Avis juridique important

Council Directive 81/602/EEC of 31 July 1981 concerning the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action Official Journal L 222 , 07/08/1981 P. 0032 - 0033 Finnish special edition: Chapter 3 Volume 13 P. 0214 Spanish special edition: Chapter 03 Volume 23 P. 0038 Swedish special edition: Chapter 3 Volume 13 P. 0214 Portuguese special edition Chapter 03 Volume 23 P. 0038

COUNCIL DIRECTIVE of 31 July 1981 concerning the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action (81/602/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas, due to the residues that they leave in meat, certain substances with a thyrostatic, oestrogenic, androgenic or gestagenic action may be dangerous for consumers ; whereas these substances may also affect the quality of the meat; Whereas, in the interest of the consumer, the administering to any animal of stilbenes and thyrostatic substances and the marketing of these substances must be prohibited and the use of the other substances must be regulated; Whereas, in particular, if the use of certain substances may be authorized for therapeutic purposes, this must be controlled; Whereas, moreover, the harmless or harmful effects of the use of Oestradiol 17/ß, Progesterone, Testosterone, Trenbolone and Zeranol still have to be examined in detail ; whereas, pending the adoption of a decision relating to these substances, the current measures governing them should be maintained as a precautionary measure with due regard for the general provisions of the Treaty; Whereas provision should be made for the effective control of the application of the provisions deriving from this Directive, HAS ADOPTED THIS DIRECTIVE: Article 1 1. For the purposes of this Directive, the definitions of meat and meat products contained in Directives 64/433/EEC (4), 71/118/EEC (5) and 77/99/EEC (6) shall apply. 2. In addition, the following definitions shall apply: - farm animals : domestic animals of the bovinespecies, swine, sheep, goats, solipeds and poultry,and wild animals of these species and wild ruminantswhich have been raised on a holding, - therapeutic treatment : the administering to a farmanimal of any of the substances referred to inArticle 4 (1) to treat a pathological state diagnosed,on examination, by a veterinarian. (1) OJ No C 305, 22.11.1980, p. 2. (2) OJ No C 50, 9.3.1981, p. 87. (3) OJ No C 138, 9.6.1981, p. 29. (4) OJ No 121, 29.7.1964, p. 2012/64. (5) OJ No L 55, 8.3.1971, p. 23. (6) OJ No L 26, 31.1.1977, p. 85. Article 2 Subject to Articles 4 and 5, Member States shall ensure that the following are prohibited: (a) the administering to a farm animal, by any meanswhatsoever, of substances having a thyrostaticaction or substances having an oestrogenic, androgenicor gestagenic action; (b) the placing on the market or slaughtering of farmanimals to which the abovementioned substanceshave been administered; (c) the placing on the market of meat of the farmanimals referred to in (b); (d) processing of the meat referred to in (c) and theplacing on the market of meat products preparedfrom or with such meat. Article 3 From the date laid down in Article 9 (a), Member States shall prohibit the placing on the market of stilbenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species. Article 4 1. Notwithstanding Article 2, Member States may authorize the administering to farm animals of substances with oestrogenic, androgenic or gestagenic action approved in accordance with the Directives on veterinary medicinal products other than the substances referred to in Article 3, for therapeutic use, synchronization of oestrus, termination of unwanted gestation, the improvement of fertility and the preparation of donors and recipients for the implantation of embryos. 2. The administering of the substances referred to in paragraph 1 shall be effected by a veterinarian. 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 but under his direct responsibility. Article 5 The Council, acting unanimously on a proposal from the Commission shall take a decision as soon as possible on the administering to farm animals of oestradiol 17/ß, Progesterone, Testosterone, Trenbolone and Zeranol for fattening purposes. Pending adoption of this decision, the national regulations in force and the arrangements made by Member States concerning these substances shall continue to apply while complying with the general provisions of the Treaty and without prejudice to measures adopted in accordance with a Community procedure designed for their approximation. Member States may not authorize the use of new substances during this transitional period. Article 6 Member States shall ensure that, pending adoption of relevant Community rules, their national provisions applying to products imported from third countries are not more favourable than those applying to intra-Community trade pursuant to this Directive. Article 7 Member States shall ensure that farm animals, the meat of such animals and the meat products obtained therefrom are subjected to controls. The detailed rules for carrying out such controls and the financing thereof shall be laid down by the Council acting unanimously on a proposal from the Commission. Article 8 Not later than 1 July 1984, the Commission shall submit to the Council a report on the experience acquired and scientific developments, accompanied, if necessary, by proposals which take these developments into account. Article 9 Member States shall bring into force the measures necessary to comply with: (a) the provisions of Article 3 no later than twomonths after the date of notification of this Directive; (b) the other Articles of this Directive not later than12 months after the date of notification of thisDirective. They shall forthwith inform the Commission thereof. Article 10 This Directive is addressed to the Member States. Done at Brussels, 31 July 1981. For the Council The President P. WALKER

