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 After expiry of the period referred to in paragraph 3, if an applicant has not withdrawn the application and in case of disagreement the Commission shall decide which parts of the information are to remain confidential and, in case a decision has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 Where an applicant withdraws, or has withdrawn, its application, the Commission, the Member States and the Authority shall not disclose confidential information, including the information whose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