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The Food and Feed (Miscellaneous Amendments) Regulations 2022

Type Statutory-Instrument

Publication 2022-12-14

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: 14th December 2022

Coming into force: 31st December 2022

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[^f00002], there has been open and transparent public consultation during the preparation and evaluation of these Regulations.

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[^f00003] 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[^f00004] 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”;

(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”;

(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[^f00005] 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”;

(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”;

(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[^f00006], 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—

(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[^f00007]. (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[^f00008] 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/EC of 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[^f00009] 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 1829/2003 on genetically modified food and feed

7

(1) Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed[^f00010] 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[^f00011]— (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 1831/2003 on additives for use in animal nutrition

8

(1) Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition[^f00012] 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[^f00013]”;

(b) in paragraph 4, for “Directive 95/69/EC” substitute “Regulation (EC) No 183/2005[^f00014]”.

(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[^f00015]”.

(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 882/2004 of the European Parliament and of the Council” substitute “Regulation (EU) 2017/625[^f00016]”;

(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 853/2004 laying down specific hygiene rules for food of animal origin

9

(1) Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin[^f00017] 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 378/2005 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

10

(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[^f00018] 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.

(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,”;

(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”;

(10) Omit Annex 3.

Amendment of Commission Decision 2007/305/EC on 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/EC on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products[^f00019], for “2022” substitute “2025”.

Amendment of Commission Decision 2007/306/EC on 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/EC on the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products[^f00020], for “2022” substitute “2025”.

Amendment of Commission Decision 2007/307/EC on 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/EC on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products[^f00021], for “2022” substitute “2025”.

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

14

(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[^f00022] 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;

(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[^f00023]”;

(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/EC applies. 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[^f00024]”;

(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[^f00025]”;

(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[^f00026]”;

(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 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings

15

In Article 7(4) 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[^f00027], for “Community” substitute “domestic”.

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

16

(1) Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed[^f00028] is amended as follows.

(2) In Article 1—

(a) in the first paragraph, for “Directive 2002/32/EC of 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[^f00029]; and (c) in relation to Wales, the Animal Feed (Composition, Marketing and Use) (Wales) Regulations 2016[^f00030]. ‘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”;

(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 450/2009 on active and intelligent materials and articles intended to come into contact with food

17

(1) Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food[^f00031] 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/EC of 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.[^f00032],”;

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

(3) Omit Annex 1.

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

18

(1) Regulation (EC) No 767/2009 of 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 619/2011 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[^f00033], after “2012,” insert “in the case of products falling within Decision 2007/304/EC[^f00034] or Decision 2007/308/EC[^f00035], or after 30 December 2025, in the case of products falling within Decision 2007/305/EC, Decision 2007/306/EC or 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.[^f00036]—

(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[^f00037] 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[^f00038], 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[^f00039] is updated to authorise the novel food in accordance with Article 12(1) of this Regulation.

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—

SCHEDULE5 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. 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.

