Introduction
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 former 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 confirmed the prohibition of substances having a hormonal action for growth promotion in farm animals and moreover, drastically reduced the circumstances under which oestradiol 17ß could be administered for other purposes to food producing animals. In October 2005 the Commission presented 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 and in November 2008, Directive 96/22/EC was further amended to prohibit all uses of oestradiol 17ß and its ester-like derivatives in food-producing animals (Directive (2008/97/EC).
The Commission keeps taking into account any new emerging scientific data from any source.
International aspects
The United States and Canada contested the prohibition of the use of hormones as growth promoters in food producing animals, and in 1997 a panel of the World Trade Organisation (WTO) ruled that the EU measure was not in line with the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS).
The EU appealed against this ruling and, in 1998, the WTO Appellate Body reversed most of the findings of the panel. The WTO Appellate Body only upheld the finding that prohibition of imports of meat from hormone-treated animals to the EU did not comply with the requirement that such a measure should be based on a relevant assessment of the risks to human health.
In reaction to these findings, the EU mandated a new assessment of the risks to human health from hormone residues in bovine meat and meat products treated with six hormones used for growth promotion. Subsequently the EU amended Directive 96/22/EC by adoption of Directive 2003/74/EC and thus implemented its international obligations in the context of the World Trade Organisation.
Scientific opinions
- Opinion on review of previous SCVPH opinions of 30 April 1999 and 3 May 2000 on the potential risks to human health from hormone residues in bovine meat and meat products (adopted on 10 April 2002).
- Review of specific documents relating to the SCVPH opinion of 30 April 99 on the potential risks to human health from hormone residues in bovine meat and meat products (adopted on 03 May 2000).
- Opinion of the Scientific Committee on Veterinary Measures Relating to Public Health: Assessment of potential risks to human health from hormone residues in bovine meat and meat products (30 April 1999).
Legislation
- Directive 2003/74/EC, concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists (22 July 2003)
- Directive 96/22/EC, concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists (29 April 1996)