# Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance), Article 12: Confidentiality

Extent: E+W+S+N.I.

1. Among the information provided by applicants, confidential treatment may be given to information the disclosure of which might significantly harm their competitive position.
Information relating to the following shall not, in any circumstances, be regarded as confidential:
(a) the name and address of the applicant;
(b) the name and a clear description of the substance;
(c) the justification for the use of the substance in or on specific foodstuffs or food categories;
(d) information that is relevant to the assessment of the safety of the substance;
(e) where applicable, the analysis method(s).
2. For the purposes of implementing paragraph 1, applicants shall indicate which of the information provided they wish to be treated as confidential. Verifiable justification must be given in such cases.
3. The Authority shall decide after consulting with the applicants which information can remain confidential and shall notify applicants ... accordingly.
4. After being made aware of the Authority's position, applicants shall have three weeks in which to withdraw their application so as to preserve the confidentiality of the information provided. Confidentiality shall be preserved until this period expires.
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6. If an applicant withdraws, or has withdrawn, its application, the appropriate authority and the Authority shall not disclose confidential information, including information the confidentiality of which is the subject of disagreement between the Authority and the applicant.
7. The implementation of paragraphs 1 to 6 shall not affect the circulation of information between the appropriate authority and the Authority.

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Source: https://www.legislation.gov.uk/eur/2008/1331/article/12 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-1331/article-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.