Modification of the existing MRLs for metalaxyl-M in lettuce and other salad plants.pdf

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1、 EFSA Journal 2012;10(1):2549 Suggested citation: European Food Safety Authority; Modification of the existing MRLs for metalaxyl-M in lettuce and other salad plants. EFSA Journal 2012;10(1):2549. 25 pp. doi:10.2903/j.efsa.2012.2549. Available online: www.efsa.europa.eu/efsajournal European Food Saf

2、ety Authority, 2012 REASONED OPINION Modification of the existing MRLs for metalaxyl-M in lettuce and other salad plants1 European Food Safety Authority2 European Food Safety Authority (EFSA), Parma, Italy SUMMARY According to Article 6 of the Regulation (EC) No 396/2005, France, herewith referred t

3、o as the Evaluating Member State (EMS), received an application from the company Syngenta AGRO S.A.S. to modify the existing MRLs for metalaxyl-M in lettuce, lambs lettuce, scarole, cress, land cress, rocket/rucola, red mustard, leaves and sprouts of Brassica. In order to accommodate for the intende

4、d use of metalaxyl-M on these crops in France, the EMS proposed to raise the existing MRLs to 3 mg/kg. The EMS France drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 23 June 2011. EFSA derives

5、the following conclusions based on the submitted evaluation report prepared by France, the Draft Assessment Report (DAR) prepared by the Rapporteur Member State (RMS) Belgium under Directive 91/414/EEC as well as the EFSA reasoned opinion on the review of the existing MRLs for metalaxyl-M according

6、to Article 12 of Regulation (EC) No 396/2005. The toxicological profile of metalaxyl-M was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI value of 0.08 mg/kg bw/day and an ARfD of 0.5 mg/kg bw. In the framework of the peer review

7、 the metabolism of metalaxyl was investigated for foliar treatment on fruits and fruiting vegetables (grapes) and root and tuber vegetables (potatoes) and as foliar or soil treatment on leafy vegetables (foliar on lettuce, and soil on tobacco). The metabolism data on metalaxyl can also be applied to

8、 metalaxyl-M. The residue definition proposed by the peer review for the risk assessment was metalaxyl-M, whereas the enforcement residue definition was finally set as “metalaxyl and metalaxyl-M (metalaxyl including other mixtures of constituent isomers including metalaxyl-M (sum of isomers)”. Metal

9、axyl and metalaxyl-M have similar toxicity and therefore in the review of the existing MRLs for metalaxyl-M under Article 12 of Regulation (EC) No 396/2005, EFSA proposed the following wording for the risk assessment and enforcement residue definitions: “metalaxyl, including other mixtures of consti

10、tuent isomers including metalaxyl-M (sum of isomers)”. For the leafy vegetables under consideration EFSA concludes that the metabolism of metalaxyl-M is sufficiently investigated and the same residue definitions apply. 1 On request from the European Commission, Question No EFSA-Q-2011-00827, issued

11、on 13 January 2012. 2 Correspondence: pesticides.mrlefsa.europa.eu Modification of the existing MRLs for metalaxyl-M in lettuce and other salad plants EFSA Journal 2012;10(1):2549 2 The submitted residue data are sufficient to support the proposed residue data extrapolation from lettuce and to deriv

12、e the MRL proposal of 3 mg/kg in lettuce, lambs lettuce, scarole, cress, land cress, rocket/rucola, red mustard, leaves and sprouts of Brassica in support of the intended critical indoor use of metalaxyl-M in France. There are adequate analytical methods available to monitor the metalaxyl (sum of is

13、omers) residues in the crops under consideration at the validated LOQ of 0.02 mg/kg. Under core processing conditions (sterilisation, pasteurization and baking/brewing/boiling) no degradation of metalaxyl-M occurs and therefore for processed commodities the same residue definition as for raw agricul

14、tural commodities is applicable. No specific studies investigating the effect of processing on the magnitude of metalaxyl residues have been submitted in the framework of the current application. Most of the crops, except scarole, are consumed fresh. The contribution of the residues in the crops und

15、er consideration to the total consumer exposure is insignificant and therefore processing studies with these crops are currently not required. The possible occurrence of metalaxyl-M residues in rotational/succeeding crops was also investigated. The nature of metalaxyl-M in rotational crops and prima

16、ry crops is expected to be similar and therefore the same residue definitions apply. The Member States, before granting an authorization of plant protection products containing metalaxyl-M, are recommended to implement the necessary risk mitigation measures to avoid residues of metalaxyl-M in rotati

17、onal/succeeding crops. Residues of metalaxyl-M in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are normally not fed to livestock. The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Inta

