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The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025

Type Statutory-Instrument

Publication 2025-03-17

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: 17th March 2025

Coming into force: 1st April 2025

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[^f00003], there has been open and transparent public consultation during the preparation and evaluation of these Regulations.

PART 1 — Introductory

Citation, commencement and interpretation

1

(1) These Regulations may be cited as the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025.

(2) These Regulations come into force on 1st April 2025.

(3) In these Regulations—

(a) “Regulation (EC) No 1829/2003” means Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed[^f00004];

(b) “Regulation (EC) No 1831/2003” means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition[^f00005];

(c) “Regulation (EC) No 2065/2003” means Regulation (EC) No 2065/2003 of the European Parliament and of the Council on smoke flavourings used or intended for use in or on foods[^f00006].

Extent and application

2

(1) The following provisions of these Regulations extend to England and Wales—

(a) this Part and Parts 2 to 8;

(b) Schedules 2 to 9, 11 and 12.

(2) The provisions in paragraph (1) apply to England and Wales, save as follows—

(a) Schedules 2 and 11 apply only in relation to Wales;

(b) Schedules 3 and 12 apply only in relation to England.

(3) The following provisions of these Regulations extend to Scotland—

(a) this Part and Parts 2 to 8;

(b) Schedules 1 and 4 to 10.

PART 2 — Amendments relating to feed additives

Amendment of Regulation (EC) No 1831/2003

3

(1) Regulation (EC) No 1831/2003 is amended as follows.

(2) In Article 2(2), after point (s) insert—

(t) ‘Register’ means the Register of Feed Additives referred to in Article 17.

(3) In Article 3(3), omit “Regulation”.

(4) In Article 4(2), omit “renewed,”.

(5) In Article 5(1), for “Regulation authorising” substitute “authorisation concerned in respect of”.

(6) In Article 9—

(a) in the heading, after “Authorisation” insert “by the appropriate authority”;

(b) in paragraph 1, in the third sentence, for “The authorisation must be prescribed by the appropriate authority and” substitute “Where the appropriate authority determines that the feed additive is to be authorised, the authorisation”;

(7) Where the appropriate authority determines that a feed additive is, or is not, to be authorised: (a) in the event of a determination to authorise the feed additive: (i) the appropriate authority must specify the date on which the authorisation is to have effect; and (ii) the Food Safety Authority must enter the authorisation, including the elements mentioned in Article 8(4)(b), (c), (d) and (e) and an identification number, in the Register; (b) the appropriate authority must communicate the determination to the Food Safety Authority.

(7) After Article 12, insert—

(1) This Article applies where the Food Safety Authority receives, or becomes aware of, any information which might affect the assessment of the safety, or the suitability of the method of analysis, of the feed additive. (2) Where the Food Safety Authority receives, or becomes aware of, information under paragraph 1, the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 13. (3) The Food Safety Authority may ask a relevant person to provide, within a specified period, such other information as the Food Safety Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 13. (4) The Food Safety Authority may extend the period of time described in paragraph 3. (5) Where the Food Safety Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 13 based on such information as the Food Safety Authority has which might affect the assessment of the safety, or the suitability of the method of analysis, of the feed additive. (6) In this Article, “relevant person” means any person who is— (a) the holder of the authorisation concerned; (b) a producer or manufacturer of the feed additive concerned; or (c) any feed business placing on the market, processing or using the feed additive concerned.

(8) In Article 13—

(a) in paragraph 1, in the first sentence, for “or following a request from the appropriate authority, the Food Safety Authority must” substitute “, the Food Safety Authority may, or following a request from the appropriate authority, the Food Safety Authority must,”;

(b) in paragraphs 2 and 3, in both places, for “in light of” substitute “having regard to”;

(3A) The appropriate authority must, in relation to any determination it makes under this Article: (a) specify the date on which the modification, suspension or revocation is to have effect; and (b) communicate the determination to the Food Safety Authority.

(d) in paragraph 4—

(i) in the words before point (a), for “appropriate authority must, without delay” substitute “Food Safety Authority, without delay after being informed by the appropriate authority, must”;

(ii) omit point (b);

(e) after paragraph 4 insert—

(4A) Where the appropriate authority determines that an authorisation of a feed additive is to be modified, suspended or revoked, the Food Safety Authority must update the Register accordingly.

(f) after paragraph 5 insert—

(6) For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which: (a) existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used; (b) the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used; (c) the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied. (7) The appropriate authority may prescribe other transitional measures not falling within paragraph 6 in relation to the modification, suspension or revocation of an authorisation.

(9) Omit Article 14.

(10) In Article 15—

(a) the existing paragraph is renumbered as paragraph 1;

(b) in paragraph 1, as so renumbered, omit the second sentence;

(2) The appropriate authority may withdraw a provisional authorisation given under paragraph 1. (3) Where the appropriate authority determines that a provisional authorisation is to be withdrawn, the appropriate authority may specify, in relation to the withdrawal of a provisional authorisation, a period of time, or different periods of time, within which: (a) existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used; (b) the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used; (c) the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied. (4) The appropriate authority may prescribe other transitional measures not falling within paragraph 3 in relation to the withdrawal of a provisional authorisation. (5) Where the appropriate authority determines that a feed additive is, or is not, to be provisionally authorised (including a determination to withdraw a provisional authorisation), the appropriate authority must communicate the determination to the Food Safety Authority and: (a) in the event of a determination to provisionally authorise a feed additive: (i) the provisional authorisation must, to the extent that it is possible to do so, include information equivalent to that which must be included for an authorisation under Article 9(1); (ii) the appropriate authority must specify the date on which the provisional authorisation is to have effect; and (iii) the Food Safety Authority must enter the provisional authorisation, including the information mentioned in paragraph (i), in the Register; (b) in the event of a determination to withdraw a provisional authorisation: (i) the appropriate authority must specify the date on which the withdrawal is to have effect; and (ii) the Food Safety Authority must update the Register accordingly.

(11) In Article 17, for paragraph 2 substitute—

(2) The Food Safety Authority must make the Register available to the public.

(12) In Annex IV, in paragraph 1, omit “Regulation”.

Amendment of Commission Regulation (EC) No 378/2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives

4

(1) Commission Regulation (EC) No 378/2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives[^f00007] is amended as follows.

(2) In Article 3(3), in the first subparagraph—

(a) for “valid for the entire period of” substitute “for”;

(b) for “those expired” substitute “any that expire”.

(3) In Article 5(4), omit point (c).

(4) In Annex IV, omit paragraph 5.

Amendment of Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives

5

(1) Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives[^f00008] is amended as follows.

