Directive 2008/97 - Amendment of Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists - Main contents

EN

Official Journal of the European Union

L 318/9

Article 2 of Directive 96/22/EC (3) prohibits, inter alia, the placing on the market of stilbenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species.

The reason for that absolute prohibition was that potential abuse or misuse would be more difficult if there were no product authorised for any animal species whatsoever on the market.

However, experience gained in particular with national residue plans submitted under Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (4) has shown that the misuse of product presentations intended for pet animals does not play a role as a source of abuse or misuse. That is partly because it is economically unattractive to use presentations intended for pet animals for growth promotion in food-producing animals.

Moreover, the prohibition of thyrostatic substances has harmful consequences for the welfare of pet animals (dogs and cats) due to the lack of an alternative treatment for hyperthyroidism in those animals.

The Protocol on protection and welfare of animals annexed to the Treaty provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market.

It is therefore appropriate to limit the scope of Directive 96/22/EC only to food-producing animals and withdraw the prohibition for pet animals, as well as to adjust the definition of therapeutic treatment.

The Opinion of the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) of 30 April 1999 on the potential risks to human health from hormone residues in bovine meat and meat products (which was reviewed on 3 May 2000 and confirmed on 10 April 2002) concluded that there is a substantial body of recent evidence suggesting that oestradiol 17ß has to be considered as a complete carcinogen, as it exerts both tumour-initiating and tumour-promoting effects, and that the data currently available do not make it possible to give a quantitative estimate of the risk to human health. As a result, Directive 96/22/EC was amended by Directive 2003/74/EC so as to, inter alia, prohibit permanently the use of oestradiol 17β as a growth promoter and reduce substantively all other circumstances in which it can be administered to all farm animals for therapeutic or zootechnical purposes pending further examination of the factual and scientific situation and the veterinary practices in the Member States.

Article 11a of Directive 96/22/EC required the Commission to present a report by 14 October 2005 concerning the availability of alternative veterinary medicinal products to those containing oestradiol 17β for food-producing animals for therapeutic purposes. The Commission sought expert advice and...