Regulation (EU) 2015/2283 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER V U.K. DATA PROTECTION

Article 26 U.K. Authorisation procedure in case of data protection

1. On request by the applicant, and where supported by appropriate and verifiable information included in the application provided for in Article 10(1), newly developed scientific evidence or scientific data supporting the application shall not be used for the benefit of a subsequent application during a period of five years from the date of the authorisation of the novel food without the agreement of the initial applicant.

2. The data protection shall be granted by the [F1 appropriate authority] under Article 27(1) where the following conditions are met:

(a) the newly developed scientific evidence or scientific data was designated as proprietary by the initial applicant at the time the first application was made;

(b) the initial applicant had exclusive right of reference to the proprietary scientific evidence or scientific data at the time the first application was made; and

(c) the novel food could not have been assessed by the Authority and authorised without the submission of the proprietary scientific evidence or scientific data by the initial applicant.

However, the initial applicant may agree with a subsequent applicant that such scientific evidence and scientific data may be used.

3. Paragraphs 1 and 2 shall not apply to notifications and applications concerning the placing on the market within [F2 Great Britain] of traditional foods from third countries.

Textual Amendments

F1 Words in Art. 26(2) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 32(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 26(3) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 32(b) (as substituted by S.I. 2020/1504, regs. 1(2), 15(9)); 2020 c. 1, Sch. 5 para. 1(1)

[F3 Article 27 U.K. Authorisation of a novel food F4 ... based on protected proprietary scientific evidence or scientific data

1. Where a novel food is authorised F5 ... pursuant to Articles 10 to 12 based on proprietary scientific evidence or scientific data that are granted data protection as provided for in Article 26(1), the [F6 authorisation of that novel food] must indicate, in addition to the information referred to in Article 9(3)—

(a) the date of [F7 authorisation];

(b) the fact that that inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26;

(c) the name and address of the applicant;

(d) the fact that during the period of data protection the novel food is authorised for placing on the market within Great Britain only by the applicant specified in point (c) of this paragraph, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 or with the agreement of the initial applicant;

(e) the end date of the data protection provided for in Article 26.

2. Scientific evidence or scientific data protected in accordance with Article 26 or for which the protection period under that Article has expired is not to be granted renewed protection.]

Textual Amendments

F3 Art. 27 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 33 (as amended by S.I. 2020/1504, regs. 1(2), 15(5)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 27 heading omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(13)(a) (with reg. 23)

F5 Words in Art. 27(1) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(13)(b)(i)(aa) (with reg. 23)

F6 Words in Art. 27(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(13)(b)(i)(bb) (with reg. 23)

F7 Word in Art. 27(1)(a) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(13)(b)(ii) (with reg. 23)

Article 28 U.K. Authorisation procedure in case of a parallel application for the authorisation of a health claim

1. The [F8 appropriate authority must], on request by the applicant, stay an authorisation procedure for a novel food started following an application, where the applicant has submitted:

(a) a request for data protection in accordance with Article 26; and

(b) an application for the authorisation of a health claim on the same novel food in accordance with Article 15 or 18 of Regulation (EC) No 1924/2006, in conjunction with a request for data protection in accordance with Article 21 of that Regulation.

The stay of the authorisation procedure shall be without prejudice to the assessment of the food by the [F9 Food Safety Authority] in accordance with Article 11.

2. The [F8 appropriate authority must] inform the applicant about the date of effect of the stay.

3. While the authorisation procedure is stayed, time shall cease to run for the purposes of the time-limit laid down in Article 12(1).

4. The authorisation procedure shall resume when [F10 the opinion has been received] on the health claim pursuant to Regulation (EC) No 1924/2006.

The [F8 appropriate authority must] inform the applicant about the date of resumption of the authorisation procedure. From the date of resumption, time shall begin to run afresh from the beginning for the purposes of the time-limit laid down in Article 12(1) of this Regulation.

5. In the cases referred to in paragraph 1 of this Article, where data protection has been granted in accordance with Article 21 of Regulation (EC) No 1924/2006, the period of data protection granted in accordance with Article 26 of this Regulation shall not exceed the period of data protection granted in accordance with Article 21 of Regulation (EC) No 1924/2006.

6. The applicant may withdraw at any time the request for staying the authorisation procedure submitted in accordance with paragraph 1. In that case, the authorisation procedure shall resume and paragraph 5 shall not apply.

Textual Amendments

F8 Words in Art. 28 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 34(a) (as substituted by S.I. 2020/1504, regs. 1(2), 15(10)); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 28(1) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 34(b) (as substituted by S.I. 2020/1504, regs. 1(2), 15(10)); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 28(4) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, reg. 34(c) (as substituted by S.I. 2020/1504, regs. 1(2), 15(10)); 2020 c. 1, Sch. 5 para. 1(1)