Article 16

In giving its opinion, the Authority shall endeavour to respect a time limit of six months from the date of receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2. The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time limit. In order to prepare its opinion, the Authority shall: verify that the proposed wording of the health claim is substantiated by scientific data; consider whether the wording of the health claim complies with the criteria laid down in this Regulation; give advice on whether the proposed wording of the health claim is understandable and meaningful to the average consumer. In the event of an opinion in favour of authorising the health claim, the opinion shall include the following particulars: the name and address of the applicant; the nutrient or other substance, or the food or the category of food, in respect of which a claim is to be made and its particular characteristics; the recommended wording of the proposed health claim, including, as the case may be, the specific conditions of use; where applicable, conditions or restrictions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and in advertising. The Authority shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the health claim and stating the reasons for its opinion and the information on which its opinion was based. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public. The applicant or members of the public may make comments to the Commission within 30 days from such publication.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-08 · Text as adopted (Official Journal); later amendments are not incorporated in this text.