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Brussels, 21 November 2002

Byrne welcomes Parliament vote on safer rules for feed additives - prohibition of antibiotics as growth promoters confirmed

David Byrne, the Commissioner responsible for Health and Consumer Protection, today welcomed the European Parliament's adoption of the Keppelhoff-Wiechert report on additives for use in animal nutrition. He hailed Parliament's vote as being an important step forward in the European Union's drive to phase out antibiotics and other potentially harmful substances in animal feed. 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 phenomenon of antibiotic resistant "super bugs"). The Council of Ministers is expected to respond rapidly to Parliament's First Reading and may agree a Common Position on the Regulation as early as the 16-19 December Agriculture Council.

Commenting after the vote Commissioner Byrne said "This is an important step forward in our drive to ban antibiotics being used as growth promoters in animal feed. I very much welcome the priority Parliament has attached to passing this Regulation, and I applaud Mrs. Keppelhoff-Wiechert for her hard work. Crises such as dioxin in chicken and BSE have taught us the inescapable link between the safety of animal feed and human health. I look forward to working with the Council to get this Regulation on the statue books as soon as possible."

Parliament supported the broad lines of the Commission proposal but wished to bring the deadline for phasing out to an earlier date, namely 1 January 2005 instead of 2006.

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 drugs not used in human medicine that are still currently allowed on the EU market. These antibiotics are:

  • 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 were 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.

Next steps

The next step in the legislative process is for the Council of Ministers to agree its Common Position on the Regulation. This could happen at the 16-19 December Agriculture Council.

Further information:

See MEMO/02/66


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