Chapter II, Article 11 · Regulation (EU) 2026/1388

Contents

Article 11Confidentiality#

1.The requester referred to in Article 6 may submit a request to the Member State competent authority, and the requester referred to in Article 7 may submit a request to the Authority, to treat certain parts of the information submitted under this Chapter as confidential. The confidentiality request shall be accompanied by verifiable justification in accordance with paragraphs 3 and 6 of this Article.

2.The Member State competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

3.The Member State competent authority or the Authority, as appropriate, may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the requester demonstrates that the disclosure of such information would potentially harm the requester’s interests to a significant degree:

(a)items of information referred to in Article 39(2), points (a), (b) and (c), of Regulation (EC) No 178/2002;

(b)DNA sequence information; and

(c)breeding patterns and strategies.

4.Where the Member State competent authority assesses the confidentiality request, it shall, after consultation with the requester, decide which information is to be treated as confidential and shall inform the requester of its decision. Where the Authority assesses the confidentiality request, it shall apply the procedure set out in Article 39b of Regulation (EC) No 178/2002.

5.The Commission, the Authority and Member States shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.

6.The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

7.If the requester withdraws the verification request referred to in Article 6 or 7, the Commission, the Authority and Member States shall respect the confidentiality as granted by the Member State competent authority or the Authority in accordance with this Article. Where the verification request is withdrawn before the Member State competent authority or the Authority has decided on the corresponding confidentiality request, the Commission, the Authority and Member States shall not make public the information for which confidentiality has been requested.