SI 2025/361 - The Food and Feed (Regulated Products) (Amendment, - 21st March 2025 - UK Parliament

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. STATUTORY INSTRUMENTS 2025 No. 361 AGRICULTURE FOOD RETAINED EU LAW REFORM The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 Made - - - - 17th March 2025 Coming into force - - 1st April...

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

STATUTORY INSTRUMENTS 2025 No. 361 AGRICULTURE FOOD RETAINED EU LAW REFORM The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 Made - - - - 17th March 2025 Coming into force - - 1st April 2025 The Secretary of State makes these Regulations in exercise of the powers conferred by sections 14(1), (3), (4)(a) and (b) and 20(1) of the Retained EU Law (Revocation and Reform) Act 2023 (“the 2023 Act”)(1).

The Secretary of State is a relevant national authority for the purposes of section 14(1) and (3) of the 2023 Act(2).

In accordance with paragraph 5(1) and (5) of Schedule 5 to the 2023 Act, a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.

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(3), there has been open and transparent public consultation during the preparation and evaluation of these Regulations.

(1) 2023 c. 28.

(2) The term “relevant national authority” is defined in section 21(1) of the 2023 Act.

(3) EUR 2002/178, amended by S.I. 2019/641 and 2022/377.Document Generated: 2025-04-01

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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(4);

(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(5);

(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(6).

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”.

(4) EUR 2003/1829, amended by S.I. 2019/705, 2022/377 and 1351.

(5) EUR 2003/1831, amended by S.I. 2019/654 and 2022/1351.

(6) EUR 2003/2065, amended by S.I. 2019/860.

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(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”;

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— “Article 12A

Supervision: supplementary

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

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(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”;

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;

(c) after paragraph 1, insert— “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;

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(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(7) 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.

(7) EUR 2005/378, amended by S.I. 2019/654 and 2022/1351.

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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(8) 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(9) 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”;

(8) EUR 2008/429, amended by S.I. 2019/654 and 2022/1351.

(9) EUR 2008/1331, amended by S.I. 2019/860.

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(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 2A Requirement 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 2B Determination 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;

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 2C Domestic 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.”.

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(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,”;

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”.

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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.(10) 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— “Article 8A Details 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.”.

(10) EUR 2008/1332, amended by S.I. 2019/860.

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(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”.

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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(11) 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(12), the Food Supplements (Scotland) Regulations 2003(13), the Food Supplements (England) Regulations 2003(14), the Food Supplements (Wales) Regulations 2003(15) 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.(16), 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 4 Requirement 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.

(11) EUR 2008/1333, amended by S.I. 2019/860, S.S.I. 2023/78, S.I. 2023/334 and 343 (W. 50), S.S.I. 2024/156, S.I. 2024/685 and 741 (W. 102).

(12) EUR 2006/1925, amended by S.I. 2019/651.

(13) S.S.I. 2003/278, amended by S.S.I. 2009/438, 2014/312, 2019/54, S.I. 2023/131 and S.S.I. 2023/374.

(14) S.I. 2003/1387, amended by S.I. 2009/3251, 2014/1855, 2019/651 and 2023/131.

(15) S.I. 2003/1719 (W. 186), amended by S.I. 2005/3254 (W. 247), 2009/3252 (W. 282), 2014/2303 (W. 227), 2019/179 (W. 45), 2023/131 and 1332 (W. 240).

(16) EUR 2013/609, amended by S.I. 2019/651 and 2023/28.

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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”.

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(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 14A

Ethylene 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 14B Details 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”;

(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.

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(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.(17), 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(18); 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”.

(17) EUR 2008/1334, amended by S.I. 2019/860, S.S.I. 2023/78, S.I. 2023/334 and 343 (W. 50), S.S.I. 2024/156, S.I. 2024/685 and 741 (W. 102).

(18) EUR 2012/872, amended by S.I. 2019/860.

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(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 9A Flavouring 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 10 Flavourings 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”;

(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 12A Details 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 15Document Generated: 2025-04-01

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(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(19) 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.(20) 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)—

(19) EUR 2011/234, amended by S.I. 2019/860.

(20) EUR 2004/1935, amended by S.I. 2019/704.

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(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(21)— “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;

(21) Paragraphs 5 and 6 of Article 8 were revoked by S.I. 2019/704.

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(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— “Article 12A Domestic list of authorised substances

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(22) 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(23).”.

(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—

(22) EUR 2009/450, amended by S.I. 2019/704 and 2022/1351.

(23) OJ L 135, 30.5.2009, p.3. The Register can be viewed at: https://food.ec.europa.eu/document/download/a9c36f0e- b3b1-457a-84fb-b5b57662e911_en?filename=cs_fcm_legis_active-intelligent_register.pdf 18Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. “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— “Article 8A Registered substances

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.

Article 8B

Determination of authorisation status: registered substances

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.

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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(24) 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.

(24) EUR 2011/10, amended by S.I. 2019/704.

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(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”;

(c) after paragraph 2, insert— “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”;

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(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— 22Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. “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— “Article 9A

Supervision: supplementary

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.

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

(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 23Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. determination to the Food Safety Authority, and the Food Safety Authority must update the Register accordingly.”;

(c) after paragraph 3 insert— “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—

(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— “Article 21A

Supervision: supplementary

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.

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 24Document Generated: 2025-04-01

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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

(11) In Article 22—

(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 25Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. an authorisation procedure is pending or the authorisation of which has expired(25) 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.(26), 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.(27) is amended as follows.

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

(3) After Article 3, insert— “Article 3A Determination of authorisation status

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;

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—

(25) EUR 2011/619, amended by S.I. 2019/654 and 2022/1351.

(26) EUR 2013/503, amended by S.I. 2019/705.

(27) EUR 2015/2283, amended by S.I. 2019/702 and 2022/1351.

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(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.

Article 3B Domestic list of authorised novel foods

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— “Article 6 Requirement for authorisation 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— 27Document Generated: 2025-04-01

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(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”;

(c) after paragraph 2, insert— “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— 28Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. “Article 19 Application of provisions to authorised traditional foods from third countries 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.(28), 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.(29), 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).

(28) EUR 2017/2468, amended by S.I. 2019/702.

(29) EUR 2017/2469, amended by S.I. 2019/702.

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(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— “Article 6A Domestic list of authorised smoke flavouring primary products

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— “Article 9A Supervision

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.

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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”;

(c) for paragraph 4 substitute— “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)”;

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(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— subject to paragraph (6), an “authorisation”—

(a) means, and includes, the terms, conditions and specifications on, or pursuant to, which anything was, immediately before the entry into force of these Regulations, permitted to 32Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. be used, processed or placed on the market in or under regulated products legislation, and for this purpose “specifications” includes any specifications set out in the Annex to Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council(30) as it had effect immediately before the entry into force of these Regulations; and

(b) includes any terms, conditions and specifications on, or pursuant to, which anything, immediately before the entry into force of these Regulations, remained allowed to be used, processed or placed on the market by virtue of the operation of any of the following provisions, as they had effect immediately before the entry into force of these Regulations—

(i) Article 11(4) or 23(4) of Regulation (EC) No 1829/2003;

(ii) Article 14(4) of Regulation (EC) No 1831/2003; or

(iii) Article 12(4) of Regulation (EC) No 2065/2003; “authorisation period end date” means a date—

(a) at, on or by which the authorisation or the period of authorisation was expressed as ending; or

(b) until which the authorisation was expressed as being valid; “period of validity” means a period during which the authorisation concerned was expressed as being valid; “regulated products legislation” means an instrument amended by Parts 2 to 7 of these Regulations;

“relevant revoked provision” means—

(a) the instruments revoked by Schedules 1, 2 and 3;

(b) the assimilated direct legislation revoked by Schedules 4 to 7;

(d) Annex I to 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.; or

(e) Annex I to Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

(6) But, for the purpose of this regulation, an authorisation does not include any terms, conditions and specifications on, or pursuant to, which anything was, immediately before the entry into force of these Regulations, permitted to be used, processed or placed on the market pursuant to a saving or transitional provision in an instrument—

(i)made under Regulation (EC) No 1829/2003;

(ii)made under Regulation (EC) No 1831/2003;

(iii)that amended relevant revoked provision; or

(iv)revoked by Schedule 1, 2 or 3.

(30) EUR 2012/231, amended by S.I. 2019/860, S.S.I. 2023/78, S.I. 2023/334 and 343 (W. 50), S.S.I. 2024/156, S.I. 2024/685 and 741 (W. 102).

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Savings in relation to the operation of Article 10 of Regulation (EC) No 1831/2003

24. Notwithstanding the amendments or revocations made by regulations 3(4) and (9), 4 and 5, the following provisions continue to have effect as they did immediately before the entry into force of these Regulations insofar as is necessary for the continued operation of Article 10 of Regulation

(EC) No 1831/2003 after the entry into force of these Regulations—

(a) Article 4(2) and 14 of Regulation (EC) No 1831/2003;

(b) Article 3(3), 5(4)(c) and Annex IV paragraph 5 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;

(c) Annex I, II and III 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.

Signed by authority of the Secretary of State for Health and Social Care Ashley Dalton Parliamentary Under Secretary of State 17th March 2025 Department of Health and Social Care 34Document Generated: 2025-04-01

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SCHEDULE 1 Regulation 21(1)

Revocations with savings: Scotland statutory instruments The following Scottish statutory instruments are revoked in full unless specified otherwise—

(a) the Genetically Modified Food and Feed (Authorisations) (Scotland) Regulations 2022(31);

(b) the Novel Foods (Authorisations) and Smoke Flavourings (Modification of Authorisations) (Scotland) Regulations 2022(32);

(c) the Feed Additives (Authorisations) (Scotland) Regulations 2022(33), except the transitional provisions in regulations 8 to 10, and regulations 1, 2, 4 to 7 and 11 and Schedule 12 to the extent necessary for the continued operation of regulations 8 to 10;

(d) the Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (Scotland) Regulations 2023(34);

(e) the Food Additives, Food Flavourings and Novel Foods (Authorisations) (Scotland) Regulations 2023(35), except the transitional provision in regulation 5, and regulations 1 and 2 to the extent necessary for the continued operation of regulation 5;

(f) the Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds)

(Scotland) Regulations 2023(36);

(g) the Feed Additives (Authorisations) (Scotland) Regulations 2023(37), except the transitional provision in regulation 4, and regulations 1, 2, 7(1) and paragraph 1 of Schedule 14 to the extent necessary for the continued operation of regulation 4;

(h) the Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Scotland) Regulations 2024(38), except the transitional provision in regulation 7, and regulations 1, 2 and 6(2)(a) to (v) to the extent necessary for the continued operation of regulation 7;

(i) the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Miscellaneous Amendment) (Scotland) Regulations 2024(39), except for regulation 8, the amendment in Part 3 and the transitional provisions in Part 4, and Part 1 to the extent necessary for the continued operation of regulation 8 and Parts 3 and 4.

SCHEDULE 2 Regulation 21(1)

Revocations with savings: Wales statutory instruments The following statutory instruments are revoked in full unless specified otherwise—

(a) the Genetically Modified Food and Feed (Authorisations) (Wales) Regulations 2022(40);

(b) the Novel Foods (Authorisations) and Smoke Flavourings (Modification of Authorisations) (Wales) Regulations 2022(41);

(31) S.S.I. 2022/137, amended by S.S.I. 2023/59.

(32) S.S.I. 2022/168.

(33) S.S.I. 2022/288, amended by S.S.I. 2022/373 and 2023/374.

(34) S.S.I. 2023/59.

(35) S.S.I. 2023/78.

(36) S.S.I. 2023/170.

(37) S.S.I. 2023/339.

(38) S.S.I. 2024/156.

(39) S.S.I. 2024/330.

(40) S.I. 2022/472 (W. 116).

(41) S.I. 2022/575 (W. 133).

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(c) the Feed Additives (Authorisations) (Wales) Regulations 2022(42), except the transitional provisions in regulations 9 to 11, and regulations 1 and 2 and 4 to 7 to the extent necessary for the continued operation of regulations 9 to 11;

(d) the Food Additives, Food Flavourings, and Novel Foods (Authorisations) and Food and Feed (Miscellaneous Amendments) (Wales) Regulations 2023(43), except the transitional provision in regulation 4 and the amendments set out in Part 5, and regulation 1 to the extent necessary for the continued operation of regulation 4 and Part 5;

(e) the Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (Wales) Regulations 2023(44);

(f) the Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds) (Wales) Regulations 2023(45);

(g) the Feed Additives (Authorisations) (Wales) Regulations 2023(46), except the transitional provision in regulation 4, and regulations 1 and 2 to the extent necessary for the continued operation of regulation 4;

(h) the Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Wales) Regulations 2024(47), except the transitional provision in regulation 5, and regulations 1 and 4(2)(a) to (v) to the extent necessary for the continued operation of regulation 5;

(i) the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024(48), except for regulation 8, the transitional provisions in Part 3 and the amendment in Part 4, and Part 1 to the extent necessary for the continued operation of regulation 8 and Parts 3 and 4.

SCHEDULE 3 Regulation 21(1)

Revocations with savings: England statutory instruments The following statutory instruments are revoked in full unless specified otherwise—

(a) the Genetically Modified Food and Feed (Authorisations) (England) Regulations 2022(49);

(b) the Novel Foods (Authorisations) and Smoke Flavourings (Modification of Authorisations) (England) Regulations 2022(50);

(c) the Novel Foods (Authorisations) and Smoke Flavourings (Modification of Authorisations) (Amendment) (England) Regulations 2022(51);

(d) the Feed Additives (Authorisations) (England) Regulations 2022(52), except the transitional provisions in regulations 8 to 10, and regulations 1, 2, 4 to 7 and 11 and Schedule 12 to the extent necessary for the continued operation of regulations 8 to 10;

(42) S.I. 2022/1118 (W. 233), amended by S.I. 2023/1332 (W. 240).

(43) S.I. 2023/343 (W. 50).

(44) S.I. 2023/379 (W. 59).

(45) S.I. 2023/678 (W. 100).

(46) S.I. 2023/1276 (W. 224).

(47) S.I. 2024/741 (W. 102).

(48) S.I. 2024/1251 (W. 209).

(49) S.I. 2022/486.

(50) S.I. 2022/560, amended by S.I. 2022/619.

(51) S.I. 2022/619.

(52) S.I. 2022/1129.

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(e) the Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (England) Regulations 2023(53);

(f) the Food Additives, Food Flavourings and Novel Foods (Authorisations) (England) Regulations 2023(54), except the transitional provision in regulation 4, and regulation 1 to the extent necessary for the continued operation of regulation 4;

(g) the Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds)

(England) Regulations 2023(55);

(h) the Feed Additives (Authorisations) (England) Regulations 2023(56), except the transitional provision in regulation 6, and regulations 1, 2, 7(2) and Part 2 of Schedule 14 to the extent necessary for the continued operation of regulation 6;

(i) the Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (England) Regulations 2024(57), except the transitional provision in regulation 5, and regulations 1 and 4(2)(a) to (v) to the extent necessary for the continued operation of regulation 5;

(j) the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024(58), except for the amendment in Part 3 and the transitional provisions in Part 5, and Part 1 to the extent necessary for the continued operation of Parts 3 and 5.

SCHEDULE 4 Regulation 21(2)

Revocations: miscellaneous assimilated direct legislation

Revocation of assimilated direct legislation: miscellaneous instruments

1. Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council.

2. Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008, etc.

3. Commission Regulation (EU) No 873/2012 on transitional measures concerning the Union list of flavourings and source materials set out in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council(59).

4. Commission Implementing Regulation (EU) No 1321/2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings(60).

(53) S.I. 2023/235.

(54) S.I. 2023/334.

(55) S.I. 2023/689.

(56) S.I. 2023/1196.

(57) S.I. 2024/685.

(58) S.I. 2024/1101.

(59) EUR 2012/873, amended by S.I. 2019/860.

(60) EUR 2013/1321, amended by S.I. 2019/860, S.S.I. 2022/168, S.I. 2022/560 and 575 (W. 133).

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SCHEDULE 5 Regulation 21(2)

Revocation of assimilated direct legislation: instruments containing feed additives authorisations Revocation of assimilated direct legislation containing feed additives authorisations

1. Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs(61).

2. Commission Regulation (EC) No 255/2005 of 15 February 2005 concerning the permanent authorisations of certain additives in feedingstuffs(62).

3. Commission Regulation (EC) No 358/2005 of 2 March 2005 concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffs(63).

4. Commission Regulation (EC) No 521/2005 of 1 April 2005 concerning the permanent authorisation of an additive and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs(64).

5. Commission Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs(65).

6. Commission Regulation (EC) No 1200/2005 of 26 July 2005 concerning the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs(66).

7. Commission Regulation (EC) No 1206/2005 of 27 July 2005 concerning the permanent authorisation of certain additives in feedingstuffs(67).

8. Commission Regulation (EC) No 1458/2005 of 8 September 2005 concerning the permanent and provisional authorisations of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs(68).

9. Commission Regulation (EC) No 1811/2005 of 4 November 2005 concerning the provisional and permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs(69).

10. Commission Regulation (EC) No 252/2006 of 14 February 2006 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisations of new uses of certain additives already authorised in feedingstuffs(70).

11. Commission Regulation (EC) No 479/2006 of 23 March 2006 as regards the authorisation of certain additives belonging to the group compounds of trace elements(71).

(61) EUR 2004/2148.

(62) EUR 2005/255.

(63) EUR 2005/358.

(64) EUR 2005/521.

(65) EUR 2005/600.

(66) EUR 2005/1200.

(67) EUR 2005/1206.

(68) EUR 2005/1458.

(69) EUR 2005/1811.

(70) EUR 2006/252.

(71) EUR 2006/479.

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12. Commission Regulation (EC) No 773/2006 of 22 May 2006 concerning the provisional and permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs(72).

13. Commission Regulation (EC) No 1284/2006 of 29 August 2006 concerning the permanent authorisations of certain additives in feedingstuffs(73).

14. Commission Regulation (EC) No 1443/2006 of 29 September 2006 concerning the permanent authorisations of certain additives in feedingstuffs and an authorisation for 10 years for a coccidiostat(74).

15. Commission Regulation (EC) No 1446/2006 of 29 September 2006 concerning the authorisation of Enterococcus faecium (Biomin IMB52) as a feed additive(75).

16. Commission Regulation (EC) No 1876/2006 of 18 December 2006 concerning the provisional and permanent authorisation of certain additives in feedingstuffs(76).

17. Commission Regulation (EC) No 184/2007 of 20 February 2007 concerning the authorisation of potassium diformate (Formi LHS) as a feed additive(77).

18. Commission Regulation (EC) No 242/2007 of 6 March 2007 concerning the authorisation of endo-1,4-beta xylanase EC 3.2.1.8 (Belfeed B1100MP and Belfeed B1100ML) as a feed additive(78).

19. Commission Regulation (EC) No 244/2007 of 7 March 2007 concerning the authorisation of L-histidine monohydrochloride monohydrate as a feed additive(79).

20. Commission Regulation (EC) No 497/2007 of 4 May 2007 concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive(80).

21. Commission Regulation (EC) No 537/2007 of 15 May 2007 concerning the authorisation of the fermentation product of Aspergillus oryzae (NRRL 458) (Amaferm) as a feed additive(81).

22. Commission Regulation (EC) No 1140/2007 of 1 October 2007 concerning the provisional authorisation of a new use of an additive already authorised in feedingstuffs(82).

23. Commission Regulation (EC) No 1141/2007 of 1 October 2007 concerning the authorisation of 3-phytase (ROVABIO PHY AP and ROVABIO PHY LC) as a feed additive(83).

24. Commission Regulation (EC) No 1501/2007 of 18 December 2007 concerning the authorisation of a new use of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive(84).

25. Commission Regulation (EC) No 1520/2007 of 19 December 2007 concerning the permanent authorisation of certain additives in feedingstuffs(85).

26. Commission Regulation (EC) No 167/2008 of 22 February 2008 concerning a new authorisation for ten years of a coccidiostat as an additive in feedingstuffs(86).

(72) EUR 2006/773.

(73) EUR 2006/1284.

(74) EUR 2006/1443.

(75) EUR 2006/1446.

(76) EUR 2006/1876.

(77) EUR 2007/184.

(78) EUR 2007/242.

(79) EUR 2007/244.

(80) EUR 2007/497.

(81) EUR 2007/537.

(82) EUR 2007/1140.

(83) EUR 2007/1141.

(84) EUR 2007/1501.

(85) EUR 2007/1520.

(86) EUR 2008/167.

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

27. Commission Regulation (EC) No 554/2008 of 17 June 2008 concerning the authorisation of 6-phytase (Quantum Phytase) as a feed additive(87).

28. Commission Regulation (EC) No 721/2008 of 25 July 2008 concerning the authorisation of a preparation of red carotenoid-rich bacterium Paracoccus carotinifaciens as a feed additive(88).

29. Commission Regulation (EC) No 775/2008 of 4 August 2008 establishing maximum residue limits for the feed additive canthaxanthin in addition to the conditions provided for in Directive 2003/7/EC(89).

30. Commission Regulation (EC) No 971/2008 of 3 October 2008 concerning a new use of a coccidiostat as additive in feedingstuffs(90).

31. Commission Regulation (EC) No 1290/2008 of 18 December 2008 concerning the authorisation of a preparation of Lactobacillus rhamnosus (CNCM-I-3698) and Lactobacillus farciminis (CNCM-I-3699) (Sorbiflore) as a feed additive(91).

32. Commission Regulation (EC) No 271/2009 of 2 April 2009 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase as a feed additive for weaned piglets, chickens for fattening, laying hens, turkeys for fattening and ducks for fattening (holder of the authorisation BASF SE)(92).

33. Commission Regulation (EC) No 322/2009 of 20 April 2009 concerning the permanent authorisations of certain additives in feedingstuffs(93).

34. Commission Regulation (EC) No 403/2009 of 14 May 2009 concerning the authorisation of a preparation of L-valine as a feed additive(94).

35. Commission Regulation (EC) No 887/2009 of 25 September 2009 concerning the authorisation of a stabilised form of 25-hydroxycholecalciferol as a feed additive for chickens for fattening, turkeys for fattening, other poultry and pigs(95).

36. Commission Regulation (EC) No 900/2009 of 25 September 2009 concerning the authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 as a feed additive(96).

37. Commission Regulation (EC) No 1087/2009 of 12 November 2009 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), subtilisin produced by Bacillus subtilis (ATCC 2107) and alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) as a feed additive for chickens for fattening, for ducks and for turkeys for fattening (holder of authorisation Danisco Animal Nutrition, legal entity Finnfeeds International Limited)(97).

38. Commission Regulation (EC) No 1088/2009 of 12 November 2009 concerning the authorisation of a new use of an enzyme preparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) as a feed additive for weaned piglets, pigs for fattening, poultry for fattening and poultry for laying (holder of authorisation DSM Nutritional Products Ltd., represented by DSM Nutritional Products Sp. Z.o.o.)(98).

(87) EUR 2008/554.

(88) EUR 2008/721.

(89) EUR 2008/775.

(90) EUR 2008/971.

(91) EUR 2008/1290.

(92) EUR 2009/271.

(93) EUR 2009/322.

(94) EUR 2009/403.

(95) EUR 2009/887.

(96) EUR 2009/900.

(97) EUR 2009/1087.

(98) EUR 2009/1088.

40Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

39. Commission Regulation (EC) No 1091/2009 of 13 November 2009 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for chickens for fattening (holder of authorisation Aveve NV)(99).

40. Commission Regulation (EU) No 1270/2009 of 21 December 2009 concerning the permanent authorisations of certain additives in feedingstuffs(100).

41. Commission Regulation (EU) No 104/2010 of 5 February 2010 concerning the authorisation of potassium diformate as a feed additive for sows (holder of authorisation BASF SE) and amending Regulation (EC) No 1200/2005(101).

42. Commission Regulation (EU) No 514/2010 of 15 June 2010 concerning the authorisation of Pediococcus pentosaceus (DSM 16244) as a feed additive for all animal species(102).

