PART 1 Introductory

Citation, commencement, extent and application

1.—(1) These Regulations may be cited as the Food and Feed (Miscellaneous Amendments) Regulations 2022 and come into force on 31st December 2022.

(2) This Part and Part 3 extend to England and Wales and Scotland.

(3) Part 2 extends to England and Wales but applies in relation to England only.

PART 2 Amendment of statutory instruments that apply in England

Amendment of the Materials and Articles in Contact with Food (England) Regulations 2012

2.—(1) The Materials and Articles in Contact with Food (England) Regulations 2012( 3) are amended as follows.

(2) In regulation 2—

(a) in paragraph (1)—

(i) omit the definition of “Directive 84/500/EEC”;

(ii) omit the definition of “ Directive 2007/42/EC”;

(b) in paragraph (3), in both places, omit “EU”.

(3) In regulation 9—

(a) omit the “and” at the end of paragraph (a)(iii);

(b) omit paragraph (b).

(4) In regulation 11, omit paragraph (3).

(5) In regulation 12—

(a) in paragraph (1)—

(i) in both places, for “Annex II” substitute “Schedule 5”;

(ii) for “that Annex” substitute “that Schedule”;

(b) in paragraph (2), for “Annex II” substitute “Schedule 5”.

(6) In regulation 30—

(a) in paragraph (2), for the words from “how the EU” to the end substitute “the operation of the relevant retained EU instruments”;

(b) in paragraph (6)—

(i) in the defined term, before “EU instruments” insert “relevant retained”;

(ii) omit the words from “Council Directive 78/142/EEC” to “ Directive 2007/42/EC,”.

(7) Schedule 1 has effect.

Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013

3.—(1) The Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013( 4) are amended as follows.

(2) In regulation 2—

(a) in paragraph (1)—

(i) omit the definition of “Directive 2009/32”;

(ii) in the definition of “the EU Regulations”, before “EU” insert “retained”;

(b) in paragraph (2) omit “EU”;

(c) in paragraph (3) omit “EU”;

(d) in paragraph (4) for “EU instruments are Directive 2009/32,” substitute “instruments are”.

(3) Omit regulation 9.

(4) In regulation 10(a), for “Annex I” substitute “Schedule 6”.

(5) In regulation 11(a)—

(a) in sub-paragraph (i), for “Annex I” substitute “Schedule 6”;

(b) in sub-paragraph (ii), for “that Annex” substitute “Schedule 6”;

(c) in sub-paragraph (iii), insert “and”at the end;

(d) in sub-paragraph (iv), omit the “and” at the end;

(e) omit sub-paragraph (v).

(6) In regulation 14(1)(a), for “Annex I” substitute “Schedule 6”.

(7) In regulation 16, before “EU Regulations” insert “retained”.

(8) In regulation 19(2), before “EU Regulations” insert “retained”.

(9) Omit regulation 22(2).

(10) Schedule 2 has effect.

Amendment of the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015

4.—(1) The Animal Feed (Composition, Marketing and Use) (England) Regulations 2015( 5) are amended as follows.

(2) In regulation 2—

(a) in paragraph (1)—

(i) omit the definition of “Directive 82/475”;

(ii) omit the definition of “Directive 2002/32”;

(b) in paragraph (2), before “EU” insert “retained”;

(c) in paragraph (3), in both places, omit “EU”.

(3) In regulation 12(2), for “the Annex to Directive 82/475” substitute “Schedule 3”.

(4) In Part 6 (immediately before regulation 14), for the heading to that Part substitute “Undesirable substances in products intended for animal feed”.

(5) In regulation 14, omit paragraph (a).

