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The Nutrition (Amendment etc.) (EU Exit) Regulations 2019

Type Statutory-Instrument

Publication 2019-03-22

Last updated 2024-08-10

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Made: 22nd March 2019

Coming into force in accordance with regulation 1

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1) and 23 of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018 .

A draft of this instrument has been approved by a resolution of each House of Parliament, in accordance with paragraph 1 of Schedule 7 to the European Union (Withdrawal) Act 2018.

There has been consultation as required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council 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 .

PART 1 — PRELIMINARY

Citation, commencement and application

1

(1) These Regulations may be cited as the Nutrition (Amendment etc.) (EU Exit) Regulations 2019 and come into force on exit day.

(2) These Regulations apply to England and Wales and Scotland, except for Part 3 which applies to England only.

PART 2 — PROVISION ABOUT FOOD SUPPLEMENTS

Food supplements

2

(1) The following Schedules take effect—

(a) Schedule 1: Vitamins and minerals which may be used in the manufacture of food supplements;

(b) Schedule 2: Vitamin and mineral substances which may be used in the manufacture of food supplements.

(2) Regulations may be made to amend Schedule 1 or 2.

Purity criteria for substances listed in Schedule 2

3

Regulations may be made to set purity criteria for any vitamin and mineral substance listed in Schedule 2.

Amounts of vitamins and minerals

4

(1) Regulations may be made to set the maximum amounts of vitamins and minerals that may be present in food supplements per daily portion of consumption as recommended by the manufacturer, taking into account—

(a) the upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups;

(b) the intake of vitamins and minerals from other dietary sources.

(2) Regulations may be made to set minimum amounts of vitamins and minerals required to be present in food supplements per daily portion of consumption as recommended by the manufacturer.

(3) When setting the maximum amounts referred to in paragraph (1), the appropriate authority must take into account reference intakes of vitamins and minerals for the population.

Regulations: general

5

(1) Any power to make regulations under this Part is exercisable by the appropriate authority.

(2) But the power to make regulations under this Part may be exercised by the Secretary of State for the whole or part of Great Britain if consent is given by—

(a) for regulations applying in relation to Scotland, the Scottish Ministers;

(b) for regulations applying in relation to Wales, the Welsh Ministers;

(3) Regulations made under this Part may—

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

(b) make different provision for different purposes.

(4) In this Part—

“appropriate authority” means:for regulations applying in relation to England, the Secretary of State;for regulations applying in relation to Scotland, the Scottish Ministers;for regulations applying in relation to Wales, the Welsh Ministers;...

“enactment” includes any enactment of the types specified in the definition of “enactment” in section 20(1) of the European Union (Withdrawal) Act 2018.

Regulations: Secretary of State

6

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

(2) A statutory instrument containing regulations made under regulation 2 (food supplements) is subject to annulment in pursuance of a resolution of either House of Parliament.

(3) A statutory instrument containing regulations made under regulation 3 (purity criteria for substances listed in Schedule 2) or 4 (amounts of vitamins and minerals) may not be made unless a draft of the instrument has been laid before, and approved by, a resolution of, each House of Parliament.

Regulations: The Scottish Ministers

7

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

(2) Regulations made by the Scottish Ministers under regulation 2 (food supplements) 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 regulation 3 (purity criteria for substances listed in Schedule 2) or 4 (amounts of vitamins and minerals) are subject to the affirmative procedure (see section 29 of the Interpretation and Legislative Reform (Scotland) Act 2010).

Regulations: The Welsh Ministers

8

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

(2) A statutory instrument containing regulations made under regulation 2 (food supplements) by the Welsh Ministers is subject to annulment in pursuance of a resolution of the National Assembly for Wales.

(3) A statutory instrument containing regulations made under regulation 3 (purity criteria for substances listed in Schedule 2) or 4 (amounts of vitamins and minerals) 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.

Regulations: Northern Ireland

9

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

PART 3 — AMENDMENT OF SUBORDINATE LEGISLATION

Amendment of the Medical Food (England) Regulations 2000

10

(1) The Medical Food (England) Regulations 2000 are amended as follows.

(2) Regulation 2 (interpretation) is renumbered as paragraph (1) of that regulation.

(3) After paragraph (1) as so renumbered, insert—

(2) In these Regulations, any reference to compliance with a provision of the Directive is to be read as a reference to complying with that provision as would be required if the provision formed part of domestic law. (3) For the purposes of these Regulations, Articles 4 to 5 of, and the Annex to, the Directive are to be read subject to the modifications set out in Schedule 1.

(4) In regulation 5A (application of the improvement notice provisions of the Act), for “Schedule”, in each place where it appears, substitute “ Schedule 2 ”.

(5) The Schedule is renumbered as Schedule 2.

(6) Before Schedule 2 as so renumbered, insert—

SCHEDULE 1 (1) The Directive is modified as follows. (2) Article 4(2) is to be read as if for “Article 3 of Directive 79/112/EEC,” there were substituted “ Article 9 of Regulation (EU) No 1169/2011 ”. (3) Article 5 is to be read as if— (a) in paragraph 1— (i) for “where a product is manufactured in a third country” there were substituted “ where a product is manufactured outside of the United Kingdom ”; (ii) for the first reference to “Member States” there were substituted “ territories within the United Kingdom ”; (iii) the words “Member States may, if they can demonstrate that notification is not necessary in order to monitor those products efficiently in their territory, not impose that obligation” were omitted. (b) in paragraph 2, for “are those referred to in Article 9(4) of Directive 89/398/EEC” there were substituted– are– (a) in respect of England, the Secretary of State, (b) in respect of Scotland, Food Standards Scotland , (c) in respect of Wales, the Welsh Ministers, (d) in respect of Northern Ireland, the Food Standards Agency . (4) In the Annex, paragraph 4 is to be read as if for “Directive 91/321/EEC and its subsequent modifications” there were substituted “ Directive 2006/141/EC ”.

