Health and Consumers

Implementation of EU Plant protection legislation

Laurence Cordier European Commission

DG Health and Consumers Unit E3

April 2013

Health and Consumers

Overview

1. 1. Introduction EU plant protection

legislation

2. 2. Approval of actives substances in the EU

3. 3. Authorisation of plant protection

products

4. 4. Judicial review of Regulations on active

substances

Health and Consumers

EU Pesticide legislation

PLACING ON THE MARKET

SUSTAINABLE USE

RESIDUES IN FOOD/FEED

Regulation 1107/2009

Directive 2009/128/EC

Regulation 396/2005

+

Health and Consumers

Placing on the market of plant protection products

Regulation 1107/2009

+

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

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Reg. 1107/2009

Dual system

Active substances

EU approval

Plant protection products

National authorisation

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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

Approval of Active Substances

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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)

Reg. 1107/2009

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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

Reg. 1107/2009

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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)

Reg. 1107/2009

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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)

Reg. 1107/2009

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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)

Reg. 1107/2009

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North

Center

South

Zonal system Reg. 1107/2009

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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

Reg. 1107/2009

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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)

Reg. 1107/2009

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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

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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)

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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)

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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

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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