Control plans on the use of pharmacologically active substances/residues

Commission Delegated Regulation (EU) 2024/2562 of 3 June 2024 amending Delegated Regulation (EU) 2022/1644 as regards certain criteria for the selection of samples

Update

Competent authorities must put in place national control plans for checking residues of pharmacologically active substances in animals and animal products. These control plans must be based on combinations of group of substances with group of products (combinations are listed in Regulation 2022/1644, Annex II). The EU has removed the following two combinations because they are not relevant:

• “Plant protection products and biocides used in animal husbandry of food-producing animals” for “raw milk (from cows, ewes, goats) and honey”
• “Anti-inflammatory substances, sedatives, and any other pharmacologically active substances” for “aquaculture products and eggs”.

Impacted Products

raw milk, aquaculture products, honey, eggs

What is changing?

To export animal products to the EU, non-EU countries must put in place control plans on the use of pharmacologically active substances at least equivalent to those required for EU production. There are separate lists of substances that must be controlled for each commodity group, e.g. bovine animal products, aquaculture products, honey (Regulation 2022/1644, Annex II).

Under the new Regulation, the following substances no longer need to be controlled:

• Plant protection products and biocides used in animal husbandry of food-producing animals in raw milk (from cows, ewes, goats) and honey
• Anti-inflammatory substances, sedatives, and any other pharmacologically active substances in aquaculture products and eggs.

The lists of groups of substances can be found in Annex I of Regulation 2022/1644.

Why?

Based on practical experience gained since the application of Regulation 2022/1644, the substances that have now been removed were found to be not relevant for these specific commodity groups.

Timeline

The new rules apply from 1 January 2025.

What are the major implications for exporting countries?

In the control plan that non-EU competent authorities must submit to the European Commission every year to allow exports of animal products to the EU, there is no longer a need to plan controls of the removed substances for raw milk, honey, aquaculture products, and eggs.

Background

EU Member States must carry out controls of pharmacologically active substances authorised as veterinary medicinal products, feed additives, and prohibited or unauthorised pharmacologically active substances and residues in animal products, including those imported from non-EU countries (Regulation 2017/625; see Official Controls Regulation – explained). The groups of substances to be controlled are set out in Annex I of Regulation 2022/1644, and the requirements for each type of animal product are in Annex II.

Non-EU countries exporting to the EU have to put in place control plans at least equivalent to the “risk-based control plan for production in the Member States” (Regulation 2022/2292, Art. 9; see Public health requirements for exporting live animals, products of animal origin, composite products and sprouted seeds to the EU), in compliance with Regulations 2022/1644 (see Official controls of veterinary drug residues in products of animal origin) and 2022/1646 (see Official controls on the use of pharmacologically active substances and their residues).

When the control plans are validated, non-EU countries are authorised to export animals or animal products to the EU (the list of authorised non-EU countries is in Regulation 2021/405, Annex I). The control plan must be submitted by 31 March each year using the template provided by the EU in the Guidelines, point 4.4.

Resources

Sources