Amendment of the Kava-kava in Food (England) Regulations 2002

11

(1) The Kava-kava in Food (England) Regulations 2002 are amended as follows.

(2) In regulation 2 (interpretation) —

(a) omit the definitions of “EEA Agreement”, “EEA State” and “free circulation in member States”;

(b) after the definition of port health authority, insert—

“third country” means a country other than the United Kingdom.

(3) In regulation 3 (prohibition on sale etc of food consisting of or containing Kava-kava) for paragraph (2), substitute—

(2) The prohibition imposed by paragraph (1) shall not apply where the food consisting of or containing Kava-kava is imported from a third country if the food is being, or is to be, exported to a third country.

Amendment of the Food Supplements (England) Regulations 2003

12

(1) The Food Supplements (England) Regulations 2003 are amended as follows.

(2) In regulation 2 (interpretation) omit—

(a) the definitions of “Directive 2001/83” and “Directive 2002/46”;

(b) paragraphs (3) and (4).

(3) In regulation 3 (scope of regulations) in paragraph (2), for “as defined by Directive 2001/83” substitute “ as defined by regulation 2(1) of the Human Medicines Regulations 2012 ”.

(4) In regulation 5 (prohibitions on sale relating to composition of food supplements)—

(a) in paragraph (1)—

(i) in sub-paragraph (a) for “Annex I to Directive 2002/46” substitute “ Schedule 1 to the Nutrition (Amendment) (EU Exit) Regulations 2019 ”;

(ii) in sub-paragraph (b)(i) for “Annex II to Directive 2002/46” substitute “ Schedule 2 to the Nutrition (Amendment) (EU Exit) Regulations 2019 ”;

(b) in paragraph (2) for sub-paragraph (a) substitute—

(a) the purity criteria, if any, specified in EU-derived domestic legislation, retained direct EU legislation or in regulations made by the Secretary of State under regulation 3 of the Nutrition (Amendment) (EU Exit) Regulations 2019; or

(5) In regulation 6 (restrictions on sale relating to labelling etc of food supplements) in paragraph (3)(b) for “Annex I to Directive 2002/46” substitute “ Schedule 1 to the Nutrition (Amendment) (EU Exit) Regulations 2019 ”.

Amendment of the Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007

13

(1) The Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007 are amended as follows.

(2) In regulation 4 (offences and penalties)—

(a) in paragraph (1), omit “Subject to the transitional measures contained in Article 18 (relating to foods placed on the market before 1 July 2007),”;

(b) in paragraph (2)(a), omit “as read with Article 17(1) (transitional application of national rules)”.

Amendment of the Infant Formula and Follow-on Formula (England) Regulations 2007

14

(1) The Infant Formula and Follow-on Formula (England) Regulations 2007 are amended as follows.

(2) In regulation 2 (interpretation) , after paragraph (6) insert—

(7) In these Regulations, any reference to compliance with a provision of the Directive is to be read as a reference to complying with that provision as would be required if the provision formed part of domestic law.

(3) In regulation 12 (listed substances and their purity criteria (infant formula and follow-on formula)) , in paragraph (3)(a) for “EU legislation” substitute “ retained EU law ”.

Amendment of the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009

15

(1) The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009 are amended as follows.

(2) In Schedule 1 (specified provisions) , in the “subject matter” column of the table—

(a) in the entry relating to Article 2(1), for “covered by Directive 2009/39 of the European Parliament and the Council on foodstuffs intended for particular nutritional uses” substitute “(foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability);

(b) in the entry relating to Article 3(2), for “competent authority referred to in Article 11 of Directive 2009/39” substitute “ Secretary of State, Welsh Ministers or Food Standards Scotland ”;

Amendment of the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016

16

(1) The Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 are amended as follows.

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) In regulation 7 (review), omit paragraph (2).

(4) In Schedule 1 (Specified EU requirements) in the entry in column 1, for “Article 15(1) (Union list)” substitute “ Article 15(1) (Great Britain list) ”.

PART 4 — AMENDMENT OF EU REGULATIONS

Amendment of Regulation (EC) No 1924/2006

17

(1) 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 is amended as follows.

(2) In Article 1 (subject matter and scope)—

(a) omit paragraph 1;

(b) in paragraph 2, in the second sub-paragraph—

(i) after “shall not apply” insert “ , unless the appropriate authority by regulations prescribes that those provisions shall apply. ”;

(ii) omit the words from “National provisions” to the end of that sub-paragraph;

(i) for the words from “a derogation” to “Article 25(3)” substitute “ the appropriate authority may by regulations grant a derogation from paragraph 3 ”;

(ii) for “national competent authority of a Member State” substitute “ competent authority ”;

(iii) for “Commission”, in the first place it appears, substitute “ relevant authorities ”;

(iv) for the final sentence substitute “ The appropriate authority may publish guidelines setting out the procedure and requirements for applications made by food business operators under this paragraph. ”;

(d) in paragraph 5—

(i) omit “the following Community provisions”;

(ii) in point (a), for “Directive 89/398/EEC and Directives adopted” substitute “ Regulation (EU) No 609/2013 and other relevant enactments ”;

(iii) in point (b)—

(aa) before “Council” insert “ enactments implementing ”;

(bb) after “natural mineral waters” insert “ and 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) ; ”

(iv) in point (c), before “Council”, insert “ enactments implementing ”;

(v) in point (d), before “Directive”, insert “ enactments implementing ”.

