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FVE General AssemblyBrussels, 17 November 2007

Maximum Residue Levels

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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

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Title I General Provisions

Title II Maximum Residue LimitsChapter 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

Structure of the Regulation

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Classification4 classes of substances (Comp. to Annexes 1, 3, 2 and 4 of Regulation 2377/90)

1. A maximum residue limitOn the base of opinion of CVMPVote by Community in Codex Alimentarius (see 6)

2. A provisional maximum residue limitIncomplete data

3. The absence of a maximum residue limitNot necessary for protection of human health

4. A prohibition on the administration of a substanceWhere any use constitutes a hazard

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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

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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.

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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

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In Parliament for 1rst reading

Introducing further safety factorsProcedure with scrutiny by EPIntroducing extra hurdles for marketing

authorisations