFSA Journal 2011;9(8):2348
12
Review of the existing MRLs for dimethomorph
2004). Also considering the available studies on rotational crops (see section 3.1.2), all uses of
dimethomorph that would lead to a potential uptake of residues from the soil are considered to be
sufficiently covered by available metabolism studies.
Table 3-1: Summary of available metabolism studies in plants
Group
Crop
Label position
Application and sampling details
Method,
F or G (a)
Fruits and fruiting
vegetable
Rate
No
Sampling
(DAT)
Remarks
Grapes
chlorophenyl
ring label 14Cdimethomorph
Foliar
treatment
(F)
0.9 kg
as/ha
4
35
Covered
with a
plastic foil
to avoid
wash off
Tomatoes
chlorophenyl
ring label 14Cdimethomorph
Nutrient
media in a
hydroponic
system (G)
8 mg/L
-
7, 14 and
28
Plant
uptake
study;
application
lasted for
7d
Leafy vegetables
Lettuce
chlorophenyl
ring label 14Cdimethomorph
Foliar
treatment
1.14 kg
as/ha
4
4
30 d ;
intervals
of 10 +/- 1
days
Root and tuber
vegetables
Potatoes
chlorophenyl
ring label 14Cdimethomorph
Foliar
treatment
(G)
0.6 kg
as/ha
4
7
Foliar
treatment
(lysimeter
study)
0.3 kg
as/ha
3
28
morpholine ring
label 14Cdimethomorph
chlorophenyl
ring label 14Cdimethomorph
Plant
uptake
study
(a): Outdoor/field application (F) or glasshouse/protected/indoor application (G)
Consequently, the relevant residue for enforcement and risk assessment in all plant commodities is
defined as dimethomorph (sum of isomers). Validated analytical methods for enforcement of the
proposed residue definition are available (see also section 1.1). The conclusions reached by EFSA
reflect the views of the RMS and are also in line with those of the JMPR (FAO, 2007).
3.1.1.2. Magnitude of residues
The use of dimethomorph is reported on a large number of crops by the RMS (Appendix A). To
assess the magnitude of dimethomorph residues resulting from these GAPs, EFSA considered all
residues trials reported in the PROFile, including residues trials evaluated in the framework of the
peer review (EFSA, 2006) or in the framework of an MRL application (EFSA, 2009, 2010 and 2011a
and 2011b) and the German, French and British evaluation reports submitted during the Member
States consultation (Germany, 2011, France, 2011 and United Kingdom 2010). All available residues
trials that, according to the RMS, comply with the authorised GAPs, are summarized in Table 3-1.
EFSA Journal 2011;9(8):2348
13
Review of the existing MRLs for dimethomorph
Table 3-2: Overview of the available residues trials data
Commodity
Region
(a)
Outdoor
/Indoor
Orange
SEU
Table Grapes
Wine grapes
Strawberries
Individual trial results (mg/kg)
Median
residue
(mg/kg)
(b)
Highest
residue
(mg/kg)
(c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(dimethomorph sum
of isomers)
Risk assessment
(dimethomorph sum
of isomers)
Outdoor
0.06; 0.066; 0.092;
0.182; 0.205; 0.228;
0.240; 0.607
0.06; 0.066; 0.092;
0.182; 0.205; 0.228;
0.240; 0.607
0.19
0.61
0.8
1.00
Trials compliant with the
GAP (EFSA, 2011b).
Rmax=0.77
Rber=0.47
NEU
Outdoor
0.09; 0.11; 0.19;
0.21; 0.24; 0.25;
0.29; 0.30; 0.31; 2 x
0.38; 2 x 0.42; 0.44;
2 x 0.50; 0.51; 0.54;
0.55; 0.62; 0.65;
0.68; 0.70; 0.75;
0.76; 0.79; 2 x 0.87;
0.91; 0.95; 0.99; 1.0;
3 x1.1; 1.3; 2 x 1.7
0.09; 0.11; 0.19;
0.21; 0.24; 0.25;
0.29; 0.30; 0.31; 2 x
0.38; 2 x 0.42; 0.44;
2 x 0.50; 0.51; 0.54;
0.55; 0.62; 0.65;
0.68; 0.70; 0.75;
0.76; 0.79; 2 x 0.87;
0.91; 0.95; 0.99; 1.0;
3 x1.1; 1.3; 2 x 1.7
0.59
1.70
2
1.00
Trials compliant with the
GAP.
Rmax=1.51
Rber=1.84
SEU
Outdoor
2 x <0.02; 0.03; 2 x
0.04; 0.06; 4 x 0.07;
2 x0.08; 0.09; 0.11;
0.12; 0.21; 0.24;
0.36; 0.38; 0.42;
0.47; 2.3
2 x <0.02; 0.03; 2 x
0.04; 0.06; 4 x 0.07;
2 x0.08; 0.09; 0.11;
0.12; 0.21; 0.24;
0.36; 0.38; 0.42;
0.47; 2.3
0.08
2.30
3
1.00
Trials compliant with the
GAP.
Rmax=1.37
Rber=0.54
NEU
Outdoor
4 x 0.01; 0.013;
0.016; 2 x 0.02
4 x 0.01; 0.013;
0.016; 2 x 0.02
0.01
0.02
0.05
1.00
Trials compliant with the
GAP.
Rmax=0.03
Rber=0.04
EFSA Journal 2011;9(8):2348
14
Review of the existing MRLs for dimethomorph
Commodity
Region
(a)
Outdoor
/Indoor
EU
Indoor
Blackberries
Raspberries
NEU
Potatoes
Radishes
Individual trial results (mg/kg)
Median
residue
(mg/kg)
(b)
Highest
residue
(mg/kg)
(c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
0.13
0.51
0.7
1.00
Trials compliant with the
GAP (EFSA, 2011).
Rmax=0.71
Rber=0.55
-
-
-
1.00
No trials available. Although
intended before consumable
parts of the crops have
started to form quantifiable
levels of residues were found
in strawberries (same use); 4
residues trials are required.
Enforcement
(dimethomorph sum
of isomers)
Risk assessment
(dimethomorph sum
of isomers)
2x0.04; 2 x 0.05;
0.21; 0.23; 0.29; 0.51
2x0.04; 2 x 0.05;
0.21; 0.23; 0.29; 0.51
Outdoor
-
-
NEU
Outdoor
13 x <0.01; 18 x
<0.02; 2 x 0.02; 0.04
13 x <0.01; 18 x
<0.02; 2 x 0.02; 0.04
0.02
0.04
0.04
1.00
Trials compliant with the
GAP.
Rmax=0.03
Rber=0.04
SEU
Outdoor
7 x <0.05
7 x <0.05
0.05
0.05
0.05
1.00
Trials compliant with the
GAP
Rmax=0.05
Rber=0.10
NEU
Outdoor
5 x <0.02; 0.02; 0.03
5 x <0.02; 0.02; 0.03
0.02
0.03
0.05
1.00
Trials compliant with the
GAP
Rmax=0.03
Rber=0.04
EU
Indoor
0.02; 0.14; 0.40; 0.63
0.02; 0.14; 0.40; 0.63
0.27
0.63
1.5
1.00
Trials compliant with the
GAP.
Rmax=1.70
Rber=1.15
EFSA Journal 2011;9(8):2348
15
Review of the existing MRLs for dimethomorph
Commodity
Region
(a)
Outdoor
/Indoor
NEU
Individual trial results (mg/kg)
Median
residue
(mg/kg)
(b)
Highest
residue
(mg/kg)
(c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(dimethomorph sum
of isomers)
Risk assessment
(dimethomorph sum
of isomers)
Outdoor
2 x <0.01; 0.03;
0.04; 0.05; 0.06;
0.08; 0.1
2 x <0.01; 0.03;
0.04; 0.05; 0.06;
0.08; 0.1
0.05
0.1
0.15
1.00
Trials on onions compliant
with northern outdoor GAP;
extrapolation to shallots and
garlic (EFSA, 2010).
Rmax=0.15
Rber=0.1
SEU
Outdoor
2 x <0.01; 0.01; 2 x
0.02; 0.03; 0.08; 0.09
2 x <0.01; 0.01; 2 x
0.02; 0.03; 0.08; 0.09
0.02
0.09
0.15
1.00
Trials on onions compliant
with southern outdoor GAP;
extrapolation to shallots and
garlic (EFSA, 2010).
Rmax=0.14
Rber=0.14
Spring onion
NEU
Outdoor
4 x <0.02; 0.02; 0.09
4 x <0.02; 0.02; 0.09
0.02
0.09
0.2
1.00
Trials compliant with the
GAP.
Rmax=0.14
Rber=0.08
Tomatoes
NEU
Outdoor
0.04; 0.05; 0.06; 0.07
0.04; 0.05; 0.06; 0.07
0.06
0.07
0.2
1.00
Overdosed trials on tomatoes
(7-8 x 0.3-0.6 kg as/ha) are
considered sufficient for
demonstrating that northern
outdoor use is less critical
than the indoor use.
Rmax=0.12
Rber=0.14
SEU
Outdoor
<0.01; 0.03; 0.04;
0.05; 0.06; 0.07;
0.08; 0.11; 0.13
<0.01; 0.03; 0.04;
0.05; 0.06; 0.07;
0.08; 0.11; 0.13
0.06
0.13
0.3
1.00
Trials compliant with the
GAP.
Rmax=0.20
Rber=0.23
Onion
Garlic
Shallots
EFSA Journal 2011;9(8):2348
16
Review of the existing MRLs for dimethomorph
Commodity
Pepper
Aubergines (egg
plants)
Region
(a)
Outdoor
/Indoor
EU
Indoor
SEU
Outdoor
EU
Indoor
NEU
Individual trial results (mg/kg)
Median
residue
(mg/kg)
(b)
Highest
residue
(mg/kg)
(c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
0.27
0.74
1
1.00
Trials compliant with the
GAP.
Rmax=1.14
Rber=1.34
-
-
-
1.00
No trials available.
Although residues are not
expected to be higher than
indoor use, 8 residues trials
are normally required.
Enforcement
(dimethomorph sum
of isomers)
Risk assessment
(dimethomorph sum
of isomers)
0.11; 0.16; 0.17;
0.19; 0.27; 0.32;
0.61; 0.73; 0.74
0.11; 0.16; 0.17;
0.19; 0.27; 0.32;
0.61; 0.73; 0.74
-
-
0.03; 0.05; 0.05;
0.06; 0.07; 0.08;
0.09; 0.15; 0.16;
0.26; 0.26; 0.33
0.03; 0.05; 0.05;
0.06; 0.07; 0.08;
0.09; 0.15; 0.16;
0.26; 0.26; 0.33
0.09
0.33
0.5
1.00
Trials compliant with the
GAP.
Rmax=0.41
Rber=0.47
Outdoor
0.02; 2 x <0.05; 0.07;
0.08; 0.14; 0.16; 0.19
0.02; 2 x <0.05; 0.07;
0.08; 0.14; 0.16; 0.19
0.08
0.19
0.3
1.00
Trials on tomatoes
representative for the GAP
on aubergines (EFSA, 2010).
Rmax=0.29
Rber=0.24
SEU
Outdoor
<0.01; 0.03; 0.05;
0.06; 0.07; 0.08;
0.11; 0.13
<0.01; 0.03; 0.05;
0.06; 0.07; 0.08;
0.11; 0.13
0.07
0.14
0.2
1.00
Extrapolation from the
southern outdoor use on
tomatoes.
Rmax=0.19
Rber=0.21
EU
Indoor
0.03; 0.04; 0.06,
0.07; 0.07; 0.08;
0.09; 0.1; 0.1; 0.13;
0.15; 0.19
0.03; 0.04; 0.06,
0.07; 0.07; 0.08;
0.09; 0.1; 0.1; 0.13;
0.15; 0.19
0.09
0.19
0.3
1.00
Trials on tomatoes
representative for the GAP
on aubergines (EFSA, 2010).
Rmax=0.22
Rber=0.24
EFSA Journal 2011;9(8):2348
17
Review of the existing MRLs for dimethomorph
Commodity
Cucumber
Courgettes
Gherkins
Melon
Region
(a)
Outdoor
/Indoor
NEU
Individual trial results (mg/kg)
Median
residue
(mg/kg)
(b)
Highest
residue
(mg/kg)
(c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(dimethomorph sum
of isomers)
Risk assessment
(dimethomorph sum
of isomers)
Outdoor
<0.01; <0.02; 0.04
<0.01; <0.02; 0.04
0.02
0.04
0.1
1.00
Trials on cucumber
compliant with the GAP.
Extrapolation to courgettes
and gherkins.
Rmax=0.14
Rber=-
SEU
Outdoor
4 x <0.01; <0.02; 4 x
0.02; 0.06
4 x <0.01; <0.02; 4 x
0.02; 0.06
0.02
0.06
0.1
1.00
Combined dataset on
cucumbers (5) and
courgettes (5) compliant
with the GAP for these two
crops. No registration on
gherkins in SEU.
Rmax=0.06
Rber=0.04
EU
Indoor
0.13; 0.15; 0.16;
0.20; 0.20; 0.22;
0.23; 0.24; 0.25; 0.39
0.13; 0.15; 0.16;
0.20; 0.20; 0.22;
0.23; 0.24; 0.25; 0.39
0.21
0.39
0.5
1.00
Trials on cucumber
compliant with the GAP.
Extrapolation to courgettes
and gherkins.
Rmax=0.43
Rber=0.49
SEU
Outdoor
0.02; 0.03; 2x 0.04;
0.05; 2x 0.06; 0.09;
2x0.11; 2x0.29;
0.02; 0.03; 2x 0.04;
0.05; 2x 0.06; 0.09;
2x0.11; 2x0.29;
0.06
0.29
0.4
1.00
Trials compliant with the
GAP (France, 2011).
Rmax=0.36
Rber=0.22
EU
Indoor
-
-
-
-
-
1.00
No trials available and 8
residues trials are required.
EFSA Journal 2011;9(8):2348
18
Review of the existing MRLs for dimethomorph
Commodity
Region
(a)
Outdoor
/Indoor
Broccoli
Cauliflower
NEU
Kohlrabi
Lettuce, other
salad plants and
herbs
Individual trial results (mg/kg)
Median
residue
(mg/kg)
(b)
Highest
residue
(mg/kg)
(c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(dimethomorph sum
of isomers)
Risk assessment
(dimethomorph sum
of isomers)
Outdoor
6 x <0.02; 0.04
6 x <0.02; 0.04
0.02
0.04
0.05
1.00
Trials on broccoli compliant
with the GAP. Extrapolation
to cauliflower is accepted
because residues are below
or close to the LOQ.
Rmax=0.05
Rber=0.04
NEU
Outdoor
2 x <0.02
2 x <0.02
0.02
0.02
0.02
1.00
Trials compliant with the
GAP.
EU
Indoor
4 x <0.02
4 x <0.02
0.02
0.02
0.02
1.00
Trials compliant with the
GAP.
NEU
Outdoor
6 x <0.02; 0.06
6 x <0.02; 0.06
0.02
0.06
0.1
1.00
Trials on lettuce compliant
with the GAP; extrapolation
possible to scarole, rucola
and fresh herbs. No
registration on other salad
plants in NEU.
SEU
Outdoor
<0.01; 0.02; 0.04;
0.05; 0.06; 0.07;
0.08; 0.1; 0.1; 0.13;
0.13; 0.16; 0.26;
0.38; 0.39; 0.43; 0.5;
1.2; 1.2; 2.5
<0.01; 0.02; 0.04;
0.05; 0.06; 0.07;
0.08; 0.1; 0.1; 0.13;
0.13; 0.16; 0.26;
0.38; 0.39; 0.43; 0.5;
1.2; 1.2; 2.5
0.13
2.50
3
1.00
Combined dataset on lettuce
(8), head lettuce (8) and
lamb’s lettuce (4) compliant
with the GAP. No
registration on other salad
plants or herbs in SEU.
Rmax=1.84
Rber=0.84
EFSA Journal 2011;9(8):2348
19
Review of the existing MRLs for dimethomorph
Commodity
Region
(a)
Outdoor
/Indoor
EU
Indoor
Spinach
NEU
Outdoor
Witloof
EU
Indoor
Beans (fresh
without pods)
NEU
Peas (fresh
without pods)
Lettuce, other
salad plants and
herbs
Globe
artichokes
Individual trial results (mg/kg)
Median
residue
(mg/kg)
(b)
Highest
residue
(mg/kg)
(c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(dimethomorph sum
of isomers)
Risk assessment
(dimethomorph sum
of isomers)
0,28; 0,31; 0,37;
0,46; 0,53; 0,78;
1,07; 1,09; 1,27; 1,3;
2,3; 3,41; 3,5; 5,4;
5,55; 6,34; 7,06
0,28; 0,31; 0,37;
0,46; 0,53; 0,78;
1,07; 1,09; 1,27; 1,3;
2,3; 3,41; 3,5; 5,4;
5,55; 6,34; 7,06
1.27
7.06
10
1.00
Combined data set on head
lettuce (13) and lamb's
lettuce (4) (EFSA, 2011b);
extrapolation to all other
salad plants and herbs is
possible.
Rmax=8.90
Rber=8.22
0.01; 0.02
0.01; 0.02
0.02
0.02
0.05
(tentative)
1.00
Trials compliant with the
GAP but 2 additional trials
are required.
2 x <0.02; 3 x <0.03;
0.03
2 x <0.02; 3 x <0.03;
0.03
0.03
0.03
0.05
1.00
Trials compliant with the
GAP.
Rmax=0.05
Rber=0.06
Outdoor
3 x <0.02; 0.02
3 x <0.02; 0.02
0.02
0.02
0.04
1.00
Trials compliant with the
GAP.