(3) In Article 2 (definitions)—

(a) in paragraph 1—

(i) in point (c), for “Directive 90/496/EEC” substitute “ Annex I to Regulation (EU) 1169/2011 ”;

(ii) in point (d), for “Article 1(3)(a) of Directive 2001/13/EC” substitute “ Article 2(1)(j) of Regulation (EU) 1169/2011 ”;

(b) in paragraph 2—

(i) in point (1), for “Community or national legislation” substitute “ any enactment ”;

(ii) in point (2), for “the Annex to Directive 90/496/EEC” substitute “ Annex I to Regulation (EU) 1169/2011 ”;

(iii) for point (7) substitute—

(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;

(iv) after point (7) insert—

(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; (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (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.

(4) In Article 3 (general principles for all claims)—

(a) omit “in the Community”;

(b) in the second paragraph—

(i) for “Directives 2000/13/EC and 84/450/EEC” substitute “ Regulation (EU) No 1169/2011 and the Business Protection from Misleading Marketing Regulations 2008 ”;

(ii) in point (d), for the words from “Derogations” to the end of that point, substitute—

The 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.

(5) In Article 4 (conditions for the use of nutrition and health claims)—

(a) in paragraph 1—

(i) for the first sub-paragraph substitute—

The 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.

(ii) in the fourth sub-paragraph, for “In setting the nutrient profiles, the Commission shall request the Authority”, substitute “ Before making regulations to establish the nutrient profiles, the appropriate authority must request an expert committee ”;

(iii) in the fifth sub-paragraph, for “In setting the nutrient profiles, the Commission shall carry out consultations with”, substitute “ Before making regulations to establish the nutrient profiles, the appropriate authority must carry out consultations with the other relevant authorities and ”;

(iv) for the final sub-paragraph substitute—

The 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.

(b) omit paragraph 4;

(i) for “Measures determining” substitute “ The appropriate authority may by regulations specify ”;

(ii) for the words from “and designed” to the end of the paragraph, substitute “ , in the light of scientific evidence. ”.

(6) In Article 5 (general conditions), in paragraph 1, in points (b)(i) and (d), for “Community legislation” substitute “ applicable enactments ”.

(7) In Article 6 (scientific substantiation for claims), in paragraph 3, for “competent authorities of the Member States”, substitute “ competent authority ”.

(8) In Article 7 (nutrition information), in the third paragraph, after “Directive 2002/46/EC.” insert “For 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 ”.

(9) In Article 8 (nutrition claims: specific conditions), in paragraph 2—

(a) for the words from the beginning to “the Authority”, substitute “ The appropriate authority may by regulations amend the Annex, after consulting an expert committee ”;

(b) for “Commission” substitute “ appropriate authority ”.

(10) In Article 9 (comparative claims), in paragraph 1, for “Directive 84/450/EEC” substitute “ the Business Protection from Misleading Marketing Regulations 2008 ”.

(11) In Article 10 (health claims: specific conditions)—

(a) in paragraph 1, for the words from “included in” to the end of that paragraph substitute “ are 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 ”;

(b) in paragraph 3, for the words “included in the lists provided for in Article 13 or 14” substitute “ authorised for the purposes of Article 13 or 14 ”;

(c) in paragraph 4, for the words from “guidelines” to the end of that paragraph substitute “ the appropriate authority may, after consultation with interested parties, in particular food business operators and consumer groups, publish guidelines on the implementation of this Article. ”.

(12) Omit Article 11.

(13) In Article 12 (restrictions on the use of certain health claims), in point (c), for “other associations not referred to in Article 11.” substitute “ associations other than national associations of medical, nutrition or dietetic professionals and health-related charities. ”.

(14) In Article 13 (health claims other than those referring to the reduction of disease risk and to children's development and health)—

(a) in paragraph 1—

(i) in point (c), before “Directive 96/8/EC”, insert “ any enactment implementing ”;

(ii) for “provided for in paragraph 3” substitute “ in the Annex to Commission Regulation (EU) 432/2012 ”;

(b) omit paragraphs 2 and 3;

(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.

(15) In Article 14 (reduction of disease risk claims and claims referring to children's development and health), in paragraph 1—

(a) for “Article 2(1)(b) of Directive 2000/13/EC” substitute “ Article 7(3) of Regulation (EU) 1169/2011 ”;

(b) for the words from “the following” to “authorised”, substitute “ the appropriate authority may by regulations authorise the use of the following claims, together with all the necessary conditions for the use of such claims, ”;

(d) after paragraph 1, insert—

(1A) 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.

(16) In Article 15 (application for authorisation)—

(a) after paragraph 1, insert—

(1A) 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.

(b) in paragraph 2—

(i) omit “The application shall be sent to the national competent authority of a Member State”;

(ii) in point (a)—

(aa) omit “national”;

(bb) in point (ii), for “the Authority” substitute “ an expert committee and the relevant authorities ”;

(cc) in point (iii), for “Authority” substitute “ expert committee and the relevant authorities ”;

(iii) in point (b)—

(aa) for “Authority” substitute “ expert committee ”;

(bb) omit point (i);

(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;

(d) for paragraph 4 substitute—

(4) 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.

(e) in paragraph 5, for the words from “The Commission” to “make available” substitute “ The appropriate authority, in close cooperation with an expert committee and the other relevant authorities, may issue ”.

