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FVE General Assembly Brussels, 17 November 2007 Maximum Residue Levels

This proposal aims to establish procedures for setting residue limits of pharmacologically active substances in animal-based food. It includes risk assessment, classification, and reference points for action. The regulation also addresses the extrapolation of maximum residue limits and the contribution to international standards. The proposal introduces additional safety factors and scrutiny for marketing authorizations.

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FVE General Assembly Brussels, 17 November 2007 Maximum Residue Levels

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  1. FVE General AssemblyBrussels, 17 November 2007Maximum Residue Levels

  2. Proposal for a Regulation • Laying down procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin • Co-decision • 1rst reading in European Parliament

  3. Structure of the Regulation • Title I General Provisions • Title II Maximum Residue Limits • Chapter I risk assessment and risk management • Section 1 pharm active substances intended for use in vmps • Section 2 pharm active substances not intended for use in vmps • Chapter II Classification • Title III Reference points for action

  4. Classification • 4 classes of substances • (Comp. to Annexes 1, 3, 2 and 4 of Regulation 2377/90) • A maximum residue limit • On the base of opinion of CVMP • Vote by Community in Codex Alimentarius (see 6) • A provisional maximum residue limit • Incomplete data • The absence of a maximum residue limit • Not necessary for protection of human health • 4. A prohibition on the administration of a substance • Where any use constitutes a hazard

  5. Extrapolation • The committee shall - when carrying out risk assessments and drawing up risk management conditions - consider using • MRLs established for a pharmacol. active substance • in a particular foodstuff for another foodstuff • derived from the same species, • or • in one or more species for other species

  6. Community contributes in Codex Alimentarius to development of international standards on MRLs. • The Community should take over without further risk assessment those Codex Alimentarius limits it has supported.

  7. Extrapolation and adopting of MRLs already accepted in the Codex Alimentarius will reduce the investments needed for the development of new products • Will contribute to solve the problem of product availability

  8. In Parliament for 1rst reading • Introducing further safety factors • Procedure with scrutiny by EP • Introducing extra hurdles for marketing authorisations

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