An EU ambassadors meeting in the Committee of Permanent Representatives (Coreper) has confirmed an agreement reached between the Bulgarian Presidency of the Council and European Parliament representatives on a regulation on medicated feed.
The aim of the new rules is to harmonise at a high safety levelthe manufacture, marketing and use of medicated feed and intermediate products in the EU and to reflect technical progressin this field.
Rumen Porodzanov, minister of agriculture, food and forestry of the Republic of Bulgaria and president of the Council, said: “We have put in the last piece of the puzzle: the animal medicines package is complete, the sector is now equipped with modern rules that will help, competitiveness and innovation, will also facilitate trade and reinforce the EU fight against antimicrobial resistance.”
The current legal framework for medicated feed dates back to 1990, before the creation of the internal market, and since then it has never been adapted, creating discrepancies in its implementation across the EU member states.
To make up for this situation and create the necessary conditions for a level playing field and innovation in the sector, the new rules will:
- set out criteria for the approval of feed business operators and their obligations when manufacturing medicated feed;
- for the first time lay down harmonised requirements in order to avoid cross contamination of active from veterinary medicinal products into non target feed. Within four years from the entry into force of the regulation, the Commission will have to set maximum levels of cross contamination for antimicrobials, based on the scientific evidence provided by the European Food Safety Authority (EFSA) or the European Medicines Agency (EMA);
- clarify the prescription and use of medicated feed containing antimicrobials in food-producing animals; and
- prohibit prophylaxis (the preventive administration of antibiotics or antimicrobials to animals, when a disease has not been diagnosed).
The new regulation on medicated feed is part of the animal medicines package, a package of three proposals updating the existing legislative framework for veterinary medicines and medicated feed by tailoring it to the specificities of the animal health sector.
Now that the agreement on medicated feed has been confirmed by EU ambassadors on behalf of the Council, the regulation will be submitted to the European Parliament for a vote at first reading, and will subsequently go back to the Council for adoption. The new rules will apply three yearsafter the entry into force of the regulation.