43. Commission Regulation (EU) No 874/2010 of 5 October 2010 concerning the authorisation of lasalocid A sodium as a feed additive for turkeys up to 16 weeks (holder of authorisation Alpharma

(Belgium) BVBA) and amending Regulation (EC) No 2430/1999(103).

44. Commission Regulation (EU) No 875/2010 of 5 October 2010 concerning the authorisation for 10 years of an additive in feedingstuffs(104).

45. Commission Regulation (EU) No 885/2010 of 7 October 2010 concerning the authorisation of the preparation of narasin and nicarbazin as a feed additive for chickens for fattening (holder of authorisation Eli Lilly and Company Ltd) and amending Regulation (EC) No 2430/1999(105).

46. Commission Regulation (EU) No 998/2010 of 5 November 2010 concerning the authorisation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening (holder of the authorisation Lactosan GmbH & Co KG)(106).

47. Commission Regulation (EU) No 999/2010 of 5 November 2010 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 17594) as a feed additive for sows (holder of authorisation DSM Nutritional Products Ltd)(107).

48. Commission Regulation (EU) No 1117/2010 of 2 December 2010 concerning the authorisation of a preparation of citric acid, sorbic acid, thymol and vanillin as a feed additive for weaned piglets (holder of the authorisation Vetagro SpA)(108).

49. Commission Regulation (EU) No 1118/2010 of 2 December 2010 concerning the authorisation of diclazuril as a feed additive for chickens for fattening (holder of authorisation Janssen Pharmaceutica NV) and amending Regulation (EC) No 2430/1999(109).

50. Commission Regulation (EU) No 26/2011 of 14 January 2011 concerning the authorisation of vitamin E as a feed additive for all animal species(110).

51. Commission Regulation (EU) No 169/2011 of 23 February 2011 concerning the authorisation of diclazuril as a feed additive for guinea fowls (holder of authorisation Janssen Pharmaceutica N.V.)(111).

(99) EUR 2009/1091.

(100)EUR 2009/1270.

(101)EUR 2010/104.

(102)EUR 2010/514.

(103)EUR 2010/874.

(104)EUR 2010/875.

(105)EUR 2010/885.

(106)EUR 2010/998.

(107)EUR 2010/999.

(108)EUR 2010/1117.

(109)EUR 2010/1118.

(110)EUR 2011/26.

(111)EUR 2011/169.

41Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

52. Commission Regulation (EU) No 171/2011 of 23 February 2011 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223 as a feed additive for poultry and for porcine species and amending Regulation (EC) No 255/2005 (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. z o.o)(112).

53. Commission Regulation (EU) No 221/2011 of 4 March 2011 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223 as a feed additive for salmonids (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o)(113).

54. Commission Regulation (EU) No 337/2011 of 7 April 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase as feed additive for poultry, weaned piglets and pigs for fattening (holder of the authorisation Danisco Animal Nutrition)(114).

55. Commission Implementing Regulation (EU) No 361/2011 of 13 April 2011 concerning the authorisation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional products Ltd represented by DSM Nutritional Products Sp. z o.o) and amending Regulation (EC) No 943/2005(115).

56. Commission Implementing Regulation (EU) No 371/2011 of 15 April 2011 concerning the authorisation of dimethylglycine sodium salt as feed additive for chickens for fattening (holder of the authorisation Taminco N.V.)(116).

57. Commission Implementing Regulation (EU) No 388/2011 of 19 April 2011 concerning the authorisation of maduramicin ammonium alpha as a feed additive for chickens for fattening (holder of authorisation Alpharma (Belgium) BVBA) and amending Regulation (EC) No 2430/1999(117).

58. Commission Implementing Regulation (EU) No 389/2011 of 19 April 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase as feed additive for laying hens (holder of authorisation Danisco Animal Nutrition)(118).

59. Commission Implementing Regulation (EU) No 496/2011 of 20 May 2011 concerning the authorisation of sodium benzoate as a feed additive for weaned piglets (holder of the authorisation Kemira Oyj)(119).

60. Commission Implementing Regulation (EU) No 527/2011 of 30 May 2011 concerning the authorisation of a preparation of endo-1,4-β-xylanase produced by Trichoderma reesei (MUCL 49755), endo-1,3(4)-β-glucanase produced by Trichoderma reesei (MUCL 49754) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) as feed additive for weaned piglets (holder of the authorisation Aveve NV)(120).

61. Commission Implementing Regulation (EU) No 532/2011 of 31 May 2011 concerning the authorisation of robenidine hydrochloride as a feed additive for rabbits for breeding and rabbits for fattening (holder of authorisation Alpharma Belgium BVBA) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004(121).

(112)EUR 2011/171.

(113)EUR 2011/221.

(114)EUR 2011/337.

(115)EUR 2011/361.

(116)EUR 2011/371.

(117)EUR 2010/388.

(118)EUR 2011/389.

(119)EUR 2011/496.

(120)EUR 2011/527.

(121)EUR 2011/532.

42Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

62. Commission Implementing Regulation (EU) No 868/2011 of 31 August 2011 concerning the authorisation of a preparation of Lactobacillus plantarum (DSM 21762) and of a preparation of Lactobacillus buchneri (DSM 22963) as feed additives for all animal species(122).

63. Commission Implementing Regulation (EU) No 887/2011 of 5 September 2011 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation Norel SA)(123).

64. Commission Implementing Regulation (EU) No 888/2011 of 5 September 2011 concerning the authorisation of diclazuril as a feed additive for turkeys for fattening (holder of authorisation Janssen Pharmaceutica N.V.) and amending Regulation (EC) No 2430/1999(124).

65. Commission Implementing Regulation (EU) No 900/2011 of 7 September 2011 concerning the authorisation of lasalocid A sodium as a feed additive for pheasants, guinea fowl, quails and partridges other than laying birds (holder of authorisation Alpharma (Belgium) BVBA)(125).

66. Commission Implementing Regulation (EU) No 1068/2011 of 21 October 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds (holder of authorisation BASF SE)(126).

67. Commission Implementing Regulation (EU) No 1074/2011 of 24 October 2011 concerning the authorisation of Saccharomyces cerevisiae NCYC R-625 as a feed additive for weaned piglets (holder of the authorisation Integro Gida SAN. ve TIC. A.S. represented by RM Associates Ltd)(127).

68. Commission Implementing Regulation (EU) No 1088/2011 of 27 October 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MULC 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MULC

49754) as a feed additive for weaned piglets (holder of authorisation Aveve NV)(128).

69. Commission Implementing Regulation (EU) No 1111/2011 of 3 November 2011 concerning the authorisation of Lactobacillus plantarum (NCIMB 30236) as a feed additive for all animal species(129).

70. Commission Implementing Regulation (EU) No 1263/2011 of 5 December 2011 concerning the authorisation of Lactobacillus buchneri (DSM 16774), Lactobacillus buchneri (DSM 12856), Lactobacillus paracasei (DSM 16245), Lactobacillus paracasei (DSM 16773), Lactobacillus plantarum (DSM 12836), Lactobacillus plantarum (DSM 12837), Lactobacillus brevis (DSM

12835), Lactobacillus rhamnosus (NCIMB 30121), Lactococcus lactis (DSM 11037), Lactococcus lactis (NCIMB 30160), Pediococcus acidilactici (DSM 16243) and Pediococcus pentosaceus (DSM

12834) as feed additives for all animal species(130).

71. Commission Implementing Regulation (EU) No 91/2012 of 2 February 2012 concerning the authorisation of Bacillus subtilis (CBS 117162) as a feed additive for weaned piglets and pigs for fattening (holder of authorisation Krka d.d.)(131).

(122)EUR 2011/868.

(123)EUR 2011/887, amended by S.S.I. 2024/330 and S.I. 2024/1101 and 1251 (W. 209).

(124)EUR 2011/888.

(125)EUR 2011/900.

(126)EUR 2011/1068.

(127)EUR 2011/1074.

(128)EUR 2011/1088.

(129)EUR 2011/1111.

(130)EUR 2011/1263.

(131)EUR 2012/91.

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

72. Commission Implementing Regulation (EU) No 93/2012 of 3 February 2012 concerning the authorisation of Lactobacillus plantarum (DSM 8862 and DSM 8866) as a feed additive for all animal species(132).

73. Commission Implementing Regulation (EU) No 131/2012 of 15 February 2012 concerning the authorisation of a preparation of caraway oil, lemon oil with certain dried herbs and spices as a feed additive for weaned piglets (holder of authorisation Delacon Biotechnik GmbH)(133).

74. Commission Implementing Regulation (EU) No 136/2012 of 16 February 2012 concerning the authorisation of sodium bisulphate as feed additive for pets and other non-food producing animals(134).

75. Commission Implementing Regulation (EU) No 227/2012 of 15 March 2012 concerning the authorisation of Lactococcus lactis (NCIMB 30117) as a feed additive for all animal species(135).

76. Commission Implementing Regulation (EU) No 237/2012 of 19 March 2012 concerning the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS

120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours)(136).

77. Commission Implementing Regulation (EU) No 269/2012 of 26 March 2012 concerning the authorisation of dicopper chloride trihydroxide as feed additive for all animal species(137).

78. Commission Implementing Regulation (EU) No 333/2012 of 19 April 2012 concerning the authorisation of a preparation of potassium diformate as a feed additive for all animal species and amending Regulation (EC) No 492/2006(138).

79. Commission Implementing Regulation (EU) No 334/2012 of 19 April 2012 concerning the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for rabbits for fattening and non food-producing rabbits and amending Regulation (EC) No 600/2005 (holder of the authorisation Société Industrielle Lesaffre)(139).

80. Commission Implementing Regulation (EU) No 832/2012 of 17 September 2012 concerning the authorisation of a preparation of ammonium chloride as a feed additive for lambs for fattening (holder of authorisation Latochema Co. Ltd)(140).

81. Commission Implementing Regulation (EU) No 837/2012 of 18 September 2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 22594) as feed additive for poultry, weaned piglets, pigs for fattening and sows (holder of authorisation DSM Nutritional Products)(141).

82. Commission Implementing Regulation (EU) No 838/2012 of 18 September 2012 concerning the authorisation of Lactobacillus brevis (DSMZ 21982) as a feed additive for all animal species(142).

83. Commission Implementing Regulation (EU) No 839/2012 of 18 September 2012 concerning the authorisation of urea as a feed additive for ruminants(143).

(132)EUR 2012/93.

(133)EUR 2012/131.

(134)EUR 2012/136.

(135)EUR 2012/227.

(136)EUR 2012/237.

(137)EUR 2012/269.

(138)EUR 2012/333.

(139)EUR 2012/334.

(140)EUR 2012/832.

(141)EUR 2012/837.

(142)EUR 2012/838.

(143)EUR 2012/839.

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

84. Commission Implementing Regulation (EU) No 840/2012 of 18 September 2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC

5233) as a feed additive for all avian species for fattening other than chickens for fattening, turkeys for fattening and ducks for fattening and all avian species for laying other than laying hens (holder of authorisation Danisco Animal Nutrition)(144).

85. Commission Implementing Regulation (EU) No 841/2012 of 18 September 2012 concerning the authorisation of Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB

30148) as feed additives for all animal species(145).

86. Commission Implementing Regulation (EU) No 842/2012 of 18 September 2012 concerning the authorisation of a preparation of lanthanum carbonate octahydrate as a feed additive for dogs (holder of authorisation Bayer Animal Health GmbH)(146).

87. Commission Implementing Regulation (EU) No 849/2012 of 19 September 2012 concerning the authorisation of the preparation of citric acid, sorbic acid, thymol and vanillin as a feed additive for chickens for fattening, chickens reared for laying, all minor avian species for fattening and reared for laying and weaned Suidae other than Sus scrofa domesticus (holder of the authorisation Vetagro SpA)(147).

88. Commission Implementing Regulation (EU) No 868/2012 of 24 September 2012 concerning the authorisation of azorubine as a feed additive for cats and dogs(148).

89. Commission Implementing Regulation (EU) No 869/2012 of 24 September 2012 concerning the authorisation of thaumatin as a feed additive for all animal species(149).

90. Commission Implementing Regulation (EU) No 870/2012 of 24 September 2012 concerning the authorisation of naringin as a feed additive for all animal species(150).

91. Commission Implementing Regulation (EU) No 989/2012 of 25 October 2012 concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MULC 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MULC 49754) as a feed additive for laying hens and minor poultry species for fattening and laying (holder of authorisation Aveve NV)(151).

92. Commission Implementing Regulation (EU) No 990/2012 of 25 October 2012 concerning the authorisation of a preparation of Propionibacterium acidipropionici (CNCM MA 26/4U) as a feed additive for all animal species(152).

93. Commission Implementing Regulation (EU) No 991/2012 of 25 October 2012 concerning the authorisation of zinc chloride hydroxide monohydrate as feed additive for all animal species(153).

94. Commission Implementing Regulation (EU) No 1065/2012 of 13 November 2012 concerning the authorisation of preparations of Lactobacillus plantarum (DSM 23375, CNCM I-3235, DSM 19457, DSM 16565, DSM 16568, LMG 21295, CNCM MA 18/5U, NCIMB 30094, VTT E-78076, ATCC PTSA-6139, DSM 18112, DSM 18113, DSM 18114, ATCC 55943 and ATCC

55944) as feed additives for all animal species(154).

(144)EUR 2012/840.

(145)EUR 2012/841.

(146)EUR 2012/842.

(147)EUR 2012/849.

(148)EUR 2012/868.

(149)EUR 2012/869.

(150)EUR 2012/870.

(151)EUR 2012/989.

(152)EUR 2012/990.

(153)EUR 2012/991.

(154)EUR 2012/1065.

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95. Commission Implementing Regulation (EU) No 1119/2012 of 29 November 2012 concerning the authorisation of preparations of Pediococcus acidilactici CNCM MA 18/5M DSM 11673, Pediococcus pentosaceus DSM 23376, NCIMB 12455 and NCIMB 30168, Lactobacillus plantarum DSM 3676 and DSM 3677 and Lactobacillus buchneri DSM 13573 as feed additives for all animal species(155).

96. Commission Implementing Regulation (EU) No 1195/2012 of 13 December 2012 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma koningii (MUCL 39203) for turkeys for fattening and turkeys reared for breeding (holder of authorisation Lyven)(156).

97. Commission Implementing Regulation (EU) No 1206/2012 of 14 December 2012 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM

10287) as a feed additive for poultry for fattening, weaned piglets and pigs for fattening and amending Regulations (EC) No 1332/2004 and (EC) No 2036/2005 (holder of the authorisation DSM Nutritional Products)(157).

98. Commission Implementing Regulation (EU) No 96/2013 of 1 February 2013 concerning the authorisation of a preparation of Lactobacillus buchneri NCIMB 30139 and of a preparation of Lactobacillus casei ATTC PTA 6135 as feed additives for all animal species(158).

99. Commission Implementing Regulation (EU) No 159/2013 of 21 February 2013 concerning the authorisation of a preparation of sodium benzoate, propionic acid and sodium propionate as a feed additive for pigs, poultry, bovines, sheep, goats, rabbits and horses and amending Regulations

(EC) No 1876/2006 and (EC) No 757/2007(159).

100. Commission Implementing Regulation (EU) No 161/2013 of 21 February 2013 concerning the authorisation of a preparation of sodium hydroxide as a feed additive for cats, dogs and ornamental fish(160).

101. Commission Implementing Regulation (EU) No 306/2013 of 2 April 2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) for weaned piglets and weaned Suidae other than Sus scrofa domesticus (holder of authorisation Kemin Europa N.V.)(161).

102. Commission Implementing Regulation (EU) No 308/2013 of 3 April 2013 concerning the authorisation of a preparation of Lactobacillus plantarum NCIMB 30083 and of a preparation of Lactobacillus plantarum NCIMB 30084 as feed additives for all animal species(162).

103. Commission Implementing Regulation (EU) No 403/2013 of 2 May 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4- beta-glucanase produced by Trichoderma reesei (ATCC 74444) as a feed additive for poultry for fattening and for laying and for weaned piglets and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005 and (EC) No 1876/2006 (holder of authorisation DSM Nutritional Products)(163).

104. Commission Implementing Regulation (EU) No 427/2013 of 8 May 2013 concerning the authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R646 as a feed additive for all animal species and amending Regulations (EC) No 1750/2006, (EC) No 634/2007 and (EC) No 900/2009 as regards the maximum supplementation with selenised yeast(164).

(155)EUR 2012/1119.

(156)EUR 2012/1195.

(157)EUR 2012/1206.

(158)EUR 2013/96.

(159)EUR 2013/159.

(160)EUR 2013/161.

(161)EUR 2013/306, amended by S.S.I. 2022/288 and 373, S.I. 2022/1118 (W. 233) and 1129.

(162)EUR 2013/308.

(163)EUR 2013/403.

(164)EUR 2013/427.

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105. Commission Implementing Regulation (EU) No 445/2013 of 14 May 2013 concerning the authorisation of hydroxy-analogue of selenomethionine as a feed additive for all animal species(165).

106. Commission Implementing Regulation (EU) No 469/2013 of 22 May 2013 concerning the authorisation of DL-methionine, DL-methionine sodium salt, hydroxy analogue of methionine, calcium salt of hydroxy analogue of methionine, isopropyl ester of hydroxy analogue of methionine, DL-methionine protected with copolymer vinylpyridine/styrene and DL-methionine protected with ethylcellulose as feed additives(166).

107. Commission Implementing Regulation (EU) No 544/2013 of 14 June 2013 concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens for fattening (holder of authorisation Biomin GmbH)(167).

108. Commission Implementing Regulation (EU) No 601/2013 of 24 June 2013 concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed additives(168).

109. Commission Implementing Regulation (EU) No 636/2013 of 1 July 2013 concerning the authorisation of zinc chelate of methionine (1:2) as a feed additive for all animal species(169).

110. Commission Implementing Regulation (EU) No 642/2013 of 4 July 2013 concerning the authorisation of niacin and niacinamide as feed additives for all animal species(170).

111. Commission Implementing Regulation (EU) No 643/2013 of 4 July 2013 concerning the authorisation of Patent Blue V as a feed additive for non-food producing animals and amending Regulation (EC) No 358/2005(171).

112. Commission Implementing Regulation (EU) No 651/2013 of 9 July 2013 concerning the authorisation of clinoptilolite of sedimentary origin as a feed additive for all animal species and amending Regulation (EC) No 1810/2005(172).

113. Commission Implementing Regulation (EU) No 667/2013 of 12 July 2013 concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation Eli Lilly and Company Ltd) and repealing Regulation (EC) No 162/2003(173).

114. Commission Implementing Regulation (EU) No 725/2013 of 26 July 2013 concerning the authorisation of ammonium chloride as a feed additive for ruminants, cats and dogs (holder of the authorisation BASF SE)(174).

115. Commission Implementing Regulation (EU) No 774/2013 of 12 August 2013 concerning the authorisation of a preparation of Lactobacillus kefiri DSM 19455 as a feed additive for all animal species(175).

116. Commission Implementing Regulation (EU) No 775/2013 of 12 August 2013 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens

(165)EUR 2013/445.

(166)EUR 2013/469.

(167)EUR 2013/544.

(168)EUR 2013/601, amended by S.S.I. 2023/339, S.I. 2023/1196 and 1276 (W. 224).

(169)EUR 2013/636.

(170)EUR 2013/642.

(171)EUR 2013/643.

(172)EUR 2013/651.

(173)EUR 2013/667.

(174)EUR 2013/725.

(175)EUR 2013/774.

47Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. reared for laying and minor poultry species other than those used for laying (holder of authorisation Lactosan GmbH & Co KG)(176).

117. Commission Implementing Regulation (EU) No 787/2013 of 16 August 2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin Europa N.V.)(177).

118. Commission Implementing Regulation (EU) No 795/2013 of 21 August 2013 concerning the authorisation of choline chloride as a feed additive for all animal species(178).

119. Commission Implementing Regulation (EU) No 797/2013 of 21 August 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation Chr. Hansen A/S) and repealing Regulation (EC) No 1333/2004(179).

120. Commission Implementing Regulation (EU) No 803/2013 of 22 August 2013 concerning the authorisation of folic acid as a feed additive for all animal species(180).

121. Commission Implementing Regulation (EU) No 1006/2013 of 18 October 2013 concerning the authorisation of L-cystine as a feed additive for all animal species(181).

122. Commission Implementing Regulation (EU) No 1016/2013 of 23 October 2013 concerning the authorisation of a preparation of a micro-organism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for pigs(182).

123. Commission Implementing Regulation (EU) No 1040/2013 of 24 October 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for pigs for fattening and minor porcine species for fattening other than Sus scrofa domesticus and turkeys for fattening (holder of authorisation Aveve NV)(183).

124. Commission Implementing Regulation (EU) No 1055/2013 of 25 October 2013 concerning the authorisation of a preparation of orthophosphoric acid as a feed additive for all animal species(184).

125. Commission Implementing Regulation (EU) No 1059/2013 of 29 October 2013 concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for cattle for fattening and amending Regulation (EC) No 492/2006 (holder of the authorisation Prosol SpA)(185).

126. Commission Implementing Regulation (EU) No 1060/2013 of 29 October 2013 concerning the authorisation of bentonite as a feed additive for all animal species(186).

127. Commission Implementing Regulation (EU) No 1061/2013 of 29 October 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 10415 as a feed additive for calves, kids, cats and dogs and amending Regulation (EC) No 1288/2004 (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o)(187).

(176)EUR 2013/775.

(177)EUR 2013/787, amended by S.S.I. 2022/288 and 373, S.I. 2022/1118 (W. 233) and 1129.

(178)EUR 2013/795.

(179)EUR 2013/797.

(180)EUR 2013/803.

(181)EUR 2013/1006.

(182)EUR 2013/1016

(183)EUR 2013/1040.

(184)EUR 2013/1055.

(185)EUR 2013/1059.

(186)EUR 2013/1060.

(187)EUR 2013/1061.

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

128. Commission Implementing Regulation (EU) No 1077/2013 of 31 October 2013 concerning the authorisation of a preparation of Enterococcus faecium NBIMCC 8270, Lactobacillus acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC 8269, Lactobacillus delbrueckii ssp.

lactis NBIMCC 8250, Lactobacillus delbrueckii ssp. bulgaricus NBIMCC 8244, and Streptococcus thermophilus NBIMCC 8253 as a feed additive for suckling piglets (holder of authorisation Lactina Ltd)(188).

129. Commission Implementing Regulation (EU) No 1078/2013 of 31 October 2013 concerning the authorisation of fumaric acid as a feed additive for all animal species(189).

130. Commission Implementing Regulation (EU) No 1101/2013 of 6 November 2013 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 and Lactobacillus rhamnosus DSM 7133 as a feed additive for calves for rearing and amending Regulation (EC) No 1288/2004 (holder of authorisation Lactosan GmbH & CoKG)(190).

131. Commission Implementing Regulation (EU) No 1113/2013 of 7 November 2013 concerning the authorisation of preparations of Lactobacillus plantarum NCIMB 40027, Lactobacillus buchneri DSM 22501, Lactobacillus buchneri NCIMB 40788/CNCM I-4323, Lactobacillus buchneri LN 40177/ATCC PTA-6138, and Lactobacillus buchneri LN 4637/ATCC PTA-2494 as feed additives for all animal species(191).

132. Commission Implementing Regulation (EU) No 1222/2013 of 29 November 2013 concerning the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for ruminants, pigs and poultry(192).

133. Commission Implementing Regulation (EU) No 1365/2013 of 18 December 2013 concerning the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604) as a feed additive for minor poultry species for fattening and for chickens reared for laying (holder of authorisation Kerry Ingredients and Flavours)(193).

134. Commission Implementing Regulation (EU) No 1404/2013 of 20 December 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for pigs for fattening (holder of authorisation BASF SE)(194).

135. Commission Implementing Regulation (EU) No 84/2014 of 30 January 2014 concerning the authorisation of preparations of Pediococcus pentosaceus DSM 14021, Pediococcus pentosaceus DSM 23688 or Pediococcus pentosaceus DSM 23689 as feed additives for all animal species(195).