Denominations	Restrictions
A. Regenerated cellulose	Not less than 72% (w/w)
B. Additives
1. Softeners	Not more than 27% (w/w) in total
— Bis (2-hydroxyethyl) ether [= diethyleneglycol]	Only for films intended to be coated and then used for foodstuffs which are not moist, namely which do not contain water which is physically free at the surface. The total amount of bis(2-hydroxyethyl)ether and ethanediol present in foodstuffs that have been in contact with film of this type may not exceed 30 mg/kg of the foodstuff.
— Ethanediol [= monoethyleneglycol]
— 1.3-butanediol
— Glycerol
— 1.2-propanediol [= 1.2 propyleneglycol]
— Polyethylene oxide [= polyethyleneglycol]	Average molecular weight between 250 and 1200.
— 1.2-polypropylene oxide [= 1.2 polypropyleneglycol]	Average molecular weight not greater than 400 and free 1.3-propanediol content not greater than 1% (w/w) in substance.
— Sorbitol
— Tetraethyleneglycol
— Triethyleneglycol
— Urea
2. Other additives	Not more than 1% (w/w) in total.
First class	The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm² of the uncoated film.
— Acetic acid and its NH₄, Ca, Mg, K and Na salts
— Ascorbic acid and its NH₄, Ca, Mg, K and Na salts
— Benzoic acid and sodium benzoate
— Formic acid and its NH₄, Ca, Mg, K and Na salts
— Linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also behenic and ricinoleic acids and the NH₄, Ca, Mg, K, Na, Al, Zn salts of these acids
— Citric, d- and l-lactic, maleic, l-tartaric acids and their Na and K salts
— Sorbic acid and its NH₄, Ca, Mg, K and Na salts
— Amides of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also the amides of behenic and ricinoleic acids
— Natural edible starches and flours
— Edible starches and flours modified by chemical treatment
— Amylose
— Calcium and magnesium carbonates and chlorides
— Esters of glycerol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and/or with adipic, citric, 12-hydroxystearic (oxystearin), ricinoleic acids
— Esters of polyoxyethylene (8 to 14 oxyethylene groups) with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive
— Esters of sorbitol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive
— Mono-and/or di-esters of stearic acid with ethanediol and/or bis (2-hydroxyethyl) ether and/or triethylene glycol
— Oxides and hydroxides of aluminium, calcium, magnesium and silicon and silicates and hydrated silicates of aluminium, calcium, magnesium and potassium
— Polyethylene oxide [= polyethyleneglycol]	Average molecular weight between 1200 and 4000.
— Sodium propionate
Second class	The total quantity of the substances may not exceed 1 mg/dm² of the uncoated film and the quantity of the substance or group of substances in each indent may not exceed 0.2 mg/dm² (or a lower limit where one is specified) of the uncoated film.
— Sodium alkyl (C₈-C₁₈) benzene sulphonate
— Sodium isopropyl naphthalene sulphonate
— Sodium alkyl (C₈-C₁₈) sulphate
— Sodium alkyl (C₈-C₁₈) sulphonate
— Sodium dioctylsulphosuccinate
— Distearate of dihydroxyethyl diethylene triamine monoacetate	Not more than 0.05 mg/dm² of the uncoated film.
— Ammonium, magnesium and potassium lauryl sulphates
— N,N′-distearoyl diaminoethane, N,N′-dipalmitoyl diaminoethane and N,N′-dioleoyl diaminoethane
— 2-heptadecyl-4.4-bis(methylene-stearate) oxazoline
— Polyethylene-aminostearamide ethylsulphate	Not more than 0.1 mg/dm² of the uncoated film.
Third class — Anchoring agent	The total quantity of substances may not exceed 1 mg/dm² of the uncoated film.
— Condensation product of melamine-formaldehyde unmodified, or which may be modified with one or more of the following products: butanol, diethylenetriamine, ethanol, triethylenetetramine, tetraethylenepentamine, tri-(2-hydroxyethyl) amine, 3.3′-diaminodipropylamine, 4.4′-diaminodibutylamine	Free formaldehyde content not greater than 0.5 mg/dm² of the uncoated film. Free melamine content not greater than 0.3 mg/dm² of the uncoated film.
— Condensation product of melamine-urea-formaldehyde modified with tris-(2-hydroxyethyl)amine	Free formaldehyde content not greater than 0.5 mg/dm² of the uncoated film. Free melamine content not greater than 0.3 mg/dm² of the uncoated film.
— Cross-linked cationic polyalkyleneamines: (a) polyamide-epichlorhydrin resin based on diaminopropylmethylamine and epichlorhydrin; (b) polyamide-epichlorhydrin resin based on epichlorhydrin, adipic acid, caprolactam, diethylenetriamine and/or ethylenediamine; (c) polyamide-epichlorhydrin resin based on adipic acid, diethylenetriamine and epichlorhydrin, or a mixture of epichlorhydrin and ammonia; (d) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, dimethyl adipate and diethylenetriamine; (e) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, adipamide and diaminopropylmethylamine
— Polyethyleneamines and polyethyleneimines	Not more than 0.75 mg/dm ² of the uncoated film.
— Condensation product of urea-formaldehyde unmodified, or which may be modified with one or more of the following products: aminomethylsulphonic acid, sulphanilic acid, butanol, diaminobutane, diaminodiethylamine, diaminodipropylamine, diaminopropane, diethylenetriamine, ethanol, guanidine, methanol, tetraethylenepentamine, triethylenetetramine, sodium sulphite	Free formaldehyde content not greater than 0.5 mg/dm ² of the uncoated film.
