Article 1 
1. For the purposes of this Directive, the definitions of meat and meat products given in Directives 64/433/EEC ( 7 ), 71/118/EEC ( 8 ), 77/99/EEC ( 9 ), and 91/495/EEC ( 10 ), the definitions of aquaculture products given in Directive 91/493/EEC ( 11 ) and the definitions of veterinary medicinal products given in Directives 81/851/EEC ( 12 ) and 81/852/EEC ( 13 ) shall apply.
Article 2 
Member States shall prohibit the placing on the market of the substances listed in Annex II for administering to any animals, the meat and products of which are intended for human consumption, for purposes other than those provided for in point 2 of Article 4.
Article 3 
Member States shall prohibit, for substances listed in Annex II, and shall provisionally prohibit, for substances listed in Annex III: (a) the administering of those substances to farm or aquaculture animals, by any means whatsoever; (b) — the holding, except under official control, of animals referred to in point (a) on a farm, and — the placing on the market or the slaughter for human consumption of farm animals, which contain the substances referred to in Annex II and Annex III or in which the presence of such substances has been established, unless proof can be given that the animals in question have been treated in accordance with Articles 4, 5 or 5a ; (c) the placing on the market for human consumption of aquaculture animals to which substances referred to above have been administered and of processed products derived from such animals; (d) the placing on the market of meat from animals referred to in point (b); (e) the processing of the meat referred to in (d).
Article 4 
Notwithstanding Articles 2 and 3, Member States may authorize: 1. the administering to farm animals, for therapeutic purposes, of oestradiol 17 β , testosterone and progesterone and derivatives which readily yield the parent compound on hydrolysis after absorption at the site of application. Veterinary medicinal products used for therapeutic treatment must comply with the requirements for placing on the market laid down in Directive 81/851/EEC and be administered only by a veterinarian, by injection or for the treatment of ovarian dysfunction in the form of vaginal spirals, but not by implant, to farm animals which have been clearly identified. Treatment of identified animals must be registered by the veterinarian responsible. The latter must record at least the following details in a register, which may be the one provided for in Directive 81/851/EEC: — type of treatment, — the type of products authorized, — the date of treatment, — the identity of the animals treated. The register must be made available to the competent authority at its request; 2. However, without prejudice to the first subparagraph of point 2 (ii), therapeutic treatment of production animals, including breeding animals at the end of their reproductive life, shall be prohibited.
Article 5 
Notwithstanding Article 3(a) and without prejudice to Article 2, Member States may authorise the administering to farm animals, for the purpose of zootechnical treatment, of veterinary medicinal products having an oestrogenic (other than oestradiol 17β and its ester-like derivatives), androgenic or gestagenic action which are authorised in accordance with 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 ( 14 ). ch veterinary medicinal products must be administered by a veterinarian to clearly identified animals; the treatment must be recorded by the veterinarian responsible in accordance with point 1 of Article 4. However, Member States may allow the synchronization of oestrus and the preparation of donors and recipients for the implantation of embryos to be effected not by the veterinarian direct, but under his responsibility. With regard to aquaculture animals young fish may be treated for the first three months for the purpose of sex inversion with veterinary medicinal products that have an androgenous action and are authorized in accordance with Directives 81/851/EEC and 81/852/EEC. In the cases provided for in this Article, the veterinarian shall make out a non-renewable prescription, specifying the treatment in question and the quantity of the product required and shall record the products prescribed. However, zootechnical treatment of production animals, including during the fattening period for breeding animals at the end of their reproductive life, shall be prohibited.
Article 6 
1. Hormonal products and beta-agonists the administration of which to farm animals is authorised in accordance with Articles 4, 5 or 5a must meet the requirements of Directive 2001/82/EC.
Article 7 
1. For the purpose of trade, Member States may authorise the placing on the market of animals for breeding and breeding animals at the end of their reproductive life which, during the latter period, have undergone a treatment referred to in Articles 4, 5 or 5a and may authorise the affixing of the Community stamp to meat from such animals where the conditions laid down in Articles 4, 5 or 5a and the withdrawal periods provided for in the authorisation to place on the market are complied with. However, trade in high-value horses, and in particular racehorses, competition horses, circus horses or horses intended for stud purposes or for exhibitions, including registered equidae to which veterinary medicinal products containing allyl trenbolone or beta-agonists have been administered for the purposes referred to in Article 4, may take place before the end of the withdrawal period, provided that the conditions governing administration are fulfilled and that the type and date of treatment are entered on the certificate or passport accompanying these animals. 2. Meat or products from animals to which substances having an oestrogenic, androgenic or gestagenic action or beta-agonists have been administered in accordance with the dispensatory provisions of this Directive may not be placed on the market for human consumption unless the animals in question have been treated with veterinary medicinal products complying with the requirements of Article 6 and in so far as the withdrawal period laid down was observed before the animals were slaughtered.