136. Commission Implementing Regulation (EU) No 101/2014 of 4 February 2014 concerning the authorisation of L-tyrosine as a feed additive for all animal species(196).

137. Commission Implementing Regulation (EU) No 121/2014 of 7 February 2014 concerning the authorisation of L-selenomethionine as a feed additive for all animal species(197).

138. Commission Implementing Regulation (EU) No 290/2014 of 21 March 2014 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 as a feed additive for poultry, weaned piglets

(188)EUR 2013/1077.

(189)EUR 2013/1078.

(190)EUR 2013/1101.

(191)EUR 2013/1113.

(192)EUR 2013/1222.

(193)EUR 2013/1365.

(194)EUR 2013/1404.

(195)EUR 2014/84.

(196)EUR 2014/101.

(197)EUR 2014/121.

49Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. and pigs for fattening and amending Regulations (EC) No 1259/2004, (EC) No 943/2005, (EC) No 1206/2005 and (EC) No 322/2009 (holder of the authorisation Adisseo France S.A.S.)(198).

139. Commission Implementing Regulation (EU) No 292/2014 of 21 March 2014 concerning the authorisation of a preparation of 6-phytase produced by Trichoderma reesei (CBS 126897) as a feed additive for poultry, weaned piglets, pigs for fattening and sows (holder of the authorisation ROAL Oy)(199).

140. Commission Implementing Regulation (EU) No 302/2014 of 25 March 2014 concerning the authorisation of a preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS

126896) as a feed additive for chickens for fattening and weaned piglets (holder of the authorisation ROAL Oy)(200).

141. Commission Implementing Regulation (EU) No 304/2014 of 25 March 2014 concerning the authorisation of the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 as feed additives for all animal species(201).

142. Commission Implementing Regulation (EU) No 305/2014 of 25 March 2014 concerning the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for all animal species other than ruminants, pigs and poultry(202).

143. Commission Implementing Regulation (EU) No 399/2014 of 22 April 2014 concerning the authorisation of the preparations of Lactobacillus brevis DSM 23231, Lactobacillus brevis DSMZ 16680, Lactobacillus plantarum CECT 4528 and Lactobacillus fermentum NCIMB 30169 as feed additives for all animal species(203).

144. Commission Implementing Regulation (EU) No 669/2014 of 18 June 2014 concerning the authorisation of calcium D-pantothenate and D-panthenol as feed additives for all animal species(204).

145. Commission Implementing Regulation (EU) No 684/2014 of 20 June 2014 concerning the authorisation of canthaxanthin as a feed additive for breeder hens (holder of the authorisation DSM Nutritional products Ltd)(205).

146. Commission Implementing Regulation (EU) No 847/2014 of 4 August 2014 concerning the authorisation of DL-selenomethionine as a feed additive for all animal species(206).

147. Commission Implementing Regulation (EU) No 848/2014 of 4 August 2014 concerning the authorisation of L-valine produced by Corynebacterium glutamicum as a feed additive for all animal species and amending Regulation (EC) No 403/2009 as regards the labelling of the feed additive L-valine(207).

148. Commission Implementing Regulation (EU) No 849/2014 of 4 August 2014 concerning the authorisation of the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 as feed additives for all animal species(208).

(198)EUR 2014/290.

(199)EUR 2014/292.

(200)EUR 2014/302.

(201)EUR 2014/304.

(202)EUR 2014/305.

(203)EUR 2014/399.

(204)EUR 2014/669.

(205)EUR 2014/684.

(206)EUR 2014/847.

(207)EUR 2014/848.

(208)EUR 2014/849.

50Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

149. Commission Implementing Regulation (EU) No 852/2014 of 5 August 2014 concerning the authorisation of L-methionine as a feed additive for all animal species(209).

150. Commission Implementing Regulation (EU) No 1076/2014 of 13 October 2014 concerning the authorisation of a preparation containing a smoke flavouring extract-2b0001 as feed additive for dogs and cats(210).

151. Commission Implementing Regulation (EU) No 1083/2014 of 15 October 2014 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive for sows(211).

152. Commission Implementing Regulation (EU) No 1109/2014 of 20 October 2014 concerning the authorisation of the preparation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for cattle for fattening, minor ruminant species for fattening, dairy cows and minor dairy ruminant species and amending Regulations (EC) No 1288/2004 and (EC) No 1811/2005 (holder of authorisation Alltech France)(212).

153. Commission Implementing Regulation (EU) No 1115/2014 of 21 October 2014 concerning the authorisation of a preparation of fumonisin esterase produced by Komagataella pastoris (DSM

26643) as a feed additive for pigs(213).

154. Commission Implementing Regulation (EU) No 1138/2014 of 27 October 2014 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 as a feed additive for sows (holder of the authorisation Adisseo France S.A.S.)(214).

155. Commission Implementing Regulation (EU) No 1230/2014 of 17 November 2014 concerning the authorisation of copper bilysinate as a feed additive for all animal species(215).

156. Commission Implementing Regulation (EU) No 1236/2014 of 18 November 2014 concerning the authorisation of L-valine produced by Corynebacterium glutamicum (DSM 25202) as a feed additive for all animal species(216).

157. Commission Implementing Regulation (EU) No 1249/2014 of 21 November 2014 concerning the authorisation of inositol as a feed additive for fish and crustaceans(217).

158. Commission Implementing Regulation (EU) 2015/38 of 13 January 2015 concerning the authorisation of the preparation of Lactobacillus acidophilus CECT 4529 as a feed additive for laying hens and amending Regulation (EC) No 1520/2007 (holder of authorisation Centro Sperimentale del Latte)(218).

159. Commission Implementing Regulation (EU) 2015/46 of 14 January 2015 concerning the authorisation of diclazuril as a feed additive for chickens for fattening, for turkeys for fattening and for guinea fowl for fattening and breeding (holder of authorisation Huvepharma NV)(219).

160. Commission Implementing Regulation (EU) 2015/47 of 14 January 2015 concerning the authorisation of a preparation of alpha-amylase produced by Bacillus licheniformis (DSM 21564) as

(209)EUR 2014/852.

(210)EUR 2014/1076.

(211)EUR 2014/1083.

(212)EUR 2014/1109.

(213)EUR 2014/1115.

(214)EUR 2014/1138.

(215)EUR 2014/1230.

(216)EUR 2014/1236.

(217)EUR 2014/1249.

(218)EUR 2015/38.

(219)EUR 2015/46.

51Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. a feed additive for dairy cows (holder of the authorisation DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. Z.o.o)(220).

161. Commission Implementing Regulation (EU) 2015/244 of 16 February 2015 concerning the authorisation of Quinoline Yellow as a feed additive for non food-producing animals(221).

162. Commission Implementing Regulation (EU) 2015/264 of 18 February 2015 concerning the authorisation of neohesperidine dihydrochalcone as a feed additive for sheep, fish, dogs, calves and certain categories of pigs(222).

163. Commission Implementing Regulation (EU) 2015/489 of 23 March 2015 concerning the authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R645 as a feed additive for all animal species(223).

164. Commission Implementing Regulation (EU) 2015/502 of 24 March 2015 concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows (holder of the authorisation Micro Bio-System Ltd)(224).

165. Commission Implementing Regulation (EU) 2015/518 of 26 March 2015 concerning the authorisation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying and amending Implementing Regulation (EU) No 361/2011 as regards the compatibility with coccidiostats (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. z o.o)(225).

166. Commission Implementing Regulation (EU) 2015/661 of 28 April 2015 concerning the authorisation of the preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying (holder of the authorisation Adisseo France S.A.S.)(226).

167. Commission Implementing Regulation (EU) 2015/662 of 28 April 2015 concerning the authorisation of L-carnitine and L-carnitine L-tartrate as feed additives for all animal species(227).

168. Commission Implementing Regulation (EU) 2015/722 of 5 May 2015 concerning the authorisation of taurine as a feed additive for Canidae, Felidae, Mustelidae and carnivorous fish(228).

169. Commission Implementing Regulation (EU) 2015/723 of 5 May 2015 concerning the authorisation of biotin as a feed additive for all animal species(229).

170. Commission Implementing Regulation (EU) 2015/724 of 5 May 2015 concerning the authorisation of retinyl acetate, retinyl palmitate and retinyl propionate as feed additives for all animal species(230).

171. Commission Implementing Regulation (EU) 2015/897 of 11 June 2015 concerning the authorisation of thiamine hydrochloride and thiamine mononitrate as feed additives for all animal species(231).

(220)EUR 2015/47.

(221)EUR 2015/244.

(222)EUR 2015/264.

(223)EUR 2015/489.

(224)EUR 2015/502.

(225)EUR 2015/518.

(226)EUR 2015/661.

(227)EUR 2015/662.

(228)EUR 2015/722.

(229)EUR 2015/723.

(230)EUR 2015/724.

(231)EUR 2015/897.

52Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

172. Commission Implementing Regulation (EU) 2015/1020 of 29 June 2015 concerning the authorisation of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying (holder of the authorisation Kemin Europa NV)(232).

173. Commission Implementing Regulation (EU) 2015/1043 of 30 June 2015 concerning the authorisation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) as a feed additive for chickens for fattening, turkeys for fattening, laying hens, weaned piglets, pigs for fattening and minor poultry species for fattening and for laying, and amending Regulations (EC) No 2148/2004, (EC) No 828/2007 and (EC) No 322/2009 (holder of authorisation Huvepharma NV)(233).

174. Commission Implementing Regulation (EU) 2015/1053 of 1 July 2015 concerning the authorisation of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs and amending Regulations (EC) No 1259/2004, (EC) No 255/2005, (EC) No 1200/2005 and (EC) No 1520/2007 (holder of authorisation Chevita Tierarzneimittel-GmbH)(234).

175. Commission Implementing Regulation (EU) 2015/1060 of 2 July 2015 concerning the authorisation of betaine anhydrous and betaine hydrochloride as feed additives for all animal species(235).

176. Commission Implementing Regulation (EU) 2015/1061 of 2 July 2015 concerning the authorisation of ascorbic acid, sodium ascorbyl phosphate, sodium calcium ascorbyl phosphate, sodium ascorbate, calcium ascorbate and ascorbyl palmitate as feed additives for all animal species(236).

177. Commission Implementing Regulation (EU) 2015/1103 of 8 July 2015 concerning the authorisation of beta-carotene as a feed additive for all animal species(237).

178. Commission Implementing Regulation (EU) 2015/1105 of 8 July 2015 concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, the authorisation of that feed additive for use in water for drinking for chickens for fattening and amending Regulation (EU) No 544/2013 as regards the maximum content of that feed additive in complete feedingstuff and its compatibility with coccidiostats (holder of the authorisation Biomin GmbH)(238).

179. Commission Implementing Regulation (EU) 2015/1114 of 9 July 2015 concerning the authorisation of L-valine produced by Escherichia coli as a feed additive for all animal species and amending Regulation (EC) No 403/2009 and Implementing Regulations (EU) No 848/2014 and

(EU) No 1236/2014(239).

180. Commission Implementing Regulation (EU) 2015/1152 of 14 July 2015 concerning the authorisation of tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta rich) and alpha-tocopherol as feed additives for all animal species(240).

181. Commission Implementing Regulation (EU) 2015/1408 of 19 August 2015 concerning the authorisation of DL-methionyl-DL-methionine as a feed additive for fish and crustaceans(241).

(232)EUR 2015/1020, amended by S.S.I. 2022/288 and 373, S.I. 2022/1118 (W. 233) and 1129.

(233)EUR 2015/1043.

(234)EUR 2015/1053.

(235)EUR 2015/1060.

(236)EUR 2015/1061.

(237)EUR 2015/1103.

(238)EUR 2015/1105.

(239)EUR 2015/1114.

(240)EUR 2015/1152.

(241)EUR 2015/1408.

53Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

182. Commission Implementing Regulation (EU) 2015/1415 of 20 August 2015 concerning the authorisation of astaxanthin as a feed additive for fish, crustaceans and ornamental fish(242).

183. Commission Implementing Regulation (EU) 2015/1416 of 20 August 2015 concerning the authorisation of sodium bisulphate as feed additive for all animal species(243).

184. Commission Implementing Regulation (EU) 2015/1417 of 20 August 2015 concerning the authorisation of diclazuril as a feed additive for rabbits for fattening and for breeding (holder of the authorisation Huvepharma NV)(244).

185. Commission Implementing Regulation (EU) 2015/1426 of 25 August 2015 concerning the authorisation of the preparation of benzoic acid, thymol, eugenol and piperine as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying (holder of the authorisation DSM Nutritional Product)(245).

186. Commission Implementing Regulation (EU) 2015/1486 of 2 September 2015 concerning the authorisation of canthaxanthin as feed additive for certain categories of poultry, ornamental fish and ornamental birds(246).

187. Commission Implementing Regulation (EU) 2015/1489 of 3 September 2015 concerning the authorisation of the preparation of Lactobacillus plantarum NCIMB 30238 and Pediococcus pentosaceus NCIMB 30237 as a feed additive for all animal species(247).

188. Commission Implementing Regulation (EU) 2015/1490 of 3 September 2015 concerning the authorisation of the preparation of carvacrol, cinnamaldehyde and capsicum oleoresin as a feed additive for chickens for fattening (holder of the authorisation Pancosma France S.A.S.)(248).

189. Commission Implementing Regulation (EU) 2015/2304 of 10 December 2015 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov DSM 26702 as a feed additive for turkeys for fattening and for breeding (holder of the authorisation Adisseo France S.A.S.)(249).

190. Commission Implementing Regulation (EU) 2015/2305 of 10 December 2015 concerning the authorisation of a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, and amending Regulations (EC) No 2148/2004 and (EC) No 1520/2007 (holder of authorisation Huvepharma NV)(250).

191. Commission Implementing Regulation (EU) 2015/2306 of 10 December 2015 concerning the authorisation of L-cysteine hydrochloride monohydrate as a feed additive for cats and dogs(251).

192. Commission Implementing Regulation (EU) 2015/2307 of 10 December 2015 concerning the authorisation of menadione sodium bisulphite and menadione nicotinamide bisulphite as feed additives for all animal species(252).

193. Commission Implementing Regulation (EU) 2015/2382 of 17 December 2015 concerning the authorisation of the preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by

(242)EUR 2015/1415.

(243)EUR 2015/1416.

(244)EUR 2015/1417.

(245)EUR 2015/1426.

(246)EUR 2015/1486.

(247)EUR 2015/1489.

(248)EUR 2015/1490.

(249)EUR 2015/2304.

(250)EUR 2015/2305.

(251)EUR 2015/2306.

(252)EUR 2015/2307.

54Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

Aspergillus niger (CBS 120604) as a feed additive for laying hens and minor poultry species for laying (holder of the authorisation Kerry Ingredients and Flavours)(253).

194. Commission Implementing Regulation (EU) 2016/104 of 27 January 2016 concerning the authorisation of a preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for minor ruminant species for fattening and dairy production (holder of the authorisation Prosol SpA)(254).

195. Commission Implementing Regulation (EU) 2016/329 of 8 March 2016 concerning the authorisation of 6-phytase as a feed additive for all avian species and for weaned piglets, pigs for fattening, sows and minor porcine species (holder of the authorisation Lohmann Animal Nutrition GmbH)(255).

196. Commission Implementing Regulation (EU) 2016/896 of 8 June 2016 concerning the authorisation of iron sodium tartrates as a feed additive for all animal species(256).

197. Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation(257).

198. Commission Implementing Regulation (EU) 2016/898 of 8 June 2016 concerning the authorisation of a preparation of Bacillus licheniformis (ATCC 53757) and its protease (EC

3.4.21.19) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying and ornamental birds (holder of authorisation Novus Europe SA/NV)(258).

199. Commission Implementing Regulation (EU) 2016/899 of 8 June 2016 concerning the authorisation of a 6-phytase produced by Trichoderma reesei (ATCC SD-6528) as a feed additive for all poultry species and all porcine species (other than suckling piglets) (holder of authorisation Danisco (UK) Ltd)(259).

200. Commission Implementing Regulation (EU) 2016/900 of 8 June 2016 concerning the authorisation of benzoic acid as a feed additive for sows (holder of authorisation DSM Nutritional Product Sp. z o. o.)(260).

201. Commission Implementing Regulation (EU) 2016/972 of 17 June 2016 concerning the authorisation of L-arginine produced by Corynebacterium glutamicum KCTC 10423BP as a feed additive for all animal species(261).

202. Commission Implementing Regulation (EU) 2016/973 of 17 June 2016 concerning the authorisation of zinc bislysinate as a feed additive for all animal species(262).

203. Commission Implementing Regulation (EU) 2016/997 of 21 June 2016 concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma reesei (ATCC PTA

5588) and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Trichoderma reesei (ATCC SD 2106)

(253)EUR 2015/2382.

(254)EUR 2016/104.

(255)EUR 2016/329.

(256)EUR 2016/896.

(257)EUR 2016/897, amended by S.S.I. 2024/330 and S.I. 2024/1101 and 1251 (W. 209).

(258)EUR 2016/898.

(259)EUR 2016/899.

(260)EUR 2016/900.

(261)EUR 2016/972.

(262)EUR 2016/973.

55Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. as a feed additive for lactating sows and minor porcine species (holder of authorisation Danisco

(UK) Ltd)(263).

204. Commission Implementing Regulation (EU) 2016/1007 of 22 June 2016 concerning the authorisation of ammonium chloride as a feed additive for ruminants other than lambs for fattening, cats and dogs (holder of the authorisation Latochema Co. Ltd)(264).

205. Commission Implementing Regulation (EU) 2016/1095 of 6 July 2016 concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate, Zinc chelate of protein hydrolysates, Zinc chelate of glycine hydrate (solid) and Zinc chelate of glycine hydrate

(liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006, (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013(265).

206. Commission Implementing Regulation (EU) 2016/1220 of 26 July 2016 concerning the authorisation of L-threonine produced by Escherichia coli as a feed additive for all animal species(266).

207. Commission Implementing Regulation (EU) 2016/1768 of 4 October 2016 concerning the authorisation of guanidinoacetic acid as a feed additive for chickens for fattening, weaned piglets and pigs for fattening and repealing Commission Regulation (EC) No 904/2009(267).

208. Commission Implementing Regulation (EU) 2016/1833 of 17 October 2016 concerning the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets (holder of authorisation Biolek Sp. z o.o.)(268).

209. Commission Implementing Regulation (EU) 2016/1964 of 9 November 2016 concerning the authorisations of a preparation of dolomite-magnesite for dairy cows and other ruminants for dairy production, weaned piglets and pigs for fattening and a preparation of montmorillonite-illite for all animal species as feed additives(269).

210. Commission Implementing Regulation (EU) 2016/2023 of 18 November 2016 concerning the authorisation of sodium benzoate, potassium sorbate, formic acid and sodium formate as feed additives for all animal species(270).

211. Commission Implementing Regulation (EU) 2016/2150 of 7 December 2016 concerning the authorisation of the preparations of Lactobacillus plantarum DSM 29025 and Lactobacillus plantarum NCIMB 42150 as feed additives for all animal species(271).

212. Commission Implementing Regulation (EU) 2016/2261 of 15 December 2016 concerning the authorisation of copper(I) oxide as a feed additive for all animal species(272).

213. Commission Implementing Regulation (EU) 2017/53 of 14 December 2016 concerning the authorisation of butan-1-ol, hexan-1-ol, octan-1-ol, nonan-1-ol, dodecan-1-ol, heptan-1-ol, decan-1- ol, pentan-1-ol, ethanol, acetaldehyde, propanal, butanal, pentanal, hexanal, octanal, decanal, dodecanal, nonanal, heptanal, undecanal, 1,1-diethoxyethane, formic acid, acetic acid, propionic acid, valeric acid, hexanoic acid, octanoic acid, decanoic acid, dodecanoic acid, oleic acid, hexadecanoic acid, tetradecanoic acid, heptanoic acid, nonanoic acid, ethyl acetate, propyl acetate,

(263)EUR 2016/997.

(264)EUR 2016/1007.

(265)EUR 2016/1095, amended by S.S.I. 2024/330 and S.I. 2024/1101 and 1251 (W. 209).

(266)EUR 2016/1220.

(267)EUR 2016/1768.

(268)EUR 2016/1833.

(269)EUR 2016/1964.

(270)EUR 2016/2203.

(271)EUR 2016/2150.

(272)EUR 2016/2261.

56Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. butyl acetate, hexyl acetate, octyl acetate, nonyl acetate, decyl acetate, dodecyl acetate, heptyl acetate, methyl acetate, methyl butyrate, butyl butyrate, pentyl butyrate, hexyl butyrate, octyl butyrate, ethyl decanoate, ethyl hexanoate, propyl hexanoate, pentyl hexanoate, hexyl hexanoate, methyl hexanoate, ethyl formate, ethyl dodecanoate, ethyl tetradecanoate, ethyl nonanoate, ethyl octanoate, ethyl propionate, methyl propionate, ethyl valerate, butyl valerate, ethyl hex-3- enoate, ethyl hexadecanoate, ethyl trans-2-butenoate, ethyl undecanoate, butyl isovalerate, hexyl isobutyrate, methyl 2-methylbutyrate, hexyl 2-methylbutyrate, triethyl citrate, hexyl isovalerate and methyl 2-methylvalerate as feed additives for all animal species(273).

214. Commission Implementing Regulation (EU) 2017/54 of 14 December 2016 concerning the authorisation of 2-methylpropan-1-ol, isopentanol, 3,7-dimethyloctan-1-ol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methylnonanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl hexanoate, 3- methylbutyl dodecanoate, 3-methylbutyl octanoate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate as feed additives for all animal species(274).

215. Commission Implementing Regulation (EU) 2017/55 of 14 December 2016 concerning the authorisation of octan-2-ol, isopropanol, pentan-2-ol, octan-3-ol, heptan-2-one, pentan-2-one, 6-methyl-hepta-3,5-dien-2-one, nonan-3-one, decan-2-one and isopropyl tetradecanoate as feed additives for all animal species(275).

216. Commission Implementing Regulation (EU) 2017/56 of 14 December 2016 concerning the authorisation of lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4- lactone and hexano-1,4-lactone as feed additives for all animal species(276).

217. Commission Implementing Regulation (EU) 2017/57 of 14 December 2016 concerning the authorisation of 1,8-cineole, 3,4-dihydrocoumarin and 2-(2-methylprop-1-enyl)-4- methyltetrahydropyran as feed additives for all animal species(277).

218. Commission Implementing Regulation (EU) 2017/58 of 14 December 2016 concerning the authorisation of alpha-terpineol, nerolidol, 2-(4-methylphenyl) propan-2-ol, terpineol and linalyl acetate as feed additives for all animal species(278).

219. Commission Implementing Regulation (EU) 2017/59 of 14 December 2016 concerning the authorisation of 1,1-dimethoxy-2-phenylethane, phenethyl formate, phenethyl octanoate, phenethyl isobutyrate, phenethyl 2-methyl-butyrate and phenethyl benzoate as feed additives for all animal species(279).

220. Commission Implementing Regulation (EU) 2017/60 of 14 December 2016 concerning the authorisation of isoeugenol as a feed additive for pigs, ruminants and horses except those producing milk for human consumption and pets(280).

(273)EUR 2017/53.

(274)EUR 2017/54.

(275)EUR 2017/55.

(276)EUR 2017/56.

(277)EUR 2017/57.

(278)EUR 2017/58.

(279)EUR 2017/59.

(280)EUR 2017/60.

57Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

221. Commission Implementing Regulation (EU) 2017/61 of 14 December 2016 concerning the authorisation of 4-allyl-2,6-dimethoxyphenol and eugenyl acetate as feed additives for all animal species except for fish and poultry(281).

