Additional information concerning risk management
1. Where the Commission requests from an applicant additional information on matters concerning risk management, it shall determine, together with the applicant, the period within which that information is to be provided.
In such cases, the period provided for in Article 12(1) or (2) or in Article 18(1) may be extended accordingly. The Commission shall inform the Member States of that extension and shall make the additional information available to Member States once it has been received.
2. Where the additional information referred to in paragraph 1 is not received within the additional period referred to in that paragraph, the Commission shall act on the basis of the available information.
Ad hoc extension of time periods
In exceptional circumstances, the Commission may extend the time periods provided for in Articles 11(1), 12(1) or (2), 17(1) and 18(1) on its own initiative or, where applicable, at the Authority's request, where the nature of the matter in question justifies an appropriate extension.
The Commission shall inform the applicant and the Member States of the extension and the reasons therefor.
Confidentiality of applications for updates of the Union list
1. Applicants may request confidential treatment of certain information submitted under this Regulation where disclosure of such information may harm their competitive position.
2. For the purposes of paragraph 1, applicants shall indicate which parts of the information provided they wish to be treated as confidential and provide all the necessary details to substantiate their request for confidentiality. Verifiable justification shall be given in such cases.
3. After being informed of the Commission's position on the request, applicants may withdraw their application within three weeks, during which the confidentiality of the information provided shall be observed.
4. After expiry of the period referred to in paragraph 3, if an applicant has not withdrawn the application and in case of disagreement the Commission shall decide which parts of the information are to remain confidential and, in case a decision has been taken, notify the Member States and the applicant accordingly.
However, confidentiality shall not apply to the following information:
(a)
the name and address of the applicant;
(b)
the name and description of the novel food;
(c)
the proposed conditions of use of the novel food;
(d)
a summary of the studies submitted by the applicant;
(e)
the results of the studies carried out to demonstrate the safety of the food;
(f)
where appropriate, the analysis method(s);
(g)
any prohibition or restriction imposed in respect of the food by a third country.
5. The Commission, the Member States and the Authority shall take necessary measures to ensure appropriate confidentiality of the information as referred to in paragraph 4 and received by them under this Regulation, except for information which is required to be made public in order to protect human health.
6. Where an applicant withdraws, or has withdrawn, its application, the Commission, the Member States and the Authority shall not disclose confidential information, including the information whose confidentiality is the subject of disagreement between the Commission and the applicant.
7. The application of paragraphs 1 to 6 shall not affect the exchange of information concerning the application between the Commission, the Member States and the Authority.
8. The Commission may, by means of implementing acts, adopt detailed rules on the implementation of paragraphs 1 to 6.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).
Post-market monitoring requirements
The Commission may, for food safety reasons and taking into account the opinion of the Authority, impose post-market monitoring requirements. Such requirements may include, on a case-by-case basis, the identification of the relevant food business operators.
Additional information requirements
Any food business operator which has placed a novel food on the market shall immediately inform the Commission of any information of which it has become aware concerning:
(a)
any new scientific or technical information which might influence the evaluation of the safety of use of the novel food;
(b)
any prohibition or restriction imposed by a third country in which the novel food is placed on the market.
The Commission shall make that information available to the Member States.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
