Medicated animal feed — manufacture, marketing and use
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 feed* including medicated pet food.
It promotes a more prudent and responsible use of antimicrobials* in order to fight antimicrobial resistance* among animals and prevent the spread of antibiotic-resistant bacteria via the food chain.
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.
Regulation (EU) 2019/4 repeals Directive 90/167/EEC (see summary on Preparation and marketing of medicated feedingstuffs for animals) with effect from 28 January 2022.
FROM WHEN DOES THE REGULATION APPLY?
It applies from 28 January 2022.
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.
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.
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.
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 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, 7.1.2019, pp. 1-23)
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, pp. 43-167)
last update 03.04.2019