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Brussels, 16 December 2002

Council backs prohibition of antibiotics as growth promoters : Byrne welcomes political agreement on feed additives

David Byrne, EU Commissioner for Health and Consumer Protection, has welcomed the political agreement reached today in the Agriculture Council on new rules to control the use of additives in animal feed. The new EU Regulation will strengthen the control of all types of additives in animal feed, but in particular it completes the EU´s drive to phase out antibiotics as growth promoters. Strengthening rules on the safety of animal feed is one of the cornerstones of the EU's food safety strategy. Banning the use of antibiotics as growth promoters in feed is also vital to efforts to combat anti-microbial resistance. The final text of the Regulation is likely to be agreed between the Council and the European Parliament during the first half of 2003.

Speaking after the Agriculture Council reached its political agreement Commissioner David Byrne said: "I very much welcome the fact that Council has managed to reach political agreement today. This Regulation will strengthen the EU's rules on the safety of animal feed and complete the EU ban on the use of antibiotics as growth promoters. Both these objectives are of major importance to the EU's food safety strategy, and indeed to wider considerations of public health. I hope the European Parliament will respond positively to today's agreement and work with myself and the Council to ensure the new Regulation is finally adopted early in the New Year."

Towards a total ban on antibiotic growth promoters in feed

The EU has already banned antibiotics used in human medicine from being added to animal feed. The new Regulation will complete this ban on antibiotic growth promoters in feed by prohibiting the use of four substances namely:

  • monensin sodium

  • salinomycin sodium

  • avilamycin

  • flavophospholipol

The Scientific Steering Committee of the EU has recommended the progressive phasing out of the use of all antibiotics 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 in June 2001.

According to a study by 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

Background: a new safety formula for feed additives

The Commission's proposal for a Regulation was presented on 25 March 2002 (see IP/02/466). Updating EU rules on animal feed additives is one of the priority actions outlined in the Commission's White Paper on Food Safety. It was a measure specifically promised by Commissioner Byrne during his inauguration hearings in the European Parliament in September 1999. The proposed Regulation represents both a strengthening and a streamlining of the laws on safety evaluation and marketing authorisation of feed additives.

Under the Regulation only additives that have been through an authorisation procedure could be put on the market, used or processed. Authorisations would be for specific animal species and with a maximum dosage allowance. Authorisations of new feed additives would be for a ten year period only. Companies marketing feed additives authorised under existing legislation would have to apply for re-evaluation and re-authorisation within the next seven years. The new rules would require that companies demonstrate the additive's positive effect for the animal (efficacy) and the absence of risk for human health, animal health and the environment (safety). The European Food Safety Authority (EFSA) would be responsible for conducting these evaluations.

The Regulation covers all types of additives not just antibiotic growth promoters. These are divided additives into 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)

  • Coccidiostats (additives to prevent poultry disease)

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 will be introduced if they are of antibiotic origin. A new dossier for re-evaluation within a four year period will have to 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.

Key role for EFSA in evaluation procedure

The proposed new procedure for authorising a new feed additive would see the European Food Safety Authority (EFSA) evaluating applications from industry. 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.

Further information:

See Memo/02/66


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