(2) In Annex I, in the application form, in the first part, omit “Renewal of a feed additive authorisation (Article 14 of Regulation (EC) No 1831/2003)” and the corresponding checkbox.

(3) In Annex II—

(a) in the first paragraph (general aspects)—

(i) at the end of the second indent, insert “or”;

(ii) at the end of the third indent, omit “, or”;

(iii) omit the fourth indent (“a renewal of the authorisation of a feed additive”);

(b) in section 5 (post-market monitoring plan), in the fourth paragraph, omit “, preferably during the latter part of the period of authorisation”.

(4) In Annex III—

(a) in the text before part 1 (technological additives), in the second paragraph (list of the specific requirements for establishing dossiers for:), omit “(10) Renewal of authorisations”;

(b) in part 2 (sensory additives), in point 2.2.3.1., in paragraph (2), omit “(following by analogy Regulation (EU) No 872/2012)”;

PART 3 — Amendments relating to food additives, food enzymes and food flavourings

Amendment of Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings

6

(1) Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings[^f00009] is amended as follows.

(2) In Article 1—

(a) in paragraph 2—

(i) for “updating the lists” substitute “determining the authorisation status”;

(ii) for “the marketing of which is authorised pursuant to” substitute “for the purposes of”;

(b) in paragraph 3, for “included on the domestic list” to “Article 7” substitute “authorised”.

(3) In Article 2—

(a) for the heading, substitute “Definitions”;

(b) omit paragraphs 1 and 2;

(7) ‘Substance’ includes a flavouring substance under evaluation, within the meaning given in Regulation (EC) No 1334/2008.

(4) After Article 2, insert—

The appropriate authority must determine the authorisation status of substances in accordance with the sectoral food law concerned and this Regulation. (1) For the purposes of this Regulation, determining the authorisation status of a substance is to consist of the appropriate authority determining whether or not to: (a) authorise the placing on the market, or the use in or on food, of a substance; (b) modify the authorisation of a substance, including modifying any conditions, restrictions or specifications associated with the authorisation concerned; (c) revoke or suspend the authorisation of a substance. (2) For the purposes of paragraph 1, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which— (a) existing stocks of the substance concerned, and any products derived from it or containing it, may be placed on the market or used; (b) the substance concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used; (c) the labelling of the substance concerned, and any products derived from it or containing it, may continue to be applied. (3) The appropriate authority may prescribe other transitional measures not falling within paragraph 2 in relation to the modification, suspension or revocation of an authorisation under the sectoral food law concerned and this Regulation. (4) In this Article, “authorisation” includes the permission for a substance to be placed on the market or used in or on food under the sectoral food law concerned, and for this purpose includes food enzymes for which an application for initial authorisation has been entered in the Register under Regulation (EC) No 1332/2008 and flavouring substances under evaluation under Regulation (EC) No 1334/2008; and related terms are to be construed accordingly. (1) The Authority must establish and maintain a list (the “domestic list”) of substances, the placing on the market, or the use in or on food, of which is permitted in accordance with the sectoral food law concerned and this Regulation. (2) The Authority must make the domestic list available to the public.

(5) In Article 3—

(a) in paragraph 1, for “updating the domestic list” substitute “determining the authorisation status of a substance”;

(b) in paragraph 2, in the second subparagraph—

(i) for “the updates referred to in Article 2(2)(b) and (c)” substitute “a determination of the authorisation status of a substance described in Article 2B(1)(b) or (c)”;

(ii) for “the updates”, in the second place it occurs, substitute “any changes as a result of the determination”;

(c) in paragraph 3, for “prescribing the update” substitute “determining the authorisation status of the substance concerned”;

(d) in paragraph 4—

(i) in the first subparagraph, in the first sentence—

(aa) for “a planned update” substitute “determining the authorisation status of a substance”;

(bb) for “an update” substitute “a determination”;

(ii) in the second subparagraph, for “considering the update justified” substitute “determining the authorisation status of the substance concerned”.

(6) In Article 4(1), in the words before point (a), for “update the domestic list” substitute “determine the authorisation status of a substance”.

(7) In Article 7—

(a) for the heading, substitute “Determination of authorisation status and amendment of sectoral food laws”;

(b) in paragraph 1, for “take the decision whether to update the domestic list” substitute “determine the authorisation status of the substance concerned,”;

(1A) Where the appropriate authority makes a determination as to the authorisation status of a substance: (a) the appropriate authority must: (i) specify the date on which the authorisation, modification, suspension or revocation is to have effect; and (ii) communicate the determination to the Authority; (b) the Authority must update the domestic list referred to in Article 2C accordingly.

(d) in paragraph 3, for “decision”, in both places, substitute “determination”;

(e) in paragraph 4, for “removal of a substance from the domestic list” substitute “revocation of the authorisation of substances generally”;

(f) in paragraph 5—

(i) for “addition of a substance to the domestic list” substitute “authorisation of substances generally”;

(ii) for “adding, removing or changing” substitute “modifying”;

(iii) for “presence of the substance on the domestic list” substitute “authorisation of substances generally”.

Amendment of Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes, etc.

7

(1) Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes, etc.[^f00010] is amended as follows.

(2) In Article 1, for point (a) substitute—

(a) the authorisation of food enzymes in accordance with this Regulation and Regulation (EC) No 1331/2008;

(3) Before Article 4, for the heading for Chapter II, substitute “AUTHORISATION OF FOOD ENZYMES”.

(4) In Article 4—

(a) for the heading, substitute “Requirement for authorisation”;

(b) in the text—

(i) after “Only” insert “authorised”;

(ii) omit “included in the domestic list”;

(iii) after “Article 7(2)” insert “(but see Article 24 with respect to the date of application of this Article)”.

(5) In Article 6—

(a) in the heading, for “inclusion of food enzymes in the domestic list” substitute “authorisation of food enzymes”;

(b) in the words before point (a), for “included in the domestic list” substitute “authorised”.

(6) In Article 7—

(a) in the heading, for “the domestic list of food enzymes” substitute “an authorisation of a food enzyme”;

(b) in paragraph 1, for “included in the domestic list” substitute “authorised”;

(i) for “entry” substitute “authorisation”;

(ii) omit “in the domestic list”;

(d) in paragraph 3—

(i) for “domestic list” substitute “authorisation status of a food enzyme”;

(ii) for “amended” substitute “determined”.

(7) In Article 8—

(a) in paragraph 1, for “included in the domestic list” substitute “authorised”;

(b) in paragraph 2, for “already included in the domestic list” substitute “that is already authorised”.

