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, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC

1. For the purposes of this Directive, the definitions of meat and meat products given in Directives 64/433/EEC (1), 71/118/EEC (2), 77/99/EEC (3), and 91/495/EEC (4), the definitions of aquaculture products given in Directive 91/493/EEC (5) and the definitions of veterinary medicinal products given in Directives 81/851/EEC (6) and 81/852/EEC (7) shall apply.

2. In addition, the following definitions shall apply:

(a) 'farm animals' shall mean domestic animals of the bovine, porcine, ovine and caprine species, domestic solipeds, poultry and rabbits, as well as wild animals of those species and wild ruminants which have been raised on a holding;

(b) 'therapeutic treatment' shall mean the administering - under Article 4 of this Directive - to an individual farm animal of an authorized substance to treat, after examination by a veterinarian, a fertility problem - including the termination of unwanted gestation - and, in the case of beta-agonists, to induce tocolysis in cows when calving and to treat respiratory problems and to induce tocolysis in equidae raised for purposes other than meat production;

(c) 'zootechnical treatment' shall mean the administering:

(i) to an individual farm animal of any substance authorized under Article 5 of this Directive for synchronizing oestrus and preparing donors and recipients for the implantation of embryos, after examination of the animal by a veterinarian or, in accordance with the second paragraph of Article 5, under his responsibility;

 

(ii) in the case of aquaculture animals, to a group of breeding animals for sex inversion, on a veterinarian's prescription and under his responsibility;

(d) 'illegal treatment' shall mean the use of unauthorized substances or products or the use of substances or products authorized under Community legislation for purposes or under conditions other than those laid down in Community legislation.

(1) OJ No 121, 29. 7. 1964, p. 2012/64. Directive as last amended by Directive 95/23/EC (OJ No L 243, 11. 10. 1995, P 7)

(2) OJ No L 55, 8. 3. 1971, p. 23. Directive as last amended by the 1994 Act of Accession.

(3) OJ No L 26, 31. 1. 1977, p. 85. Directive as last amended by Directive 85/68/EC (OJ No L 332, 30. 12. 1995, p. 10).

(4) OJ No L 268, 24. 9. 1991, p. 41. Directive as last amended by the 1994 Act of Accession.

(5) OJ No L 268, 24. 9. 1991, p. 15. Directive as last amended by Directive 95/71/EC (OJ No L 332, 30. 12. 1995, p. 40).

(6) OJ No L 317, 6. 11. 1981, p. 1. Directive as last amended by Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31).

(7) OJ No L 317, 6. 11. 1981, p. 16. Directive as last amended by Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31).

Member States shall prohibit:

(a) the placing on the market of stilbenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species;

(b) the placing on the market of beta-agonists for adminisrering to animals the flesh and products of which are intended for human consumption for purposes other than those provided for in point 2 of Article 4.

Member States shall prohibit:

(a) the administering to a farm or aquaculture animal, by any means whatsoever, of substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and of beta-agonists;

(b) the holding, except under official control, of animals referred to in (a) on a farm, the placing on the market or slaughter for human consumption of farm animals or of aquaculture animals which contain the substances referred to in (a) 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 or 5;

(c) the placing on the market for human consumption of aquaculture animals to which substances referred to in (a) have been administered and of processed products derived from such animals;

(d) the placing on the market of meat of the animals referred to in (b);

(e) the processing of the meat referred to in (d).

Notwithstanding Articles 2 and 3, Member States may authorize:

1. the administering to farm animals, for therapeutic purposes, of oestradiol 17 ß, 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 ovarien dysfunction in the form of vaginal spirale, 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 aurhority at its request;

2. the administering for therapeutic purposes of authorized veterinary medicinal products containing:

(i) allyl trenbolone, administered orally, or beta- agonists to equidae and pets, provided they are used in accordance with the manufacturer's instructions;

 

(ii) beta-agonists, in the form of an injection to induce tocolysis in cows when calving.

Such substances must be administered by a veterinarian or, in the case of the veterinary medicinal products referred to in (i), under his direct responsibility; treatment must be registered by the veterinarian responsible, who shall record at least the details referred to in point 1.

Farmers shall be prohibited from holding veterinary medicinal products containing beta-agonists which may be used for induction purposes in the treatment of tocolysis.

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.

Notwithstanding Article 3 (a) and without prejudice to Article 2, Member States may authorize the administering to farm animals, for the purpose of zootechnical treatment, of veterinary medicinal products having an oestrogenic, androgenic or gestagenic action which are authorized in accordance with Directives 81/851/EEC and 81/852/EEC. Such 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 tris 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 theor reproductive life, shall be prohibited.

