Consulting, Compliance and Validation

Veterinary medicines: EU Regulation 2022/1644 in force

Veterinary medicines: EU Regulation 2022/1644 in force

Commission Delegated Regulation 2022/1644 which governs official controls on the use of pharmacologically active substances in DPA animals (intended for food production) came into force on 15 December 2022. It follows that the transitional measures which had, up until 14 December 2022, allowed the relative authorities to carry out these checks on residues in accordance as per directive 96/23/EC have expired.

EU Member States are now required to control the use of these pharmacological substances, authorised as veterinary medicinal products or as feed additives, and the presence of prohibited or unauthorised pharmacologically active substances and their residues.

The Regulation establishes, among other things, sample-taking methods during the production, transformation and distribution phases. It also defines the combinations of substance groups and product groups that States must sample. Lastly, the sampling strategy and the criteria for defining the content of national risk-based plans and national surveillance plans are specified.

Substances to be controlled

Annex 1 of the Regulation lists the active substances to be controlled. They are divided into two groups:

Group A
Prohibited or unauthorised pharmacologically active substances in food-producing animals.

  • Substances with hormonal and thyrostatic action and beta agonists the use of which is prohibited.
  • Substances not authorised for use in the feed of food-producing animals.

Pharmacologically active substances authorised for use in food-producing animals.

  • Antimicrobial substances.
  • Insecticides.
  • Fungicides.
  • Anthelmintics and other antiparasitic agents.
  • Sedatives.
  • Non-steroidal anti-inflammatory drugs (NSAIDs).
  • Corticosteroids and glucocorticoids.
  • Other pharmacologically active substances, coccidiostats and histomonostats.

In using the term “residue” the Commission means a residue of substances having a pharmacological action, of metabolites of such substances, degradation products of such substances and of other related substances present in animals or products of animal origin. The contents and maximum residue limits of these substances are established by European Union legislation.


The Regulation also establishes the sampling strategy and national control plans, both risk-based and randomised and, lastly, plans relating to imports from third countries.

Consult the full Regulation