Explanatory Memorandum to COM(2000)320 - 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
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| dossier | COM(2000)320 - Amendment of Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a ... |
|---|---|
| source | COM(2000)320  |
| date | 24-05-2000 |
In light of the results of a dispute settlement case brought before the World Trade Organisation (WTO) by the United States of America and by Canada (the Hormones case) and the recommendations made in that respect by the WTO Dispute Settlement Body on 13 February 1998, the Commission initiated immediately a complementary risk assessment in accordance with the requirements of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), as interpreted by the Appellate Body in the Hormones case, of the six hormonal substances (oestradiol 17 รข, testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate) whose administration for animal growth promotion purposes is prohibited by Council Directive 96/22/EC.
On 30 April 1999, the Scientific Committee on Veterinary measures relating to Public Health (SCVPH) issued an opinion concerning the assessment of potential adverse effects to human health from hormone residues in bovine meat and meat products (Commission Document XXIV/B3/SC4). The main conclusion was that no acceptable daily intake (ADI) can be established for any of the six hormones evaluated when they are administered to bovine animals for growth promotion purposes.
As regards in particular oestradiol 17(, the SCVPH assessment is that a substantial body of recent evidence suggests that it has to be considered as a complete carcinogen, as it exerts both tumour initiating and tumour promoting effects, and that the currently available data does not allow to make a quantitative estimate of the risk.
The SCVPH has been reviewing recently scientific information available to the Commission for some of the six hormones, including the United Kingdom's Veterinary Products Committee (October 1999), the Committee on Veterinary Medicinal Products of the EC (in December 1999) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (February 2000) and adopted its final opinion on 3 May 2000. The SCVPH concluded that this recent information did not provide convincing data and arguments demanding revision of its opinion of 30 April 1999.
Therefore, in the light of the opinion of the SCVPH, the Commission proposes to definitively ban the use of oestradiol 17( and its ester-like derivatives in farm animals and to only allow its administration to non-farm animals for therapeutic purposes only.
As regards the five other hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate), the need for further information has been identified. Therefore, the Commission proposes to continue provisionally to apply the prohibition on these five hormones until more complete scientific information is made available. This will be kept under regular review. The use of some of these substances may, however, continue to be authorised for therapeutical purposes and zootechnical treatment under the conditions of Council Directive 96/22/EC.
In comparison to the present situation, this proposal has an impact on imports from third countries who legally use oestradiol 17( and its ester-like derivatives for therapeutical purposes or zootechnical treatment in farm animals.
The Commission considers that the presentation of this proposal represents another step towards the implementation of the international obligations of the Community.