222. Commission Implementing Regulation (EU) 2017/62 of 14 December 2016 concerning the authorisation of 3-(methylthio) propionaldehyde, methyl 3-(methylthio) propionate, allylthiol, dimethyl sulfide, dibutyl sulfide, diallyl disulfide, diallyl trisulfide, dimethyl trisulfide, dipropyl disulfide, allyl isothiocyanate, dimethyl disulfide, 2-methylbenzene-1-thiol, S-methyl butanethioate, allyl methyl disulfide, 3-(methylthio) propan-1-ol, 3-(methylthio) hexan-1-ol, 1-propane-1-thiol, diallyl sulfide, 2,4-dithiapentane, 2-methyl-2-(methyldithio) propanal, 2-methylpropane-1-thiol, methylsulfinyl methane, propane-2-thiol, 3,5-dimethyl-1,2,4-trithiolane and 2-methyl-4-propyl-1,3- oxathiane as feed additives for all animal species(282).

223. Commission Implementing Regulation (EU) 2017/63 of 14 December 2016 concerning the authorisation of benzyl alcohol, 4-isopropylbenzyl alcohol, benzaldehyde, 4- isopropylbenzaldehyde, salicylaldehyde, p-tolualdehyde, 2-methoxybenzaldehyde, benzoic acid, benzyl acetate, benzyl butyrate, benzyl formate, benzyl propionate, benzyl hexanoate, benzyl isobutyrate, benzyl isovalerate, hexyl salicylate, benzyl phenylacetate, methyl benzoate, ethyl benzoate, isopentyl benzoate, pentyl salicylate and isobutyl benzoate as feed additives for all animal a species and of veratraldehyde and gallic acid as feed additives for certain animal species(283).

224. Commission Implementing Regulation (EU) 2017/64 of 14 December 2016 concerning the authorisation of glycyrrhizic acid ammoniated as a feed additive for all animal species (Text with EEA relevance.)(284).

225. Commission Implementing Regulation (EU) 2017/65 of 14 December 2016 concerning the authorisation of 1-isopropyl-4-methylbenzene, pin-2(10)-ene, pin-2(3)-ene, beta-caryophyllene, camphene, 1-isopropenyl-4-methylbenzene, delta-3-carene and d-limonene as feed additives for all animal species(285).

226. Commission Implementing Regulation (EU) 2017/66 of 14 December 2016 concerning the authorisation of tannic acid as a feed additive for all animal species(286).

227. Commission Implementing Regulation (EU) 2017/187 of 2 February 2017 concerning the authorisation of a preparation of Bacillus subtilis (DSM 28343) as a feed additive for chickens for fattening (holder of authorisation Lactosan GmbH & Co. KG)(287).

228. Commission Implementing Regulation (EU) 2017/194 of 3 February 2017 concerning the authorisation of the preparation of Lactobacillus diolivorans DSM 32074 as a feed additive for all animal species(288).

229. Commission Implementing Regulation (EU) 2017/210 of 7 February 2017 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702 as a feed additive for laying hens (holder of the authorisation Adisseo France S.A.S.)(289).

230. Commission Implementing Regulation (EU) 2017/211 of 7 February 2017 concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) as a feed additive for poultry, weaned piglets and pigs for fattening,

(281)EUR 2017/61.

(282)EUR 2017/62.

(283)EUR 2017/63.

(284)EUR 2017/64.

(285)EUR 2017/65.

(286)EUR 2017/66.

(287)EUR 2017/187.

(288)EUR 2017/194.

(289)EUR 2017/210.

58Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005, and (EC) No 322/2009 and repealing Regulation (EC) No 516/2007 (holder of authorisation Beldem, a division of Puratos NV)(290).

231. Commission Implementing Regulation (EU) 2017/219 of 8 February 2017 concerning the authorisation of a preparation of Bacillus subtilis (DSM 27273) as a feed additive for weaned piglets and weaned minor porcine species (holder of authorisation Chr. Hansen A/S)(291).

232. Commission Implementing Regulation (EU) 2017/307 of 21 February 2017 concerning the authorisation of dry grape extract of Vitis vinifera spp. vinifera as a feed additive for all animal species except for dogs(292).

233. Commission Implementing Regulation (EU) 2017/420 of 9 March 2017 concerning the authorisation of a preparation of thyme oil, synthetic star anise oil and quillaja bark powder as feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying (holder of the authorisation Delacon Biotechnik GmbH)(293).

234. Commission Implementing Regulation (EU) 2017/429 of 10 March 2017 concerning the authorisation of a preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha- amylase produced by Bacillus amyloliquefaciens (DSM 9553) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) as a feed additive for all avian species and amending Regulations (EC) No 358/2005 and (EC) No 1284/2006 and repealing Regulation (EU) No 516/2010 (holder of the authorisation Kemin Europa NV)(294).

235. Commission Implementing Regulation (EU) 2017/439 of 13 March 2017 concerning the authorisation of L-lysine sulphate produced by Escherichia coli as a feed additive for all animal species(295).

236. Commission Implementing Regulation (EU) 2017/440 of 13 March 2017 concerning the authorisation of the preparation of Bacillus amyloliquefaciens (PTA-6507), Bacillus amyloliquefaciens (NRRL B-50013) and Bacillus amyloliquefaciens (NRRL B-50104) as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition)(296).

237. Commission Implementing Regulation (EU) 2017/447 of 14 March 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM

5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S)(297).

238. Commission Implementing Regulation (EU) 2017/455 of 15 March 2017 concerning the authorisation of a preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantarum (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640) as a feed additive for dogs(298).

(290)EUR 2017/211.

(291)EUR 2017/219.

(292)EUR 2017/307.

(293)EUR 2017/420.

(294)EUR 2017/429.

(295)EUR 2017/439.

(296)EUR 2017/440.

(297)EUR 2017/447.

(298)EUR 2017/455.

59Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

239. Commission Implementing Regulation (EU) 2017/873 of 22 May 2017 concerning the authorisation of L-tryptophan produced by Escherichia coli as a feed additive for all animal species(299).

240. Commission Implementing Regulation (EU) 2017/895 of 24 May 2017 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening and laying hens (holder of authorisation Fertinagro Nutrientes S.L.)(300).

241. Commission Implementing Regulation (EU) 2017/896 of 24 May 2017 concerning the authorisation of a preparation of 6-phytase, produced by Trichoderma reesei (ATCC SD-6528) as a feed additive in solid form for all poultry species and all porcine species (other than suckling piglets) (holder of the authorisation Danisco (UK) Ltd)(301).

242. Commission Implementing Regulation (EU) 2017/912 of 29 May 2017 concerning the authorisation of the preparation of Lactobacillus plantarum DSM 29024 as a feed additive for all animal species(302).

243. Commission Implementing Regulation (EU) 2017/913 of 29 May 2017 concerning the authorisation of a preparation of fumonisin esterase produced by Komagataella pastoris (DSM

26643) as a feed additive for all avian species(303).

244. Commission Implementing Regulation (EU) 2017/930 of 31 May 2017 concerning the authorisation of a preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for all avian species and amending Implementing Regulation (EU) No 1016/2013(304).

245. Commission Implementing Regulation (EU) 2017/940 of 1 June 2017 concerning the authorisation of formic acid as a feed additive for all animal species(305).

246. Commission Implementing Regulation (EU) 2017/961 of 7 June 2017 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, and amending Regulation (EC) No 2036/2005 and Regulation (EU) No 887/2011 (holder of authorisation Evonik Nutrition & Care GmbH)(306).

247. Commission Implementing Regulation (EU) 2017/962 of 7 June 2017 suspending the authorisation of ethoxyquin as a feed additive for all animal species and categories(307).

248. Commission Implementing Regulation (EU) 2017/963 of 7 June 2017 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) and bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) as a feed additive for all avian species and weaned piglets and amending Regulations (EC) No 358/2005 and (EU) No 1270/2009 (holder of the authorisation Kemin Europa NV)(308).

(299)EUR 2017/873.

(300)EUR 2017/895.

(301)EUR 2017/896.

(302)EUR 2017/912.

(303)EUR 2017/913.

(304)EUR 2017/930.

(305)EUR 2017/940.

(306)EUR 2017/961, amended by S.S.I. 2024/330 and S.I. 2024/1101 and 1251 (W. 209).

(307)EUR 2017/962.

(308)EUR 2017/963.

60Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

249. Commission Implementing Regulation (EU) 2017/1007 of 15 June 2017 concerning the authorisation of a preparation of lecithins as feed additive for all animal species(309).

250. Commission Implementing Regulation (EU) 2017/1008 of 15 June 2017 concerning the authorisation of the preparation of of Lactococcus lactis PCM B/00039, Carnobacterium divergens PCM KKP 2012p, Lactobacillus casei PCM B/00080, Lactobacillus plantarum PCM B/00081 and Saccharomyces cerevisiae PCM KKP 2059p as a feed additive for chickens for fattening (holder of authorisation JHJ Ltd)(310).

251. Commission Implementing Regulation (EU) 2017/1490 of 21 August 2017 concerning the authorisation of manganous chloride tetrahydrate, manganese (II) oxide, manganous sulphate monohydrate, manganese chelate of amino acids hydrate, manganese chelate of protein hydrolysates, manganese chelate of glycine hydrate and dimanganese chloride trihydroxide as feed additives for all animal species(311).

252. Commission Implementing Regulation (EU) 2017/1492 of 21 August 2017 concerning the authorisation of cholecalciferol as a feed additive for all animal species(312).

253. Commission Implementing Regulation (EU) 2017/1896 of 17 October 2017 concerning the authorisation of a preparation o endo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta- xylanase (EC 3.2.1.8) produced by Aspergillus niger (NRRL 25541) as a feed additive for chickens for fattening, laying hens, pigs for fattening, minor poultry species and minor porcine species for fattening and amending Regulation (EC) No 255/2005 and repealing Regulation (EC) No 668/2003 (holder of the authorisation Andrés Pintaluba S.A.)(313).

254. Commission Implementing Regulation (EU) 2017/1903 of 18 October 2017 concerning the authorisation of the preparations of Pediococcus parvulus DSM 28875, Lactobacillus casei DSM 28872 and Lactobacillus rhamnosus DSM 29226 as feed additives for all animal species(314).

255. Commission Implementing Regulation (EU) 2017/1904 of 18 October 2017 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV)(315).

256. Commission Implementing Regulation (EU) 2017/1905 of 18 October 2017 concerning an authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for chickens for fattening and for minor poultry species for fattening (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)(316).

257. Commission Implementing Regulation (EU) 2017/1906 of 18 October 2017 concerning the authorisation of a preparation of endo-1,4-b-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135) as a feed additive for chickens reared for laying and minor poultry species reared for laying (holder of authorisation Huvepharma NV)(317).

258. Commission Implementing Regulation (EU) 2017/1907 of 18 October 2017 concerning the authorisation of a preparation of Lactobacillus plantarum (KKP/593/p and KKP/788/p) and Lactobacillus buchneri (KKP/907/p) as a feed additive for cattle and sheep(318).

259. Commission Implementing Regulation (EU) 2017/1914 of 19 October 2017 concerning the authorisation of salinomycin sodium (Sacox 120 microGranulate and Sacox 200 microGranulate) as

(309)EUR 2017/1007.

(310)EUR 2017/1008.

(311)EUR 2017/1490.

(312)EUR 2017/1492.

(313)EUR 2017/1896.

(314)EUR 2017/1903.

(315)EUR 2017/1904.

(316)EUR 2017/1905.

(317)EUR 2017/1906.

(318)EUR 2017/1907.

61Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. a feed additive for chickens for fattening and chickens reared for laying and repealing Regulations

(EC) No 1852/2003 and (EC) No 1463/2004 (holder of authorisation Huvepharma NV)(319).

260. Commission Implementing Regulation (EU) 2017/2274 of 8 December 2017 concerning the authorisation of a new use of a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish (holder of authorisation Huvepharma EOOD)(320).

261. Commission Implementing Regulation (EU) 2017/2275 of 8 December 2017 concerning the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for chickens for fattening (holder of the authorisation Centro Sperimentale del Latte)(321).

262. Commission Implementing Regulation (EU) 2017/2276 of 8 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for sows (holder of the authorisation Kemin Europa N.V.)(322).

263. Commission Implementing Regulation (EU) 2017/2308 of 13 December 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for suckling piglets (holder of authorisation Chr. Hansen A/S)(323).

264. Commission Implementing Regulation (EU) 2017/2312 of 13 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co.

Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office)(324).

265. Commission Implementing Regulation (EU) 2017/2325 of 14 December 2017 concerning the authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species and amending Implementing Regulation (EU) 2017/1007(325).

266. Commission Implementing Regulation (EU) 2017/2330 of 14 December 2017 concerning the authorisation of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran as feed additive for piglets and amending Regulations (EC) No 1334/2003 and (EC) No 479/2006(326).

267. Commission Implementing Regulation (EU) 2018/129 of 25 January 2018 concerning the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80099 as a feed additive for all animal species(327).

268. Commission Implementing Regulation (EU) 2018/130 of 25 January 2018 concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) as a feed additive for pigs for fattening (holder of authorisation Berg and Schmidt GmbH Co. KG)(328).

269. Commission Implementing Regulation (EU) 2018/238 of 15 February 2018 concerning the authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate as feed additives for all animal species(329).

(319)EUR 2017/1914.

(320)EUR 2017/2274.

(321)EUR 2017/2275.

(322)EUR 2017/2276, amended by S.S.I. 2022/288 and 373, S.I. 2022/1118 (W. 233) and 1129.

(323)EUR 2017/2308.

(324)EUR 2017/2312, amended by S.S.I. 2024/330 and S.I. 2024/1101 and 1251 (W. 209).

(325)EUR 2017/2325.

(326)EUR 2017/2330.

(327)EUR 2018/129.

(328)EUR 2018/130.

(329)EUR 2018/238.

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

270. Commission Implementing Regulation (EU) 2018/239 of 15 February 2018 concerning the authorisation of methyl N-methylanthranilate and methylanthranilate as feed additives for all animal species except avian species(330).

271. Commission Implementing Regulation (EU) 2018/240 of 15 February 2018 concerning the authorisation of trimethylamine, trimethylamine hydrochloride, 3-methylbutylamine for all animal species except laying hens and 2-methoxyethyl benzene, 1,3-dimethoxy-benzene, 1,4-dimethoxy- benzene, 1-isopropyl-2-methoxy-4-methylbenzene as feed additives for all animal species(331).

272. Commission Implementing Regulation (EU) 2018/241 of 15 February 2018 concerning the authorisation of piperine, 3-methylindole, indole, 2-acetylpyrrole and pyrrolidine as feed additives for all animal species(332).

273. Commission Implementing Regulation (EU) 2018/242 of 15 February 2018 concerning the authorisation of hex-3(cis)-en-1-ol, non-6-en-1-ol, oct-3-en-1-ol, non-6(cis)-enal, hex-3(cis)- enal, hept-4-enal, hex-3(cis)-enyl acetate, hex-3(cis)-enyl formate, hex-3-enyl butyrate, hex-3-enyl hexanoate, hex-3(cis)-enyl isobutyrate, citronellol, (-)-3,7-dimethyl-6-octen-1-ol, citronellal, 2,6- dimethylhept-5-enal, citronellic acid, citronellyl acetate, citronellyl butyrate, citronellyl formate, citronellyl propionate, 1-ethoxy-1-(3-hexenyloxy)ethane and hex-3-enyl isovalerate as feed additives for all animal species(333).

274. Commission Implementing Regulation (EU) 2018/243 of 15 February 2018 concerning the authorisation of 3-hydroxybutan-2-one, pentan-2,3-dione, 3,5-dimethyl cyclopentan-1,2- dione, hexan-3,4-dione, sec-butan-3-onyl acetate, 2,6,6-trimethylcyclohex-2-en-1,4-dione and 3- methylnona-2-,4-dione as feed additives for all animal species(334).

275. Commission Implementing Regulation (EU) 2018/244 of 15 February 2018 concerning the authorisation of vanillyl acetone and 4-(4-methoxyphenyl) butan-2-one as feed additives for all animal species and the denial of 1-phenylethan-1-ol(335).

276. Commission Implementing Regulation (EU) 2018/245 of 15 February 2018 concerning the authorisation of menthol, d-carvone, menthyl acetate, d,l-isomenthone, 3-methyl-2-(pent-2(cis)- enyl)cyclopent-2-en-1-one, 3,5,5-trimethylcyclohex-2-en-1-one, d-fenchone, fenchyl alcohol, carvyl acetate, dihydrocarvyl acetate and fenchyl acetate as feed additives for all animal species(336).

277. Commission Implementing Regulation (EU) 2018/246 of 15 February 2018 concerning the authorisation of linalool oxide as a feed additive for all animal species except fish(337).

278. Commission Implementing Regulation (EU) 2018/247 of 15 February 2018 concerning the authorisation of 2,4,5-trimethylthiazole, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, 2-acetylthiazole, 2-ethyl-4- methylthiazole, 5,6-dihydro-2,4,6,tris(2-methylpropyl)4H-1,3,5- dithiazine and thiamine hydrochloride as feed additives for all animal species(338).

279. Commission Implementing Regulation (EU) 2018/248 of 15 February 2018 concerning the authorisation of 2,3-diethylpyrazine, 2,5 or 6-methoxy-3-methylpyrazine, 2- acetyl-3-ethylpyrazine, 2,3-diethyl-5-methylpyrazine, 2-(sec-butyl)-3-methoxypyrazine, 2-ethyl-3- methoxypyrazine, 5,6,7,8-tetrahydroquinoxaline, 2-ethylpyrazine and 5-methylquinoxaline as feed additives for all animal species(339).

(330)EUR 2018/239.

(331)EUR 2018/240.

(332)EUR 2018/241.

(333)EUR 2018/242.

(334)EUR 2018/243.

(335)EUR 2018/244.

(336)EUR 2018/245.

(337)EUR 2018/246.

(338)EUR 2018/247.

(339)EUR 2018/248.

63Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

280. Commission Implementing Regulation (EU) 2018/249 of 15 February 2018 concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L- isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs(340).

281. Commission Implementing Regulation (EU) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2- methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate as feed additives for all animal species(341).

282. Commission Implementing Regulation (EU) 2018/327 of 5 March 2018 concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IMI SD135) as a feed additive for carp (holder of authorisation Huvepharma NV)(342).

283. Commission Implementing Regulation (EU) 2018/328 of 5 March 2018 concerning the authorisation of the preparation of Bacillus subtilis DSM 29784 as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation Adisseo France SAS)(343).

284. Commission Implementing Regulation (EU) 2018/338 of 7 March 2018 concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets (holder of the authorisation BASF SE)(344).

285. Commission Implementing Regulation (EU) 2018/346 of 5 March 2018 concerning the authorisation of a preparation of Lactobacillus buchneri NRRL B-50733 as a feed additive for all animal species(345).

286. Commission Implementing Regulation (EU) 2018/347 of 5 March 2018 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for piglets and sows and amending Regulations (EC) No 1847/2003 and (EC) No 2036/2005 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)(346).

287. Commission Implementing Regulation (EU) 2018/982 of 11 July 2018 concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as feed additive for chickens for fattening and chickens reared for laying (holder of the authorisation Novus Europe N.A./S.V.)(347).

288. Commission Implementing Regulation (EU) 2018/983 of 11 July 2018 concerning the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction (holder of authorisation DSM Nutritional Products Sp. z o. o.)(348).

289. Commission Implementing Regulation (EU) 2018/1039 of 23 July 2018 concerning the authorisation of Copper(II) diacetate monohydrate, Copper(II) carbonate dihydroxy monohydrate, Copper(II) chloride dihydrate, Copper(II) oxide, Copper(II) sulphate pentahydrate, Copper(II)

(340)EUR 2018/249.

(341)EUR 2018/250.

(342)EUR 2018/327.

(343)EUR 2018/328.

(344)EUR 2018/338.

(345)EUR 2018/346.

(346)EUR 2018/347.

(347)EUR 2018/982.

(348)EUR 2018/983.

64Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. chelate of amino acids hydrate, Copper(II) chelate of protein hydrolysates, Copper(II) chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006 and (EU) No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261(349).

290. Commission Implementing Regulation (EU) 2018/1079 of 30 July 2018 concerning the authorisation of a preparation of Bacillus subtilis DSM 28343 as a feed additive for weaned piglets (holder of authorisation Lactosan GmbH & Co. KG)(350).

291. Commission Implementing Regulation (EU) 2018/1080 of 30 July 2018 concerning the authorisation of the preparation of Bacillus subtilis DSM 29784 as a feed additive for minor poultry species for fattening and reared for laying (holder of authorisation Adisseo France SAS)(351).

292. Commission Implementing Regulation (EU) 2018/1081 of 30 July 2018 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office)(352).

293. Commission Implementing Regulation (EU) 2018/1090 of 31 July 2018 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, all avian species reared for laying or for breeding purposes, weaned piglets and minor porcine species (weaned) (holder of the authorisation Kaesler Nutrition GmbH)(353).

294. Commission Implementing Regulation (EU) 2018/1533 of 12 October 2018 concerning the authorisation of sodium alginate as a feed additive for cats, dogs, other non-food-producing animals and fish and potassium alginate as a feed additive for cats and dogs(354).

295. Commission Implementing Regulation (EU) 2018/1543 of 15 October 2018 concerning the authorisation of a preparation of Pediococcus pentosaceus DSM 32291 as a feed additive for all animal species(355).

296. Commission Implementing Regulation (EU) 2018/1550 of 16 October 2018 concerning the renewal of the authorisation of benzoic acid as a feed additive for weaned piglets and pigs for fattening and repealing Regulations (EC) No 1730/2006 and (EC) No 1138/2007 (holder of authorisation DSM Nutritional Products Ltd)(356).

297. Commission Implementing Regulation (EU) 2018/1558 of 17 October 2018 concerning the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for cats and dogs (holder of the authorisation Centro Sperimentale del Latte)(357).

298. Commission Implementing Regulation (EU) 2018/1559 of 17 October 2018 concerning the authorisation of cumin tincture (Cuminum cyminum L.) as a feed additive for all animal species(358).

299. Commission Implementing Regulation (EU) 2018/1564 of 17 October 2018 concerning the authorisation of a preparation of dolomite-magnesite as a feed additive for all animal species with

(349)EUR 2018/1039, amended by S.S.I. 2024/330 and S.I. 2024/1101 and 1251 (W. 209).

(350)EUR 2018/1079.

(351)EUR 2018/1080.

(352)EUR 2018/1081, amended by S.S.I. 2024/330 and S.I. 2024/1101 and 1251 (W. 209).

(353)EUR 2018/1090.

(354)EUR 2018/1533.

(355)EUR 2018/1543.

(356)EUR 2018/1550.

(357)EUR 2018/1558.

(358)EUR 2018/1559.

65Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. the exception of dairy cows and other ruminants for dairy production, weaned piglets and pigs for fattening(359).

300. Commission Implementing Regulation (EU) 2018/1565 of 17 October 2018 concerning the authorisation of a preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM

28088) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species other than laying birds, turkeys for fattening, turkeys reared for breeding, weaned piglets, pigs for fattening and minor porcine species (holder of authorisation Elanco GmbH)(360).

301. Commission Implementing Regulation (EU) 2018/1566 of 18 October 2018 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger

(ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.)(361).

302. Commission Implementing Regulation (EU) 2018/1568 of 18 October 2018 concerning the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159) as a feed additive for all pigs and all poultry species(362).

303. Commission Implementing Regulation (EU) 2019/8 of 3 January 2019 concerning the authorisation of hydroxy analogue of methionine and its calcium salt as a feed additive for all animal species(363).

304. Commission Implementing Regulation (EU) 2019/9 of 3 January 2019 concerning the authorisation of betaine anhydrous as a feed additive for food-producing animals except rabbits(364).

305. Commission Implementing Regulation (EU) 2019/10 of 3 January 2019 concerning the authorisation of a preparation of a natural mixture of illite- montmorillonite-kaolinite as a feed additive for all animal species(365).

306. Commission Implementing Regulation (EU) 2019/11 of 3 January 2019 concerning the authorisation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for sows, suckling piglets, weaned piglets, pigs for fattening, and amending Regulations (EC) No 252/2006,

(EC) No 943/2005 and (EC) No 1200/2005 (holder of authorisation DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.)(366).

307. Commission Implementing Regulation (EU) 2019/12 of 3 January 2019 concerning the authorisation of L-arginine as a feed additive for all animal species(367).

