No L 276/16 Official Journal of the European Communities 9. 11. 93 COMMISSION DECISION of 19 October 1993 concerning the placing on the market of a product containing genetically modified organisms pursuant to Article 13 of Council Directive 90/220/EEC (93/572/EEC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of geneti- cally modified organisms (GMOs) ('), and in particular Article 13 thereof, Whereas, in accordance with Part C of Council Directive 90/220/EEC, there is a Community procedure enabling the competent authority of a Member State to give consent to the placing on the market of products contai- ning GMOs ; ‘Whereas, a notification concerning the placing on the market of such a product (a live vaccine) has been submitted to the competent authorities of a Member State ; whereas, in consequence, the competent authority has forwarded the dossier thereon to the Commission with a favourable opinion ; Whereas the Commission has forwarded the dossier to the competent authorities of all Member States ; whereas the competent authority of another Member State has raised an objection to the said dossier; Whereas, therefore, in accordance with Article 13 (3). the Commission is required to take a decision in accordance with the procedure provided for in Article 21 of Directive 90/220/EEC ; Whereas under Directive 90/220/EEC only the risks related to the use of the genetically modified organism are evaluated ; whereas other aspects of the vaccine are evaluated under specific Community product legislation ; Whereas the Commission having examined the dossier and having taken into account all the information submitted by the authorities of the Member States, inclu- ding extensive evidence of testing, has found that the potential risks for human health and the environment presented by the use of the genetically modified virus contained in Raboral V-RG (Vaccinia virus, Copenhagen strain, tk-phenotype, expressing glycoprotein G of the rabies virus, ERA strain) when used as an oral live anti- () OJ No L 117, 8. 5. 1990, p. 15. rabies vaccine for foxes and administered in bait, are not expected to be significant; Whereas, the information submitted and the evidence from testing indicate in particular that the genetic modifi- cation of the virus is not expected to result in any post- release shift in biological interactions or host range or in any known or predictable effects on non-target organisms in the environment or other potentially significant inter- action with the environment or in any increase in patho- genicity as compared to the parental virus strain and/or in any increase in the capacity of the Raboral V-RG virus to recombine with other related viruses ; Whereas, consequently, the Commission can take a favourable decision on the placing on the market of the said product under Directive 90/220/EEC; ' Whereas this Decision is in accordance with the opinion of the Committee of Member States Representatives established under Article 21 of Directive 90/220/EEC, HAS ADOPTED THIS DECISION : Article 1 1. A favourable decision is hereby taken, according to which, consent, subject to paragraph 2 below, shall be given under Article 13 of Directive 90/220/EEC by the authorities of Belgium for the placing on the market of the following product, notified by Rhéne Mérieux (Ref. C/B/92/B28 and C/F/93/03-02): — Raboral V-RG (Vaccinia virus, Copenhagen strain, tk-phenotype, expressing glycoprotein G of the rabies virus, ERA strain) — Oral live anti-rabies vaccine for foxes, to be adminis- tered in bait. 2. The conditions of use and labelling shall be as follows : (i) Raboral is an oral vaccine against rabies administered in bait to foxes and shall not be used for human vaccination ; (ii) Raboral shall only be made available to and used by duly designated competent administrative authorities or their authorized agents;