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[X1CHAPTER V U.K. GENERAL AND FINAL PROVISIONS

Article 20 U.K. F1... Register

1 .[F2The appropriate authority must] establish and maintain a F3... Register of nutrition and health claims made on food, hereinafter referred to as ‘the Register’ .

2 . The Register shall include the following:

(a) the nutrition claims and the conditions applying to them as set out in the Annex;

(b) restrictions adopted in accordance with Article 4(5);

(c) the authorised health claims and the conditions applying to them provided for in [F4the list in the Annex to Commission Regulation (EU) 432/2012, as amended from time to time], Articles 14(1), 19(2), 21 F5...;

(d) a list of rejected health claims and the reasons for their rejection.

Health claims authorised on the basis of proprietary data shall be recorded in a separate Annex to the Register together with the following information:

1)

the date [F6the health claim was authorised] and the name of the original applicant that was granted authorisation.

2)

[F7the fact that [F6the health claim was authorised] on the basis of proprietary data and restricted use;

3)

in the cases referred to in Article 17(3), second subparagraph, and Article 18(5), second subparagraph, the fact that the health claim is authorised for a limited duration.]

3 . The Register shall be made available to the public.

Textual Amendments

Article 21 U.K. Data protection

1. The scientific data and other information in the application required under Article 15(3) may not be used for the benefit of a subsequent applicant for a period of five years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:

(a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and

(b) the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and

(c) the health claim could not have been authorised without the submission of the proprietary data by the prior applicant.

2 . Until the end of the five-year period specified in paragraph 1, no subsequent applicant shall have the right to refer to data designated as proprietary by a prior applicant unless and until the [F8appropriate authority] takes a decision on whether a claim could be or could have been [F9authorised under] Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.

Textual Amendments

[F10Article 21AU.K. Regulations: general

Regulations made under this Regulation may:

(a)contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);

(b)make different provision for different cases or descriptions of case, different circumstances, different purposes or different areas.

Textual Amendments

Article 21BU.K.Regulations: Secretary of State

1.Any power of the Secretary of State to make regulations under this Regulation is exercisable by statutory instrument.

2.Except as specified in paragraph 3, a statutory instrument made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.

3.A statutory instrument containing (whether alone or with other provision) regulations made under Article 4(1) may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.

4.The Secretary of State must not make regulations under this Regulation which will apply in Scotland or Wales without the consent of:

(a)the Scottish Ministers, in respect of any proposed application in Scotland;

(b)the Welsh Ministers, in respect of any proposed application in Wales.

Textual Amendments

Article 21CU.K. Regulations: Scottish Ministers

1.For regulations made by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010.

2.Except as specified in paragraph 3, regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).

3.Regulations made by the Scottish Ministers under Article 4(1) are subject to the affirmative procedure (see section 29 of the Interpretation and Legislative Reform (Scotland) Act 2010).

Textual Amendments

Article 21DU.K.Regulations: Welsh Ministers

1.Any power of the Welsh Ministers to make regulations under this Regulation is exercisable by statutory instrument.

2.Regulations made by the Welsh Ministers under this Regulation are subject to annulment in pursuance of a resolution of the National Assembly for Wales.

3.A statutory instrument containing (whether alone or with other provision) regulations made under Article 4(1) may not be made unless a draft of the instrument has been laid before, and approved by, a resolution of, the National Assembly for Wales.]

Textual Amendments

F11 Article 22 U.K. National provisions

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F11 Article 23 U.K. Notification procedure

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F11 Article 24 U.K. Safeguard measures

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F11 Article 25 U.K. Committee procedure

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F11 Article 26 U.K. Monitoring

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F11 Article 27 U.K. Evaluation

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Textual Amendments

Article 28 U.K. Transitional measures

1 .F12...With regard to the provisions in Article 4(1), foods may be marketed until twenty-four months following adoption of the relevant nutrient profiles and their conditions of use.

2 . Products bearing trade marks or brand names existing before 1 January 2005 which do not comply with this Regulation may continue to be marketed until 19 January 2022 after which time the provisions of this Regulation shall apply.

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Textual Amendments

Article 29 U.K. Entry into force

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Textual Amendments

Editorial Information