9/23/2002 European Court Backs Ban on Antibiotics in Animal Feed - 9/17 Meat Processing News

"Despite uncertainty as to whether there is a link between the use of certain antibiotics as additives and increased resistance to those antibiotics in humans, the ban on the products is not a disproportionate measure given the need to protect public health," the court ruling states.

A Council regulation adopted on 17 December 1998 banned the use of four antibiotics as additives in animal feedingstuffs: virginiamycin, bacitracin zinc, spiramycin and tylosin phosphate. The Council decided, however, that four other antibiotics could remain on the market. Safeguard measures had been introduced prior to the regulation by various Member States, in particular Denmark, and Sweden had requested that Community legislation should be amended.

For many years the antibiotics had been added in very low doses to the feedingstuffs of certain animals as growth promoters. The practice is known to result in improved growth in the animal and in improved weight gain, so that an animal needs less time and less food to attain its required weight for slaughter.

The court said: "The practice is also said to have certain beneficial side effects, in particular it prevents certain diseases in animals." However the court added that since the 1970s many scientists have claimed that the practice entails a risk of resistance to those antibiotics developing in animals and being transferred to humans, notably via the food chain, with the result that those and certain other related antibiotics could no longer be used effectively in human medicine for the treatment of certain dangerous diseases. "In particular, in 1997 and 1998, various specialist international, Community and national bodies, such as the World Health Organisation (WHO), recommended the immediate or gradual discontinuance of the practice," said the court statement.

"At the time when the regulation at issue was adopted, it had not been proved that there was a link between use of the antibiotics concerned and the development of resistance to those antibiotics in humans. It was against that background that the Council had recourse to the precautionary principle in the contested regulation."

When the regulation was adopted, Pfizer Animal Health SA was the only producer of virginiamycin in the world and Alpharma Inc. was the only manufacturer and the largest supplier of bacitracin zinc in Europe. They brought actions for annulment of the Council regulation before the Court of First instance. Pfizer Animal Health was supported by several agricultural associations. The Council was supported by the Commission and also by Denmark, Sweden, Finland and the United Kingdom. In 1999 applications for suspension of operation of the regulation were dismissed by two orders of the President of the Court of First Instance. One of those orders was upheld on appeal by the President of the Court of Justice.

Before the Court of First Instance, Pfizer and Alpharma claim that,instead of undertaking a thorough assessment of the risks associated with those products, the Council and the Commission attempted to exclude any risk, taking an unrealistic approach referred to as "zero risk" and basing their decision on political expediency rather than on an objective scientific analysis.

The Court of First Instance set out in this case the conditions on which the precautionary principle is to apply in Community law. It reaffirmed to a large extent the principles stated by the Commission in 2000 in its communication on the precautionary principle. The Court said that in other cases dealing with food safety (in particular the BSE crisis), the Community Courts have already held that it is possible to take preventive measures without having to wait until the reality and seriousness of the risks become fully apparent. However, it said that a preventive measure cannot be founded on mere conjecture, which has not been scientifically verified but may be taken only where there is a real risk.

In the Court's view, the concept of risk entails some probability that the negative effects, which the measure is specifically designed to prevent, will occur. The degree of risk cannot be set at "zero risk". In its judgement, the Court laid great stress on the conditions with which the public authority must comply in its risk assessment. It placed particular emphasis on the essential role of scientists in this context and concludes that the view of the competent scientific committees must be obtained even if this is not specifically provided for by legislation, unless the public authority can ensure that it is acting on an equivalent scientific basis. However, the Court pointed out that the decision to ban a product is not a matter for the scientists but rather for the public authority to whom political responsibility has been entrusted.

The Court concluded that, despite uncertainty as to whether there is a link between the use of the antibiotics as additives and the development of resistance to them in humans, the ban on the products is not a disproportionate measure by comparison with the objective pursued, namely the protection of human health.

An appeal, limited to points of law, may be brought before the Court of Justice of the European Communities against the decision of the Court of First Instance within two months of its notification.


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