Fourth class	The total quantity of substances may not exceed 0.01 mg/dm ² of the uncoated film.
— Products resulting from the reaction of the amines of edible oils with polyethylene oxide
— Monoethanolamine lauryl sulphate
Denominations	Restrictions
---	---
A. Regenerated cellulose	See first part.
B. Additives	See first part.
C. Coating
1. Polymers	The total quantity of substances may not exceed 50 mg/dm ² of the coating on the side in contact with foodstuffs.
— Ethyl, hydroxyethyl, hydroxypropyl and methyl ethers of cellulose
— Cellulose nitrate	Not more than 20 mg/dm ² of the coating on the side in contact with foodstuffs; nitrogen content between 10.8 % (w/w) and 12.2 % (w/w) in the cellulose nitrate.
2. Resins	The total quantity of substances may not exceed 12.5 mg/dm ² of the coating on the side in contact with foodstuffs and which is used solely for the preparation of regenerated cellulose films with cellulose nitrate based coatings.
— Casein
— Colophony and/or its products of polymerization, hydrogenation, or disproportionation and their esters of methyl, ethyl or C ₂ to C ₆ polyvalent alcohols, or mixtures of these alcohols
— Colophony and/or its products of polymerization, hydrogenation, or disproportionation condensed with acrylic, maleic, citric, fumaric and/or phthalic acids and/or 2.2 bis (4-hydroxyphenyl) propane formaldehyde and esterified with methyl ethyl or C ₂ to C ₆ polyvalent alcohols or mixtures of these alcohols
— Esters derived from bis(2-hydroxyethyl) ether with addition products of betapinene and/or dipentene and/or diterpene and maleic anhydride
— Edible gelatine
— Castor oil and its products of dehydration or hydrogenation and its condensation products with polyglycerol, adipic, citric, maleic, phthalic and sebacic acids
— Natural gum [= damar]
— Poly-beta-pinene [= terpenic resins]
— Urea-formaldehyde resins (see anchoring agents)
3. Plasticisers	The total quantity of substances may not exceed 6 mg/dm ² of the coating on the side in contact with foodstuffs.
— Acetyl tributyl citrate
— Acetyl tri(2-ethylhexyl) citrate
— Di-isobutyl adipate
— Di-n-butyl adipate
— Di-n-hexyl azelate
— Dicyclohexyl phthalate	Not more than 4.0 mg/dm ² of the coating on the side in contact with foodstuffs.
— 2-ethylhexyl diphenyl phosphate (synonym: phosphoric acid diphenyl 2 ethylhexyl ester)	The amount of 2-ethylhexyl diphenyl phosphate shall not exceed: (a) 2.4 mg/kg of the foodstuff in contact with this type of film; or (b) 0.4 mg/dm² in the coating on the side in contact with foodstuffs.
— Glycerol monoacetate [= monoacetin]
— Glycerol diacetate [= diacetin]
— Glycerol triacetate [= triacetin]
— Di-butyl sebacate
— Di-n-butyl tartrate
— Di-isobutyl tartrate
4. Other additives	The total quantity of substances may not exceed 6 mg/dm ² in the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs.
4.1. Additives listed in the first part	Same restrictions as in the first part (however the quantities in mg/dm ² refer to the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs).
4.2. Specific coating additives	The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm ² (or a lower limit where one is specified) of the coating on the side in contact with foodstuffs.
— 1-hexadecanol and 1-octadecanol
— Esters of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and of ricinoleic acid with ethyl, butyl, amyl and oleyl linear alcohols
— Montan waxes, comprising purified montanic (C ₂₆ to C ₃₂) acids and/or their esters with ethanediol and/or 1.3 butanediol and/or their calcium and potassium salts
— Carnauba wax
— Beeswax
— Esparto wax
— Candelilla wax
— Dimethylpolysiloxane	Not more than 1 mg/dm ² of the coating on the side in contact with foodstuffs.
— Epoxidised soya-bean oil (oxirane content 6 to 8 %)
— Refined paraffin and microcrystalline waxes
— Pentaerythritol tetrastearate
— Mono and bis(octadecyldiethyleneoxide)-phosphates	Not more than 0.2 mg/dm ² of the coating on the side in contact with foodstuffs.
— Aliphatic acids (C ₈ to C ₂₀) esterified with mono- or di-(2-hydroxyethyl)amine
— 2- and 3-tert.butyl-4-hydroxyanisole [= butylated hydroxyanisole — BHA]	Not more than 0.06 mg/dm ² of the coating on the side in contact with foodstuffs.
— 2.6-di-tert.butyl-4-methylphenol [= butylated hydroxytoluene — BHT]	Not more than 0.06 mg/dm ² of the coating on the side in contact with foodstuffs.
— Di-n-octyltin-bis(2-ethylhexyl) maleate	Not more than 0.06 mg/dm ² of the coating on the side in contact with foodstuffs.
5. Solvents	The total quantity of substances may not exceed 0.6 mg/dm ² of the coating on the side in contact with foodstuffs.
— Butyl acetate
— Ethyl acetate
— Isobutyl acetate
— Isopropyl acetate
— Propyl acetate
— Acetone
— 1-butanol
— Ethanol
— 2-butanol
— 2-propanol
— 1-propanol
— Cyclohexane
— Ethyleneglycol monobutyl ether
— Ethyleneglycol monobutyl ether acetate
— Methyl ethyl ketone
— Methyl isobutyl ketone
— Tetrahydrofuran
— Toluene	Not more than 0.06 mg/dm ² of the coating on the side in contact with foodstuffs.

