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. 2014 Jan 15;12(1):3543. doi: 10.2903/j.efsa.2014.3543

Reasoned opinion on the modification of maximum residue levels (MRLs) for fipronil following the withdrawal of the authorised uses on kale and head cabbage

European Food Safety Authority
PMCID: PMC13159804  PMID: 42125105

Abstract

In accordance with Article 43 of Regulation (EC) No 396/2005, EFSA received a request of the European Commission for a scientific opinion on the modification of MRLs for the active substance fipronil. The European Commission requested EFSA to recalculate the MRLs for fipronil in animal commodities which were recommended by EFSA in its previous reasoned opinion on the review of the existing MRLs for fipronil according to Article 12 of Regulation (EC) No 396/2005, and to update EFSA's conclusion on the safety of all proposed MRLs. For this assessment EFSA was also requested to take into account the existing emergency authorisation of fipronil on potatoes as granted in Germany and the recent withdrawal of fipronil authorisations in Europe on head cabbage and kale. MRL proposals were derived by EFSA according to different scenarios, as requested by the European Commission, and a consumer risk assessment was carried out for each scenario. Regardless of the scenario presented, no information required by the regulatory framework was found to be missing and no risk to consumers was identified.

Keywords: fipronil, potatoes, food of animal origin, consumer risk assessment, phenylpyrazole, insecticide

European Food Safety Authority , 2014. Reasoned opinion on the modification of maximum residue levels (MRLs) for fipronil following the withdrawal of the authorised uses on kale and head cabbage. EFSA Journal 2014;12(1):3543, 37 pp. doi: 10.2903/j.efsa.2014.3543

Correspondence: pesticides.mrl@efsa.europa.eu

Approval date: 15 January 2014

Published date: 15 January 2014

Question number: EFSA‐Q‐2013‐00843

On request from: European Commission

References

  1. EC (European Commission) , 1996. Appendix G. Livestock Feeding Studies. 7031/VI/95‐rev.4.
  2. EC (European Commission) , 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95‐rev.3.
  3. EC (European Commission) , 1997b. Appendix B. General recommendations for the design, preparation and realisation 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.
  4. EC (European Commission) , 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95‐rev.2.
  5. EC (European Commission) , 1997d. Appendix E. Processing studies. 7035/VI/95‐rev.5.
  6. EC (European Commission) , 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95‐rev.3.
  7. EC (European Commission) , 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95‐rev.5.
  8. EC (European Commission) , 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95.
  9. 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.
  10. EC (European Commission) , 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of 23‐24 March 2010.
  11. EC (European Commission) , 2010b. Residue analytical methods. For post‐registration control. SANCO/825/00‐rev.8.1.
  12. EC (European Commission) , 2011. Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95‐rev.9.
  13. EFSA (European Food Safety Authority) , 2006. Conclusion on the peer review of the pesticide risk assessment of the active substance fipronil. The EFSA Journal 2006, 65r, 1–110. [Google Scholar]
  14. EFSA (European Food Safety Authority) , 2007. Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. Available online: www.efsa.europa.eu
  15. EFSA (European Food Safety Authority) , 2012a. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for fipronil according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2012;10(4):2688, 44 pp. doi:10.2903/j.efsa.2012.2688 [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. EFSA (European Food Safety Authority) , 2012b. Reasoned opinion on the modification of the existing MRLs for fipronil in poultry fat. EFSA Journal 2012;10(5):2707, 32 pp. doi:10.2903/j.efsa.2012.2707 [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. EFSA (European Food Safety Authority) , 2013. Conclusion on the peer review of the pesticide risk assessment for bees for the active substance fipronil. EFSA Journal 2013;11(5):3158, 51 pp. doi:10.2903/j.efsa.2013.3158 [DOI] [PMC free article] [PubMed] [Google Scholar]
  18. 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.
  19. France , 2004. Draft assessment report on the active substance fipronil prepared by the rapporteur Member State France in the framework of Council Directive 91/414/EEC, April 2004.
  20. France , 2006. Final addendum to the draft assessment report on the active substance fipronil prepared by the rapporteur Member State France in the framework of Council Directive 91/414/EEC, Part 2 compiled by EFSA, January 2006
  21. OECD (Organisation for Economic Co‐operation and Development) , 2011. OECD MRL Calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March 2011. In: Pesticide Publications/Publications on Pesticide Residues.

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