1. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 1

3. International Crop-Science Conference & Exhibition 24 - 25 January 2008 Daniel ROQUES – President of the association AUDACE Stéphane DELAUTRE DROUILLON – Secretary General

4. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 4 European Union Strategy Since 1973, the EU's environmental action programmes define the future orientations of EU policy in the environmental field and suggest specific proposals that the Commission intends to put forward over the next years The sixth environmental action programme (6th EAP) was proposed by the Commission in 2001 and adopted under the co-decision procedure by Council and Parliament in 2002

5. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 5 European Union Strategy Seven thematic strategies are defined within the 6th European Action Programme for the environmental (2002-2012), one of which concerns the “sustainable use of pesticides” –Common objectives and requirements in order to ensure coherence throughout the EU –Minimise the hazards and risks to health and environment from the use of pesticides in a way that is compatible with the necessary protection of crops

6. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 6 Sustainable use of pesticides strategy In order to implement the strategy Measures integrated within existing legislation Regulation 1698/2005 - Rural Development Regulation 396/2005 – harmonised maximum residue levels of pesticides in food and feed MRL Framework Directive 60/2000 – water New legislations

7. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 7 Proposed new legislations 1. Framework directive on the sustainable use of pesticides 2. Regulation to replace directive 91/414/EEC 3. Directive relating to the essential requirements in environmental protection concerning new equipments for applying pesticides 4. Regulation relating to statistics on pesticides

8. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 8 Proposed Framework Directive Sustainable Use of Pesticides 1. Minimising the hazards and risks to health and environment from the use of pesticides through –national plans for reduction of hazards, risks and dependence on chemical control –best practices in river basin management –specific protection of sensitive areas –general ban of aerial spraying with derogations under specific conditions –support to research programmes for epidemiological research on users, consumers –technical improvements of application and protection equipment –risks / benefits analysis for PPPs and alternatives …

9. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 9 Proposed Framework Directive Sustainable Use of Pesticides 2. Improved controls on the use and distribution of pesticides –statistics of production, import / export and use (logbooks) –control of spraying equipment –packaging waste –compulsory training of users …

10. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 10 Proposed Framework Directive Sustainable Use of Pesticides 3. Application of the substitution principle –quicker implementation (review of old active ingredient) + amendments of 91/414 = pre- requisites –pest resistance concern

11. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 11 Proposed Framework Directive Sustainable Use of Pesticides 4. Encouraging low-input or pesticide-free crop farming –Integrated Pest Management (IPM) –potential of genetically modified organisms (GMO) –Good Farming Practices / financial support (CAP) / penalties (compliance) –special levies on PPPs, harmonised VAT rate for PPPs

12. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 12 Proposed Framework Directive Sustainable Use of Pesticides 5. Feed-back, indicators to evaluate progress : report by MS on risk reduction programmes, quantitative targets, OECD work on harmonisation of indicators 6. Candidate countries : support of programmes for obsolete PPPs, support through SAPARD- measures 7. International aspect : Prior Informed Consent (PIC) and Persistent Organic Pollutants (POPs) conventions to be ratified, support to ACP countries

13. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 13 Proposed new legislations 1. Framework directive on the sustainable use of pesticides 2. Regulation to replace directive 91/414/EEC 3. Directive relating to the essential requirements in environmental protection concerning new equipments for applying pesticides 4. Regulation relating to statistics on pesticides

14. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 14 Proposed New Regulation to replace directive 91/414/EEC Objectives : reinforce the high level of protection of human health and the environment improve functioning of the internal market maintain and enhance the competitiveness of the EU chemical industry harmonise availability of plant protection products between farmers in different Member States, increase transparency avoid repetition of animal testing update and simplify the procedures – speed up decision taking define the role of the European Food Safety Authority

15. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 15 Proposed New Regulation to replace directive 91/414/EEC Measures aiming at protecting public health and the environment : Reinforced approval criteria for active substances Comparative assessment and substitution principal Regulation to apply to safeners and synergists and to produce a negative list of co-formulants Producers, suppliers, distributors and professional users of plant protection products shall keep records Informing neighbours of the use of plant protection products Integrated Pest Management (IPM) by January 2014 Control measures are reinforced New rule prohibiting the duplication of tests on vertebrate animals

16. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 16 Proposed New Regulation to replace directive 91/414/EEC Measures aiming at improving the working of the single market : Direct effect for all provisions included in a regulation without transposition in national law, as opposed to a directive EU divided in 3 zones The marketing authorisation application will be assessed by one member State and on behalf of the others in the same zone Abolishment of provisional authorisations

17. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 17 Proposed New Regulation to replace directive 91/414/EEC Measures aiming at increasing transparency : Access to information Role of EFSA Rules governing confidentiality Provisions on record keeping and information about the use of plant protection products Obligation to inform any neighbours who could be exposed to the spray drift Rules to ensure that advertisements do not mislead users of plant protection products Provisions on packaging and labelling over and above directive 1999/45/EC

18. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 18 Proposed New Regulation to replace directive 91/414/EEC Measures for promoting innovation : Access to information (MS ; EFSA) Limitation on data protection Information relating to the list of protected data Harmonised and enforceable rules to share data and avoid duplication of tests and studies involving vertebrates Provision of strict deadlines for decisions at all levels, thus increasing predictability and improving access to the market Obligatory zonal mutual recognition will bring benefits of administrative and procedural simplification

19. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 19 Proposed New Regulation to replace directive 91/414/EEC The proposed new regulation follows the CODECISION PROCEDURE based on the principle of parity, it means that neither institution (European Parliament or Council) may adopt legislation without the other's assent

20. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 20 Proposed New Regulation to replace directive 91/414/EEC The Council experts working group under German presidency Comparative assessment and substitution principle (workshop in Sweden, 8 May 2007) Abolishment of provisional authorisations – contested Mutual recognition (workshop in Germany 14-15 June 2007) –Volontary v obligatory –More zones; inter zone … Data protection – contested –5 years following the review –Extended in case of support to ‘minor use’ Parallel imports – introduction of a new article 49a Integrated Pest Management (IPM) – contested –January 2014 v 2019 AUDACE had obtained ‘no data protection over and above patent protection’, i.e. following the review

21. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 21 Proposed New Regulation to replace directive 91/414/EEC EU Parliament vote on First Reading on the 23rd October 2007 253 amendments –One zone –…

22. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 22 Community revision programme of existing active substances Sept. 2007Number of active substances to be reviewed of which so many were not notified and notified First phase 90 0 Second phase148 96 52 Third phase403240163 Fourth phase343 82261 In total984418566

23. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 23 Community review programme of existing active substances Sept. 2007Total number of active substances notified of which (*) ‘not included’ of which ‘included in the positive list’ Yet to be reviewed First phase 90 3159 0 Second phase 52 2031 1 Third phase163 26 0137 Dec. 2008 deadline Fourth phase261110 0151 Dec. 2008 deadline In total56618690290 (*) following assessment or withdrawn Authorisations on those active substances included in Annex I early in the Review Programme will need to be renewed

24. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 24 Community revision programme of existing active substances as a consequence 90 a. s. included in annexe 1 (30 septembre 2007) 289 a. s. still under review from 1000 a. s. available on the EU market in 1991 only 379 at the most can still pretend to be present at the end of the review programme National plans can further influence the number of a. s. available on the market

25. AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 25 2008 2010 … Since the programme was launched in 2002, local and international conditions have drastically changed factors underpinning policy Legal Economic Agricultural Public opinion

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