Pharmacologically Active Substances 

MRLs are used as points of reference to establish marketing authorisations for veterinary medicinal products in food-producing animals and for the control of residues in food of animal origin. Pharmacologically active substances contained in food-producing animals must be assessed as safe following rules laid out in Regulation (EEC) No 2377/90 before being authorised on the market.

However, according to the Commission, this Regulation should be amended for a number of reasons. The availability of veterinary medicinal products has decreased, which leads to a difficult situation both for consumer health and the food industry. In addition, in the existing legislation, active substances, which have been assessed by Codex Alimentarius, need a separate scientific assessment by the European Medicines Agency before being included in EU legislation. Finally, Member States’ control services have divergent control reference points and have no points of reference for substances detected in food from third countries. This generates unnecessary burdens on industry.

This proposal aims to provide clear references for the control of residues in foodstuffs, improve the availability of veterinary medicinal products, simplify and clarify existing legislation and enhance consistency between international standards, such as Codex Alimentarius, and EU legislation. It also intends to maintain high level consumer health protection.

To ensure the availability of authorised veterinary medicinal products the Commission proposes to make extrapolation a compulsory part of scientific risk assessment. This means that the Committee for Medicinal Products for Veterinary Use, responsible for carrying out risk assessments, shall consider using the same MRL established for a substance in a particular foodstuff for another foodstuff derived from the same species, or in one or more species for other species.

To develop consistency with international standards, the proposal introduces an obligation to include MRLs set by Codex Alimentarius and supported by the EU into EU legislation. This would also simplify application procedures for substances, as international standards would be automatically recognised without the need to submit any additional application for a separate scientific assessment at EU level.

To reduce the administrative burden for economic operators, the proposal intends to harmonise the control standards for certain residues in food. This would lead to a single control reference point applied by competent authorities in all Member States.

The Commission’s objective is also an overall simplification and clarification of the Regulation. In particular, it intends to adopt a separate Commission Regulation that would include the rules relating to individual substances (MRLs, conditions of use, prohibitions). These rules are currently outlined in the 4 Annexes to the Regulation. Furthermore, it proposes to create a specific legal framework to set MRL for pharmacologically active substances not intended to be authorised as veterinary medicines.

While waiting for Parliament to vote in second reading, the Council in its common position called for more clarity and underlined the urgent need to improve the availability of veterinary medicinal products.