31997D0549

COMMISSION DECISION of 14 July 1997 concerning the placing on the market of T102-test (Streptococcus thermophilus T102) pursuant to Council Directive 90/220/EEC (Text with EEA relevance) (97/549/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (1), as last amended by Commission Directive 97/35/EC (2), and in particular Article 13 thereof,

Whereas Articles 10 to 18 of Directive 90/220/EEC lay down a Community procedure enabling the competent authority of a Member State to give consent to the placing on the market of products containing, or consisting of, genetically modified organisms;

Whereas a notification concerning the placing on the market of such a product has been submitted to the competent authority of Finland;

Whereas the competent authority of Finland has subsequently forwarded the dossier thereon to the Commission with a favourable opinion;

Whereas the competent authority of a Member State has raised an objection to the said dossier;

Whereas, therefore, in accordance with Article 13 (3) of Directive 90/220/EEC, the Commission is required to take a decision in accordance with the procedure laid down in Article 21 of that Directive;

Whereas the Commission, having examined the objection raised in the light of the scope of Directive 90/220/EEC and the information submitted in the dossier, has reached the conclusion that there is no reason to believe that there will be any adverse effects on human health or the environment from the introduction into Streptococcus thermophilus T102 of the gene coding for chloramphenicol-acetyl-transferase on the plasmid pMJ 763;

Whereas Articles 11 (6) and 16 (1) of Directive 90/220/EEC provide additional safeguards if new information on risks of the product becomes available;

Whereas the measures provided for in this Decision are in accordance with the opinion of the committee established under Article 21 of Directive 90/220/EEC,

HAS ADOPTED THIS DECISION:

Article 1

Without prejudice to other Community legislation, consent shall be given by the competent authority of Finland to the placing on the market of the following product, notified by Valio Oy (ref. C/FI/96-1NA):

vials containing a freezedried preparation of Streptococcus thermophilus T102 which has been transformed with the plasmid pMJ 763 containing synthetic luxA, luxB genes derived from Xenorhabdus luminescens, the chloramphenicol-acetyl-transferase gene from plasmid pVS2 under the regulation of a P45 Lactococcal promotor and a transcriptional terminator from Escherichia coli rrnB.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 14 July 1997.

For the Commission

Ritt BJERREGAARD

Member of the Commission

(1) OJ No L 117, 8. 5. 1990, p. 15.

(2) OJ No L 169, 27. 6. 1997, p. 72.