NEU
Outdoor
6 x <0.01; 0.02;
0.044; 0.063; 0.071
6 x <0.01; 0.02;
0.044; 0.063; 0.071
0.01
0.07
0.1
1.00
Trials compliant with the
GAP (EFSA, 2009)
Rmax=0.10
Rber=0.10
SEU
Outdoor
4 x <0.01
4 x <0.01
0.01
0.01
0.01
1.00
Trials compliant with the
GAP (EFSA, 2009)
NEU
Outdoor
0.11; 0.24; 0.26;
0.55; 0.75
0.11; 0.24; 0.26;
0.55; 0.75
0.26
0.75
1.5
1.00
Trials compliant with the
GAP (EFSA, 2010)
Rber=1.48
Rmax=1.30
EFSA Journal 2011;9(8):2348
20
Review of the existing MRLs for dimethomorph
Commodity
Region
(a)
Outdoor
/Indoor
SEU
Individual trial results (mg/kg)
Median
residue
(mg/kg)
(b)
Highest
residue
(mg/kg)
(c)
MRL
proposal
(mg/kg)
Median
CF (d)
Comments
Enforcement
(dimethomorph sum
of isomers)
Risk assessment
(dimethomorph sum
of isomers)
Outdoor
0.06; 0.09; 0.14;
0.32; 1.14
0.06; 0.09; 0.14;
0.32; 1.14
0.14
1.14
2
1.00
Trials compliant with the
GAP (EFSA, 2010)
Rber=2.26
Rmax=1.46
NEU
Outdoor
0.01; 2 x <0.02; 0.03;
0.035; 0.036; 0.05;
0.05; 0.07; 0.08;
0.083; 0.1; 0.104;
0.111; 0.133
0.01; 2 x <0.02; 0.03;
0.035; 0.036; 0.05;
0.05; 0.07; 0.08;
0.083; 0.1; 0.104;
0.111; 0.133
0.05
0.13
0.2
1.00
Trials representative for the
GAP (EFSA, 2009)
Rmax=0.20
Rber=0.16
SEU
Outdoor
0.061; 0.076; 0.297;
0.694
0.061; 0.076; 0.297;
0.694
0.19
0.69
1.5
1.00
Trials representative for the
GAP (EFSA, 2009)
Rmax=1.20
Rber=1.80
NEU
Outdoor
2 x <0.002
2 x <0.002
0.02
0.02
0.02*
1.00
Trials compliant with the
GAP (France, 2011).
SEU
Outdoor
-
-
-
-
-
1.00
No trials available and 4
residues trials are required.
Rape seed
NEU
Outdoor
2 x <0.02
2 x <0.02
0.02
0.02
0.02*
1.00
Trials compliant with the
GAP.
Hops
NEU
Outdoor
2; 4.1; 7.7; 8.3; 8.7;
9.3; 14; 20; 21; 24;
26; 26; 28; 29; 42
2; 4.1; 7.7; 8.3; 8.7;
9.3; 14; 20; 21; 24;
26; 26; 28; 29; 42
20.00
42.00
50
1.00
Trials compliant with the
GAP.
Rmax=47.12
Rber=52.00
Leek
Poppy seed
(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.
(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.
(*): Indicates that the MRL is set at the limit of analytical quantification.
EFSA Journal 2011;9(8):2348
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Review of the existing MRLs for dimethomorph
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 (European
Commission, 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:
For the indoor use of dimethomorph on melon, no residues trials are available, while it is a
major crop. Although 8 trials complying with the indoor GAP are still required, adequate
MRL and risk assessment values in melons can be derived for the outdoor use on melons.
For blackberries and raspberries, no residues trials are available and MRL and risk assessment
values can therefore not be derived. According to the RMS, no trials are required because the
application is made before consumable parts of the plant are formed. EFSA is however of the
opinion that, considering the systemic properties of dimethomorph, translocation of residues
from the soil to the fruits cannot be excluded. This translocation was observed for a similar
type of application in strawberries. The availability of three residues trials was reported to
EFSA during the Member States consultation but they cannot be taken into consideration as
no evaluation report was provided. Consequently, 4 additional trials complying with the GAP
are required for these minor crops.
For the use of dimethomorph on potatoes in southern Europe and on kohlrabi in northern
Europe, the number of trials reported is not compliant with the data requirements for these
crops but the reduced number was considered sufficient by EFSA because all available trial
results were below or close to the LOQ. Further residues trials are not required.
For the use of dimethomorph on broccoli and cauliflower, 8 trials on broccoli are available
while 4 trials on each crop are normally required. The extrapolation from broccoli to
cauliflower, as proposed by the RMS, is however accepted by EFSA because residues were
all below or close to the LOQ. It is not expected that additional trials on cauliflower will
impact on the derived MRL.
For the southern outdoor use of dimethomorph on pepper, no residues trials are available. It is
likely that residues resulting from the southern outdoor use will be lower than those resulting
from the indoor use but this should be confirmed by residues trials data. 8 trials compliant
with the southern outdoor GAP are therefore required for this major crop. If it is demonstrated
that the outdoor use is less critical, the number of residues trials may be reduced. In the
meantime, adequate MRL and risk assessment values in peppers can be derived for the indoor
use.
For the use of dimethomorph on cucurbits with edible peel (cucumber, courgettes and
gherkins) and lettuce in northern Europe, the number of trials reported is not compliant with
the data requirements but the RMS considered that the data are sufficient because the residues
levels in outdoor conditions is not expected to be higher than those in protected conditions.
EFSA considers that the statement of the RMS is sufficiently supported by data and further
residues trials are not required.
For spinach, 2 trials compliant with the northern outdoor GAP are available while 4 trials are
required for this minor crop. MRL and risk assessment values derived are therefore tentative
and 2 additional trials complying with the northern outdoor use are still required. EFSA
highlights that an MRL application is currently ongoing.
For poppy seed in northern Europe, the number of trials reported is not compliant with the
data requirements but the reduced number was considered sufficient by EFSA because all
available trial results were below the LOQ. Further residues trials in northern Europe are
therefore not required. For the use of dimethomorph on poppy seed in southern Europe,
EFSA Journal 2011;9(8):2348
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Review of the existing MRLs for dimethomorph
however, no residues trials are available. As it is demonstrated for the northern use that no
residue are expected, only 2 trials compliant with the southern outdoor GAP are therefore
required for this minor crop. In the meantime, adequate MRL and risk assessment values in
poppy seed can be derived for the northern use.
The potential degradation of residues during storage of the residues trials samples was also assessed.
In the framework of the peer review, storage stability of dimethomorph was demonstrated for a period
of 18-24 months at -18 °C in commodities with high water (potatoes) and high acid (grapes) content
as well as in hops (EFSA, 2006). According to the RMS, several storage stability studies were
submitted after the peer review. The stability of dimethomorph was demonstrated in commodities
with high water (tomatoes, broccoli and spinach) and high oil (rape seed) content for a period of 24
and 12 months respectively at -18 °C. According to the RMS, all residues trials samples reported in
the PROFile were stored in compliance with the above reported storage conditions. Degradation of
residues during storage of the trial samples is therefore not expected.
Consequently, the available residues data are considered sufficient to derive adequate MRL proposals
as well as adequate risk assessment values for most of the commodities under evaluation, except for
spinach where the MRL derived is tentative only and for blackberries and raspberries, where the
available data were insufficient to derive tentative MRLs. It should also be noted that the MRL and
risk assessment values derived for melons, cucurbits with edible peel, peppers and poppy seed are
resulting from one of the reported uses only while data requirements may still apply to the remaining
uses (see also Table 3-1). In case where several uses are supported for one commodity, the final MRL
proposal was derived from the most critical use and indicated in bold in the table.
3.1.1.3. Effect of industrial processing and/or household preparation
The effect of processing on the nature of dimethomorph residues was investigated in the framework of
the peer review by means of hydrolysis studies simulating sterilization (20 minutes at 120 C, pH 6),
baking, brewing, boiling (60 minutes at 100 C pH 5) and pasteurization (20 minutes at 90 C, pH 4).
These studies showed that dimethomorph is hydrolytically stable under these conditions and that no
formation of toxicologically relevant metabolites occurs (EFSA, 2006). Thus, for processed
commodities the same residue definition as for raw agricultural commodities (RAC) is applicable.
Studies investigating the magnitude of residues in processed commodities of wine grapes and hops
were also reported in the framework of the peer review (EFSA, 2006). After dimethomorph was
included in Annex I to Directive 91/414/EEC, studies investigating the magnitude of residues in
processed commodities of potatoes and tomatoes were reported by the RMS in its PROFile. These
studies were never peer reviewed but, according to the RMS, they are representative for the processes
investigated. An overview of all available processing studies is summarised in Table 3-2. Robust
processing factors could only be derived for peeled oranges, wine grapes and beer. 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.
EFSA Journal 2011;9(8):2348
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Review of the existing MRLs for dimethomorph
Table 3-3: Overview of the available processing studies
Processed commodity
Number
of studies
Median
PF (a)
Median
CF (b)
Comments
Processing factors recommended for enforcement and risk assessment (sufficiently supported by data)
Orange, peeled
8
0.13
1.00
Resulting from residues trials on
oranges (EFSA, 2011b)
Wine grapes, dry pomace
4
2.60
1.00
Wine grapes,
(unheated)
19
0.31
1.00
Data submitted in the peer review
(EFSA, 2006)
Wine grapes, white wine
9
0.30
1.00
Hops, beer
5
0.002
1.00
PF ranging from <0.001 to 0.004
(EFSA, 2006).
red
wine
Indicative processing factors (limited data sets)
Potatoes, peeled and boiled
1
0.15
1.00
Potatoes, fried
1
0.50
1.00
Potatoes, granules or flakes
1
0.50
1.00
Study performed with exaggerated
dose rates as no residues above
LOQ are expected in RAC
(PROFile).
Tomatoes, paste
1
1.20
1.00
Data submitted in the PROFile.
Tomatoes, ketchup
1
1.40
1.00
Tomatoes, juice
1
0.49
1.00
(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
All crops evaluated in the framework of this MRL review, except permanent crops (grapes), might be
grown in rotation with other crops. During the peer review under Directive 91/414/EEC, it was also
demonstrated in several degradation studies that dimethomorph is persistent in soil and that DT 90
values ranged between 203d (field studies) and 319d (laboratory studies), hereby exceeding the
trigger value of 100d (EFSA, 2006). A detailed assessment of the nature and magnitude of
dimethomorph residues is therefore considered relevant.
3.1.2.2. Nature of residues
During peer review under Directive 91/41/EEC, the metabolism of radiolabelled dimethomorph in
rotational crops was evaluated in two studies. In the first study, the compound was applied to the bare
soil at a rate of 4 kg a.s./ha. After soil aging for 29, 120 and 371 days, three different crops, namely
carrots, pre-cultivated lettuces and wheat, were planted and grown under laboratory conditions. The
residues declined in all the sample materials (soil and plant) with increasing time. Dimethomorph was
the only identified (but not quantified) compound of the residue. In the second study, the dose applied
to the soil was 1.7 kg a.s./ha. The rotational crops wheat, radishes, lettuce and soybean, were grown
outdoor and samples collected at intervals from 30 to 394 days after the soil treatment. Dimethomorph
EFSA Journal 2011;9(8):2348
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Review of the existing MRLs for dimethomorph
as well as its two metabolites Z67 and Z69 (free or conjugated to glucose – see Appendix D) were
identified in small amounts (<0.01 to 0.04 mg/kg) in the rotational crops, thus indicating that
dimethomorph was taken up by the roots and that the metabolism in following crops is similar to that
observed in primary crops. Consequently, the peer review concluded that for rotational crops the same
residue definition as for primary crops applies (EFSA, 2006).
Table 3-4: Summary of available metabolism studies in rotational crops
Crop group
Crop
Leafy vegetables
Lettuce
Root and tuber
vegetables
Carrots
Cereals
Wheat
Leafy vegetables
Lettuce
Root and tuber
vegetables
Radishes
Pulses and
oilseeds
Soybeans
Cereals
Wheat
Label position
Application and sampling details
Method,
F or G (a)
Rate
(kg
a.s./ha)
Sowing
intervals
(DAT)
Harvest
Intervals
(DAT)
chlorophenyl
ring labeled
14Cdimethomorph
Bare soil,
G
4
29, 120,
371
65, 424
chlorophenyl
ring labeled
14Cdimethomorph
Bare soil,
F
1.7
30, 60,
180, 274,
394
30, 60,
181, 274,
394
Remarks
(a): Outdoor/field application (F) or glasshouse/protected/indoor application (G)
3.1.2.3. Magnitude of residues
The magnitude of dimethomorph residues was investigated on carrots, spinach and beans as following
crops sowed within 30 days after the last application of the active substance on potatoes treated three
times at an application rate of 0.18 kg a.s./ha. Dimethomorph residues were generally below the LOQ
(0.01 mg/kg) except in some circumstances (for instance, in dry beans or in case of early harvest of
carrots or spinach). The highest residues were found to be 0.09 mg/kg and 0.21 mg/kg in spinach
samples proceeding from two different trials and analysed 72 and 76 days after the last treatment,
respectively (EFSA, 2006). Thus, EFSA concludes that the need for a plant-back restriction should be
considered at national level before granting an authorization of dimethomorph. The applicant under
Directive 91/414/EEC informed the RMS that a field rotational crop study is ongoing but this study
cannot be considered by EFSA as long as it is not finalised.
3.2.
Nature and magnitude of residues in livestock
3.2.1.
Dietary burden of livestock
Dimethomorph is authorised for use on several crops that might be fed to livestock. The median and
maximum dietary burdens were therefore calculated for the different types of livestock using the
agreed European methodology (EC, 1996). The input values for all relevant commodities have been
selected according to the latest recommendations of the JMPR on this matter (FAO, 2009) and are
summarized in the Table 3-5. For orange pomace, a default processing factor has been included in the
calculation in order to consider potential concentration of residues in this commodity. For rape seed
meal, however, no default processing factor was applied because dimethomorph is applied as a seed
EFSA Journal 2011;9(8):2348
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Review of the existing MRLs for dimethomorph
treatment and residues are expected to be below the LOQ. Concentration of residues in these
commodities is therefore not expected.
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
Orange pomace
0.48
Median residue x 2.5
0.48
Median residue x 2.5
Potatoes
0.05
Median residue
0.05
Highest residue
Rape seed
0.02
Median residue
0.02
Median residue
Rape seed (meal)
0.02
Median residue
0.02
Median residue
The results of the calculations are reported in Table 3-6, indicating a significant intake for ruminant
and pigs (exceeding the trigger value of 0.1 mg/kg DM feed). No significant intake was identified for
poultry.
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
?
Dairy ruminants
0.012
0.012
Potatoes
0.32
Yes
Meat ruminants
0.036
0.036
Potatoes
0.83
Yes
Poultry
0.004
0.004
Potatoes
0.07
No
Pigs
0.008
0.008
Potatoes
0.20
Yes
3.2.2.
Nature of residues
The nature of dimethomorph residues in commodities of animal origin was investigated in the
framework of Directive 91/414/EEC (EFSA, 2006). Reported metabolism studies include studies in
lactating goats and laying hens using 14C-phenyl labelled dimethomorph.
Lactating goats were dosed at 1 mg/kg bw/d, corresponding to an approximate dietary burden of 25
mg/kg diet. Total radioactive residues (TRR) were readily and almost completely extractable in edible
tissues and were present at the highest levels in liver (7 mg/kg). TRR in the other organs were ranging
from 0.04 mg/kg (muscle) to 0.3 mg/kg (kidneys). No sign of accumulation was present. The major
component of the extractable residue in kidney, liver, muscle and fat was the unchanged parent
compound, representing 9, 72, 7 and 75 % of the TRR in these tissues respectively. Metabolites Z67
and Z69 (see Appendix E) were also detected in liver, indicating that dimethomorph in the lactating
goat is initially metabolised via demethylation of one of the phenolic methoxy-groups. Additional
EFSA Journal 2011;9(8):2348
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Review of the existing MRLs for dimethomorph
metabolic processes involve morpholine-ring cleavage and degradation, leading to metabolite CUR
711719 which is the only compound identified in milk, representing 48 % of the TRR (EFSA, 2006).
Laying hens received a daily dose of 4 mg/kg bw, corresponding to dietary burden of 40 mg/kg diet.
TRR in edible tissues ranged from 0.016 mg/kg (muscle) to 1.05 mg/kg (liver). Extractability of
residues was high and parent compound was present in fat only. The metabolic pattern observed in
tissues indicates that the degradation pathway in laying hens is similar to that observed in goat, being
based on demethylation of the phenolic methoxy-groups and on degradation of the morpholine ring
(EFSA, 2006).
Based on these findings, the peer review concluded that the parent compound is a valid indicator in
livestock, except for milk and poultry products, where metabolites CUR 7117 and the sum of
metabolites Z67 and Z69, respectively, seem more appropriate (EFSA, 2006). However, given the low
dietary burdens calculated in the framework of this review, in particular for poultry and dairy
ruminants, the relevant residue definition in products of animal origin is dimethomorph, both for
enforcement and risk assessment. It must be kept in mind that this definition should be revised for
milk and poultry products in case of animal exposure significantly exceeding the trigger value of 0.1
mg/kg DM in feed. These conclusions reached by EFSA reflect the views of the RMS and are also in
line with those of the JMPR (FAO, 2007). Validated methods are available for enforcement of the
proposed residue definition.
3.2.3.
Magnitude of residues
During the peer review of Directive 91/414/EEC the magnitude of dimethomorph residues in
livestock was investigated in a feeding study in dairy cows (EFSA, 2006). Dimethomorph was
administered twice daily at level doses equivalent to 0.5, 150 and 500 mg/cow/day for 4 or 5 weeks.