308. Commission Implementing Regulation (EU) 2019/49 of 4 January 2019 concerning the authorisation of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine as feed additives for all animal species(368).

309. Commission Implementing Regulation (EU) 2019/111 of 24 January 2019 concerning the authorisation of hop extract (Humulus lupulus L. flos) as a feed additive for weaned piglets, pigs for fattening and minor porcine species weaned and for fattening(369).

310. Commission Implementing Regulation (EU) 2019/144 of 28 January 2019 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as

(359)EUR 2018/1564.

(360)EUR 2018/1565.

(361)EUR 2018/1566.

(362)EUR 2018/1568.

(363)EUR 2019/8.

(364)EUR 2019/9.

(365)EUR 2019/10.

(366)EUR 2019/11.

(367)EUR 2019/12.

(368)EUR 2019/49.

(369)EUR 2019/111.

66Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. a feed additive for chickens reared for laying and minor poultry species for fattening or reared for laying or for breeding (holder of authorisation Fertinagro Biotech S.L.)(370).

311. Commission Implementing Regulation (EU) 2019/454 of 20 March 2019 concerning the authorisation of preparations of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well as a preparation of endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001 as silage additives for all animal species(371).

312. Commission Implementing Regulation (EU) 2019/764 of 14 May 2019 concerning the authorisation of a preparation of Lactobacillus hilgardii CNCM I-4785 and Lactobacillus buchneri CNCM I-4323/NCIMB 40788 as a feed additive for all animal species(372).

313. Commission Implementing Regulation (EU) 2019/781 of 15 May 2019 concerning the authorisation of a preparation of 3-phytase produced by Komagataella phaffii (CECT 13094) as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species for fattening, for breeding and reared for laying (holder of authorisation Fertinagro Nutrientes S.L.)(373).

314. Commission Implementing Regulation (EU) 2019/804 of 17 May 2019 concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species and repealing Regulations (EC) No 1750/2006 and (EC) No 634/2007(374).

315. Commission Implementing Regulation (EU) 2019/805 of 17 May 2019 concerning the authorisation of a preparation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for chickens for fattening and minor poultry species for fattening (holder of authorisation DSM Nutritional Products Ltd, represented in EU by DSM Nutritional Products Sp. Z o.o)(375).

316. Commission Implementing Regulation (EU) 2019/857 of 27 May 2019 concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for dairy sheep and dairy goats and repealing Regulation (EC) No 226/2007 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)(376).

317. Commission Implementing Regulation (EU) 2019/892 of 28 May 2019 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for all pigs other than weaned piglets and sows and all minor porcine species (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)(377).

318. Commission Implementing Regulation (EU) 2019/894 of 28 May 2019 concerning the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for all animal species(378).

319. Commission Implementing Regulation (EU) 2019/898 of 29 May 2019 concerning the authorisation of the preparation of eugenol as a feed additive for chickens for fattening (holder of authorisation Lidervet SL)(379).

(370)EUR 2019/144.

(371)EUR 2019/454.

(372)EUR 2019/764.

(373)EUR 2019/781.

(374)EUR 2019/804, amended by S.S.I. 2024/330 and S.I. 2024/1101 and 1251 (W. 209).

(375)EUR 2019/805.

(376)EUR 2019/857.

(377)EUR 2019/892.

(378)EUR 2019/894.

(379)EUR 2019/898.

67Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

320. Commission Implementing Regulation (EU) 2019/899 of 29 May 2019 concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for lambs for fattening, dairy goats, dairy sheep, dairy buffaloes, horses and pigs for fattening and repealing Regulations (EC) No 1447/2006, (EC) No 188/2007, (EC) No 232/2009, (EC) No 186/2007 and

(EC) No 209/2008 (holder of authorisation S.I. Lesaffre)(380).

321. Commission Implementing Regulation (EU) 2019/900 of 29 May 2019 concerning the authorisation of 8-mercapto-p-menthan-3-one and p-menth-1-ene-8-thiol as feed additives for all animal species(381).

322. Commission Implementing Regulation (EU) 2019/901 of 29 May 2019 concerning the authorisation of riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) (sources of vitamin B2) as feed additives for all animal species(382).

323. Commission Implementing Regulation (EU) 2019/913 of 29 May 2019 concerning the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats and repealing Regulation (EC) No 163/2008 (holder of authorisation Bayer HealthCare AG)(383).

324. Commission Implementing Regulation (EU) 2019/914 of 29 May 2019 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying (holder of authorisation HuvePharma NV)(384).

325. Commission Implementing Regulation (EU) 2019/929 of 5 June 2019 concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) as a feed additive for chickens for fattening and weaned piglets (holder of authorisation Berg and Schmidt GmbH Co. KG)(385).

326. Commission Implementing Regulation (EU) 2019/1125 of 5 June 2019 concerning the authorisation of zinc chelate of methionine sulfate as a feed additive for all animal species(386).

327. Commission Implementing Regulation (EU) 2019/1289 of 31 July 2019 concerning the authorisation of L-valine produced by Corynebacterium glutamicum KCCM 11201P as a feed additive for all animal species(387).

328. Commission Implementing Regulation (EU) 2019/1313 of 2 August 2019 concerning the authorisation of a preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening and minor porcine species for fattening (holder of authorisation Cargill Incorporated, represented by Provimi Holding BV)(388).

329. Commission Implementing Regulation (EU) 2019/1315 of 2 August 2019 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive (in water for drinking) for sows (holder of authorisation Lactosan GmbH & Co)(389).

330. Commission Implementing Regulation (EU) 2019/1324 of 5 August 2019 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588

(380)EUR 2019/899.

(381)EUR 2019/900.

(382)EUR 2019/901.

(383)EUR 2019/913.

(384)EUR 2019/914.

(385)EUR 2019/929.

(386)EUR 2019/1125.

(387)EUR 2019/1289.

(388)EUR 2019/1313.

(389)EUR 2019/1315.

68Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, minor poultry species for fattening or reared for laying or for breeding, weaned piglets, pigs for fattening and minor porcine species (holder of authorisation Puratos)(390).

331. Commission Implementing Regulation (EU) 2019/1947 of 22 November 2019 concerning the authorisation of cassia gum as a feed additive for cats and dogs(391).

332. Commission Implementing Regulation (EU) 2019/1964 of 26 November 2019 concerning the authorisation of L-lysine base, liquid, L-lysine monohydrochloride, liquid, L-lysine monohydrochloride, technically pure, and L-lysine sulphate as feed additives for all animal species(392).

333. Commission Implementing Regulation (EU) 2019/1965 of 26 November 2019 concerning the authorisation of sodium molybdate dihydrate as feed additive for sheep(393).

334. Commission Implementing Regulation (EU) 2019/1977 of 26 November 2019 concerning the authorisation of phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4-hydroxy-5- methyl-3(2H)-furanone as feed additives for cats and dogs(394).

335. Commission Implementing Regulation (EU) 2020/106 of 23 January 2020 concerning the authorisation of sodium formate as a feed additive for all animal species(395).

336. Commission Implementing Regulation (EU) 2020/107 of 23 January 2020 concerning the authorisation of ponceau 4R as a feed additive for dogs, cats and ornamental fish(396).

337. Commission Implementing Regulation (EU) 2020/147 of 3 February 2020 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for weaned piglets, sows (in order to have a benefit for suckling piglets) and dairy cows and amending Regulations (EC) No 2148/2004, (EC) No 1288/2004 and (EC) No 1811/2005 (holder of authorisation S.I. Lesaffre)(397).

338. Commission Implementing Regulation (EU) 2020/148 of 3 February 2020 concerning the authorisation of robenidine hydrochloride (Robenz 66G) as a feed additive for chickens for fattening and amending Regulation (EC) No 1800/2004 (holder of authorisation Zoetis SA)(398).

339. Commission Implementing Regulation (EU) 2020/149 of 4 February 2020 concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for lambs and horses and repealing Regulations (EC) No 1293/2008 and (EC) No 910/2009 (holder of authorisation Danstar Ferment AG represented in the Union by Lallemand SAS)(399).

340. Commission Implementing Regulation (EU) 2020/150 of 4 February 2020 concerning the authorisation of the preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 as a feed additive for chickens for fattening, chickens reared for laying and for breeding and minor poultry species for fattening or reared for laying or for breeding purposes (holder of authorisation Andrés Pintaluba S.A.)(400).

341. Commission Implementing Regulation (EU) 2020/151 of 4 February 2020 concerning the authorisation of Pediococcus acidilactici CNCM I-4622 as a feed additive for all porcine species

(390)EUR 2019/1324.

(391)EUR 2019/1947.

(392)EUR 2019/1964.

(393)EUR 2019/1965.

(394)EUR 2019/1977.

(395)EUR 2020/106.

(396)EUR 2020/107.

(397)EUR 2020/147.

(398)EUR 2020/148.

(399)EUR 2020/149.

(400)EUR 2020/150.

69Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. for fattening and for breeding other than sows, all avian species, all fish species and all crustaceans and repealing Regulations (EC) No 911/2009, (EU) No 1120/2010 and (EU) No 212/2011 and Implementing Regulations (EU) No 95/2013, (EU) No 413/2013 and (EU) 2017/2299 (holder of authorisation Danstar Ferment AG represented in the Union by Lallemand SAS)(401).

342. Commission Implementing Regulation (EU) 2020/157 of 5 February 2020 concerning the authorisation of tartrazine as a feed additive for dogs, cats, ornamental fish, grain-eating ornamental birds and small rodents(402).

343. Commission Implementing Regulation (EU) 2020/159 of 5 February 2020 concerning the renewal of the authorisation of Enterococcus faecium DSM 7134 as a feed additive for weaned piglets and pigs for fattening and repealing Regulation (EC) No 538/2007 (holder of authorisation Lactosan Starterkulturen GmbH & Co)(403).

344. Commission Implementing Regulation (EU) 2020/160 of 5 February 2020 concerning the authorisation of the preparation of oregano oil, caraway oil, carvacrol, methyl salicylate and L- menthol as a feed additive for weaned piglets (holder of authorisation Biomin GmbH)(404).

345. Commission Implementing Regulation (EU) 2020/161 of 5 February 2020 concerning the renewal of the authorisation of Bacillus subtilis DSM 17299 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1137/2007 (holder of authorisation Chr. Hansen A/ S)(405).

346. Commission Implementing Regulation (EU) 2020/162 of 5 February 2020 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I#1079 as a feed additive for turkeys for fattening (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)(406).

347. Commission Implementing Regulation (EU) 2020/163 of 5 February 2020 concerning the authorisation of a preparation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for turkeys for fattening, turkeys reared for breeding, chickens reared for breeding and other poultry species reared for breeding (holder of authorisation DSM Nutritional Products Ltd.

represented in the Union by DSM Nutritional Products Sp. Z o.o)(407).

348. Commission Implementing Regulation (EU) 2020/164 of 5 February 2020 concerning the authorisation of 6-phytase produced by Schizosaccharomyces pombe (ATCC 5233) as a feed additive for all avian species and all swine species and repealing Regulation (EC) No 379/2009 (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)(408).

349. Commission Implementing Regulation (EU) 2020/165 of 5 February 2020 concerning the authorisation of endo-1,4-beta-mannanase produced by Paenibacillus lentus DSM 32052 as a feed additive for chickens for fattening, for chickens reared for laying, turkeys for fattening or reared for breeding and for minor poultry species and repealing Regulation (EC) No 786/2007 (holder of authorisation Elanco GmbH)(409).

350. Commission Implementing Regulation (EU) 2020/166 of 5 February 2020 concerning the renewal of the authorisation of 6-phytase produced by Schizosaccharomyces pombe (ATCC 5233) as a feed additive for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening,

(401)EUR 2020/151.

(402)EUR 2020/157.

(403)EUR 2020/159.

(404)EUR 2020/160.

(405)EUR 2020/161.

(406)EUR 2020/162.

(407)EUR 2020/163.

(408)EUR 2020/164.

(409)EUR 2020/165.

70Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. weaned piglets, pigs for fattening and sows and repealing Regulation (EC) No 785/2007 (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)(410).

351. Commission Implementing Regulation (EU) 2020/172 of 6 February 2020 concerning the renewal of the authorisation of 3-phytase produced by Aspergillus niger (CBS 101.672) as a feed additive for piglets (weaned), pigs for fattening, sows, chickens for fattening, turkeys for fattening, laying hens, ducks and all other minor avian species, ornamental birds and the new authorisation for chickens reared for laying or for breeding purposes, turkeys reared for breeding or breeding hens and suckling piglets and repealing Regulations (EC) No 243/2007, (EC) No 1142/2007, (EC) No 165/2008, (EC) No 505/2008 and (EU) No 327/2010 (holder of authorisation BASF SE)(411).

352. Commission Implementing Regulation (EU) 2020/173 of 6 February 2020 concerning the authorisation of brilliant blue FCF as a feed additive for cats and dogs(412).

353. Commission Implementing Regulation (EU) 2020/180 of 7 February 2020 concerning the authorisation of a preparation of Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP as a feed additive for all animal species(413).

354. Commission Implementing Regulation (EU) 2020/196 of 13 February 2020 concerning the renewal of the authorisation of endo-1,4-beta-xylanase produced by Aspergillus niger CBS 109.713 as a feed additive for chickens for fattening, turkeys for fattening, turkeys reared for breeding, minor avian species (except laying birds) and ornamental birds and repealing Regulations (EC) No 1380/2007, (EC) No 1096/2009 and Implementing Regulation (EU) No 843/2012 (holder of authorisation BASF SE)(414).

355. Commission Implementing Regulation (EU) 2020/197 of 13 February 2020 concerning the authorisation of allura red AC as a feed additive for cats and dogs(415).

356. Commission Implementing Regulation (EU) 2020/228 of 19 February 2020 concerning the authorisation of erythrosine as a feed additive for dogs and cats(416).

357. Commission Implementing Regulation (EU) 2020/229 of 19 February 2020 concerning the authorisation of L-tryptophan as a feed additive for all animal species(417).

358. Commission Implementing Regulation (EU) 2020/238 of 20 February 2020 concerning the authorisation of L-threonine as a feed additive for all animal species(418).

359. Commission Implementing Regulation (EU) 2020/376 of 5 March 2020 concerning the authorisation of Norbixin (annatto F) as a feed additive for cats and dogs(419).

360. Commission Implementing Regulation (EU) 2020/377 of 5 March 2020 concerning the authorisation of sodium selenate as a feed additive for ruminants(420).

361. Commission Implementing Regulation (EU) 2020/378 of 5 March 2020 concerning the authorisation of L-leucine as a feed additive for all animal species(421).

(410)EUR 2020/166.

(411)EUR 2020/172.

(412)EUR 2020/173.

(413)EUR 2020/180.

(414)EUR 2020/196.

(415)EUR 2020/197.

(416)EUR 2020/228.

(417)EUR 2020/229.

(418)EUR 2020/238.

(419)EUR 2020/376.

(420)EUR 2020/377.

(421)EUR 2020/378.

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362. Commission Implementing Regulation (EU) 2020/992 of 9 July 2020 concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for all avian species for laying (holder of the authorisation BASF SE)(422).

363. Commission Implementing Regulation (EU) 2020/993 of 9 July 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) as a feed additive for all avian species for fattening other than chickens for fattening, ornamental birds, all weaned porcine species other than weaned piglets and all porcine species for fattening other than pigs for fattening (holder of authorisation Berg und Schmidt GmbH Co. KG)(423).

364. Commission Implementing Regulation (EU) 2020/994 of 9 July 2020 concerning the authorisation of monensin and nicarbazin (Monimax) as a feed additive for turkeys for fattening, chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV)(424).

365. Commission Implementing Regulation (EU) 2020/995 of 9 July 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM

26372) as a feed additive for lactating sows (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o)(425).

366. Commission Implementing Regulation (EU) 2020/996 of 9 July 2020 concerning the authorisation of the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species reared for laying (holder of authorisation Biomin GmbH)(426).

367. Commission Implementing Regulation (EU) 2020/997 of 9 July 2020 concerning the authorisation of L-lysine base, liquid, L-lysine sulphate and L-lysine monohydrochloride, technically pure, as feed additives for all animal species(427).

368. Commission Implementing Regulation (EU) 2020/998 of 9 July 2020 concerning the renewal of the authorisation of astaxanthin-dimethyldisuccinate as a feed additive for fish and crustaceans and repealing Regulation (EC) No 393/2008(428).

369. Commission Implementing Regulation (EU) 2020/1031 of 15 July 2020 concerning the authorisation of benzoic acid as a feed additive for pigs for fattening (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o)(429).

370. Commission Implementing Regulation (EU) 2020/1032 of 15 July 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 28343 as a feed additive for calves for rearing and pigs for fattening (holder of authorisation Lactosan GmbH & Co. KG)(430).

371. Commission Implementing Regulation (EU) 2020/1033 of 15 July 2020 concerning the renewal of the authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870 and the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 as feed additives for all animal species, and repealing Regulation (EC) No 1139/2007(431).

372. Commission Implementing Regulation (EU) 2020/1034 of 15 July 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM

(422)EUR 2020/992.

(423)EUR 2020/993.

(424)EUR 2020/994.

(425)EUR 2020/995.

(426)EUR 2020/996.

(427)EUR 2020/997.

(428)EUR 2020/998.

(429)EUR 2020/1031.

(430)EUR 2020/1032.

(431)EUR 2020/1033.

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26372) as a feed additive for laying hens (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o)(432).

373. Commission Implementing Regulation (EU) 2020/1090 of 24 July 2020 concerning the authorisation of L-histidine monohydrochloride monohydrate as a feed additive for all animal species(433).

374. Commission Implementing Regulation (EU) 2020/1091 of 24 July 2020 concerning the authorisation of L-threonine as a feed additive for all animal species(434).

375. Commission Implementing Regulation (EU) 2020/1094 of 24 July 2020 concerning the renewal of the authorisation of the preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for sows and repealing Regulation (EC) No 896/2009 (holder of authorisation Prosol S.p.A.)(435).

376. Commission Implementing Regulation (EU) 2020/1095 of 24 July 2020 amending Implementing Regulation (EU) 2015/502 concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows(436).

377. Commission Implementing Regulation (EU) 2020/1096 of 24 July 2020 concerning the renewal of the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for dairy cows and horses and repealing Regulation (EU) No 1119/2010 (holder of authorisation Prosol S.p.A.)(437).

378. Commission Implementing Regulation (EU) 2020/1097 of 24 July 2020 concerning the authorisation of lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta as feed additives for poultry (except turkeys) for fattening and laying and for minor poultry species for fattening and laying(438).

379. Commission Implementing Regulation (EU) 2020/1098 of 24 July 2020 concerning the authorisation of cardamom essential oil from Elettaria cardamomum (L.) Maton as a feed additive for all animal species(439).

380. Commission Implementing Regulation (EU) 2020/1175 of 7 August 2020 concerning the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 as a feed additive for all animal species(440).

381. Commission Implementing Regulation (EU) 2020/1363 of 30 September 2020 concerning the authorisation of the preparation of Bacillus amyloliquefaciens DSM 25840 as a feed additive for all porcine species (holder of authorisation Chr. Hansen A/S)(441).

382. Commission Implementing Regulation (EU) 2020/1370 of 1 October 2020 concerning the authorisation of a preparation of lanthanide citrate as a feed additive for weaned piglets (holder of authorisation Treibacher Industrie AG)(442).

383. Commission Implementing Regulation (EU) 2020/1371 of 1 October 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase as a feed additive for lactating sows (holder of the authorisation BASF SE)(443).

(432)EUR 2020/1034.

(433)EUR 2020/1090.

(434)EUR 2020/1091.

(435)EUR 2020/1094.

(436)EUR 2020/1095.

(437)EUR 2020/1096.

(438)EUR 2020/1097.

(439)EUR 2020/1098.

(440)EUR 2020/1175.

(441)EUR 2020/1363.

(442)EUR 2020/1370.

(443)EUR 2020/1371.

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384. Commission Implementing Regulation (EU) 2020/1372 of 1 October 2020 concerning the authorisation of L-tryptophan produced by Escherichia coli CGMCC 7.267, CGMCC 11674 or KCCM 10534 as a feed additive for all animal species(444).

385. Commission Implementing Regulation (EU) 2020/1373 of 1 October 2020 concerning the authorisation of zinc chelate of lysine and glutamic acid as a feed additive for all animal species(445).

386. Commission Implementing Regulation (EU) 2020/1374 of 1 October 2020 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for calves, all minor ruminant species (for rearing) other than lambs and camelids (for rearing) (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)(446).

387. Commission Implementing Regulation (EU) 2020/1375 of 1 October 2020 concerning the authorisation of the preparation of citric acid, sorbic acid, thymol and vanillin as a feed additive for suckling piglets, turkeys for fattening and turkeys reared for breeding (holder of authorisation Vetagro SpA)(447).

388. Commission Implementing Regulation (EU) 2020/1376 of 1 October 2020 concerning the authorisation of a preparation of 6-phytase, produced by Komagataella phaffii (CGMCC 12056) as feed additive for turkeys for fattening, turkeys reared for breeding, piglets (suckling and weaned) and minor porcine species (holder of the authorisation Andrés Pintaluba S.A)(448).

389. Commission Implementing Regulation (EU) 2020/1377 of 1 October 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG S-15136) as a feed additive for suckling piglets, all minor porcine species other than reproductive animals (holder of authorisation Beldem, a division of Puratos NV)(449).

390. Commission Implementing Regulation (EU) 2020/1378 of 1 October 2020 concerning the authorisation of copper chelate of lysine and glutamic acid as a feed additive for all animal species(450).

391. Commission Implementing Regulation (EU) 2020/1379 of 1 October 2020 concerning the authorisation of L-cystine produced by Pantoea ananatis NITE BP-02525 as a feed additive for all animal species(451).

392. Commission Implementing Regulation (EU) 2020/1395 of 5 October 2020 concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, and repealing Regulation (EC) No 1292/2008 (holder of authorisation Evonik Nutrition & Care GmbH)(452).

393. Commission Implementing Regulation (EU) 2020/1396 of 5 October 2020 concerning the authorisation of geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate as feed additives for all animal species except for marine animals(453).

394. Commission Implementing Regulation (EU) 2020/1397 of 5 October 2020 concerning the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a nutritional additive, its extension of use and the authorisation of L-isoleucine produced by

(444)EUR 2020/1372.

(445)EUR 2020/1373.

(446)EUR 2020/1374.

(447)EUR 2020/1375.

(448)EUR 2020/1376.

(449)EUR 2020/1377.

(450)EUR 2020/1378.

(451)EUR 2020/1379.

(452)EUR 2020/1395, amended by S.S.I. 2024/330 and S.I. 2024/1101 and 1251 (W. 209).

(453)EUR 2020/1396.

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Corynebacterium glutamicum KCCM 80189 as a feed additive for all animal species, and repealing Regulation (EU) No 348/2010(454).

395. Commission Implementing Regulation (EU) 2020/1398 of 5 October 2020 concerning the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses and repealing Regulation (EC) No 886/2009 (holder of authorisation All-Technology Ireland Ltd)(455).

396. Commission Implementing Regulation (EU) 2020/1399 of 5 October 2020 concerning the authorisation of butylated hydroxyanisole as a feed additive for all animal species except cats(456).

397. Commission Implementing Regulation (EU) 2020/1400 of 5 October 2020 concerning the authorisation of ethyl ester of β-apo-8’-carotenoic acid as a feed additive for chickens for fattening, laying hens and minor poultry species for laying and for fattening(457).

398. Commission Implementing Regulation (EU) 2020/1418 of 6 October 2020 concerning the authorisation of saponified paprika (Capsicum annuum) extract (capsanthin) as a feed additive for chickens for fattening, minor poultry species for fattening, laying hens and minor poultry species for laying(458).

399. Commission Implementing Regulation (EU) 2020/1497 of 15 October 2020 concerning the authorisation of L-methionine produced by Corynebacterium glutamicum KCCM 80184 and Escherichia coli KCCM 80096 as a feed additive for all animal species(459).