(6) In regulation 15—

(a) in paragraph (1)—

(i) in sub-paragraph (a), for “Annex I” substitute “a table in Schedule 4”;

(ii) in the words after sub-paragraph (b), for “Annex” substitute “table”;

(b) in paragraph (2)—

(i) in sub-paragraph (a), for “Annex I” substitute “a table in Schedule 4”;

(ii) in sub-paragraph (b), for “Annex” substitute “table”;

(c) in paragraph (3)—

(i) for “Annex I” substitute “a table in Schedule 4”;

(ii) for “Annex”, in the second place it occurs, substitute “table”;

(d) in paragraph (5)—

(i) for “Annex I” substitute “a table in Schedule 4”;

(ii) for “Annex”, in the second place it occurs, substitute “table”;

(e) in paragraph (7)—

(i) omit the “and” at the end of sub-paragraph (c);

(ii) after sub-paragraph (d) insert—

“(e) peat;

(f) leonardite. ”;

(f) after paragraph (8) insert—

“(9)  In order to reduce or eliminate sources of undesirable substances in products intended for animal feed, feed authorities must, in cooperation with feed business operators( 6) , carry out investigations to identify the sources of undesirable substances, in cases where the maximum levels are exceeded and in cases where increased levels of such substances are detected, taking into account background levels; for the purpose of ensuring a uniform approach in cases of increased levels, action thresholds to trigger investigations are set out in Schedule 5.

(10)  Feed authorities must transmit to the Agency all relevant information and findings of the source and the measures taken to reduce the level of, or eliminate, undesirable substances.

(11)  Where the Secretary of State has grounds to believe that a level fixed in Schedule 4 or 5, or an undesirable substance not listed in Schedule 4 or 5, presents a danger to animal or human health, or to the environment, the Secretary of State—

(a) may, pending amendment of Schedule 4 or 5—

(i) change an existing level;

(ii) introduce a level; or

(iii) prohibit the presence,

of the undesirable substance concerned in products intended for animal feed by issuing a direction; and

(b) must decide whether to make an amendment to Schedule 4 or 5 that corresponds with the direction issued under sub-paragraph (a).

(12)  A direction issued under paragraph (11)(a)—

(a) must be in writing;

(b) may specify a period of time during which it has effect;

(c) may be revoked by the Secretary of State at any time, by way of a written notice;

(d) irrespective of any period of time specified under sub-paragraph (b), ceases to have effect upon the entry into force of any corresponding amendment of Schedule 4 or 5 made pursuant to paragraph (11)(b).

(13)  A direction issued under paragraph (11)(a) and a revocation notice under paragraph (12)(c) must be published by the Secretary of State without delay. ”.

(7) After regulation 15 insert—

“Regulations

15A.— (1)  The Secretary of State may, by regulations, make provision to—

(a) add, amend or remove an entry in Schedule 4 or 5;

(b) amend the acceptability criteria for detoxification processes in Regulation (EU) 2015/786( 7) .

(2)  Any power to make regulations under this Part is exercisable by statutory instrument.

(3)  A statutory instrument containing regulations is subject to annulment in pursuance of a resolution of either House of Parliament.

(4)  Regulations made under this regulation may—

(a) contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking retained direct EU legislation);

(b) make different provision for different purposes. ”.

(8) Omit regulation 22(2).

(9) Schedule 3 has effect.

Amendment of the Animal Feed (Hygiene, Sampling etc. and Enforcement) (England) Regulations 2015

5.—(1) The Animal Feed (Hygiene, Sampling etc. and Enforcement) (England) Regulations 2015( 8) are amended as follows.

(2) In regulation 4—

(a) in paragraph (1)(a), for “20(2), 21(1) and 22(2)(b)” substitute “19(3) and (7) and 21(1)”;

(b) in paragraph (2)(a), for “2(e)” substitute “2(f)”.

(3) In regulation 30(1)(b), for “Article 4.2 of Directive 2002/32/ECof the European Parliament and of the Council on undesirable substances in animal feed” substitute “regulation 15(9) of the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015”.

(4) Omit regulation 41(2).

Amendment of the Animal Feed (Basic Safety Standards) (England) Regulations 2019

6.—(1) The Animal Feed (Basic Safety Standards) (England) Regulations 2019( 9) are amended as follows.

(2) In regulation 2—

(a) in paragraph (1), omit the definition of “the Directive”;

(b) in paragraph (3), in both places, for “, Regulation 767/2009 and in the Directive” substitute “and Regulation 767/2009”.

(3) Omit regulation 9(2).

PART 3 Amendment of retained direct EU legislation

Amendment of Regulation (EC) No 1829/2003on genetically modified food and feed

7.—(1) Regulation (EC) No 1829/2003of the European Parliament and of the Council on genetically modified food and feed( 10) is amended as follows.