(17) In Article 16 (opinion of the Authority)—

(a) in the heading, for “Authority” substitute “ expert committee ”;

(b) in paragraph 1, for “Authority”, in both places, substitute “ expert committee ”;

(c) in paragraph 2, for “The Authority or a national competent authority, through the Authority” substitute “ The expert committee or the competent authority through the expert committee ”;

(d) in paragraphs 3 and 5, for “Authority” substitute “ expert committee ”;

(e) in paragraph 5, for “Commission, the Member States” substitute “ relevant authorities ”;

(f) for paragraph 6 substitute—

(6) 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.

(18) In Article 17 (Community authorisation)—

(a) for the heading substitute “ Authorisation by the appropriate authority ”;

(b) omit paragraphs 1 and 2;

(i) for the first sub-paragraph substitute—

Where 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 ... (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The appropriate authority for each of England, Scotland and Wales must consult each other appropriate authority prior to making a decision on the application.

(ii) after the first sub-paragraph insert—

Where 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.

(iii) in the second sub-paragraph—

(aa) for “the Commission” substitute “ the appropriate authority ”;

(bb) for points (a) and (b) substitute—

(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.

(d) omit paragraph 4;

(e) in paragraph 5, for “included in the lists provided for in Articles 13 and 14” substitute “ authorised for the purposes of Articles 13 and 14 ”.

(19) In Article 18 (claims referred to in Article 13(5))—

(a) in paragraph 1, for “provided for in Article 13(3)” substitute “ in the Annex to Commission Regulation (EU) 432/2012 ”;

(b) after paragraph 1, insert—

(1A) 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.

(d) in paragraph 3—

(i) for “the Authority”, in the first place it appears, substitute “ an expert committee ”;

(ii) for “the Commission and the Member States” substitute “ the relevant authorities ”;

(iii) for “Authority”, in the second and third places that it appears, substitute “ expert committee ”;

(iv) for “Authority's” substitute “expert committee's”;

(e) for paragraph 4, substitute—

(4) 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; ... (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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.

(f) after paragraph 4, insert—

(4A) 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.

(g) in paragraph 5—

(i) omit the first sub-paragraph;

(ii) in the second sub-paragraph—

(aa) omit “However,”;

(bb) for “the Commission” substitute “ the appropriate authority ”;

(cc) for points (a) and (b) substitute—

(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.

(20) In Article 19 (modification, suspension and revocation of authorisations)—

(a) for the first sentence of paragraph 1, substitute “ The 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. ”;

(b) in paragraph 2,

(i) in the first sub-paragraph, omit “On its own initiative or”;

(ii) for “a Member State or from the Commission, the Authority” substitute “ an appropriate authority, an expert committee ”;

(iii) for “included in the lists provided for in Articles 13 and 14” substitute “ authorised for the purposes of Article 13 or 14 ”;

(iv) in the second sub-paragraph, for “Commission, the Member States” substitute “ relevant authorities ”;

(v) for “Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002,” substitute “ expert committee ”;

(vi) in the third sub-paragraph, for “Commission”, substitute “ appropriate authority ”;

(vii) for “The Commission shall examine the opinion of the Authority” substitute “ The appropriate authority shall examine the opinion of the expert committee ”;

(viii) for the final sentence, substitute “ Having 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 ”.

(3) 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.

(21) In Article 20 (Community register)—

(a) in the heading, omit “Community”;

(b) in paragraph 1—

(i) for “The Commission shall” substitute “ The appropriate authority must ”;

(ii) omit “Community”;

(i) in point (c)—

(aa) for “13(3) and (5)” substitute “ the list in the Annex to Commission Regulation (EU) 432/2012, as amended from time to time ”;

(bb) omit from “, 24(2)” to the end of that point;

(ii) in both points (1) and (2), for “the Commission authorised the health claim” substitute “ the health claim was authorised ”.

(22) In Article 21 (data protection), in paragraph 2—

(a) for “Commission” substitute “ appropriate authority ”;

(b) for “included in the list provided for in” substitute “ authorised under ”.

(23) After Article 21, insert—

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. (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... (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (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). (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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(24) Omit Articles 22 to 27.

(25) In Article 28 (transitional measures)—

(a) in paragraph (1), omit the words from the beginning to “2009”;

(b) omit paragraphs (3) to (6).

(26) Omit Article 29.

Amendment of Regulation (EC) No 1925/2006

18

(1) Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to food is amended as follows.

(2) In Article 1 (subject matter and scope)—

(a) omit paragraph 1;

(b) in paragraph 3, for “Community legislation” substitute “ other relevant enactments ”.

(3) In Article 2 (definitions)—

(a) for point (1), substitute—

(1) ‘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

(b) after point (2), insert—

(3) ‘appropriate authority’ means: (a) for regulations applying in relation to England and for the establishment and maintenance of a register in relation to England, the Secretary of State; (b) for regulations applying in relation to Scotland and for the establishment and maintenance of a register in relation to Scotland, the Scottish Ministers; (c) for regulations applying in relation to Wales and for the establishment and maintenance of a register in relation to Wales, the Welsh Ministers; (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4) But the appropriate authority is the Secretary of State if consent is given by: (a) for regulations applying in relation to Scotland and for the establishment and maintenance of a register in relation to Scotland, the Scottish Ministers; (b) for regulations applying in relation to Wales and for the establishment and maintenance of a register in relation to Wales, the Welsh Ministers; (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (5) ‘relevant authorities’ means the Secretary of State, the Scottish Ministers or the Welsh Ministers, the Department of Health.

(4) In Article 3 (requirements for the addition of vitamins and minerals), in paragraph 3—

(a) for the first sub-paragraph substitute—

The appropriate authority may by regulations, after taking into account the opinion of an expert committee, specify modifications to the lists referred to in paragraph 1 of this Article.