400. Commission Implementing Regulation (EU) 2020/1510 of 16 October 2020 concerning the authorisation of cinnamyl alcohol, 3-phenylpropan-1-ol, 2-phenylpropanal, 3-(p- cumenyl)-2-methylpropionalde-hyde, alpha-methylcinnamaldehyde, 3-phenylpropanal, cinnamic acid, cinnamyl acetate, cinnamyl butyrate, 3-phenylpropyl isobutyrate, cinnamyl isovalerate, cinnamyl isobutyrate, ethyl cinnamate, methyl cinnamate and isopentyl cinnamate as feed additives for all animal species except for marine animals(460).

401. Commission Implementing Regulation (EU) 2020/1755 of 24 November 2020 concerning the authorisation of a preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH)(461).

402. Commission Implementing Regulation (EU) 2020/1760 of 25 November 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S)(462).

403. Commission Implementing Regulation (EU) 2020/1761 of 25 November 2020 concerning the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 as a feed additive for all animal species(463).

404. Commission Implementing Regulation (EU) 2020/1762 of 25 November 2020 concerning the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and

(454)EUR 2020/1397.

(455)EUR 2020/1398.

(456)EUR 2020/1399.

(457)EUR 2020/1400.

(458)EUR 2020/1418.

(459)EUR 2020/1497.

(460)EUR 2020/1510.

(461)EUR 2020/1755.

(462)EUR 2020/1760.

(463)EUR 2020/1761.

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Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation Chr. Hansen A/S)(464).

405. Commission Implementing Regulation (EU) 2020/1764 of 25 November 2020 concerning the authorisation of disodium 5’-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 as a feed additive for all animal species(465).

406. Commission Implementing Regulation (EU) 2020/1795 of 30 November 2020 concerning the authorisation of iron chelate of lysine and glutamic acid as a feed additive for all animal species(466).

407. Commission Implementing Regulation (EU) 2020/1796 of 30 November 2020 concerning the authorisation of L-glutamine produced by Corynebacterium glutamicum NITE BP-02524 as a feed additive for all animal species(467).

408. Commission Implementing Regulation (EU) 2020/1797 of 30 November 2020 concerning the authorisation of L-valine produced by Escherichia coli KCCM 80159 as a feed additive for all animal species(468).

409. Commission Implementing Regulation (EU) 2020/1798 of 30 November 2020 concerning the authorisation of L-lysine monohydrochloride produced by Corynebacterium glutamicum DSM 32932 and L-lysine sulphate produced by Corynebacterium glutamicum KFCC 11043 as feed additives for all animal species(469).

410. Commission Implementing Regulation (EU) 2020/1799 of 30 November 2020 concerning the authorisation of a preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 as a feed additive for laying hens and other laying birds (holder of authorisation: Andrés Pintaluba S.A.)(470).

411. Commission Implementing Regulation (EU) 2020/1800 of 30 November 2020 concerning the authorisation of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80188 as a feed additive for all animal species(471).

SCHEDULE 6 Regulation 21(2)

Revocation of assimilated direct legislation: instruments containing authorisations of products containing, consisting of, or produced from, genetically modified organisms Revocation of assimilated direct legislation containing authorisations of products containing, consisting of, or produced from, genetically modified organisms

1. Commission Decision 2007/692/EC of 24 October 2007 authorising the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(472).

2. Commission Decision 2007/701/EC of 24 October 2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize

(464)EUR 2020/1762.

(465)EUR 2020/1764.

(466)EUR 2020/1795.

(467)EUR 2020/1796.

(468)EUR 2020/1797.

(469)EUR 2020/1798.

(470)EUR 2020/1799.

(471)EUR 2020/1800.

(472)EUDN 2007/692, amended by S.I. 2019/705.

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NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(473).

3. Commission Decision 2007/702/EC of 24 October 2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(474).

4. Commission Decision 2007/703/EC of 24 October 2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(475).

5. Commission Decision 2008/837/EC of 29 October 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified LLCotton25 (ACS- GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(476).

6. Commission Decision 2008/933/EC of 4 December 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(477).

7. Commission Decision 2009/184/EC of 10 March 2009 authorising the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third countries until 2005 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(478).

8. Commission Decision 2010/136/EU of 2 March 2010 authorising the placing on the market of feed produced from the genetically modified potato EH92-527-1 (BPS-25271-9) and the adventitious or technically unavoidable presence of the potato in food and other feed products under Regulation (EC) No 1829/2003 of the European Parliament and of the Council(479).

9. Commission Decision 2011/354/EU of 17 June 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614 (BCS- GHØØ2-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(480).

10. Commission Decision 2011/891/EU of 22 December 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236x3006-210-23 (DAS-24236-5xDAS-21Ø23-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(481).

11. Commission Implementing Decision 2012/81/EU of 10 February 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A5547-127 (ACS-GMØØ6-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(482).

(473)EUDN 2007/701, amended by S.I. 2019/705.

(474)EUDN 2007/702, amended by S.I. 2019/705.

(475)EUDN 2007/703, amended by S.I. 2019/705.

(476)EUDN 2008/837.

(477)EUDN 2008/933, amended by S.I. 2019/705.

(478)EUDN 2009/184.

(479)EUDN 2010/136.

(480)EUDN 2011/354, amended by S.I. 2019/705.

(481)EUDN 2011/891, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(482)EUDN 2012/81, amended by S.I. 2019/705.

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12. Commission Implementing Decision 2012/82/EU of 10 February 2012 as regards the renewal of the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified soybean 40-3-2 (MON-Ø4Ø32-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(483).

13. Commission Implementing Decision 2012/83/EU of 10 February 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87701 (MON-877Ø1-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(484).

14. Commission Implementing Decision 2012/84/EU of 10 February 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 356043 (DP-356Ø43-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(485).

15. Commission Implementing Decision 2012/347/EU of 28 June 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87701 × MON 89788 (MON-877Ø1-2 × MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(486).

16. Commission Implementing Decision 2012/651/EU of 18 October 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR162 (SYN-IR162-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(487).

17. Commission Implementing Decision 2013/327/EU of 25 June 2013 authorising the placing on the market of food containing or consisting of genetically modified oilseed rape Ms8, Rf3 and Ms8 × Rf3, or food and feed produced from those genetically modified organisms pursuant to Regulation

(EC) No 1829/2003 of the European Parliament and of the Council(488).

18. Commission Implementing Decision 2013/648/EU of 6 November 2013 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON89034 × 1507 × NK603 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(489).

19. Commission Implementing Decision 2013/649/EU of 6 November 2013 authorising the placing on the market of pollen produced from maize MON 810 (MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(490).

20. Commission Implementing Decision 2013/650/EU of 6 November 2013 authorising the placing on the market of products containing, consisting of, or produced from genetically modified

(GM) maize MON 89034 × 1507 × MON88017 × 59122 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7), four related GM maizes combining three different single GM events (MON89034 × 1507 × MON88017 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON88Ø17-3), MON89034 × 1507 × 59122 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7), MON89034 × MON88017 × 59122 (MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7), 1507 × MON 88017 × 59122 (DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7)) and four related GM maizes combining two different single GM events (MON89034 × 1507 (MON-89Ø34-3 × DASØ15Ø7-1), MON89034 × 59122 (MON-89Ø34-3 × DAS-59122-7), 1507 × MON88017 (DASØ15Ø7-1 × MON-88Ø17-3),

(483)EUDN 2012/82, amended by S.I. 2019/705.

(484)EUDN 2012/83, amended by S.I. 2019/705.

(485)EUDN 2012/84, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(486)EUDN 2012/347, amended by S.I. 2019/705.

(487)EUDN 2012/651, amended by S.I. 2019/705.

(488)EUDN 2013/327, amended by S.I. 2019/705.

(489)EUDN 2013/648, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(490)EUDN 2013/649, amended by S.I. 2019/705.

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MON 88017 × 59122 (MON-88Ø17-3 × DAS-59122-7)) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(491).

21. Commission Implementing Decision (EU) 2015/683 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87460 (MON 8746Ø-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(492).

22. Commission Implementing Decision (EU) 2015/684 of 24 April 2015 authorising the placing on the market of genetically modified maize NK603 (MON-ØØ6Ø3-6) and renewing the existing maize NK603 (MON-ØØ6Ø3-6) products, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(493).

23. Commission Implementing Decision (EU) 2015/685 of 24 April 2015 authorising the placing on the market of genetically modified cotton MON 15985 (MON-15985-7) and renewing the authorisation for existing genetically modified cotton MON 15985 (MON-15985-7) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(494).

24. Commission Implementing Decision (EU) 2015/686 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87769 (MON-87769-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(495).

25. Commission Implementing Decision (EU) 2015/687 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified oilseed rape MON 88302 (MON-883Ø2-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(496).

26. Commission Implementing Decision (EU) 2015/688 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton MON 88913 (MON-88913-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(497).

27. Commission Implementing Decision (EU) 2015/689 of 24 April 2015 renewing the authorisation for existing genetically modified cotton MON 531 (MON-ØØ531-6) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(498).

28. Commission Implementing Decision (EU) 2015/690 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614xLLCotton25 (BCS-GHØØ2-5xACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(499).

29. Commission Implementing Decision (EU) 2015/691 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean BPS-CV127-9 (BPS-CV127-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(500).

(491)EUDN 2013/650, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(492)EUDN 2015/683, amended by S.I. 2019/705.

(493)EUDN 2015/684, amended by S.I. 2019/705.

(494)EUDN 2015/685, amended by S.I. 2019/705.

(495)EUDN 2015/686, amended by S.I. 2019/705.

(496)EUDN 2015/687, amended by S.I. 2019/705.

(497)EUDN 2015/688, amended by S.I. 2019/705.

(498)EUDN 2015/689, amended by S.I. 2019/705.

(499)EUDN 2015/690, amended by S.I. 2019/705.

(500)EUDN 2015/691, amended by S.I. 2019/705.

79Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

30. Commission Implementing Decision (EU) 2015/693 of 24 April 2015 renewing the authorisation for existing genetically modified cotton MON 1445 (MON-Ø1445-2) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(501).

31. Commission Implementing Decision (EU) 2015/695 of 24 April 2015 renewing the authorisation for existing genetically modified cotton MON 531 x MON 1445 (MON-ØØ531-6 x MON-Ø1445-2) products and authorising the placing on the market of cottonseed oil produced from genetically modified cotton MON 531 x MON 1445 (MON-ØØ531-6 x MON-Ø1445-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(502).

32. Commission Implementing Decision (EU) 2015/696 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON87705 (MON-877Ø5-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(503).

33. Commission Implementing Decision (EU) 2015/697 of 24 April 2015 authorising the placing on the market of genetically modified maize T25 (ACS-ZMØØ3-2) and renewing the existing maize T25 (ACS-ZMØØ3-2) products, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(504).

34. Commission Implementing Decision (EU) 2015/698 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 (DP-3Ø5423-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(505).

35. Commission Implementing Decision (EU) 2015/699 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton T304-40 (BCS-GHØØ4-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(506).

36. Commission Implementing Decision (EU) 2015/700 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON87708 (MON-877Ø8-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(507).

37. Commission Implementing Decision (EU) 2015/701 of 24 April 2015 authorising the placing on the market of food containing or consisting of genetically modified oilseed rape GT73, or food and feed produced from that genetically modified organism pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(508).

38. Commission Implementing Decision (EU) 2015/2279 of 4 December 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603 × T25 (MON-ØØ6Ø3-6 × ACS-ZMØØ3-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(509).

39. Commission Implementing Decision (EU) 2015/2281 of 4 December 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 (MON-87427-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(510).

(501)EUDN 2015/693, amended by S.I. 2019/705.

(502)EUDN 2015/695, amended by S.I. 2019/705.

(503)EUDN 2015/696, amended by S.I. 2019/705.

(504)EUDN 2015/697, amended by S.I. 2019/705.

(505)EUDN 2015/698, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(506)EUDN 2015/699, amended by S.I. 2019/705.

(507)EUDN 2015/700, amended by S.I. 2019/705.

(508)EUDN 2015/701, amended by S.I. 2019/705.

(509)EUDN 2015/2279, amended by S.I. 2019/705.

(510)EUDN 2015/2281, amended by S.I. 2019/705.

80Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

40. Commission Implementing Decision (EU) 2016/1215 of 22 July 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(511).

41. Commission Implementing Decision (EU) 2016/1216 of 22 July 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87708 × MON 89788 (MON-877Ø8-9 × MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(512).

42. Commission Implementing Decision (EU) 2016/1217 of 22 July 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788 (MON-877Ø5-6 × MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(513).

43. Commission Implementing Decision (EU) 2016/1685 of 16 September 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21, and genetically modified maizes combining two or three of the events Bt11, MIR162, MIR604 and GA21, and repealing Decisions 2010/426/EU, 2011/892/ EU, 2011/893/EU and 2011/894/EU(514).

44. Commission Implementing Decision (EU) 2017/1207 of 4 July 2017 renewing the authorisation for the placing on the market of genetically modified maize MON 810 (MON- ØØ81Ø-6) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(515).

45. Commission Implementing Decision (EU) 2017/1208 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(516).

46. Commission Implementing Decision (EU) 2017/1209 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, and genetically modified maize combining two, three or four of the events Bt11, 59122, MIR604, 1507 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European parliament and of the Council on genetically modified food and feed(517).

47. Commission Implementing Decision (EU) 2017/1211 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (DAS-24236-5 × DAS-21Ø23-5 × MON-88913-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(518).

48. Commission Implementing Decision (EU) 2017/1212 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize DAS-40278-9, pursuant to Regulation (EC) No 1829/2003 of the European parliament and of the Council on genetically modified food and feed(519).

49. Commission Implementing Decision (EU) 2017/2448 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically

(511)EUDN 2016/1215, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(512)EUDN 2016/1216, amended by S.I. 2019/705.

(513)EUDN 2016/1217, amended by S.I. 2019/705.

(514)EUDN 2016/1685, amended by S.I. 2019/705.

(515)EUDN 2017/1207.

(516)EUDN 2017/1208, amended by S.I. 2019/705.

(517)EUDN 2017/1209, amended by S.I. 2019/705.

(518)EUDN 2017/1211, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(519)EUDN 2017/1212, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

81Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. modified soybean 305423 × 40-3-2 (DP-3Ø5423-1 × MON-Ø4Ø32-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(520).

50. Commission Implementing Decision (EU) 2017/2449 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-68416-4, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(521).

51. Commission Implementing Decision (EU) 2017/2450 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-44406-6, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(522).

52. Commission Implementing Decision (EU) 2017/2451 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 × A5547-127, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(523).

53. Commission Implementing Decision (EU) 2017/2452 of 21 December 2017 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(524).

54. Commission Implementing Decision (EU) 2017/2453 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified oilseed rapes MON 88302 × Ms8 × Rf3 (MON-883Ø2-9 × ACSBNØØ5-8 × ACS-BNØØ3-6), MON 88302 × Ms8 (MON-883Ø2-9 × ACSBNØØ5-8) and MON 88302 × Rf3 (MON-883Ø2-9 × ACS-BNØØ3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(525).

55. Commission Implementing Decision (EU) 2018/1109 of 1 August 2018 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(526).

56. Commission Implementing Decision (EU) 2018/1110 of 3 August 2018 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 × 59122 × MON 810 × NK603, and genetically modified maize combining two or three of the single events 1507, 59122, MON 810 and NK603, and repealing Decisions 2009/815/EC, 2010/428/EU and 2010/432/EU(527).

57. Commission Implementing Decision (EU) 2018/1112 of 3 August 2018 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(528).

58. Commission Implementing Decision (EU) 2018/1113 of 3 August 2018 renewing the authorisation for the placing on the market of food and feed produced from genetically modified

(520)EUDN 2017/2448, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(521)EUDN 2017/2449, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(522)EUDN 2017/2450, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(523)EUDN 2017/2451, amended by S.I. 2019/705.

(524)EUDN 2017/2452, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(525)EUDN 2017/2453, amended by S.I. 2019/705.

(526)EUDN 2018/1109, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(527)EUDN 2018/1110, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(528)EUDN 2018/1112, amended by S.I. 2019/705.

82Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(529).

59. Commission Implementing Decision (EU) 2018/2045 of 19 December 2018 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize NK603 × MON 810 (MON-ØØ6Ø3-6 × MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(530).

60. Commission Implementing Decision (EU) 2018/2046 of 19 December 2018 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122, and genetically modified maize combining two, three or four of the single events MON 87427, MON 89034, 1507, MON 88017 and 59122 and repealing Decision 2011/366/EU(531).

61. Commission Implementing Decision (EU) 2019/1302 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × LLCotton25 × MON 15985 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(532).

62. Commission Implementing Decision (EU) 2019/1303 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 5307 (SYN-Ø53Ø7-1), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(533).

63. Commission Implementing Decision (EU) 2019/1304 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 4114 (DP- ØØ4114-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(534).

64. Commission Implementing Decision (EU) 2019/1305 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × 1507 × GA21 and sub-combinations Bt11 × MIR162 × 1507, MIR162 × 1507 × GA21 and MIR162 × 1507 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(535).

65. Commission Implementing Decision (EU) 2019/1306 of 26 July 2019 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(536).

66. Commission Implementing Decision (EU) 2019/1307 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87403 (MON-874Ø3-1), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(537).

67. Commission Implementing Decision (EU) 2019/1308 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87411 (MON-87411-9), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(538).

(529)EUDN 2018/1113.

(530)EUDN 2018/2045, amended by S.I. 2019/705.

(531)EUDN 2018/2046, amended by S.I. 2019/705.

(532)EUDN 2019/1302, amended by S.I. 2019/705.

(533)EUDN 2019/1303, amended by S.I. 2019/705.

(534)EUDN 2019/1304, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(535)EUDN 2019/1305, amended by S.I. 2019/705.

(536)EUDN 2019/1306, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(537)EUDN 2019/1307, amended by S.I. 2019/705.

(538)EUDN 2019/1308, amended by S.I. 2019/705.

83Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

68. Commission Implementing Decision (EU) 2019/1309 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87751 (MON-87751-7), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(539).

69. Commission Implementing Decision (EU) 2019/2080 of 28 November 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MZHG0JG (SYN-ØØØJG-2), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(540).

70. Commission Implementing Decision (EU) 2019/2081 of 28 November 2019 renewing the authorisation for the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2), resulting from the commercialisation of this oilseed rape in third countries until 2005, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(541).

71. Commission Implementing Decision (EU) 2019/2082 of 28 November 2019 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified cotton LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(542).

72. Commission Implementing Decision (EU) 2019/2083 of 28 November 2019 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(543).

73. Commission Implementing Decision (EU) 2019/2084 of 28 November 2019 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(544).

74. Commission Implementing Decision (EU) 2019/2085 of 28 November 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and sub-combinations MON 89034 × NK603 × DAS-40278-9, 1507 × NK603 × DAS-40278-9 and NK603 × DAS-40278-9 pursuant to Regulation

(EC) No 1829/2003 of the European Parliament and of the Council(545).

75. Commission Implementing Decision (EU) 2019/2086 of 28 November 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9 and genetically modified maize combining two, three or four of the single events MON 89034, 1507, MON 88017, 59122 and DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(546).

76. Commission Implementing Decision (EU) 2019/2087 of 28 November 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and genetically modified maize combining two, three, four or five of the single events Bt11, MIR162, MIR604, 1507, 5307 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(547).

(539)EUDN 2019/1309, amended by S.I. 2019/705.

(540)EUDN 2019/2080, amended by S.I. 2019/705.

(541)EUDN 2019/2081, amended by S.I. 2019/705.

(542)EUDN 2019/2082, amended by S.I. 2019/705.

(543)EUDN 2019/2083, amended by S.I. 2019/705.

(544)EUDN 2019/2084, amended by S.I. 2019/705.

(545)EUDN 2019/2085, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(546)EUDN 2019/2086, amended by S.I. 2019/705, S.S.I. 2023/59, S.I. 2023/235 and 579 (W. 59).

(547)EUDN 2019/2087, amended by S.I. 2019/705.

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

77. Commission Implementing Decision (EU) 2020/1360 of 28 September 2020 authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87708 × MON 89788 × A5547-127, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(548).

SCHEDULE 7 Regulation 21(2)

Revocation of assimilated direct legislation: instruments containing, and relating to, novel foods authorisations Revocation of assimilated direct legislation containing, and relating to, novel foods authorisations

1. Commission Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods(549).

2. Commission Implementing Regulation (EU) 2018/460 of 20 March 2018 authorising the placing on the market of Ecklonia cava phlorotannins as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(550).

3. Commission Implementing Regulation (EU) 2018/461 of 20 March 2018 authorising an extension of use of taxifolin-rich extract as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470(551).

4. Commission Implementing Regulation (EU) 2018/462 of 20 March 2018 authorising an extension of use of L-ergothioneine as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470(552).

5. Commission Implementing Regulation (EU) 2018/469 of 21 March 2018 authorising the placing on the market of an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation

(EU) 2017/2470(553).

6. Commission Implementing Regulation (EU) 2018/991 of 12 July 2018 authorising the placing on the market of hen egg white lysozyme hydrolysate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470(554).

7. Commission Implementing Regulation (EU) 2018/1011 of 17 July 2018 authorising an extension of use levels of UV-treated mushrooms as a novel food under Regulation (EU) 2015/2283

(548)EUDN 2020/1360.

(549)EUR 2017/2470, amended by S.I. 2019/702, S.S.I. 2022/168, S.I. 2022/560 and 575 (W. 133), S.S.I. 2023/78, S.I. 2023/334 and 343 (W. 50), S.S.I. 2024/156, S.I. 2024/685 and 741 (W. 102).

(550)EUR 2018/460.

(551)EUR 2018/461.

(552)EUR 2018/462.

(553)EUR 2018/469.

(554)EUR 2018/991.

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. of the European Parliament and of the Council, and amending Commission Implementing Regulation

(EU) 2017/2470(555).

8. Commission Implementing Regulation (EU) 2018/1018 of 18 July 2018 authorising an extension of use of UV-treated baker’s yeast (Saccharomyces cerevisiae) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(556).

9. Commission Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods(557).

10. Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018 authorising the extension of use of oil from the micro algae Schizochytrium sp. as a novel food under Regulation

(EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470(558).

11. Commission Implementing Regulation (EU) 2018/1122 of 10 August 2018 authorising the placing on the market of pyrroloquinoline quinone disodium salt as a novel food under Regulation

(EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(559).

12. Commission Implementing Regulation (EU) 2018/1123 of 10 August 2018 authorising the placing on the market of 1-methylnicotinamide chloride as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(560).

13. Commission Implementing Regulation (EU) 2018/1132 of 13 August 2018 authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(561).

14. Commission Implementing Regulation (EU) 2018/1133 of 13 August 2018 authorising the placing on the market of dried aerial parts of Hoodia parviflora as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(562).

15. Commission Implementing Regulation (EU) 2018/1293 of 26 September 2018 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food lactitol(563).

16. Commission Implementing Regulation (EU) 2018/1631 of 30 October 2018 authorising the placing on the market of cranberry extract powder as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation

(EU) 2017/2470(564).

17. Commission Implementing Regulation (EU) 2018/1632 of 30 October 2018 authorising the placing on the market of bovine milk basic whey protein isolate as a novel food under Regulation

(555)EUR 2018/1011.

(556)EUR 2018/1018.

(557)EUR 2018/1023.

(558)EUR 2018/1032.

(559)EUR 2018/1122.

(560)EUR 2018/1123.

(561)EUR 2018/1132.

(562)EUR 2018/1133.

(563)EUR 2018/1293.

(564)EUR 2018/1631.

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

(EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(565).

18. Commission Implementing Regulation (EU) 2018/1633 of 30 October 2018 authorising the placing on the market of refined shrimp peptide concentrate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(566).

19. Commission Implementing Regulation (EU) 2018/1647 of 31 October 2018 authorising the placing on the market of egg membrane hydrolysate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(567).

20. Commission Implementing Regulation (EU) 2018/1648 of 29 October 2018 authorising the placing on the market of xylo-oligosaccharides as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation

(EU) 2017/2470(568).

