现行茶叶中己噻唑的最大残留限量修改.pdf

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1、 EFSA Journal 2012;10(1):2514 Suggested citation: European Food Safety Authority; Modification of the existing MRL for hexythiazox in tea. EFSA Journal 2012;10(1):2514. 24 pp. doi:10.2903/j.efsa.2012.2514. Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2012 REASONED

2、 OPINION Modification of the existing MRL for hexythiazox in tea1 European Food Safety Authority2 European Food Safety Authority (EFSA), Parma, Italy SUMMARY According to Article 6 of the Regulation (EC) No 396/2005, Finland, herewith referred to as the Evaluating Member State (EMS), received an app

3、lication from Nisso Chemical Europe GmbH to set an import tolerance for hexythiazox in tea. In order to accommodate the authorized use of hexythiazox on tea in India, it is proposed to raise the existing MRL from 0.05* mg/kg to 4 mg/kg. The Rapporteur Member State (RMS) Finland drafted an evaluation

4、 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 the following conclusions based on the submitted evaluation report prepared by the EMS as well as the Draft Assessment Report (DAR) and the

5、 Assessment Report (AR) prepared by Finland under Directive 91/414/EEC (Finland 2006 and 2009). The toxicological profile of hexythiazox was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.03 mg/kg bw/day. Due to the low acut

6、e toxicity of the active substance the setting of an ARfD was considered not necessary. The metabolism of hexythiazox in primary crops was investigated in fruit crops (grape, citrus, pear and apple) and a leafy crop (tea). From these studies the peer review concluded to establish the residue definit

7、ion for risk assessment and enforcement as hexythiazox alone. For the use on tea, EFSA concluded that the metabolism in primary crops is sufficiently elucidated and that the derived residue definitions are appropriate. The supervised residue trials are sufficient and adequate to derive an import tol

8、erance of 4 mg/kg (based on the new classes for setting pesticides MRLs) for the intended use of hexythiazox on tea. Analytical methods are available to analyse for residues of hexythiazox. The methods are fully validated on high water and high acid containing plant matrices, but additional validati

9、on data for tea are required to demonstrate the suitability of these methods for tea. The effects of processing on the nature of the residues have been investigated during the peer review. In the standard hydrolysis study, a limited degradation of hexythiazox was observed under pasteurisation and ba

10、king/cooking conditions. In contrast, hexythiazox was strongly degraded to the metabolite PT-1-3 under sterilisation conditions. No final conclusions could be made on the nature of the residues in processed commodities, as no sufficient data were provided on PT-1-3 in processed 1 On request from the

11、 European Commission, Question No EFSA-Q-2011-00826, issued on 21 December 2011. 2 Correspondence: pesticides.mrlefsa.europa.eu Modification of the existing MRL for hexythiazox in tea EFSA Journal 2012;10(1):2514 2 fractions. Moreover, as it was demonstrated that PT-1-3 is more acutely toxic than he

12、xythiazox, additional toxicological information and additional data on the transfer of PT-1-3 are required before to conclude on a residue definition for hexythiazox in processed commodities and to derive processing factors. The residues of hexythiazox in rotational crops are of no relevance for the

13、 import tolerance application. Residues of hexythiazox in commodities of animal origin were not assessed in the framework of this application, since tea is normally not fed to livestock. The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the calculation of the chronic

14、exposure EFSA used the STMR value for tea as derived from the supervised field trials. For other food commodities of animal and plant origin, the existing MRLs as established in Annex III of Regulation (EC) No 396/2005 were used as input values. STMR values were not available to refine the intake ca

15、lculations. Acute exposure calculations were not undertaken as the setting of an ARfD was considered not necessary for hexythiazox. No long-term consumer intake concerns were identified for any of the European diets. The total calculated intake values ranged from 15 to 93 % of the ADI (DE child diet

16、). The contribution of residues in tea to the total consumer exposure accounted for a maximum of 0.6 % of the ADI (IE adult diet). EFSA concludes that the proposed MRL on imported tea will not result in a consumer exposure posing a consumer health risk. Thus EFSA proposes to amend the current MRLs a

17、s proposed in the table below: Code numbera Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Justification for the proposal Enforcement residue definition: hexythiazox 0610000 Tea (dried leaves and stalks of Camellia sinensis) 0.05* 4 No risk for consumers was identified for the use on tea.

