Commission Implementing Regulation (EU) 2018/456Dangos y teitl llawn

Article 1 U.K. Scope and subject matter

This Regulation lays down rules for the implementation of Article 4 of Regulation (EU) 2015/2283 as regards the procedural steps of the consultation process to determine whether or not a food falls within the scope of that Regulation.

Article 2 U.K. Definitions

In addition to the definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council(1) and Regulation (EU) 2015/2283, the following definitions shall apply:

(a)

‘consultation request’ means a request from a food business operator F1 ... to determine the novel food status of a particular food;

(b)

F2 ...

Textual Amendments

F1 Words in Art. 2(a) omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 66(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Art. 2(b) omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 66(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 3 U.K. Submission of a consultation request

1. The food business operator shall consult the [F3 Food Safety Authority] as provided for in Article 4(2) of Regulation (EU) 2015/2283 by submitting a consultation request to [F4 the Food Safety Authority].

F5 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F3 Words in Art. 3(1) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 67(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 3(1) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 67(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F5 Art. 3(2) omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 67(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 4 U.K. Content and presentation of a consultation request

1. The consultation request shall be submitted electronically to the [F6 Food Safety Authority] and shall consist of the following:

(a) a cover letter;

(b) a technical dossier;

(c) supporting documentation;

(d) an explanatory note clarifying the purpose and relevance of the submitted documentation.

2. The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.

3. The technical dossier referred to in paragraph 1(b) shall contain the information necessary to enable the [F6 Food Safety Authority] to conclude on the novel food status and shall be drafted in accordance with the template provided in Annex II.

4. By way of derogation from paragraph 3, an applicant is not required to provide all the elements referred to in Annex II, provided that the applicant has submitted verifiable justification for the absence of each missing element.

Textual Amendments

F6 Words in Art. 4 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 68; 2020 c. 1, Sch. 5 para. 1(1)

Article 5 U.K. Procedures for verifying the validity of a consultation request

1. The [F7 Food Safety Authority] shall without delay verify whether the consultation request complies with the requirements of Article 4.

2. Where the food business operator submits insufficient information in the consultation request, the [F7 Food Safety Authority] shall request the food business operator to provide additional information or make the relevant updates to the consultation request within the time period specified by the [F7 Food Safety Authority].

3. The consultation request shall be considered not valid where:

(a) the food business operator does not provide requested additional information or updated consultation request within the period specified by the [F7 Food Safety Authority];

(b) the submitted additional information is insufficient to conclude that the consultation request is valid.

4. The [F7 Food Safety Authority] shall decide on the validity of the consultation request and without delay inform the food business operator, the [F8 appropriate authority] of the decision. Where the consultation request is considered not valid, the [F7 Food Safety Authority] shall provide the reasons for that conclusion.

Textual Amendments

F7 Words in Art. 5 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 69(a); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 5(4) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 69(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 6 U.K. Procedures for evaluating a valid consultation request

1. The [F9 Food Safety Authority] shall conclude on the novel food status of a food within 4 months from the date on which it decided on the validity of the consultation request.

2. Where the [F9 Food Safety Authority] identifies that it does not have sufficient evidence to decide on the novel food status of a food, it may request the food business operator to provide additional information. The period of that request shall be determined together with the food business operator.

F10 ....

3. Without prejudice to paragraph 4, a request for additional information referred to in paragraph 2 shall not extend the time period referred to in paragraph 1.

4. In duly justified cases, the [F9 Food Safety Authority] may extend the time period referred to in paragraph 1 by a maximum of 4 months. The [F9 Food Safety Authority] shall inform the food business operator, the [F11 appropriate authority] of their decision and shall provide justification.

5. On concluding on the novel food status of a food, the [F9 Food Safety Authority] shall without delay notify the food business operator, the [F12 appropriate authority] of the decision and shall provide justification in accordance with Article 7 of this Regulation.

Textual Amendments

F9 Words in Art. 6 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 70(b); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 6(2) omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 70(a); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in Art. 6(4) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 70(c); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 6(5) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 70(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 7 U.K. Information on the novel food status and publication

1. The notification referred to in Article 6(5) of this Regulation shall include the following:

(a) the name and description of the food concerned;

(b) a statement indicating whether the food concerned is novel, not novel or not novel only in food supplements;

(c) reasons justifying the statement referred to in point (b);

(d) where the food is novel food, the most appropriate food category under which it falls in accordance with Article 3(2) of Regulation (EU) 2015/2283.

2. The [F13 Food Safety Authority] shall without delay make the information on the novel food status publicly available on the [F14 Food Safety Authority's] website.

Textual Amendments

F13 Words in Art. 7(2) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 71(a); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Art. 7(2) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 71(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 8 U.K. Competent authorities of the Member States

F15 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Art. 8 omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 72; 2020 c. 1, Sch. 5 para. 1(1)

Article 9 U.K. Confidentiality

1. Food business operators may request the [F16 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 [F16 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 [F16 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).

F17 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 [F18 Food Safety Authority ] shall take necessary measures to ensure appropriate confidentiality of the information referred to in paragraphs 3 and received by [F19 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, [F20 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 [F21 Food Safety Authority and the appropriate authority] necessary to consider the consultation requests submitted under this Regulation.

Textual Amendments

F16 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)

F17 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)

F18 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)

F19 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)

F20 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)

F21 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)

Article 10 U.K. Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

F22 ...

Done at Brussels, 19 March 2018.

For the Commission

The President

Jean-Claude Juncker

Textual Amendments

F22 Words in Signature omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 74; 2020 c. 1, Sch. 5 para. 1(1)