18、ke Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue value as derived from the indoor residue trials on lettuce. The median residue value for lettuce was used as an input value also for all other crops under consideration. For the remaining commodities of plant

19、 and animal origin, the existing MRLs as established in Annexes II and IIIB of Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to the commodities under consideration assuming the consumption of a large portion of the food items as r

20、eported in the national food surveys containing residues at the highest level as observed in supervised residue field trials. The estimated exposure was then compared with the toxicological reference values derived for metalaxyl-M. No long-term consumer intake concerns were identified for any of the

21、 European diets incorporated in the EFSA PRIMo. The total calculated intake values ranged from 3.1 to 25.7% of the ADI (DE child). The contribution of residues in the crops under consideration to the total consumer exposure was insignificant, being the highest for lettuce (0.7% of the ADI (ES adult

22、diet). No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 31.5% for scarole and below 10% of the ARfD for other crops under consideration. EFSA concludes that the intended use of meta

23、laxyl-M on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern. The recommendations of EFSA are compiled in the table below: Modification of the existing MRLs for metalaxyl-M in lettuce

24、and other salad plants EFSA Journal 2012;10(1):2549 3 Code numbera Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Justification for the proposal Enforcement residue definition: Metalaxyl, including other mixtures of constituent isomers including metalaxyl-M (sum of isomers) 02510010 Lambs

25、 lettuce 0.2 3 The MRL proposals have been sufficiently supported by data and no risk for consumers was identified. 02510020 Lettuce 2 3 02510030 Scarole (broad-leaf endive) 1 3 02510040 Cress 0.05* 3 02510050 Land cress 1 3 02510060 Rocket, rucola 2 3 02510070 Red mustard 0.05* 3 02510080 Leaves an

26、d sprouts of Brassica spp., including turnip greens 2 3 (*): Indicates that the MRL is set at the limit of analytical quantification. a according to Annex I of Regulation (EC) No 396/2005 KEY WORDS Metalaxyl-M, metalaxyl, lettuce, lambs lettuce, scarole, cress, land cress, rocket/rucola, red mustard

27、, leaves and sprouts of Brassica , MRL application, Regulation (EC) No 396/2005, consumer risk assessment, phenylamide fungicide Modification of the existing MRLs for metalaxyl-M in lettuce and other salad plants EFSA Journal 2012;10(1):2549 4 TABLE OF CONTENTS Summary . 1 Table of contents . 4 Back

28、ground . 5 Terms of reference . 5 The active substance and its use pattern . 6 Assessment . 7 1. Methods of analysis . 7 1.1. Methods for enforcement of residues in food of plant origin . 7 1.2. Methods for enforcement of residues in food of animal origin . 7 2. Mammalian toxicology . 7 3. Residues

29、. 8 3.1. Nature and magnitude of residues in plant . 8 3.1.1. Primary crops . 8 3.1.2. Rotational crops . 11 3.2. Nature and magnitude of residues in livestock . 12 4. Consumer risk assessment . 12 Conclusions and recommendations . 14 References . 15 Appendix A. Good Agricultural Practices (GAPs). 1

30、8 Appendix B. Pesticide Residues Intake Model (PRIMo) . 19 Appendix C. Existing EU maximum residue limits (MRLs) . 21 Abbreviations . 24 Modification of the existing MRLs for metalaxyl-M in lettuce and other salad plants EFSA Journal 2012;10(1):2549 5 BACKGROUND Commission Regulation (EC) No 396/200

31、53 establishes the rules governing the setting of pesticide MRLs at Community level. Article 6 of that regulation lays down that a party requesting an authorisation for the use of a plant protection product in accordance with Council Directive 91/414/EEC4, shall submit to a Member State, when approp

32、riate, an application to set or modify an MRL in accordance with the provisions of Article 7 of that regulation. France, hereafter referred to as the evaluating Member State (EMS), received an application from the company Syngenta AGRO S.A.S.5 to modify the existing MRLs for the active substance met

33、alaxyl-M in lettuce and other salad plants including Brassicaceae (lettuce, lambs lettuce, scarole, cress, land cress, rocket/rucola, red mustard, leaves and sprouts of Brassica). This application was notified to the European Commission and EFSA and subsequently evaluated by the EMS in accordance wi

34、th Article 8 of the Regulation. After completion, the evaluation report of the EMS was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 23 June 2011. The application was included in the EFSA Register of Questions with the