18、 However, the applicability of the analytical method for tea needs to be confirmed by providing validation data. (*): 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 Hexythiazox, tea, MRL application, Regulation

19、 (EC) No 396/2005, consumer risk assessment, thiazolidine. Modification of the existing MRL for hexythiazox in tea EFSA Journal 2012;10(1):2514 3 TABLE OF CONTENTS Summary . 1 Table of contents . 3 Background . 4 Terms of reference . 4 The active substance and its use pattern . 5 Assessment . 6 1. M

20、ethods of analysis . 6 1.1. Methods for enforcement of residues in food of plant origin . 6 1.2. Methods for enforcement of residues in food of animal origin . 6 2. Mammalian toxicology . 7 3. Residues . 7 3.1. Nature and magnitude of residues in plant . 7 3.1.1. Primary crops . 7 3.1.2. Rotational

21、crops . 11 3.2. Nature and magnitude of residues in livestock . 11 4. Consumer risk assessment . 11 Conclusions and recommendations . 13 References . 15 Appendix A. Good Agricultural Practices (GAPs). 17 Appendix B. Pesticide Residues Intake Model (PRIMo) . 18 Appendix C. Existing EU maximum residue

22、 limits (MRLs) . 19 Appendix D. List of metabolites and related structural formula . 22 Abbreviations . 23 Modification of the existing MRL for hexythiazox in tea EFSA Journal 2012;10(1):2514 4 BACKGROUND Commission Regulation (EC) No 396/20053 establishes the rules governing the setting of pesticid

23、e MRLs at Community level. Article 6 of that regulation lays down that any party having a legitimate commercial interest may submit to the rapporteur Member State designated pursuant to Council Directive 91/414/EEC4 an application to set an import tolerance in accordance with the provisions of Artic

24、le 7 of that regulation. Finland, hereafter referred to as the evaluating Member State (EMS), received from the company Nisso Chemical Europe GmbH5 an application to modify the existing MRL for the active substance hexythiazox in tea. This application was notified to the European Commission and EFSA

25、 and subsequently evaluated by the EMS in accordance with 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

26、was included in the EFSA Register of Questions with the reference number EFSA-Q-2011-00826 and the following subject: Hexythiazox Application to modify the existing MRL in tea EFSA then proceeded with the assessment of the application as required by Article 10 of the Regulation. TERMS OF REFERENCE I

27、n 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 associated with the application. In accordance with Article 11 of that Regulation, the reasoned opi

28、nion 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 application. Where EFSA requests supplementary information, the time limit laid down shall be

29、suspended until that information has been provided. In this particular case the calculated deadline for providing the reasoned opinion is 23 September 2011. 3 Commission Regulation (EC) No 396/2005 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

30、 230, 19.8.1991, p. 1-32. 5 Nisso Chemical Europe GmbH, Berliner Allee 42, 40212 Dsseldorf, Germany Modification of the existing MRL for hexythiazox in tea EFSA Journal 2012;10(1):2514 5 THE ACTIVE SUBSTANCE AND ITS USE PATTERN Hexythiazox is the ISO common name for (4RS,5RS)-5-(4-chlorophenyl)-N-cy

31、clohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide (IUPAC). The chemical structure of the compound is herewith reported. NSOCONHClCH3 Molecular weight: 352.9 g/mol Hexythiazox is a non-systemic acaricide belonging to the thiazolidine chemical group and used in agriculture and horticulture. Hexyt

32、hiazox acts by contact and stomach action. It has ovicidal, larvicidal and nymphicidal activity. It is not active against adult species, but eggs laid by treated females do not survive. Hexythiazox is an active substance which was evaluated according to Directive 91/414/EEC with Finland designated a

33、s rapporteur Member State (RMS). It was included in Annex I of this Directive by Directive 2011/46/EU6 which entered into force on 1st June 2011 for use as acaricide only. The representative uses evaluated in the peer review and supported by the applicant were foliar applications on oranges, mandari

34、ns, pome fruits and grapes. The Draft Assessment Report (DAR) and Additional Report (AR) of hexythiazox have been peer reviewed by EFSA (EFSA, 2011). The EU MRLs for hexythiazox are established in Annex III of Regulation (EC) No 396/2005 (Appendix C) for a wide range of crops. The existing EU MRL fo

35、r hexythiazox on tea is set at the LOQ of 0.05 mg/kg. Codex Alimentarius has established CXLs for hexythiazox on a wide range of commodities but no CXL has been set for tea. The intended GAPs for which the import tolerance is requested in EU refer to the Indian agricultural practices defined as 2 fo

