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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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Changes over time for: Regulation (EC) No 1924/2006 of the european parliament and of the council (without Annexes)

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[X1CHAPTER I U.K. SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 U.K. Subject matter and scope

F1 1 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2 . This Regulation shall apply to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer.

[F2In the case of non-prepackaged foodstuffs (including fresh products such as fruit, vegetables or bread) put up for sale to the final consumer or to mass caterers and foodstuffs packed at the point of sale at the request of the purchaser or pre-packaged with a view to immediate sale, Article 7 and Article 10(2)(a) and (b) shall not apply [F3, unless the appropriate authority by regulations prescribes that those provisions shall apply]. F4...]

This Regulation shall also apply in respect of foods intended for supply to restaurants, hospitals, schools, canteens and similar mass caterers.

3 . A trade mark, brand name or fancy name appearing in the labelling, presentation or advertising of a food which may be construed as a nutrition or health claim may be used without undergoing the authorisation procedures provided for in this Regulation, provided that it is accompanied by a related nutrition or health claim in that labelling, presentation or advertising which complies with the provisions of this Regulation.

[F24 . For generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on human health, [F5the appropriate authority may by regulations grant a derogation from paragraph 3], on application by the food business operators concerned. The application shall be sent to the [F6competent authority] which will forward it to the [F7relevant authorities] without delay. [F8The appropriate authority may publish guidelines setting out the procedure and requirements for applications made by food business operators under this paragraph.]]

5 . This Regulation shall apply without prejudice to F9...:

(a)[F10Regulation (EU) No 609/2013 and other relevant enactments] relating to foodstuffs for particular nutritional uses;

(b)[F11enactments implementing] Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (1) [F12and Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral water (Recast)];

(c)[F13enactments implementing] Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (2) ;

(d)[F14enactments implementing] Directive 2002/46/EC.

Textual Amendments

Article 2 U.K. Definitions

1 . For the purposes of this Regulation:

(a) the definitions of ‘food’, ‘food business operator’, ‘placing on the market’, and ‘final consumer’ set out in Articles 2, 3(3), 3(8) and 3(18) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (3) shall apply;

(b) the definition of ‘ food supplement ’ set out in Directive 2002/46/EC shall apply;

(c) the definitions of ‘nutrition labelling’, ‘protein’, ‘carbohydrate’, ‘sugars’, ‘fat’, ‘saturates’, ‘mono-unsaturates’, ‘poly-unsaturates’, ‘fibre’ set out in [F15Annex I to Regulation (EU) 1169/2011] shall apply;

(d) the definition of ‘ labelling ’ set out in [F16Article 2(1)(j) of Regulation (EU) 1169/2011] shall apply.

2. The following definitions shall also apply:

(1) ‘claim’ means any message or representation, which is not mandatory under [F17any enactment], including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics;

(2) ‘nutrient’ means protein, carbohydrate, fat, fibre, sodium, vitamins and minerals listed in [F18Annex I to Regulation (EU) 1169/2011], and substances which belong to or are components of one of those categories;

(3) ‘other substance’ means a substance other than a nutrient that has a nutritional or physiological effect;

(4) ‘nutrition claim’ means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to:

(a) the energy (calorific value) it

(i) provides;

(ii) provides at a reduced or increased rate; or

(iii) does not provide; and/or

(b) the nutrients or other substances it

(i) contains;

(ii) contains in reduced or increased proportions; or

(iii) does not contain;

(5) ‘health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health;

(6) ‘reduction of disease risk claim’ means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease;

[F19(7)‘expert committee’ means a committee with appropriate expertise in the matter to be considered, approved by an appropriate authority to give advice for the purposes of this Regulation;]

[F20(8)‘appropriate authority’, subject to point 9, means:

(a)for regulations, guidelines, applications or the register of claims in relation to England, the Secretary of State;

(b)for regulations, guidelines, applications or the register of claims in relation to Scotland, the Scottish Ministers;

(c)for regulations, guidelines, applications or the register of claims in relation to Wales, the Welsh Ministers;

(9) The appropriate authority is the Secretary of State if consent is given by:

(a)for regulations, guidelines, applications or the register of claims in relation to Scotland, the Scottish Ministers;

(b)for regulations, guidelines, applications or the register of claims in relation to Wales, the Welsh Ministers;

(10)‘relevant authorities’ means the Secretary of State, the Scottish Ministers and the Welsh Ministers;

(11)‘enactment’ includes any enactment of the types specified in the definition of ‘enactment’ in section 20(1) of the European Union (Withdrawal) Act 2018.]

Textual Amendments

Editorial Information

CHAPTER II U.K. GENERAL PRINCIPLES

Article 3 U.K. General principles for all claims

Nutrition and health claims may be used in the labelling, presentation and advertising of foods placed on the market F21... only if they comply with the provisions of this Regulation.

Without prejudice to [F22Regulation (EU) No 1169/2011 and the Business Protection from Misleading Marketing Regulations 2008], the use of nutrition and health claims shall not:

(a)

be false, ambiguous or misleading;

(b)

give rise to doubt about the safety and/or the nutritional adequacy of other foods;

(c)

encourage or condone excess consumption of a food;

(d)

[F2state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general. [F23The appropriate authority may by regulations adopt derogations in the case of nutrients for which sufficient quantities cannot be provided by a balanced and varied diet, including the conditions for their application, taking into account the special conditions present in the parts of Great Britain in relation to which the regulations are to be made.]]