Results of the livestock feeding study are summarized in Table 3-7. Levels of dimethomorph Z67,
Z69 and CUR 7117 (see Appendix E) were measured in all commodities but only the levels of
dimethomorph are reported in the table as it is the only compound considered in the residue
definition. Levels of the parent compound were all below the LOQ of 0.01 mg/kg, except at the
highest dosing levels in fat and liver where dimethomorph levels amounted to 0.04 and 0.05 mg/kg,
respectively.
Storage stability of dimethomorph in commodities of animal origin was evaluated under the peer
review of Directive 91/414/EEC (Germany, 2004). Dimethomorph was stable in milk and animal
tissues for up to 16 months when stored deep frozen. No storage stability study was performed on
poultry eggs. The storage conditions of samples of livestock feeding study were not reported.
Consequently, considering the livestock dietary burden of pigs and ruminants, it is expected that
residues in ruminant and swine products will not exceed the enforcement LOQ of 0.01 mg/kg. For
poultry, there is no need to derive MRLs because a significant exposure to dimethomorph residues is
not expected.
19
N-[3-(4-chlorophenyl)-3-3,4-dimethoxyphenyl)-1-oxo-2-propenyl-glycine (see Appendix E)
EFSA Journal 2011;9(8):2348
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Review of the existing MRLs for dimethomorph
Table 3-7: Overview of the values derived from the livestock feeding studies
Livestock
Dietary burden
Median
(mg/kg
bw/d)
Commodity
Max
(mg/kg
bw/d)
Results of livestock feeding study
Dose
level
(mg/kg
bw/d)
No
of
samples
Result for
enforcement
Mean
Max
(mg/kg)
(mg/kg)
Result for risk
assessment
Mean
Max
(mg/kg)
(mg/kg)
Median
residue
(mg/kg)
Highest
residue
(mg/kg)
MRL
proposal
CF
<0.01
<0.01
0.01*
1.0
<0.01
<0.01
0.01*
1.0
<0.01
<0.01
0.01*
1.0
<0.01
<0.01
0.01*
1.0
<0.01
<0.01
0.01*
1.0
Residue definition for enforcement and risk assessment: dimethomorph
Dairy
ruminants
Meat
ruminants
Pig (1)
0,004
0,009
0,004
0,009
Milk
Muscle/
Meat
Fat
Liver
Kidney
0,094
3
<0.02
n.a
<0.02
n.a
0,280
3
<0.02
n.a
<0.02
n.a
0,940
6
<0.02
n.a
<0.02
n.a
0,094
3
<0.02
<0.02
<0.02
<0.02
0,280
3
<0.02
<0.02
<0.02
<0.02
0,940
6
<0.02
<0.02
<0.02
<0.02
0,094
3
<0.02
<0.02
<0.02
<0.02
0,280
3
<0.02
<0.02
<0.02
<0.02
0,940
6
0.02
0.04
0.02
0.04
0,094
3
<0.02
<0.02
<0.02
<0.02
0,280
3
<0.02
<0.02
<0.02
<0.02
0,940
6
0.02
0.05
0.02
0.05
0,094
3
<0.02
<0.02
<0.02
<0.02
0,280
3
<0.02
<0.02
<0.02
<0.02
0,940
6
<0.02
<0.02
<0.02
<0.02
n.a.: not applicable – only the mean values are considered for calculating MRLs in milk
(*): Indicates that the MRL is set at the limit of analytical quantification
(1): The feeding studies were carried out with ruminants; according to the metabolism pathway, an extrapolation between ruminant and pig is acceptable
EFSA Journal 2011;9(8):2348
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Review of the existing MRLs for dimethomorph
4.
Consumer risk assessment
In the framework of this review, only the uses of dimethomorph reported by the RMS in Appendix A
were considered but the use of dimethomorph was previously also assessed by the JMPR (FAO,
2007). The CXLs, resulting from this assessment 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 and acute 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, 2007).
Input values for the intake calculations were derived in compliance with Appendix D and are
summarized in Table 4-1. The median residue and highest residue values selected for chronic and
acute intake calculations are based on the residue levels in the raw agricultural commodities. The
contributions of other commodities, for which no MRL was derived in the framework of this review,
were not included in the calculation.
Table 4-1: Input values for the consumer risk assessment (without consideration of CXLs)
Commodity
Chronic risk assessment
Input value
(mg/kg)
Comment
Acute risk assessment
Input value
(mg/kg)
Comment
Risk assessment residue definition: dimethomorph (sum of isomers)
Oranges
0.19
Median residue(1)
0.61
Highest residue(1)
Table and wine grapes
0.59
Median residue(1)
2.30
Highest residue(1)
Strawberries
0.13
Median residue(1)
0.51
Highest residue(1)
Blackberries
0.05
EU MRL (3)
0.05
EU MRL (3)
Raspberries
0.05
EU MRL (3)
0.05
EU MRL (3)
Potatoes
0.05
Median residue(1)
0.05
Highest residue(1)
Radishes
0.27
Median residue(1)
0.63
Highest residue(1)
Garlic
0.05
Median residue(1)
0.1
Highest residue(1)
Onions
0.05
Median residue(1)
0.1
Highest residue(1)
Shallots
0.05
Median residue(1)
0.1
Highest residue(1)
Spring onions
0.02
Median residue(1)
0.09
Highest residue(1)
Tomatoes
0.27
Median residue(1)
0.74
Highest residue(1)
Peppers
0.09
Median residue(1)
0.33
Highest residue(1)
Aubergines (egg plants)
0.09
Median residue(1)
0.19
Highest residue(1)
Cucurbits with edible peel
0.21
Median residue(1)
0.39
Highest residue(1)
Melons
0.06
Median residue(1)
0.29
Highest residue(1)
Flowering brassica
0.02
Median residue(1)
0.04
Highest residue(1)
EFSA Journal 2011;9(8):2348
29
Review of the existing MRLs for dimethomorph
Commodity
Chronic risk assessment
Acute risk assessment
Input value
(mg/kg)
Comment
Input value
(mg/kg)
Comment
Kohlrabi
0.02
Median residue(1)
0.02
Highest residue(1)
Lamb’s lettuce
1.27
Median residue(1)
7.06
Highest residue(1)
Lettuce
1.27
Median residue(1)
7.06
Highest residue(1)
Scarole (broad-leaf endive)
1.27
Median residue(1)
7.06
Highest residue(1)
0.02
Median residue
(fall-back MRL) (5)
0.06
Highest residue
(fall-back MRL) (5)
Cress
1.27
Median residue(1)
7.06
Highest residue(1)
Land cress
1.27
Median residue(1)
7.06
Highest residue(1)
Rocket, Rucola
1.27
Median residue(1)
7.06
Highest residue(1)
Red mustard
1.27
Median residue(1)
7.06
Highest residue(1)
Leaves and sprouts of
Brassica spp
1.27
Median residue(1)
7.06
Highest residue(1)
Spinach
0.02
Median residue
(tentative)(2)
0.02
Highest residue
(tentative)(2)
Witloof
0.03
Median residue(1)
0.03
Highest residue(1)
Fresh herbs
1.27
Median residue(1)
7.06
Highest residue(1)
Beans (fresh, without pods)
0.02
Median residue(1)
0.02
Highest residue(1)
Peas (fresh, without pods)
0.01
Median residue(1)
0.07
Highest residue(1)
Globe artichokes
0.26
Median residue(1)
1.14
Highest residue(1)
Leek
0.19
Median residue(1)
0.69
Highest residue(1)
Poppy seed
0.02
Median residue(1)
0.02
Highest residue(1)
Rape seed
0.02
Median residue(1)
0.02
Highest residue(1)
Hops (dried),
20.00
Median residue(1)
42.00
Highest residue(1)
Swine meat, liver and kidneys
0.01
Median (=LOQ)(4)
0.01
Highest (=LOQ)(4)
Swine fat
0.01
Median (=LOQ)(4)
0.01
Highest (=LOQ)(4)
Ruminant meat, liver and
kidneys
0.01
Median (=LOQ)(4)
0.01
Highest (=LOQ)(4)
Ruminant fat
0.01
Median (=LOQ)(4)
0.01
Highest (=LOQ)(4)
Milk
0.01
Median (=LOQ)(4)
0.01
Highest (=LOQ)(4)
(1): At least one relevant GAP reported by the RMS is fully supported by data for this commodity; the risk assessment
values derived in section 3 are used for the exposure calculations.
(2): Use reported by the RMS is not fully supported by data but the risk assessment values derived in section 3 are used for
indicative exposure calculations.
(3): Use reported by the RMS is not fully supported by data; the existing EU MRL is used for indicative exposure
calculations.
(4): Livestock dietary burden resulting from the GAPs reported by the RMS is fully supported by data for this commodity;
the risk assessment values derived in section 3 are used for the exposure calculations.
(5): Most critical GAP leads to an exceedance of the ARfD for this commodity but a fall-back GAP is sufficiently supported
by data; the risk assessment values derives in section 3 are used for the exposure calculations.
EFSA Journal 2011;9(8):2348
30
Review of the existing MRLs for dimethomorph
The calculated exposures were compared with the toxicological reference values derived for
dimethomorph (see Table 2-1); detailed results of the calculations are presented as EU scenario 1 in
Appendix B.1. The highest chronic exposure was calculated for the WHO Cluster diet B, representing
6.7 % of the ADI. With regard to the acute exposure, however, an exceedance of the ARfD was
identified for scarole, representing 102.9 % of the ARfD. A second exposure calculation was
therefore performed considering a fall-back MRL of 0.1 mg/kg for scarole based on the use of
dimethomorph in northern Europe (see Table 3-1). According to the results of this second calculation
(see Appendix B.2 – EU scenario 2), the highest chronic exposure declined to 6.6 % of the ADI for
WHO Cluster diet B; the highest acute exposure is then calculated for lettuce, representing 31.7 % of
the ARfD.
Based on the above calculations, EFSA concludes that the use of dimethomorph on crops fully
supported by data (footnote 1 in Table 4-1), is acceptable with regard to consumer exposure, except
for the indoor use on scarole. For all remaining crops, major uncertainties remain due to the data gaps
identified in section 3, but considering the tentative MRL or existing EU MRLs in the exposure
calculation did not indicate a risk to consumers.
It is noted by EFSA that the above risk assessment was performed disregarding the possible impact of
the isomer ratios due to plant or livestock metabolism. Considering however that the specified E/Z
isomer ratio of the active substance is 44/56 and that toxicological studies have been carried out
according to these specifications (EFSA, 2006), a change of isomer ratios in the residue might, in the
worst case situation, to a duplication of the toxicological burden of the residue. As the ADI and ARfD
exhaustions calculated in Appendix B.2 amounted to less than 50 %, EFSA concludes that the
potential change of isomer ratios in the final residue will not be of concern for the uses supported in
the framework of this review, except for the indoor use on scarole. In case future uses of
dimethomorph would lead to a higher consumer exposure, further information regarding the impact of
plant and livestock metabolism on the isomer ratio might be required.
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.
Table 4-2: Input values for the consumer risk assessment (with consideration of CXLs)
Commodity
Chronic risk assessment
Input value
(mg/kg)
Comment
Acute risk assessment
Input value
(mg/kg)
Comment
Risk assessment residue definition : dimethomorph (sum of isomers)
Oranges
0.19
Median residue (1)
0.61
Highest residue (1)
Table and wine grapes
0.59
Median residue (1)
2.30
Highest residue (1)
Strawberries
0.13
Median residue (1)
0.51
Highest residue (1)
Blackberries
0.05
EU MRL(3)
0.05
EU MRL(3)
Raspberries
0.05
EU MRL(3)
0.05
EU MRL(3)
Pineapples
0.01
Median (CXL) (4)
0.01
Highest (CXL) (4)
Potatoes
0.05
Median residue (1)
0.05
Highest residue (1)
EFSA Journal 2011;9(8):2348
31
Review of the existing MRLs for dimethomorph
Commodity
Chronic risk assessment
Acute risk assessment
Input value
(mg/kg)
Comment
Input value
(mg/kg)
Comment
Radishes
0.27
Median residue(1)
0.63
Highest residue(1)
Garlic
0.05
Median residue (1)
0.10
Highest residue (1)
Onions
0.05
Median residue(1)
0.10
Highest residue(1)
Shallots
0.05
Median residue (1)
0.10
Highest residue (1)
Spring onions
0.02
Median residue(1)
0.09
Highest residue(1)
Tomatoes
0.27
Median residue(1)
0.74
Highest residue(1)
Peppers
0.22
Median (CXL) (4)
0.56
Highest (CXL) (4)
Aubergines (egg plants)
0.22
Median (CXL) (4)
0.56
Highest (CXL) (4)
Okra, lady’s fingers
0.22
Median (CXL) (4)
0.56
Highest (CXL) (4)
Cucurbits with edible peel
0.21
Median residue(1)
0.39
Highest residue(1)
Melons
0.04
Median (CXL) (4)
0.24
Highest (CXL) (4)
Pumpkins
0.02
Median (CXL) (4)
0.12
Highest (CXL) (4)
Watermelons
0.02
Median (CXL) (4)
0.12
Highest (CXL) (4)
Broccoli
0.19
Median (CXL) (4)
0.52
Highest (CXL) (4)
Cauliflower
0.02
Median residue(1)
0.04
Highest residue(1)
Head cabbage
0.40
Median (CXL) (4)
1.40
Highest (CXL) (4)
Kohlrabi
0.02
Median residue (1)
0.02
Highest residue (1)
Lamb's lettuce
3.35
Median (CXL) (4)
7.10
Highest (CXL) (4)
Lettuce
3.60
Median (CXL) (4)
7.20
Highest (CXL) (4)
Scarole (broad-leaf endive)
0.02
Median residue (1)
0.06
Highest residue (1)
Cress
1.27
Median residue(1)
7.06
Highest residue(1)
Land cress
1.27
Median residue(1)
7.06
Highest residue(1)
Rocket, Rucola
1.27
Median residue(1)
7.06
Highest residue(1)
Red mustard
1.27
Median residue(1)
7.06
Highest residue(1)
Leaves and sprouts of Brassica
spp
1.27
Median residue(1)
7.06
Highest residue(1)
Spinach
0.02
Median residue
(tentative)(2)
0.02
Highest residue
(tentative)(2)
Witloof
0.03
Median residue(1)
0.03
Highest residue(1)
Fresh herbs
1.27
Median residue(1)
7.06
Highest residue(1)
Beans (fresh, without pods)
0.02
Median residue(1)
0.02
Highest residue(1)
Peas (fresh, without pods)
0.01
Median residue(1)
0.07
Highest residue(1)
Globe artichokes
0.26
Median residue(1)
1.14
Highest residue(1)
Leek
0.19
Median residue(1)
0.69
Highest residue(1)
Poppy seed
0.02
Median residue(1)
0.02
Highest residue(1)
Rape seed
0.02
Median residue(1)
0.02
Highest residue(1)
EFSA Journal 2011;9(8):2348
32
Review of the existing MRLs for dimethomorph
Commodity
Chronic risk assessment
Acute risk assessment
Input value
(mg/kg)
Comment
Input value
(mg/kg)
Comment
Hops (dried)
26.00
Median (CXL) (4)
42.00
Highest (CXL) (4)
Swine meat, liver and kidneys
0.01
Median (=LOQ)(5)
0.01
Highest (=LOQ)(5)
Swine fat
0.01
Median (=LOQ)(5)
0.01
Highest (=LOQ)(5)
Ruminant meat, liver and
kidneys
0.01
Median (=LOQ)(5)
0.01
Highest (=LOQ)(5)
Ruminant fat
0.01
Median (=LOQ)(5)
0.01
Highest (=LOQ)(5)
Poultry meat and liver
0.01
Median (CXL) (4)
0.01
Highest (CXL) (4)
Poultry fat
0.01
Median (=LOQ)(5)
0.01
Highest (=LOQ)(5)
Bird’s eggs
0.01
Median (CXL) (4)
0.01
Highest (CXL) (4)
Milk
0.01
Median (=LOQ)(5)
0.01
Highest (=LOQ)(5)
(1): At least one relevant GAP reported by the RMS is fully supported by data for this commodity; the risk assessment
values derived in section 3 are used for the exposure calculations.
(2): Use reported by the RMS is not fully supported by data but the risk assessment values derived in section 3 are used for
indicative exposure calculations.
(3): Use reported by the RMS is not fully supported by data; the existing EU MRL is used for indicative exposure
calculations.
(4): CXL is supported by data; the corresponding risk assessment values are used for the exposure calculations.
(5): Livestock dietary burden resulting from the GAPs reported by the RMS is fully supported by data for this commodity;
the risk assessment values derived in section 3 are used for the exposure calculations
Chronic and acute exposure calculations were also performed using revision 2 of the EFSA PRIMo
and calculated exposures were compared with the toxicological reference values derived for
dimethomorph (see Table 2-1); detailed results of the calculations are presented in as EU/Codex
scenario in Appendix B.3. The highest chronic exposure was calculated for WHO Cluster diet B,
representing 8.8 % of the ADI, and the highest acute exposure was calculated for lettuce, representing
32.3 % of the ARfD.
It is also noted that at EU level the GAP on hops result in an MRL of 50 mg/kg while the CAC
established a CXL at 80 mg/kg based on the same GAP and residues trials. This difference is mainly
due to the different approaches of the EU and JMPR for calculating MRLs. Nevertheless, EFSA
proposes to implement the value of 80 mg/kg because this is an international recommendation that
was agreed upon by the EU.
Also in this case, the above risk assessment was performed disregarding the possible impact of the
isomer ratios due to plant or livestock metabolism. The same considerations as those detailed in
section 4.1 apply.
EFSA Journal 2011;9(8):2348
33
Review of the existing MRLs for dimethomorph
CONCLUSIONS AND RECOMMENDATIONS
CONCLUSIONS
The toxicological profile of dimethomorph was evaluated in the framework of Directive 91/414/EEC,
which resulted in an ADI of 0.05 mg/kg bw/d and an ARfD of 0.6 mg/kg bw.
