Commission Implementing Regulation (EU) 2018/456Show full title

Article 9 U.K. Confidentiality

1. Food business operators may request the [F1 Food Safety Authority] to agree that the disclosure of certain information submitted as part of the consultation request needs to benefit from confidential treatment where disclosure of such information may harm their competitive position.

2. For the purpose of paragraph 1, food business operators shall indicate to the [F1 Food Safety Authority] the parts of the information provided that they wish to be treated as confidential and provide all the necessary details to substantiate their request for confidentiality.

3. The [F1 Food Safety Authority] shall inform the food business operator of its views on which parts of the information are to remain confidential.

However, confidentiality shall not apply to the following information:

(a) the name and address of the applicant;

(b) the name and description of the food;

(c) a summary of the studies submitted by the applicant;

(d) where appropriate, the analysis method(s).

F2 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. After being informed pursuant to paragraph 3, the food business operator may withdraw its consultation request within 3 weeks during which the confidentiality of the information provided shall be observed.

6. The [F3 Food Safety Authority ] shall take necessary measures to ensure appropriate confidentiality of the information referred to in paragraphs 3 and received by [F4 it] under this Regulation, except for information which is required to be made public in order to protect human health.

7. Where a food business operator withdraws or has withdrawn its consultation request in accordance with paragraph 5, [F5 the Food Safety Authority must not] disclose information for which confidentiality was requested by the food business operator pursuant to paragraph 1.

8. The application of paragraphs 1 to 7 shall not affect the exchange of information between the [F6 Food Safety Authority and the appropriate authority] necessary to consider the consultation requests submitted under this Regulation.

Textual Amendments

F1 Words in Art. 9 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 73(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Art. 9(4) omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 73(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 9(6) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 73(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Art. 9(6) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 73(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 9(7) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 73(d); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 9(8) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 73(e); 2020 c. 1, Sch. 5 para. 1(1)