(b) omit the second sub-paragraph;

(c) in the third sub-paragraph for “these modifications, the Commission” substitute “ regulations under this paragraph, the appropriate authority ”.

(5) In Article 4 (restrictions on the addition of vitamins and minerals)—

(a) for point (b)(i) substitute—

(i) referred to in paragraph B3 of Annex VIII to Regulation (EU) No 1308/2013; and

(b) in point (b)(ii), after “Regulation;” omit “and”;

(d) for the final sub-paragraph, substitute—

The appropriate authority may by regulations determine the additional foods or categories of foods to which particular vitamins and minerals may not be added, in the light of scientific evidence and taking into account their nutritional value.

(6) In Article 5 (purity criteria)—

(a) in paragraph 1—

(i) for “Measures determining” substitute “ The appropriate authority may by regulations determine ”;

(ii) omit the words from “and designed” to “Article 14(3)”;

(b) in paragraph 2, for “Community legislation” substitute “ other relevant enactments ”;

(i) for “Community legislation” substitute “ other relevant enactments ”;

(ii) for “such specifications are adopted” substitute “ the appropriate authority makes regulations under paragraph 1 ”;

(iii) omit the words from “and national” to the end of that paragraph.

(7) In Article 6 (conditions for the addition of vitamins and minerals)—

(a) in paragraph 1, for the words from “and designed” to “2009” substitute “ may be adopted by regulations made by the appropriate authority ”;

(b) in paragraph 2—

(i) for “Any” substitute “ The appropriate authority may by regulations specify ”;

(ii) omit the words from “and designed” to the end of that paragraph;

(i) for “Annex to Directive 90/496/EEC” substitute “ Annex XIII to Regulation (EU) No 1169/2011 ”;

(ii) for the words from “and designed” to the end of the paragraph substitute “ may be adopted by regulations made by the appropriate authority. ”.

(8) In Article 7 (labelling, presentation and advertising)—

(a) in paragraph 1, for the words from “and designed” to the end of the paragraph substitute “ may be adopted by regulations made by the appropriate authority. ”;

(b) in paragraph 6, for “accordance with the procedure referred to in Article 14(2)” substitute “ regulations made by the appropriate authority ”.

(9) In Article 8 (restricted or prohibited substances)—

(a) in the heading, omit “Community”;

(b) in paragraph 2—

(i) for the words from the beginning to “Article 14(3)” substitute “ Following an assessment of available evidence by an expert committee, the appropriate authority may make regulations ”;

(ii) omit the words from “On imperative grounds” to the end of that paragraph;

(d) for paragraph 4, substitute—

(4) Food business operators, or any other interested parties, may at any time submit to the appropriate authority a file containing the scientific data demonstrating the safety of a substance listed in Annex III, Part C, under the conditions of its use in a food or in a category of foods and explaining the purpose of that use. The appropriate authority shall submit the file to an expert committee for evaluation and shall inform the other relevant authorities of the submission and shall make the file available to them.

(e) for paragraph 5, substitute—

(5) Within four years from the date a substance has been listed in Annex III, Part C, the appropriate authority must consider, in consultation with the other relevant authorities and taking into account the opinion of the expert committee on any files submitted for evaluation as mentioned in paragraph 4 of this Article, whether to make regulations to generally allow the use of a substance listed in Annex III, Part C, or to list it in Annex III, Part A or B, as appropriate.

(f) for paragraph 6, substitute—

(6) The appropriate authority may by regulations amend Commission Implementing Regulation (EU) No 307/2012 in order to modify the implementing rules for the application of this Article.

(10) In Article 9—

(a) in the heading, omit “Community”;

(b) in paragraph 1, for the words from the beginning to “Community” substitute “ The appropriate authority must establish and maintain a ”;

(d) information regarding enactments applicable in any part of Great Britain on: (i) the mandatory addition of vitamins and minerals to specified foods or categories of foods; or (ii) the prohibition or restriction on the use of certain other substances in the manufacture of specified foods;

(d) omit point 2(f).

(11) After Article 9 insert—

(1) 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 purposes. (1) Any power of the Secretary of State to make regulations under this Regulation is exercisable by statutory instrument. (2) A statutory instrument made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament. (3) The Secretary of State may 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; and (b) the Welsh Ministers, in respect of any proposed application in Wales ... (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (1) For regulations made by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010. (2) 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). (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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(12) Omit Articles 10 to 18.

Amendment of Regulation (EU) No 609/2013

19

(1) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 is amended as follows.

(2) In Article 1 (subject matter), in paragraph 2, for “Union” substitute “ Great Britain ”.

(3) In Article 2 (definitions), after paragraph (h) insert—

(i) ‘Great Britain list’ means the list set out in the Annex.

(4) In Article 3 (interpretation decisions)—

(a) for the first paragraph, substitute “ The appropriate authority may make regulations specifying: ”;

(b) omit the final paragraph.

(5) In Article 4 (placing on the market), omit paragraph 3.

(6) In Article 6 (general provisions), for “Union law” in each place where those words appear substitute “ retained EU law ”.

(7) Omit Articles 7 and 8.

(8) In Article 9 (general compositional and information requirements), in paragraph 4, for “Article 1 of Regulation (EC) No 258/97” substitute “ Regulation (EU) 2015/2283 ”.

(9) In Article 11 (specific compositional and information requirements)—

(a) in paragraph 1—

(i) omit the words from “Subject to the general requirements” to “article 10, and”;

(ii) for the words from “the Commission” to “Article 18” substitute “ and having regard to such scientific opinion as an appropriate authority considers appropriate, the appropriate authority may make regulations ”;

(iii) in sub-paragraph (b) omit the words from “The specific requirements” in the second place they appear to the end of that sub-paragraph;

(iv) in sub-paragraph (d) omit the words from “and on the basis” until the end of that sub-paragraph;

(v) omit the words “Those delegated acts shall be adopted by 20 July 2015.”.

