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

International Crop-Science

Conference & Exhibition 

24 - 25 January 2008

Daniel ROQUES – President of the association AUDACEStéphane DELAUTRE DROUILLON – Secretary General

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

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

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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

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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

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Proposed Framework DirectiveSustainable 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 …

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Proposed Framework DirectiveSustainable 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 …

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Proposed Framework DirectiveSustainable 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

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Proposed Framework DirectiveSustainable 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

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Proposed Framework DirectiveSustainable 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

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Proposed new legislations

1. Framework directive on the sustainable use of pesticides

2. Regulation to replace directive 91/414/EEC3. Directive relating to the essential

requirements in environmental protection concerning new equipments for applying pesticides

4. Regulation relating to statistics on pesticides

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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

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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

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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

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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

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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

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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

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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

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Proposed New Regulation to replace directive 91/414/EEC

EU Parliament vote on First Reading on the 23rd October 2007

253 amendments– One zone

– …

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Community revision programme of existing active substancesSept. 2007 Number of active

substances to bereviewed

of which somany werenot notified

and notified

First phase 90 0 90

Second phase 148 96 52

Third phase 403 240 163

Fourth phase 343 82 261

In total 984 418 566

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Community review programme of existing active substancesSept. 2007 Total number

of activesubstances

notified

of which

(*) ‘not included’

of which‘included in

the positive list’

Yet to bereviewed

First phase 90 31 59 0

Second phase 52 20 31 1

Third phase 163 26 0 137Dec. 2008 deadline

Fourth phase 261 110 0 151Dec. 2008 deadline

In total 566 186 90 290

(*) following assessment or withdrawn

Authorisations on those active substances included in Annex I early in the Review Programme

will need to be renewed

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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

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2008 2010 …

Since the programme was launched in 2002, local and international conditions have drastically changed factors underpinning policy

Legal Economic Agricultural Public opinion

Thank you

www.audace-ass.com

sdd@audace-ass.comroques.audace@club-internet.fr