Implementation of EU Plant protection legislation Laurence Cordier European Commission DG Health and Consumers Unit E3 April 2013

Transcription

1 Implementation of EU Plant protection legislation Laurence Cordier European Commission DG Unit E3 April 2013

2 Overview Introduction EU plant protection legislation Approval of actives substances in the EU Authorisation of plant protection products Judicial review of Regulations on active substances

3 EU Pesticide legislation PLACING ON THE MARKET SUSTAINABLE USE RESIDUES IN FOOD/FEED Regulation 1107/2009 Directive 2009/128/EC Regulation 396/2005 +

4 Placing on the market of plant protection products Regulation 1107/ Objectives High level of protection of human and animal health and of the environment Safeguard competitiveness of EU agriculture Increase free movement and availability of plant protection products

5 Reg. 1107/2009 Dual system Active substances Plant protection products EU approval National authorisation

6 Approval of Active Substances COMPANY (or consortium): Application according to the data requirements Rapporteur MEMBER STATE: Admissibility check (45 days) Evaluation (12 months) EFSA: Consultations (2 months) Conclusions (4 months) COMMISSION: Review report + draft Regulation (6 months) TOTAL =minimum 2,5 years for the approval

7 Reg. 1107/2009 Risk assessment of active substances (I) Member State =>Rapporteur for a substance Checks the completeness of the application Evaluates the application according to the Uniform Principles of Evaluation Within one year prepare the Draft Assessment Report (DAR)

8 Reg. 1107/2009 Risk assessment of active substances (II) EFSA => peer review Publishes = summary dossier + Draft Assessment Report (except confidential information) Circulates Draft Assessment Report and collects comments from other Member States Organises a consultation of experts (optional) Adopts its CONCLUSIONS

9 Reg. 1107/2009 Risk Management The Commission prepares a Review report and a draft Regulation: risk management decision Approval/Renewal of the active substance Non approval Set conditions for the approval: restrictions or confirmatory data Amendment of approval Adopts the Regulation (involvement of the MS through the committee)

10 Reg. 1107/2009 Approvals: Cut-off Criteria Substances of high concern for human health Carcinogens (cat 1A,1B) Mutagens (cat 1A,1B) Toxic for reproduction (cat 1A,1B) Endocrine disrupters Substances of high concern for the environment POP (persistent, organic pollutant) PBT (persistent, bioaccumulative and toxic) vpvb (very persistent and very bioaccumulative)

11 Reg. 1107/2009 Authorisation of Plant protection products (zonal system) Company: prepares an application with complete dossier concerning the product + sends it to rapporteur and 'concerned' Member States NB New Data requirements (Reg 283/2013 and 284/2013) Zonal Rapporteur Member State: performs admissibility check (45 days) + Evaluation (12 months) according to the Uniform principles of evaluation (Reg 546/2011)

12 Reg. 1107/2009 Zonal system North Center South

13 Reg. 1107/2009 Authorisation of plant protection products (zonal system) 3 zones instead of 27 Member States One evaluation per zone = less administrative burden Authorisations granted in all 'concerned' Member States of the same zone within 120 days = harmonisation (Possibility to refuse only in cases of specific environmental or agricultural circumstances) In the case of products for post-harvest treatment, seed treatment and greenhouse => one zone

14 Reg. 1107/2009 Cooperation between Commission and Member States Development of Guidance and 'Questions and Answers' Regular meetings: Standing committee meetings (all Member States) Post-approval Working Group (discuss issues such as authorisations, data protection, parallel trade) 3 Zonal steering groups +interzonal steering committee Repartition of work (e.g. renewal of approvals)

15 JUDICIAL REVIEW OF APPROVALS AND NON APPROVALS Article 263 of the Treaty on the Functioning of the European Union (ex. Article 230 TEC) => Court of Justice reviews the legality of the acts of the Commission. "Any natural or legal person may institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures." => Proceedings must be instituted within two months

16 Judicial review (I) Approvals and non-approvals of substances are regularly challenged before the European Court of Justice. Since 2003 = 74 cases (Main cases 41 - Interim measures 33) Mostly from Industry (Article 263 of TFEU) Member States: 1 case (C-229/04) NGOs more recently (5 related to Internal reviews and 2 to Access to documents)

17 Judicial review (II) Challenges by Industry Basis for challenges of approval and non-approval Regulations 1. - contradiction with the principle of proportionality 2. - contradiction with the precautionary principle 3. - contradiction with the principle of subsidiarity See for example Judgement in T-31/07 (12/4/2013)

18 Judicial Review (III) Challenges by environmental NGOs Request for Internal Reviews on the basis of Aarhus Regulation (Reg 1367/2006) I. => Challenges of refusal to perform an Internal review (cases T-192/12 prochloraz; T-458/12 metam ; T-8/13 bifenthrin) II. => Challenge of the Internal reviews (T-574/12) Request for access to documents =>Challenge of refusal to grant access to the confidential part of applications

19 Conclusion 1. - Pesticide Regulation based on dual system - Requires an important cooperation between Commission and MS authorities - Subject to a large amount of challenges from industry and more and more from NGOs