(2) In Article 8, after paragraph 5, insert—

“6.   Where the notification and accompanying particulars referred to in paragraphs 1 and 2 are, or were, not supplied within the period specified or are, or were, found to be incorrect, or where an application is, or was, not submitted as required by paragraph 4 within the period specified, the appropriate authority may prescribe( 11) —

(a) that the product concerned, and any products derived from it, be withdrawn from the market;

(b) a period of time within which existing stocks of the product concerned, and any products derived from it, may be used up. ”.

(3) In Article 20, after paragraph 5, insert—

“6.   Where the notification and accompanying particulars referred to in paragraphs 1 and 2 are, or were, not supplied within the period specified or are, or were, found to be incorrect, or where an application is, or was, not submitted as required by paragraph 4 within the period specified, the appropriate authority may prescribe—

(a) that the product concerned, and any products derived from it, be withdrawn from the market;

(b) a period of time within which existing stocks of the product concerned, and any products derived from it, may be used up. ”.

Amendment of Regulation (EC) No 1831/2003on additives for use in animal nutrition

8.—(1) Regulation (EC) No 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition( 12) is amended as follows.

(2) In Article 1—

(a) in paragraph 2(b), omit “as defined in Directive 2001/82/EC”;

(b) after paragraph 2 insert—

“3.   In this Article ‘veterinary medicinal product’ means:

(a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or

(b) any substance or combination of substances which may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

For the purposes of the definition of ‘veterinary medicinal product’, ‘substance’ means any matter, irrespective of origin, which may be:

(a) human, including human blood and human blood products;

(b) animal, including micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts and blood products;

(c) vegetable, including micro-organisms, plants, parts of plants, vegetable secretions and extracts; or

(d) chemical, including elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis. ”.

(3) In Article 2(2)—

(a) for points (b) to (d) substitute—

“(b) ‘feed materials’ means products of vegetable or animal origin, whose principal purpose is to meet animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from their industrial processing, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as a carrier of premixtures;

(c) ‘compound feed’ means a mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete feed or complementary feed;

(d) ‘complementary feed’ means compound feed which has a high content of certain substances but which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed; ”;

(b) for point (g) substitute—

“(g) ‘complete feed’ means compound feed which, by reason of its composition, is sufficient for a daily ration; ”.

(4) In Article 3—

(a) in paragraph 2, for “Directive 87/153/EEC, Directive 83/228/EEC” substitute “Regulation (EC) No 767/2009( 13)”;

(b) in paragraph 4, for “ Directive 95/69/EC” substitute “Regulation (EC) No 183/2005( 14)”.

(5) In Article 4(2), for “Articles 53 and 54” substitute “Article 53”.

(6) In Article 7—

(a) in paragraph 3—

(i) in point (e), for “feedingstuffs” substitute “feed”;

(ii) in point (f), for “have been sent by the applicant directly” substitute “will be made available, upon request,”;

(b) in paragraph 4, omit the final sentence.

(7) In Article 8(4)(e), for the words from “Annex I” to the end substitute “Regulation (EC) No 470/2009( 15)”.

(8) Omit Article 13(6).

(9) In Article 16(1)—

(a) in the words before point (a), for “Great Britain” substitute “the British Islands”;

(b) in point (d)—

(i) omit “Article 10 of”;

(ii) omit “or, as applicable, to Article 5 of Directive 95/69/EC”.

(10) In Annex 2—

(a) before point 2 insert—

“1A.   The reference laboratory may be assisted by scientific experts or official laboratories with the performance of the duties and tasks set out in this Annex. ”;

(b) in point 4, for “Articles 11 and 32 of Regulation (EC) No 882/2004of the European Parliament and of the Council” substitute “Regulation (EU) 2017/625( 16)”;

(c) after point 5 insert—

“6.   The reference laboratory shall:

(a) be responsible for the overall coordination of scientific experts or official laboratories; and

(b) ensure that the relevant data concerning the applications are made available to the scientific experts or official laboratories. ”;

(d) in point 7, for “Article 32 of Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”.

(11) In Annex 4, in point 3, for “complete feedingstuffs” substitute “complete feed”.

