EN Official Journal of the European Union CE 33/262

(2004/C 33 E/272)

WRITTEN QUESTION E-2404/03

by Bart Staes (Verts/ALE) to the Commission

(21 July 2003)

Subject: Zinc bacitracin used by rabbit breeders to combat Epizootic Rabbit Enterocolitis: prohibited in Belgium under EU law but now in use again in the Netherlands and in France

Council Regulation (EC) No 2821/98 (1) of 17 December 1998 amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524/EEC (2) concerning additives in feedingstuffs prohibits the use of zinc bacitracin as an additive in feedingstuffs. Zinc bacitracin is used, inter alia, by rabbit breeders to combat Epizootic Rabbit Enterocolitis (ERE). In accordance with the Regulation, the Belgian Government has banned the use of zinc bacitracin. The problem is that Allpharma, the company which markets the product, was late in initiating the application procedure for the registration of zinc bacitracin as a medicinal product. As a result, there is currently no product available to rabbit breeders to combat ERE. In the interim, the Netherlands and France have introduced emergency legislation to permit the use of zinc bacitracin by rabbit breeders. That has led to unfair competition between, on the one hand, Dutch and French rabbit breeders and, on the other, Belgian rabbit breeders.

Is the Commission aware of the fact that, inter alia, the Netherlands and France have renewed authorisation to use zinc bacitracin, although such use is actually prohibited under European law, and that it results in a distortion of the market in rabbit breeding?

Does the Commission acknowledge that, given that zinc bacitracin is the only currently known means of combating ERE, this results in a distortion of the market?

If so, is the Commission intending to seek a solution to this problem?

Answer given by Mr Liikanen on behalf of the Commission

(1 September 2003)

Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs modified by Council Regulation (EC) 2821/98 of 17 December 1998 prohibits the use of zinc bacitracin as feed additive for the purpose of growth promotion, not as active substance included in veterinary medicinal products for the treatment/prevention of specific diseases.

The authorisation of veterinary medicinal products is governed by Directive 2001/82/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (3). Article 6 of this Directive states that as a prerequisite for such an authorisation, the active substance must be shown in Annexes I, II or III of Council Regulation (EEC) No 2377/90 (4). Zinc bacitracin is included in Annex I of said Regulation since 27 March 2003 (5). It is therefore perfectly legal for the competent national authorities to grant marketing authorisations for veterinary medicinal products containing zinc bacitracin for the treatment of enterocolitis in rabbits provided that the quality, safety and efficacy of the product has been demonstrated.

According to Article 7 of Directive 2001/82/EC, Member States may, where the health situation so requires, authorise the marketing or administration to animals of veterinary medicinal products authorised in another Member State. It is therefore within the competence of the Belgian authorities to judge whether such measures are warranted in this case. The Commission cannot comment on a possible distortion of the market in an area as a result of decisions taken by Member States in the their field of competence.

(1) OJ L 351, 29.12.1998, p. 4.

(2) OJ L 270, 14.12.1970, p. 1.

(3) OJ L 311, 28.11.2001.

(4) 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, OJ L 224, 18.8.1990.

(5) OJ L 81, 28.3.2003.