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Stockfarming: prohibition of certain substances having a hormonal or thyreostatic action and of beta-agonists

2007/0102(COD)

PURPOSE: to amend Council Directive 96/22/EC concerning the prohibition on the use in stock farming of certain substances having a hormonal or thyreostatic action and of beta-agonists.

PROPOSED ACT: Directive of the European Parliament and of the Council.

CONTENT: this proposal aims to:

  • take pet animals out of the scope of the legislation;
  • prohibit the use of oestradiol 17ß in food producing animals entirely.

Article 2 (a) of Council Directive 96/22/EC specifically prohibits the placing on the market of substances listed in Annex II for administering to animals of "all species". The motive behind the prohibition of substances for all species is that misuse would be more difficult if no product authorised for whatever species were on the market.

Several Member States and the veterinary pharmaceutical industry complained to the Commission services that marketing authorisations cannot be granted for products containing substances to treat hyperthyroidism in pet animals due to the restrictions of Directive 96/22/EC. They appealed to the Commission to mitigate the situation.

As regards Oestradiol 17ß and its ester like derivates, it appears that the use of the alternative substances such as prostaglandins is already common. Veterinarians predict an insignificant impact of future unavailability of oestradiol 17ß and its ester like derivates on farmers and on animal welfare. It is also observed that the unavailability of oestradiol and its ester like derivates would have minimal economic effect. This is because the incidence of fetal mummification and fetal maceration is low, and although the incidence of pyometra is higher, methods of prevention not involving use of oestradiol do exist and would be preferable.

Member States and the veterinary pharmaceutical industry provided their opinion on thyrostatic substances. The Member States have also confirmed in a Council meeting on 11 October 2005 in July 2006 that if oestradiol 17ß and its ester like derivates were to be prohibited for food producing animals, the substance should remain available for pet animals.