Explanatory Memorandum to COM(2007)292 - Amendment of Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of beta agonists - Main contents
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| dossier | COM(2007)292 - Amendment of Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a ... |
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| source | COM(2007)292  |
| date | 04-06-2007 |
● General context 1. Prohibition of the use of certain substances for non food producing species (pet animals) Article 2 (a) of Council Directive 96/22/EC specifically prohibits the placing on the market of substances listed in Annex II for administering to animals of 'all species'. The motive behind the prohibition of substances for all species is that misuse would be more difficult if no product authorised for whatever species were on the market. Comparison of the prices and presentations of products with e.g. thyreostatic action intended for use in pet animals, however, shows that it is economically unattractive to use pet products e.g. in cattle. Reports of the Member States related to the implementation of the national residue plans to be established according to Directive 96/23/EC i show that illegal use can rather be linked to illegal production or import of substances. This is emphasised by the growing importance of the Internet and the increasing international trade. The same reports show that no illegal uses of stilbenes, stilbene derivates, their salts and esters could be discovered in more than five years past. Several Member States and the veterinary pharmaceutical industry complained to the Commission services that marketing authorisations cannot be granted for products containing substances to treat hyperthyroidism in pet animals due to the restrictions of Directive 96/22/EC. They appealed to the Commission to mitigate the situation. 2. Oestradiol 17ß and its ester like derivates In 1981 (with Directive 81/602/EEC), the EU prohibited the use of substances having a hormonal action for growth promotion in farm animals. These prohibitions apply to Member States and imports from third countries alike. One of these substances is oestradiol 17ß. The legal instrument in force is Directive 96/22/EC as amended by Directive 2003/74/EC. The legislative proposal that preceded Directive 2003/74/EC i intended the prohibition of oestradiol 17ß and its ester like derivates for all purposes (growth promotion, zootechnical purposes and treatment applications). In the adoption procedure it was, however, amended to only reduce the circumstances under which oestradiol 17ß may be administered for purposes other than growth promotion. Only three uses remained 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 (Article 5a). The latter use has to be phased out by until 14 October 2006 and for the rest of the uses the Commission was to present a report in October 2005. The report was presented on 11 October 2005 to Council and Parliament. It comes to the conclusion that the use of the alternative substances such as prostaglandins is already common. Veterinarians predict an insignificant impact of future unavailability of oestradiol 17ß and its ester like derivates on farmers and on animal welfare. It was moreover observed that the unavailability of oestradiol and its ester like derivates would have minimal economic effect. This is because the incidence of fetal mummification and fetal maceration is low, and although the incidence of pyometra is higher, methods of prevention not involving use of oestradiol do exist and would be preferable.
● Existing provisions in the area of the proposal 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, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC, 29 April 1996, as amended by Directive 2003/74/EC. This proposal intends to modify the above directive.
● Consistency with the other policies and objectives of the Union The proposal is consistent with the marketing authorisation provisions in Directive 2001/82/EC i (Veterinary Medicinal Products Code) and Regulation (EC) n°726/2004 of the European Parliament and of the Council of 31 March 2004 i. Oestradiol 17ß is currently classified in Annex II of Regulation (EEC) No 2377/90 i with restrictions of use. This entry will have to be modified if the proposal is adopted because it identifies oestradiol 17ß as a substance that can be used in food producing animals. Further specified exemptions for pet animals would make this already complex legislation even more complex. It will therefore be in line with the Communities goal to simplify legislation if pet animals are deleted from the scope of this legislation.
● Consultation of interested parties Member States and the veterinary pharmaceutical industry have provided their opinion on thyrostatic substances. The Member States have also confirmed in a Council meeting on 11 October 2005 in July 2006 i that if oestradiol 17ß and its ester like derivates were to be prohibited for food producing animals, the substance should remain available for pet animals. Moreover, pet animals affected by hyperthyroidism suffer due the continuous unavailability of appropriate treatment. In can therefore be taken for granted that a proposal allowing such treatment is supported by veterinarians and pet owners.
The changes proposed in relation to oestradiol 17ß are the direct result of the activities required by Article 11a of Directive 2003/74/EC. Council discussed the report presented on 11 October 2005 in July 2006.
● Collection and use of expertise
Methodology used Study
Main organisations/experts consulted
University of Liverpool, Department of Veterinary Clinical Science, Prof Hilary Dobson
Summary of advice received and used
The existence of potentially serious risks with irreversible consequences has not been mentioned.