(8) After Article 8, insert—

The Authority must include the details described in Article 7(2) in the domestic list published and maintained under Regulation (EC) No 1331/2008.

(9) In Article 14(2), for “approved” substitute “authorised”.

(10) In Article 17—

(a) for the heading, substitute “Initial authorisation of food enzymes”;

(b) for paragraph 1, substitute—

(1) This Article applies for the purpose of the authorisation (“initial authorisation”) of food enzymes which are to be included in the domestic list of food enzymes published and maintained under Regulation (EC) No 1331/2008 when it is first established by the Authority. The initial authorisation of food enzymes must be made in accordance with this Article.

(i) for “inclusion” substitute “initial authorisation”;

(ii) omit “in the domestic list”;

(d) in paragraph 3—

(i) for “inclusion in the domestic list” substitute “initial authorisation”;

(ii) for “hereinafter referred to as the Register” substitute “referred to in this Regulation as the ‘Register’”;

(e) in paragraph 4—

(i) in the first subparagraph—

(aa) for “The domestic list shall be adopted by the appropriate authority in” substitute “In”;

(bb) after “food flavourings,” insert “the appropriate authority must determine the authorisation status of all of the applications for initial authorisation entered in the Register”;

(ii) in the second subparagraph, omit point (b);

(f) after paragraph 4, insert—

(4A) This Article, and the Register, shall cease to have effect at the start of the day after the day on which the appropriate authority has determined the authorisation status of all initial authorisation applications in the Register.

(11) In Article 18(1)—

(a) in the words before point (a)—

(i) omit “the domestic list shall, when drawn up, include”;

(ii) after “enzymes” insert “are, immediately after the end of the day on which the appropriate authority determines the authorisation status of all the applications for initial authorisation in the Register in accordance with Article 17, to be deemed to be authorised for the purposes of this Regulation”;

(b) in point (a), for “stating the conditions governing their use as specified in Annex I and Part C of Annex III to Directive 95/2/EC” substitute “in accordance with any conditions of use set out in authorisations under Regulation (EC) No 1333/2008”.

(12) In Article 24, in the second subparagraph, for “date of application of the domestic list” substitute “start of the day after the day on which the appropriate authority has determined the authorisation status of all initial authorisation applications in the Register in accordance with Article 17”.

Amendment of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives

8

(1) Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives[^f00011] is amended as follows.

(2) In Article 1, in the second subparagraph—

(a) for point (a), substitute—

(a) the authorisation of food additives;

(b) in point (b)—

(i) after “enzymes”, in the first place it occurs, insert “, food flavourings or nutrients,”;

(ii) omit “in food flavourings as covered by”;

(iii) omit “of the European Parliament and of the Council of 16 December 2008”.

(3) In Article 2(3), for “date of adoption of the domestic list of food enzymes in accordance with Article 17” substitute “start of the day after the day on which the appropriate authority has determined the authorisations status of all initial authorisation applications on the Register referred to in Article 17(3)”.

(4) In Article 3(2), after point (i) insert—

(j) ‘nutrients’ means vitamins, minerals and other substances added for nutritional purposes, as well as substances added for physiological purposes, in accordance with 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[^f00012], the Food Supplements (Scotland) Regulations 2003[^f00013], the Food Supplements (England) Regulations 2003[^f00014], the Food Supplements (Wales) Regulations 2003[^f00015] and Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control, etc.[^f00016], for the purposes of secondary use; (k) ‘primary use’ means the use of a food additive in food in accordance with the terms of its authorisation under Regulation (EC) No 1331/2008 and this Regulation; (l) ‘secondary use’ means the use of a food additive, including carriers, in food additives, food enzymes, food flavourings or nutrients in accordance with the terms of its authorisation under Regulation (EC) No 1331/2008 and this Regulation.

(5) Before Article 4, in the heading for Chapter II, for “DOMESTIC LISTS OF APPROVED” substitute “AUTHORISATION OF”.

(6) For Article 4, substitute—

(1) Only food additives authorised for primary use may be placed on the market as such and used in foods under the conditions of use specified in the authorisation concerned. (2) Only food additives authorised for secondary use may be used in food additives, food enzymes, food flavourings and in nutrients under the conditions of use specified in the authorisation concerned. (3) Where a food additive is authorised for primary use, the authorisation must include the categories of food to which the additive may be added. (4) Where a food additive is authorised for secondary use, the authorisation must include the food additives, food enzymes, food flavourings and nutrients or categories thereof to which the food additive may be added. (5) Food additives must comply with the specifications referred to in Article 14.

(7) In Article 6—

(a) for the heading, substitute “General conditions for authorisation of food additives”;

(b) in paragraph 1, in the words before point (a), for “included in the domestic lists in Annexes II and III” substitute “authorised”;

(c) in paragraph 2, in the words before point (a), for “included in the domestic lists in Annexes II and III” substitute “authorised”;

(d) in paragraph 3, in the words before point (a), for “included in the domestic list in Annex II” substitute “authorised for primary use”.

(8) In Article 7, in the words before point (a), for “included in the domestic list in Annex II” substitute “authorised for primary use”.

(9) In Article 8, in the words before point (a), for “included in the domestic list in Annex II” substitute “authorised for primary use”.

(10) In Article 9(1), for “Food additives may be assigned in Annexes II and III” substitute “An authorisation may state that a food additive is assigned”.

(11) In Article 10—

(a) in the heading, for “the domestic lists” substitute “an authorisation”;

(b) in paragraph 1, for “included in:” to the end substitute “authorised.”;

(i) in the words before point (a), for “entry for a food additive in the domestic lists in Annexes II and III” substitute “authorisation of a food additive”;

(ii) in point (b), after “the foods” insert “, food additives, food enzymes, food flavourings or nutrients or categories thereof”;

(iii) after point (d) insert—

(e) any specifications concerned, in accordance with Article 14.

(d) omit paragraph 3.

(12) In Article 11—

(a) in paragraph 3, in the first sentence, for “Annex II” substitute “the authorisation for primary use concerned,”;

(b) in paragraph 4, for “Annex II” substitute “the authorisation for primary use concerned”.

(13) In Article 12—

(a) in the heading and in the text, in each place, for “included in a domestic list” substitute “authorised”;

(b) for “entry in the domestic lists or a change in the specifications” substitute “authorisation or a modification to the existing authorisation”.

(14) In Article 13—

(a) in paragraph 1, for “included in the domestic lists in Annexes II and III” substitute “authorised”;

(b) in paragraph 2, for “already included in the domestic list” substitute “that is already authorised”.

(15) In Article 14—

(a) for “adopted” substitute “set out in the authorisation concerned”;

(b) for “included in the domestic lists in Annexes II and III for the first time” substitute “authorised”.

