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Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance) article 12 CELEX: 02015R2283-20210327 Authorisation of a novel food and updates of the Union list
1. Within seven months from the date of publication of the Authority's opinion, the Commission shall submit to the committee referred to in Article 30(1) a draft implementing act authorising the placing on the market within the Union of a novel food and updating the Union list, taking into account the following:
the conditions provided for in points (a) and (b) of Article 7 and, where applicable, in point (c) of that Article;
any relevant provision of Union law, including the precautionary principle as referred to in Article 7 of Regulation (EC) No 178/2002;
the Authority's opinion;
any other legitimate factors relevant to the application under consideration.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 30(3). 2. Where the Commission has not requested an opinion from the Authority in accordance with Article 10(3), the seven-month period provided for in paragraph 1 of this Article shall start from the date on which a valid application is received by the Commission in accordance with Article 10(1). |