EU Regulation on MRLs

1
EU Regulation on MRLs

• Draft Regulation of European Parliament and
  Council on MRLs of pesticides in/on food and feed
  of plant and animal origin
• J.W. Dornseiffen
• Ministry of Health, Welfare and Sport
• P.O. Box 20350
• 2500 EJ The Hague, The Netherlands

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Items to be discussed

• Background information
• Why this new Regulation?
• Key issues of the Regulation
• Discussions in the Council
• Adoption of the Common position
• Discussion in the European Parliament
• Agreement at Second Reading?
• Future developments

3
Background information

• Trade problems between EU Member States resulted
  in 1976 in a first attempt to harmonize MRLs for
  fruits and vegetables (Directive 76/895)
• In 1983 extension of harmonization with MRLs for
  cereals (86/362) and animal products (86/363)
• In 1990 (updated) directive for products of
  plant origin, including fruit and vegetables
  (90/642)
• Since then, these 4 framework directives were
  filled in with MRLs for old and new (uses of)
  pesticides
• In 1997, update on comitology, scope,
  conciliation procedure, baby food harmonization
  of articles
• Now synchronization with PPP Directive 91/414

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Why this new Regulation?

• Consolidation 4 framework directives (Council)
  to be replaced by 1 Regulation (EP Council)
• Simplification of existing procedures
• Introduction of a legal basis to levy fees for
  monitoring/enforcement and setting of MRLs
• Urgent problems internal market remaining
  national MRLs lack of import MRLs in the EU
• Coherence with 91/414 discrepancy between Member
  States competence on authorizations and Community
  competence on setting MRLs

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Key issues of the Regulation (1)

• Definition of role of EFSA (risk assessor) and
  the Commission (risk manager) in setting MRLs
• Extension of scope of Regulation to animal feed,
  in principle also for non food-producing animals
• Introduction of a default-MRL of 0.01 mg/kg for
  non-authorized uses
• Possibility for Member States to recover costs
  for setting, modifying or deleting MRLs
• Synchronization with EU procedures for the
  control of pesticide residues in food and feed

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Key issues of the Regulation (2)

• Uniform EU procedure for the establishment of
  import tolerances for products from third
  countries
• Possibility of setting MRLs based on monitoring
  data
• Possibility of taking into account the
  shelf-life of products when setting MRLs
• Establishment of temporary EU MRLs as an interim
  measure for active substances which are not yet
  harmonized

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Key issues of the Regulation (3)

• The Regulation contains the following Annexes
• - I Products of plant and animal origin to
  which harmonized MRLs will apply
• - II List of harmonized MRLs
• - III List of harmonized temporary MRLs
• - IV List of a.s. for which no MRLs are
  required
• - V List of realistic default LODs
• - VI Concentration/dilution factors for
  processing
• - VII Derogations for residues of fumigants

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Discussions in the Council (1)

• Member States supported the proposal in general,
  confirming the objectives and most of the
  arrangements as proposed by the Commission
• Concern was expressed on the sustainability of
  minor uses
• A number of Member States proposed realistic LODs
  for authorized pesticides
• No clear difference existed between (mandatory)
  monitoring and/or enforcement activities

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Discussions in the Council (2)

• Synchronization with/modification of 91/414 in
  relation to interim period of retaining current
  MRLs after inclusion of a.s. in Annex I of 91/414
  
• Difference in opinion between Member States and
  Commission on role of Commission and task of EFSA
  related to applications concerning MRLs
• Political agreement achieved in Council in April
• Common position adopted by Council in July with
  unanimity, thereby outvoting the Commission

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Common position of Council (1)

• Interim period up to 4 years for temporary MRLs
  after inclusion of active substance in Annex I of
  91/414 (commitment after 2 years)
• Realistic LODs (listed in Annex V) for active
  substances included in Annex II
• No differentiation between monitoring and
  enforcement (now grouped as official control)
• Introduction of a list of processing factors
  (Annex VI) to be used to calculate MRLs for
  processed foods (mainly concentration/dilution)

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Common position of Council (2)

• Derogation from MRL-requirements for post-harvest
  applications of fumigants (Annex VII)
• Increased attention for the need of financial
  support for development of MRLs for minor uses
• No exclusive role for EFSA in the application
  procedure for MRLs Member States retain their
  preparatory work, while role EFSA is restricted
  to mainly carrying out the risk assessment
• Harmonized community procedure for setting import
  tolerances

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Discussion in EP (1)

• European Parliament and Council adopt Regulation
  following a co-decision procedure
• Environment Committee of the EP appointed a
  rapporteur and started discussions on the
  Regulation at the same time as Council
• EP (plenary) adopted its Opinion at first reading
  at the end of April
• A lot of EP amendments were already included in
  the Common position of the Council (as a result
  of discussions between EP and Council)

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Discussion in EP (2)

• Part of remaining amendments were partially
  acceptable to Commission, and could possibly be
  introduced after redrafting
• Some amendments were not acceptable and require
  negotiation with (rapporteurs of) EP
• Problematic amendments concern
• - amendments based on misinterpretations
• - cumulative/synergistic effects
• - sanctions on/publications of MRL exceedings

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Agreement at second reading? (1)

• (New) EP started procedure on 16 September
• Informal contacts between Presidency and EP
• Rapporteur just produced his draft Opinion
• First examination in Environment Committee of EP
  on 25 October
• Deadline for amendments 26 October
• Council to discuss draft Opinion on 28 October
• Negotiations of Presidency with EP
• Rapporteur revises draft opinion

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Agreement at second reading? (2)

• Vote in Environmental Committee on 24-11
• Council to discuss outcome vote (end of november)
• Negotiations between Presidency and EP first half
  of December
• EP (plenary) votes on its Opinion at second
  reading (between 13 and 16 December)
• Council accepts all amendments Regulation
  adopted if not Conciliation procedure!

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Future developments

• Inventory of national MRLs is under way to be
  completed end of February 2005
• Member States with highest MRLs have (overall) to
  defend MRL, especially on consumer intake
• Most important chapters of the Regulation shall
  enter into force 6 months after adoption of
  Annexes I, II, III and IV (2006?)
• Sufficient capacity and expertise of EFSA is not
  (yet) guaranteed
• Adaptations of Regulation in the future foreseen