(16) After Article 14, insert—

(1) Ethylene oxide may not be used for sterilising purposes in food additives. (2) Total residues of ethylene oxide (sum of ethylene oxide and 2-chloroethanol expressed as ethylene oxide (i.e. ethylene oxide + (0.55 x 2-chloroethanol))), irrespective of origin, in authorised food additives, or mixtures of those food additives, must not exceed 0.1 mg/kg. The Authority must include the details described in Article 10(2) in the domestic list published and maintained under Regulation (EC) No 1331/2008.

(17) In Article 15—

(a) after “Food additives” insert “authorised for primary use”;

(b) for “Annex II” substitute “the authorisations concerned”.

(18) In Article 16—

(a) after “Food additives” insert “authorised for primary use”;

(b) for “Annex II to this Regulation” substitute “the authorisations concerned”.

(19) In Article 17, for “listed in Annex II to this Regulation may be used” substitute “that are authorised for primary use may be used, as provided for in the authorisations concerned,”.

(20) In Article 18—

(a) in paragraph 1(a), for “Annex II” substitute “an authorisation for primary use for the food additive concerned”;

(b) in paragraph 1(b), for “or food flavouring”, in each place it occurs, substitute “, food flavouring or nutrient”;

(d) after paragraph 4, insert—

(5) Paragraph 1(a) does not apply to foods listed in Table 1, as regards food additives in general, or in Table 2, as regards food colours, in Annex Ia.

(21) In Article 22(1)(a), for “in”, in the first place it occurs, substitute “under”.

(22) In Article 23(1)(a), for “in”, in the first place it occurs, substitute “under”.

(23) Omit Article 30.

(24) Omit Article 31.

(25) Omit Article 34.

(26) After Annex I, insert—

(27) Annex II is omitted, save that in Part A, in Section 2—

(a) Table 1 (foods in which the presence of an additive may not be permitted by virtue of the carry-over principle set out in Article 18(1)(a) of Regulation (EC) No 1333/2008); and

(b) Table 2 (foods in which the presence of a food colour may not be permitted by virtue of the carry-over principle set out in Article 18(1)(a) of Regulation (EC) No 1333/2008),

respectively, including their headings, become Table 1 and Table 2 following the heading in Annex Ia (as inserted by the previous paragraph of this regulation).

(28) Omit Annex III.

Amendment of Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc.

9

(1) Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods, etc.[^f00017], is amended as follows.

(2) In Article 1, in the second subparagraph—

(a) for point (a) substitute—

(a) the authorisation of food flavourings and source materials for use in or on foods;

(b) after point (c) insert—

(d) the use of flavouring substances under evaluation in or on foods.

(3) In Article 3(2), after point (l) insert—

(m) ‘flavouring substance under evaluation’ means a substance which, immediately before the entry into force of the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025, was: (i) permitted to be placed on the market and used in or on foods by virtue of Article 4 of Commission Implementing Regulation (EU) No 872/2012[^f00018]; and (ii) listed in a table (whether the table concerned related to England, Scotland or Wales) in Part A of Annex I to this Regulation and, in the entry for the substance concerned in that table, that substance was indicated by a footnote in column (8) of the table concerned.

(4) In Article 8—

(a) in the heading, for “approval” substitute “authorisation”;

(b) in paragraph 1, for “approval” substitute “authorisation”.

(5) Before Article 9, for the heading for Chapter III, substitute “AUTHORISATION OF FOOD FLAVOURINGS AND SOURCE MATERIALS FOR USE IN OR ON FOODS”.

(6) In Article 9, in the heading, for “approval” substitute “authorisation”.

(7) For Article 10, substitute—

(1) A flavouring substance under evaluation may, pursuant to regulation 23 (savings and transitional provision: general) of the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025, continue to be placed on the market and used in or on foods, until the appropriate authority determines the authorisation status of that substance. (2) The authorisation status of a flavouring substance under evaluation is to be determined in accordance with Regulation (EC) No 1331/2008. (3) A substance ceases to be a flavouring substance under evaluation once the appropriate authority has determined the authorisation status of that substance. Only authorised flavourings and source materials referred to in Article 9 and, pursuant to regulation 23 (savings and transitional provision: general) of the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025, flavouring substances under evaluation, may be placed on the market as such and used in or on foods under the conditions of use specified in relation to the substance concerned.

(8) In Article 11—

(a) for the heading, substitute “Authorisation of flavourings and source materials”;

(b) in paragraph 1, for “included in the domestic list” substitute “authorised”;

(i) for “entry for” substitute “authorisation of”;

(ii) omit “in the domestic list”;

(iii) for “approved” substitute “authorised”;

(d) omit paragraph 3.

(9) In Article 12—

(a) in paragraph 1, for “included in the domestic list in Annex I” substitute “authorised”;

(b) in paragraph 2, for “already included in the domestic list” substitute “that is already authorised”.

(10) After Article 12, insert—

The Authority must include in the domestic list published and maintained under Regulation (EC) No 1331/2008: (a) the details described in Article 11(2); and (b) equivalent information for each flavouring substance under evaluation.

(11) In Article 19(2), for “approved” substitute “authorised”.

(12) Omit Annex I.

Amendment of Commission Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008, etc.

10

(1) Commission Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings[^f00019] is amended as follows.

(2) In Article 4—

(a) in point (g), omit “as defined in retained EU law on food additives”;

(b) in point (i), omit “as defined in retained EU law on flavourings”.

(3) In Article 6(1)(g)—

(a) after “use levels in” omit “the”;

(b) omit “mentioned in the domestic list”.

(4) In Article 7(2)(f)—

(a) after “use levels in” omit “the”;

(b) omit “mentioned in the domestic list”.

(5) In Article 10(1)(e)—

(a) after “use levels in” omit “the”;

(b) omit “according to the domestic list”.

(6) In Article 12—

(a) in paragraph 3, in the second subparagraph, for “establishment of the domestic list” substitute “the determination of applications for initial authorisation”;

(b) in paragraph 4, for “update the domestic list” substitute “determine the authorisation status”.

(7) In the Annex, in each model letter, in each place it occurs, for “in order to update the domestic list on” substitute “for a determination of authorisation status in relation to”.

PART 4 — Amendments relating to food contact materials

Amendment of Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food, etc.

11

(1) Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food, etc.[^f00020] is amended as follows.

(2) In Article 2(2), after point (g) insert—

(h) ‘specific measure’ means a measure under Article 5.

