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EU's precautionary principle wins court backing

12th September 2002

ENDS - Environment Daily

The EU's legal framework for applying the precautionary principle in environmental and health decision making has been reinforced by two important legal rulings delivered yesterday by the Court of first instance, part of the European court of justice.

The linked judgements provide critical judicial guidance on how EU authorities can legitimately apply the principle. According to an EU source, they will also strengthen the EU's hand in its efforts to promote the precautionary principle internationally.

Both cases arose from a 1999 EU regulation banning use as animal feed additives of four antibiotics: virginiamycin, bacitracin zinc, spiramycin and tylosin phosphate. The justification advanced for prohibition was that bacterial resistance to the antibiotics might be transferred to humans.

Pharmaceutical firms Pfizer Animal Health and Alpharma challenged the regulation, arguing that it was based on an attempt to achieve "zero risk" and not on a thorough risk assessment. Pfizer was at the time the only producer of virginiamycin, and Alpharma the only European producer of bacitracin.

Both companies' cases have been dismissed by the court, which has also set out in detail the conditions under which the precautionary principle can be invoked under EU law. The guidance very largely reaffirms the approach taken by the European Commission in a 2000 communication which has hitherto been the main reference point for how the principle should be applied .

The court reaffirms that precautionary action can be justified in appropriate circumstances, though it cannot mean abolishing all risk. It goes on to give guidance on how risk should be assessed and reaffirms that authorities - as risk managers - have broad scope to interpret scientific risk assessments.

A risk assessment is vital, the court holds, and must comprise both a scientific and a political component. Competent scientific committees must always be asked for an opinion, even if this is not specifically required in legislation.

Authorities can take precautionary action without backing from a competent scientific committee, but only under certain conditions. In this case, the court concludes, they must be "able to rely on a proper examination, carefully and impartially carried out, of all the relevant aspects of the individual case, which includes the reasoning on which the committee concerned based its findings in the opinion".

In the case of virginiamycin, the competent EU scientific committee advised that there was insufficient evidence to justify prohibition. The court concludes that the EU council's decision to ban was nevertheless justified in the interest of protecting human health.

Regarding bacitracin zinc, the EU authorities did not even seek advice from a relevant scientific committee before prohibition. However, the court concludes that scientific knowledge about other similar antibiotics justified a "horizontal approach".

Sweden, Denmark, Finland and the UK supported the EU Council in the cases. Swedish acting environment minister Lena Sommestad expressed satisfaction with the rulings today, describing them as "a breakthrough" for the Swedish view on the precautionary principle. Alpharma and Pfizer expressed disappointment, and said they might appeal to the European court of justice.