contents table Lexparency.org
Health Claims
Article 17

Article 17 — Community authorisation

  1. Within two months after receiving the opinion of the Authority, the Commission shall submit to the Committee referred to in Article 23(2) a draft decision on the lists of permitted health claims, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration. Where the draft decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.
  2. Any draft decision to amend the lists of permitted health claims shall include the particulars referred to in Article 16(4).
  3. A final decision on the application, designed to amend non essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).

    However, where at the applicant's request for the protection of proprietary data, the Commission proposes to restrict the use of the claim in favour of the applicant:

    1. a decision on the authorisation of the claim shall be taken in accordance with the regulatory procedure referred to in Article 25(2). In such case, the authorisation, if granted, shall expire after five years;
    2. before the expiry of the five-year period, if the claim still meets the conditions laid down in this Regulation, the Commission shall submit a draft of measures designed to amend non-essential elements of this Regulation by supplementing it for authorisation of the claim without restriction for use which shall be decided on in accordance with the regulatory procedure with scrutiny referred to in Article 25(3).
  4. The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.
  5. Health claims included in the lists provided for in Articles 13 and 14 may be used, in conformity with the conditions applying to them, by any food business operator, if they are not restricted for use in accordance with the provisions of Article 21.
  6. The granting of authorisation shall not lessen the general civil and criminal liability of any food business operator in respect of the food concerned.