(3) In Article 5(1)—

(a) in point (a), for “a list of” substitute “provision regulating”;

(b) in point (b)—

(i) for “list(s) of”, in the first place it occurs, substitute “provision regulating”;

(ii) in the second place it occurs, omit “list(s) of”;

(iii) omit “and, when necessary, special conditions of use for these substances”;

(d) in point (e) omit “specific”;

(e) in point (m)—

(i) for “provisions requiring the appropriate authority to establish and maintain” substitute “provision relating to the establishment and maintenance of”;

(ii) after “Register” insert “or list”.

(4) In Article 8—

(a) for paragraph 1 substitute—

(1) A person seeking an authorisation for a substance in accordance with a specific measure, where that substance has not yet been authorised by the appropriate authority, must submit an application in accordance with Article 9(1) and any relevant provisions in the specific measure concerned.

(b) in paragraph 2—

(i) for “in the specific measures” substitute “out in the authorisation concerned”;

(ii) after “Article 4” insert “and any relevant specific measures”.

(5) In Article 11—

(a) in paragraph 1—

(i) for “prescribed” substitute “determined”;

(ii) for “in light of” substitute “, having regard to”;

(b) after paragraph 1, insert—

(1A) Where the appropriate authority determines that a substance is, or is not to be, authorised, the appropriate authority must: (a) in the event of a determination to authorise the substance, specify the date on which the authorisation is to have effect; and (b) communicate the determination to the Food Safety Authority.

(6) In Article 12—

(a) in paragraph 4, for “may prescribe amendments to the authorisation” substitute “determine whether the authorisation is to be modified, suspended or revoked”;

(b) after paragraph 4 insert[^f00021]—

(4A) Where the appropriate authority determines that an authorisation is, or is not, to be modified, suspended or revoked: (a) the appropriate authority must: (i) specify the date on which the modification, suspension or revocation is to have effect; and (ii) communicate the determination to the Food Safety Authority; (b) the Food Safety Authority must ensure that the domestic list referred to in Article 12A is updated accordingly. (4B) For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which: (a) existing stocks of the substance, material or article concerned, and any products derived from it or containing it, may be placed on the market or used; (b) the substance, material or article concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used; (c) the labelling of the substance, material or article concerned, and any products derived from it or containing it, may continue to be applied. (4C) The appropriate authority may prescribe other transitional measures not falling within paragraph 4B in relation to the modification, suspension or revocation of an authorisation.

(7) After Article 12, insert—

(1) The Food Safety Authority must establish and maintain a list (the “domestic list”) of substances authorised for use in materials and articles, including any restrictions or conditions specified by the appropriate authority under Article 11. (2) The domestic list must be made available to the public.

(8) In Article 18(1), for “application of the provisions” substitute “the authorisation of the material or article”.

Amendment of Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food

12

(1) Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food[^f00022] is amended as follows.

(2) In Article 3, for point (g) substitute—

(g) ‘appropriate authority’ and ‘Food Safety Authority’ have the meanings given in Regulation (EC) No 1935/2004; (h) ‘registered substance’ means a substance that was entered in the Register immediately before IP completion day; (i) ‘Register’ means the “Register of substances for which a valid application for authorisation was submitted under Regulation (EC) No 450/2009” published by the European Commission, dated 14 June 2012, version 1.1, as it had effect in the European Union immediately before IP completion day[^f00023].

(3) Before Article 5, for the heading for “Section 1”, substitute “Authorised substances”.

(4) In Article 5—

(a) for the heading, substitute “Requirement for authorisation”;

(b) for paragraph 1 substitute—

(1) Only substances that are authorised by the appropriate authority in accordance with the procedure in Regulation (EC) No 1935/2004 may be used in components of active and intelligent materials and articles.

(5) In Article 6—

(a) in the heading, for “inclusion of substances in the list” substitute “authorisation”;

(b) in the text, for “included in the list” substitute “authorised”.

(6) In Article 7—

(a) in the heading, for “the list” substitute “an authorisation”;

(b) in the words before point (a), for “The list” substitute “An authorisation”.

(7) For Article 8, substitute—

(1) The Food Safety Authority may ask a person (“the applicant”) who applied for a registered substance to be entered in the Register to provide, within a specified period, such supplementary information or additional data as the Food Safety Authority considers necessary to evaluate that substance for the purpose of delivering its opinion to the appropriate authority prior to the determination of the authorisation status of that substance. (2) The Food Safety Authority may extend the period of time described in paragraph 1. (3) Where the Food Safety Authority makes a request under paragraph 1 and the applicant fails to provide the information or data requested within the specified period (including any extension of that period), the substance shall cease to be treated as a registered substance after the end of the day on which the applicant was required to provide the requested information but failed to do so. (4) Before determining the authorisation status of all registered substances (which, under Article 14, would cause Article 4(e) and 5 to begin to apply), the appropriate authority must: (a) have regard to substances (“unregistered substances”) other than registered substances lawfully placed on the market; and (b) consider the time that may reasonably be needed by a person to apply for an unregistered substance to be authorised in accordance with Regulation (EC) No 1935/2004 and this Regulation. (1) For the purposes of Article 8A, determining the authorisation status of a registered substance is to consist of the appropriate authority determining whether the registered substance is: (a) to be authorised for placing on the market or for use in contact with food; (b) to cease to be permitted to be placed on the market or used in contact with food, and to cease to be a registered substance. (2) A determination of a type falling within paragraph 1(b) may specify a period of time, or different periods of time, within which: (a) existing stocks of the registered substance concerned, and any products derived from it or containing it, may be placed on the market or used; (b) the registered substance concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used; (c) the labelling of the registered substance concerned, and any products derived from it or containing it, may continue to be applied. (3) Where the appropriate authority makes a determination as to the authorisation status of a registered substance, the appropriate authority must: (a) in the event of a determination to authorise the substance, specify the date on which the authorisation is to have effect; and (b) communicate the determination to the Food Safety Authority.

(8) Before Article 9, in the heading for “Section 2”, for “not to be included in the list” substitute “referred to in Article 5(2)”.

(9) In Article 14—

(a) in the second paragraph, for “of application of the Community list” substitute “that the appropriate authority determines the authorisation status of all registered substances in the Register pursuant to Article 8A and 8B”;

(b) in the final paragraph—

(i) for “of application of the Community list,” substitute “described in the second paragraph of this Article, registered substances and other”;

(ii) for “authorised” substitute “permitted to be placed on the market”;

(iii) in the second place it occurs, omit “Community”.

Amendment of Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

13

(1) Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food[^f00024] is amended as follows.

(2) In Article 3, after paragraph (19) insert—

(20) ‘appropriate authority’ and ‘Food Safety Authority’ have the meanings given in Regulation (EC) No 1935/2004.

