This latest opinion follows a re-appraisal of 17 studies as well as taking into account the latest scientific evidence available from other relevant sources. The 17 studies were launched by the European Commission to address certain research gaps identified following the ruling of the WTO Appellate Body concerning the scientific basis of the EU import ban on meat and products treated with growth-promoting hormones. The studies addressed toxicological aspects, potential abuse and control problems, as well as environmental aspects of six hormones: oestradiol 17-â, progesterone, testosterone, zeranol, trenbolone acetate and melengestrol acetate and their metabolites.
Following the completion of all 17 studies, the SCVPH was asked to review its previous opinions on the potential risks to human health from hormone residues in bovine meat and meat products. The Committee confirmed the validity of its previous opinions stating that "no amendments to those opinions are justified".
The Committee made particular reference to the disposition of stable lipoidal esters in animal body fats and the dose-dependent increase in residue levels of all hormones in edible tissues.
Furthermore, the accumulating evidence confirmed the mutagenic and genotoxic potential of 17 â oestradiol. The complex biotransformation of trenbolone, zeranol and melengestrol acetate was identified. Experimental and epidemiological data were evaluated regarding possible consequences for the incidence of cancer from pre- and perinatal exposure to hormones.
The final opinion of the SCVPH "Review of previous SCVPH opinions of 30 April 1999 and 3 May 2000 on the potential risks to human health from hormones residues in bovine meat and meat products" is available on the Internet at:
http://europa.eu.int/comm/food/fs/sc/scv/outcome_en.html
For further background information on the "hormone-case", go to:
http://europa.eu.int/comm/food/fs/him/him_index_en.html
Background
In 1988, the EU prohibited of the use of oestradiol 17, testosterone, progesterone, zeranol, trenbolone acetate and melengestrol acetate (MGA) for growth promotion in farm animals. This prohibition applies to Member States and imports from third countries alike.
The United States and Canada contested the prohibition and, in 1997, a panel of the World Trade Organisation (WTO) ruled that the 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 carried out a complementary risk assessment and mandated the Scientific Committee on Veterinary measures relating to Public Health (SCVPH) to evaluate the risks to human health from hormone residues in bovine meat and meat products treated with six hormones for growth promotion. The SCVPH concluded in 1999, again in 2000 and again today that no acceptable daily intake (ADI) could be established for any of the six hormones evaluated. For oestradiol 17â it concluded that there is a substantial body of evidence suggesting that oestradiol 17â 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.
In the light of the opinions of the SCVPH of April 1999 and May 2000, the Commission proposed in May 2000 to definitively prohibit the use of oestradiol 17â and its ester-like derivatives in farm animals. As regards the five other hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate), the Commission proposed to continue provisionally to apply the prohibition on these five hormones for growth promotion until more complete scientific information is made available. This means that some of these substances, after re-evaluation by another scientific committee of the EU, would continue to be authorised only for therapeutical and zootechnical purposes under specific conditions. The Commission considered that the presentation of that draft law in 2000 represented another step towards the implementation of the international obligations of the EU whilst maintaining its chosen high level of health protection.
At the time of making that proposal, the Commission confirmed that it will continue to take into account any new emerging scientific data from any source. This is what it did with the third opinion on these six hormones by the SCVPH of today. The Commission considers, therefore, that the latest opinion confirms once again the scientific basis of its risk management decision.
The European Parliament had its first reading on the proposal in 2001 and it is now up to the Council to adopt a common position.