Article 8 
Member States shall ensure that: 1. at the time of the import, manufacture, storage, distribution, sale and use of the substances referred to in Articles 2 and 3, their possession is restricted to the persons authorised by national legislation in accordance with Article 68 of Directive 2001/82/EC. 3. the tests for the presence of: (a) the substances referred to in point 1 in animals, in the drinking water of animals and in all places where animals are bred or kept; (b) residues of the aforementioned substances in live animals, their excrement and body fluids and in animal tissues and products are carried out in accordance with Annexes III and IV to Directive 96/23/EC;
Article 9 
Without prejudice to Directive 81/851/EEC, undertakings buying or producing substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and beta-agonists, undertakings authorized in any capacity to market such substances and undertakings buying or producing pharmaceutical and veterinary medicinal products from such substances shall be required to keep registers detailing, in chronological order, quantities produced or acquired and those sold or used for the production of pharmaceutical and veterinary medicinal products and the names of the persons to whom such quantities were sold or from whom they were purchased. The above information must be made available to the competent authority at its request and, in the case of computerized records, in the form of a printout.
Article 10 
Where the results of checks carried out in a Member State show failure to comply with the requirements of this Directive in the country of origin of the animals or products, the competent authority of that Member State shall have recourse to Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters ( 17 ).
Article 11 
1. Third countries whose legislation authorises the placing on the market and administration of stilbenes, stilbene derivatives, their salts and esters, or of thyrostatic substances for administering to all species of animals the meat and products of which are intended for human consumption may not appear on any of the lists of countries provided for under Community legislation from which Member States are authorised to import farm or aquaculture animals or meat or products obtained from such animals. 3. However, animals intended for breeding, breeding animals at the end of their reproductive life, or meat therefrom, from third countries may be imported subject to their affording guarantees at least equivalent to those laid down in this Directive, which have been established in accordance with the procedure laid down in Article 33 of Directive 96/23/EC for the purpose of giving effect to Chapter V of that Directive. 4. Checks on imports from third countries shall be carried out in accordance with Article 4 (2) (c) of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries ( 18 ) and Article 8 (2) of Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries ( 19 ).
Article 11a 
With regard to the substances listed in Annex III, the Commission shall seek additional information, taking into account recent scientific data from all possible sources, and keep the measures applied under regular review with a view to the timely presentation to the European Parliament and to the Council of any necessary proposals.
Article 11b 
The Commission, in collaboration with the Member States, shall set up an information and awareness campaign on the complete ban on the use of oestradiol 17β in food-producing animals, aimed at farmers and veterinary organisations in the EU as well as the relevant organisations outside the EU which are directly or indirectly involved in the export to the EU of food of animal origin falling within the scope of this Directive.
Article 12 
The Council, acting by a qualified majority on a proposal from the Commission, may adopt transitional measures necessary for the introduction of the arrangements provided for in this Directive.
Article 13 
1. Directives 81/602/EEC, 88/146/EEC and 88/299/EEC are hereby repealed as from 1 July 1997. 2. References made to the repealed Directives shall be construed as being made to this Directive and should be read in accordance with the correlation table in the Annex.
Article 14 
1. Member States shall bring into force the laws, regulations and administrative provisions, including any penalties, necessary to comply with this Directive on 1 July 1997, and, for beta-agonists, by 1 July 1997 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive. 3. Pending application of the provisions of this Directive as regards beta-agonists, the relevant national rules shall continue to apply in compliance with the general provisions of the Treaty.
Article 14a 
Notwithstanding Articles 3 and 5a , and without prejudice to Article 2, farm animals for which it can be certified that they have been administered oestradiol 17β or its ester-like derivatives for therapeutic or zootechnical purposes prior to 14 October 2004 shall be subject to the same provisions as those laid down for the substances authorised in accordance with Article 4(1) as regards therapeutic use and Article 5 as regards zootechnical use.
Article 15 
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities .
Article 16 
This Directive is addressed to the Member States.