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[X1CHAPTER IV U.K. HEALTH CLAIMS

Article 18 U.K. Claims referred to in Article 13(5)

1 . A food business operator intending to use a health claim not included in the list [F1in the Annex to Commission Regulation (EU) 432/2012] may apply for the inclusion of the claim in that list.

[F21A.The application for this inclusion may be made either:

(a)for use of the health claim in Great Britain; or

(b)for use of the health claim in one of England, Scotland or Wales only.

1B.The application must be sent to:

(a)for use of the health claim in England, the competent authority in England;

(b)for use of the health claim in Scotland, the competent authority in Scotland;

(c)for use of the health claim in Wales, the competent authority in Wales;

(d) for use of the health claim in Great Britain, any competent authority.]

2 .[F3The competent authority] shall acknowledge receipt of the application in writing within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application. The application shall include the data provided for in Article 15(3) and the reasons for the request.

3 . The valid application, in line with the guidance referred to in Article 15(5), and any information supplied by the applicant shall be sent without delay to [F4an expert committee] for a scientific assessment as well as to [F5the relevant authorities] for information. The [F6expert committee] shall issue its opinion within a time limit of five months from the date of receipt of the request. Such time limit may be extended by up to one month if the [F6expert committee] considers it necessary to seek supplementary information from the applicant. In such a case the applicant shall submit the requested information within 15 days from the date of receipt of the [F7expert committee's] request.

The procedure laid down in Article 16(3)(a) and (b), (5) and (6) shall apply mutatis mutandis.

[F84 .Where the application is for the use of the health claim in Great Britain, within two months of receiving the opinion of the expert committee, a decision must be made by:

(a)the appropriate authority for applications in relation to England, in relation to authorisation of the claim in England;

(b)the appropriate authority for applications in relation to Scotland, in relation to authorisation of the claim in Scotland; and

(c)the appropriate authority for applications in relation to Wales, in relation to authorisation of the claim in Wales.

The appropriate authorities for each of England, Scotland and Wales must consult each other prior to making a decision on the application and must take into account the opinion of the expert committee, any relevant enactments and other factors relevant to the matter under consideration.]

[F94A.Where the application is for the use of the health claim in one of England, Scotland or Wales only, the appropriate authority must make a decision on the application within two months of receiving the opinion of the expert committee. The appropriate authority must consult the other relevant authorities prior to making such a decision and must take into account the opinion of the expert committee, any relevant enactments and other factors relevant to the matter under consideration.]

[F105 .F11...

F12... where at the applicant's request for the protection of proprietary data [F13the appropriate authority] proposes to restrict the use of the claim in favour of the applicant:

[F14(a)the appropriate authority may by regulations made under the powers in Articles 13 or 14 authorise the claim for sole use by the applicant. In such case, the authorisation for restricted use shall expire at the end of the period of five years after the date on which the regulations are made;

(b)before the expiry of the five-year period, if the claim still meets the conditions laid down in this Regulation, the appropriate authority must consider, in consultation with an expert committee and the other relevant authorities, whether to authorise the claim without restriction for use under the powers in Articles 13 or 14.]]]

Textual Amendments

F2Art. 18(1A)(1B) inserted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 17(19)(b) (as amended by (S.I. 2020/1476), regs. 1(2), 5(2)(g)(i)); 2020 c. 1, Sch. 5 para. 1(1)

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