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Document 32019R0004

Medicated animal feed — manufacture, marketing and use

Date of last review:
20/05/2024
Initial creation date:
01/07/2019
Summarised document(s):
Author:
Publications Office of the European Union
Responsible entity(ies):
Directorate-General for Health and Food Safety

Medicated animal feed — manufacture, marketing and use

SUMMARY OF:

Regulation (EU) 2019/4 on the manufacture, placing on the market and use of medicated feed

WHAT IS THE AIM OF THE REGULATION?

  • It aims to ensure a high level of public health protection, high quality and safety standards for manufacturing and increased availability of medicated feed1 including medicated pet food.
  • It promotes a more prudent and responsible use of antimicrobials2 in order to fight antimicrobial resistance3 among animals and prevent the spread of antibiotic-resistant bacteria via the food chain.

KEY POINTS

Medicated feed is a mixture of animal food and veterinary medicine produced under controlled conditions, and requires a veterinary prescription following a clinical examination. The Regulation, repealing Directive 90/167/EEC:

Sets out rules at every stage from production to distribution, covering a number of areas including:

  • facilities and equipment (e.g. hygiene and access aspects);
  • personnel (e.g. training aspects, manufacturing and quality control staff must function separately);
  • manufacturing and quality control (e.g. quality control aspects, dispersal of veterinary medicinal products in feed, etc.);
  • storage and transport (e.g. separate and secure facilities, rules to avoid cross-contamination);
  • record-keeping (of purchases, manufacturing, storage, transport and placing on the market to ensure traceability);
  • complaints and product recall (systems for registering and processing complaints, and for product withdrawal and recall);
  • packaging, labelling and advertising (e.g. tamper-proof, single-use packaging, advertising exclusively to veterinarians);
  • approval of establishments.

Sets out rules on the use of medicated feed:

  • prescribed medicated feed to be used only on veterinary prescription and for the animals for which the veterinary prescription has been issued;
  • special rules on medicated feed containing immunological veterinary medicinal products and antiparasitics.

Contributes to the EU’s action to fight antimicrobial resistance:

  • bans the use of antimicrobials via medicated feed for prophylaxis and growth promotion;
  • restricts the validity and duration of veterinary prescriptions with antimicrobials;
  • sets harmonised residue limits for antimicrobials.

Creates the legal framework for manufacturing, placing on the market and use of medicated pet food:

  • permits the decentralised production of medicated pet food;
  • allows for specific distribution routes of medicines for pets;
  • stipulates specific rules for veterinary prescriptions.

The regulation is part of a package which includes Regulation (EU) 2019/6 on veterinary medicinal products.

Repeal

Regulation (EU) 2019/4 repeals Directive 90/167/EEC (see summary on Preparation and marketing of medicated feedingstuffs for animals) with effect from .

FROM WHEN DOES THE REGULATION APPLY?

It applies from .

BACKGROUND

See also:

KEY TERMS

  1. Medicated feed: a feed, which is ready to be directly fed to animals without further processing, which is a mixture of one or more veterinary medicinal products and feed materials.
  2. Antimicrobial: any substance with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antifungals and antiprotozoals.
  3. Antimicrobial resistance: the ability of micro-organisms to survive or to grow in the presence of an antimicrobial agent which would normally be able to inhibit or kill a similar micro-organism.

MAIN DOCUMENT

Regulation (EU) 2019/4 of the European Parliament and of the Council of on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, , pp. 1-23)

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