Medicated Animal Feed

Medicated animal feed — manufacture, marketing and use

Regulation (EU) 2019/4 on the manufacture, placing on the market and use of medicated feed.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.Regulation (EU) 2019/4 repeals Directive 90/167/EEC (see summary on Preparation and marketing of medicated foodstuffs for animals) with effect from 28 January 2022.

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.

DOCUMENTS

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)

Preparation and marketing of medicated feedingstuffs for animals

Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs

It lays down rules to:

safeguard public health from dangers arising from the administration of medicated feedingstuffs to animals intended for food production; and
prevent distortions in competition in the keeping and rearing of farm animals.
Regulation (EU) 2019/4 repeals Directive 90/167/EEC with effect from 28 January 2022.

KEY POINTS

The directive requires that:

only authorised medicated pre-mixes be used to manufacture medicated feedingstuffs; and
precise instructions be given for the utilisation of such feedingstuffs.
EU countries must ensure that medicated feedingstuffs are manufactured only under certain conditions:

producers’ premises have already been approved by the competent national authority, as have their technical equipment, their storage and inspection facilities;
producers’ premises, staff and equipment comply with national manufacturing hygiene rules and principles;
producers’ staff have adequate levels of knowledge of and qualifications in mixing technology;
the manufacturing process conforms to the rules of good manufacturing practice.

Manufacturers’ responsibilities

EU countries must also oblige producers to be responsible for ensuring that:

only feedingstuffs or combinations thereof which comply with EU rules on feedingstuffs are used;
the feedingstuff used produces a homogeneous and stable mix with the authorised medicated pre-mix;
the authorised medicated pre-mix is used during the manufacturing process in accordance with the conditions laid down when authorisation for placing on the market was given (for example, no possibility of any undesirable interaction between veterinary medicinal products, additives and feedingstuffs);
the daily dose of medicinal product is contained in a quantity of feedingstuff corresponding to at least half the daily feed ration of the animals treated or, in the case of ruminants (for example, cattle and sheep), corresponding to at least half the daily requirement of non-mineral supplementary feedingstuffs.

Placing of products on the market

Producers are also responsible for the quality of the products placed on the market.

Medicated feedingstuffs may be:

placed on the market only in sealed packaging labelled in accordance with the rules in force;
supplied to stockfarmers only on presentation of a prescription from a veterinarian subject to certain specific conditions.
Administration of medicated feedingstuffs

Where medicated feedingstuffs are administered to animals intended for human consumption, treated animals must not be slaughtered before the end of the legally stipulated withdrawal period.To permit effective controls, those concerned must keep a register, or retain documents for a certain period.

Veterinary checks

The safeguard measures laid down by Directive 89/662/EEC and the rules on veterinary checks laid down in that directive apply to trade in medicated pre-mixes.

DOCUMENT

Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (OJ L 92, 7.4.1990, pp. 42-48)

Successive amendments to Directive 90/167/EEC have been incorporated into the original text. This consolidated version is of documentary value only.

Directive 90/167/EEC is repealed by Regulation (EU) 2019/4 (see summary on Medicated animal feed — manufacture, marketing and use) as of 28 January 2022.

It has applied since 6 April 1990 and had to become law in the EU countries by 1 October 1991, except as regards the requirements in Article 11(2) in relation to Directive 89/662/EEC for which the deadline was 31 December 1992.

DOCUMENTS

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1-142)

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, pp. 1-66)

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, pp. 70-73)

Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (OJ L 395, 30.12.1989, pp. 13-22)