WRITTEN QUESTION E-4061/98

by Graham Mather (PPE) to the Commission

(13 January 1999)

Subject: Agriculture Council of 15 December 1998 - decision to ban certain antibiotic digestive enhancers

At this meeting of the Agriculture Council, the decision was taken to phase out the routine use of zinc bacitracin, spiramycin, virginiamycin and tysolin phosphate within six months from 1 January 1999.

Can the Commission please provide a full explanation for this decision, indicating in particular the scientific basis upon which it was taken?

In the light of this decision, would the Commission please also comment on the work of:

1. the DG XXIV Multi-disciplinary Working Party reviewing the human health aspects of the use of antibiotics in human medicine and agriculture; and

2. the animal health industry's surveillance programme in collaboration with DG VI mandated by the Commission to review the safety aspects of these products?

Answer given by Mr Fischler on behalf of the Commission

(16 February 1999)

In accordance with Annex XV to the Act of Accession, the Commission was required to take a decision before 31 December 1998 on Sweden's application to ban all the antibiotics authorised by Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(1). The Commission was also required to give a ruling as to the validity of Finland's ban on the antibiotics spiramycin and tylosin and Denmark's ban on the antibiotic virginiamycin.

As stated in the recitals to Council Regulation (EC) 2821/98 of 17 December 1998 amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524/EEC concerning additives in feedingstuffs(2), withdrawal of authorisation for zinc bacitracin, spiramycin, virginiamycin and tylosin phosphate is scientifically based on a number of findings by the Scientific Committee on Animal Nutrition and on the conclusions and recommendations of the World Health Organisation conference held in Berlin in October 1997, the Economic and Social Committee, the International Office of Epizootics and the conference on antibiotic resistance held in Copenhagen in September 1998. According to those recommendations, antibiotic resistance must henceforth be regarded as a major, complex problem of international dimensions and all available means must be used to address the phenomena of resistance encountered not only in hospitals but also in the general population.

The authorisations for the four antibiotics referred to above were therefore withdrawn with the sole aim of protecting human health: authorisation as additives should no longer be granted in respect of antibiotics authorised as human medicinal products or known to select cross-resistance to antibiotics used in human medicine. For fundamental reasons, these substances should henceforth be reserved for human medicine. Banning the use of these four antibiotics in feedingstuffs should contribute towards not increasing the reservoir of resistances in animals, thereby reducing the risk of transferring those resistances to humans. This is an interim protective measure taken as a precaution, which can be reconsidered in the light of the investigations which will be carried out and of the information supplied by the programme for monitoring resistance which has been set up.

The Commission has asked the scientific steering committee to address the various aspects relating to the use of antimicrobials and the development of resistance. The committee has set up a multidisciplinary working party with a broad remit which includes examining the extent of the problem, its aetiology in terms of scientific mechanisms and how these relate to practices in human and veterinary medicine, animal husbandry and plant health protection. Initial guidelines are expected to be available shortly, and the committee has been asked to deliver its final opinion by April this year.

The results of the antimicrobial resistance monitoring programme set up by the Commission in cooperation with industry at the beginning of 1998 should be available at the end of the first quarter of 2000.

(1) OJ L 270, 14.12.1970.

(2) OJ L 351, 29.12.1998.