PART 3Amendments 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(1) 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;

(c)after paragraph 6, insert—

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

(4) After Article 2, insert—

“Article 2ARequirement for appropriate authority to determine authorisation status

The appropriate authority must determine the authorisation status of substances in accordance with the sectoral food law concerned and this Regulation.

Article 2BDetermination of authorisation status

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.

Article 2CDomestic list of substances

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,”;

(c)after paragraph 1, insert—

“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.(2) 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”;

(c)in paragraph 2, in the words before point (a)—

(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—

“Article 8ADetails to be included in the domestic list

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.”;

(c)in paragraph 2—

(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(3) 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(4), the Food Supplements (Scotland) Regulations 2003(5), the Food Supplements (England) Regulations 2003(6), the Food Supplements (Wales) Regulations 2003(7) 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.(8), 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—

“Article 4Requirement for authorisation

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.”;

(c)in paragraph 2—

(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—

“Article 14AEthylene oxide: restrictions

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.

Article 14BDetails to be included in the domestic list

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”;

(c)in paragraph 3, for “or food enzyme”, in both places, substitute “, food enzyme 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—

“ANNEX Ia

Carry-over principle: Article 18(1)(a) – exceptions”.

(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.(9), 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(10); 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—

“Article 9AFlavouring substances under evaluation

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.

Article 10Flavourings and source materials that may be placed on the market or used in or on foods

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”;

(c)in paragraph 2—

(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—

“Article 12ADetails to be included in the domestic list

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(11) 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”.