(b) omit paragraph 2.

(10) Omit Articles 12 and 13.

(11) In Article 14 (technical guidelines)—

(a) for “The Commission” substitute “ The Secretary of State, the Scottish Ministers and the Welsh Ministers ”;

(b) for “SMEs” substitute “ small or medium sized enterprises as defined in the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises ”;

, as it applies in their territory. For the purposes of this Article, the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises is to be read as if— (a) in Article 2— (i) in paragraph 1, for “EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million” there were substituted “ £44,000,000, and/or an annual balance sheet total not exceeding £38,000,000 ”; (ii) in paragraph 2, for “EUR 10 million” there were substituted “ £8,800,000 ”; (iii) in paragraph 3, for “EUR 2 million” there were substituted “ £1,750,000 ”; (b) in Article 3— (i) in paragraph 2(a), for “EUR 1 250 000” there were substituted “ £1,100,000 ”; (ii) in paragraph 2(d), for “EUR 10 million” there were substituted “ £8,800,000 ”; (iii) in paragraph 5, for “by national or Community rules” there were substituted “ under the law of Great Britain (or any part of it) ”; (c) in Article 5, in paragraph (b), for “national law” there were substituted “the law of Great Britain (or any part of it).

(12) In the heading to Chapter III, substitute “ Great Britain list ”.

(13) In Article 15—

(a) for “Union list” in the heading and in each place where those words appear substitute “ Great Britain list ”;

(b) in paragraphs 4 and 5, for “Union law” substitute “ retained EU law and any other legislation applying in any part of Great Britain ”;

(d) in paragraph 6, for the words from “the Commission” to “Article 18” substitute “ an appropriate authority may make regulations in relation to the categories of substances listed in paragraph 1 of this Article ”.

(14) In Article 16 (updating the union list)—

(a) for “Union list” in the heading and in each place where those words appear, substitute “ Great Britain list ”;

(b) in paragraph 1—

(i) omit the words from “Subject to the general requirements” to “article 11, and”;

(ii) for the words from “the Commission” to “Article 18 to” substitute “ the appropriate authority may by regulations ”;

(15) After Article 16, in Chapter IV (procedural provisions) insert—

(1) Any power to make regulations under this Regulation may be exercised by the Secretary of State for the whole or part of Great Britain if consent is given by— (a) for regulations applying in relation to Scotland, the Scottish Ministers; (b) for regulations applying in relation to Wales, the Welsh Ministers; (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (2) 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 purposes. (3) In this Regulation– - “appropriate authority” means: 1. for regulations applying in relation to England, the Secretary of State; 2. for regulations applying in relation to Scotland, the Scottish Ministers; 3. for regulations applying in relation to Wales, the Welsh Ministers; 4. ... - “enactment” includes any enactment of the types specified in the definition of ‘enactment’ in section 20(1) of the European Union (Withdrawal) Act 2018. (1) Any power of the Secretary of State to make regulations under this Regulation is exercisable by statutory instrument. (2) A statutory instrument containing regulations made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament. (1) For regulations made by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010. (2) 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). (1) Any power of the Welsh Ministers to make regulations under this Regulation is exercisable by statutory instrument. (2) A statutory instrument containing regulations made under this Regulation by the Welsh Ministers is subject to annulment in pursuance of a resolution of the National Assembly for Wales. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(16) Omit Articles 17 to 20.

(17) In Article 21—

(a) in paragraph 1, omit the second sentence;

(b) after paragraph 2, insert—

(3) In this Article, any reference to compliance with a provision of the Directive is to be read as a reference to complying with that provision as would be required if the provision formed part of domestic law.

(18) Omit Article 22.

(19) In the heading to the Annex, for “Union list” substitute “ Great Britain list ”.

PART 5 — AMENDMENT OF EU TERTIARY LEGISLATION

Amendment of Commission Regulation (EC) No 353/2008

20

(1) Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council is amended as follows.

(2) In paragraph (b) of Article 1 (subject matter), for “Article 13(3)” substitute “ Article 13(4) ”.

(3) Omit Article 8.

(4) In the Annex, in paragraph 5, for “a competent authority of either a Member State or a third country” substitute “ another country ”.

Amendment of Commission Regulation (EC) No 953/2009

21

(1) Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses is amended as follows.

(2) For Article 1 (scope) substitute—

(1) This Regulation shall apply to foods for particular nutritional uses, excluding foodstuffs for particular nutritional use: (a) fulfilling the particular requirements of infants and young children in good health in Great Britain and intended for use by infants while they are being weaned, and by young children as a supplement to their diet and/or for their progressive adaptation to ordinary food; (b) by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding; and (c) by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants (2) In this Regulation: - “infants” means children under the age of 12 months; - “young children” means children aged between one and three years.

(3) In Article 2 (eligible substances)—

(a) in paragraph 1, for “covered by Directive 2009/39/EC” substitute “ (foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability) ”.

(b) in paragraph 2, for “Regulation (EC) No 258/97” substitute “ Regulation (EU) 2015/2283 ”.

(4) In Article 3 (general requirements) in paragraph 2, for “competent authorities referred to in Article 11 of Directive 2009/39/EC” substitute “ Secretary of State, Welsh Ministers or Food Standards Scotland ”.

(5) In Article 4 (specific requirements for substances listed in the Annex)—

(a) omit paragraph 1;

(b) in paragraph 2, for “by Community legislation” substitute “ in retained EU law ”;

(i) omit “by Community legislation” substitute “ in retained EU law ”;

(ii) omit “National rules setting stricter purity criteria may be maintained”.

