Considerations on 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 ... |
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| document | COM(2000)320  |
| date | September 22, 2003 |
(2) Article 11(2) of Directive 96/22/EC requires Member States to prohibit the importation from third countries of farm or aquaculture animals to which substances or products referred to in Article 3(a) of that Directive have been administered, unless those products were administered in compliance with the provisions and requirements laid down in Articles 4, 5 and 7 thereof, as well as of meat or products obtained from animals the importation of which is prohibited.
(3) In the 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)(5) and recommendations made in that respect by the WTO Dispute Settlement Body on 13 February 1998, the Commission immediately initiated a complementary risk assessment, in accordance with the requirements of the Agreement on the application of sanitary and phytosanitary measures (WTO-GATT)(6) as interpreted by the appellate body in the Hormones case, of the six hormonal substances (oestradiol 17ß, testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate) whose administration for animal growth promotion purposes is prohibited by Directive 96/22/EC.
(4) In parallel, the Commission initiated and funded a number of specific scientific studies and research projects on these six hormones in order to obtain as much as possible of the missing scientific information, as identified in the interpretations and findings of the WTO panel and appellate body reports in the Hormones case. Moreover, the Commission addressed specific requests to the USA, Canada and other third countries, which authorise the use of these six hormones for animal growth promotion, and published an open call for documentation(7) requesting any interested party, including the industry, to provide any relevant and recent scientific data and information in their possession to be taken into account in the complementary risk assessment.
(5) On 30 April 1999, as requested by the Commission, 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. The major conclusions of that opinion were, first, that, as concerns excess intake of hormone residues and their metabolites, and in view of the intrinsic properties of hormones and the epidemiological findings, a risk to the consumer has been identified with different levels of conclusive evidence for the six hormones evaluated. Secondly, for the six hormones endocrine, developmental, immunological, neurobiological, immunotoxic, genotoxic and carcinogenic effects could be envisaged and, of the various susceptible risk groups, prepubertal children constitute the group of greatest concern and, third, in view of the intrinsic properties of the hormones and taking into account epidemiological findings, no threshold levels and, therefore, 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.
(6) As regards, in particular, the use of oestradiol 17ß, with the aim of promoting growth, 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 data currently available do not make it possible to give a quantitative estimate of the risk.
(7) As regards the other five hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate), the SCVPH assessment is that, in spite of the individual toxicological and epidemiological data available, which were taken into account, the current state of knowledge does not make it possible to give a quantitative estimate of the risk to consumers.
(8) Subsequent to the opinion of the SCVPH of 30 April 1999, new and more recent scientific information on some of the six hormones under consideration was made available to the Commission from the United Kingdom's Veterinary Products Committee, in October 1999, the Committee on Veterinary Medicinal Products of the European Community (CVM), in December 1999, and the Joint FAO/WHO Expert Committee on Food Additives (JECFA), in February 2000. The CVM has noted in particular that oestradiol 17ß has a carcinogenic effect only after prolonged exposure and at levels which are considerably higher than those needed for a physiological (oestrogenic) response. All this latest scientific information was brought to the attention of the SCVPH, which reviewed it and, on 3 May 2000, concluded that it did not provide convincing data and arguments requiring revision of the conclusions drawn in its opinion of 30 April 1999. The SCVPH confirmed in its opinion of 10 April 2002 the validity of its previous opinion, after revising it in the light of the most recent scientific data.
(9) As regards, in particular, oestradiol 17ß, this substance can potentially be used in all farm animals and residue intake for all segments of the human population and in particular the susceptible groups at high risk can therefore be especially relevant. The avoidance of such intake is of absolute importance to safeguard human health. Furthermore, the routine use of the above substances for animal growth promotion purposes is likely to lead to increased concentration of those substances in the environment.
(10) Taking into account the results of the risk assessment and all other available pertinent information, it has to be concluded that, in order to achieve the chosen level of protection in the Community from the risks posed, in particular to human health, by the routine use of these hormones for growth promotion and the consumption of residues found in meat derived from animals to which these hormones have been administered for growth promotion, it is necessary to maintain the permanent prohibition laid down in Directive 96/22/EC on oestradiol 17ß and to continue provisionally to apply the prohibition to the other five hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate). Furthermore, according to Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(8), the provisional prohibition of these five hormones should apply while the Community seeks more complete scientific information from any source, which could shed light and clarify the gaps in the present state of knowledge of these substances.
(11) However, the use of certain of the above substances, where this is necessary, for therapeutic purposes or zootechnical treatment may continue to be authorised as it is not likely to constitute a hazard for public health owing to the nature and the limited duration of the treatments, the limited quantities administered and the strict conditions laid down in Directive 96/22/EC in order to prevent any possible misuse.
(12) However, in the light of the existing information it is appropriate to limit as far the exposure to oestradiol 17ß and only authorise those treatments for which no viable effective alternatives exist. In general, there are alternative treatments or strategies available to replace most of the uses of oestradiol 17ß for therapeutic or zootechnical purposes. Nonetheless, studies appear to show that at present no viable effective alternatives exist in all the Member States for certain treatments which are currently authorised. In order to allow for the necessary adjustments and in particular for the authorisation or the mutual recognition of the pharmaceutical products needed, it is appropriate to phase out the use of oestradiol 17ß for oestrus induction over a given period. It is also appropriate to maintain the possibility of authorising, under strict and verifiable conditions so as to prevent any possible misuse and any unacceptable risk for public health, its use for the treatment of certain conditions (foetus maceration or mummification and pyometra in cattle) which have serious consequences for animal health and welfare. It is necessary to review this possibility within a given time.
(13) The proposed amendments to Directive 96/22/EC are necessary to achieve the chosen level of health protection from the residues in meat of farm animals treated with these hormones for growth promotion purposes, whilst respecting the general principles of food law set out in Regulation (EC) No 178/2002 and the international obligations of the Community. Moreover, there is no other means that is reasonably available at present, taking into account technical and economic feasibility, which is significantly less restrictive of trade and can achieve equally effectively the chosen level of health protection. In addition, minor drafting amendments are equally necessary in particular in view of the replacement of a number of Directives by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(9).