Proposal for a COUNCIL REGULATION amending Annex II of Council 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

(presented by the Commission)

EXPLANATORY MEMORANDUM

A. Regulatory framework

Pursuant to Council Regulation (EEC) N° 2377/90 of 26 June 1990 [1], binding maximum residue limits for veterinary medicinal products in foodstuffs of animal origin are established at a Community level. These limits (hereinafter MRL) are established in accordance with the regulatory committee procedure, laid down in article 8, following scientific evaluation by the Committee for Veterinary Medicinal Products. The pharmacologically active substances are then classified in one of the four annexes to the Regulation:

[1] OJ L 224, 18.8.1990, p. 1.

- Annex I: reserved for substances for which a MRL can be set following evaluation of the toxicological risk they pose to human health;

- Annex II: substances for which there is no need to set a MRL;

- Annex III: substances for which, given the lack of scientific data, a MRL cannot be set definitively but which, without compromising consumer health, may be given a provisional MRL for a defined period calculated according to the time needed to complete the scientific studies. This period may be extended once only in exceptional cases;

- Annex IV: substances for which it appears no MRL can be set because they pose a risk to human health in whatever quantity.

B. Scientific elements

BST is a substance with hormonal effect which is used to increase lactation in cows. The Committee for Veterinary Medicinal Products recommended that recombinant bovine somatotropins (rBST) (substances produced by a biotechnological process, which are proteins closely related to the four variants of natural bovine somatotropin), when used on bovine, be included in Annex II on the following grounds:

- rBST are biologically active analogues of endogenous bovine somatotropin which is a normal component of the bovine milk;

- rBST are degrated in the gastrointestinal tract;

- rBST stimulate the production of insulin growth factor I (IGF-I) (for which production is stimulated by rBST and possible factor that may be involved in the development of insulin-dependent diabetes and suggested as a marker of ongoing breast cancer) but may be absorbed to a low degree from the gastrointestinal tract;

- Levels of both bovine somatotropin and IGF-I after treatment with rBST have been shown to be at or within physiological limits in milk and tissues;

- The additional intake of IGF-I through ingestion of cow's milk from rBST-treated cows is regarded as biologically insignificant compared to the endogenous amount produced daily in the human gastrointestinal tract and therefore does not constitute a health hazard for the consumer.

C. Regulatory procedure and referral to the Council

1. Despite of the existing marketing ban [2] two companies [3] have maintained their application to obtain the fixing of MRLs for rBST in accordance with Regulation (EEC) n°2377/90. The Court of First instance ruled in that context that the existence of a marketing ban does not justify to refuse the granting of an MRL (cases T-120/96 [4] and T-112/97 [5]) but that decision is now subject to appeal before the Court of Justice (Case C-298/99 P).

[2] Council Decision 1999/879/EC of 17.12.1999.

[3] Eli Lilly and Monsanto Company.

[4] Judgement of the Court of First Instance of 25 June 1998, EC Reports 1998 page II-2571.

[5] Judgement of the Court of First Instance of 22 April 1996, EC Reports 1999.

2. In the light of new scientific findings and information available since the original recommendation issued by the former Committee for Veterinary Medicinal Products in November 1994, which recommended that rBST be included in Annex II of Council Regulation (EEC) No 2377/90 and taking into account the judgement of the Court of First Instance in the case T-120/96, the European Commission requested the EMEA to re-examine its previous recommendation on 1 February 1999.

After this re-evaluation the Committee of Veterinary Medicinal Products confirmed on 14 July 1999 his previous recommendation to include recombinant bovine somatotropin (rBST) in annex II. The Commission decided on 8 December 1999 to submit the draft proposal for establishing MLRs for rBST to the Standing Committee on Veterinary Medicinal Products.

3. The Commission sent to the Standing Committee a draft implementing regulation adding (inter alia) rBST, on the above grounds, to Annex II of Regulation (EEC) N° 2377/90. The draft failed to elicit a favourable opinion from the Committee on 4 February 2000 where 10 Member States (73 votes) voted against, 4 Member States (13 votes) in favour and 1 Member State (4 votes) abstained.

4. Indeed, the representatives of the ten Member States opposed the very principle of classifying rBST in one of the annexes to Regulation (EEC) N° 2377/90, because of the existing marketing ban (despite the judgements of the CFI) and because of the remaining scientific uncertainty concerning the human health implications of residues of IGF I in milk and milk products.

It should be noted in this connection that (a) no scientific evidence of a risk concerning a likely initiation of cancer linked to IGF-I has been demonstrated so far (b) it emerges from the scientific assessment carried out by the Committee on Veterinary Medicinal Products that both rBST and IGF-I (for which production is stimulated by rBST) are either degraded or absorbed at very low and physiological level. However, the Commission is aware of the remaining scientific uncertainty concerning the human health implications of residues of IGF I in milk and milk products.

From a general point of view, it should be stressed that because of the existing prohibition concerning the placing on the market and administration of BST, any marketing authorisation application for rBST would be rejected.

5. As the proposed measures are not in accordance with the opinion of the Standing Committee, the Commission is sending to the Council a proposal for a regulation to be adopted under the procedure laid down in Article 8 of Regulation (EEC) No 2377/90.

By virtue of the same Article, the Council is invited to adopt the proposed measures within three months of the date of referral.

Proposal for a COUNCIL REGULATION amending Annex II of Council 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

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin [6], as last amended by Commission Regulation (EC) No 2758/99 [7] and in particular Articles 6 and 8 thereof,

[6] OJ L 224, 18.8.1990, p. 1.

[7] OJ L 331, 23.12.1999.

Having regard to the proposal from the Commission,

Whereas:

(1) In accordance with Regulation (EEC) No 2377/90, maximum residue limits must be established progressively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals.

(2) Maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs.

(3) In establishing maximum residue limits for residues of veterinary medicinal products in foodstuffs of animal origin, it is necessary to specify the animal species in which residues may be present, the levels which may be present in each of the relevant meat tissues obtained from the treated animal (target tissue) and the nature of the residue which is relevant for the monitoring of residues (marker residue).

(4) Recombinant Bovine Somatotropins should be inserted into Annex II to Regulation (EEC) No 2377/90.

(5) The Commission is aware that there remains scientific uncertainty concerning the human health implications of residues of IGF I in milk and milk products and that its intention is to pursue these matters through further scientific studies and research and by requesting at the appropriate time a new opinion from one of its Scientific Committees.

(6) The Council has adopted decision 1999/879/EC [8] of 17 December 1999 con cerning the placing on the market and administration of bovine somatotrophin (BST) and repealing Decision 90/218/EEC [9] in such a way that it permanently prohibits the use of BST in the Community for reasons of animal health and welfare.

[8] OJ L 331, 23.12.1999, p. 71-72.

[9] OJ L 116, 8.5.1990, p. 27.

(7) The Standing Committee on Veterinary Medicinal Products referred to in Article 8 of Regulation (EEC) No 2377/90 and consulted by the Commission has not delivered a favourable opinion on the Commission proposed measures.

HAS ADOPTED THIS REGULATION:

Article 1

Annex II of Regulation (EEC) No 2377/90 is hereby amended as set out in the Annex hereto.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the Council

The President

ANNEX

The following substance is inserted in Annex II to Regulation (EEC) No 2377/90 (List of substances not subject to maximum residue limits)

2. Organic compounds

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