(3) In Article 5—

(a) for the heading, substitute “Requirement for authorisation”;

(b) for paragraph 1 substitute—

(1) Only substances of a type falling within paragraph 2 and which are authorised by the appropriate authority in accordance with the procedure in Regulation (EC) 1935/2004 may be intentionally used in the manufacture of plastic layers in plastic materials and articles.

(c) in paragraph 2, in the words before point (a), for “The list shall contain:” substitute “For the purposes of paragraph 1, the types of substances that may be authorised are:”;

(d) omit paragraph 3.

(4) Omit Article 5A.

(5) In Article 6—

(a) in the heading, for “not included in the list” substitute “that are not authorised”;

(b) in paragraph 1, for “included in the list” substitute “that are authorised”;

(c) in paragraph 3, for “not included in the list are authorised” substitute “, if not otherwise authorised, are nevertheless deemed to be authorised,”;

(d) in paragraph 4, for “not included in the list” substitute “, if not otherwise authorised,”;

(e) in paragraph 5—

(i) for “not included in the list” substitute “that were not authorised”;

(ii) for “to include or not to include them in the list” substitute “on whether or not they are to be authorised,”.

(6) In Article 7—

(a) in paragraph 1, for “regularly prescribe” substitute “determine whether there are to be”;

(b) in paragraph 2—

(i) in point (a), for “included in the list set out in Annex 1” substitute “authorised”;

(ii) in point (b), for “include it in the list” substitute “authorise it”;

(3) Where the appropriate authority determines that there is to be an update to the provisional list, the appropriate authority must: (a) specify the date on which the update is to have effect; and (b) communicate the determination to the Food Safety Authority. (4) The Food Safety Authority must publish and maintain the provisional list, and where the Food Safety Authority is informed by the appropriate authority that there is to be an update to the provisional list, the Food Safety Authority must publish the update.

(7) In Article 9—

(a) in paragraph 1—

(i) in point (c)—

(aa) for “the” substitute “any”;

(bb) for “column 10 of Table 1 of point 1 of Annex I” substitute “the authorisations for the substances concerned”;

(ii) in point (d)—

(aa) for “the” substitute “any”;

(bb) for “in point 4 of Annex I” substitute “the authorisations for the substances concerned”;

(b) in paragraph 2, for “in Annex I” substitute “concerned”.

(8) In Article 11—

(a) in paragraph 1, for “Annex I” substitute “the authorisations for the substances concerned”;

(b) in paragraph 3(a), for “in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation” substitute “pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008 or this Regulation”;

(9) In Article 13—

(a) in paragraph 2—

(i) in point (a)—

(aa) after “set out in” insert “, or pursuant to,”;

(bb) for “Annex I” substitute “the authorisation for the substance concerned”;

(ii) in point (b), for “not listed in the list or” substitute “that are not authorised or not listed”;

(b) in paragraph 4, omit “not listed in the list or provisional list”.

(10) In Article 14—

(a) in paragraph 2, for “not listed in the list or” substitute “that are not authorised or in”;

(b) in paragraph 3, in the words before point (a), omit “not listed in the list or provisional list”;

(11) In Article 19—

(a) in the heading, for “not included in the list” substitute “that are not authorised”;

(b) in the text, for “covered by an inclusion in Annex I to this Regulation” substitute “authorised substances”.

(12) In Article 22, omit paragraph 4.

(13) Omit Annex I.

(14) In Annex II—

(a) in note (2) to Table 1, omit “The note in Annex I, Table 1, FCM No 398 applies:”;

(b) after the notes to Table 1, in paragraph 2 (which begins with the words “Primary aromatic amines”)—

(i) for “Table 1 of Annex I” substitute “an authorisation for the substance concerned”;

(ii) for “Annex I”, in the second place it occurs, substitute “the authorisation concerned”.

(15) In Annex IV, in point (6), for “Annex I and” substitute “the authorisation for the substance concerned and in Annex”.

(16) In Annex V—

(a) in Chapter 2, in point 2.1.8., for “Annex I” substitute “the authorisation for the substance concerned”;

(b) in Chapter 4, in point 4.1., in the first sentence—

(i) omit “in Annex I”;

(ii) for “column 7” substitute “the authorisation for the substance concerned”.

PART 5 — Amendments relating to products containing, consisting of, or produced from, genetically modified organisms

Amendment of Regulation (EC) No 1829/2003

14

(1) Regulation (EC) No 1829/2003 is amended as follows.

(2) In Article 2, after paragraph 23 insert—

(24) ‘Register’ means the register of genetically modified food and feed referred to in Article 28.

(3) In Article 4(5), omit “renewed,”.

(4) In Article 7—

(a) in paragraph 3, for “Any authorisation” to “authority and” substitute “Where the appropriate authority determines that there is to be an authorisation in respect of an application, the appropriate authority must specify the date on which the authorisation is to have effect and communicate the determination to the Food Safety Authority, and the authorisation”;

(b) in paragraph 4—

(i) omit the first sentence;

(ii) in the second sentence, after “entered” insert “, by the Food Safety Authority,”.

(5) After Article 9, insert—

(1) This Article applies where the Food Safety Authority receives, or becomes aware of, any information which might affect the assessment of the safety, or the suitability of the method of detection, of the authorised food concerned. (2) Where the Food Safety Authority receives, or becomes aware of, information under paragraph 1, the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 10. (3) The Food Safety Authority may ask a relevant person to provide, within a specified period, such other information as the Food Safety Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 10. (4) The Food Safety Authority may extend the period of time described in paragraph 3. (5) Where the Food Safety Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 10 based on such information as the Food Safety Authority has which might affect the assessment of the safety of the food concerned or the suitability of the method of detection. (6) In this Article, “relevant person” means any person who is— (a) the authorisation-holder; (b) a producer or manufacturer of the food concerned; or (c) any food business placing on the market the food concerned.

(6) In Article 10—

(a) in paragraph 2, for the third sentence substitute “The appropriate authority must, having regard to the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.”;

(b) after paragraph 2, insert—

(2A) Where the appropriate authority determines that an authorisation is to be modified, suspended or revoked, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the Register accordingly.

(4) For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which— (a) existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used; (b) the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used; (c) the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied. (5) The appropriate authority may prescribe other transitional measures not falling within paragraph 4 in relation to the modification, suspension or revocation of an authorisation.

(7) Omit Article 11.

(8) In Article 16(5), omit “renewed,”.

