For the first time, the Court has been called upon to rule in
an action by a Member State contesting a refusal by the Commission to
authorise it to maintain national measures which derogate from a harmonisation directive. The
Treaty allows the Member States to maintain or to introduce national measures which
derogate from a harmonisation measure for reasons relating, inter alia, to the protection
of public health.
A Council framework directive of 1988 on food additives provides that, in order
to be included in the list of authorised additives, they must be essential
for the purpose of achieving the desired objective and must not present any
risk to health. If there is any doubt as to the risk to
health posed by an additive, the Scientific Committee for Food (SCF) must be
consulted. A 1995 directive relates to food additives other than colours and sweeteners.
Denmark had voted against the directive at the time of its adoption, on
the ground that it did not meet health requirements as regards, in particular,
nitrites, nitrates and sulphites.
Sulphites are preservatives used, inter alia, in wine, jam, pastries and dried fruit.
Ingested in large amounts, they can cause lesions in the digestive tract and
provoke severe allergic reactions in asthmatics.
Nitrites and nitrates also have a preservative effect and are used, inter alia,
in meats. They inhibit the growth of bacterial pathogens such as Clostridium botulinum,
which is responsible for botulism, and it is recognised that they can cause
cancer.
Denmark requested authorisation to maintain its provisions concerning those additives. In 1999, the
Commission decided not to authorise the national provisions, which were considered disproportionate in
relation to the objective of protecting public health. Denmark then requested the Court
of Justice to annul that decision.
The Court first points out that the EC Treaty provides harmonisation measures for
the purpose of establishing the internal market. In that context, the Treaty also
lays down an approval procedure for derogating national provisions, whilst distinguishing between pre-existing
and new national provisions. The former may be justified on grounds of the
major needs referred to in Article 30 EC or the protection of the
environment or the working environment, because they are known to the Community legislature
at the time harmonisation takes place. By contrast, a Member State which wishes
to adopt national provisions subsequent to harmonisation must provide new scientific evidence and
demonstrate the existence of a problem specific to the Member State concerned which
arose after the adoption of the harmonisation measure.
The Court observes that the maintenance of the national provisions at issue was
not considered to be justified by a problem specific to Denmark or on
new scientific evidence. Nevertheless, the Court considers that a Member State which asks
to maintain derogating national provisions may argue that its assessment of the risk
to public health is different from that made by the Community legislature. In
the light of the uncertainty inherent in assessing public health risks, divergent assessments
of those risks can legitimately be made, without necessarily being based on new
or different scientific evidence. The Court considers that a Member State may ask
to maintain derogating national provisions which already exist on the basis of an
assessment of the risk to public health different from that accepted by the
Community legislature at the time it adopted the harmonisation measure. The Member State
must prove that the derogating national provisions ensure a level of health protection
which is higher than the Community harmonisation measure and that they do not
go beyond what is necessary to attain that objective.
In its consideration of the Community harmonisation measures for sulphites, the Court takes
the view that they appear to be sufficient in the light of the
1994 opinion by the SCF and that the Commission's decision not to authorise
the stricter Danish system does not contain any error of fact or assessment
in that regard.
None the less, as regards nitrites and nitrates, the Court finds that the
Commission decision did not take sufficient account of the 1995 opinion by the
SCF, which called into question the maximum amounts of nitrites set under the
1995 directive.
The Court therefore holds that, by failing to take into account that opinion
when assessing the Danish provisions on nitrites and nitrates, the Commission's decision is
unlawful and must be annulled.
Available in Danish, English, French, German, Greek, Italian and Spanish. For the full text of the Judgment, please consult our internet page www.curia.eu.int at approximately 3 pm today. For additional information please contact Christopher Fretwell Phone: (00 352) 4303 3355; Fax: (00 352) 4303 2731. |