ext/celex/31985L0649
No L 382 /228 Official Journal of the European Communities 31 . 12 . 85
COUNCIL DIRECTIVE
of 31 December 1985
prohibiting the use in livestock farming of certain substances having a hormonal action
(85/649/ EEC)
THE COUNCIL OF THE EUROPEAN Whereas the use of hormonal substances for fattening COMMUNITIES , purposes should therefore be prohibited ; whereas the use of certain substances for therapeutic purposes may be authorized but must be strictly controlled in order to prevent any mistfse of them ; Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Whereas , furthermore, since it would be difficult to be Having regard to the proposal from the Commission, certain of correct operation of the scheme as a whole if animals so treated and the meat from such animals were to be traded, this should as a general rule be Having regard to the opinion of the European Parlia prohibited ; whereas, however, derogations from this ment ( ! ), rule may be allowed where satisfactory guarantees can be provided ; Having regard to the opinion of the Economic and Social Committee (2),
Whereas the administration to farm animals of certain Whereas as part of the adoption of harmonized rules substances having a hormonal action is at present in the Community arrangements for importation from regulated in different ways in the Member States ; third countries that offer equivalent guarantees should whereas while their immediate effect on animals from be introduced ; whereas these guarantees can be the farmer's point of view is clear, assessments of theii: required under Directives 72/462/ EEC (3) and effect on human health vary and this is reflected in 85/358/ EEC (4); the regulations governing their use ; whereas this diver gence distorts the conditions of competition in pro ¬ ducts that are the subject of common market organiza ¬ tions and is a serious barrier to intra-Community Whereas in order to ensure that the provisions of this trade ; Directive can be implemented effectively the latest date for introduction of the provisions of Directive 85 /358 / EEC should be made to fall before that for Whereas these distortions of competition and barriers introduction of the provisions of this Directive ; whe to trade, must therefore be removed by ensuring that reas Community control measures should ensure uni all consumers are able to buy the products in question form application in all Member States of the rules under largely identical conditions of supply and that applicable on administration of substances having a these products correspond to their anxieties and hormonal or thyrostatic action, expectations in the best possible manner ; whereas such a course of action is bound to bring about an increase in consumption of the product in question ;
(») OJ No C 288 , 11.11 . 1985 , p. 158 . (3) OJ No L 302, 31 . 12 . 1972, p . 28 . (2) OJ No C 44, 15.2 . 1985 , p . 14. (4) OJ No L 191 , 23 . 7 . 1985 , p. 46 .
31 . 12 . 85 Official Journal of the European Communities No L 382/229
HAS ADOPTED THIS DIRECTIVE : Pending the decisions referred to in the first sub paragraph, products which have already received authorization to be placed on the market shall continue to be authorized . Article 1 Products authorized pursuant to the above provi sions shall be subject to the rules of Articles 24 to For the purposes of implementation of this Directive 50 of Directive 8 1 /851 /EEC, with the exception of the definitions ot meats and of farm animals given in those which relate to national marketing authori Article 1 of Directive 81 /602/EEC (*) shall apply . zations ; For the purposes of implementation of this Directive and of Directive 81 /602/EEC 'therapeutic treatment' (b) products used for therapeutic treatment may be shall mean the administering to an individual farm administered only by a veterinarian, in the form animal of any of the substances authorized in of an injection — to the exclusion of implantation Article 3 of this Directive to treat a fertility problem — to farm animals which have been clearly identi fied . diagnosed, on examination, by a veterinarian . Such therapeutic treatment shall be prohibited for animals intended for fattening. Treatment of identified animals must be registered by the veterinarian . An animal which has been treated may not be slaughtered before expiry of the period fixed pursuant to the provisions set out Article 2 in (a);
(c) any decision on the possible inclusion in the Without prejudice to Article 4 of Directive 81 /602/ group of substances referred to in Article 2 of any EEC, Member States may not authorize any deroga new substance having a direct or indirect oestro tion from Article 2 of the said Directive . However, the genic, androgenic or gestagenic action shall be administering to farm animals for therapeutic pur taken by the Council acting on a proposal from poses of oestradiol - 17-P, testosterone and progeste the Commission in accordance with the voting rone and those derivatives which readily yield the procedure laid down in Article 43(2) of the Treaty. parent compound on hydrolysis after absorption at Any new substance must, in order to be able to be the site of application may be authorized . subject to such a decision, satisfy the relevant principles and criteria of Directives 8 1 /851 /EEC and 81 /852 / EEC .