21. Commission Implementing Regulation (EU) 2018/1991 of 13 December 2018 authorising the placing on the market of berries of Lonicera caerulea L. as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(569).

22. Commission Implementing Regulation (EU) 2018/2016 of 18 December 2018 authorising the placing on the market of decorticated grains of Digitaria exilis as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(570).

23. Commission Implementing Regulation (EU) 2018/2017 of 18 December 2018 authorising the placing on the market of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(571).

24. Commission Implementing Regulation (EU) 2019/108 of 24 January 2019 authorising the change of specifications of the novel food ingredient lipid extract from Antarctic Krill (Euphausia superba) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(572).

25. Commission Implementing Regulation (EU) 2019/109 of 24 January 2019 authorising an extension of use of Schizochytrium sp. oil as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation

(EU) 2017/2470(573).

26. Commission Implementing Regulation (EU) 2019/110 of 24 January 2019 authorising an extension of use of Allanblackia seed oil as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(574).

(565)EUR 2018/1632.

(566)EUR 2018/1633.

(567)EUR 2018/1647.

(568)EUR 2018/1648.

(569)EUR 2018/1991.

(570)EUR 2018/2016.

(571)EUR 2018/2017.

(572)EUR 2019/108.

(573)EUR 2019/109.

(574)EUR 2019/110.

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27. Commission Implementing Regulation (EU) 2019/387 of 11 March 2019 authorising an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food and the change of the designation and of the specific labelling requirement of Schizochytrium sp. (ATCC PTA-9695) oil under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470(575).

28. Commission Implementing Regulation (EU) 2019/388 of 11 March 2019 authorising the change of the specifications of the novel food 2′-fucosyllactose produced with Escherichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(576).

29. Commission Implementing Regulation (EU) 2019/456 of 20 March 2019 authorising the change of the specifications of the novel food coriander seed oil from Coriandrum sativum under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(577).

30. Commission Implementing Regulation (EU) 2019/506 of 26 March 2019 authorising the placing on the market of D-ribose as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470(578).

31. Commission Implementing Regulation (EU) 2019/760 of 13 May 2019 authorising the placing on the market of Yarrowia lipolytica yeast biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(579).

32. Commission Implementing Regulation (EU) 2019/1272 of 29 July 2019 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods and Implementing Decision (EU) 2017/2078 authorising an extension of use of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council(580).

33. Commission Implementing Regulation (EU) 2019/1294 of 1 August 2019 authorising the placing on the market of betaine as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(581).

34. Commission Implementing Regulation (EU) 2019/1314 of 2 August 2019 authorising the change of the specifications of the novel food Lacto-N-neotetraose produced with Escherichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(582).

35. Commission Implementing Regulation (EU) 2019/1686 of 8 October 2019 authorising the extension of use of bovine milk basic whey protein isolate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(583).

36. Commission Implementing Regulation (EU) 2019/1976 of 25 November 2019 authorising the placing on the market of Phenylcapsaicin as a novel food under Regulation (EU) 2015/2283 of

(575)EUR 2019/387.

(576)EUR 2019/388.

(577)EUR 2019/456.

(578)EUR 2019/506.

(579)EUR 2019/760.

(580)EUR 2019/1272.

(581)EUR 2019/1294.

(582)EUR 2019/1314.

(583)EUR 2019/1686.

88Document Generated: 2025-04-01

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(EU) 2017/2470(584).

37. Commission Implementing Regulation (EU) 2019/1979 of 26 November 2019 authorising the placing on the market of 2’-Fucosyllactose/Difucosyllactose mixture as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(585).

38. Commission Implementing Regulation (EU) 2019/2165 of 17 December 2019 authorising the change of the specifications of the novel food coriander seed oil from Coriandrum sativum under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(586).

39. Commission Implementing Regulation (EU) 2020/16 of 10 January 2020 authorising the placing on the market of nicotinamide riboside chloride as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(587).

40. Commission Implementing Regulation (EU) 2020/24 of 13 January 2020 authorising an extension of use of chia seeds (Salvia hispanica) as a novel food and the change of the conditions of use and the specific labelling requirements of chia seeds (Salvia hispanica) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(588).

41. Commission Implementing Regulation (EU) 2020/206 of 14 February 2020 authorising the placing on the market of fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Implementing Regulation (EU) 2017/2470(589).

42. Commission Implementing Regulation (EU) 2020/443 of 25 March 2020 authorising the change of the specifications of the novel food spermidine-rich wheat germ extract (Triticum aestivum) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(590).

43. Commission Implementing Regulation (EU) 2020/478 of 1 April 2020 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods(591).

44. Commission Implementing Regulation (EU) 2020/484 of 2 April 2020 authorising the placing on the market of lacto-N-tetraose as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(592).

45. Commission Implementing Regulation (EU) 2020/500 of 6 April 2020 authorising the placing on the market of partially defatted chia seed (Salvia hispanica) powders as novel foods under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(593).

46. Commission Implementing Regulation (EU) 2020/916 of 1 July 2020 authorising the extension of use of xylo-oligosaccharides as a novel food under Regulation (EU) 2015/2283 of the

(584)EUR 2019/1976.

(585)EUR 2019/1979.

(586)EUR 2019/2165.

(587)EUR 2020/16.

(588)EUR 2020/24.

(589)EUR 2020/206.

(590)EUR 2020/443.

(591)EUR 2020/478.

(592)EUR 2020/484.

(593)EUR 2020/500.

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European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(594).

47. Commission Implementing Regulation (EU) 2020/917 of 1 July 2020 authorising the placing on the market of infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Implementing Regulation (EU) 2017/2470(595).

48. Commission Implementing Regulation (EU) 2020/973 of 6 July 2020 authorising a change of the conditions of use of the novel food ‛protein extract from pig kidneys’ and amending Implementing Regulation (EU) 2017/2470(596).

49. Commission Implementing Regulation (EU) 2020/1163 of 6 August 2020 authorising the placing on the market of vitamin D2 mushroom powder as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(597).

50. Commission Implementing Regulation (EU) 2020/1559 of 26 October 2020 amending Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods(598).

51. Commission Implementing Regulation (EU) 2020/1634 of 4 November 2020 authorising the placing on the market of sugars obtained from cocoa (Theobroma cacao L.) pulp as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(599).

52. Commission Implementing Regulation (EU) 2020/1820 of 2 December 2020 authorising the placing on the market of dried Euglena gracilis as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation

(EU) 2017/2470(600).

53. Commission Implementing Regulation (EU) 2020/1821 of 2 December 2020 authorising the placing on the market of an extract from Panax notoginseng and Astragalus membranaceus as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(601).

54. Commission Implementing Regulation (EU) 2020/1822 of 2 December 2020 authorising the placing on the market of chromium-containing yeast (Yarrowia lipolytica) biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(602).

55. Commission Implementing Regulation (EU) 2020/1993 of 4 December 2020 authorising the placing on the market of selenium-containing yeast (Yarrowia lipolytica) biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470(603).

(594)EUR 2020/916.

(595)EUR 2020/917.

(596)EUR 2020/973.

(597)EUR 2020/1163.

(598)EUR 2020/1559.

(599)EUR 2020/1634.

(600)EUR 2020/1820.

(601)EUR 2020/1821.

(602)EUR 2020/1822.

(603)EUR 2020/1993.

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SCHEDULE 8 Regulation 21(2) Revocation of assimilated direct legislation that is redundant by virtue of the revocations in Schedules 5 and 6 PART 1

Assimilated direct legislation: redundant feed additives amending instruments

1. Commission Regulation (EC) No 2028/2006 of 18 December 2006 amending Regulation (EC) No 600/2005 as regards the authorisation of the feed additive preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, belonging to the group of microorganisms(604).

2. Commission Regulation (EC) No 496/2007 of 4 May 2007 amending Regulation (EC) No 600/2005 as regards the introduction of a maximum residue limit for the feed additive Salinomax 120G , belonging to the group of coccidiostats and other medicinal substances(605).

3. Commission Regulation (EC) No 1143/2007 of 1 October 2007 amending Regulation (EC) No 256/2002 as regards the authorisation of the feed additive preparation of Bacillus cereus var. toyoi , belonging to the group of microorganisms(606).

4. Commission Regulation (EC) No 156/2008 of 21 February 2008 amending Regulation (EC) No 109/2007 as regards the minimum content of the feed additive monensin sodium (Coxidin)(607).

5. Commission Regulation (EC) No 516/2008 of 10 June 2008 amending Regulations (EC) No 1200/2005, (EC) No 184/2007, (EC) No 243/2007, (EC) No 1142/2007, (EC) No 1380/2007 and

(EC) No 165/2008 as regards the terms of the authorisation of certain additives for use in animal nutrition(608).

6. Commission Regulation (EC) No 1095/2008 of 6 November 2008 amending Regulation

(EC) No 109/2007 as regards the terms of the authorisation of the feed additive monensin sodium

(Coxidin)(609).

7. Commission Regulation (EC) No 202/2009 of 16 March 2009 amending Regulation (EC) No 600/2005 as regards the use of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 in compound feed containing lasalocid sodium(610).

8. Commission Regulation (EC) No 899/2009 of 25 September 2009 amending Regulation (EC) No 1290/2008 as regards the name of the holder of the authorisation of a preparation of Lactobacillus rhamnosus (CNCM-I-3698) and Lactobacillus farciminis (CNCM-I-3699) (Sorbiflore)(611).

9. Commission Regulation (EC) No 905/2009 of 28 September 2009 amending Regulation (EC) No 537/2007 as regards the name of the holder of the authorisation of the fermentation product of Aspergillus oryzae (NRRL 458) (Amaferm)(612).

10. Commission Regulation (EU) No 334/2010 of 22 April 2010 amending Regulation (EC) No 721/2008 as regards the composition of feed additives(613).

(604)EUR 2006/2028.

(605)EUR 2007/496.

(606)EUR 2007/1143.

(607)EUR 2008/156.

(608)EUR 2008/516.

(609)EUR 2008/1095.

(610)EUR 2009/202.

(611)EUR 2009/899.

(612)EUR 2009/905.

(613)EUR 2010/334.

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11. Commission Regulation (EU) No 879/2010 of 6 October 2010 amending Regulation (EC) No 554/2008 as regards the minimum content of 6-phytase (Quantum Phytase) as a feed additive in feed for laying hens(614).

12. Commission Regulation (EU) No 335/2011 of 7 April 2011 amending Regulation (EC) No 1091/2009 as regards the minimum content of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive in feed for chickens for fattening(615).

13. Commission Implementing Regulation (EU) No 495/2011 of 20 May 2011 amending Regulation (EC) No 109/2007 as regards the composition of the feed additive monensin sodium(616).

14. Commission Implementing Regulation (EU) No 516/2011 of 25 May 2011 amending Regulation (EC) No 600/2005 as regards the use of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 in feed containing formic acid(617).

15. Commission Implementing Regulation (EU) No 413/2012 of 15 May 2012 amending Implementing Regulation (EU) No 496/2011 as regards the minimum content of sodium benzoate as a feed additive in feed for weaned piglets(618).

16. Commission Implementing Regulation (EU) No 414/2012 of 15 May 2012 amending Regulation (EC) No 554/2008 as regards the minimum content and the minimum recommended dose of an enzyme preparation of 6-phytase as a feed additive in feed for turkeys for fattening(619).

17. Commission Implementing Regulation (EU) No 1265/2012 of 17 December 2012 amending Implementing Regulation (EU) No 837/2012 as regards the minimum activity of a preparation of 6- phytase produced by Aspergillus oryzae (DSM 22594) as feed additive for poultry, weaned piglets, pigs for fattening and sows (holder of authorisation DSM Nutritional Products)(620).

18. Commission Implementing Regulation (EU) No 105/2013 of 4 February 2013 amending Implementing Regulation (EU) No 371/2011 as regards the name of the holder of the authorisation of dimethylglycine sodium salt(621).

19. Commission Implementing Regulation (EU) No 160/2013 of 21 February 2013 amending Regulations (EC) No 162/2003, (EC) No 971/2008, (EU) No 1118/2010 and (EU) No 169/2011 and Implementing Regulation (EU) No 888/2011 as regards the name of the holder of the authorisation of diclazuril in animal feed(622).

20. Commission Implementing Regulation (EU) No 1334/2013 of 13 December 2013 amending Regulation (EC) No 1290/2008 as regards the name of the holder of the authorisation and as regards the recommended dose of a preparation of Lactobacillus rhamnosus (CNCM-I-3698) and Lactobacillus farciminis (CNCM-I-3699)(623).

21. Commission Implementing Regulation (EU) No 131/2014 of 11 February 2014 amending Implementing Regulation (EU) No 601/2013 concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate, cobalt(II)

(614)EUR 2010/879.

(615)EUR 2011/335.

(616)EUR 2011/495.

(617)EUR 2011/516.

(618)EUR 2012/413.

(619)EUR 2012/414.

(620)EUR 2012/1265.

(621)EUR 2013/105.

(622)EUR 2013/160.

(623)EUR 2013/1334.

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22. Commission Implementing Regulation (EU) No 862/2014 of 7 August 2014 amending Implementing Regulation (EU) No 496/2011 as regards the name of the holder of the authorisation of the feed additive sodium benzoate(625).

23. Commission Implementing Regulation (EU) No 1070/2014 of 10 October 2014 amending Regulation (EC) No 271/2009 as regards the minimum content of the preparation of endo-1,4-beta- xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for laying hens (holder of authorisation BASF SE)(626).

24. Commission Implementing Regulation (EU) 2015/1104 of 8 July 2015 amending Implementing Regulation (EU) No 237/2012 as regards a new form of alpha-galactosidase (EC

3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC

3.2.1.4) produced by Aspergillus niger (CBS 120604) (holder of authorisation Kerry Ingredients and Flavours)(627).

25. Commission Implementing Regulation (EU) 2015/1414 of 20 August 2015 amending Implementing Regulation (EU) No 136/2012 concerning the authorisation of sodium bisulphate as feed additive for pets and for non-food producing animals(628).

26. Commission Implementing Regulation (EU) 2015/1747 of 30 September 2015 correcting the Annex to Regulation (EU) No 26/2011 concerning the authorisation of vitamin E as a feed additive for all animal species(629).

27. Commission Implementing Regulation (EU) 2016/348 of 10 March 2016 amending Implementing Regulation (EU) No 98/2012 as regards the minimum content of the preparation of 6- phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for pigs for fattening (holder of authorisation Huvepharma EOOD)(630).

28. Commission Implementing Regulation (EU) 2016/842 of 27 May 2016 amending Regulation

(EC) No 167/2008 as regards the name of the holder of the authorisation and the trade name of a coccidiostat(631).

29. Commission Implementing Regulation (EU) 2016/895 of 8 June 2016 amending Regulation

(EC) No 1290/2008 as regards the name of the holder of the authorisation of a preparation of Lactobacillus rhamnosus (CNCM-I-3698) and Lactobacillus farciminis (CNCM-I-3699)(632).

30. Commission Implementing Regulation (EU) 2016/1881 of 24 October 2016 amending Implementing Regulation (EU) No 837/2012 as regards the minimum activity of 6-phytase produced by Aspergillus oryzae (DSM 22594) as feed additive for sows (holder of authorisation DSM Nutritional Products Ltd)(633).

31. Commission Implementing Regulation (EU) 2017/173 of 1 February 2017 amending Regulation (EC) No 1292/2008 and Implementing Regulation (EU) No 887/2011, as regards the

(624)EUR 2014/131.

(625)EUR 2014/862.

(626)EUR 2014/1070.

(627)EUR 2015/1104.

(628)EUR 2015/1414.

(629)EUR 2015/1747.

(630)EUR 2016/348.

(631)EUR 2016/842.

(632)EUR 2016/895.

(633)EUR 2016/1881.

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32. Commission Implementing Regulation (EU) 2017/410 of 8 March 2017 amending Regulations (EC) No 184/2007 and (EU) No 104/2010, as regards the name of the holder of the authorisation of potassium diformate(635).

33. Commission Implementing Regulation (EU) 2017/950 of 2 June 2017 amending Implementing Regulation (EU) No 1068/2011 as regards the minimum content of the preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for chickens reared for laying and all avian species for laying (holder of authorisation BASF SE)(636).

34. Commission Implementing Regulation (EU) 2017/1006 of 15 June 2017 amending Implementing Regulation (EU) No 1206/2012 as regards the change of the production strain of the preparation of endo-1,4-beta-xylanase, produced by Aspergillus oryzae (DSM 10287) as feed additive for poultry for fattening, weaned piglets and pigs for fattening (holder of authorisation DSM Nutritional Products Ltd)(637).

35. Commission Implementing Regulation (EU) 2017/2231 of 4 December 2017 amending Implementing Regulation (EU) 2016/329 as regards the name of the holder of the authorisation of 6-phytase(638).

36. Commission Implementing Regulation (EU) 2017/2233 of 4 December 2017 amending Regulation (EC) No 900/2009 as regards the characterisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399(639).

37. Commission Implementing Regulation (EU) 2018/1567 of 18 October 2018 correcting Implementing Regulation (EU) 2018/249 concerning the authorisation of taurine, beta-alanine, L- alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L- proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs(640).

38. Commission Implementing Regulation (EU) 2018/1936 of 10 December 2018 amending Implementing Regulation (EU) No 371/2011 as regards the maximum limit of dimethylaminoethanol

(DMAE)(641).

39. Commission Implementing Regulation (EU) 2018/1957 of 11 December 2018 amending Regulation (EC) No 885/2010 as regards the terms of authorisation of the preparation of narasin and nicarbazin as a feed additive for chickens for fattening (holder of authorisation Eli Lilly and Company Ltd)(642).

40. Commission Implementing Regulation (EU) 2018/1980 of 13 December 2018 amending Implementing Regulation (EU) 2017/2325 as regards the terms of authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species(643).

(634)EUR 2017/173.

(635)EUR 2017/410.

(636)EUR 2017/950.

(637)EUR 2017/1006.

(638)EUR 2017/2231.

(639)EUR 2017/2233.

(640)EUR 2018/1567.

(641)EUR 2018/1936.

(642)EUR 2018/1957.

(643)EUR 2018/1980.

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41. Commission Implementing Regulation (EU) 2019/146 of 30 January 2019 amending Implementing Regulation (EU) 2015/502, concerning the authorisation of the preparation of Saccharomyces cerevisiae NCYC R404 as a feed additive for dairy cows(644).

42. Commission Implementing Regulation (EU) 2019/221 of 6 February 2019 amending Regulations (EC) No 785/2007, (EC) No 379/2009, (EC) No 1087/2009, (EU) No 9/2010, (EU) No 337/2011 and Implementing Regulations (EU) No 389/2011, (EU) No 528/2011, (EU) No 840/2012,

(EU) No 1021/2012, (EU) 2016/899, (EU) 2016/997, (EU) 2017/440 and (EU) 2017/896 as regards the name of the holder of the authorisation and the representative of the holder of the authorisation for certain feed additives(645).

43. Commission Implementing Regulation (EU) 2019/230 of 7 February 2019 correcting certain language versions of Implementing Regulation (EU) 2017/2330 concerning the authorisation of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran as feed additive for piglets and amending Regulations (EC) No 1334/2003 and (EC) No 479/2006(646).

44. Commission Implementing Regulation (EU) 2019/849 of 24 May 2019 amending Implementing Regulation (EU) 2017/1492 as regards the maximum content of cholecalciferol (vitamin D3) in feed for salmonids(647).

45. Commission Implementing Regulation (EU) 2020/1092 of 24 July 2020 amending Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species(648).

46. Commission Implementing Regulation (EU) 2019/1290 of 31 July 2019 amending Implementing Regulation (EU) 2018/338 as regards the minimum content of a preparation of 6- phytase, produced by Aspergillus niger (DSM 25770) as a feed additive for chickens for fattening or reared for laying (holder of authorisation BASF SE)(649).

PART 2

Assimilated direct legislation: redundant amending instruments in respect of products containing, consisting of, or produced from, genetically modified organisms

1. Commission Implementing Decision (EU) 2019/60 of 11 January 2019 amending Decision 2009/866/EC, Decision 2010/419/EU, Implementing Decision 2012/651/EU and Implementing Decision (EU) 2016/1685 as regards the representative of the authorisation holder(650).

2. Commission Implementing Decision (EU) 2019/239 of 6 February 2019 amending Decision 2011/891/EU and Implementing Decisions (EU) 2017/1211, (EU) 2017/1212, (EU) 2017/2449 and

(EU) 2017/2450 as regards the representative or the authorisation holder(651).

(644)EUR 2019/146.

(645)EUR 2019/221.

(646)EUR 2019/230.

(647)EUR 2019/849.

(648)EUR 2019/1092.

(649)EUR 2019/1290.

(650)EUDN 2019/60.

(651)EUDN 2019/239.

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3. Commission Implementing Decision (EU) 2019/240 of 6 February 2019 amending Implementing Decisions 2013/648/EU and 2013/650/EU as regards the representative of the authorisation holders(652).

4. Commission Implementing Decision (EU) 2019/241 of 6 February 2019 amending Decision 2007/703/EC and Implementing Decisions (EU) 2017/2452 and (EU) 2018/1109 as regards the representative of the authorisation holder(653).

5. Commission Implementing Decision (EU) 2019/1166 of 28 June 2019 amending Implementing Decision (EU) 2018/1113 as regards the representative of the authorisation holder(654).

6. Commission Implementing Decision (EU) 2019/1167 of 28 June 2019 amending Implementing Decision (EU) 2017/2453 as regards the authorisation holders and the representatives(655).

7. Commission Implementing Decision (EU) 2019/1195 of 10 July 2019 amending Decisions 2008/730/EC, 2008/837/EC, 2009/184/EC, 2011/354/EU, Implementing Decisions 2012/81/EU, 2013/327/EU, (EU) 2015/690, (EU) 2015/697, (EU) 2015/699, (EU) 2016/1215, (EU) 2017/1208 and (EU) 2017/2451 as regards the authorisation holder and the representative for the placing on the market of genetically modified soybean, cotton, oilseed rape and maize(656).

8. Commission Implementing Decision (EU) 2019/1301 of 26 July 2019 amending Implementing Decision 2013/327/EU as regards the renewal of the authorisation to place on the market feed containing or consisting of genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council(657).

9. Commission Implementing Decision (EU) 2019/1579 of 18 September 2019 amending Decisions 2008/933/EC, 2009/813/EC, 2009/814/EC and 2010/429/EU and Implementing Decisions 2012/82/EU, 2012/83/EU, 2012/347/EU, 2013/649/EU, (EU) 2015/683, (EU) 2015/684,

(EU) 2015/685, (EU) 2015/686, (EU) 2015/687, (EU) 2015/688, (EU) 2015/689, (EU) 2015/693,

(EU) 2015/695, (EU) 2015/696, (EU) 2015/700, (EU) 2015/701, (EU) 2015/2279, (EU) 2015/2281,

(EU) 2016/1216, (EU) 2016/1217, (EU) 2017/1207, (EU) 2018/1111, (EU) 2018/2045 and (EU) 2018/2046 as regards the representative of the authorisation holder for placing on the market certain genetically modified food and feed in the Union(658).

SCHEDULE 9 Regulation 22 Consequential amendments to assimilated direct legislation Amendment of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, etc.

1.—(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, etc.(659), is amended as follows.

(652)EUDN 2019/240.

(653)EUDN 2019/241.

(654)EUDN 2019/1166.

(655)EUDN 2019/1167.

(656)EUDN 2019/1195.

(657)EUDN 2019/1301.

(658)EUDN 2019/1579.

(659)EUR 2008/1272, amended by S.I. 2019/720. There are other amendments, but these are not relevant for this instrument.

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(2) In Article 1(5)(e)(ii), omit “or Commission implementing Regulation (EU) No 872/2012” to the end.

Amendment of Regulation (EC) No 1907/2006 (REACH), etc.

2.—(1) Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, etc.(660), is amended as follows.

(2) In Article 2(5)(b)(ii) and (6)(d)(ii), in each place, omit “or Commission Implementing Regulation (EU) No 872/2012” to the end.

