Art. 23

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before (32015R2283)

Article 23
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 After expiry of the period referred to in paragraph 3, if an applicant has not withdrawn the application and in case of disagreement the Commission shall decide which parts of the information are to remain confidential and, in case a decision has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 Where an applicant withdraws, or has withdrawn, its application, the Commission, the Member States and the Authority shall not disclose confidential information, including the information whose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).

after (02015R2283-20210327)

Article 23
Transparency and confidentiality
1. Where the Commission requests the opinion of the Authority in accordance with Article 10(3) and Article 16 of this Regulation, the Authority shall make public the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, in accordance with Articles 38 to 39e of Regulation (EC) No 178/2002 and with this Article.
2. The applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification, upon submission of the application.
3. Where the Commission requests the opinion of the Authority in accordance with Article 10(3) and Article 16 of this Regulation, the Authority shall assess the confidentiality request submitted by the applicant in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.
4. In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:
(a) where applicable, information provided in detailed descriptions of starting substances and starting preparations and on how they are used to manufacture the novel food subject to the authorisation, and detailed information on the nature and composition of the specific foods or food categories in which the applicant intends to use that novel food, except for information which is relevant to the assessment of safety;
(b) where applicable, detailed analytical information on the variability and stability of individual production batches, except for information which is relevant to the assessment of safety.
5. Where the Commission does not request the Authority's opinion pursuant to Articles 10 and 16 of this Regulation, the Commission shall assess the confidentiality request submitted by the applicant. Articles 39, 39a and 39d of Regulation (EC) No 178/2002 and paragraph 4 of this Article shall apply mutatis mutandis.
6. This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.