Post on 08-Jan-2016
description
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
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
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
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 8
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 …
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 9
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 …
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 10
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
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 11
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
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 12
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
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/EEC3. Directive relating to the essential
requirements in environmental protection concerning new equipments for applying pesticides
4. Regulation relating to statistics on pesticides
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
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
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
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
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
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
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
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
– …
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 22
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
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia 24-25 January 2008 23
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
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
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
Thank you
www.audace-ass.com
sdd@audace-ass.comroques.audace@club-internet.fr