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Regulation (EC) No 1924/2006 of the european parliament and of the councilDangos y teitl llawn

Regulation (EC) No 1924/2006 of the european parliament and of the council of 20 December 2006 on nutrition and health claims made on foods

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[X1CHAPTER IV U.K. HEALTH CLAIMS

Article 10 U.K. Specific conditions

1 . Health claims shall be prohibited unless they comply with the general requirements in Chapter II and the specific requirements in this Chapter and are authorised in accordance with this Regulation and [F1are included in the list of authorised claims in the Annex to Commission Regulation (EU) 432/2012 or are authorised for the purposes of Article 14].

2 . Health claims shall only be permitted if the following information is included in the labelling, or if no such labelling exists, in the presentation and advertising:

(a) a statement indicating the importance of a varied and balanced diet and a healthy lifestyle;

(b) the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;

(c) where appropriate, a statement addressed to persons who should avoid using the food; and

(d) an appropriate warning for products that are likely to present a health risk if consumed to excess.

3 . Reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim [F2authorised for the purposes of Article 13 or 14].

4 . Where appropriate, [F3the appropriate authority may, after consultation with interested parties, in particular food business operators and consumer groups, publish guidelines on the implementation of this Article.]

Textual Amendments

F4 Article 11 U.K. National associations of medical, nutrition or dietetic professionals and health-related charities

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 12 U.K. Restrictions on the use of certain health claims

The following health claims shall not be allowed:

(a)

claims which suggest that health could be affected by not consuming the food;

(b)

claims which make reference to the rate or amount of weight loss;

(c)

claims which make reference to recommendations of individual doctors or health professionals and [F5associations other than national associations of medical, nutrition or dietetic professionals and health-related charities.]

Textual Amendments

Article 13 U.K. Health claims other than those referring to the reduction of disease risk and to children's development and health

1 . Health claims describing or referring to:

(a)

the role of a nutrient or other substance in growth, development and the functions of the body; or

(b)

psychological and behavioural functions; or

(c)

without prejudice to [F6any enactment implementing] Directive 96/8/EC, slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet,

which are indicated in the list [F7in the Annex to Commission Regulation (EU) 432/2012] may be made without undergoing the procedures laid down in Articles 15 to 19, if they are:

(i)

based on generally accepted scientific evidence; and

(ii)

well understood by the average consumer.

F8 2 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F9 3 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F10 4 .The appropriate authority may, by regulations and after consulting an expert committee, make changes to the list in the Annex to Commission Regulation (EU) 432/2012, if such changes are based on generally accepted scientific evidence.

5 .The appropriate authority may make regulations adding a claim to the list in the Annex to Commission Regulation (EU) 432/2012 which:

(a)is based on newly developed scientific evidence; or

(b)includes a request for the protection of proprietary data,

after making a decision under the procedure laid down in Article 18 or, where the claim relates to children's development and health, the procedure laid down in Articles 15, 16, 17, and 19.]

Textual Amendments

Article 14 U.K. Reduction of disease risk claims and claims referring to children's development and health

[F111 . Notwithstanding [F12Article 7(3) of Regulation (EU) 1169/2011], [F13the appropriate authority may by regulations authorise the use of the following claims, together with all the necessary conditions for the use of such claims,] in accordance with the procedure laid down in Articles 15, 16, 17 and 19 of this Regulation F14...:

(a) reduction of disease risk claims;

(b) claims referring to children's development and health.]

[F151A.Claims which have been authorised for the purposes of Article 14 before IP completion day are to be treated as authorised for use in Great Britain on and after IP completion day, provided that they continue to meet the general requirements of this Regulation, the specific requirements of Article 14 and any other relevant legislative requirements.]

2 . In addition to the general requirements laid down in this Regulation and the specific requirements of paragraph 1, for reduction of disease risk claims the labelling or, if no such labelling exists, the presentation or advertising shall also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.

Textual Amendments

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.

[F161A.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 .F17...

(a) The F18... 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 [F19an expert committee and the relevant authorities]; and

(iii)

make the application and any supplementary information supplied by the applicant available to the [F20expert committee and the relevant authorities];

(b) The [F21expert committee] shall:

(i)

F22...

