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Proposal for a Regulation to replace Directive 91/414/EEC

Proposal for a Regulation to replace Directive 91/414/EEC. July 2008. T Lyall. Proposal to Replace Directive 91/414/EEC. HISTORY: Commission proposal adopted 12 th July 2006 Parliament Plenary (1 st reading) in October 2007 Council ‘political agreement’ in June 2008

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Proposal for a Regulation to replace Directive 91/414/EEC

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  1. Proposal for a Regulation to replace Directive 91/414/EEC July 2008 T Lyall

  2. Proposal to Replace Directive 91/414/EEC HISTORY: • Commission proposal adopted 12th July 2006 • Parliament Plenary (1st reading) in October 2007 • Council ‘political agreement’ in June 2008 • Parliament & Council 2nd reading in 1st half 2009 • Publication in mid 2009 • Application 18 months after entry into force (Q1 2011)

  3. EU process (and timelines for Regulation) Commission makes proposal (July 2006) 1st reading Parliament (October 2007) Council of Ministers (June 2008) 2nd reading Parliament (February 2009?) Council of Ministers (April 2009?)

  4. Major issues One issue has become the focus of industry • Cut-off criteria Other issues of interest: • Comparative assessment • Data Protection • Zonal authorisation

  5. Cut-off criteria • Cut-off criteria: • Ban on active substances classified as: • POPs • PBT • vPvB • CMR 1&2 (unless negligible exposure) • Endocrine disruptors (unless negligible exposure) • Derogation for endocrine disruptors, and C-2 & R-2: 5 years authorisation for AS “necessary to control a serious danger to plant health” • Derogation is however limited!!

  6. PSD evaluation of cut-offs - What impact...? PSD evaluation of Commission proposal • Cut-off • Higher figure includes possible endocrine disruptors

  7. PSD evaluation of cut-offs - What impact...? PSD evaluation of Parliament proposal • Cut-off • Combined impact: cut-off OR substitution • Higher figure includes possible endocrine disruptors

  8. What global impact? According to current text, certain substances would be banned “...unless the exposure of humans to that active substance (...), under realistic proposed conditions of use, is negligible Negligible is defined as • ...the product is used in closed systems (...) and • where residues of the active substance (...) on food and feed do not exceed the default value set in accordance with Article 18(1) (b) of Regulation (EC) No 396/2005”. Such a definition would potentially have a negative effect on third countries if the same definition is used in the setting of import tolerances. • ECPA currently discussing with US and other representatives

  9. Proposed Regulation (Point 3.6 of Annex II) “...unless the exposure of humans to that active substance (...), under realistic proposed conditions of use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance (...) on food and feed do not exceed the default value set in accordance with Article 18(1) (b) of Regulation (EC) No 396/2005”. Regulation 396/2005 (Article 18.1(b) The products covered by Annex I shall not contain, from the time they are placed on the market as food or feed, or fed to animals, any pesticide residue exceeding:  (b) 0,01 mg/kg for those products for which no specific MRL is set out in Annexes II or III, or for active substances not listed in Annex IV unless different default values are fixed for an active substance in accordance with the procedure referred to in Article 45(2) while taking into account the routine analytical methods available. Such default values shall be listed in Annex V. Key legislative areas

  10. Comparative Assessment & Substitution • Proposal: • “Candidate for substitution" approved for 10 years by Council • Conditions for comparative assessment in MSs • ECPA View: • Recognise political support for comparative assessment but need to minimise uncertainty Few changes expected in final decision making process

  11. DataProtection • Proposal: • Protection for data for 1st product (not AS) authorisation (incl. extensions) • Study protected for 2.5 years for the review of a product (not AS) authorisation • Extension of data protection provisions: 3 months for each additional minor use (max. 3 additional years) • ECPA View: • No data protection for reviews will reduce investment. More protection needed to encourage minor crop uses. Likely to be agreed with few changes

  12. Conclusion • Advocacy focus is now in the European Parliament • Cut-offs is key issue – food price discussion will help... • ECPA advocacy will include discussions with MEPs from 27 Member States

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