In 1981 (with Directive 81/602/EEC), the EU prohibited the use of substances having a hormonal action for growth promotion in farm animals. Examples for these kind of growth promoters are oestradiol 17ß, testosterone, progesterone, zeranol, trenbolone acetate and melengestrol acetate (MGA).

This prohibition applies to Member States and imports from third countries alike. The legal instrument in force is Directive 96/22/EC as amended by Directive 2003/74/EC.

The Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) thoroughly re-evaluated the risks to human health from hormone residues in bovine meat and meat products treated with six hormones for growth promotion. In 1999 this independent scientific advisory body concluded that no acceptable daily intake (ADI) could be established for any of these hormones. For oestradiol 17ß it concluded that there is a substantial body of evidence suggesting that oestradiol 17ß has to be considered as a complete carcinogen (exerts both tumour initiating and tumour promoting effects) and that the data available would not allow a quantitative estimate of the risk. Having examined additional scientific data the SCVPH confirmed its opinion in 2000 and 2002.

Based on this scientific opinion, the Commission proposed to the European Parliament and to the Council to amend Directive 96/22/EC concerning the prohibition of the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists in May 2000.

The European Parliament and the Council on 22 September 2003 amended Directive 96/22/EC through the adoption of Directive 2003/74/EC following a co-decision procedure according to Article 252 of the Treaty.

As amended, the Directive confirms the prohibition of substances having a hormonal action for growth promotion in farm animals. Moreover, it drastically reduces the circumstances under which oestradiol 17ß may be administered for other purposes to food producing animals. Only three uses remain permissible on a transitional basis and under strict veterinary control: treatment of foetus maceration/ mummification, pyometra in cattle (for animal welfare reasons) and oestrus induction in cattle, horses, sheep and goats. The latter use was phased out in autumn 2006.

By October 2005 the Commission will present a report on the availability of alternative veterinary medicinal products to those containing oestradiol 17ß or its ester-like derivatives for the treatment of foetus maceration/mummification in cattle and for the treatment of pyometra in cattle. The Commission will also continue to take into account any new emerging scientific data from any source.