15.1.2008   

EN

Official Journal of the European Union

C 10/51

1.1

The European Economic and Social Committee notes the steps taken by the European Commission.

1.2

The Committee would like any pharmacological substance intended for food-producing animals to be submitted to the European Medicines Agency (EMEA) and the Maximum Residue Limits (MRLs) to be assessed by the Committee for Medicinal Products for Veterinary Use (CVMP).

1.3

Any company producing pharmacological products for animals should be authorised by the EMEA and have had its MRLs assessed by the CVMP.

1.4

In order to prevent any hindrance to the movement of products within the European Community, these authorisations will be valid throughout all the EU Member States.

1.5

The procedure for placing products on the market should be simplified, whilst maintaining a high level of consumer protection.

1.6

Simplifying European documents and making them more readable would benefit all Europeans. Access to such documents would help everyone to discover and understand Europe's contribution to their daily lives.

2.1

The aim is to continue to limit consumer exposure to pharmacologically active substances.

2.2

Whilst maintaining a high level of consumer protection, the proposal should also help to simplify legislation.

2.3

In order to achieve the desired aim, specific objectives should be borne in mind:

3.1

The current legal framework for MRLs has led to particular problems:

4.1

The main changes proposed are as follows:

4.2

The Commission has taken care to consult the parties concerned, in order to determine what changes might be needed.

5.1

The European Economic and Social Committee notes the steps taken by the European Commission.

5.2

The Committee would like any pharmacological substance intended for food-producing animals to be submitted to the European Medicines Agency (EMEA) and the Maximum Residue Limits (MRLs) to be assessed by the Committee for Medicinal Products for Veterinary Use (CVMP).

5.3

Any company producing pharmacological products for animals should be authorised by the EMEA and have had its MRLs assessed by the CVMP.

5.4

In order to prevent any hindrance to the movement of products within the European Community, these authorisations will be valid throughout Europe.

5.5

The procedure for placing products on the market should be simplified, whilst maintaining a high level of consumer protection.

5.6

Developments in scientific knowledge will help to determine whether products are innocuous and how long to wait between administering the medicine to an animal and slaughtering it for consumption.

5.7

Developments in scientific knowledge should enable the Council to set a maximum residue limit.

5.8

Request for procedures: the current procedure has proved its worth and managing requests for authorisation should still form part of it.

5.9

The classification of pharmacologically active substances should thus take account of the following:

5.10

The EMEA should consult the reference laboratories, in order to determine the process for analysing residues.

5.11

The movement of foodstuffs of animal origin in the European Union must not be hindered.

5.12

Simplifying European documents and making them more readable would benefit all Europeans. Access to such documents would help everyone to discover and understand Europe's contribution to their daily lives.

5.13

Meat products from outside the Community treated with medicines not licensed in the EU should be subject to a scientific study proving that these products are innocuous, be submitted to the EMEA, and then have their MRLs validated by the Committee, in order to ensure that consumers are fully protected.

5.14

The Commission should consider the issues surrounding the availability of medicinal substances for certain species, such as goats, rabbits, etc., which laboratories choose not to develop because they are not profitable.