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Brussels, 25 March 2002

Commission proposes new safety rules for feed additives and to prohibit antibiotics as growth promoters

The European Commission has presented proposals to prohibit the use of antibiotics as growth-promoting feed additives. The four remaining authorised antibiotics currently used as growth-promoters in feed would have to be phased out as of January 2006. "This fulfils my commitment to the European Parliament in September 1999", Byrne stressed. The proposal represents a major streamlining of the existing rules on the safety evaluation and marketing authorisation of feed additives. All new authorisations of feed additives would be granted for a ten-year period only. Companies marketing feed additives authorised under existing legislation would have to, within the next seven years, apply for re-evaluation and re-authorisation of their products. The new rules would require that companies demonstrate the positive effect for the animal (efficacy) and the absence of a risk for human health, animal health and the environment (safety). The European Food Safety Authority (EFSA) would be in charge of evaluating all feed additives. It would set up clear guidelines and a transparent assessment process including public consultation of interested parties. Procedures for authorising feed additives as they evolved since 1970 have become time-consuming, cumbersome and confusing for companies and regulators alike. Their simplification and streamlining was therefore one of the actions prioritised by David Byrne in the White Paper on Food Safety.

"We have all learned the prime importance of safe animal feed during the food crises of the recent past", Commissioner Byrne for Health and Consumer protection said. "That is why I have embarked upon this major initiative to simplify and clarify the maze of rules and procedures on feed additives. Antibiotics used in feed as growth promoters will be phased out. Additionally, the European Food Safety Authority will play a major role in the new authorisation procedure for feed additives to make sure that no additives remain on the market which could pose a risk to human or animal health."

The new rules would cover additives like flavours or vitamins intended for use in feedingstuffs and in drinking water for animals. Only additives that are authorised could be put on the market, used or processed, for specific animal species and with a maximum dosage allowance. These substances would be listed in five broad categories: technological additives (e.g. preservatives), sensory additives (e.g. flavours, colorants), nutritional additives (e.g. vitamins), zootechnical additives (e.g. gut flora improvers, non-microbial growth promoters) and coccidiostats (additives to prevent poultry diseases).

Antibiotics - out

The proposed new Regulation would phase out by January 2006 the authorisations of the four antibiotic feed additives that are still on the EU market. They are monensin sodium, salinomycin sodium, avilamycin, flavophospholipol - substances that are not currently used in human medicine. Antibiotic feed additives which are used in human and veterinary medicine have already been phased out under previous Commission decisions. The Scientific Steering Committee of the EU has recommended the progressive phasing out of the use of anti-microbials as growth promoters while preserving animal health. This commitment is part of the Community Strategy to combat the threat to human, animal and plant health posed by anti-microbial resistance which was adopted last June.


Additionally, maximum residue limits (MRLs) will be established for some feed additives where it proves necessary. A post-monitoring system as well as regular testing of foodstuffs, as is already common practice, would assure that these are observed.

In the case of Coccidiostats - which are feed additives used to treat infections caused by a micro-organism in poultry - stricter measures would be introduced if they were of antibiotic origin. A new dossier for re-evaluation within a four year period would be presented and MRLs would be set to avoid risks to human or animal health.

As is common practice already, feed additives would need to be clearly labelled.

According to a study of the European Federation of Animal Health (FEDESA), in 1999 farm animals consumed 4700 tonnes (35%) of all the antibiotics administered in the European Union, while humans consumed 8500 tonnes (65%). Of the antibiotics that were given to animals, 3 900 tonnes (or 29% of the total usage) were administered to help sick animals recover from disease, while 786 tonnes (or 6% of the total usage) were given to farm animals in their feed as growth promoters. The survey estimates that the amount of antibiotics used as growth promoters fell by 50% since 1997, when animals consumed around 1600 tonnes, as feed additives.

A clear and transparent authorisation procedure

The proposed new procedure for authorising a new feed additive would see the European Food Safety Authority (EFSA) evaluating the dossier submitted by a company. The Authority would, on the basis of residue studies, propose maximum residues levels (MRLs) to be set in the legislation authorising the feed additive to allow proper monitoring of the effects of the additives on human health.

If the additive complied with safety and other requirements, the Commission, within three months of receipt of the EFSA opinion, would propose a draft Regulation authorising the additive for a ten year period and setting maximum residues limits for the active substance in the additive. All authorisations would be renewable for ten-year periods upon application to the EFSA at least one year before the expiry date.

Companies marketing feed additives already authorised under existing legislation would need to notify the EFSA accordingly.

The EFSA would verify the information concerning the current authorisation and inform the Commission. Companies would nonetheless have to submit applications for re-evaluation and re-authorisation within a seven-year period after the entry into force of the Regulation, or one year before the expiry date of the existing authorisation.

Authorisations in certain categories would be linked to an authorisation holder who would be responsible for the implementation of a post-monitoring plan. The authorisation holder would have to communicate to the Authority any new information concerning the safety of the product.

Next steps

The Regulation as proposed today is subject to co-decision by the Council of Ministers and the European Parliament.

(See also MEMO/02/66).

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