(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;

[F23(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.

[F244.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 .[F25The 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.

Textual Amendments

Article 16 U.K. Opinion of the [F26expert committee]

1 . In giving its opinion, the [F27expert committee] shall respect a time limit of five months from the date of receipt of a valid application. Whenever the [F27expert committee] seeks supplementary information from the applicant as provided for in paragraph 2, such time limit shall be extended by up to two months following the date of receipt of the requested information submitted by the applicant.

2 .[F28The expert committee or the competent authority through the expert committee] may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time limit.

3 . In order to prepare its opinion, the [F29expert committee] shall verify:

(a) that the health claim is substantiated by scientific evidence;

(b) that the wording of the health claim complies with the criteria laid down in this Regulation.

4 . In the event of an opinion in favour of authorising the health claim, the opinion shall include the following particulars:

(a) the name and address of the applicant;

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

(c) a proposal for the wording of the health claim, including, as the case may be, the specific conditions of use;

(d) where applicable, conditions or restrictions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and in advertising.

5 . The [F30expert committee] shall forward its opinion to the [F31relevant authorities] and the applicant, including a report describing its assessment of the health claim and stating the reasons for its opinion and the information on which its opinion was based.

[F326 .The expert committee shall make its opinion public. The applicant or members of the public may make comments to the competent authority which received the application within 30 days from publication of the opinion of the expert committee.]

Textual Amendments

Article 17 U.K. [F33Authorisation by the appropriate authority]

F34 1 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34 2 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F353 .[F36Where the application is made on a Great Britain-wide basis, 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 authority for each of England, Scotland and Wales must consult each other appropriate authority prior to making a decision on the application.]

[F37Where the application is made for authorisation in one of England, Scotland or Wales only, the appropriate authority shall make a decision on the application, having consulted the other relevant authorities.]

However, where at the applicant's request for the protection of proprietary data, [F38the appropriate authority] proposes to restrict the use of the claim in favour of the applicant:

[F39(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.]]

F40 4 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5 . Health claims [F41authorised for the purposes of Articles 13 and 14] may be used, in conformity with the conditions applying to them, by any food business operator, if they are not restricted for use in accordance with the provisions of Article 21.

6 . The granting of authorisation shall not lessen the general civil and criminal liability of any food business operator in respect of the food concerned.

Textual Amendments

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 [F42in the Annex to Commission Regulation (EU) 432/2012] may apply for the inclusion of the claim in that list.

[F431A.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 .[F44The 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 [F45an expert committee] for a scientific assessment as well as to [F46the relevant authorities] for information. The [F47expert 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 [F47expert 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 [F48expert committee's] request.

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

[F494 .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.]

[F504A.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.]

[F515 .F52...

F53... where at the applicant's request for the protection of proprietary data [F54the appropriate authority] proposes to restrict the use of the claim in favour of the applicant:

[F55(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

F43Art. 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)

Article 19 U.K. Modification, suspension and revocation of authorisations

1 .[F56The applicant/user of a claim authorised for the purposes of Articles 13 and 14 may apply for a modification of that health claim to be authorised.] The procedures laid down in Articles 15 to 18 shall apply mutatis mutandis.

2 .F57... Following a request from [F58an appropriate authority, an expert committee] shall issue an opinion on whether a health claim [F59authorised for the purposes of Article 13 or 14] still meets the conditions laid down in this Regulation.

It shall forthwith transmit its opinion to the [F60relevant authorities] and, where relevant, to the original applicant of the claim in question. The [F61expert committee] shall make its opinion public.

The applicant/user or a member of the public may make comments to the [F62appropriate authority] within 30 days of such publication.

[F63The appropriate authority shall examine the opinion of the expert committee] and any comments received as soon as possible. [F64Having regard to the opinion of the expert committee, the appropriate authority may by regulations modify or revoke the relevant authorisation by amending as appropriate the list in the Annex to Commission Regulation (EU) 432/2012 or the regulations or retained direct EU legislation authorising a claim for the purposes of Article 14.]

[F653.On imperative grounds of urgency, the appropriate authority may exercise the power to make regulations under paragraph 2 without allowing for the 30 day comment period in the third paragraph of paragraph 2.]]

Textual Amendments

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