Primary crop metabolism was investigated after foliar applications of dimethomorph in grapes (fruit
and fruiting vegetables), potatoes (root and tuber vegetables) and lettuce (leafy vegetables) and
following application through a hydroponic system in tomatoes. Metabolic patterns in the different
studies were shown to be similar and representative for all uses supported in the framework of this
review. Metabolism in lactating ruminants and laying hens was sufficiently investigated and findings
can be extrapolated to pigs as well. The relevant residue definition for both enforcement and risk
assessment in all plant commodities and in foods of animal origin was therefore defined as
dimethomorph.
Dimethomorph (sum of isomers) can be enforced in food of plant origin with an LOQ of 0.01 mg/kg
in high water content, dry and acidic commodities, 0.02 mg/kg in high fat content commodities and
0.2 mg/kg in hops as well as in food of animal origin with an LOQ of 0.01 mg/kg in milk, meat, fat,
kidney, liver and eggs.
Regarding the magnitude of residues in primary crops, the available residues data are considered
sufficient to derive adequate MRL proposals as well as adequate risk assessment values for most of
the commodities under evaluation, except for spinach where the MRL derived is tentative only and for
blackberries and raspberries, where the available data were insufficient to derive tentative MRLs. It
should also be noted that the MRL and risk assessment values derived for melons, cucurbits with
edible peel, peppers and poppy seed are resulting from one of the reported uses only while data
requirements may still apply to the remaining uses.
In processed commodities, dimethomorph was shown to be stable during pasteurisation, baking,
boiling, brewing and sterilisation. Studies investigating the magnitude of residues in some processed
products are also available but in most cases they only allowed EFSA to derive indicative processing
factors. For enforcement purposes, only the following robust processing factors could be derived:
Oranges, peeled:
0.13
Wine grapes, dry pomace:
2.6
Wine grapes, red wine (unheated):
0.31
Wine grapes, white wine:
0.30
Hops, beer:
0.002
Further processing studies are not required because they are not expected to affect the outcome of the
risk assessment. However, if there would be the intention from risk managers to derive more
processing factors for enforcement purposes, additional processing studies might be required.
The potential incorporation of soil residues into succeeding and rotational crops was investigated in
wheat, radishes, carrots, lettuce and soybean. These studies showed a comparable metabolism patterns
in primary and succeeding crops. However, occurrence of parent dimethomorph in dry beans or in
case of early harvest of carrots or spinach was demonstrated. A plant-back restriction at national level
when granting an authorization of dimethomorph is therefore recommended.
Based on the uses reported by the RMS, significant intakes were calculated for dairy ruminant, meat
ruminants and pigs. The RMS reported a livestock feeding study on dairy cows, which demonstrated
that residues of dimethomorph are not expected in significant amounts and MRLs in pigs and
ruminants can be set at the LOQ. For poultry products no MRLs are required because there is no
significant exposure of poultry to dimethomorph residues.
EFSA Journal 2011;9(8):2348
34
Review of the existing MRLs for dimethomorph
Both chronic and acute consumer exposure resulting from the MRLs proposed in the framework of
this review were calculated and an exceedance of the ARfD was identified for scarole, representing
102.9 % of the ARfD. Considering the fall-back MRL for scarole resulting from the northern
European GAP, the highest chronic exposure represented 6.6 % of the ADI (WHO Cluster diet B) and
the highest acute exposure amounted to 31.7 % of the ARfD (lettuce).
Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs
have also been established for dimethomorph. Additional calculations of the consumer exposure,
including these CXLs, were therefore performed. The highest chronic exposure represented 8.8 % of
the ADI (WHO Cluster diet B) and the highest acute exposure amounted to 32.3 % of the ARfD
(lettuce).
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 as
‘Recommended’ in the table 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:
4 trials complying with the northern outdoor GAP on blackberries or raspberries;
2 trials complying with the northern outdoor GAP on spinach;
It is highlighted that some of the recommended MRLs resulted 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 validity of the
recommended MRLs but which might have an impact on national authorisations:
8 trials complying with the indoor GAP on melons;
8 trials complying with the southern outdoor GAP on pepper unless it is demonstrated that the
outdoor use is less critical than the indoor use, then, the number of residues trials may be
reduced;
2 trials complying with the southern outdoor GAP on poppy seeds.
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 actions are therefore considered desirable but not essential:
a detailed review of the analytical method in commodities of animal origin.
EFSA Journal 2011;9(8):2348
35
Review of the existing MRLs for dimethomorph
Code
number
Commodity
Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
Enforcement residue definition: dimethomorph (sum of isomers)
0.8
-
0.8
Recommended(a)
Table grapes
3
2
3
Recommended(b)
0151020
Wine grapes
3
2
3
Recommended(b)
0152000
Strawberries
0.7
0.05
0.7
Recommended(b)
0153010
Blackberries
0.05*
-
0.05
Further consideration needed(c)
0153030
Raspberries
0.05*
-
0.05
Further consideration needed(c)
0163080
Pineapples
0.05*
0.01*
0.01*
Recommended(d)
0211000
Potatoes
0.5
0.05
0.05
Recommended(b)
0213080
Radishes
1
-
1.5
Recommended(a)
0220010
Garlic
0.15
-
0.15
Recommended(a)
0220020
Onions
0.15
-
0.15
Recommended(a)
0220030
Shallots
0.15
-
0.15
Recommended(a)
0220040
Spring onions
0.3
-
0.2
Recommended(a)
0231010
Tomatoes
1
1
1
Recommended(b)
0231020
Peppers
0.50
1
1
Recommended(e)
0231030
Aubergines (egg plants)
0.3
1
1
Recommended(e)
0231040
Okra, lady’s fingers
0.05*
1
1
Recommended(d)
0232010
Cucumbers
1
0.5
0.5
Recommended(b)
0232020
Gherkins
1
0.5
0.5
Recommended(b)
0232030
Courgettes
1
0.5
0.5
Recommended(b)
0233010
Melons
1
0.5
0.5
Recommended(e)
0233020
Pumpkins
0.05*
0.5
0.5
Recommended(d)
0233030
Watermelons
0.05*
0.5
0.5
Recommended(d)
0241010
Broccoli
0.05*
1
1
Recommended(e)
0241020
Cauliflower
0.05*
-
0.05
Recommended(a)
0242020
Head cabbage
0.05*
2
2
Recommended(d)
0244000
Kohlrabi
0.05*
0.02
0.02
Recommended(b)
0251010
Lamb's lettuce
10
10
10
Recommended(e)
0251020
Lettuce
10
10
10
Recommended(e)
0251030
Scarole (broad-leaf endive)
1
-
0.1
Recommended(a)
0251040
Cress
10
-
10
Recommended(a)
0251050
Land cress
10
-
10
Recommended(a)
0251060
Rocket, Rucola
10
-
10
Recommended(a)
0251070
Red mustard
10
-
10
Recommended(a)
0110020
Oranges
0151010
EFSA Journal 2011;9(8):2348
36
Review of the existing MRLs for dimethomorph
Code
number
Commodity
Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
MRL
(mg/kg)
Comment
Recommended(a)
0251080
Leaves and sprouts of
Brassica spp. including
turnip greens
10
-
10
0252010
Spinach
0.1
-
0.05
Further consideration needed(f)
0255000
Witloof
10
-
0.05
Recommended(a)
0256000
Herbs
10
-
10
Recommended(a)
0260020
Beans (fresh, without
pods)
0.05*
-
0.04
Recommended(a)
0260040
Peas (fresh, without pods)
0.1
-
0.1
Recommended(a)
0270050
Globe artichokes
2
-
2
Recommended(a)
0270060
Leek
1.5
-
1.5
Recommended(a)
0401030
Poppy seed
0.05*
-
0.02*
Recommended(a)
0401060
Rape seed
0.05*
-
0.02*
Recommended(a)
0700000
Hops (dried)
50
80
80
Recommended(e)
1011010
Swine meat
0.05*
0.01*
0.01*
Recommended(b)
1011020
Swine fat (free of lean
meat)
0.05*
0.01*
0.01*
Recommended(b)
1011030
Swine liver
0.05*
0.01*
0.01*
Recommended(b)
1011040
Swine kidney
0.05*
0.01*
0.01*
Recommended(b)
1012010
Bovine meat
0.05*
0.01*
0.01*
Recommended(b)
1012020
Bovine fat
0.05*
0.01*
0.01*
Recommended(b)
1012030
Bovine liver
0.05*
0.01*
0.01*
Recommended(b)
1012040
Bovine kidney
0.05*
0.01*
0.01*
Recommended(b)
1013010
Sheep meat
0.05*
0.01*
0.01*
Recommended(b)
1013020
Sheep fat
0.05*
0.01*
0.01*
Recommended(b)
1013030
Sheep liver
0.05*
0.01*
0.01*
Recommended(b)
1013040
Sheep kidney
0.05*
0.01*
0.01*
Recommended(b)
1014010
Goat meat
0.05*
0.01*
0.01*
Recommended(b)
1014020
Goat fat
0.05*
0.01*
0.01*
Recommended(b)
1014030
Goat liver
0.05*
0.01*
0.01*
Recommended(b)
1014040
Goat kidney
0.05*
0.01*
0.01*
Recommended(b)
1016010
Poultry meat
0.05*
0.01*
0.01*
Recommended(d)
1016010
Poultry fat
0.05*
0.01*
0.01*
Recommended(d)
1016030
Poultry liver
0.05*
0.01*
0.01*
Recommended(d)
1020010
Cattle milk
0.05*
0.01*
0.01*
Recommended(b)
1020020
Sheep milk
0.05*
0.01*
0.01*
Recommended(b)
1020030
Goat milk
0.05*
0.01*
0.01*
Recommended(b)
EFSA Journal 2011;9(8):2348
37
Review of the existing MRLs for dimethomorph
Code
number
1030000
Commodity
Birds' eggs
Other products of plant
and animal origin
Existing
EU MRL
(mg/kg)
Existing
CXL
(mg/kg)
Outcome of the review
0.05*
0.01*
0.01*
See App
C
-
-
MRL
(mg/kg)
Comment
Recommended(d)
Further consideration needed(g)
(*): 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): 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).
(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): 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).
(e): 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 fully supported by data, leads to a lower MRL (combination G-VII 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; no CXL is available (combination E-I in Appendix D).
(g): 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).
DOCUMENTATION PROVIDED TO EFSA
1.
Pesticide Residues Overview File (PROFile) on dimethomorph prepared by the rapporteur
Member State Germany in the framework of Article 12 of Regulation (EC) No 396/2005.
Submitted to EFSA on 18 December 2008. Last updated on 05 November 2009.
REFERENCES
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.
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/95rev.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
EFSA Journal 2011;9(8):2348
38
Review of the existing MRLs for dimethomorph
EC (European Commission), 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95rev.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), 2006. Conclusion on the peer review of the pesticide risk
assessment of the active substance dimethomorph. EFSA Scientific Report (2006) 82, 1-69.
EFSA (European Food Safety Authority), 2007. 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), 2009. Modification of the existing MRLs for dimethomorph
in peas (without pods) and leeks. EFSA Journal 2009;7(12):1434, [22 pp.]
doi:10.2903/j.efsa.2009.1434. Available online: www.efsa.europa.eu/efsajournal.htm
EFSA (European Food Safety Authority), 2010. Modification of the existing MRLs for dimethomorph
in various crops. EFSA Journal 2010;8(5):1622, [25 pp.] doi:10.2903/j.efsa.2010.1622. Available
online: www.efsa.europa.eu/efsajournal.htm
EFSA (European Food Safety Authority), 2011a. Modification of the existing MRLs for
dimethomorph in strawberries and lamb’s lettuce. EFSA Journal 2011;9(1):1978 [29 pp.].
doi:10.2903/j.efsa.2011.1978. Available online: www.efsa.europa.eu/efsajournal.htm
EFSA (European Food Safety Authority), 2011b. Modification of the existing MRLs for
dimethomorph in various commodities. EFSA Journal 2011;9(5):2165 [36 pp.].
doi:10.2903/j.efsa.2011.2165. Available online: www.efsa.europa.eu/efsajournal.htm
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), 2007. Dimethomorph. In: Pesticide
residues in food – 2007. 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
191.
Available
online:
http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/jmpr/jmpr-rep/en/
EFSA Journal 2011;9(8):2348
39
Review of the existing MRLs for dimethomorph
FAO (Food and Agriculture Organization of the United Nations), 2007. Dimethomorph. In: Pesticide
residues in food – 2007. Evaluations. Part I. Residues. FAO Plant Production and Protection Paper
225.
Available
online:
http://www.fao.org/agriculture/crops/corethemes/theme/pests/pm/jmpr/jmpr-rep/en/
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 dimethomorph, May
2011.
Germany, 2004. Draft assessment report on the active substance dimethomorph prepared by the
rapporteur Member State Germany in the framework of Council Directive 91/414/EEC, May 2004
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 dimethomorph, May
2011.
United Kingdom, 2010. O/L (RR) stream application for ‘Invader’ (mancozeb and dimethomorph) for
use as a fungicide on various crops. Residues Filenote, September 2010.
EFSA Journal 2011;9(8):2348
40
Review of the existing MRLs for dimethomorph
APPENDIX A – GOOD AGRICULTURAL PRACTICES (GAPS)
Critical Outdoor GAPs for Northern Europe
Crop
Formulation
Region
Common name
Scientific name
Outdoor/
Indoor
Member state or
Country
Application
Content
Pests controlled
Method
Conc.
Application rate
Growth stage
Type
Unit
From
BBCH
Until
BBCH
Number
Interval (days)
Min. rate
Min.
Max.
Min.
Max. rate
Rate Unit
Max.
PHI or
wiaiting
period
(days)
Table grapes
Vitis euvitis
NEU
Outdoor
DE
Downy mildew
(Plasmopara viticola
DC
150.0
g/L
Foliar treatment - spraying
75
6
0.07
0.29
kg a.i./ha
28
Wine grapes
Vitis euvitis
NEU
Outdoor
DE
Downy mildew
(Plasmopara viticola
DC
150.0
g/L
Foliar treatment - spraying
75
6
0.07
0.29
kg a.i./ha
28
Strawberries
Fragaria x ananassa
NEU
Outdoor
BE
fungal diseases
WP
500.0
g/L
Local treatment - drenching
3
0.05
g a.i./unit
n.a.
Blackberries
Rubus fruticosus
NEU
Outdoor
BE
fungal diseases
WP
500.0
g/L
Local treatment - drenching
1
0.50
g a.i./unit
n.a.
Rubus idaeus
NEU
Outdoor
BE
fungal diseases
WP
500.0
g/L
Local treatment - drenching
1
0.50
g a.i./unit
n.a.
NEU
Outdoor
IE
fungal diseases
WP
500.0
g/L
Foliar treatment - spraying
8
0.18
kg a.i./ha
7
NEU
Outdoor
DE, AT
fungal diseases
DC
150.0
g/L
Foliar treatment - spraying
2
0.20
kg a.i./ha
14
Raspberries
Potatoes
Radishes
Swedes
Tuber form Solanum
Spp
Raphanus sativus var.
saitvus
Brassica napus var.
napobrassica
NEU
Outdoor
DE
fungal diseases
DC
150.0
g/L
Foliar treatment - spraying
2
0.18
kg a.i./ha
14
Turnips
Brassica rapa
NEU
Outdoor
DE
fungal diseases
DC
150.0
g/L
Foliar treatment - spraying
2
0.18
kg a.i./ha
14
Garlic
Allium sativum
NEU
Outdoor
Q_2010_00042
Downy mildew
WG
90.0
g/kg
Foliar treatment - spraying
1
3
7
10
0.18
kg a.i./ha
7
Onions
Allium cepa
NEU
Outdoor
Q_2010_00042
Downy mildew
WG
90.0
g/kg
Foliar treatment - spraying
1
3
7
10
0.18
kg a.i./ha
7
Shallots
Allium ascalonicum
(Allium cepa var.
aggregatum)
NEU
Outdoor
Q_2010_00042
Downy mildew
WG
90.0
g/kg
Foliar treatment - spraying
1
3
7
10
0.18
kg a.i./ha
7
Spring onions
Allium cepa
NEU
Outdoor
UK
fungal diseases
WG
75.0
g/kg
Foliar treatment - spraying
0.18
kg a.i./ha
14
0.23
kg a.i./ha
21
0.18
kg a.i./ha
3
13
41
11
89
4
Tomatoes
Lycopersicum
esculentum
NEU
Outdoor
CZ, SK
fungal diseases
WP
500.0
g/L
Foliar treatment - spraying
Aubergines (egg plants)
Solanum melongena
NEU
Outdoor
Q_2010_00042
fungal diseases
EC
72.0
g/L
Foliar treatment - spraying
Cucumbers
Cucumis sativus
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.30
kg a.i./ha
7
Gherkins
Cucumis sativus
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.30
kg a.i./ha
7
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.30
kg a.i./ha
7
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
14
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
14
Courgettes
Broccoli
Cauliflower
Kohlrabi
Cucurbita pepo var.
melopepo
Brassica oleracea var.
italica
Brassica oleracea var.
botrytis
Brassica oleracea
convar. acephala, var.
gongylodes
3
1
3
0.18
7
10
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
0.30
kg a.i./ha
14
Lettuce
Lactuca sativa
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
1
3
0.17
0.18
kg a.i./ha
14
Scarole (broad-leaf
endive)
Cichorium endiva
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
1
3
0.17
0.18
kg a.i./ha
14
Cress
Lepidium sativum
NEU
Outdoor
Q_2010_01482
Downy mildew
WP
50.0
% (w/w)
Foliar treatment - spraying
1
2
7
0.18
kg a.i./ha
14
Land cress
Barbarea verna
NEU
Outdoor
Q_2010_01482
Downy mildew
WP
50.0
% (w/w)
Foliar treatment - spraying
1
2
7
0.18
kg a.i./ha
14
EFSA Journal 2011;9(8):2348
2
Comments (max. 250 charachters)
application rates depending on the
growth stages
- Basis application rate: 0.072 kg
a.i./ha
- Growth stage BBCH 61: 0.144 kg
a.i./ha
- Growth stage BBCH 71: 0.216 kg
a.i./ha
- Growth stage BBCH 75: 0.288 kg
a.i./ha
application rates depending on the
growth stages
- Basis application rate: 0.072 kg
a.i./ha
- Growth stage BBCH 61: 0.144 kg
a.i./ha
- Growth stage BBCH 71: 0.216 kg
a.i./ha
- Growth stage BBCH 75: 0.288 kg
a.i./ha
0,05 g a.i./plant in 100-250 ml water
(unit = 1 plant), in spring when the
growth of the plants is resumed
0,5 g a.i./plant in 200 ml water (unit
= 1 plant), in autumn or spring
during the growth recovery
0,5 g a.i./plant in 200 ml water (unit
= 1 plant), in autumn or spring
during the growth recovery
Trials with another GAP (8 x 0,18
kg/ha - PHI 14d) are also available
Trials with another GAP (8 x 0,18
kg/ha - PHI 14d) are also available
Trials with another GAP (8 x 0,18
kg/ha - PHI 14d) are also available
GAP-UK : 3 x 0,15 kg as/ha - PHI
21d
GAP-UK : 3 x 0,15 kg as/ha - PHI
21d
41
Review of the existing MRLs for dimethomorph
Critical Outdoor GAPs for Northern Europe
Crop
Formulation
Region
Common name
Scientific name
Outdoor/
Indoor
Member state or
Country
Red mustard
Eruca sativa (Diplotaxis
spec.)
