PRESS RELEASE No 71/02
11 September 2002
Judgments of the Court of First Instance in Cases T-13/99 and T-70/99
Pfizer Animal Health SA v Council and Alpharma Inc. v Council
THE COURT OF FIRST INSTANCE UPHOLDS THE COUNCIL'S DECISION TO BAN THE
USE OF CERTAIN ANTIBIOTICS AS ADDITIVES IN ANIMAL FEED AND SETS OUT THE CONDITIONS
ON WHICH THE PRECAUTIONARY PRINCIPLE MAY BE APPLIED
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
For many years the antibiotics referred to had been added in very low doses
to the feedingstuffs of certain animals as growth promoters . That 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 practice is also said to have certain beneficial side effects,
in particular it prevents certain diseases in animals.
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.
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
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 supplierof 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 sets out in this case the conditions on which
the precautionary principle is to apply in Community law. It reaffirms to
a large extent the principles stated by the Commission in 2000 in its communication
on the precautionary principle.
The Court starts by observing that in other cases dealing with food safety
(in particular the "mad cow" 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 perceived become fully apparent.
However, it points out 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
Before taking any preventive measure, a public authority must therefore carry
out a risk assessment, which involves two components: a scientific component,
i.e. as thorough a scientific risk assessment as possible account being taken
of how urgent the matter is, and a political component ("risk management")
in the context of which the public authority must decide on the measure it deems
appropriate given the degree of risk set by it.
In its judgment, the Court lays great stress on the conditions with which
the public authority must comply in its risk assessment. It places 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 points 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.
Having been consulted about the scientific material submitted by the Danish
authorities with regard to their safeguard measures, the competent Community
scientific committee took the view that there was insufficient scientific evidence
to find that virginiamycin entailed a risk and it did not advise the competent
Community institutions to withdraw it from the market. The Council none the
less decided to ban it.
The Court upholds this decision pointing out the role of expert scientific
advice, which must ensure that the measure in question is taken on an objective
scientific basis. However, it holds that, unless the legislation provides
otherwise, a public authority is not bound by that advice. In the present case,
which concerns a measure whose objective is the protection of human health,
the view taken by the institutions, which differs from that expressed in the
scientific advice, must be founded on that objective alone. Thus, if the
institutions are to depart from the findings in the opinion of the competent
scientific committee, they must be able to rely on
o a proper examination
o carefully and impartially carried out
o of all the relevant aspects of the individual case,
o which include the reasoning on which the committee concerned based the findings in its opinion.
The Court finds that in this case the decision of the institutions not to accept the scientific opinion is justified in the interest of the protection of human health.
The view of the scientific committee on this particular product was not sought
before the contested regulation was adopted. The institutions nevertheless found
that the product belonged to one of the classes of antibiotics in respect of
which, according to available research, the risk of transfer was highest.
The Court finds that, given the scientific knowledge already available to
them concerning the various other antibiotics, the institutions were entitled
to take a horizontal approach to that entire class of antibiotics by systematically
excluding the use as additives in feedingstuffs of products also used in human
medicine (the exclusion of "dual-use" products). The Court accepts
that horizontal approach and holds that the institutions were able to ban bacitracin
zinc without first obtaining an opinion specific to that product from the competent
The Court concludes that, despite uncertainty as to whether there is a
link between the use of those 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
Reminder: 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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