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MRL re-evaluation_&_guidelines_on_mrls_of_pesticides_and_veterinary_drugs_in_food

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  • Re-evaluation of pesticides,Testking 70-662 Marls for somebody rural products of adopted pesticides without scientific information in the past,Testking 650-987 Pesticides not to be detected because they are not used or recorded domestically There are pesticides and Marls to be deleted for nonnative countries
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MRL re-evaluation_&_guidelines_on_mrls_of_pesticides_and_veterinary_drugs_in_food

  1. 1. MRLs Re-evaluation & Guidelines on MRLs Re-of Pesticides and Veterinary Drugs in Food 2011.10.28 Food Standards Division Korea Food & Drug Administration
  2. 2. CONTENTSPerspectives on Food Safety Risk Maximum Residue Limits(MRLs) Re-evaluation Re- 1 and the Management Guidelines on MRLs of Pesticides and Veterinary 2 Drugs in Food 3 Revision and Establishment of Pesticides MRLs 4 Questions and Answers for the Guidelines
  3. 3. MRLs Re-evaluation and the Management• Pesticides that are not • Re-evaluation Collection registered domestically • Deletion of of comments• Agricultural products pesticides that are not registered for • Deletion of MRLs registered pesticides Deletion of Deletion of agricultural Adoption of MRLs pesticides exemption products for imported that are not lists that are not food registered domestically registered <Positive List System (2014)>
  4. 4. MRLs Re-evaluation and the Management Notice No. 2010-294 of the KFDA(December 31, 2010)- SPS 383• Re-evaluation of pesticides MRLs for individual agricultural products of adopted pesticides without scientific evidence in the past• Pesticides not to be detected because they are not used or registered domestically There are pesticides and MRLs to be deleted for foreign countries to prepare for a period of time (in the attachment 1).
  5. 5. Guidelines on MRLs of Pesticides and Veterinary Drugs in Food Notice No. 2011-159 of the KFDA(August 19, 2011)To clarify procedures of establishment of MRLs, and stablishment Attachment to Foods Import Reportto improve scientific transparency and predictabilityin establishment of MRLs to related companies. stablishment(attachment 2) (SPS- 396)
  6. 6. Clarification for Scope of for the Establishment of MRLsof Pesticides and Veterinary DrugsProcedures and Methods for the Establishment of MRLsExpert Review Foods Import its Operation Attachment to Panel and ReportScope of Materials Submitted for the Establishment of MRLs- Stipulation in Toxicity and Residue Data for theEstablishment of MRLsMethods for the Establishment of MRLs at Each StepVarious forms for the Establishment of MRLs
  7. 7. Article 1 PurposeArticle 2 DefinitionArticle 3 Scope of ApplicationArticle 4 Applications Import Report Amend or Exemption of MRLs Attachment to Foods to Establish,Article 5 Review to Establish, Amend or Exemption of MRLsArticle 6 Expert Review Panel and its OperationArticle 7 Matters for Consideration in Submitting documentArticle 8 Supplementary Data, etc.Article 9 Announcement and NotificationArticle 10 Scope of Documents Submitted for the Establishment of MRLs of PesticidesArticle 11 Scope of Materials Submitted for the Establishment of MRLs of Veterinary Drugs
  8. 8. Revision and Establishment of Pesticides MRLsNotice No. 2011-159 of the KFDA(August 19, 2011)- Establishment of new Group MRLs of stone fruits and pome fruits for Acetamiprid or etc.- Establishment of new MRLs for imported food(orange, lemon, grapefruit) for Azoxystrobin and Fludioxonil- Establishment of new MRLs of agricultural products for 31 types of registered pesticides- Establishment of new MRLs for a newly registered pesticide : Ametoctradin, Imicyafos (attachment 2) WTO (SPS- 396)
  9. 9. Revision and Establishment ofPesticides MRLsNotice No. 2011-189 of the KFDA(September 30, 2011)- Establishment of new Group MRLs of pome fruits for Difenoconazole and Fenarimol- Establishment of new MRLs for imported food(cherry) for Fenpropathrin- Establishment of new MRLs of agricultural products for 16 types of registered pesticides- Revision of MRLs for 10 types including Bifenthrin (attachment 3) WTO (SPS- 397)
  10. 10. Q&A for the GuidelinesQ: Do we have to submit data to both Rural Development Administration(RDA) and Food and Drug Administration to establish MRLs of pesticides? You do not have to submit any data to KFDA if you have submitted toxicity and residue data to RDA to register new pesticides or additional crops. Accordingly, there is no difference from the existing method. However, please note that the time to review the establishment of MRLs of pesticides can be shortened if you submit data to both RDA and KFDA at the same time when you consider submitting data to RDA. -> attachment 4
  11. 11. Q&A for the GuidelinesQ: Is it possible for a company to apply for the establish- ment, change and/or exemption of standards individually to KFDA without going through RDA? If you want to change the MRLs for the currently registered pesticides, the establishment, change and/or exemption of the MRLs can be done when you submit the related data to KFDA and those data are recognized as valid. If you want to change the MRLs for usage and production, the establishment, change and/or exemption of the MRLs can be done if it is considered as valid when you submit the related data to KFDA which will discuss it with RDA. -> attachment 4
  12. 12. Q&A for the GuidelinesQ: It is necessary to clarify data to be submitted and standards for exemptions in case of toxicity because the respiratory toxicity, nervous toxicity and repetitive toxicity among others belong to certain types of pesti- cides. The submission of data can be omitted if you submit the valid reasons when it is recognized as unnecessary to submit data considering foreign regulations and examples among others. -> attachment 4
  13. 13. Q&A for the GuidelinesQ: What does information about impurities in the product mean? Information about impurities shall be submitted if there is any concern of harm to health due to the remaining impurities in any food because some pesticides include the undesired impurities during the manufacturing of crude materials. Example) Dioxin as the impurity during the manufacturing process of 2, 4, 5-T. -> attachment 4
  14. 14. Q&A for the Guidelines Q: Could the time to establish the MRLs be shortened as an enormous deal of economic damages to the company might be caused if the review time takes longer?We are planning to ensure that the announcement of data can bedone generally within 180 days for the additional registration ofcrops, alleviation of standards and/or exemptions, and that thedata review and administrative procedures can be completedwithin 210 days if the time has to be extended because anyopinion is submitted due to the preliminary administrationannouncement. However, it is difficult to shorten the time toestablish the standards because it takes a long time to develop thetesting methods for the applicable pesticides in case of any newpesticides. -> attachment 4
  15. 15. Q&A for the Guidelines Q: It is necessary to improve the submission method because two copies of toxic data and five copies of residue data seem to be not only too many to be submitted, but also vulnerable in security in case of CD and/or DVD.We will make efforts to minimize the number of copies necessaryfor the review when the related regulations are established andenforced, although the number of copies necessary for the reviewshould be submitted by the company due to no regulation on therelated charges as of now. Korea KFDA will ensure no leakage ofany data due to CD and/or DVD which any company submit to usunder our responsibility. -> attachment 4
  16. 16. Thank you! Food Standards Division Korea Food & Drug Administration HP: www.kfda.go.kr☎ 043-719-2416, E-mail: kfda4797@korea.kr

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