With a view to protecting public health, on 26 June 1990 the Council adopted a regulation introducing a procedure for the establishment of maximum residue limits (MRL) acceptable in or on foodstuffs of animal origin for residues resulting from the use of veterinary medicinal products.
The Council imposed a moratorium on socio-economic grounds until 31 December 1999 on the marketing and administration of bovine recombinant somatotrophin (BST), a growth hormone.
Lilly Industries has developed a veterinary medicine in which the pharmacologically active substance is somidobove, a growth hormone intended for administration to dairy cows to boost milk production.
The Commission rejected Lilly Industries' request for the inclusion of somidobove in the list of substances not subject to maximum residue limits.
To justify its decision, the Commission pointed out inter alia that the Council had imposed a moratorium until 31 December 1999 temporarily banning the marketing of the growth hormone BST in the Community.
The Court of First Instance has today annulled the Commission's decision rejecting that request.
It takes the view that the Commission was wrong to use the moratorium on BST as a basis for its decision to reject the request by Lilly Industries for the inclusion of somidobove in the list of substances not subject to maximum residue limits. The purpose of the Regulation of 26 June 1990 is to protect public health whereas the moratorium on BST was imposed for socio-economic reasons. As the procedures are independent and distinct from each other, and the establishment of maximum residue limits is only one of the stages leading to the marketing of a product such as that developed by Lilly Industries, it follows that, after a favourable opinion from the Committee for Veterinary Medicinal Products, the independent procedure for the establishment of maximum residue limits must be followed and brought to its conclusion.
However, annulment of the decision in no way implies automatic marketing authorisation. Community and national rules on veterinary medicines apply for that purpose and expressly provide for the possibility that a product such as that of Lilly Industries may be denied marketing authorisation if other provisions of Community law preclude it.
NB : an appeal against this decision, limited to points of law, may be brought before the Court of Justice of the European Communities within two months of its notification.
This press release is an unofficial document for media use which does not bind the Court of First Instance.
It is available in French, English, German and Dutch. For the full text of the judgment, consult our Internet page www.curia.eu.int. at around 3 pm today.
For further information, contact Tom Kennedy phone: (352) 4303 3355 fax: (352) 4303 2734.