Amendment of Regulation (EC) No 853/2004laying down specific hygiene rules for food of animal origin

9.—(1) Regulation (EC) No 853/2004of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin( 17) is amended as follows.

(2) Omit Article 1(4).

(3) In Article 10—

(a) after paragraph 1 insert—

“1A.   Amendments under paragraph 1 may, in particular, prescribe—

(a) the requirements on the identification marking of products of animal origin;

(b) the objectives of HACCP-based procedures;

(c) the requirements on the food chain information;

(d) the specific hygiene requirements for the premises, including means of transport, where products of animal origin are produced, handled, processed, stored or distributed;

(e) the specific hygiene requirements for the operations involving the production, handling, processing, storage, transport or distribution of products of animal origin;

(f) the rules for the transport of meat while it is warm;

(g) the health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

(h) the extension of Annex III, Section VII, Chapter IX (specific requirements for pectinidae, marine gastropods and echinoderms which are not filter feeders harvested outside classified production areas), to live bivalve molluscs other than pectinidae;

(i) the criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D (requirements concerning parasites);

(j) the additional health standards for live bivalve molluscs in cooperation with the relevant reference laboratory, including:

(i) limit values and analysis methods for other marine biotoxins;

(ii) virus testing procedures and virological standards; and

(iii) sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards. ”;

(b) in paragraph 2—

(i) for “exemptions” substitute “derogations”;

(ii) after “Annexes 2 and 3” insert—

“taking into account the relevant risk factors and provided that such derogations do not affect the achievement of the following objectives of this Regulation:

(a) to facilitate the fulfilment, by small businesses, of the requirements laid down in the Annexes;

(b) to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food;

(c) to accommodate the needs of food businesses situated in regions that are subject to special geographic constraints;

(d) to facilitate the work of establishments producing raw material which is intended for the production of highly refined food products and which has undergone a treatment ensuring its safety ”.

(4) In Article 11, in the words before point 1, omit “to Annex 2 or 3”.

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

10.—(1)  Commission Regulation (EC) No 378/2005on detailed rules for the implementation of Regulation (EC) No 1831/2003of 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( 18) is amended as follows.

(2) In Article 3—

(a) in paragraph 1—

(i) in the first subparagraph, after “reference samples” insert “to the reference laboratory, upon request,”;

(ii) in the second subparagraph—

(aa) in the words before point (a), after “In addition,” insert “and upon request,”;

(bb) in point (a), in the final indent, omit “in Annex I or III of Council Regulation (EEC) No 2377/90”;

(b) in paragraph 3, in the second sentence of the second subparagraph—

(i) for “national reference laboratories of the consortium” substitute “scientific experts or official laboratories working on behalf of the reference laboratory”;

(ii) for “of Articles 11, 32 and 33 of Regulation (EC) No 882/2004” substitute “to Regulation (EU) 2017/625”.

(3) In Article 6—

(a) in paragraph 1, for “a consortium of national” substitute “scientific experts or official”;

(b) for paragraph 2 substitute—

“2.   For the purposes of paragraph 1, scientific experts or official laboratories must comply with the requirements set out in Annex I. ”;

(c) in paragraph 3—

(i) for “members of the consortium”, in the first place it appears, substitute “scientific experts or official laboratories”;

(ii) for “other members of the consortium” substitute “scientific experts or official laboratories”;

(iii) in the final sentence, omit “to the members of the consortium”.

(4) In Article 9—

(a) in the heading, for “the laboratories participating in the consortium” substitute “scientific experts or official laboratories assisting the reference laboratory”;

(b) in paragraph 1, for “The laboratories participating in the consortium” substitute “Scientific experts or official laboratories, who are assisting the reference laboratory,”;

(c) in paragraph 2—

(i) for “Each laboratory” substitute “A scientific expert or official laboratory, who, or which, is assisting the reference laboratory,”;

(ii) before “laboratory considers” insert “scientific expert or official”;

(iii) in the final sentence, before “laboratories” insert “scientific experts or official”.

(5) In Article 10(1), in the second subparagraph, for “the consortium” substitute “scientific experts or official laboratories”.

