WRITTEN QUESTION E-1540/98

by Phillip Whitehead (PSE) to the Commission

(18 May 1998)

Subject: Antibiotics

To what extent has the Commission considered the animal and public health implications of the use of antibiotics in animal husbandry?

Can the Commission confirm whether any of the Member States have taken steps to encourage the use of records on antibiotic use and doses?

Answer given by Mr Fischler on behalf of the Commission

(17 July 1998)

Several scientific committees have drawn the attention of the Commission to the potential risk to public health arising from increased antimicrobial resistance and to the multi-disciplinary nature of the problem, involving food, animal nutrition as well as human and veterinary medicinal practice. In the light of these concerns, the Commission asked the scientific steering committee to examine the question of antimicrobial resistance and a working group with representatives of various scientific committees has been established. The Commission has also initiated and co-ordinated a surveillance programme in some Member States, for which the industry producing additives is paying. The Commission is thus giving this matter considerable priority.

For every authorisation of an antibiotic to be used in feedingstuffs, the Commission examines, in accordance with Directive 70/524/EEC concerning additives in feedingstuffs(1), that the substance does not adversely affect human or animal health nor harm the consumer by altering the characteristics of livestock products. A dossier is established by the applicant for authorisation of the antibiotic according to Council Directive 87/153/CEE fixing the guidelines for the assessment of additives in animal nutrition(2). The authorisation conditions specify the species and category of animal, maximum age, minimum and maximum content in feedingstuffs, and possibly a withdrawal time. Under Article 11 of Directive 70/524/EEC, authorised feed additives can be temporarily suspended by a Member State, if there are grounds indicating that their use constitutes a danger to human health. The Commission examines the grounds, consults the Member States within the standing committee for feedingstuffs and takes the appropriate measures. This was the case for the provisional ban by the Commission from April 1997 for avoparcin, following a national ban in Denmark in 1995 and in Germany in 1996. At present, the grounds provided by Denmark for banning virginiamycin are being examined by the Commission.

Under Council Regulation 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products(3), products are only authorised if documentation shows that the requirements on safety, quality and efficiency have been met.

These requirements are laid down in Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmatoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products(4). For substances in products to be used in food producing animals the residues are evaluated according to Council Regulation (EEC) 2377/90(5) and a withdrawal time is established, which determines how long after the treatment food products may be taken from the treated animals. Veterinary medicinal products may be dispensed only on a vet's prescription.

When an antibiotic is authorised as an additive in feedingstuffs, the authorisation conditions include a minimum and a maximum content. Levels beyond these contents are forbidden. These levels are set in order to ensure efficacy as well as to meet safety criteria and they are enforced by the Member States.

The Commission does not have figures for the overall quantities of antibiotics used as additives in feedingstuffs. However, these data will be in the possession of the Member States from 1 April 1998. Indeed under Directive 95/69/EEC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC(6) establishments have to hold a register in order to ensure traceability of the quantities of antibiotics used, specifying the nature and quantity of additive bought or produced and of product sold, with dates and batch numbers. This register is at the disposal of the authorities of the Member States which ensure, by means of appropriate checks, that the requirements established by the Directive are met.

Retailers of veterinary medicinal products are required to keep detailed records of their quantities and to ensure traceability.

The information to be recorded in respect of each transaction includes the date, precise identity of the veterinary medicinal product, manufacturer's batch number, quantity received or supplied, name and address of the supplier or recipient where relevant, name and address of the prescribing vet and a copy of the prescription. At least once a year a detailed audit has to be carried out, and incoming and outgoing products have to be reconciled with products currently held in stock, any discrepancies being recorded.

(1) OJ L 270, 14.12.1970.

(2) OJ L 64, 7.3.1987.

(3) As amended by Council Directive 90/676/EEC and 93/40/EEC (OJ L 317, 6.11.1981, 90/676/EEC, OJ L 373, 31.12.1990, 93/40/EEC, OJ L 214, 24.8.1993.).

(4) OJ 317, 6.11.1981.

(5) Council Regulation (EEC) 2377/90 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. Amended by Council Regulation (EC) 434/97 of 3 March 1997 amending Council Regulation (EEC) 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 67, 7.3.1997.).

(6) OJ L 332, 30.12.1995.