(6) Omit Articles 5 and 6.

(7) In the Annex (Substances that may be added for specific nutritional purposes in foods for particular nutritional uses) for the definition of “ foods for special medical purposes ” substitute “means a category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients and to be used under medical supervision. They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two”.

Amendment of Commission Regulation (EC) No 983/2009

22

(1) Commission Regulation (EC) No 983/2009 of 21 October 2009 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) for “Community” substitute “ Great Britain ”;

(b) omit the second sentence.

(3) Omit Articles 3 and 4.

Amendment of Commission Regulation (EC) No 984/2009

23

(1) Commission Regulation (EC) No 984/2009 of 21 October 2009 refusing to authorise certain health claims made on food, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1, for “Community” substitute “ Great Britain ”.

(3) Omit Articles 2 and 3.

Amendment of Commission Regulation (EC) No 1024/2009

24

(1) Commission Regulation (EC) No 1024/2009 of 29 October 2009 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) for “Community” substitute “ Great Britain ”;

(b) omit the second sentence.

(3) For Article 2, substitute—

(2) The health claims set out in Annex II to this Regulation may not be made on foods on the Great Britain market.

(4) Omit Article 3.

Amendment of Commission Regulation (EC) No 1025/2009

25

(1) Commission Regulation (EC) No 1025/2009 of 29 October 2009 refusing to authorise certain health claims made on food, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Community”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Regulation (EC) No 1167/2009

26

(1) Commission Regulation (EC) No 1167/2009 of 30 November 2009 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) in the first sentence, for “shall not be included” to the end of that sentence substitute “ may not be made on foods on the Great Britain market ”;

(b) omit the second sentence.

(3) Omit Article 2.

Amendment of Commission Regulation (EC) No 1168/2009

27

(1) Commission Regulation (EC) No 1168/2009 of 30 November 2009 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Community”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 375/2010

28

(1) Commission Regulation (EU) No 375/2010 of 3 May 2010 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Community”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 382/2010

29

(1) Commission Regulation (EU) No 382/2010 of 5 May 2010 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Community”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 383/2010

30

(1) Commission Regulation (EU) No 383/2010 of 5 May 2010 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Community”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”.

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 384/2010

31

(1) Commission Regulation (EU) No 384/2010 of 5 May 2010 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) in the first sentence, for “European Union” substitute “ Great Britain ”;

(b) omit the second sentence.

(3) In Article 2, for the words from “shall not” to the end of that Article, substitute “ may not be made on foods on the Great Britain market ”.

(4) Omit Article 3.

Amendment of Commission Regulation (EU) No 957/2010

32

(1) Commission Regulation (EU) No 957/2010 of 22 October 2010 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) in the first sentence, for “European Union” substitute “ Great Britain ”;

(b) omit the second sentence.

(3) In Article 2—

(a) in the first sentence, for the words from “shall not” to the end of that sentence, substitute “ may not be made on foods on the Great Britain market ”;

(b) omit the second sentence.

(4) Omit Article 3.

Amendment of Commission Regulation (EU) No 958/2010

33

(1) Commission Regulation (EU) No 958/2010 of 5 May 2010 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Union”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 1161/2010

34

(1) Commission Regulation (EU) No 1161/2010 of 9 December 2010 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Union”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 1162/2010

35

(1) Commission Regulation (EU) No 1162/2010 of 9 December 2010 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1–

(a) in the first sentence, for the words from “shall not” to the end of that sentence, substitute “ may not be made on foods on the Great Britain market ”;

(b) omit the second sentence.

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 432/2011

36

(1) Commission Regulation (EU) No 432/2011 of 4 May 2011 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Union”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 440/2011

37

(1) Commission Regulation (EU) No 440/2011 of 6 May 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to children's development and health is amended as follows.

(2) In Article 1—

(a) in paragraph 1, for “European Union” substitute “ Great Britain ”;

(b) omit paragraph 2.

(3) In Article 2—

(a) in paragraph 1, for the words from “shall not” to the end of that paragraph, substitute “ may not be made on foods on the Great Britain market ”;

(b) omit paragraph 2.

(4) Omit Article 3.

Amendment of Commission Regulation (EU) No 665/2011

38

(1) Commission Regulation (EU) No 665/2011 of 11 July 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to the reduction of disease risk is amended as follows.

(2) In Article 1—

(a) in paragraph 1, for “European Union” substitute “ Great Britain ”;

(b) omit paragraph 2.

(3) In Article 2, for the words from “shall not” to the end of that Article, substitute “ may not be made on foods on the Great Britain market ”

(4) Omit Article 3.

Amendment of Commission Regulation (EU) No 666/2011

39

(1) Commission Regulation (EU) No 666/2011 of 11 July 2011 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Union”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 1160/2011

40

(1) Commission Regulation (EU) No 1160/2011 of 14 November 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to the reduction of disease risk is amended as follows.

(2) In Article 1—

(a) in paragraph 1, for “European Union” substitute “ Great Britain ”;

(b) omit paragraph 2.

(3) In Article 2, for the words from “shall not” to the end of that Article, substitute “ may not be made on foods on the Great Britain market. ”.

Amendment of Commission Regulation (EU) No 1170/2011

41

(1) Commission Regulation (EU) No 1170/2011 of 16 November 2011 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk is amended as follows.

(2) In Article 1, for the words from “shall not” to the end of that Article, substitute “ may not be made on foods on the Great Britain market. ”.