(9) In Article 19—

(a) in paragraph 3, for “Any authorisation” to “authority and” substitute “Where the appropriate authority determines that there is to be an authorisation in respect of an application, the appropriate authority must specify the date on which the authorisation is to have effect and communicate the determination to the Food Safety Authority, and the authorisation”;

(b) in paragraph 4—

(i) omit the first sentence;

(ii) in the second sentence, after “entered” insert “, by the Food Safety Authority,”.

(10) After Article 21, insert—

(1) This Article applies where the Food Safety Authority receives, or becomes aware of, any information which might affect the assessment of the safety, or the suitability of the method of detection, of the authorised feed concerned. (2) Where the Food Safety Authority receives, or becomes aware of, information under paragraph 1, the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 22. (3) The Food Safety Authority may ask a relevant person to provide, within a specified period, such other information as the Food Safety Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 22. (4) The Food Safety Authority may extend the period of time described in paragraph 3. (5) Where the Food Safety Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 22 based on such information as the Food Safety Authority has which might affect the assessment of the safety of the feed concerned or the suitability of the method of detection. (6) In this Article, “relevant person” means any person who is— (a) the authorisation-holder; (b) a producer or manufacturer of the feed concerned; or (c) any feed business placing on the market, processing or using the feed concerned.

(11) In Article 22—

(a) in paragraph 2, for the third sentence substitute “The appropriate authority must, having regard to the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.”;

(b) after paragraph 2, insert—

(2A) Where the appropriate authority determines that an authorisation is to be modified, suspended or revoked, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the Register accordingly.

(4) For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which— (a) existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used; (b) the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used; (c) the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied. (5) The appropriate authority may prescribe other transitional measures not falling within paragraph 4 in relation to the modification, suspension or revocation of an authorisation.

(12) Omit Article 23.

(13) In Article 28—

(a) in paragraph 1—

(i) omit “and maintain”; and

(ii) for “hereinafter” substitute “in this Regulation”;

(b) for paragraph 2, substitute—

(2) The Food Safety Authority must maintain the Register and make it available to the public.

(14) In Article 44(1), omit “renewal,”.

Amendment of Commission Regulation (EU) No 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material, etc.

15

(1) Commission Regulation (EU) No 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired[^f00025] is amended as follows.

(2) In Article 2—

(a) in point (b), omit the “and” at the end;

(b) omit point (c).

Amendment of Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed, etc.

16

(1) Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council, etc.[^f00026], is amended as follows.

(2) In Article 1, in the words before point (a), for “5, 11, 17 and 23” substitute “5 and 17”.

(3) In Article 8—

(a) in the heading, for “5(3), 11(2), 17(3) and 23(2)” substitute “5(3) and 17(3)”;

(b) omit paragraph 2.

(4) In Annex III, in section 4 (certified reference material), in the second paragraph, for “throughout the period of validity of the authorisation” substitute “with respect to the authorisation, and whilst the authorisation continues to have effect”.

PART 6 — Amendments relating to novel foods

Amendment of Regulation (EU) 2015/2283 on novel foods, etc.

17

(1) Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc.[^f00027] is amended as follows.

(2) In Article 3(2), omit point (k).

(3) After Article 3, insert—

(1) For the purposes of this Regulation, determining the authorisation status of a novel food is to consist of the appropriate authority determining whether or not to: (a) authorise the placing on the market, or the use in or on food, of a novel food; (b) modify the authorisation of a novel food, including modifying any conditions of use, post-market monitoring requirements, restrictions, specific labelling requirements or specifications associated with the authorisation of the novel food concerned; (c) revoke or suspend the authorisation of a novel food. (2) For the purposes of paragraph 1, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which— (a) existing stocks of the novel food concerned, and any products derived from it or containing it, may be placed on the market or used; (b) the novel food concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used; (c) the labelling of the novel food concerned, and any products derived from it or containing it, may continue to be applied. (3) The appropriate authority may prescribe other transitional measures not falling within paragraph 2 in relation to the modification, suspension or revocation of an authorisation. (1) The Food Safety Authority must establish and maintain a list (the “domestic list”) of novel foods, the placing on the market or use of which has been authorised in accordance with this Regulation, including the details described in Article 9(3). (2) The domestic list must be made available to the public.

(4) For Article 6, substitute—

Only novel foods authorised by the appropriate authority in accordance with this Regulation may be placed on the market within Great Britain as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified in the authorisations concerned.

(5) In Article 7—

(a) in the heading, for “inclusion of novel foods in the list” substitute “authorisation of novel foods”;

(b) in the words before point (a), for “and include a novel food in the list” substitute “a novel food”.

(6) In Article 9—

(a) for the heading, substitute “Obligations of the appropriate authority in relation to the procedure for determining authorisation status and content of an authorisation”;

(b) in paragraph 1, in the words before point (a), for “authorise a novel food and update the list” substitute “determine the authorisation status of a novel food”;

(d) in paragraph 3, in the words before point (a), for “The entry for a novel food in the list provided for in paragraph 2” substitute “The authorisation of a novel food”.

(7) In Article 10—

(a) for the heading, substitute “Procedure for determining authorisation status”;

(b) in paragraph 1, in the first sentence—

(i) for “authorising the placing on the market within Great Britain” substitute “determining the authorisation status”;

(ii) omit “and updating the list”;

(d) in paragraph 5—

(i) omit “and updating the list”;

(ii) for “prescribes an update of the list in respect” substitute “determines the authorisation status”;

(e) in paragraph 6—

(i) for “an update of the list” substitute “a determination of the authorisation status of the novel food concerned”;

(ii) for “an update”, in the second place it occurs, substitute “a determination”.

(8) In Article 12—

(a) in the heading, omit “and updates of the list”;

(b) in paragraph 1, in the words before point (a), for “, by prescribing an update of the list, authorise the placing on the market within Great Britain” substitute “determine the authorisation status”;

(2A) Where the appropriate authority determines the authorisation status of a novel food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.

(9) In Article 15—

(a) in paragraph 4—

(i) in the first sentence, omit “by prescribing an update to the list”;

(ii) in the second sentence, for “entry in the list” substitute “authorisation”;

(b) in paragraph 5, omit “or update the list”.

(10) In Article 18—

(a) in the heading, omit “and updates of the list”;

(b) in paragraph 1, in the words before point (a), omit “by prescribing an update of the list”;

(i) in the first sentence—

(aa) for “update”, in the first place it occurs, substitute “authorisation”;

(bb) for “proceed with an update of the list where it considers that such an update” substitute “authorise the placing on the market of the traditional food where it considers that authorisation”;

(ii) in the second sentence, for “not considering the update to be justified” substitute “its decision”;

(d) after paragraph 3, insert—

(4) Where the appropriate authority determines the authorisation status of a traditional food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.

