Medicated feed: manufacture, placing on the market and use

The European Parliament adopted by 583 votes to 31 with 6 abstentions a legislative resolution on the for a Regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC.

The European Parliament’s position adopted at first reading under the ordinary legislative procedure amended the Commission proposal as follows:

Purpose: the proposed Regulation shall establish new rules on more responsible ways to produce, sell and use medicated feed to tackle the spread of antimicrobial resistance. It shall apply to: (i) the manufacture, storage and transport of medicated feed and intermediate products; (ii) the placing on the market, including import from third countries, and the use of medicated feed and intermediate products; (iii) the export to third countries of medicated feed and intermediate products.

Composition: the feed business operator manufacturing the medicated feed or intermediate product shall ensure that the medicated feed or intermediate product is manufactured in compliance with the relevant conditions laid down in the veterinary prescription for medicated feed or, in the summary of the product characteristics, related to the veterinary medicinal products to be incorporated in the fee.

Those conditions shall include particular provisions regarding known interactions between the veterinary medicinal products and the feed that may impair the safety or the efficacy of the medicated feed or intermediate product.

Operators shall also take measures to avoid cross-contamination, i. e. contamination of a non-target feed with an active substance originating from the previous use of the facilities or equipment.

The Commission shall be empowered to adopt delegated acts in order to supplement this Regulation by establishing specific maximum levels of cross-contamination for active substances in non-target feed. Those delegated acts shall be based on a scientific risk assessment carried out by EFSA.

Approval of establishments: the competent authority shall approve establishments only where an on-site visit, prior to start-up of the relevant activity, has demonstrated that the system put in place for the manufacture, storage, transport or placing on the market of medicated feed or intermediate products meets the specific requirements.

Feed business operators dealing with some lower risk activities, such as certain types of transport, storage and retail, should be exempted from the approval obligation, however this should not exempt them from the registration obligation.

Prudent use of antibiotics: the amended text emphasises that medical treatments, especially with antimicrobials, should never replace good husbandry, bio-security and management practices.

The new rules shall ban prophylactic (preventive) use of medicated feed or its use for improving animal performance, except in some cases for medicated feed containing antiparasitic and immunological veterinary drugs. Metaphylactic use, i.e. treating the whole group of animals when one is infected, will be allowed only when the risk of spread of infection is high and there is no appropriate alternative.

The use of medicated feed containing some antiparasitics shall be based on the knowledge of the parasite infestation status in the animal or group of animals.

Prescription: in order to ensure the safe use of medicated feed, its supply and use shall be subject to presentation of a valid veterinary prescription for medicated feed which has been issued by a veterinarian after examination or any other proper assessment of the health status of the animals to be treated.

Advertising: the new rules shall prohibit the advertising of medicated feed and intermediate products. That prohibition shall not apply to advertising made exclusively to veterinarians. The advertising shall not include information in any form which could be misleading or lead to incorrect use of the medicated feed. In addition, medicated feed shall not be distributed for promotional purposes except for small quantities of samples.

Imports into the EU: operators importing medicated feed or intermediate products into the EU shall ensure that the use of veterinary medicinal products used for the manufacture of such medicated feed or intermediate products is authorised.