Brassica juncea var.
rugosa
Application rate
Growth stage
Type
Method
Conc.
Rocket, Rucola
Application
Content
Pests controlled
Unit
From
BBCH
Until
BBCH
Number
Interval (days)
Min.
Max.
Min.
Min. rate
Max. rate
Rate Unit
0.17
Max.
PHI or
wiaiting
period
(days)
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
1
3
0.18
kg a.i./ha
14
NEU
Outdoor
Q_2010_01482
Downy mildew
WP
50.0
% (w/w)
Foliar treatment - spraying
1
2
7
0.18
kg a.i./ha
14
1
2
7
Leaves and sprouts of
Brassica spp
Brassica spp
NEU
Outdoor
Q_2010_01482
Downy mildew
WP
50.0
% (w/w)
Foliar treatment - spraying
0.18
kg a.i./ha
14
Spinach
Spinacia oleracea
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.30
kg a.i./ha
14
Chervil
Anthriscus cerefolium
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Chives
Allium schoenoprasum
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Celery leaves
Apium graveolens var.
seccalinum
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Parsley
Petroselinum crispum
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Sage
Salvia officinalis
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Rosemary
Rosmarinus officinalis
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Thyme
Thymus spp.
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Basil
Ocimum basilicum
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Bay leaves (laurel)
Laurus nobilis
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Tarragon
Artemisia dracunculus
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
21
Beans (without pods)
Phaseolus vulgaris
NEU
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.18
kg a.i./ha
14
Peas (without pods)
Pisum sativum
NEU
Outdoor
Q_2009_00792
fungal diseases
WG
90.0
g/kg
Foliar treatment - spraying
15
60
2
0.18
kg a.i./ha
21
Globe artichokes
Cynara scolymus
NEU
Outdoor
Q_2010_00042
fungal diseases
EC
72.0
g/L
Foliar treatment - spraying
50
85
0.18
kg a.i./ha
3
Leek
Allium porrum
NEU
Outdoor
Q_2009_00792
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
14
48
3
0.18
kg a.i./ha
14
Poppy seed
Papaver somniferum
NEU
Outdoor
FR
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.18
kg a.i./ha
56
Rape seed
Brassica napus
NEU
Outdoor
DE
Downy mildew
WP
500.0
g/kg
Seed treatment - general (see also
comment field)
1
0.03
kg a.i./ha
n.a.
Hops
Humulus lupulus
NEU
EFSA Journal 2011;9(8):2348
Outdoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
1
3
6
7
8
10
12
0.27
0.60
kg a.i./ha
10
Comments (max. 250 charachters)
GAP-UK : 3 x 0,15 kg as/ha - PHI
21d
GAP-UK : 3 x 0,15 kg as/ha - PHI
21d
seed dressing, 5 g a.i./kg seed, 5
kg seeds/ha
application rates depending on the
growth stages in 1000-4000 l
water/ha, 0.015-0.03 kg as/hl
- up to BBCH 37: 0.27 kg a.i./ha
- up to BBCH 55: 0.4 kg a.i./ha
-.exceeding BBCH 55: 0.6 kg a.i./ha
42
Review of the existing MRLs for dimethomorph
Critical Outdoor GAPs for Southern Europe
Crop
Formulation
Region
Common name
Scientific name
Outdoor/
Indoor
Member state or
Country
Application
Content
Pests controlled
Application rate
Growth stage
Type
Method
Conc.
Unit
From
BBCH
Until
BBCH
85
89
Number
Interval (days)
Min. rate
Min.
Max.
Min.
2,7 kg product/ha
0,014 kg as/hL and 3000 water L/ha
Rate Unit
0.41
kg a.i./ha
7
Citrus sinensis
SEU
Outdoor
Q_2010_01483
fungal diseases
DC
150.0
g/L
Foliar treatment - spraying
Table grapes
Vitis euvitis
SEU
Outdoor
FR
fungal diseases
DC
150.0
g/L
Foliar treatment - spraying
5
0.30
kg a.i./ha
28
Wine grapes
Vitis euvitis
SEU
Outdoor
FR
fungal diseases
DC
150.0
g/L
Foliar treatment - spraying
5
0.30
kg a.i./ha
28
Potatoes
Tuber form Solanum
Spp
SEU
Outdoor
DAR
fungal diseases
WP
500.0
g/L
Foliar treatment - spraying
5
0.18
kg a.i./ha
7
Garlic
Allium sativum
SEU
Outdoor
Q_2010_00042
fungal diseases
WG
90.0
g/kg
Foliar treatment - spraying
1
3
7
10
0.18
kg a.i./ha
7
Onions
Allium cepa
SEU
Outdoor
Q_2010_00042
fungal diseases
WG
90.0
g/kg
Foliar treatment - spraying
1
3
7
10
0.18
kg a.i./ha
7
SEU
Outdoor
Q_2010_00042
fungal diseases
WG
90.0
g/kg
Foliar treatment - spraying
1
3
7
10
0.18
kg a.i./ha
7
SEU
Outdoor
CY, HU, IT, PT
fungal diseases
WP
75.0
g/kg
Foliar treatment - spraying
0.21
kg a.i./ha
3
0.15
kg a.i./ha
7
0.18
kg a.i./ha
3
Tomatoes
Peppers
Allium ascalonicum
(Allium cepa var.
aggregatum)
Lycopersicum
esculentum
Capsicum annuum, var
grossum and var.
longum
SEU
Outdoor
CY
fungal diseases
WP
75.0
g/kg
Foliar treatment - spraying
Aubergines (egg plants)
Solanum melongena
SEU
Outdoor
Q_2010_00042
fungal diseases
EC
72.0
g/L
Foliar treatment - spraying
Cucumbers
Cucumis sativus
SEU
Outdoor
CY, EL
fungal diseases
WP
75.0
g/kg
Courgettes
Cucurbita pepo var.
melopepo
SEU
Outdoor
EL
fungal diseases
WP
75.0
Melons
Cucumis melo
SEU
Outdoor
CY
fungal diseases
WG
Lettuce
Lactuca sativa
SEU
Outdoor
ES
fungal diseases
Peas (without pods)
Pisum sativum
SEU
Outdoor
Q_2010_00042
Globe artichokes
Cynara scolymus
SEU
Outdoor
Leek
Allium porrum
SEU
Outdoor
Poppy seed
Papaver somniferum
SEU
Outdoor
EFSA Journal 2011;9(8):2348
15
Comments (max. 250 charachters)
Max. rate
Max.
Oranges
Shallots
2
PHI or
wiaiting
period
(days)
3
0.18
1
3
1
3
Foliar treatment - spraying
3
4
0.15
0.38
kg a.i./ha
7
g/kg
Foliar treatment - spraying
3
4
0.15
0.38
kg a.i./ha
7
60.0
g/kg
Foliar treatment - spraying
3
0.18
0.21
kg a.i./ha
7
WP
75.0
g/kg
Foliar treatment - spraying
0.23
kg a.i./ha
7
fungal diseases
WG
90.0
g/kg
Foliar treatment - spraying
15
60
0.18
kg a.i./ha
21
Q_2010_00042
fungal diseases
EC
72.0
g/L
Foliar treatment - spraying
50
85
Q_2009_00792
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
14
48
FR
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
11
89
7
10
2
1
3
0.18
kg a.i./ha
3
3
7
10
0.18
kg a.i./ha
14
2
0.18
kg a.i./ha
56
43
Review of the existing MRLs for dimethomorph
Critical Indoor GAPs for Northern and Southern Europe (incl. post-harvest treatments)
Crop
Formulation
Region
Common name
Scientific name
Outdoor/
Indoor
Member state or
Country
Application
Content
Pests controlled
Application rate
Growth stage
Type
Method
Conc.
Unit
From
BBCH
Until
BBCH
Number
Interval (days)
Min. rate
Min.
Max.
Min.
Max. rate
Rate Unit
Max.
PHI or
wiaiting
period
(days)
Comments (max. 250 charachters)
Max rate calculated considering an
application rate of 0.125 g a.s./plant
and 20000-100000 plants grown per
ha
Strawberries
Fragaria x ananassa
NEU/SEU
Indoor
NL
Phytophthora
WP
500.0
g/kg
Local treatment - drenching
1
12.50
kg a.i./ha
35
Radishes
Raphanus sativus var.
saitvus
NEU/SEU
Indoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.30
kg a.i./hL
14
Tomatoes
Lycopersicum
esculentum
NEU/SEU
Indoor
DE
Phytophthora infestans
DC
150.0
g/L
Foliar treatment - spraying
Peppers
Capsicum annuum, var
grossum and var.
longum
NEU/SEU
Indoor
CY
fungal diseases
WP
75.0
g/kg
Foliar treatment - spraying
Aubergines (egg plants)
Solanum melongena
NEU/SEU
Indoor
Q_2010_00042
fungal diseases
EC
72.0
g/L
Foliar treatment - spraying
3
11
89
1
3
1
3
0.30
7
10
0.60
kg a.i./ha
3
0.15
kg a.i./ha
7
0.18
kg a.i./ha
3
Cucumbers
Cucumis sativus
NEU/SEU
Indoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.30
0.60
kg a.i./ha
3
Gherkins
Cucumis sativus
NEU/SEU
Indoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.30
0.60
kg a.i./ha
3
Courgettes
Cucurbita pepo var.
melopepo
NEU/SEU
Indoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
3
0.30
0.60
kg a.i./ha
3
Melons
Cucumis melo
NEU/SEU
Indoor
CY
fungal diseases
WG
60.0
g/kg
Foliar treatment - spraying
3
0.18
0.21
kg a.i./hL
7
Kohlrabi
Brassica oleracea
convar. acephala, var.
gongylodes
NEU/SEU
Indoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.30
kg a.i./ha
14
Lamb's lettuce
Valerianella locusta
NEU/SEU
Indoor
NL
Downy mildew
WP
500.0
g/kg
Foliar treatment - spraying
2
0.18
kg a.i./ha
14
Lettuce
Lactuca sativa
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Scarole (broad-leaf
endive)
Cichorium endiva
NEU/SEU
Indoor
DE
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Cress
Lepidium sativum
NEU/SEU
Indoor
Q_2010_01482
Downy mildew
WP
50.0
% (w/w)
Foliar treatment - spraying
1
2
0.18
kg a.i./ha
14
Land cress
Barbarea verna
NEU/SEU
Indoor
Q_2010_01482
Downy mildew
WP
50.0
% (w/w)
Foliar treatment - spraying
1
2
0.18
kg a.i./ha
14
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
0.18
kg a.i./ha
14
NEU/SEU
Indoor
Q_2010_01482
Downy mildew
WP
50.0
% (w/w)
Foliar treatment - spraying
1
2
0.18
kg a.i./ha
14
1
2
0.18
kg a.i./ha
14
0.25
g a.i./hL
n.a.
Rocket, Rucola
Red mustard
Eruca sativa (Diplotaxis
spec.)
Brassica juncea var.
rugosa
10
49
2
0.15
Leaves and sprouts of
Brassica spp
Brassica spp
NEU/SEU
Indoor
Q_2010_01482
Downy mildew
WP
50.0
% (w/w)
Foliar treatment - spraying
Witloof
Cichorium intybus. var.
Foliosum
NEU/SEU
Indoor
BE
fungal diseases
WP
500.0
g/kg
Local treatment - general (see also
comment field)
1
Chervil
Anthriscus cerefolium
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Chives
Allium schoenoprasum
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Celery leaves
Apium graveolens var.
seccalinum
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Parsley
Petroselinum crispum
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
EFSA Journal 2011;9(8):2348
3 applications with application rates
depending on the plant height
- Plant height up to 50 cm: 0.3 kg
a.i./ha
- Plant height 50 up to 125 cm:
0.45 kg a.i./ha
- Plant height more than 125 cm:
0.6 kg a.i./ha
3 applications with application rates
depending on the plant height
- Plant height up to 50 cm: 0.3 kg
a.i./ha
- Plant height 50 up to 125 cm:
0.45 kg a.i./ha
- Plant height more than 125 cm:
0.6 kg a.i./ha
3 applications with application rates
depending on the plant height
- Plant height up to 50 cm: 0.3 kg
a.i./ha
- Plant height 50 up to 125 cm:
0.45 kg a.i./ha
- Plant height more than 125 cm:
0.6 kg a.i./ha
3 applications with application rates
depending on the plant height
- Plant height up to 50 cm: 0.3 kg
a.i./ha
- Plant height 50 up to 125 cm:
0.45 kg a.i./ha
- Plant height more than 125 cm:
0.6 kg a.i./ha
forcing
44
Review of the existing MRLs for dimethomorph
Critical Indoor GAPs for Northern and Southern Europe (incl. post-harvest treatments)
Crop
Formulation
Region
Common name
Scientific name
Outdoor/
Indoor
Member state or
Country
Application
Content
Pests controlled
Growth stage
Type
Method
Conc.
Unit
From
BBCH
Until
BBCH
Application rate
Number
Min.
Interval (days)
Max.
Min.
Min. rate
Max. rate
Rate Unit
Max.
PHI or
wiaiting
period
(days)
Sage
Salvia officinalis
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Rosemary
Rosmarinus officinalis
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Thyme
Thymus spp.
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Basil
Ocimum basilicum
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Bay leaves (laurel)
Laurus nobilis
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
Tarragon
Artemisia dracunculus
NEU/SEU
Indoor
DE, NL
Downy mildew
DC
150.0
g/L
Foliar treatment - spraying
2
0.15
0.18
kg a.i./ha
14
EFSA Journal 2011;9(8):2348
Comments (max. 250 charachters)
45
Review of the existing MRLs for dimethomorph
APPENDIX B – PESTICIDE RESIDUES INTAKE MODEL (PRIMO)
Appendix B.1 – EU scenario 1 including all EU MRL proposals resulting from the GAPs reported by the RMS
Appendix B.2 – EU scenario 2 including demonstrated safe EU MRL proposals resulting from the GAPs reported by the RMS
Appendix B.3 – EU/Codex scenario 1 including demonstrated safe EU MRL proposals and all CXLs
EFSA Journal 2011;9(8):2348
46
Review of the existing MRLs for dimethomorph
APPENDIX B.1 – EU SCENARIO 1 INCLUDING ALL EU MRL PROPOSALS RESULTING FROM THE GAPS REPORTED BY THE RMS
Dimethomorph
Status of the active substance:
LOQ (mg/kg bw):
Included
0.02
Code no.
proposed LOQ:
Toxicological end points
ADI (mg/kg bw/day):
Source of ADI:
Year of evaluation:
0.05
ARfD (mg/kg bw):
0.6
EFSA
2006
Source of ARfD:
Year of evaluation:
EFSA
2006
Chronic risk assessment - refined calculations
No of diets exceeding ADI:
Highest calculated
TMDI values in %
of ADI
6.7
5.9
5.1
4.9
4.6
4.0
3.6
3.3
3.2
3.2
3.1
3.1
2.9
2.6
2.5
2.4
2.3
2.2
2.1
2.1
2.0
2.0
1.9
1.5
1.4
1.2
1.2
MS Diet
WHO Cluster diet B
FR all population
NL child
DE child
PT General population
WHO cluster diet E
IE adult
WHO regional European diet
ES adult
NL general
ES child
WHO Cluster diet F
FR toddler
UK Adult
UK vegetarian
WHO cluster diet D
DK adult
IT adult
IT kids/toddler
FR infant
UK Toddler
DK child
SE general population 90th percentile
FI adult
PL general population
UK Infant
LT adult
Highest contributor
to MS diet
(in % of ADI)
2.1
4.7
1.2
1.5
2.9
1.9
1.5
1.0
1.4
0.7
1.1
0.8
0.8
1.3
1.0
0.5
1.6
1.0
0.8
0.5
0.8
0.7
0.4
0.4
0.5
0.5
0.3
TMDI (range) in % of ADI
minimum - maximum
1
7
---
Commodity /
group of commodities
Wine grapes
Wine grapes
Oranges
Table grapes
Wine grapes
Wine grapes
Wine grapes
Lettuce
Lettuce
Wine grapes
Lettuce
Lettuce
Oranges
Wine grapes
Wine grapes
Tomatoes
Wine grapes
Lettuce
Tomatoes
Milk and milk products: Cattle
Oranges
Cucumbers
Potatoes
Oranges
Tomatoes
Oranges
Tomatoes
2nd contributor to
MS diet
(in % of ADI)
1.7
0.2
0.9
1.5
0.5
0.4
0.4
0.6
0.5
0.6
0.8
0.7
0.5
0.3
0.4
0.4
0.2
0.6
0.7
0.4
0.3
0.4
0.4
0.4
0.4
0.3
0.3
Commodity /
group of commodities
Tomatoes
Tomatoes
Table grapes
Oranges
Potatoes
Potatoes
Oranges
Tomatoes
Oranges
Oranges
Oranges
Wine grapes
Potatoes
Lettuce
Lettuce
Wine grapes
Tomatoes
Tomatoes
Lettuce
Potatoes
Potatoes
Lettuce
Tomatoes
Wine grapes
Table grapes
Potatoes
Potatoes
3rd contributor to
MS diet
(in % of ADI)
0.9
0.2
0.6
0.5
0.5
0.3
0.3
0.4
0.5
0.3
0.5
0.4
0.4
0.2
0.3
0.4
0.1
0.2
0.2
0.4
0.3
0.3
0.3
0.2
0.3
0.2
0.2
Commodity /
group of commodities
Lettuce
Lettuce
Potatoes
Tomatoes
Tomatoes
Tomatoes
Table grapes
Potatoes
Wine grapes
Lettuce
Tomatoes
Tomatoes
Tomatoes
HOPS (dried),
Tomatoes
Potatoes
Potatoes
Table grapes
Oranges
Oranges
Tomatoes
Tomatoes
Oranges
Tomatoes
Potatoes
Tomatoes
Cucumbers
pTMRLs at
LOQ
(in % of ADI)
0.1
0.1
0.7
0.3
0.0
0.1
0.1
0.2
0.1
0.2
0.3
0.1
0.1
0.0
0.0
0.1
0.0
0.0
0.0
0.6
0.0
0.0
0.3
0.0
0.0
0.0
0.1
Conclusion:
The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI.