(6) In Article 11, in both places, for “consortium” substitute “scientific experts or official laboratories”.

(7) In Article 12(2), for “laboratories, including criteria for appointing rapporteur laboratories” substitute “scientific experts or official laboratories, including criteria for appointing scientific experts or official laboratories”.

(8) Omit Article 13.

(9) In Annex 1—

(a) for the heading substitute “Requirements for participating scientific experts and official laboratories, as referred to in Article 6”;

(b) in the words before point (b), for “Laboratories participating in the consortium” substitute “Scientific experts or official laboratories assisting the reference laboratory”;

(c) in point (e), omit “with the other laboratories participating in the consortium”.

(10) Omit Annex 3.

Amendment of Commission Decision 2007/305/ECon the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products

11.  In Article 2(1) of Commission Decision 2007/305/ECon the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products( 19), for “2022” substitute “2025”.

Amendment of Commission Decision 2007/306/ECon the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products

12.  In Article 2(1) of Commission Decision 2007/306/ECon the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products( 20), for “2022” substitute “2025”.

Amendment of Commission Decision 2007/307/ECon the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products

13.  In Article 1(2) of Commission Decision 2007/307/ECon the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products( 21), for “2022” substitute “2025”.

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

14.—(1)  Commission Regulation (EC) No 429/2008on detailed rules for the implementation of Regulation (EC) No 1831/2003of 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( 22) is amended as follows.

(2) In Annex 1—

(a) after point 1.3 insert—

“Note: where applicable, in accordance with Regulation (EC) No 378/2005 , reference samples, documentation and payment will be requested after submission of the feed additive application by the reference laboratory. ”;

(b) omit point 1.4;

(c) in point 1.5, omit the words from “three samples of” to “378/2005”.

(3) In Annex 2—

(a) in the sixth unnumbered subparagraph, before “ Directive 2004/10/EC” insert “Annex I to”;

(b) in the eighth unnumbered subparagraph, for the words from “Council Directive 67/548/EEC” to “ 2004/73/EC” substitute “Regulation (EC) No 1272/2008( 23)”;

(c) in the tenth unnumbered subparagraph—

(i) before “ Directive 2004/10/EC” insert “Annex I to”;

(ii) for the words from “Article 11 of” to the end substitute “Articles 34 and 35 of Regulation (EU) 2017/625”;

(d) in point 2.3.1, in the second subparagraph, for “Council Directive 90/219/ECapplies. A” substitute “a”;

(e) in point 2.5.2.1—

(i) omit “material”;

(ii) for the words from “Commission Directive” to “ 88/379/EEC” substitute “Regulation (EC) No 1907/2006( 24)”;

(f) in point 2.6—

(i) in the third unnumbered subparagraph—

(aa) for the words from “Council Regulation (EEC)” to “animal origin” substitute “Regulation (EC) No 470/2009”;

(bb) for the words from “to European Medicines Agency” to the end substitute “in accordance with Commission Implementing Regulation (EU) 2017/12( 25)”;

(ii) in the fifth unnumbered subparagraph, for “prior to the evaluation of the technical dossier” substitute “, upon request”;

(g) in point 2.6.1.1, for “Article 11 of Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625.”;

(h) in point 2.6.1.2, for “Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”;

(i) in point 2.6.1.4, for “Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”;

(j) in point 2.6.2.1, for “Article 11 of Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”;

(k) in point 2.6.2.2, for “Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”;

(l) in point 2.6.3—

(i) in the third unnumbered subparagraph, before “ Directive 2004/10/EC” insert “Annex I to”;

(ii) in the fourth unnumbered subparagraph, for “Article 11 of Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”;

(m) in point 3.4, in the second unnumbered subparagraph, for “Directive 67/548/EEC” substitute “Regulation (EC) No 1272/2008”.

(4) In Annex 3—

(a) in point 2.2.3.1, in subparagraph 2, for the words from “of the Commission Regulation (EC) No 1565/2000” to “European Parliament and of the Council” substitute “Regulation (EU) No 872/2012( 26)”;

(b) in point 3.3.1.1, in subparagraph 1—

(i) omit “authorised by Directive 82/471/EEC”;

(ii) for “Directive 70/524/EEC” substitute “Article 10 of Regulation (EC) No 1831/2003”.