Amendment of Commission Regulation (EU) No 101/2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases

3.—(1) Commission Regulation (EU) No 101/2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases(661) is amended as follows.

(2) In the Annex, in Part 1, in paragraph 1, for “Regulation (EU) No 231/2012” substitute “accordance with authorisations for food additives under Regulation (EC) No 1333/2008”.

Amendment of Commission Delegated Regulation (EU) 2019/934 supplementing Regulation

(EU) No 1308/2013 as regards wine-growing areas where the alcoholic strength may be increased, etc.

4.—(1) Commission Delegated Regulation (EU) 2019/934 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards wine-growing areas where the alcoholic strength may be increased, authorised oenological practices and restrictions applicable to the production and conservation of grapevine products, the minimum percentage of alcohol for by- products and their disposal, and publication of OIV files(662) is amended as follows.

(2) In Article 9(1), for “by Commission Regulation (EU) No 231/2012” substitute “in specifications for food additives authorised under Regulation (EC) No 1333/2008”.

(3) In Annex I—

(a) in Part A, in Table 2 (authorised oenological compounds as referred to in Article 3(1)), in rows 4.1 and 4.1a (microcrystalline cellulose), in column 7 (conditions and limits of use), for “laid down in the Annex to Regulation (EU) No 231/2012” substitute “for food additives authorised under Regulation (EC) No 1333/2008”;

(b) in Appendix 1 (tartaric acid (L(+)-) and derived products), in paragraph 2, for “Regulation

(EU) No 231/2012” substitute “accordance with authorisations for food additives under Regulation (EC) No 1333/2008”.

(660)EUR 2006/1907, amended by S.I. 2019/758. There are other amendments, but these are not relevant for this instrument.

(661)EUR 2013/101, amended by S.I. 2019/640.

(662)EUR 2019/934, amended by S.I. 2021/632, S.S.I. 2022/361, S.I. 2022/1150 and 1215 (W. 252), S.S.I. 2024/11, S.I. 2024/83 (W. 23) and 115. There are other amendments, but these are not relevant for this instrument.

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SCHEDULE 10 Regulation 22 Consequential amendments to Scotland statutory instruments or to provision in statutory instruments extending only to Scotland Amendment of the Bread and Flour Regulations 1998

1.—(1) The Bread and Flour Regulations 1998(663) are amended as follows.

(2) In regulation 2(1), in the definition of “food additive” omit “as last amended by Commission Regulation (EU) 2018/1497”.

Amendment of the Specified Sugar Products (Scotland) Regulations 2003

2.—(1) The Specified Sugar Products (Scotland) Regulations 2003(664) are amended as follows.

(2) In Schedule 1, in Part 1, in the notes following the table, for note 7 substitute— “7. Specified sugar products may contain—

(a) a permitted extraction solvent, as defined in regulation 9 of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013;

(b) any food additive authorised under Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives.”.

Amendment of the Materials and Articles in Contact with Food (Scotland) Regulations 2012

3.—(1) The Materials and Articles in Contact with Food (Scotland) Regulations 2012(665) are amended as follows.

(2) In regulation 12(3)—

(a) for “listed in Annex I to” substitute “authorised under”;

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

(3) In regulation 14(1), for “22(4) and (5)” substitute “22(5)”.

(4) In Schedule 1, in the first column of the table—

(a) in each place it occurs, omit “and Annex I” and “and Annex 1”;

(b) in the row relating to Article 9, omit “as read with Annex I”.

Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents

(Scotland) Regulations 2013

4.—(1) The Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013(666) are amended as follows.

(2) In regulation 2—

(a) in paragraph (1)—

(i)in the definition of “Regulation 1333/2008”, omit “, as read with” to the end;

(ii)in the definition of “Regulation 1334/2008”, omit “, as read with” to the end;

(663)S.I. 1998/141, amended by S.S.I. 2014/312, 2019/33 and 2021/477. There are other amendments, but these are not relevant for this instrument.

(664)S.S.I. 2003/527, amended by S.S.I. 2009/436. There are other amendments, but these are not relevant for this instrument.

(665)S.S.I. 2012/318, amended by S.S.I. 2015/100, 2019/32 and 52 and 2022/373. There are other amendments, but these are not relevant for this instrument.

(666)S.S.I. 2013/266, amended by S.S.I. 2019/53, 2022/373 and 2023/374. There are other amendments, but these are not relevant for this instrument.

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(b) in paragraph (3)—

(i)for “an Article of or Annex to” substitute “a provision of”;

(ii)for “Article or Annex” substitute “provision”.

(3) In regulation 4, omit “Article 4” to “Council and with”.

(4) In regulation 5, omit “as read with Article 20 (transitional measures) of that Regulation,”.

(5) In regulation 16(1)—

(a) in sub-paragraph (b), omit “as read with Article 4 of Commission Implementing Regulation (EU) No 872/2012 and”;

(b) in sub-paragraph (c), omit “, as read with Article 20 of Regulation 2065/2003”.

(6) In Schedule 1, in the table, in the second column—

(a) in the row for Article 4.1—

(i)for “included in the list in Annex II to” substitute “authorised in accordance with”;

(ii)for “that Annex” substitute “in the authorisations concerned”;

(b) in the row for Article 4.2—

(i)for “included in the list in Annex III to” substitute “authorised in accordance with”;

(ii)for “that Annex” substitute “the authorisations concerned”;

(c) in the rows for Article 15 and for Article 16, for “Annex II to”, in both places, substitute “authorisations in accordance with”;

(d) in the row for Article 17, for “listed in Annex II to” substitute “authorised in accordance with”.

(7) In Schedule 2, in the table, in the second column, in the row for Article 10, for “included on the Union list” substitute “permitted to be placed on the market or used in or on foods in accordance with Regulation 1334/2008”.

(8) In Schedule 3, in the table, in the second column, in the first row for Article 4.2, for “not on the list of authorised smoke flavourings” substitute “that is not authorised in accordance with Regulation 2065/2003”.

(9) In Schedule 4, in the table, in the second column, in the row for Article 4, for “appear in the list” to the end substitute “are authorised in accordance with Regulation 1332/2008, and in accordance with any specifications and conditions of use set out in the authorisations concerned, subject to Article 24 of Regulation 1332/2008”.

Amendment of the Products Containing Meat etc. (Scotland) Regulations 2014

5.—(1) The Products Containing Meat etc. (Scotland) Regulations 2014(667) are amended as follows.

(2) In the Schedule, in the definition of “curing salt”, in sub-paragraph (c)—

(a) after “use in” insert “accordance with”;

(b) omit “as last amended by Commission Regulation (EU) 2018/1497”.

Amendment of the Novel Foods (Scotland) Regulations 2017

6.—(1) The Novel Foods (Scotland) Regulations 2017(668) are amended as follows.

(2) In regulation 4, for “6(2)” substitute “6”.

(667)S.S.I. 2014/289, amended by S.S.I. 2019/33. There are other amendments, but these are not relevant for this instrument.

(668)S.S.I. 2017/415.

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(3) In regulation 5(2)—

(a) in the modifications to subsections (1), (3) and (6) of section 9, in each place, for “6(2)” substitute “6”;

(b) in the modifications to subsection (5) of section 9, for “on the Union list of authorised novel foods as established” substitute “authorised, as required”.

Amendment of the Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022

7.—(1) The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022(669) are amended as follows.

(2) In regulation 5, omit paragraphs (5) to (14).

SCHEDULE 11 Regulation 22 Consequential amendments to Wales statutory instruments Amendment of the Specified Sugar Products (Wales) Regulations 2003

1.—(1) The Specified Sugar Products (Wales) Regulations 2003(670) are amended as follows.

(2) In Schedule 1, in the notes following the table—

(a) in the Welsh language text, for note 7 substitute— “7. Caiff cynhyrchion siwgr penodedig gynnwys—

(a) toddydd echdynnu a ganiateir, fel y’i diffinnir yn rheoliad 11 o Reoliadau Ychwanegion, Cyflasynnau, Ensymau a Thoddyddion Echdynnu Bwyd

(Cymru) 2013;

(b) unrhyw ychwanegyn bwyd a awdurdodir o dan Reoliad (EC) Rhif 1333/2008 Senedd Ewrop a’r Cyngor ar ychwanegion bwyd.”.

(b) in the English language text, for note 7 substitute— “7. Specified sugar products may contain—

(a) a permitted extraction solvent, as defined in regulation 11 of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013;

(b) any food additive authorised under Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives.”.

Amendment of the Plastic Kitchenware (Conditions on Imports from China) (Wales) Regulations 2011

2.—(1) The Plastic Kitchenware (Conditions on Imports from China) (Wales) Regulations 2011(671) are amended as follows.

(2) In regulation 8(2)—

(a) in the Welsh language text, in sub-paragraph (ch)(ii) omit “fel y diwygir Atodiad I iddo o bryd i’w gilydd”;

(669)S.S.I. 2022/373.

(670)S.I. 2003/3047 (W. 290), amended by S.I. 2009/3378 (W. 300) and 2018/806 (W. 162). There are other amendments, but these are not relevant for this instrument.

(671)S.I. 2011/1605 (W. 186), amended by S.I. 2018/806 (W. 162), 2019/434 (W. 102) and 1482 (W. 266).

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(b) in the English language text, in sub-paragraph (d)(ii) omit “as Annex I to which is amended from time to time”.

Amendment of the Materials and Articles in Contact with Food (Wales) Regulations 2012

3.—(1) The Materials and Articles in Contact with Food (Wales) Regulations 2012(672) are amended as follows.

(2) In regulation 12(3)—

(a) in the Welsh language text—

(i)for “a restrir yn Atodiad I i” substitute “a awdurdodir o dan”;

(ii)for “yr Atodiad hwnnw” substitute “yr awdurdodiadau o dan sylw”;

(b) in the English language text—

(i)for “listed in Annex I to” substitute “authorised under”;

(ii)for “that Annex” substitute “the authorisations concerned”.

(3) In Schedule 1, in the first column of the table—

(a) in the Welsh language text—

(i)in the row relating to Article 5, omit “ac Atodiad I”;

(ii)in the row relating to Article 9, omit “fel y’i darllenir gydag Atodiad I”;

(iii)in the row relating to Article 11, for “ac Atodiad I, fel y’u” substitute “, fel y’i”;

(iv)in the row relating to Article 13, for “ac Atodiad I fel y’i” substitute “, fel y’u”;

(v)in the row relating to Article 14, for “ac Atodiad 1, fel y’i” substitute “, fel y’u”;

(b) in the English language text—

(i)in each place it occurs, omit “and Annex I” and “and Annex 1”;

(ii)in the row relating to Article 9, omit “as read with Annex I”.

Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013

4.—(1) The Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013(673) are amended as follows.

(2) In regulation 2—

(a) in paragraph (1)—

(i)in the Welsh language text—

(aa)in the definition of “Rheoliad 1333/2008” (“Regulation 1333/2008”) omit “, fel y’i darllenir gyda’r canlynol” to the end;

(bb)in the definition of “Rheoliad 1334/2008” (“Regulation 1334/2008”) omit “, fel y’i darllenir gyda” to the end;

(ii)in the English language text—

(aa)in the definition of “Regulation 1333/2008” (“Rheoliad 1333/2008”) omit “, as read with” to the end;

(672)S.I. 2012/2705 (W. 291), amended by S.I. 2017/832 (W. 202), 2018/913 (W. 179), 2019/425 (W. 99) and 2022/1362 (W. 273).

There are other amendments, but these are not relevant for this instrument.

(673)S.I. 2013/2591 (W. 255), amended by S.I. 2018/806 (W. 162), 2020/1581 (W. 331), 2022/1362 (W. 273) and 2023/1332 (W.

240). There are other amendments, but these are not relevant for this instrument.

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(bb)in the definition of “Regulation 1334/2008” (“Rheoliad 1334/2008”) omit “, as read with” to the end;

(b) in paragraph (3)—

(i)in the Welsh language text—

(aa)for “Erthygl neu Atodiad i” substitute “darpariaeth mewn”;

(bb)for “yr Erthygl honno neu’r Atodiad hwnnw” substitute “y ddarpariaeth honno”;

(ii)in the English language text—

(aa)for “an Article of or Annex to” substitute “a provision of”;

(bb)for “Article or Annex” substitute “provision”.

(3) In regulation 4—

(a) in the Welsh language text, for “gydag Erthygl” to “Cyngor a chyda” substitute “gyda”;

(b) in the English language text, omit “Article 4” to “Council and with”.

(4) In Schedule 1, in Table 1, in the second column—

(a) in the row for Article 4.1—

(i)in the Welsh language text—

(aa)for “a gynhwysir yn y rhestr yn Atodiad II i Reoliad” substitute “a awdurdodir yn unol â Rheoliad”;

(bb)for “a’r Atodiad hwnnw” substitute “ac yn yr awdurdodiadau o dan sylw”;

(ii)in the English language text—

(aa)for “included in the list in Annex II to” substitute “authorised in accordance with”;

(bb)for “that Annex” substitute “in the authorisations concerned”;

(b) in the row for Article 4.2—

(i)in the Welsh language text—

(aa)for “a gynhwysir yn y rhestr yn Atodiad III i Reoliad” substitute “a awdurdodir yn unol â Rheoliad”;

(bb)for “yr Atodiad hwnnnw” substitute “yr awdurdodiadau o dan sylw”;

(ii)in the English language text—

(aa)for “included in the list in Annex III to” substitute “authorised in accordance with”;

(bb)for “that Annex” substitute “the authorisations concerned”;

(i)in the Welsh language text, for “yn Atodiad II i Reoliad”, in both places, substitute “mewn awdurdodiadau yn unol â Rheoliad”;

(ii)in the English language text, for “Annex II to”, in both places, substitute “authorisations in accordance with”;

(d) in the row for Article 17—

(i)in the Welsh language text, for “a restrir yn Atodiad II i Reoliad” substitute “a awdurdodir yn unol â Rheoliad”;

(ii)in the English language text, for “listed in Annex II to” substitute “authorised in accordance with”.

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(5) In Schedule 2, in Table 1, in the second column, in the row for Article 10—

(a) in the Welsh language text, for “sydd heb eu cynnwys ar y rhestr ddomestig” substitute “na chaniateir eu gosod ar y farchnad na’u defnyddio mewn bwydydd neu ar fwydydd yn unol â Rheoliad 1334/2008”;

(b) in the English language text, for “included on the domestic list” substitute “permitted to be placed on the market or used in or on foods in accordance with Regulation 1334/2008”.

(6) In Schedule 3, in Table 1, in the second column, in the first row for Article 4.2—

(a) in the Welsh language text, for “ar y rhestr o gyflasynnau mwg awdurdodedig” substitute “wedi ei awdurdodi yn unol â Rheoliad 2065/2003”;

(b) in the English language text, for “not on the list of authorised smoke flavourings” substitute “that is not authorised in accordance with Regulation 2065/2003”.

(7) In Schedule 4, in Table 1, in the second column, in the row for Article 4—

(a) in the Welsh language text, for “yn ymddangos yn y rhestr ddomestig” to the end substitute “wedi eu hawdurdodi yn unol â Rheoliad 1332/2008, ac yn unol ag unrhyw fanylebau ac amodau defnyddio a nodir yn yr awdurdodiadau o dan sylw, yn ddarostyngedig i Erthygl 24 o Reoliad 1332/2008”;

(b) in the English language text, for “appear in the domestic list” to the end substitute “are authorised in accordance with Regulation 1332/2008, and in accordance with any specifications and conditions of use set out in the authorisations concerned, subject to Article 24 of Regulation 1332/2008”.

Amendment of the Products Containing Meat etc. (Wales) Regulations 2014

5.—(1) The Products Containing Meat etc. (Wales) Regulations 2014(674) are amended as follows.

(2) In Schedule 1—

(a) in the Welsh language text, in the definition of “halen halltu” (“curing salt”), in sub- paragraph (c)—

(i)after “defnyddio yn” insert “unol â”;

(ii)omit “fel y diwygir yr Atodiadau iddo o bryd i’w gilydd”;

(b) in the English language text, in the definition of “curing salt” (“halen halltu”), in sub- paragraph (c)—

(i)after “use in” insert “accordance with”;

(ii)omit “as the Annexes to which are amended from time to time”.

Amendment of the Novel Foods (Wales) Regulations 2017

6.—(1) The Novel Foods (Wales) Regulations 2017(675) are amended as follows.

(2) In regulation 4—

(a) in the Welsh language text, for “6(2)” substitute “6”;

(b) in the English language text, for “6(2)” substitute “6”.

(3) In regulation 5(2)—

(a) in the Welsh language text, for “6(2)” substitute “6”;

(674)S.I. 2014/3087 (W. 308), amended by S.I. 2018/806 (W. 162). There are other amendments, but these are not relevant for this instrument.

(675)S.I. 2017/1103 (W. 279), amended by S.I. 2019/1046 (W. 185).

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(b) in the English language text, for “6(2)” substitute “6”.

(4) In Schedule 1, in the table, in the row for Article 6(2)—

(a) in the first column—

(i)in the Welsh language text, for “6(2)” substitute “6”;

(ii)in the English language text, for “6(2)” substitute “6”;

(b) in the second column—

(i)in the Welsh language text—

(aa)for “ac a gynhwysir yn y rhestr” substitute “yn unol â Rheoliad (EU) 2015/2283”;

(bb)after “rhoi ar y farchnad” insert “, yn yr awdurdodiadau o dan sylw”;

(ii)in the English language text—

(aa)for “and included in the list” substitute “in accordance with Regulation (EU) 2015/2283”;

(bb)after “monitoring requirements” insert “, in the authorisations concerned”.

(5) In Schedule 2—

(a) in Part 2, in the modifications to subsections (1), (3) and (5) of section 9—

(i)in the Welsh language text, for “6(2)”, in each place it occurs, substitute “6”;

(ii)in the English language text, for “6(2)”, in each place it occurs, substitute “6”;

(b) in Part 3, in the table, in the entry for section 32, in the second column—

(i)in the Welsh language text, for “6(2)” substitute “6”;

(ii)in the English language text, for “6(2)” substitute “6”.

SCHEDULE 12 Regulation 22 Consequential amendments to England statutory instruments Amendment of the Materials and Articles in Contact with Food (England) Regulations 2012

1.—(1) The Materials and Articles in Contact with Food (England) Regulations 2012(676) are amended as follows.

(2) In regulation 12(3)—

(a) for “listed in Annex I to” substitute “authorised under”;

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

(3) In regulation 13, in the heading and in the text, for “the Schedule” substitute “Schedule 1”.

(4) In regulation 14(1)—

(a) for “22(4) and (5)” substitute “22(5)”;

(b) for “the Schedule” substitute “Schedule 1”.

(5) In regulation 15, omit “and Annex 1, Table 3 (notes on verification of compliance), Notes

(23) and (27) to”.

(676)S.I. 2012/2619, amended by S.I. 2019/704, 2020/1410 and 2022/1351.

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(6) In regulation 20(3)(d), omit “and Annex 1, Table 3 (notes on verification of compliance), Notes (23) and (27) to”.

(7) The first Schedule (specified provisions of Regulation 10/2011) is renumbered as Schedule 1.

(8) In Schedule 1 (as so renumbered), in the first column of the table—

(a) in each place it occurs, omit “and Annex I” and “and Annex 1”;

(b) in the row relating to Article 9, omit “as read with Annex I”.

Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents

(England) Regulations 2013

2.—(1) The Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013(677) are amended as follows.

(2) In regulation 2—

(a) in paragraph (1)—

(i)in the definition of “Regulation 1333/2008”, omit “, as read with” to the end;

(ii)in the definition of “Regulation 1334/2008”, omit “, as read with” to the end;

(b) in paragraph (3)—

(i)for “an Article of or Annex to” substitute “a provision of”;

(ii)for “Article or Annex” substitute “provision”.

(3) In regulation 4, omit “Article 4” to “Council and with”.

(4) In regulation 5, omit “as read with Article 20 (transitional measures),”.

(5) In Schedule 1, in Table 1, in the second column—

(a) in the row for Article 4.1—

(i)for “included in the list in Annex II to” substitute “authorised in accordance with”;

(ii)for “that Annex” substitute “in the authorisations concerned”;

(b) in the row for Article 4.2—

(i)for “included in the list in Annex III to” substitute “authorised in accordance with”;

(ii)for “that Annex” substitute “the authorisations concerned”;

(c) in the rows for Article 15 and for Article 16, for “Annex II to”, in both places, substitute “authorisations in accordance with”;

(d) in the row for Article 17, for “listed in Annex II to” substitute “authorised in accordance with”.

(6) In Schedule 2, in Table 1, in the second column, in the row for Article 10, for “included on the domestic list” substitute “permitted to be placed on the market or used in or on foods in accordance with Regulation 1334/2008”.

(7) In Schedule 3, in Table 1, in the second column, in the first row for Article 4.2, for “not on the list of authorised smoke flavourings” substitute “that is not authorised in accordance with Regulation 2065/2003”.

(8) In Schedule 4, in Table 1, in the second column, in the row for Article 4, for “appear in the domestic list” to the end substitute “are authorised in accordance with Regulation 1332/2008, and in accordance with any specifications and conditions of use set out in the authorisations concerned, subject to Article 24 of Regulation 1332/2008”.

(677)S.I. 2013/2210, amended by S.I. 2019/860 and 2022/1351. There are other amendments, but these are not relevant for this instrument.

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Amendment of the Products Containing Meat etc. (England) Regulations 2014

3.—(1) The Products Containing Meat etc. (England) Regulations 2014(678) are amended as follows.

(2) In Schedule 1, in the definition of “curing salt”, in sub-paragraph (c)—

(a) after “use in” insert “accordance with”;

(b) omit “as last amended by Commission Regulation (EU) 2018/1497”.

Amendment of the Novel Foods (England) Regulations 2018

4.—(1) The Novel Foods (England) Regulations 2018(679) are amended as follows.

(2) In Schedule 1, in the table, in the row for Article 6.2—

(a) in the first column, for “6.2” substitute “6”;

(b) in the second column—

(i)for “and included in the list” substitute “in accordance with Regulation (EU) 2015/2283”;

(ii)omit “therein”;

(iii)after “monitoring requirements” insert “, in the authorisations concerned”.

EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations amend, revoke and replace various provisions in secondary assimilated law within the meaning of section 12(2) of the Retained EU Law (Revocation and Reform) Act 2023 (c. 28).

Part 2 contains amendments to Regulation (EC) No 1831/2003 on additives for use in animal nutrition (EUR 2003/1831). It also contains consequential amendments to 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 (EUR 2005/378) and 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 (EUR 2008/429).

Part 3 contains amendments to the following assimilated direct legislation relating to food additives,

food enzymes and food flavourings:

(a) 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 (EUR 2008/1331);

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

(678)S.I. 2014/3001, amended by S.I. 2019/526. There are other amendments, but these are not relevant for this instrument.

(679)S.I. 2018/154, amended by S.I. 2019/702.

106Document Generated: 2025-04-01

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

(d) 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., (EUR 2008/1334);

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

Part 4 contains amendments to the following assimilated direct legislation relating to food contact

materials:

(a) 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., (EUR 2004/1935);

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

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

Part 5 contains amendments to Regulation (EC) No 1829/2003 on genetically modified food and feed (EUR 2003/1829). It also contains consequential amendments to 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., (EUR 2011/619) and Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed, etc., (EUR 2013/503).

Part 6 contains amendments to Regulation (EU) 2015/2283 on novel foods, etc., (EUR 2015/2283). It also contains consequential amendments to 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 (EUR 2017/2468) and Commission Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 (EUR 2017/2469).

Part 7 contains amendments to 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 (EUR 2003/2065).

Part 8 sets out revocations, consequential amendments, savings and transitional provision, and gives effect to the Schedules.

Schedules 1 to 3, respectively, set out revocations of Scotland, Wales and England statutory instruments, with certain savings in respect of transitional provisions.

Schedules 4 to 8 contain revocations of assimilated direct legislation.

Schedules 9 to 12, respectively, set out consequential amendments to assimilated direct legislation, and to Scotland, Wales and England statutory instruments.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.

107

SI 2025/361 - The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025

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SI 2025/361 - The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025

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