A long-term intake of residues of Dimethomorph is unlikely to present a public health concern.
EFSA Journal 2011;9(8):2348
47
Review of the existing MRLs for dimethomorph
Acute risk assessment /children - refined calculations
Acute risk assessment / adults / general population - refined calculations
The acute risk assessment is based on the ARfD.
For each commodity the calculation is based on the highest reported MS consumption per kg bw and the corresponding unit weight from the MS with the critical consumption. If no data on the unit weight was available from that MS an average
European unit weight was used for the IESTI calculation.
In the IESTI 1 calculation, the variability factors were 10, 7 or 5 (according to JMPR manual 2002), for lettuce a variability factor of 5 was used.
In the IESTI 2 calculations, the variability factors of 10 and 7 were replaced by 5. For lettuce the calculation was performed with a variabilty factor of 3.
Unprocessed commodities
Threshold MRL is the calculated residue level which would leads to an exposure equivalent to 100 % of the ARfD.
No of commodities for which ARfD/ADI
is exceeded (IESTI 1):
IESTI 1
Highest % of
ARfD/ADI
102,9
31,7
25,1
13,4
7,4
*)
**)
Commodities
Scarole (broad-leaf
Lettuce
Table grapes
Oranges
Melons
pTMRL/
threshold MRL
(mg/kg)
7,06 / 6,86
7,06 / 2,3 / 0,607 / 0,294 / -
IESTI 2
No of critical MRLs (IESTI 1)
Processed commodities
No of commodities for which
ARfD/ADI is exceeded (IESTI 2):
1
1
No of commodities for which ARfD/ADI
is exceeded:
---
Highest % of
ARfD/ADI
102,9
25,1
19,0
9,7
7,4
*)
1
**)
pTMRL/
threshold MRL
Commodities
(mg/kg)
Scarole (broad-leaf 7,06 / 6,86
Table grapes
2,3 / Lettuce
7,06 / Oranges
0,607 / Melons
0,294 / -
No of commodities for which
ARfD/ADI is exceeded (IESTI 1):
IESTI 1
Highest % of
ARfD/ADI
12,9
12,2
10,4
9,1
2,6
*)
**)
Commodities
Lettuce
Table grapes
Scarole (broad-leaf
Wine grapes
Oranges
pTMRL/
threshold MRL
(mg/kg)
7,06 / 2,3 / 7,06 / 2,3 / 0,607 / -
0,2
0,2
Processed
commodities
Grape juice
Orange juice
Tomato juice
Wine
Grapes (raisins)
IESTI 2
No of critical MRLs (IESTI 2)
Highest % of
ARfD/ADI
12,2
10,4
9,1
7,8
2,2
---
*)
**)
Commodities
Table grapes
Scarole (broad-leaf endive)
Wine grapes
Lettuce
Lamb's lettuce
pTMRL/
threshold MRL
(mg/kg)
2,3 / 7,06 / 2,3 / 7,06 / 7,06 / -
1
No of commodities for which
ARfD/ADI is exceeded:
***)
Highest % of
ARfD/ADI
12,6
5,0
2,2
No of commodities for which ARfD/ADI is
exceeded (IESTI 2):
---
--***)
pTMRL/
threshold MRL
(mg/kg)
2,3 / 0,607 / 0,74 / -
Highest % of
ARfD/ADI
1,5
1,0
0,2
2,3 / 2,3 / -
0,2
0,0
Processed
commodities
Wine
Orange juice
Tomato (preservedfresh)
Raisins
Potato uree (flakes)
pTMRL/
threshold MRL
(mg/kg)
2,3 / 0,607 / 0,74 / 2,3 / 0,05 / -
*) The results of the IESTI calculations are reported for at least 5 commodities. If the ARfD is exceeded for more than 5 commodities, all IESTI values > 90% of ARfD are reported.
**) pTMRL: provisional temporary MRL
***) pTMRL: provisional temporary MRL for unprocessed commodity
Conclusion:
For Dimethomorph IESTI 1 and IESTI 2 were calculated for food commodities for which pTMRLs were submitted and for which consumption data are available.
The estimated short term intake (IESTI 1) exceeded the ARfD/ADI for 1 commodities.
Also the IESTI 2 calculation, using less conservative variability factors, resulted in exceedances of the ARfD/ADI for 1 commodities.
For processed commodities, no exceedance of the ARfD/ADI was identified.
EFSA Journal 2011;9(8):2348
48
Review of the existing MRLs for dimethomorph
APPENDIX B.2 – EU SCENARIO 2 INCLUDING DEMONSTRATED SAFE EU MRL PROPOSALS RESULTING FROM THE GAPS REPORTED BY THE RMS
Dimethomorph
Status of the active substance:
LOQ (mg/kg bw):
Included
0.02
Code no.
proposed LOQ:
Toxicological end points
ADI (mg/kg bw/day):
Source of ADI:
Year of evaluation:
0.05
ARfD (mg/kg bw):
0.6
EFSA
2006
Source of ARfD:
Year of evaluation:
EFSA
2006
Chronic risk assessment - refined calculations
No of diets exceeding ADI:
Highest calculated
TMDI values in %
of ADI
6.6
5.9
4.9
4.6
4.6
3.8
3.6
3.2
3.2
3.1
3.1
2.9
2.7
2.6
2.5
2.4
2.3
2.2
2.1
2.1
2.0
2.0
1.9
1.5
1.4
1.2
1.2
Highest contributor
to MS diet
MS Diet
(in % of ADI)
WHO Cluster diet B
2.1
FR all population
4.7
DE child
1.5
PT General population
2.9
NL child
1.2
WHO cluster diet E
1.9
IE adult
1.5
WHO regional European diet
1.0
ES adult
1.4
ES child
1.1
WHO Cluster diet F
0.8
NL general
0.7
FR toddler
0.8
UK Adult
1.3
UK vegetarian
1.0
WHO cluster diet D
0.5
DK adult
1.6
IT adult
1.0
FR infant
0.5
IT kids/toddler
0.8
UK Toddler
0.8
DK child
0.7
SE general population 90th percentile
0.4
FI adult
0.4
PL general population
0.5
UK Infant
0.5
LT adult
0.3
TMDI (range) in % of ADI
minimum - maximum
1
7
---
Commodity /
group of commodities
Wine grapes
Wine grapes
Table grapes
Wine grapes
Oranges
Wine grapes
Wine grapes
Lettuce
Lettuce
Lettuce
Lettuce
Wine grapes
Oranges
Wine grapes
Wine grapes
Tomatoes
Wine grapes
Lettuce
Milk and milk products: Cattle
Tomatoes
Oranges
Cucumbers
Potatoes
Oranges
Tomatoes
Oranges
Tomatoes
2nd contributor to
MS diet
(in % of ADI)
1.7
0.2
1.5
0.5
0.9
0.4
0.4
0.6
0.5
0.8
0.7
0.6
0.5
0.3
0.4
0.4
0.2
0.6
0.4
0.7
0.3
0.4
0.4
0.4
0.4
0.3
0.3
Commodity /
group of commodities
Tomatoes
Tomatoes
Oranges
Potatoes
Table grapes
Potatoes
Oranges
Tomatoes
Oranges
Oranges
Wine grapes
Oranges
Potatoes
Lettuce
Lettuce
Wine grapes
Tomatoes
Tomatoes
Potatoes
Lettuce
Potatoes
Lettuce
Tomatoes
Wine grapes
Table grapes
Potatoes
Potatoes
3rd contributor to
MS diet
(in % of ADI)
0.9
0.2
0.5
0.5
0.6
0.3
0.3
0.4
0.5
0.5
0.4
0.3
0.4
0.2
0.3
0.4
0.1
0.2
0.4
0.2
0.3
0.3
0.3
0.2
0.3
0.2
0.2
Commodity /
group of commodities
Lettuce
Lettuce
Tomatoes
Tomatoes
Potatoes
Tomatoes
Table grapes
Potatoes
Wine grapes
Tomatoes
Tomatoes
Lettuce
Tomatoes
HOPS (dried),
Tomatoes
Potatoes
Potatoes
Table grapes
Oranges
Oranges
Tomatoes
Tomatoes
Oranges
Tomatoes
Potatoes
Tomatoes
Cucumbers
pTMRLs at
LOQ
(in % of ADI)
0.1
0.1
0.3
0.0
0.7
0.1
0.1
0.2
0.1
0.3
0.1
0.2
0.1
0.0
0.0
0.1
0.0
0.0
0.6
0.0
0.0
0.0
0.3
0.0
0.0
0.0
0.1
Conclusion:
The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI.
A long-term intake of residues of Dimethomorph is unlikely to present a public health concern.
EFSA Journal 2011;9(8):2348
49
Review of the existing MRLs for dimethomorph
Acute risk assessment /children - refined calculations
Acute risk assessment / adults / general population - refined calculations
The acute risk assessment is based on the ARfD.
For each commodity the calculation is based on the highest reported MS consumption per kg bw and the corresponding unit weight from the MS with the critical consumption. If no data on the unit weight was available from that MS an average
European unit weight was used for the IESTI calculation.
In the IESTI 1 calculation, the variability factors were 10, 7 or 5 (according to JMPR manual 2002), for lettuce a variability factor of 5 was used.
In the IESTI 2 calculations, the variability factors of 10 and 7 were replaced by 5. For lettuce the calculation was performed with a variabilty factor of 3.
Unprocessed commodities
Threshold MRL is the calculated residue level which would leads to an exposure equivalent to 100 % of the ARfD.
No of commodities for which ARfD/ADI
is exceeded (IESTI 1):
IESTI 1
Highest % of
ARfD/ADI
31,7
25,1
13,4
7,4
7,2
---
*)
**)
Commodities
Lettuce
Table grapes
Oranges
Melons
Tomatoes
pTMRL/
threshold MRL
(mg/kg)
7,06 / 2,3 / 0,607 / 0,294 / 0,74 / -
IESTI 2
No of critical MRLs (IESTI 1)
Processed commodities
No of commodities for which
ARfD/ADI is exceeded (IESTI 2):
Highest % of
ARfD/ADI
25,1
19,0
9,7
7,4
6,7
---
No of commodities for which ARfD/ADI
is exceeded:
---
---
*)
**)
Commodities
Table grapes
Lettuce
Oranges
Melons
Celery leaves
pTMRL/
threshold MRL
(mg/kg)
2,3 / 7,06 / 0,607 / 0,294 / 7,06 / -
No of commodities for which
ARfD/ADI is exceeded (IESTI 1):
IESTI 1
Highest % of
ARfD/ADI
12,9
12,2
9,1
2,6
2,2
*)
**)
Commodities
Lettuce
Table grapes
Wine grapes
Oranges
Lamb's lettuce
pTMRL/
threshold MRL
(mg/kg)
7,06 / 2,3 / 2,3 / 0,607 / 7,06 / -
0,2
0,2
Processed
commodities
Grape juice
Orange juice
Tomato juice
Wine
Grapes (raisins)
No of commodities for which ARfD/ADI is
exceeded (IESTI 2):
IESTI 2
No of critical MRLs (IESTI 2)
Highest % of
ARfD/ADI
12,2
9,1
7,8
2,2
2,1
---
*)
**)
Commodities
Table grapes
Wine grapes
Lettuce
Lamb's lettuce
Oranges
pTMRL/
threshold MRL
(mg/kg)
2,3 / 2,3 / 7,06 / 7,06 / 0,607 / -
---
No of commodities for which
ARfD/ADI is exceeded:
***)
Highest % of
ARfD/ADI
12,6
5,0
2,2
---
--***)
pTMRL/
threshold MRL
(mg/kg)
2,3 / 0,607 / 0,74 / -
Highest % of
ARfD/ADI
1,5
1,0
0,2
2,3 / 2,3 / -
0,2
0,0
Processed
commodities
Wine
Orange juice
Tomato (preservedfresh)
Raisins
Potato uree (flakes)
pTMRL/
threshold MRL
(mg/kg)
2,3 / 0,607 / 0,74 / 2,3 / 0,05 / -
*) The results of the IESTI calculations are reported for at least 5 commodities. If the ARfD is exceeded for more than 5 commodities, all IESTI values > 90% of ARfD are reported.
**) pTMRL: provisional temporary MRL
***) pTMRL: provisional temporary MRL for unprocessed commodity
Conclusion:
For Dimethomorph IESTI 1 and IESTI 2 were calculated for food commodities for which pTMRLs were submitted and for which consumption data are available.
No exceedance of the ARfD/ADI was identified for any unprocessed commodity.
For processed commodities, no exceedance of the ARfD/ADI was identified.
EFSA Journal 2011;9(8):2348
50
Review of the existing MRLs for dimethomorph
APPENDIX B.3 – EU/CODEX SCENARIO 1 INCLUDING DEMONSTRATED SAFE EU MRL PROPOSALS AND ALL CXLS
Dimethomorph
Status of the active substance:
LOQ (mg/kg bw):
Included
0.02
Code no.
proposed LOQ:
Toxicological end points
ADI (mg/kg bw/day):
Source of ADI:
Year of evaluation:
0.05
ARfD (mg/kg bw):
0.6
EFSA
2006
Source of ARfD:
Year of evaluation:
EFSA
2006
Chronic risk assessment - refined calculations
No of diets exceeding ADI:
Highest calculated
TMDI values in %
of ADI
8.8
6.3
5.8
5.5
5.4
5.4
5.1
4.8
4.7
4.6
4.3
4.0
3.7
3.5
3.3
3.3
2.9
2.8
2.7
2.5
2.4
2.2
2.2
1.9
1.8
1.8
1.3
MS Diet
WHO Cluster diet B
FR all population
ES adult
NL child
DE child
WHO regional European diet
ES child
WHO Cluster diet F
PT General population
WHO cluster diet E
IE adult
IT adult
NL general
IT kids/toddler
UK vegetarian
UK Adult
FR toddler
DK child
WHO cluster diet D
SE general population 90th percentile
DK adult
FR infant
UK Toddler
FI adult
LT adult
PL general population
UK Infant
Highest contributor
to MS diet
(in % of ADI)
2.6
4.7
3.9
1.2
1.5
2.7
3.0
2.2
2.9
1.9
1.5
2.7
0.9
2.1
1.0
1.3
0.8
1.0
0.5
0.5
1.6
0.5
0.8
0.6
0.5
0.5
0.5
TMDI (range) in % of ADI
minimum - maximum
1
9
---
Commodity /
group of commodities
Lettuce
Wine grapes
Lettuce
Oranges
Table grapes
Lettuce
Lettuce
Lettuce
Wine grapes
Wine grapes
Wine grapes
Lettuce
Lettuce
Lettuce
Lettuce
Wine grapes
Oranges
Lettuce
Tomatoes
Head cabbage
Wine grapes
Milk and milk products: Cattle
Oranges
Lettuce
Lettuce
Tomatoes
Oranges
2nd contributor to
MS diet
(in % of ADI)
2.1
0.7
0.5
0.9
1.5
0.6
0.8
0.7
0.5
0.7
0.6
0.6
0.7
0.8
1.0
0.8
0.5
0.7
0.4
0.4
0.2
0.4
0.3
0.4
0.3
0.4
0.3
Commodity /
group of commodities
Wine grapes
Lettuce
Oranges
Table grapes
Oranges
Tomatoes
Oranges
Wine grapes
Potatoes
Lettuce
Lettuce
Tomatoes
Wine grapes
Tomatoes
Wine grapes
Lettuce
Potatoes
Cucumbers
Wine grapes
Potatoes
Tomatoes
Potatoes
Potatoes
Oranges
Tomatoes
Table grapes
Potatoes
3rd contributor to
MS diet
(in % of ADI)
1.7
0.2
0.5
0.7
0.5
0.4
0.5
0.4
0.5
0.4
0.4
0.2
0.6
0.2
0.3
0.3
0.4
0.3
0.4
0.4
0.1
0.4
0.3
0.4
0.3
0.3
0.2
Commodity /
group of commodities
Tomatoes
Tomatoes
Wine grapes
Lettuce
Tomatoes
Potatoes
Tomatoes
Tomatoes
Tomatoes
Potatoes
Oranges
Table grapes
Oranges
Oranges
Tomatoes
HOPS (dried),
Tomatoes
Tomatoes
Potatoes
Tomatoes
Potatoes
Oranges
Tomatoes
Wine grapes
Head cabbage
Potatoes
Tomatoes
pTMRLs at
LOQ
(in % of ADI)
0.2
0.1
0.1
0.7
0.3
0.2
0.3
0.1
0.0
0.1
0.1
0.0
0.2
0.0
0.0
0.0
0.1
0.0
0.2
0.3
0.0
0.6
0.0
0.0
0.1
0.0
0.0
Conclusion:
The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI.