Article 3
For the purposes of implementation of this Directive: Article 4 (a) there shall be established, after the Committee for Veterinary Medicinal Products has given its opin ion on the measures provided for in the first two The Member States shall prescribe that undertakings indents, and in accordance with the procedure laid producing substances having a thyrostatic, ©estro down in Article 8 : genic, androgenic or gestagenic action and those auth orized for whatever purpose to market those substan — a list of the products containing as active substances the substances referred to in ces, and undertakings producing pharmaceutical and veterinary products based on those substances, must Article 2 and satisfying the relevant principles _ keep a register detailing, in chronological order, quan and criteria of Directive 8 1 /851 /EEC (2) and tities produced or acquired and those sold or used for 81 /852/ EEC (3) that may be authorized by the the production of pharmaceutical and veterinary pro Member States , ducts . — the conditions of use of these products, in particular the waiting period necessary and detailed provisions concerning the control of these conditions of use, — the means of identification of animals . Article 5
Member States must ensure, that no animals are (0 OJ No L 222, 7 . 8 . 1981 , p. 32 . dispatched from their territory to that of another (2) OJ No L 317 , 6 . 11 . 1981 , p. 1 . Member State which have had administered to them (3) OJ No L 317 , 6 . 11 . 1981 , p. 16 . in any way whatsoever substances with a thyro
No L 382 / 230 Official Journal of the European Communities 31 . 12 . 85
static, oestrogenic, androgenic or gestagenic action , 7 . In accordance with the procedure laid down in and that no meat from such animals is dispatched . Article 8 , a control programme shall be drawn up They shall reserve the Community stamp for meat regarding imports from third countries, to ensure that from untreated animals . imports do not receive more favourable treatment than Community products . With effect from the date of notification of this With regard to routine inspections, this programme: Directive and until the measures adopted pursuant to Articles 2 and 6 are applicable: — will establish the frequency of controls on imports from each third country, — national provisions governing produce intended for Member States ' domestic markets shall not be — will take account of the guarantees offered by the affected , inspection regulations of third countries . — Member States which prohibit the use of the sub In the event of positive results, imports from third stances referred to in Article 5 of Directive countries will be subject to systematic inspections until 81 /602/ EEC for fattening may restrict entry into the situation is re-established . their territory to untreated fattening animals and meat from untreated fattening animals .
Article 7 Article 6
The Council, acting by a qualified majority on a 1 . Member States shall prohibit importation from proposal from the Commission, may adopt deroga third countries of animals and of meat from animals tions from Articles 5 and 6 in respect of trade in to which have been administered in any way whatsoe animals intended for reproduction and reproductive ver substances with a thyrostatic, oestrogenic, andro animals at the end of their career which , in the course genic or gestagenic action . of their existence, have been treated under the provi sions of Article 4 of Directive 81 /602/ EEC and in respect of meat from these various animals, taking 2 . To this end the decisions to be taken for imple into account the guarantees given . mentation of Directive 72/462/ EEC, taking account of Article 13 of Directive 85 /358/ EEC in the case of meat, and of the equivalent guarantee in the case of live animals, must be adopted before 1 January 1988 .
Article 8 3 . Member States shall ensure that imported fresh meat coming from approved slaughterhouses in third countries in respect of which a decision within the 1 . Where the procedure laid down in this Article is meaning of paragraph 2 has been taken is, without to be used, matters shall without delay be referred by prejudice to animal health measures , circulated in the the Chairman , either on his own initiative or at the Community in accordance with Article 25 of Directive request of a Member State, to the Standing Veterinary 72 /462 / EEC . Committee (hereinafter called 'the Commitee') set up by the Council Decision of 15 October 1968 . 4 . National rules on substances with a hormonal action dealing with imports from third countries shall 2 . The representative of the Commission shall sub remain applicable, with due regard for the general mit to the Committee a draft of the measures to be provisions of the Treaty, until each of the decisions adopted . The Committee shall deliver its opinion on referred to in paragraph 2 comes into force . the draft within a time limit which the Chairman may lay down according to the urgency of the matter . The opinion shall be delivered by a majority of 54 votes, 5 . As from 1 January 1988, Member States shall the votes of the Member States being weighted as suspend imports coming from third countries in res provided for in Article 148(2) of the Treaty . The pect of which no decision within the meaning of Chairman shall not vote . paragraph 2 has been taken .
3 . The Commission shall adopt the measures and 6 . For the purposes of application of paragraphs 1 implement them immediately where they are in accor to 5 , the Commission shall draw up a list of the dance with the opinion of the Committee. Where they products authorized by third countries for the thera are not in accordance with the opinion of the Com peutic treatments referred to in Article 4 of Directive mittee or if no opinion is delivered, the Commission 81 / 602 / EEC . shall immediately submit to the Council a
31 . 12 . 85 Official Journal of the European Communities No L 382/231
proposal on the measures to be taken . The Council Article 10 shall act by a qualified majority. Member States shall bring into force the laws, regula If within three months of the date on which a matter tions and administrative provisions necessary to com was referred to it the Council has not adopted any ply ; measures, the Commission shall adopt the proposed — with Directive 85/358/EEC, by 1 January 1987 at measures and implement them immediately, save the latest ; where the Council has decided against the measures — with this Directive, by 1 January 1988 at the latest. by a simple majority. They shall immediately inform the Commission the reof.
Article 11 Article 9 This Directive is addressed to the Member States .
The measures necessary to ensure the transition to the Done at Brussels, 31 December 1985 . final arrangements extending the ban laid down in For the Council Article 2 to domestic production may be adopted in The President accordance with the procedure laid down in Article . 8 during a maximum period af one year . R. STEICHEN