Update on EU draft Regulation Strategic Co-ordination Group for the WFD Common Implementation Strategy 11 March 2009, Brussels Update on EU draft Regulation concerning the placing of plant protection products on the market Wolfgang Reinert Unit E.3 – Chemicals, Contaminants and Pesticides

Important objectives of the proposal To protect human and animal health and the environment To safeguard the competitiveness of agriculture To provide for a common market To speed up decision making

Key issues (Impact Assessment) Commission Proposal Key issues (Impact Assessment) National provisional authorisations Zonal mutual recognition Comparative assessment and substitution principle Data protection and data sharing for renewal of approval Information about use

Other issues (Adjustments) Commission Proposal Other issues (Adjustments) Criteria for approval Scope (safeners & synergists, co-formulants) IPM Renewal of approval Role of EFSA Fees and charges (in line with recent rules) Data access / confidentiality Minor Uses Monitoring and controls Human testing Low risk/basic substances

State of affairs and dates foreseen COM proposal on 19 July 2006 First reading in European Parliament on 23 October 2007 Political agreement on 23 June 2008 in Council Common position on 15 September 2008 Second reading in European Parliament on 13 January 2009 Adoption in Council expected spring 2009 Entry into force expected mid 2010

Provisional authorisations Art. 30 Provisional authorisations can be granted under strict conditions: - Assessment delayed (> 30 months) - Dossier is admissible - MS conclude on safe use - MRLs have been established Transitional measure (78 months) with revision clause

Zonal Mutual Recognition Major issues under discussion Zonal Mutual Recognition Art 40 (also: 41, 36) 3 zones (+ greenhouse/post harvest uses) Obligatory Mutual Recognition within a zone Voluntary Mutual Recognition between zones, for candidates for substitution, for provisional authorisations, for derogations under art. 4(7) Mutual Recognition without application in case of a prevailing public interest Adapting risk mitigation measures is possible in order to address the specific situation in a MS Possibility to refuse Mutual recognition in case of a serious risk for health or the environment

Substitution and Comparative Assessment Major issues under discussion Substitution and Comparative Assessment Art. 50, Annex II.4, Annex IV Candidates for substitution identified at EU level Comparative Assessment at MS level Criteria: high ADI/ARfD/AOEL, PB/PT/BT, non-manageable concerns, high in non-active isomers, falls under derogation in Art. 4(7) Approval period: 7 years

Major issues under discussion Data protection Initial period of 10 years 13 years for low risk products Additional data protection for minor uses (3 months per additional minor use, maximum 3 years) Total period not longer than 15 years Improved protection of animals 2.5 years of data protection for additional data at review/renewal

Information of neighbours Major issues under discussion Information of neighbours Art. 31: Inform neighbours after notification of interest (possible label requirement) Art. 67: - Keep records (3 years for professional users, 5 years for producers and distribution chain) and make them available to competent authorities on request - Third parties may address the Competent Authority for access to these data - COM to explore costs and benefits of a traceability system between users and retailer

Criteria for approval (1/2) Major issues under discussion Criteria for approval (1/2) Annex II.3 CMR cat. 1&2, POP, PBT, vPvB, endocrine disruption Exemption for CR cat. 1&2 if only negligible exposure Endocrine Disruptors: - COM to present specific scientific criteria within 4 years - Transitional regime: CR cat. 3 shall and R cat. 3 + toxic to endocrine organs may be considered as endocrine disruptors

Criteria for approval (2/2) Major issues under discussion Criteria for approval (2/2) Art. 4(7) Derogation in order to control a serious danger to plant health Endocrine disruptors and CR cat. 2 can be approved for 5 years MS to report on possible phasing out Burden of proof on notifier