(e)

refer to changes in bodily functions which could give rise to or exploit fear in the consumer, either textually or through pictorial, graphic or symbolic representations.

Textual Amendments

Article 4 U.K. Conditions for the use of nutrition and health claims

1 .[F24The appropriate authority may by regulations establish specific nutrient profiles, including exemptions, which food or certain categories of food must comply with in order to bear nutrition or health claims and the conditions for the use of nutrition or health claims for foods or categories of foods with respect to the nutrient profiles.]

The nutrient profiles for food and/or certain categories of food shall be established taking into account in particular:

(a) the quantities of certain nutrients and other substances contained in the food, such as fat, saturated fatty acids, trans-fatty acids, sugars and salt/sodium;

(b) the role and importance of the food (or of categories of food) and the contribution to the diet of the population in general or, as appropriate, of certain risk groups including children;

(c) the overall nutritional composition of the food and the presence of nutrients that have been scientifically recognised as having an effect on health.

The nutrient profiles shall be based on scientific knowledge about diet and nutrition, and their relation to health.

[F25Before making regulations to establish the nutrient profiles, the appropriate authority must request an expert committee] to provide within 12 months relevant scientific advice, focusing in particular on:

(i)

whether profiles should be set for food in general and/or categories of food;

(ii)

the choice and balance of nutrients to be taken into account;

(iii)

the choice of reference quantity/basis for profiles;

(iv)

the approach to the calculation of the profiles; and

(v)

the feasibility and testing of a proposed system.

[F26Before making regulations to establish the nutrient profiles, the appropriate authority must carry out consultations with the other relevant authorities and] interested parties, in particular food business operators and consumer groups.

[F27The appropriate authority may by regulations amend the nutrient profiles and their conditions of use to take into account relevant scientific developments, after consulting the other relevant authorities and interested parties, in particular food business operators and consumer groups.]

2 . By way of derogation from paragraph 1, nutrition claims:

(a) referring to the reduction of fat, saturated fatty acids, trans-fatty acids, sugars and salt/sodium shall be allowed without reference to a profile for the specific nutrient/s for which the claim is made, provided they comply with the conditions laid down in this Regulation;

(b) shall be allowed, where a single nutrient exceeds the nutrient profile provided that a statement about the specific nutrient appears in close proximity to, on the same side and with the same prominence as the claim. This statement shall read as follows: ‘High (4) content’.

3 . Beverages containing more than 1,2 % by volume of alcohol shall not bear health claims.

As far as nutrition claims are concerned, only nutrition claims referring to low alcohol levels, or the reduction of the alcohol content, or the reduction of the energy content for beverages containing more than 1,2 % by volume of alcohol, shall be permitted.

F28 4 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F25 .[F29The appropriate authority may by regulations specify] the foods or categories of foods other than those referred to in paragraph 3 for which nutrition or health claims are to be restricted or prohibited [F30, in the light of scientific evidence.]]

Textual Amendments

Article 5 U.K. General conditions

1 . The use of nutrition and health claims shall only be permitted if the following conditions are fulfilled:

(a) the presence, absence or reduced content in a food or category of food of a nutrient or other substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific evidence;

(b) the nutrient or other substance for which the claim is made:

(i)

is contained in the final product in a significant quantity as defined in [F31applicable enactments] or, where such rules do not exist, in a quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific evidence; or

(ii)

is not present or is present in a reduced quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific evidence;

(c) where applicable, the nutrient or other substance for which the claim is made is in a form that is available to be used by the body;

(d) the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the nutrient or other substance to which the claim relates, as defined in [F32applicable enactments] or, where such rules do not exist, a significant quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific evidence;

(e) compliance with the specific conditions set out in Chapter III or Chapter IV as the case may be.

2 . The use of nutrition and health claims shall only be permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim.

3 . Nutrition and health claims shall refer to the food ready for consumption in accordance with the manufacturer's instructions.

Textual Amendments

Article 6 U.K. Scientific substantiation for claims

1 . Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence.

2 . A food business operator making a nutrition or health claim shall justify the use of the claim.

3 . The [F33competent authority] may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with this Regulation.

Textual Amendments

Article 7 U.K. Nutrition information

[F34Nutrition labelling of products on which a nutrition and/or health claim is made shall be mandatory, with the exception of generic advertising. The information to be provided shall consist of that specified in Article 30(1) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (5) . Where a nutrition and/or health claim is made for a nutrient referred to in Article 30(2) of Regulation (EU) No 1169/2011 the amount of that nutrient shall be declared in accordance with Articles 31 to 34 of that Regulation.

The amount(s) of the substance(s) to which a nutrition or health claim relates that does not appear in the nutrition labelling shall be stated in the same field of vision as the nutrition labelling and be expressed in accordance with Articles 31, 32 and 33 of Regulation (EU) No 1169/2011. The units of measurement used to express the amount of the substance shall be appropriate for the individual substances concerned.