1. Hormonal products and beta-agonists the administration of which to farm animals is authorized in accordance with Articles 4 and 5 must meet the requirements of Directives 81/851/EEC and 81/852/EEC.

2. The following may not, however, be authorized in accordance with paragraph 1:

(a) the following hormonal products:

(i) products acting as a deposit;

 

(ii) products with a withdrawal period of more than 15 days after the end of treatment;

 

(iii) products:

which were authorized under rules that preceded the amendment made by Regulation (EEC) No 2309/93(1),

whose conditions of use are not known,

for which no reagents or equipment exist for use in the analytical techniques for detecting the presence of residues in excess of the permitted limits,

(b) veterinary medicinal products containing beta agonists which have a withdrawal period of more than 28 days after the end of treatment.

1. For the purpose of trace, Member States may authorize 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 and 5 and may authorize the affixing of the Community stamp to meat from such animals where the conditions laid clown in Articles 4 and 5 and the minimum withdrawal periods laid clown in Article 6 (2), under (a) (ii) or (b) respectively or the withdrawal periods provided for in the authorization to place on the market are complied with.

However, trace in high-value horses, and in particular racehorses, competition horses, circus horses or horses intended for stuc 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 clown was observed before the animals were slaughtered.

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 (a), their possession is restricted to the persons authorized by national legislation in accordance with Article 1 of Directive 90/676/ EEC (2);

2. in addition to the checks provided for in the Directives governing the placing on the market of the various products in question, the official checks provided for in Article 11 of Directive 96/23/EC (3) are carried out by the competent national authorities without prior notice, with a view to ascertaining:

(a) the possession or presence of substances or products prohibited under Article 2, intended to be administered to animals for the purpose of fattening;

(b) the illegal treatment of animals;

(c) failure to observe the withdrawal periods provided for in Article 6;

(d) failure to observe the restrictions on the use of certain substances or products laid clown in Articles 4 and 5;

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;

4. where the checks provided for in points 2 and 3 reveal:

(a) the presence of substances or products the use or possession of which is prohibited, or the presence of residues of substances the administering of which comes under the heading of illegal treatment, such substances or products are confiscated, while any animals treated or the meat therefrom is placed under official supervision until the requisite penalties have been applied;

(b) failure to comply with the requirements of points 2 (b) and (c), the competent authority takes appropriate measures consistent with the gravity of the infringement.

(1) OJ No L 214, 24. 8. 1993, p. 1.

(2) OJ No L 373, 31. 12. 1990, p. 15.

(3) OJ No L125, 23.5.1996, p.10.

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.

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(1).

1. Third countries whose legislation authorizes the placing on the market and administration of stilbenes, stilbene derivatives, their salts and esters, or of thyrostatic substances for administering to animals of all species may not appear on any of the lists of countries provided for under Community legislation from which Member States are authorized to import farm or aquaculture animals or meat or products obtained from such animals.

2. Member States shall also prohibit the importation from third countries on any of the lists referred to in paragraph 1 of:

(a) farm or aquaculture animals

(i) to which products or substances referred to in point (a) of Article 2 have been administered by any means whatsoever;

 

(ii) to which substances or products referred to in point (a) of Article 3 have been administered, unless those substances or products were administered in compliance with the provisions and requirements laid clown in Articles 4, 5 and 7 and the withdrawal periods allowed in international recommandations have been observed;

(b) meat or products obtained from animals the importation of which is prohibited under point (a).

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 clown in this Directive, which have been established in accordance with the procedure laid clown 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 clown the principles governing the organization of veterinary checks on animals entering the Community from third countries (2) and Article 8 (2) of Council Directive 90/675/EEC of 10 December 1990 laying clown the principles governing the organization of veterinary checks on products enrering the Community from third countries (3).

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.

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.

(1) OJ No L 351, 2. 12. 1989, p. 34.

(2) OJ No L 268, 24. 9. 1991, p. S6. Directive as last amended by Commission Decision 95/157/EC (OJ No L 103, 6. 5. 1995, p. 40)

(3) OJ No L 373, 31. 12. 1990, p. 1. Directive as last amended by Directive 95/52/EC (OJ No L 265, 8. 11. 1995, p. 16).

(4) OJ No L 351, 2. 12. 1989, p. 34.

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 clown 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.

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities .

This Directive is addressed to the Member States.