A long-term intake of residues of Dimethomorph is unlikely to present a public health concern.
EFSA Journal 2011;9(8):2348
51
Review of the existing MRLs for dimethomorph
Acute risk assessment /children - refined calculations
Acute risk assessment / adults / general population - refined calculations
The acute risk assessment is based on the ARfD.
For each commodity the calculation is based on the highest reported MS consumption per kg bw and the corresponding unit weight from the MS with the critical consumption. If no data on the unit weight was available from that MS an average
European unit weight was used for the IESTI calculation.
In the IESTI 1 calculation, the variability factors were 10, 7 or 5 (according to JMPR manual 2002), for lettuce a variability factor of 5 was used.
In the IESTI 2 calculations, the variability factors of 10 and 7 were replaced by 5. For lettuce the calculation was performed with a variabilty factor of 3.
Unprocessed commodities
Threshold MRL is the calculated residue level which would leads to an exposure equivalent to 100 % of the ARfD.
No of commodities for which ARfD/ADI
is exceeded (IESTI 1):
IESTI 1
Highest % of
ARfD/ADI
32.3
25.1
13.4
12.3
7.3
---
*)
**)
Commodities
Lettuce
Table grapes
Oranges
Head cabbage
Melons
pTMRL/
threshold MRL
(mg/kg)
7.2 / 2.3 / 0.607 / 1.4 / 0.29 / -
IESTI 2
Processed commodities
No of critical MRLs (IESTI 1)
0.2
0.2
Processed
commodities
Grape juice
Orange juice
Tomato juice
Wine
Grapes (raisins)
Highest % of
ARfD/ADI
25.1
19.4
9.7
7.4
7.3
---
No of commodities for which ARfD/ADI
is exceeded:
Highest % of
ARfD/ADI
12.6
5.0
2.2
No of commodities for which
ARfD/ADI is exceeded (IESTI 2):
---
---
*)
**)
Commodities
Table grapes
Lettuce
Oranges
Head cabbage
Melons
pTMRL/
threshold MRL
(mg/kg)
2.3 / 7.2 / 0.607 / 1.4 / 0.29 / -
No of commodities for which
ARfD/ADI is exceeded (IESTI 1):
IESTI 1
Highest % of
ARfD/ADI
13.2
12.2
9.1
7.4
2.6
---
*)
**)
Commodities
Lettuce
Table grapes
Wine grapes
Head cabbage
Oranges
pTMRL/
threshold MRL
(mg/kg)
7.2 / 2.3 / 2.3 / 1.4 / 0.607 / -
IESTI 2
No of critical MRLs (IESTI 2)
**)
Commodities
Table grapes
Wine grapes
Lettuce
Head cabbage
Aubergines (egg plants)
pTMRL/
threshold MRL
(mg/kg)
2.3 / 2.3 / 7.2 / 1.4 / 0.56 / -
---
***)
***)
pTMRL/
threshold MRL
(mg/kg)
2.3 / 0.607 / 0.74 / -
Highest % of
ARfD/ADI
1.5
1.0
0.2
pTMRL/
threshold MRL
(mg/kg)
2.3 / 0.607 / 0.74 / -
2.3 / 2.3 / -
0.2
0.0
Potato uree (flakes)
Highest % of
ARfD/ADI
12.2
9.1
7.9
4.4
2.3
---
*)
---
No of commodities for which
ARfD/ADI is exceeded:
Processed
commodities
Wine
Orange juice
Tomato (preservedfresh)
Raisins
No of commodities for which ARfD/ADI is
exceeded (IESTI 2):
2.3 / 0.05 / -
*) The results of the IESTI calculations are reported for at least 5 commodities. If the ARfD is exceeded for more than 5 commodities, all IESTI values > 90% of ARfD are reported.
**) pTMRL: provisional temporary MRL
***) pTMRL: provisional temporary MRL for unprocessed commodity
Conclusion:
For Dimethomorph IESTI 1 and IESTI 2 were calculated for food commodities for which pTMRLs were submitted and for which consumption data are available.
No exceedance of the ARfD/ADI was identified for any unprocessed commodity.
For processed commodities, no exceedance of the ARfD/ADI was identified.
EFSA Journal 2011;9(8):2348
52
Review of the existing MRLs for dimethomorph
APPENDIX C – EXISTING EU MAXIMUM RESIDUE LIMITS (MRLS) AND CODEX LIMITS (CXLS)
Appendix C.1 – Existing EU MRLs
Appendix C.2 – Existing CXLs
EFSA Journal 2011;9(8):2348
53
Review of the existing MRLs for dimethomorph
APPENDIX C.1 – EXISTING EU MRLS
(Pesticides - Web Version - EU MRLs (File created on 16/08/2011 11:30)
Code
number
100000
110000
110010
110020
110030
110040
110050
110990
120000
120010
120020
120030
120040
120050
120060
120070
120080
120090
120100
120110
120990
130000
130010
130020
130030
130040
130050
130990
140000
140010
140020
140030
140040
Groups and examples of
individual products to
which the MRLs apply (a)
1. FRUIT FRESH OR
FROZEN; NUTS
(i) Citrus fruit
Grapefruit (Shaddocks,
pomelos, sweeties, tangelo,
ugli and other hybrids)
Oranges (Bergamot, bitter
orange, chinotto and other
hybrids)
Lemons (Citron, lemon )
Limes
Mandarins (Clementine,
tangerine and other hybrids)
Others
(ii) Tree nuts (shelled or
unshelled)
Almonds
Brazil nuts
Cashew nuts
Chestnuts
Coconuts
Hazelnuts (Filbert)
Macadamia
Pecans
Pine nuts
Pistachios
Walnuts
Others
(iii) Pome fruit
Apples (Crab apple)
Pears (Oriental pear)
Quinces
Medlar
Loquat
Others
(iv) Stone fruit
Apricots
Cherries (sweet cherries, sour
cherries)
Peaches (Nectarines and
similar hybrids)
Plums (Damson, greengage,
Dimethomorph
(sum of
isomers)
EFSA Journal 2011;9(8):2348
0,05*
0,05*
0,8(a)
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
Code
number
140990
150000
151000
151010
151020
152000
153000
153010
153020
153030
153990
154000
154010
154020
154030
154040
154050
154060
154070
154080
154990
160000
161000
161010
161020
161030
161040
161050
161060
Groups and examples of
individual products to
which the MRLs apply (a)
mirabelle)
Others
(v) Berries & small fruit
(a) Table and wine grapes
Table grapes
Wine grapes
(b) Strawberries
(c) Cane fruit
Blackberries
Dewberries (Loganberries,
Boysenberries, and
cloudberries)
Raspberries (Wineberries )
Others
(d) Other small fruit & berries
Blueberries (Bilberries
cowberries (red bilberries))
Cranberries
Currants (red, black and
white)
Gooseberries (Including
hybrids with other ribes
species)
Rose hips
Mulberries (arbutus berry)
Azarole (mediteranean
medlar)
Elderberries (Black
chokeberry (appleberry),
mountain ash, azarole,
buckthorn (sea sallowthorn),
hawthorn, service berries, and
other treeberries)
Others
(vi) Miscellaneous fruit
(a) Edible peel
Dates
Figs
Table olives
Kumquats (Marumi
kumquats, nagami kumquats)
Carambola (Bilimbi)
Persimmon
Dimethomorph
(sum of
isomers)
Code
number
161070
0,05*
3
3
3
0,7(a)
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
161990
162000
162010
162020
162030
162040
162050
162060
162990
163000
163010
163020
163030
163040
163050
163060
163070
163080
163090
163100
163110
163990
200000
210000
211000
212000
212010
Groups and examples of
individual products to
which the MRLs apply (a)
Jambolan (java plum) (Java
apple (water apple), pomerac,
rose apple, Brazilean cherry
(grumichama), Surinam
cherry)
Others
(b) Inedible peel, small
Kiwi
Lychee (Litchi) (Pulasan,
rambutan (hairy litchi))
Passion fruit
Prickly pear (cactus fruit)
Star apple
American persimmon
(Virginia kaki) (Black sapote,
white sapote, green sapote,
canistel (yellow sapote), and
mammey sapote)
Others
(c) Inedible peel, large
Avocados
Bananas (Dwarf banana,
plantain, apple banana)
Mangoes
Papaya
Pomegranate
Cherimoya (Custard apple,
sugar apple (sweetsop) , llama
and other medium sized
Annonaceae)
Guava
Pineapples
Bread fruit (Jackfruit)
Durian
Soursop (guanabana)
Others
2. VEGETABLES FRESH
OR FROZEN
(i) Root and tuber vegetables
(a) Potatoes
(b) Tropical root and tuber
vegetables
Cassava (Dasheen, eddoe
Dimethomorph
(sum of
isomers)
Code
number
212020
212030
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
212040
212990
213000
213010
213020
213030
213040
213050
213060
213070
213080
213090
0,05*
0,05*
0,05*
0,05*
213100
213110
213990
220000
220010
220020
220030
220040
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
220990
230000
231000
231010
231020
231030
0,5
231040
231990
232000
232010
232020
232030
0,05*
0,05*
Groups and examples of
individual products to
which the MRLs apply (a)
(Japanese taro), tannia)
Sweet potatoes
Yams (Potato bean (yam
bean), Mexican yam bean)
Arrowroot
Others
(c) Other root and tuber
vegetables except sugar beet
Beetroot
Carrots
Celeriac
Horseradish
Jerusalem artichokes
Parsnips
Parsley root
Radishes (Black radish,
Japanese radish, small radish
and similar varieties)
Salsify (Scorzonera, Spanish
salsify (Spanish oysterplant))
Swedes
Turnips
Others
(ii) Bulb vegetables
Garlic
Onions (Silverskin onions)
Shallots
Spring onions (Welsh onion
and similar varieties)
Others
(iii) Fruiting vegetables
(a) Solanacea
Tomatoes (Cherry tomatoes, )
Peppers (Chilli peppers)
Aubergines (egg plants)
(Pepino)
Okra, lady’s fingers
Others
(b) Cucurbits - edible peel
Cucumbers
Gherkins
Courgettes (Summer squash,
Dimethomorph
(sum of
isomers)
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
1
0,05*
0,05*
0,05*
0,05*
0,15
0,15
0,15
0,3
0,1
1
0,5
0,3
0,05*
0,05*
1
1
1
1
54
Review of the existing MRLs for dimethomorph
Code
number
232990
233000
233010
233020
233030
233990
234000
239000
240000
241000
241010
241020
241990
242000
242010
242020
242990
243000
243010
243020
243990
244000
250000
251000
251010
251020
251030
251040
251050
251060
251070
251080
Groups and examples of
individual products to
which the MRLs apply (a)
marrow (patisson))
Others
(c) Cucurbits-inedible peel
Melons (Kiwano )
Pumpkins (Winter squash)
Watermelons
Others
(d) Sweet corn
(e) Other fruiting vegetables
(iv) Brassica vegetables
(a) Flowering brassica
Broccoli (Calabrese, Chinese
broccoli, Broccoli raab)
Cauliflower
Others
(b) Head brassica
Brussels sprouts
Head cabbage (Pointed head
cabbage, red cabbage, savoy
cabbage, white cabbage)
Others
(c) Leafy brassica
Chinese cabbage (Indian
(Chinese) mustard, pak choi,
Chinese flat cabbage (tai goo
choi), peking cabbage (petsai), cow cabbage)
Kale (Borecole (curly kale),
collards)
Others
(d) Kohlrabi
(v) Leaf vegetables & fresh
herbs
(a) Lettuce and other salad
plants including Brassicacea
Lamb´s lettuce (Italian
cornsalad)
Lettuce (Head lettuce, lollo
rosso (cutting lettuce), iceberg
lettuce, romaine (cos) lettuce)
Scarole (broad-leaf endive)
(Wild chicory, red-leaved
chicory, radicchio, curld leave
endive, sugar loaf)
Cress
Land cress
Rocket, Rucola (Wild rocket)
Red mustard
Leaves and sprouts of
Dimethomorph
(sum of
isomers)
Code
number
1
251990
252000
252010
EFSA Journal 2011;9(8):2348
1
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
252020
252030
252990
253000
254000
255000
256000
256010
256020
256030
256040
256050
0,05*
0,05*
0,05*
0,05*
256060
256070
256080
256090
256100
256990
260000
260010
10(a)
10
260020
260030
1
10(a)
10(a)
10
10(a)
10(a)
260040
260050
260990
270000
Groups and examples of
individual products to
which the MRLs apply (a)
Brassica spp (Mizuna)
Others
(b) Spinach & similar (leaves)
Spinach (New Zealand
spinach, turnip greens (turnip
tops))
Purslane (Winter purslane
(miner’s lettuce), garden
purslane, common purslane,
sorrel, glassworth)
Beet leaves (chard) (Leaves of
beetroot)
Others
(c) Vine leaves (grape leaves)
(d) Water cress
(e) Witloof
(f) Herbs
Chervil
Chives
Celery leaves (fennel leaves ,
Coriander leaves, dill leaves,
Caraway leaves, lovage,
angelica, sweet cisely and
other Apiacea)
Parsley
Sage (Winter savory, summer
savory, )
Rosemary
Thyme ( marjoram, oregano)
Basil (Balm leaves, mint,
peppermint)
Bay leaves (laurel)
Tarragon (Hyssop)
Others
(vi) Legume vegetables (fresh)
Beans (with pods) (Green
bean (french beans, snap
beans), scarlet runner bean,
slicing bean, yardlong beans)
Beans (without pods) (Broad
beans, Flageolets, jack bean,
lima bean, cowpea)
Peas (with pods) (Mangetout
(sugar peas))
Peas (without pods) (Garden
pea, green pea, chickpea)
Lentils
Others
(vii) Stem vegetables (fresh)
Dimethomorph
(sum of
isomers)
1
0,1
1
0,05*
0,05*
10
10
10
10
10
10
Code
number
270010
270020
270030
270040
270050
270060
270070
270080
270090
270990
280000
280010
280020
280990
290000
300000
300010
10
10
300020
300030
10
10
10
300040
300990
400000
10
10
10
10
401000
401010
401020
401030
401040
401050
401060
0,05*
401070
401080
401090
401100
401110
401120
401130
401140
401150
401990
0,05*
0,05*
0,1
0,05*
0,05*
Groups and examples of
individual products to
which the MRLs apply (a)
Asparagus
Cardoons
Celery
Fennel
Globe artichokes
Leek
Rhubarb
Bamboo shoots
Palm hearts
Others
(viii) Fungi
Cultivated (Common
mushroom, Oyster
mushroom, Shi-take)
Wild (Chanterelle, Truffle,
Morel ,)
Others
(ix) Sea weeds
3. PULSES, DRY
Beans (Broad beans, navy
beans, flageolets, jack beans,
lima beans, field beans,
cowpeas)
Lentils
Peas (Chickpeas, field peas,
chickling vetch)
Lupins
Others
4. OILSEEDS AND
OILFRUITS
(i) Oilseeds
Linseed
Peanuts
Poppy seed
Sesame seed
Sunflower seed
Rape seed (Bird rapeseed,
turnip rape)
Soya bean
Mustard seed
Cotton seed
Pumpkin seeds
Safflower
Borage
Gold of pleasure
Hempseed
Castor bean
Others
Dimethomorph
(sum of
isomers)
0,05*
0,05*
0,05*
0,05*
2
1,5
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
Code
number
402000
402010
402020
402030
402040
402990
500000
500010
500020
500030
500040
500050
500060
500070
500080
500090
500990
600000
610000
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
620000
630000
631000
631010
631020
631030
631040
631050
631990
632000
632010
632020
632030
632990
633000
633010
633020
633990
639000
640000
650000
700000
800000
810000
Groups and examples of
individual products to
which the MRLs apply (a)
(ii) Oilfruits
Olives for oil production
Palm nuts (palmoil kernels)
Palmfruit
Kapok
Others
5. CEREALS
Barley
Buckwheat
Maize
Millet (Foxtail millet, teff)
Oats
Rice
Rye
Sorghum
Wheat (Spelt Triticale)
Others
6. TEA, COFFEE, HERBAL
INFUSIONS AND COCOA
(i) Tea (dried leaves and
stalks, fermented or otherwise
of Camellia sinensis)
(ii) Coffee beans
(iii) Herbal infusions (dried)
(a) Flowers
Camomille flowers
Hybiscus flowers
Rose petals
Jasmine flowers
Lime (linden)
Others
(b) Leaves
Strawberry leaves
Rooibos leaves
Maté
Others
(c) Roots
Valerian root
Ginseng root
Others
(d) Other herbal infusions
(iv) Cocoa (fermented beans)
(v) Carob (st johns bread)
7. HOPS (dried) , including
hop pellets and
unconcentrated powder
8. SPICES
(i) Seeds
Dimethomorph
(sum of
isomers)
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
50
0,05*
0,05*
55
Review of the existing MRLs for dimethomorph
Code
number
810010
810020
810030
810040
810050
810060
810070
810080
810090
810990
820000
820010
820020
820030
820040
820050
820060
820070
820080
820990
830000
830010
830990
840000
840010
840020
840030
840040
840990
850000
850010
850020
850990
860000
860010
860990
870000
870010
870990
900000
900010
900020
900030
900990
1000000
Groups and examples of
individual products to
which the MRLs apply (a)
Anise
Black caraway
Celery seed (Lovage seed)
Coriander seed
Cumin seed
Dill seed
Fennel seed
Fenugreek
Nutmeg
Others
(ii) Fruits and berries
Allspice
Anise pepper (Japan pepper)
Caraway
Cardamom
Juniper berries
Pepper, black and white
(Long pepper, pink pepper)
Vanilla pods
Tamarind
Others
(iii) Bark
Cinnamon (Cassia )
Others
(iv) Roots or rhizome
Liquorice
Ginger
Turmeric (Curcuma)
Horseradish
Others
(v) Buds
Cloves
Capers
Others
(vi) Flower stigma
Saffron
Others
(vii) Aril
Mace
Others
9. SUGAR PLANTS
Sugar beet (root)
Sugar cane
Chicory roots
Others
10. PRODUCTS OF
ANIMAL ORIGINTERRESTRIAL ANIMALS
Dimethomorph
(sum of
isomers)
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
EFSA Journal 2011;9(8):2348
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
Code
number
1010000
1011000
1011010
1011020
1011030
1011040
1011050
1011990
1012000
1012010
1012020
1012030
1012040
1012050
1012990
1013000
1013010
1013020
1013030
1013040
1013050
1013990
1014000
1014010
1014020
1014030
1014040
1014050
1014990
1015000
1015010
1015020
1015030
1015040
1015050
1015990
1016000
1016010
1016020
Groups and examples of
individual products to
which the MRLs apply (a)
(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
(a) Swine
Meat
Fat free of lean meat
Liver
Kidney
Edible offal
Others
(b) Bovine
Meat
Fat
Liver
Kidney
Edible offal
Others
(c) Sheep
Meat
Fat
Liver
Kidney
Edible offal
Others
(d) Goat
Meat
Fat
Liver
Kidney
Edible offal
Others
(e) Horses, asses, mules or
hinnies
Meat
Fat
Liver
Kidney
Edible offal
Others
(f) Poultry -chicken, geese,
duck, turkey and Guinea fowl, ostrich, pigeon
Meat
Fat
Dimethomorph
(sum of
isomers)
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
0,05*
Code
number
Groups and examples of
Dimethomorph
individual products to
(sum of
which the MRLs apply (a)
isomers)
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
concentrated, nor containing
added sugar or sweetening
matter, butter and other fats
derived from milk, cheese and
curd
0,05*
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
(a): Value voted by the Standing Committee on the
Food Chain and Animal Health, to be implemented
(SANCO 10565/2011 rev 1 and SANCO
10153/2011 rev 2).
