Legal provisions of COM(2000)320 - Amendment of 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

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dossier COM(2000)320 - Amendment of Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a ...
document COM(2000)320 EN
date September 22, 2003


Contents

Article 1

Directive 96/22/EC is hereby amended as follows:

1. Articles 2 and 3 are replaced by the following:

Article 2

Member States shall prohibit:

(a) the placing on the market of the substances listed in Annex II, list A, for administering to animals of all species;

(b) the placing on the market of the substances listed in Annex II, list B, for administering 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 and in Article 5a.

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)."

2. in Article 4, point 1, 'oestradiol 17ß' are deleted;

3. in Article 5, first paragraph, the first sentence is replaced by the following:"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 17ß 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(10)."

4. the following Article is added:

Article 5a

1. Notwithstanding Article 3(a) and without prejudice to Articles 2 and 11a, Member States may authorise the administering to farm animals of veterinary medicinal products containing oestradiol 17ß or its ester-like derivatives for:

- the treatment of foetus maceration or mummification in cattle, or

- the treatment of pyometra in cattle,

in accordance with Directive 2001/82/EC.

2. Notwithstanding Article 3(a) and without prejudice to Article 2, Member States may authorise the administering to farm animals of veterinary medicinal products containing oestradiol 17ß or its ester-like derivatives for oestrus induction in cattle, horses, sheep or goats until 14 October 2006, in accordance with Directive 2001/82/EC.

3. The treatment must be carried out by the veterinarian himself or herself on farm animals which have been clearly identified. This treatment must be registered by the veterinarian responsible. The latter must record at least the following details in a register, which may be that provided for in Directive 2001/82/EC:

- the type of product administered,

- the nature of the treatment,

- the date of treatment,

- the identity of the animals treated,

- the date of expiry of the withdrawal period.

The register must be made available to the competent authority at its request.

Stockfarmers shall be prohibited from holding on their farms veterinary medicinal products containing oestradiol 17ß or its ester-like derivatives."

5. Article 6(1) is replaced by the following:

"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."

6. Article 7(1), first subparagraph, is replaced by the following:

"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."

7. Article 8 is amended as follows:

(a) point 1 is replaced by the following:

"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."

(b) in point 2(a), 'Article 2' is replaced by 'Articles 2 and 3';

(c) in point 2(d), 'in Articles 4 and 5' is replaced by 'in Articles 4, 5 and 5a';

(d) footnote 2 is deleted and footnote 3 becomes footnote 2;

8. Article 11(2)(a) is amended as follows:

(a) in point (i), 'point (a) of Article 2' is replaced by 'Annex II, List A,';

(b) point (ii) is replaced by the following:

"(ii) to which substances referred to in Annex II, List B, and Annex III have been administered, unless those substances were administered in compliance with the provisions and requirements laid down in Articles 4, 5, 5a and 7 and the withdrawal periods allowed in international recommendations have been observed;"

9. the following Article is added:

"Article 11a

The Commission shall present within two years from 14 October 2003 to the European Parliament and to the Council, a report on the availability of alternative veterinary medicinal products to those containing oestradiol 17ß or its ester-like derivatives for the treatment of foetus maceration or mummification in cattle, and for the treatment of pyometra in cattle, and present to them the following year any necessary proposals intending to replace these substances in due time.

Likewise, 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 timely presentation to the European Parliament and to the Council of any necessary proposals."

10. the following Article is added:

"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 17ß 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."

11. all references to 'Directive 81/851/EEC' and 'Directive 81/852/EEC' are construed as references to 'Directive 2001/82/EC';

12. the Annex to Directive 96/22/EC become 'Annex I', and Annexes II and III in the Annex to this Directive are added.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 14 October 2004 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 be accompanied by such a 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 provisions of national law which they adopt in the field covered by this Directive.

Article 3

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

Article 4

This Directive is addressed to the Member States.