The advice asserts that in the majority of cases, prostaglandin is the main currently available alternative for oestradiol 17ß and its ester like derivates and that the use of this alternative by practising veterinarians is already common. It concludes that the non-availability of oestradiol 17ß and its ester like derivates would have minimal effect on farm industry economics, veterinarians and farmer's decisions, and animal health and welfare.
Means used to make the expert advice publicly available The report was sent to Council and Parliament and made available on the homepage of Directorate General Health and Consumer Protection at ec.europa.eu/food/animal/resources/publications_en under the heading 'Prevention and Control of Animal Diseases'.
● Impact assessment Information campaigns, financial incentives, self regulation or co-regulation are not an option where the authorisation of an appropriate treatment of pet animals is barred by a legal prohibition to place on the market certain substances for all animal species. It can moreover not be expected that Member States withdraw their marketing authorisations for oestradiol 17ß for food producing animals if the existing legislation still allows its use for certain purposes. On the other hand, lack of action would mean ignoring the needs of animal welfare and the advice provided by the Scientific Committee on Veterinary Measures relating to Public Health (concluding that there is a substantial body of recent evidence suggesting that oestradiol 17ß has to be considered as a complete carcinogen) as well as the advice provided by the expert report on the necessity of the use of oestradiol 17ß in animal production.
Contents
● Summary of the proposed action 1. Take pet animals out of the scope of the legislation. 2. Prohibit the use of oestradiol 17ß in food producing animals entirely.
● Legal basis Treaty Article 152(4)(b)
● Subsidiarity principle The subject of the proposal falls under the exclusive competence of the Community since 1981. There is a long standing consensus that the subject is to be regulated at Community level. The subsidiarity principle therefore does not apply.
● Proportionality principle The proposal complies with the proportionality principle for the following reason(s).
Only very limited changes are introduced necessary in order to avoid futher suffering of pet animals due to the unavailability of an appropriate treatment and in order to take scientific and expert advice concerning oestradiol 17ß into account.
Animal owners, practicing veterinarians, the veterinary pharmaceutical industry and Member States authorisation agencies will be affected by this proposal. As concerns thyrostatic substances this proposal allows the pharmaceutical industry to successfully apply for the authorisation of products containing thyrostatic substances for use in pet animals. It also keeps products containing oestradiol 17ß intended for pet animals on the market. It would allow the authorisation of veterinary medicinal products containing of stilbenes, stilbene derivates, their salts and esters. New authorisation have, however to consider potential misuse. Presentations that are likely to be misused can therefore be rejected. Products for pet animals are a growing market because the numbers of pet animals kept is raising and the animals are kept until old age. Hyperthyroidism is more frequent in old animals. Thus a proposal to allow the authorisation of veterinary medicinal products containing thyrostatic substances for pet animals will have positive effect for their owners, practicing veterinarians and the veterinary pharmaceutical industry. The withdrawal of products containing oestradiol 17β will have no or only a negligible negative effect on farmers practicing veterinarians and the veterinary pharmaceutical industry. Some veterinarians and farmers will have to accustom themselves to new veterinary medicinal products for the treatment of reproductive disorders. Member States agencies responsible for the authorisation of veterinary medicinal products will have to with draw respective marketing authorisations. This falls under the routine activities of these agencies. Nevertheless, as confirmed in the expert report, the withdrawal of products containing oestradiol 17β and its ester-like derivatives will have no or only a negligible negative effect on the veterinary pharmaceutical industry. They will, however, contribute to achieving a high level of human health protection. The proposal has no particular geographical focus nor has it a particular effect for small industries. Considering the above, it is unlikely that the proposal will have measurable effects on employment, on investment and the creation of new businesses or on the competitiveness of businesses. If at all measurable the effect will most likely be positive due to the increased business with pet animals. Accordingly the proposal does not have to contain measures to take account of the specific situation of small and medium-sized firms.
● Choice of instruments
Proposed instruments: directive.
Other means would not be adequate for the following reason(s): This proposal is an amendment of an existing Directive and therefore to maintain formal parallelism should take a form of a Directive. The only other option would be to revoke and replace the existing Directive by another instrument. Considering the limited changes proposed to the current Directive this seems unnecessary and disproportionate.
The proposal has no implication for the Community budget.
● European Economic Area The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.