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

15.  In Article 7(4) of Regulation (EC) No 1331/2008of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings( 27), for “Community” substitute “domestic”.

Amendment of Commission Regulation (EC) No 152/2009laying down the methods of sampling and analysis for the official control of feed

16.—(1)  Commission Regulation (EC) No 152/2009laying down the methods of sampling and analysis for the official control of feed( 28) is amended as follows.

(2) In Article 1—

(a) in the first paragraph, for “ Directive 2002/32/ECof the European Parliament and of the Council” substitute “the CMU Regulations”;

(b) for the third paragraph substitute—

“In this Regulation—

‘CMU Regulations’ means—

(a) in relation to England, the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015;

(b) in relation to Scotland, the Animal Feed (Scotland) Regulations 2010( 29) ; and

(c) in relation to Wales, the Animal Feed (Composition, Marketing and Use) (Wales) Regulations 2016( 30) .

‘reference laboratory’ means a reference laboratory prescribed by the appropriate authority under Regulation (EU) 2017/625. ”.

(3) In Annex 1—

(a) in point 7, in the table, in the third footnote, omit the words from “in accordance with” to the end;

(b) in point 9.4, in the final indent, for “footnote (**) in chapter 6 and footnote (*) in chapter 7” substitute “footnote (b) to the table in point 6 of this Annex and footnote (a) to the table in point 7 of this Annex”.

(4) In Annex 2, in Part C, in point 6, for “ Directive 2002/32/EC” substitute “the CMU Regulations”.

(5) In Annex 3, in Part L, in point 1, for “Council Directive 96/25/EC” substitute “Regulation (EC) No 767/2009”.

(6) In Annex 5, in Part B—

(a) in Chapter 1—

(i) in point 1, for “ Directive 2002/32/EC” substitute “the CMU Regulations”;

(ii) in point 2.1, in both places, for “ Directive 2002/32/EC” substitute “the CMU Regulations”;

(iii) in point 2.2, in each place, for “ Directive 2002/32/EC” substitute “the CMU Regulations”;

(iv) in point 3, in the heading, for “Annex II to Directive 2002/32/EC” substitute “the CMU Regulations”;

(b) in Chapter 2—

(i) in point 4.1, for “Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”;

(ii) in point 8.1.5, for “ Directive 2002/32/EC” substitute “the CMU Regulations”;

(iii) in point 8.3.3, for “ Directive 2002/32/EC” substitute “the CMU Regulations”;

(c) in Chapter 3—

(i) in point 8, for “Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”;

(ii) in point 10.5, for “ Directive 2002/32/EC” substitute “the CMU Regulations”.

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

17.—(1)  Commission Regulation (EC) No 450/2009on active and intelligent materials and articles intended to come into contact with food( 31) is amended as follows.

(2) In Article 11—

(a) in paragraph 1, for the words from “edible:” to the end substitute “edible, with the words ‘DO NOT EAT’”;

(b) in paragraph 3—

(i) for “Article 6(4)(a) of Directive 2000/13/ECof the European Parliament and of the Council” substitute “Article 2 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, etc.( 32),”;

(ii) for “that Directive” substitute “that Regulation”.

(3) Omit Annex 1.

Amendment of Regulation (EC) No 767/2009on the placing on the market and use of feed, etc.

18.—(1) Regulation (EC) No 767/2009of the European Parliament and of the Council on the placing on the market and use of feed, etc. is amended as follows.

(2) In Article 16.1(a), for “24(5)” substitute “24(2)”.

(3) In Annex 2, after point 2 insert—

“3.   In the designation of feed for pets, the expression ‘pet food’ shall be allowed. ”.

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 for which an authorisation procedure is pending or the authorisation of which has expired

19.  In Article 2(b) of Commission Regulation (EU) No 619/2011laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired( 33), after “2012,” insert “in the case of products falling within Decision 2007/304/EC( 34) or Decision 2007/308/EC( 35), or after 30 December 2025, in the case of products falling within Decision 2007/305/EC, Decision 2007/306/ECor Decision 2007/307/EC,”.