36、liar applications of an EC formulation containing 5.45 g hexythiazox/kg at a rate of 22 to 27 g a.s./ha and per application, with a PHI of 3 days. The details of the GAP are given in Appendix A. 6 Commission Implementing Directive 2011/46/EU of 14 April 2011, OJ L 101, 15.4.2011, p. 20-23. Modificat

37、ion of the existing MRL for hexythiazox in tea EFSA Journal 2012;10(1):2514 6 ASSESSMENT EFSA bases its assessment on the evaluation report submitted by the EMS (Finland, 2011), the Draft Assessment Report (DAR) and its Additional Report (AR) prepared under Council Directive 91/414/EEC (Finland, 200

38、6 and 2009), the Commission Review Report on hexythiazox (EC, 2011), the conclusion on the peer review of the pesticide risk assessment of the active substance hexythiazox (EFSA, 2010), the JMPR Evaluation report (FAO, 2008 and 2009). The assessment is performed in accordance with the legal provisio

39、ns of the Uniform Principles for the Evaluation of the Authorization of Plant Protection Products set out in Regulation (EU) No 546/20117 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (EC, 1996, 1997a, 1997b, 1997c, 1997d, 1997e, 1997

40、f, 1997g, 2000, 2004, 2008, 2010, 2011; OECD, 2011a, 2011b). 1. Methods of analysis 1.1. Methods for enforcement of residues in food of plant origin Analytical methods for the determination of hexythiazox residues in plant commodities were assessed in the DAR and the AR (Finland, 2006 and 2009) and

41、in the conclusion on the peer review under Directive 91/414/EEC (EFSA, 2010). It was confirmed that hexythiazox residues can be determined in plant commodities using either a single residue method involving HPLC-UV or the multi-residue method DFG S 19 (extended revision) with GC-ECD detection. Both

42、methods were fully validated (LOQ 0.05 mg/kg) and covered by an appropriate ILV, but for high acid and high water content matrices only. No information was provided by the applicant to confirm that these two methods are also suitable to enforce hexythiazox residues in tea. It should be noted that th

43、e samples from the residue trials were analysed according to a method which was considered as sufficiently validated by the EMS in terms of linearity, precision and specificity, achieving a LOQ of 0.01 mg/kg. This method involves extraction of tea samples with hexane and acetonitrile, clean-up on Fl

44、orisil RP and final quantification by HPLC-DAD. EFSA concludes that additional information has to be provided to confirm whether the analytical methods fully validated for high acid and high water content matrices are also applicable to enforce hexythiazox residues in tea. 1.2. Methods for enforceme

45、nt of residues in food of animal origin Analytical methods for the determination of residues in food of animal origin are not assessed in the current application, since tea is normally not fed to livestock. 7 Commission Regulation (EU) No 546/2011 of 10 June 2011, OJ L 155,11.6.2011, p.127-174 Modif

46、ication of the existing MRL for hexythiazox in tea EFSA Journal 2012;10(1):2514 7 2. Mammalian toxicology The toxicological profile of the active substance hexythiazox was assessed in the framework of the peer review under Directive 91/414/EEC. The data were sufficient to derive toxicological refere

47、nce values for hexythiazox (EFSA, 2011) which are compiled in Table 2-1. Table 2-1: Overview of the toxicological reference values Source Year Value Study relied upon Safety factor hexythiazox ADI EFSA 2011 0.03 mg/kg bw/d 2 year rat 100 ARfD EFSA 2011 Not allocated Not required - It is noted that J

48、MPR has established the same toxicological reference values for hexythiazox (FAO, 2008). 3. Residues 3.1. Nature and magnitude of residues in plant 3.1.1. Primary crops 3.1.1.1. Nature of residues The metabolism of hexythiazox in primary crops was evaluated by the RMS (Finland, 2006 and 2009) and re

49、viewed by EFSA (EFSA, 2011) in the framework of the peer review under Directive 91/414/EEC. Metabolism of hexythiazox in plants has been investigated in fruit crops (grape, citrus, pear and apple) and on a leafy crop (tea) using foliar applications of 14C-hexythiazox labelled on the thiazolidine moi

50、ety. Parent hexythiazox was by far the most predominant component of the radioactive residues, accounting for more than 60% of the TRR 60 days after the last application. Therefore, the residue definitions for enforcement and risk assessment were limited to hexythiazox only. The current residue defi