1 / 16

Implementation of Reg. (EC) No 396/2005 Maximum Residues Levels of pesticides AND

Francesca Arena European Commission Health and Consumer Protection Directorate General Unit E3 - C hemicals, Contaminants and Pesticides. Implementation of Reg. (EC) No 396/2005 Maximum Residues Levels of pesticides AND State of play concerning the review programme of Directive 91/414/EEC.

ovidio
Download Presentation

Implementation of Reg. (EC) No 396/2005 Maximum Residues Levels of pesticides AND

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Francesca ArenaEuropean CommissionHealth and Consumer Protection Directorate General Unit E3 - Chemicals, Contaminants and Pesticides Implementation of Reg. (EC) No 396/2005 Maximum Residues Levels of pesticides AND State of play concerning the review programme of Directive 91/414/EEC Advisory group on fruit and vegetables7 March 2008

  2. Pesticide ResiduesMRLs setting Legislation partially harmonised EU- MRLs ± 250 pesticides National MRLs ± 850 pesticides Dir. 76/895/EEC (selected fruits and vegetables) Dir. 86/362/EEC (cereals) Dir. 86/363/EEC (animal products) Dir. 90/642/EEC (fruits and vegetables) No harmonised risk assessment for EU consumers Trade problems 4 Directives  1 Regulation 396/2005 completing process of harmonisation

  3. Implementation of Reg. (EC) 396/2005 Reg. 396/2005 will be fully applicable as from 6 months from the publication of the last of the Annexes I, II, III and IV. Annex I Reg. (EC) No 178/2006 List of commodities Annex II Existing EU MRLs Annex III Reg. (EC) No 149/2008 published on 1 March ‘08 Temporary MRLs Substances for which no MRLs are required Annex IV Under adoption procedure Annex VII Fumigants Reg. (EC) N. 396/2005 application date: 1 September 2008

  4. ANNEX I: List of commoditiesRegulation (EC) N. 178/2006 • 315 commodities – 10 main groups. • 190 existing entries from current Directives. • 125 new entries. • Mainly minor crops (e.g. cassava, thyme, lupins), but also cocoa, coffee, sugar plants. • Fish and plants used inanimal feed listed, but for the time being exempted from MRL setting (not enough information).

  5. ANNEX II: EU-MRLsFirst establishment - Reg. (EC) No 149/2008 • 238 pesticides from current MRLs Directives. • ± 45000 MRLs • only existing crops under current Directives • combinations new crops/238 pesticides in Annex III B • Mostly pesticides for which EU risk assessment has been completed under Dir. 91/414/EEC.

  6. ANNEX III: temporary EU-MRLsFirst establishment - Reg. (EC) No 149/2008 • National MRLs collected until May 2006 on all the non-harmonised substances. • EFSA asked for an opinion (September 2006). • EFSA delivered a reasoned opinion (March 2007). • COM-EFSA-MS: refinement risk assessment (March- September 2007). • SPS notification (July 2007)

  7. ANNEX III: temporary EU-MRLsStructure • Part A • MRLs Harmonisation for 167 pesticides • ± 50000 MRLs • Mostly pesticides not yet evaluated under Dir. 91/414/EEC • Part B • combinations new crops/238 pesticides in Annex II • ± 30000 MRLs

  8. Annexes II and IIIForthcoming update Annex II • Incorporation of new MRLs set in Directives 2007/73/EC and 2008/17/EC Annex III • National MRLs set after May 2006 • Comments received from non-EU Countries (SPS) • Changes requested for 105 substances: • 45 new entries (not covered by current Annex III – part A) • 60 already covered by first establishment Annex III –part A • EFSA asked for an opinion Opinion SCoFCAH: 14 March 2008

  9. Harmonisation = Simplification EU-harmonised MRLs Annex III - Part A National MRLs ca. 65.000 500.000

  10. ANNEX IV: substances for which an MRL is not necessaryFirst establishment and forthcoming update • Reg. 149/2008: • 3 Chemicals • 5 Micro-organisms • Many substances candidate for Annex IV still under evaluation under Dir. 91/414/EEC. • In the forthcoming update several substances (about 40) to be introduced to Annex IV. Opinion SCoFCAH: 14 March 2008

  11. Compliance with MRLs Pesticides not covered by any of the Annexes Default MRL 0,01 mg/kg

  12. EU data base on MRLs It will be publicly available on the DG SANCO Website

  13. State of play concerning the review programme of Directive 91/414/EEC

  14. Commission Reg. (Ec) No 1095/2007 Simplification of procedures for stage 3 and 4 Article 11f: Substance fulfils criteria for clear indications of harmful effects Article 12 (2) (b) Withdrawal within six months of the authorisations Non-inclusion in Annex I Article 12 a “…The Commission shall request the EFSA to deliver its view on the draft review report by 31 December 2010 at the latest….” Article 11b:Substance fulfils criteria for clear indications of no harmful effects Inclusion in Annex I Draft Assessment Report Article 12 (3) “…the latest date for Member States to withdraw authorisations shall be 31 December 2010…” Article 11e Withdrawal by notifier Yes Non-inclusion in Annex I No Article 12 (2) (b) Withdrawal within six months of the authorisations Non-inclusion in Annex I Article 11c PEER REVIEW Article 12 a Inclusion in Annex I Inclusion in Annex I

  15. Documents on the Internet DG SANCO webpage http://ec.europa.eu/dgs/health_consumer/index_en.htm Pesticide Residue Legislation http://ec.europa.eu/food/plant/protection/pesticides/legislation_en.htm Approval of active substances http://ec.europa.eu/food/plant/protection/evaluation/index_en.htm EFSA model http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620776373.htm -

  16. Thank you for your attention

More Related