56
Review of the existing MRLs for dimethomorph
APPENDIX C.2 – EXISTING CXLS
Summary of CXLs for dimethomorph in plant commodities
Values adopted by the CCPR
Commodity
code
Critical values of the JMPR evaluation
Commodity name
Residue definition
151010 Table grapes
dimethomorph (sum of isomers)
151020 Wine grapes
152000 Strawberries
CXL (mg/kg)
Residue definition
Risk assessment values as calculated by EFSA
1.7
Default
variability
factor
3
Reduced
variability
factor
n.c.
STMR (-P)
(mg/kg)
HR (-P) (mg/kg)
Comments on the JMPR evaluation
STMR (mg/kg)
HR (mg/kg)
Median peeling
factor
0.385
1.7
n.a.
Median
conversion
factor
1
Year
Based on EU
GAP only?
2007
Yes
2
dimethomorph (sum of isomers)
0.39
dimethomorph (sum of isomers)
2
dimethomorph (sum of isomers)
0.39
1.7
3
n.c.
0.385
1.7
n.a.
1
2007
Yes
dimethomorph (sum of isomers)
0.05
dimethomorph (sum of isomers)
0.01
0.02
1
n.c.
0.01
0.02
n.a.
1
2007
Yes
163080 Pineapples
dimethomorph (sum of isomers)
0.01 *
dimethomorph (sum of isomers)
0
0
3
n.c.
0.01
0.01
1
1
2007
No
211000 Potatoes
dimethomorph (sum of isomers)
0.05
dimethomorph (sum of isomers)
0.02
0.05
3
n.c.
0.02
0.05
n.a.
1
2007
No
231010 Tomatoes
dimethomorph (sum of isomers)
1
dimethomorph (sum of isomers)
0.22
0.56
3
n.c.
0.22
0.56
n.a.
1
2007
No
231020 Peppers
dimethomorph (sum of isomers)
1
dimethomorph (sum of isomers)
0.22
0.56
3
n.c.
0.22
0.56
n.a.
1
2007
No
231030 Aubergines (egg plants)
dimethomorph (sum of isomers)
1
dimethomorph (sum of isomers)
0.22
0.56
3
n.c.
0.22
0.56
n.a.
1
2007
No
231040 Okra, lady’s fingers
dimethomorph (sum of isomers)
1
dimethomorph (sum of isomers)
0.22
0.56
3
n.c.
0.22
0.56
n.a.
1
2007
No
232010 Cucumbers
dimethomorph (sum of isomers)
0.5
dimethomorph (sum of isomers)
0.15
0.24
3
n.c.
0.15
0.24
n.a.
1
2007
No
232020 Gherkins
dimethomorph (sum of isomers)
0.5
dimethomorph (sum of isomers)
0.15
0.24
3
n.c.
0.15
0.24
n.a.
1
2007
No
232030 Courgettes
dimethomorph (sum of isomers)
0.5
dimethomorph (sum of isomers)
0.15
0.24
3
n.c.
0.15
0.24
n.a.
1
2007
No
233010 Melons
dimethomorph (sum of isomers)
0.5
dimethomorph (sum of isomers)
0.02
0.05
3
n.c.
0.04
0.24
0.5
1
2007
No
233020 Pumpkins
dimethomorph (sum of isomers)
0.5
dimethomorph (sum of isomers)
0.02
0.05
3
n.c.
0.04
0.24
0.5
1
2007
No
233030 Watermelons
dimethomorph (sum of isomers)
0.5
dimethomorph (sum of isomers)
0.02
0.05
3
n.c.
0.04
0.24
0.5
1
2007
No
241010 Broccoli
dimethomorph (sum of isomers)
1
dimethomorph (sum of isomers)
0.19
0.52
3
n.c.
0.19
0.52
n.a.
1
2007
No
242020 Head cabbage
dimethomorph (sum of isomers)
2
dimethomorph (sum of isomers)
0.4
1.4
3
n.c.
0.4
1.4
n.a.
1
2007
No
244000 Kohlrabi
dimethomorph (sum of isomers)
0.02
dimethomorph (sum of isomers)
0.02
0.02
3
n.c.
0.02
0.02
n.a.
1
2007
Yes
251010 Lamb's lettuce
dimethomorph (sum of isomers)
10
dimethomorph (sum of isomers)
3.4
7.1
1
n.c.
3.35
7.1
n.a.
1
2007
Yes
251020 Lettuce
dimethomorph (sum of isomers)
10
dimethomorph (sum of isomers)
3.6
7.2
3
n.c.
3.6
7.2
n.a.
1
2007
No
700000 Hops (dried),
dimethomorph (sum of isomers)
including hop pellets and
unconcentrated powder
(*) Indicates the lower limit of analytical quantification.
n.a.: not applicable
n.c.: not considered
80
dimethomorph (sum of isomers)
26
n.c.
1
n.c.
26
42
n.a.
1
2007
Yes
Other comments
Trials were carried out in the EU
according to the GAP of Spain.
Trials were carried out in Belgium
and the Netherlands according to
Belgian GAP.
Trials were conducted in the
Philippines according to GAP (preplanting seed dip). The MPF is given
as 1 as residues are below the LOQ
in both the whole fruit and flesh.
Trials were conducted according to
GAP in a number of EU and non-EU
countries.
Based on chilli pepper trials
conducted in Korea according to
GAP. Extrpolated to further fruiting
vegetables according to a USA
GAP.
Trials with courgette conducted
according to the USA GAP were
used to support the CXL for edible
peel cucurbits.
Trials were conducted in the EU
according to Israel GAP. Although
data were available for pulp and
whole fruit these were not from the
same trials and therefore a peeling
factor could not be determined.
Based on the pulp and whole fruit
STMRs, based on trials with similar
GAP, the pf could be estimated as
Trials conducted in the USA
according to Cuban GAP.
Trials conducted in the USA
according to Cuban GAP.
Trials conducted in Germany
according to GAP.
Trials conducted in Italy and Spain
according to Spanish GAP for
lettuce.
Trials conducted in a number of EU
countries according to USA GAP.
Trials conducted in Austria and
Germany according to German
GAP.
n.k.: not known
EFSA Journal 2011;9(8):2348
57
Review of the existing MRLs for dimethomorph
Summary of CXLs for dimethomorph in livestock commodities
Commodity
code
Values adopted by the CCPR
Commodity name
1011010 Swine meat
dimethomorph (sum of isomers)
Expressed
as fat?
no
1011020 Swine fat (free of lean meat)
dimethomorph (sum of isomers)
1011030 Swine liver
dimethomorph (sum of isomers)
1011040 Swine kidney
Critical values of the JM PR evaluation
Comment on the JM PR evaluation
0.01 *
dimethomorph (sum of isomers)
0
0
2007
Based on EU
GAP only?
no
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1011050 Swine edible offal
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1012010 Bovine meat
dimethomorph (sum of isomers)
no
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1012020 Bovine fat
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1012030 Bovine liver
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1012040 Bovine kidney
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1012050 Bovine edible offal
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1013010 Sheep meat
dimethomorph (sum of isomers)
no
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1013020 Sheep fat
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1013030 Sheep liver
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1013040 Sheep kidney
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1013050 Sheep edible offal
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1014010 Goat meat
dimethomorph (sum of isomers)
no
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1014020 Goat fat
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1014030 Goat liver
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1014040 Goat kidney
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1014050 Goat edible offal
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
or
dimethomorph (sum of isomers)
no
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
or
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
or
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
or
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
or
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
dimethomorph (sum of isomers)
no
0.01 *
dimethomorph (sum of isomers)
0
0
2007
yes
1016020 Poultry fat
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1016030 Poultry liver
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
yes
1016040 Poultry kidney
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
yes
1016050 Poultry edible offal
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
yes
1017010 Other farm animals meat
dimethomorph (sum of isomers)
no
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1017020 Other farm animals fat
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1017030 Other farm animals liver
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1017040 Other farm animals kidney
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1017050 Other farm animals edible offal dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1020010 Cattle milk
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1020020 Sheep milk
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1020030 Goat milk
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1020040 Horse milk
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
no
1030000 Birds' eggs
dimethomorph (sum of isomers)
n.a.
0.01 *
dimethomorph (sum of isomers)
0
0
2007
yes
1015010 Horses, asses, mules
hinnies meat
1015020 Horses, asses, mules
hinnies fat
1015030 Horses, asses, mules
hinnies liver
1015040 Horses, asses, mules
hinnies kidney
1015050 Horses, asses, mules
hinnies edible offal
1016010 Poultry meat
Residue definition
CXL (mg/kg)
Residue definition
STM R (mg/kg)
HR (mg/kg)
Year
Other comments
No residues were detected in
tissues or milk at a dose level of
12.5 ppm (estimated maximum
dietary burden is 2.3 ppm).
No residues were detected in
tissues or milk at a dose level of
12.5 ppm (estimated maximum
dietary burden is 2.3 ppm).
No residues were detected in
tissues or milk at a dose level of
12.5 ppm (estimated maximum
dietary burden is 2.3 ppm).
No residues were detected in
tissues or milk at a dose level of
12.5 ppm (estimated maximum
dietary burden is 2.3 ppm).
No residues were detected in
tissues or milk at a dose level of
12.5 ppm (estimated maximum
dietary burden is 2.3 ppm).
No residues expected in tissues or
eggs based on the estimated
dietary burden of 0.5 ppm.
No residues were detected in
tissues or milk at a dose level of
12.5 ppm (estimated maximum
dietary burden is 2.3 ppm).
No residues were detected in
tissues or milk at a dose level of
12.5 ppm (estimated maximum
dietary burden is 2.3 ppm).
No residues expected in tissues or
eggs based on the estimated
dietary burden of 0.5 ppm.
(*) Indicates the lower limit of analytical quantification.
n.a.: not applicable
n.c.: not considered
n.k.: not known
EFSA Journal 2011;9(8):2348
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Review of the existing MRLs for dimethomorph
APPENDIX D – DECISION TREE FOR DERIVING MRL RECOMMENDATIONS
Evaluation of the GAPs and available residues data at EU level
GAP or
DB >0.1 mg/kg
DM in EU?
Yes
No
MRL derived
in section 3?
Yes
No
MRL fully
supported by
data?
No
Yes
Consumer risk assessment for GAPs evaluated at EU level - EU scenarios
Tentative median/
highest values are
included in the
RA.
Current EU MRL
is included in the
RA.
Not considered
for the RA
Risk identified?
Yes
Risk identified?
Risk identified?
Yes
Yes
Fal-back MRL
available?
Yes
Median/highest
values are
included in the
RA.
No
Fal-back MRL
available?
No
No
No
No
Recommendations resulting from EU authorisations and import tolerances
(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.
Comparison
with CXLs
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Review of the existing MRLs for dimethomorph
Result EU
assessment
Comparison of the EU recommendation with the existing CXL
CXL available?
Yes
RD
comparable?
Yes
CXL higher?
Yes
No
No
No
Consumer risk assessment with consideration of the existing CXL
CXL fully
supported by
data?
No
Input values for
the RA remain
unchanged.
Input values for
the RA remain
unchanged.
Input values for
the RA remain
unchanged.
Yes
CXL is included in
the RA.
Codex median/
highest residues
are included in the
RA.
Risk identified?
Risk identified?
Yes
No
Yes
No
(VI)
Maintain EU
recommendation;
higher CXL is not
safe for consumer.
(VII)
CXL is
recommended; EU
recommendation
is covered as well.
Recommendations with consideration of the existing CXL
(I)
Maintain EU
recommendation
indicating that no
CXL is available.
EFSA Journal 2011;9(8):2348
(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?
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Review of the existing MRLs for dimethomorph
APPENDIX E – LIST OF METABOLITES AND RELATED STRUCTURAL FORMULA
Common name
dimethomorph
IUPAC name
Structural formula
Cl
Cl
(E,Z)-4-[3-(4-chlorophenyl)-3(3,4-dimethoxyphenyl)
acryloyl]morpholine
O
N
O
O
O
N-[3-(4-chlorophenyl)-3-3,4dimethoxyphenyl)-1-oxo-2propenyl-glycine
CH3O
N
O
Z-Isomer
E-Isomer
CUR 7117
(Z89)
O
O
O
OCH3
C
H
CO NHCH2 COOH
C
H
CO N
O
C
H
CO N
O
Cl
Z67
4-[(E)-and(Z)-beta-(pchlorophenyl)-3-hydroxy-4methoxycinnamoyl]morpholine
OH
CH3O
Cl
Z69
4-[(E)-and(Z)-beta-(pchlorophenyl)-4-hydroxy-3methoxycinnamoyl]morpholine
OCH3
OH
Cl
Z7
4-chloro-3’,4’-dimethoxybenzophenone
Z37
4-[3-(4-chlorophenyl)-3-3,4dimethoxy-phenyl)-1-oxo-2propenyl]-2-oxo-morpholine
Z93
3-(4-chlorophenyl)-3-(3,4dimethoxy-phenyl)-N,N-bis-(2hydroxyethyl) acrylamide
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Review of the existing MRLs for dimethomorph
Common name
IUPAC name
Z95
N-[3-(4-chlorophenyl)-3-3,4dimethoxyphenyl)-1-oxo-2propenyl-ethanolamine
Z98
3-(4-chlorophenyl)-3-(3,4dimethoxy-phenyl)-acrylamide
EFSA Journal 2011;9(8):2348
Structural formula
62
Review of the existing MRLs for dimethomorph
ABBREVIATIONS
a.s.
active substance
ADI
acceptable daily intake
ARfD
acute reference dose
BBCH
Federal Biological Research Centre for Agriculture and Forestry (Germany)
bw
body weight
CAC
Codex Alimentarius Commission
CEN
European Committee
Normalisation)
CF
conversion factor for enforcement residue definition to risk assessment
residue definition
CXL
codex maximum residue limit
d
day
DAR
draft assessment report
DAT
days after treatment
DC
dispersible concentrates
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
GAP
good agricultural practice
GC-NPD
gas chromatography with nitrogen phosphorus detection
GC-MSD
gas chromatography with mass selective detector
GC-MS/MS
gas chromatography with tandem mass spectrometry
ha
hectare
HPLC
high performance liquid chromatography
EFSA Journal 2011;9(8):2348
for
Standardization
(Comité
Européen
de
63
Review of the existing MRLs for dimethomorph
HPLC-MS/MS
high performance liquid chromatography with tandem mass spectrometry
HPLC-UV
high performance liquid chromatography with ultraviolet detection
ILV
Independent Laboratory Validation
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
MRL
maximum residue limit
MS
Member States
NEU
Northern European Union
PF
processing factor
PHI
pre harvest interval
PRIMo
(EFSA) Pesticide Residues Intake Model
PROFile
(EFSA) Pesticide Residues Overview File
Rber
statistical calculation of the MRL by using a non-parametric method
Rmax
statistical calculation of the MRL by using a parametric method
RMS
rapporteur Member State
RSD
relative standard deviation
SEU
Southern European Union
TRR
total radioactive residue
WG
water dispersible granules
WHO
World Health Organisation
WP
wettable powder
EFSA Journal 2011;9(8):2348
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