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 1171/2011

42

(1) Commission Regulation (EU) No 1171/2011 of 16 November 2011 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Union”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Implementing Regulation (EU) No 307/2012

43

(1) Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods is amended as follows.

(2) In Article 2 (definitions)—

(a) omit the definition of “request”;

(b) in the definition of “file”, for “the Authority”, substitute “ an expert committee ”.

(d) ‘appropriate authority’ and ‘expert committee’ have the same meaning as in Regulation (EC) 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to food.

(3) In Article 3 (conditions to be met for the request)—

(a) in paragraph 1—

(i) for “the assessment of” substitute “ assessing ”;

(ii) for “Member States” substitute “ parts of Great Britain ”;

(b) in paragraph 2, for “Member States may submit a request to the Commission when the assessment referred to in paragraph 1” substitute “ The power to make regulations under Article 8 of Regulation (EC) No 1925/2006 may be exercised where the assessment referred to in paragraph 1 ”;

(4) In Article 4 (content of the Request)—

(a) for the heading substitute “ Evidence required for the purposes of advice by an expert committee under Article 8 of Regulation 1925/2006 ”;

(b) in paragraph 1—

(i) for “The request shall contain” substitute “In preparing advice for the purpose of Article 8 of Regulation (EC) No 1925/2006, the Committee shall consider ;

(ii) for “and shall include” substitute “ , including ”;

(iii) omit the final sentence of point (b).

(d) for paragraph 3 substitute—

(3) Where an expert committee is asked to provide advice for the purposes of Article 8 of Regulation (EC) No 1925/2006, it shall make public the evidence referred to in paragraph 1.

(e) in paragraph 4—

(i) omit the first sentence;

(ii) for “Authority” substitute “ expert committee ”;

(f) in paragraph 5—

(i) for “Commission” substitute “ appropriate authority ”;

(ii) for “Authority” substitute “ expert committee ”;

(iii) after “opinion” insert “ , except in cases of urgency ”.

(5) In Article 5 (substance included in Annex III, Part C)—

(a) for “Authority” in each place it appears substitute “ expert committee ”;

(b) for “Commission” substitute “ appropriate authority ”.

(6) In Article 6 (opinion of the Authority)—

(a) for “Authority” in the heading and in each place it appears in paragraphs 1 and 2, substitute “ expert committee ”;

(b) for “Authority's” substitute “expert committee's”.

(7) Omit Article 7.

Amendment of Commission Regulation (EU) No 378/2012

44

(1) Commission Regulation (EU) No 378/2012 of 3 May 2012 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) in paragraph 1, for the words from “shall not” to the end of that paragraph, substitute “ may not be made on foods on the Great Britain market ”;

(b) omit paragraph 2.

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 379/2012

45

(1) Commission Regulation (EU) No 379/2012 of 3 May 2012 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Union”;

(b) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(3) Omit Article 2.

Amendment of Commission Regulation (EU) No 432/2012

46

(1) Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In paragraph 1 of Article 1 (permitted health claims), for “Article 13(3)” substitute “ Article 13(4) ”.

(3) Omit Article 2.

(4) In the Annex, in the table (list of permitted health claims), after the second entry relating to “water” insert—

(a) in the column entitled “Nutrient, substance, food or food category”, “Water-Soluble Tomato Concentrate (WSTC) I and II”;

(b) in the column entitled “Claim”, “Water-Soluble Tomato Concentrate (WSTC) I and II helps maintain normal platelet aggregation, which contributes to healthy blood flow”;

(c) in the column entitled “Conditions of use of the claim”, “Information to the consumer that the beneficial effect is obtained with a daily consumption of 3 g WSTC I or 150 mg WSTC II in up to 250 ml of either fruit juices, flavoured drinks or yogurt drinks (unless heavily pasteurised) or with a daily consumption of 3 g WSTC I or 150 mg WSTC II in food supplements when taken with a glass of water or other liquid”;

(d) in the column entitled “EFSA Journal number”, “2010; 8(7): 1689”.

Amendment of Commission Implementing Regulation (EU) No 489/2012

47

Commission Implementing Regulation (EU) No 489/2012 of 8 June 2012 establishing implementing rules for the application of Article 16 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods is revoked.

Amendment of Commission Regulation (EU) No 1048/2012

48

(1) Commission Regulation (EU) No 1048/2012 of 8 November 2012 on the authorisation of a health claim made on foods and referring to the reduction of disease risk is amended as follows.

(2) In Article 1—

(a) in paragraph 1, for “European Union” substitute “ Great Britain ”;

(b) omit paragraph 2.

(3) Omit Article 2.

Amendment of 2013/63/EU: Commission Implementing Decision

49

2013/63/EU: Commission Implementing Decision of 24 January 2013 adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council is revoked.

Amendment of Commission Regulation (EU) No 851/2013

50

(1) Commission Regulation (EU) No 851/2013 of 3 September 2013 authorising certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health and amending Regulation (EU) No 432/2012 is amended as follows.

(2) In Article 1—

(a) in paragraph 1—

(i) omit “Union”;

(ii) for “as provided for in Article 13(3) of Regulation (EC) No 1924/2006” substitute “ in the Annex to Regulation (EU) 432/2012 ”;

(b) omit paragraph 2.

(3) Omit Articles 2 and 4.

Revocation of Commission Regulation (EU) No 907/2013

51

Commission Regulation (EU) No 907/2013 of 20 September 2013 setting the rules for applications concerning the use of generic descriptors (denominations) is revoked.

Amendment of Commission Regulation (EU) No 1017/2013

52

(1) Commission Regulation (EU) No 1017/2013 of 23 October 2013 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health is amended as follows.

(2) In Article 1—

(a) omit “Union”;

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