COUNCIL DIRECTIVE of 31 July 1981 concerning the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action (81/602/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas, due to the residues that they leave in meat, certain substances with a thyrostatic, oestrogenic, androgenic or gestagenic action may be dangerous for consumers ; whereas these substances may also affect the quality of the meat;

Whereas, in the interest of the consumer, the administering to any animal of stilbenes and thyrostatic substances and the marketing of these substances must be prohibited and the use of the other substances must be regulated;

Whereas, in particular, if the use of certain substances may be authorized for therapeutic purposes, this must be controlled;

Whereas, moreover, the harmless or harmful effects of the use of Oestradiol 17/ß, Progesterone, Testosterone, Trenbolone and Zeranol still have to be examined in detail ; whereas, pending the adoption of a decision relating to these substances, the current measures governing them should be maintained as a precautionary measure with due regard for the general provisions of the Treaty;

Whereas provision should be made for the effective control of the application of the provisions deriving from this Directive,

HAS ADOPTED THIS DIRECTIVE:

1. For the purposes of this Directive, the definitions of meat and meat products contained in Directives 64/433/EEC (4), 71/118/EEC (5) and 77/99/EEC (6) shall apply.

2. In addition, the following definitions shall apply: - farm animals : domestic animals of the bovinespecies, swine, sheep, goats, solipeds and poultry,and wild animals of these species and wild ruminantswhich have been raised on a holding,

- therapeutic treatment : the administering to a farmanimal of any of the substances referred to inArticle 4 (1) to treat a pathological state diagnosed,on examination, by a veterinarian. (1) OJ No C 305, 22.11.1980, p. 2. (2) OJ No C 50, 9.3.1981, p. 87. (3) OJ No C 138, 9.6.1981, p. 29. (4) OJ No 121, 29.7.1964, p. 2012/64. (5) OJ No L 55, 8.3.1971, p. 23. (6) OJ No L 26, 31.1.1977, p. 85.

Subject to Articles 4 and 5, Member States shall ensure that the following are prohibited: (a) the administering to a farm animal, by any meanswhatsoever, of substances having a thyrostaticaction or substances having an oestrogenic, androgenicor gestagenic action;

(b) the placing on the market or slaughtering of farmanimals to which the abovementioned substanceshave been administered;

(c) the placing on the market of meat of the farmanimals referred to in (b);

(d) processing of the meat referred to in (c) and theplacing on the market of meat products preparedfrom or with such meat.

From the date laid down in Article 9 (a), Member States shall prohibit the placing on the market of stilbenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species.

1. Notwithstanding Article 2, Member States may authorize the administering to farm animals of substances with oestrogenic, androgenic or gestagenic action approved in accordance with the Directives on veterinary medicinal products other than the substances referred to in Article 3, for therapeutic use, synchronization of oestrus, termination of unwanted gestation, the improvement of fertility and the preparation of donors and recipients for the implantation of embryos.

2. The administering of the substances referred to in paragraph 1 shall be effected by a veterinarian. 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 but under his direct responsibility.

The Council, acting unanimously on a proposal from the Commission shall take a decision as soon as possible on the administering to farm animals of oestradiol 17/ß, Progesterone, Testosterone, Trenbolone and Zeranol for fattening purposes.

Pending adoption of this decision, the national regulations in force and the arrangements made by Member States concerning these substances shall continue to apply while complying with the general provisions of the Treaty and without prejudice to measures adopted in accordance with a Community procedure designed for their approximation.

Member States may not authorize the use of new substances during this transitional period.

Member States shall ensure that, pending adoption of relevant Community rules, their national provisions applying to products imported from third countries are not more favourable than those applying to intra-Community trade pursuant to this Directive.

Member States shall ensure that farm animals, the meat of such animals and the meat products obtained therefrom are subjected to controls.

The detailed rules for carrying out such controls and the financing thereof shall be laid down by the Council acting unanimously on a proposal from the Commission.

Not later than 1 July 1984, the Commission shall submit to the Council a report on the experience acquired and scientific developments, accompanied, if necessary, by proposals which take these developments into account.

Member States shall bring into force the measures necessary to comply with: (a) the provisions of Article 3 no later than twomonths after the date of notification of this Directive;

(b) the other Articles of this Directive not later than12 months after the date of notification of thisDirective.

They shall forthwith inform the Commission thereof.

Article 10

This Directive is addressed to the Member States.

Done at Brussels, 31 July 1981.

For the Council

The President

P. WALKER