Directive 90/220 on the deliberate release into the environment of genetically modified organisms, as amended by Directive 97/35, is to be interpreted as meaning that, if, after an application for placing a GMO on the market has been forwarded to the Commission, no Member State has raised an objection, in accordance with Article 13(2) of that directive, or if the Commission has taken a favourable decision under paragraph (4) of that provision, the competent authority which forwarded the application, with a favourable opinion, to the Commission must issue the consent in writing, allowing the product to be placed on the market. However, if in the meantime the Member State concerned has new information which leads it to consider that the product for which notification has been received may constitute a risk to human health and the environment, it will not be obliged to give its consent, provided that it immediately informs the Commission and the other Member States about the new information in order that, within the period laid down in Article 16(2) of Directive 90/220, a decision may be taken in the matter in accordance with the procedure provided for in Article 21 of that directive.

Where the national court finds that, owing to irregularities in the conduct of the examination of the notification by the competent national authority provided for in Article 12(1) of Directive 90/220 on the deliberate release into the environment of genetically modified organisms, as amended by Directive 97/35, it was not proper for that authority to forward the dossier with a favourable opinion to the Commission as provided for in paragraph (2) of that provision, that court must refer the matter to the Court of Justice for a preliminary ruling if it considers that those irregularities are such as to affect the validity of the Commission's favourable decision, if necessary ordering the suspension of application of the measures for implementing that decision until the Court of Justice has ruled on the question of validity.