35、 reference number EFSA-Q-2011-00827 and the following subject: Metalaxyl-M - Application to modify the existing MRLs in lettuce and other salad plants. The EMS proposed the MRL of 3 mg/kg for the whole group of lettuce and other salad plants including Brassicaceae. EFSA then proceeded with the asses

36、sment of the application as required by Article 10 of the Regulation. TERMS OF REFERENCE In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall, based on the evaluation report provided by the evaluating Member State, provide a reasoned opinion on the risks to the consumer associate

37、d with the application. In accordance with Article 11 of that Regulation, the reasoned opinion shall be provided as soon as possible and at the latest within three months (which may be extended to six months where more detailed evaluations need to be carried out) from the date of receipt of the appl

38、ication. Where EFSA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. In this particular case the calculated deadline for providing the reasoned opinion is 23 September 2011. 3 Regulation (EC) No 396/2005 of the European Parliam

39、ent and of the Council of 23 February 2005. OJ L 70, 16.3.2005, p. 1-16. 4 Council Directive 91/414/EEC of 15 July 1991, OJ L 230, 19.8.1991, p. 1-32. 5 Syngenta AGRO S.A.S., Avenue des Prs 1, CS 10537, 78286, GUYANCOURT cedex, France Modification of the existing MRLs for metalaxyl-M in lettuce and

40、other salad plants EFSA Journal 2012;10(1):2549 6 THE ACTIVE SUBSTANCE AND ITS USE PATTERN Metalaxyl-M is the ISO common name for methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate (IUPAC). The racemic mixture of metalaxyl-M and its S-enantiomer may also be available on the market, its ISO common na

41、me being metalaxyl. CH3CH3ONCHCH3CH2CCH3OCO2CH3 CH3CH3ONCHCH3CH2CCH3OCO2CH3 metalaxyl-M metalaxyl Metalaxyl-M and metalaxyl belong to the group of phenylamide compounds which are used as fungicide for the control of oomycete pathogens. They are systemic compounds which inhibit mycelial growth and sp

42、ore formation by selectively interfering with the synthesis of ribosomal ribonucleic acid (RNA) in fungi. Metalaxyl-M is considered as the most effective enantiomer. Metalaxyl-M was evaluated in the framework of Directive 91/414/EEC with Belgium being the designated rapporteur Member State (RMS). Th

43、e representative uses supported at EU level were outdoor foliar treatment of grapes and various annual crops (potatoes, onions, tomatoes, cucumbers, melons, broccoli, spinach, artichoke and tobacco), and outdoor and indoor treatments of lettuce. Following the peer review, a decision on inclusion of

44、the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2002/64/EC6, entering into force on 1 October 2002. According to Regulation (EU) No 540/20117, metalaxyl-M is approved under Regulation (EC) No 1107/20098. This approval is restricted to uses as fu

45、ngicide only. As EFSA was not involved in the peer review of metalaxyl-M, a conclusion of EFSA on this active substance is not available. It is noted that the review of the existing MRLs for metalaxyl-M according to Article 12 of Regulation (EC) No 396/2005 (Article 12 MRL review) has been recently

46、finalized and the reasoned opinion of EFSA has been issued on 6 December 2011 (EFSA, 2011). The conclusions reached in the Article 12 MRL review have been taken into consideration when assessing the current MRL application. Metalaxyl is a mixture of metalaxyl-M and its S-enantiomer, whereas metalaxy

47、l-M is individually used as an active substance. The MRLs of these active substances are therefore closely related. The EU MRLs for metalaxyl and metalaxyl-M are established in Annexes II and IIIB of Regulation (EC) No 396/2005 (Appendix C) according to the residue definition “metalaxyl and metalaxy

48、l-M (metalaxyl including other mixtures of constituent isomers including metalaxyl-M (sum of isomers)”. The existing EU MRLs for the crops under consideration are set as follows: 0.2 mg/kg in lambs lettuce, 2 mg/kg in lettuce, rocket/rucola, leaves and sprouts of Brassica, 1 mg/kg in scarole, land c

49、ress and 0.05 mg/kg (LOQ) in cress and red mustard. CXLs for metalaxyl are also established by the Codex Alimentarius Commission for a wide range of commodities, but not for all of the crops under consideration. A CXL of 2 mg/kg is established for head lettuce. These CXLs also refer to metalaxyl inc

50、luding metalaxyl-M. The intended GAPs in France for which a modification of the existing MRLs is requested are given in Appendix A. 6 Commission Directive 2002/64/EC of 15 July 2002, OJ L 189, 18.7.2002, p. 27-32. 7 Regulation (EU) No 540/2011 of 25 May 2011, OJ L 153, 11.6.2011, p1-186. 8 Regulatio