Transcript AUDACE - PMFAI Kuala Lumpur Jan2008

AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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International Crop-Science
Conference & Exhibition
24 - 25 January 2008
Daniel ROQUES – President of the association AUDACE
Stéphane DELAUTRE DROUILLON – Secretary General
European Union Strategy
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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
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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
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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
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Sustainable use of pesticides strategy
In order to implement the strategy
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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
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New legislations
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Proposed new legislations
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
1.
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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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 …
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Proposed Framework Directive
Sustainable Use of Pesticides
2.
Improved controls on the use and
distribution of pesticides
–
–
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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
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Proposed Framework Directive
Sustainable Use of Pesticides
3.
Application of the substitution principle
–
–
quicker implementation (review of old active
ingredient) + amendments of 91/414 = prerequisites
pest resistance concern
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Proposed Framework Directive
Sustainable Use of Pesticides
4.
Encouraging low-input or pesticide-free crop
farming
–
–
–
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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
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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 SAPARDmeasures
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
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Proposed new legislations
1.
2.
3.
4.
Framework directive on the sustainable use
of pesticides
Regulation to replace directive 91/414/EEC
Directive relating to the essential
requirements in environmental protection
concerning new equipments for applying
pesticides
Regulation relating to statistics on
pesticides
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Proposed New Regulation
to replace directive 91/414/EEC
Objectives :
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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
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Proposed New Regulation
to replace directive 91/414/EEC
Measures aiming at protecting public health and the environment :
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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
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Proposed New Regulation
to replace directive 91/414/EEC
Measures aiming at improving the working of the single market :
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Direct effect for all provisions included in a regulation without
transposition in national law, as opposed to a directive
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EU divided in 3 zones
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The marketing authorisation application will be assessed by one
member State and on behalf of the others in the same zone
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Abolishment of provisional authorisations
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Proposed New Regulation
to replace directive 91/414/EEC
Measures aiming at increasing transparency :
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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
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Proposed New Regulation
to replace directive 91/414/EEC
Measures for promoting innovation :
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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
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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
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Proposed New Regulation
to replace directive 91/414/EEC
The Council experts working group under German presidency
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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)
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– Volontary v obligatory
– More zones; inter zone …
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Data protection – contested
– 5 years following the review
– Extended in case of support to ‘minor use’
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Parallel imports – introduction of a new article 49a
Integrated Pest Management (IPM) – contested
AUDACE had
obtained ‘no data
protection over
and above patent
protection’, i.e.
following the
review
– January 2014 v 2019
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Proposed New Regulation
to replace directive 91/414/EEC
EU Parliament vote on First Reading on the 23rd October 2007
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253 amendments
– One zone
– …
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Community revision programme of
existing active substances
of which so
many were
not notified
and notified
Sept. 2007
Number of active
substances to be
reviewed
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
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Community review programme of
existing active substances
Authorisations on those active
substances included in Annex I
early in the Review Programme
will need to be renewed
Sept. 2007
Total number
of active
substances
notified
of which
(*) ‘not included’
of which
‘included in
the positive list’
First phase
90
31
59
0
Second phase
52
20
31
1
163
26
0
137
Third phase
Yet to be
reviewed
Dec. 2008 deadline
Fourth phase
261
110
0
151
Dec. 2008 deadline
In total
566
186
90
290
(*) following assessment or withdrawn
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Community revision programme of
existing active substances
as a consequence
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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
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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
AUDACE & PMFAI – Recent developments in EU Regulations – Kuala Lumpur, Malayia
24-25 January 2008
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Thank you
www.audace-ass.com
[email protected]
[email protected]