15.1.2008   

EN

Official Journal of the European Union

C 10/57

1.1

The European Economic and Social Committee takes note of the measures proposed by the European Commission.

1.2

The Committee welcomes the simplification and clarification of this legislation, which applies both to the general public and to companies providing pharmaceutical products for animals.

1.3

The proposal for a directive upholds the principle of proportionality, as it lays down only limited changes on the basis of the most recent scientific data and expert opinions.

1.4

The proposed directive also addresses the issue of third-country imports of food-producing animals.

1.5

The proposal for a directive does not contravene WTO commitments.

1.6

The future unavailability of Oestradiol 17ß and its ester-like derivates will have a negligible impact on farming and animal welfare.

1.7

There is no need to set maximum residue limits.

1.8

The impact on small and medium-sized enterprises will also be minimal.

2.1

The aim of the proposal is to amend Directive 96/22/EC of 29 April 1996, as amended by Directive 2003/74/EC. The proposed directive prohibits the placing on the market of certain substances 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.

List of prohibited substances:

List A:

List B:

2.2

The changes proposed are the following:

2.3

The Commission proposes making only very limited changes that are needed to prevent the further suffering of pet animals as a result of no appropriate treatment being available and to take account of scientific and expert advice concerning oestradiol 17ß (1).

3.1

Article 2(a) of Council Directive 96/22/EC specifically prohibits the placing on the market of substances listed in Annex II for administering to animals of ‘all species’.

3.2

A price-comparison of products having a thyrostatic action reveals that using them for food-producing animals is of limited economic benefit.

3.3

Illegal use more commonly involves the illegal production or import of these substances. In the last five years, no illegal use of stilbene derivates, their salts or esters has been detected.

3.4

The directive referred to above does not provide for marketing authorisations to be granted for products containing substances to treat hyperthyroidism in pet animals.

3.5

In 1981 (with Directive 81/602/EEC), the EU prohibited the use of substances having a hormonal action for growth promotion in farm animals, including oestradiol 17ß.

3.6

Although Directive 96/22/EC originally aimed to ban the use of oestradiol 17ß and its ester-like derivates for all purposes, it ultimately did no more than limit the circumstances in which oestradiol 17ß may be administered for purposes other than growth promotion. This product is totally carcinogenic, as it can both cause and promote tumours.

3.7

The report presented to the Council and Parliament on 11 October 2005 concludes that because the use of alternative substances such as prostaglandins is widespread, use of oestradiol 17ß could be phased out for food-producing animals.

3.8

Pet animals affected by hyperthyroidism often suffer as a result of the ongoing unavailability of appropriate treatment.

4.1

The European Economic and Social Committee takes note of the measures proposed by the European Commission.

4.2

The changes proposed in relation to oestradiol 17ß are the direct result of the activities required by Article 11(a) of Directive 2003/74/EC.

4.3

The changes made are extremely limited and are needed to prevent the further suffering of pet animals as a result of no appropriate treatment being available.

4.4

This proposal is relevant to pet owners, practicing veterinarians, the veterinary pharmaceutical industry and Member State authorisation agencies.

4.5

The proposal will help to ensure a high level of protection of human health.

4.6

New authorisations must, however, consider potential misuse and products that are likely to be misused could, therefore, be rejected.