(11) For Article 19, substitute—

Articles 3A and 3B and 9 to 12 apply to modifying any specifications, conditions of use, specific labelling requirements or post-market monitoring requirements associated with the authorisation of a traditional food from a third country or to suspending or revoking an authorisation of a traditional food from a third country.

(12) In Article 23, in the heading, for “updates of the list” substitute “authorisation”.

(13) In Article 27—

(a) in the heading, omit “and inclusion in the list”;

(b) in paragraph 1—

(i) in the words before point (a)—

(aa) omit “and included in the list”;

(bb) for “entry of that novel food in the list” substitute “authorisation of that novel food”;

(ii) in point (a), for “inclusion of the novel food in the list” substitute “authorisation”.

(14) In Article 35(2A), for point (d) substitute—

(d) there is a determination of the authorisation status of the novel food concerned.

Amendment of Commission Implementing Regulation (EU) 2017/2468

18

(1) Commission Implementing Regulation (EU) 2017/2468 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283, etc.[^f00028], is amended as follows.

(2) In Annexes I and II, in the template cover letter in each Annex, for “in order to update the list on” substitute “for a determination of authorisation status in relation to”.

Amendment of Commission Implementing Regulation (EU) 2017/2469

19

(1) Commission Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283, etc.[^f00029], is amended as follows.

(2) In Annex I, in the template cover letter, for “in order to update the list on” substitute “for a determination of authorisation status in relation to”.

PART 7 — Amendments relating to smoke flavourings

Amendment of Regulation (EC) No 2065/2003

20

(1) Regulation (EC) No 2065/2003 is amended as follows.

(2) In Article 1(2)—

(a) in point (a), at the end, insert “, and their conditions of use in or on foods”;

(b) omit point (b).

(3) In Article 3, omit paragraph 8.

(4) In Article 4(2), for “Article 6” substitute “this Regulation”.

(5) In Article 6—

(a) for the heading, substitute “Content of authorisations”;

(b) omit paragraph 1;

(d) omit paragraph 3.

(6) After Article 6, insert—

(1) The Authority must establish and maintain a list (the “domestic list”) of primary products for use as such in or on foods or for the production of derived smoke flavourings, which have been authorised in accordance with this Regulation, including the details described in Article 6(2). (2) The Authority must make the domestic list available to the public.

(7) In Article 7(1)—

(a) for “inclusion” substitute “authorisation”;

(b) omit “in the list referred to in Article 6(1)”.

(8) In Article 9—

(a) in paragraph 1—

(i) in the first sentence; for “include a primary product in the list referred to in Article 6(1)” substitute “authorise the primary product”;

(ii) in the second sentence, for “inform the” substitute “specify the date on which the authorisation (if it is a decision to authorise) is to have effect, and inform the Authority and the”;

(b) omit paragraphs 2 and 3.

(9) After Article 9 insert—

(1) This Article applies where the Authority receives, or becomes aware of, any information which might affect the assessment of the safety of an authorised primary product or derived smoke flavouring. (2) Where the Authority receives, or becomes aware of, information under paragraph 1, the Authority must consider whether it is necessary to issue an opinion under Article 11(2). (3) The Authority may ask a relevant person to provide, within a specified period, such other information as the Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 11(2). (4) The Authority may extend the period of time described in paragraph 3. (5) Where the Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Authority must consider whether it is necessary to issue an opinion under Article 11(2) based on such information as the Authority has which might affect the assessment of the safety of the authorised primary product or derived smoke flavouring concerned. (6) In this Article, “relevant person” means any person who is— (a) the authorisation holder of the authorised primary product or derived smoke flavouring concerned; (b) a producer or manufacturer of the authorised primary product or derived smoke flavouring concerned; or (c) any food business placing on the market or using the authorised primary product or derived smoke flavouring concerned.

(10) In Article 11—

(a) for paragraph 2 substitute—

(2) An opinion on whether an authorisation or the requested modification is still in accordance with this Regulation, following the procedure laid down in Article 8, where applicable: (a) may be delivered by the Authority of its own initiative to the appropriate authority; or (b) must be delivered by the Authority to the appropriate authority: (i) following an application under paragraph 1, but only where the modification could affect the safety assessment of the authorised primary product; or (ii) following a request to do so from the appropriate authority.

(b) in paragraph 3, for “the entry for that authorisation” substitute “, suspend or revoke the authorisation”;

(4) Where the appropriate authority decides to modify, suspend or revoke an authorisation, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the decision to the Authority, and the Authority must update the domestic list referred to in Article 6A accordingly. (4A) For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which— (a) existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used; (b) the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used; (c) the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied. (4B) The appropriate authority may prescribe other transitional measures not falling within paragraph 4A in relation to the modification, suspension or revocation of an authorisation.

(11) Omit Article 12.

(12) In Article 13(1)—

(a) in the words before point (a), omit “specified in the list referred to in Article 6(1)”;

(b) in point (a), omit “as given in the list referred to in Article 6(1)”;

(d) in point (c), for “set out in the list referred to in Article 6(1)” substitute “for that product”.

(13) In Article 18—

(a) in the heading, after “Amendments” insert “to the Annexes”;

(b) omit the “and” at the end of point (a);

(14) Omit Article 20.

PART 8 — Revocations, consequential amendments, savings and transitional provision

Revocations

21

(1) Schedules 1, 2 and 3 have effect.

(2) The instruments listed in Schedules 4 to 8 are revoked.

Consequential amendments

22

Schedules 9 to 12 have effect.

Savings and transitional provision: general

23

(1) Subject to paragraphs (2) and (3), an authorisation set out in relevant revoked provision continues to have effect following the entry into force of these Regulations—

(a) as it had effect under regulated products legislation immediately before the entry into force of these Regulations, notwithstanding the revocation of any provision by these Regulations; and

(b) as if it were an authorisation made under, and subject to, that regulated products legislation as amended by these Regulations.

(2) This paragraph applies to any authorisation made under the following instruments that is set out in relevant revoked provision—

(a) Regulation (EC) No 1829/2003;

(b) Regulation (EC) No 1831/2003, except for any urgent provisional authorisation made under Article 15 of that instrument; or

(3) For the purposes of paragraph (1), an authorisation to which paragraph (2) applies continues to have effect as if it did not contain a period of validity or an authorisation period end date.

(4) An authorisation falling within paragraph (1) must be published in accordance with the regulated products legislation applicable to the authorisation concerned, as that regulated products legislation has effect immediately after the coming into force of these Regulations.

(5) In this regulation—

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