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What role for pesticides in sustainable agriculture European Voice Conference 14 October 2008, Bruss

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Proposed Regulation of the European Parliament and of the Council concerning the ... First reading in European Parliament on 23 October 2007 ... – PowerPoint PPT presentation

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Title: What role for pesticides in sustainable agriculture European Voice Conference 14 October 2008, Bruss


1
What role for pesticides in sustainable
agriculture ? European Voice Conference 14
October 2008, Brussels
  • Proposed Regulation of the European Parliament
    and of the Council concerning the placing of
    plant protection products on the market.

Wolfgang Reinert Unit E.3 Chemicals,
Contaminants and Pesticides
2
Important objectives of the proposal
  • To protect human and animal health and the
    environment
  • To safeguard the competitiveness of agriculture
  • To provide for a common market
  • To speed up decision making

3
Key issues (Impact Assessment)
Commission Proposal
  • National provisional authorisations
  • Zonal mutual recognition
  • Comparative assessment and substitution principle
  • Data protection and data sharing for renewal of
    approval
  • Information about use

4
Other issues (Adjustments)
Commission Proposal
  • Criteria for approval
  • Scope (safeners synergists, co-formulants)
  • IPM
  • Renewal of approval
  • Role of EFSA
  • Fees and charges (in line with recent rules)
  • Data access / confidentiality
  • Minor Uses
  • Monitoring and controls
  • Human testing
  • Low risk/basic substances

5
Amended Commission Proposal
Commission Proposal
  • 247 Amendments adopted by the EP in First Reading
    on 23 October 2007
  • 139 amendments accepted by COM (fully/partly/subje
    ct to rewording)
  • COM presented an amended Proposal (Article
    250(2)) on 11 March 2008
  • Discussions in Council WP Agri from II/2006 to
    I/2008

6
Provisional authorisations
Major issues under discussion
  • COM proposal
  • Reduce administrative burden
  • Avoid conflicts with MRL legislation
  • No provisional authorisations any more

7
Provisional authorisations
  • Common position
  • Keep provisional authorisations under strict
    conditions (procedural delays, MRL,...)
  • Transitional measure with revision clause
  • European Parliament
  • Keep provisional authorisations under strict
    conditions (procedural delays, MRL,...)

8
Zonal Mutual Recognition (1/2)
Major issues under discussion
  • COM proposal
  • Increase level of harmonisation as far as
    possible
  • Take into account differences between MS where
    necessary
  • 3 zones ( greenhouse/post harvest uses)
  • Obligatory Mutual Recognition within a zone
  • Restrictions for operator/worker/bystander
    protection possible

9
Zonal Mutual Recognition (2/2)
  • Common position
  • Nearly all MS agree with the concept in principle
  • More flexibility for MS in granting
    authorisations
  • Voluntary mutual recognition between zones
  • Refrain from recognising an authorisation as last
    resort to address a serious risk to human or
    animal health or environment
  • European Parliament
  • Disagrees with the concept as such
  • Only voluntary mutual recognition without zones

10
Substitution and Comparative Assessment (1/3)
Major issues under discussion
  • COM proposal
  • Decrease risk to operators, consumers and the
    environment
  • Take into account availability of products
  • Encourage development of safer substances
  • Candidates for substitution at EU level
  • Comparative Assessment at MS level
  • Criteria high ADI/ARfD/AOEL, PB/PT/BT,
    non-manageable concerns, high in non-active
    isomers

11
Substitution and Comparative Assessment (2/3)
  • European Parliament
  • Comparative Assessment applicable to all PPP
  • Endocrine disruptors, neurotoxic or immunotoxic
    substances, leaching

12
Substitution and Comparative Assessment (3/3)
Major issues under discussion
  • Common position
  • carcinogenic or toxic for reproduction cat. 2,
    endocrine disruptors, neurotoxic and immunotoxic
  • Approval 10 years
  • Autorisation 5 years

13
Data protection
Major issues under discussion
  • COM proposal
  • 1 period of 10 years
  • 12 years for low risk products
  • Improved protection of animals
  • No data protection at renewal of approval

14
Data protection
  • European Parliament
  • Additional data protected if needed
  • Incentives for minor uses
  • Common position
  • 2.5 years of data protection for additional data
  • Incentives for minor uses

15
Information of neighbours (1/2)
Major issues under discussion
  • COM proposal
  • Inform neighbours and drinking water industry
    after notification of interest
  • Keep record available on request

16
Information of neighbours (2/2)
  • European Parliament
  • Neighbours, residents, retailers or drinking
    water industry
  • Pesticide passport to retailers and wholesalers
  • Common position
  • Third parties such as drinking water industry
  • Via competent authority

17
Criteria for approval (1/3)
Major issues under discussion
  • COM proposal
  • Essential to ensure high level of protection
  • Clear criteria to facilitate decision making
  • CMR cat. 12, POP, PBT, vPvB, endocrine
    disruption
  • Negligible exposure
  • Concept of negligible exposure more detailed in
    amended proposal

18
Criteria for approval (2/3)
  • European Parliament
  • More details on negligible exposure
  • Neurotoxic or immunotoxic substances
  • Persistence, bioaccumulation
  • Bees
  • Priority hazardous substances

19
Criteria for approval (3/3)
Major issues under discussion
  • Common position
  • Mutagens cat. 1 and 2 not approved
  • Carcinogens, toxic for reproduction or endocrine
    disruptors a) regular approval if exposure is
    negligible b) exceptional approval (5 years) in
    case of serious risk to plant health

20
Criteria for approval Impact
  • Existing active substances 983
  • Included 137
  • Not included after review 69
  • Pending 163
  • Review programme finalised end of 2008
  • New active substances 143
  • Included 82
  • Not included after review 9
  • Pending 52
  • Estimated number of substances on the market 400

21
Criteria for approval Impact
  • Carcinogenic, mutagenic, teratogenic 7
    substances
  • Endocrine disruptors 15-20 substances
  • Harmful for human health
  • Community or internationally agreed test
    guidelines
  • European Food Safety Authority
  • Community strategy for endocrine disruptors
  • COM(1999) 706
  • COM(2001) 262
  • SEC(2004) 1372
  • SEC(2007) 1635

22
Criteria for approval Impact
  • Most substances included until 2016
  • 5-year approval if no alternative for plant
    protection

23
Criteria for approval
  • 6th Environmental Action Programme
  • REACH
  • Water Framework Directive

24
Agriculture
  • Zonal autorisation and obligatory mutual
    recognition
  • Data protection
  • Clear deadlines
  • Minor uses

25
State of affairs and dates foreseen
The way ahead
  • COM proposal on 19 July 2006
  • First reading in European Parliament on 23
    October 2007
  • Political agreement on 23 June 2008 in Council
  • Common position on 15 September 2008
  • ENVI Committee vote on 5 November 2008
  • EP plenary vote in December 2008 or January 2009
  • Entry into force mid 2010

26
Backgrounds documents
  • Website http//ec.europa.eu/food/plant/protection
    /evaluation/index_en.htm
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