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[X1CHAPTER IV U.K. HEALTH CLAIMS

Article 15 U.K. Application for authorisation

1 . When reference is made to this Article, an application for authorisation shall be submitted in accordance with the following paragraphs.

[F11A.An application may be made either:

(a)for authorisation in Great Britain; or

(b)for authorisation in one of England, Scotland or Wales only.

1B.The application must be sent to:

(a)for authorisation in England, the competent authority in England;

(b)for authorisation in Scotland, the competent authority in Scotland;

(c)for authorisation in Wales, the competent authority in Wales;

(d) for authorisation in Great Britain, any competent authority.]

2 .F2...

(a) The F3... competent authority shall:

(i)

acknowledge receipt of an application in writing within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;

(ii)

inform without delay [F4an expert committee and the relevant authorities]; and

(iii)

make the application and any supplementary information supplied by the applicant available to the [F5expert committee and the relevant authorities];

(b) The [F6expert committee] shall:

(i)

F7...

(ii)

make the summary of the application referred to in paragraph 3(g) available to the public.

3 . The application shall include the following:

(a) the name and address of the applicant;

[F8(aa)a statement confirming whether the application is for authorisation of the claim for use–

(i)in Great Britain; or

(ii)in one of England, Scotland or Wales only;]

(b) the nutrient or other substance, or the food or the category of food, in respect of which the health claim is to be made and its particular characteristics;

(c) a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim and any other material which is available to demonstrate that the health claim complies with the criteria provided for in this Regulation;

(d) where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;

(e) a copy of other scientific studies which are relevant to that health claim;

(f) a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;

(g) a summary of the application.

[F94.The appropriate authority may by regulations, having first consulted the other relevant authorities, amend Commission Regulation (EC) 353/2008 to modify the procedure and requirements for applications made under this Article.]

5 .[F10The appropriate authority, in close cooperation with an expert committee and the other relevant authorities, may issue] appropriate technical guidance and tools to assist food business operators, in particular SMEs, in the preparation and presentation of the application for scientific assessment.]

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