Select Committee on European Scrutiny Tenth Report


MAXIMUM RESIDUE LIMITS FOR VETERINARY MEDICINES


(22874)

13454/01

COM(01) 627


(a)

Draft Council Regulation (EC) amending Annex I of Regulation (EEC) No. 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.

(b)

Draft Council Regulation (EC) amending Annexes I and III of Regulation (EEC) No. 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.

Legal base: Articles 7 and 8 of Council Regulation (EEC) No. 2377/90; co-decision; qualified majority voting
Document originated: 26 October 2001
Forwarded to the Council: 30 October 2001
Deposited in Parliament: 14 November 2001
Department: Environment, Food and Rural Affairs
Basis of consideration: EM of 27 November 2001
Previous Committee Report: None
To be discussed in Council: Following receipt of European Parliament opinion
Committee's assessment: Politically important
Committee's decision: Cleared, but further information requested

Background

  12.1  Because of the possible risks to human health, and in order to avoid the fragmentation of the market as a result of different actions being taken by Member States, Council Regulation (EEC) No. 2377/90[20] establishes a Community procedure for setting maximum residue limits (MRLs) of veterinary medicinal products in foodstuffs of animal origin. The Regulation also provides for substances subject to it to be classified in one of four Annexes — Annex I covers those for which MRLs have been fixed following an examination of the risk they pose to human health; Annex II those for which MRLs are judged to be unnecessary; Annex III those believed to be safe, and for which provisional MRLs have been fixed in the absence of definitive scientific data; and Annex IV those for which no MRLs can be fixed because residues, at whatever limit, constitute a health hazard.

  12.2  Under the Regulation, the responsibility for adding substances to the Annexes rests in the first instance with the Commission, acting through the Standing Committee on Veterinary Medicinal Products, and after examination by the European Medicines Evaluation Agency's Committee for Veterinary Medicinal Products (CVMP). Where the Standing Committee is unable to approve a proposal, it has to be referred to the Council — though, if the Council fails to act by a qualified majority within three months, the Commission is free to adopt the measure. These two proposals for a Council Regulation arise as a result of that procedure.

The current proposals

  12.3  The effect of the first proposal would be to add two naturally occurring steroid hormones (progesterone and norgestomet) to those for which an MRL would be set under Annex I of Regulation No.2377/90, whilst the second would set MRLs under Annexes I and III for three synthetic hormones (altrenogest, chlormadonin and flugestone). Although such hormones have therapeutic uses, they are also used as growth promoters, and their administration to animals is subject to separate controls under Council Directive 96/22/EC[21] aimed at preventing their presence in meat. The Commission nevertheless considers that action is also needed under Regulation No. 2377/90 in order to avoid any risk to consumers, in particular arising from their illegal use. In this, its view is in line with the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH), but it is at odds with that of the CVMP as regards progesterone and norgestomet. That Committee takes the view that no MRLs need to be set for those two substances, as their use would leave no residues, or residues of no risk to the consumer.

The Government's view

  12.4  In his Explanatory Memorandum of 27 November 2001, the Parliamentary Under-Secretary of State (Commons) at the Department for Environment, Food and Rural Affairs (Mr Elliot Morley) says that, whilst the UK had voted in favour of the proposal on altrenogest, chlormadonin and flugestone in the Standing Committee on 12 September, five Member States had abstained, on the grounds that Regulation No. 2377/90 is intended to regulate the legal use of medicines, rather than the illegal use of hormones. However, the UK had voted against the proposal on progesterone and norgestomet, because it conflicted with the advice of the CVMP and involved MRLs which would lead to positive results from naturally occurring levels, which cannot be distinguished from those resulting from illegal use. The Minister also points out that the UK is not aware of any validated method for detecting the hormones in tissue at the concentrations proposed as the MRL, and that, where a certain level of progesterone is exceeded, the State Veterinary Service already carries out an investigation into possible illegal use.

Conclusion

  12.5  We note that these proposals have arisen as a result of the Standing Committee on Veterinary Medicinal Products being unable to endorse the proposed Commission legislation. We also note that they have been the subject of conflicting scientific advice as regards two of the substances for which maximum residue limits would be set, and that the UK is in those instances among those Member States opposing the approach advocated by the Commission. Consequently, although we are clearing the document, we are drawing this difference of opinion, and the reasons for it, to the attention of the House.

  12.6  At the same time, however, we would like clarification on one procedural point. The Minister says in his Explanatory Memorandum that consultation with the European Parliament is mandatory on both proposals, and that they will "go to the Council once those opinions are available". However, as we have already noted, the Council needs to take a view within three months of the proposals being referred to it, which we understand means by 30 January 2002. We assume therefore that either arrangements have been made to receive the European Parliament's views in good time, or, if that is not possible, the Council will in any event proceed to take a view in order to prevent the Commission adopting the proposals by default. We would welcome confirmation of the position from the Minister.


20   OJ No. L 224, 18.8.90, p.1. Back

21   OJ No. L 125, 23.5.96, p.3. Back


 
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Prepared 17 December 2001