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

20.  In Article 35 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, etc.( 36)—

(a) omit paragraph 1;

(b) for paragraph 2 substitute—

“2.   A novel food, which is the subject of an application for authorisation submitted in accordance with Article 10, and which is received by the appropriate authority on or before 31 December 2023, may remain on the market in Great Britain until the application concludes, if—

(a) it did not fall within scope of Regulation (EC) No 258/97( 37) before that Regulation was repealed;

(b) it was lawfully placed on the market in the European Union or the United Kingdom before 1 January 2018; and

(c) it was the subject of an application for authorisation or notification of a traditional food from a third country received by the European Commission on or before 1 January 2019.

2A.   For the purpose of paragraph 2, an application concludes when—

(a) the appropriate authority informs the applicant, in accordance with Article 6(5) of Commission Implementing Regulation (EU) 2017/2469( 38) , that the application is not considered valid;

(b) the appropriate authority terminates the procedure in accordance with Article 10(6);

(c) the applicant withdraws the application; or

(d) the list established in Commission Implementing Regulation (EU) 2017/2470( 39) is updated to authorise the novel food in accordance with Article 12(1) of this Regulation. ”;

(c) omit paragraph 3.

Regulation 2(7)

SCHEDULE 1 Insertion of Schedule 5 to the Materials and Articles in Contact with Food (England) Regulations 2012

After Schedule 4 to the Materials and Articles in Contact with Food (England) Regulations 2012 insert—

Regulation 12(1)

“SCHEDULE  5 LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM

DESCRIPTION OF REGENERATED CELLULOSE FILM

Regenerated cellulose film is a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.

LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM

Notes:

• The percentages in this Schedule, in the first and second parts, are expressed in weight/weight (w/w) and are calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film.

• The usual technical denominations are given in square brackets.

• The substances used shall be of good technical quality as regards the purity criteria.

Regulation 3(10)

SCHEDULE 2 Insertion of Schedule 6 to the Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013

After Schedule 5 to the Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013 insert—

Regulations 10, 11 and 14

“SCHEDULE  6 EXTRACTION SOLVENTS WHICH MAY BE USED DURING THE PROCESSING OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD COMPONENTS OR OF FOOD INGREDIENTS

Regulation 4(9)

SCHEDULE 3 Insertion of Schedules 3, 4 and 5 to the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015

After Schedule 2 to the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015 insert—

Regulation 12(2)

“SCHEDULE  3 Categories of feed materials which may be indicated in place of individual feed materials

Regulations 15 and 15A

SCHEDULE  4 Maximum levels of undesirable substances

Regulations 15 and 15A

SCHEDULE  5 Action thresholds triggering investigations: dioxins and PCBs

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations are made in exercise of the powers in the European Union (Withdrawal) Act 2018 (c. 16)(in particular under section 8(1) and (2)(a), (b), (c), (d), (f) and (g)) in order to address failures of retained EU law to operate effectively and other deficiencies arising from the withdrawal of the United Kingdom from the European Union.

Part 2 contains amendments to various statutory instruments relating to food and feed that apply in England only. In particular, the amendments remove cross-references to various EU Directives and insert various tables from the Annexes to those Directives, as they had effect immediately before IP completion day, as new Schedules to the instruments concerned, as follows—

(a) Annexes 1 and 2 from Commission Directive 2007/42/ECrelating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (OJ L 172, 30.6.2007, p. 71–82) are inserted as Schedule 5 to the Materials and Articles in Contact with Food (England) Regulations 2012 ( S.I. 2012/2619);

(b) Annex 1 from Directive 2009/32/ECof the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (OJ L 141, 6.6.2009, p. 3–11) is inserted as Schedule 6 to the Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013 ( S.I. 2013/2210); and

(c) the Annex to Commission Directive 82/475/EEClaying down the categories of feed materials which may be used for the purposes of labelling compound feedingstuffs for pet animals (OJ L 213, 21.7.1982, p. 27–28) is inserted as Schedule 3 to the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015 ( S.I. 2015/255) and Annexes 1 and 2 from Directive 2002/32/ECof the European Parliament and of the Council on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10–22) are inserted as Schedules 4 and 5 to those Regulations.

Part 3 contains amendments to retained direct EU legislation relating to food and feed.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sectors is foreseen.