Brussels, Belgium, 27 March 2002: The animal health industry is not surprised by the contents of the Commission’s Proposal for a Regulation on Additives for Use in Animal Nutrition.  The decision to include in the proposals the phase-out, by 2006, of the use of the remaining four growth-promoting antibiotics as growth-promoters reflects a shift in policy that has been announced several times in the past by the European Commission.  It therefore does not come as any surprise. 

FEDESA member companies that have invested to produce the data required to undergo this risk assessment procedure have earned the right to market those products according to the well-established procedures and periodic reviews.  During the ongoing decision-making process of this latest proposal, therefore, it is logical to expect that FEDESA, in representing those companies, will seek to clarify what the authorities intend to do in respect of those rights. 

Furthermore, the animal health industry is concerned that, since this policy represents a blanket approach, rather than the product-by-product scientific risk assessment, this EU policy approach cannot be applied to imported animal health products, because it is not and cannot be shown to be founded on demonstrable human safety concerns. 

NOTES TO EDITORS:

1. The products in question are sodium monensin, sodium-salinomycin, flavophospholipol and avilamycin mentioned in Annex B of Directive 70/524/EEC.

2. None of the products in question have, or are likely to have, application in human medicine.  Equally, none are in a class of antibiotic that is likely to be used in humans.

3.The EU’s legally appointed scientific review body (SCAN) has not declared these remaining products (or indeed, the earlier banned ones) unsafe from either a human or an animal health point of view.  It is for this reason that DG SANCO can only adopt a policy of phase-out, there being an absence of evidence of an immediate threat to public health.

4.Two-thirds of the antibiotics prescribed in the European Union (EU) in 1999 were consumed by people while only one-third was used in veterinary medicine, according to a study by the European Federation of Animal Health (FEDESA).  The study estimates that people in the EU and Switzerland consumed 8,528 tonnes of antibiotics in 1999, or about 65% of the total, while animals consumed 4,688 tonnes, or 35% of all antibiotics prescribed during the year.

5.FEDESA, the European Federation of Animal Health, represents the animal health industry in Europe.  Its membership comprises 15 national associations and 15 companies active in the research, development and marketing of veterinary medicines.  FEDESA works towards a European environment where the value of safe and effective animal health products is recognised and where these high-quality products can be developed, registered and provided quickly and economically.

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