1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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