In the case of food supplements, the nutrition information shall be provided in accordance with Article 8 of Directive 2002/46/EC. [F35For the purposes of this Article, Article 8 of Directive 2002/46/EC is to be read as if for “the Annex to Directive 90/496/EEC” there were substituted “Annex I to Regulation (EU) 1169/2011”.]]

Textual Amendments

CHAPTER III U.K. NUTRITION CLAIMS

Article 8 U.K. Specific conditions

1 . Nutrition claims shall only be permitted if they are listed in the Annex and are in conformity with the conditions set out in this Regulation.

[F22 .[F36The appropriate authority may by regulations amend the Annex, after consulting an expert committee.] Where appropriate, the [F37appropriate authority] shall involve interested parties, in particular food business operators and consumer groups, in order to evaluate the perception and understanding of the claims in question.]

Textual Amendments

Article 9 U.K. Comparative claims

1 . Without prejudice to [F38the Business Protection from Misleading Marketing Regulations 2008], a comparison may only be made between foods of the same category, taking into consideration a range of foods of that category. The difference in the quantity of a nutrient and/or the energy value shall be stated and the comparison shall relate to the same quantity of food.

2 . Comparative nutrition claims shall compare the composition of the food in question with a range of foods of the same category, which do not have a composition which allows them to bear a claim, including foods of other brands.

Textual Amendments

CHAPTER 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 [F39are 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 [F40authorised for the purposes of Article 13 or 14].

4 . Where appropriate, [F41the 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

F42 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 [F43associations 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 [F44any 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 [F45in 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.

F46 2 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F47 3 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F48 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

[F491 . Notwithstanding [F50Article 7(3) of Regulation (EU) 1169/2011], [F51the 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 F52...:

(a) reduction of disease risk claims;

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

[F531A.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.

[F541A.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 .F55...

(a) The F56... 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 [F57an expert committee and the relevant authorities]; and

(iii)

make the application and any supplementary information supplied by the applicant available to the [F58expert committee and the relevant authorities];

(b) The [F59expert committee] shall:

(i)

F60...

(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;

[F61(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.

[F624.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 .[F63The 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 [F64expert committee]

1 . In giving its opinion, the [F65expert committee] shall respect a time limit of five months from the date of receipt of a valid application. Whenever the [F65expert 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 .[F66The 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 [F67expert 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 [F68expert committee] shall forward its opinion to the [F69relevant 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.

[F706 .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. [F71Authorisation by the appropriate authority]

F72 1 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F72 2 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F23 .[F73Where 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.]

[F74Where 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, [F75the appropriate authority] proposes to restrict the use of the claim in favour of the applicant:

[F76(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.]]

F77 4 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5 . Health claims [F78authorised 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 [F79in the Annex to Commission Regulation (EU) 432/2012] may apply for the inclusion of the claim in that list.

[F801A.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 .[F81The 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 [F82an expert committee] for a scientific assessment as well as to [F83the relevant authorities] for information. The [F84expert 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 [F84expert 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 [F85expert committee's] request.

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

[F864 .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.]

[F874A.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.]

[F885 .F89...

F90... where at the applicant's request for the protection of proprietary data [F91the appropriate authority] proposes to restrict the use of the claim in favour of the applicant:

[F92(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

F80Art. 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 .[F93The 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 .F94... Following a request from [F95an appropriate authority, an expert committee] shall issue an opinion on whether a health claim [F96authorised 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 [F97relevant authorities] and, where relevant, to the original applicant of the claim in question. The [F98expert committee] shall make its opinion public.

The applicant/user or a member of the public may make comments to the [F99appropriate authority] within 30 days of such publication.

[F100The appropriate authority shall examine the opinion of the expert committee] and any comments received as soon as possible. [F101Having 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.]

[F1023.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

CHAPTER V U.K. GENERAL AND FINAL PROVISIONS

Article 20 U.K. F103... Register

1 .[F104The appropriate authority must] establish and maintain a F105... 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 [F106the list in the Annex to Commission Regulation (EU) 432/2012, as amended from time to time], Articles 14(1), 19(2), 21 F107...;

(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 [F108the health claim was authorised] and the name of the original applicant that was granted authorisation.

2)

[F2the fact that [F108the 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 [F109appropriate authority] takes a decision on whether a claim could be or could have been [F110authorised under] Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.

Textual Amendments

[F111Article 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

F112 Article 22 U.K. National provisions

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

Textual Amendments

F112 Article 23 U.K. Notification procedure

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

Textual Amendments

F112 Article 24 U.K. Safeguard measures

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

Textual Amendments

F112 Article 25 U.K. Committee procedure

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

Textual Amendments

F112 Article 26 U.K. Monitoring

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

Textual Amendments

F112 Article 27 U.K. Evaluation

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

Textual Amendments

Article 28 U.K. Transitional measures

1 .F113...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.

F114 3 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F114 4 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F114 5 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F114 6 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 29 U.K. Entry into force

F115. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

This Regulation shall be binding in its entirety and directly applicable in all Member States.]

Yn ôl i’r brig

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