WRITTEN QUESTION E-0959/97 by Monica Baldi (UPE) to the Commission (13 March 1997)

Subject: Use of Beta-agonist drugs

Regulation (EC)1312/96 ((OJ L 170, 9.7.1996, p. 8.)) bans the oral administration, for veterinary medicinal purposes, of the beta-agonist clembuterol hydrochloride.

Little information has so far been released concerning the major outbreak of chemical poisoning which recently occurred in Italy as a result of consuming the meat of animals treated with beta-agonists (drugs commonly used to treat asthma).

The inappropriate use of these drugs can cause serious heart complaints and even lead to death from arrhythmia and cardiac neurosis, with states of psychomotor agitation and tremors.

Will the Commission:

1. step up the organization of information campaigns to alert stock farmers to the definite dangers caused by the side effects of beta-agonist drugs used in stock farming and the risks which stock farmers run when administering these drugs, given that they can be inhaled or absorbed through the skin?

2. Develop synergies for the drawing up and implementation of programmes in this area by the relevant EU institutions, particularly in view of the fact that protecting animal health means protecting human health?

Answer given by Mr Fischler on behalf of the Commission (2 May 1997)

Regulation (EC) No 1312/96 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, quoted by the Honourable Member, fixes only the maximum residue limits (MRL) permitted at Community level for clenbuterol hydrochlorate in certain foodstuffs of animal origin. The use of beta-agonists, particularly clenbuterol, is prohibited by Council Directive 96/22/EC ((OJ L 125, 23.5.1996. )), concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists. Member States must bring this Directive into force not later than 1 July 1997.

The above-mentioned Directive prohibits the use of clenbuterol in all livestock, except for certain therapeutic purposes, namely to induce tocolysis in cows when calving and to treat respiratory problems and to induce tocolysis in equidae. The conditions for administration of these substances are clearly defined by Article 4 of the Directive. In the case of cows they must be administered by the veterinarian by injection only. Farmers are prohibited from holding veterinary medicinal products containing beta-agonists which may be used for induction purposes in the treatment of tocolysis. In the case of equidae, these substances must be administered by the veterinarian or under his direct responsibility. In all cases the treatment must be recorded by the veterinarian responsible.

Article 9 of Council Directive 96/23/EC1 on measures to monitor certain substances and residues thereof in live animals and animal products1 introduces the principle that operators are jointly responsible for the illegal administration of substances to farm animals, compliance with withdrawal periods and conformity of residue levels with the MRL. Transposition of this principle into national law in each Member State obligatorily involves better information of stockfarmers, in particular, regarding the scientific bases of the various rules concerned and the health and legal risks connected with the failure to comply with these rules.

The national authorities and professional organizations are primarily responsible for promoting information campaigns targeting stockfarmers, since the Commission does not have sufficient human and material resources. In certain cases, however, the Commission may be able to contribute to the financing of such projects from appropriations available either for structural measures (training programmes), or for training and information activities eligible under heading B2-5122.