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—

SCHEDULE6

Name[^f01000]
(1) An extraction solvent is considered as being used in compliance with good manufacturing practice if its use results only in the presence of residues or derivatives in technically unavoidable quantities presenting no danger to human health.
(2) The use of Acetone in the refining of olive-pomace oil is forbidden.
Propane
Butane
Ethyl acetate
Ethanol
Carbon dioxide
Acetone[^f01001]
Nitrous oxide

Name	*Conditions of use* *(summary description of extraction)*	Maximum residue limits in the extracted foodstuff or food ingredient
(1) Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C and 70 °C. The combined use of Hexane and Ethylmethylketone is forbidden.	(1) Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C and 70 °C. The combined use of Hexane and Ethylmethylketone is forbidden.	(1) Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C and 70 °C. The combined use of Hexane and Ethylmethylketone is forbidden.
(2) The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden.	(2) The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden.	(2) The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden.
(3) ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals, in accordance with the relevant requirements of Regulation (EC) No 853/2004.	(3) ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals, in accordance with the relevant requirements of Regulation (EC) No 853/2004.	(3) ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals, in accordance with the relevant requirements of Regulation (EC) No 853/2004.
(4) ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of Regulation (EC) No 853/2004.	(4) ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of Regulation (EC) No 853/2004.	(4) ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of Regulation (EC) No 853/2004.
Hexane [^f01002]	Production or fractionation of fats and oils and production of cocoa butter	1 mg/kg in the fat or oil or cocoa butter
Hexane [^f01002]	Preparation of defatted protein products and defatted flours	10 mg/kg in the food containing the defatted protein products and the defatted flours
Hexane [^f01002]	Preparation of defatted protein products and defatted flours	30 mg/kg in the defatted soya products as sold to the final consumer
Hexane [^f01002]	Preparation of defatted cereal germs	5 mg/kg in the defatted cereal germs
Methyl acetate	Decaffeination of, or removal of irritants and bitterings from coffee and tea	20 mg/kg in the coffee or tea
Methyl acetate	Production of sugar from molasses	1 mg/kg in the sugar
Ethylmethylketone [^f01003]	Fractionation of fats and oils	5 mg/kg in the fat or oil
Ethylmethylketone [^f01003]	Decaffeination of, or removal of irritants and bitterings from coffee and tea	20 mg/kg in the coffee or tea
Dichloromethane	Decaffeination of, or removal of irritants and bitterings from coffee and tea	2 mg/kg in the roasted coffee and 5 mg/kg in the tea
Methanol	For all uses	10 mg/kg
Propan-2-ol	For all uses	10 mg/kg
Dimethyl ether	Preparation of defatted animal protein products including gelatine [^f01004]	0.009 mg/kg in the defatted animal protein products including gelatine
Dimethyl ether	Preparation of collagen [^f01005] and collagen derivatives, except gelatine	3 mg/kg in the collagen and collagen derivatives, except gelatine
Name	Maximum residue limits in the foodstuff due to the use of extraction solvents in the preparation of flavourings from natural flavouring materials
---	---
Diethyl ether	2 mg/kg
Hexane (*)	1 mg/kg
Cyclohexane	1 mg/kg
Methyl acetate	1 mg/kg
Butan-1-ol	1 mg/kg
Butan-2-ol	1 mg/kg
Ethylmethylketone (*)	1 mg/kg
Dichloromethane	0.02 mg/kg
Propan-1-ol	1 mg/kg
1,1,1,2-tetrafluoroethane	0.02 mg/kg
Methanol	1.5 mg/kg
Propan-2-ol	1 mg/kg
* The combined use of Hexane and Ethylmethylketone is forbidden.	* The combined use of Hexane and Ethylmethylketone is forbidden.

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—

SCHEDULE3

Description of the category	Definition
1.Meat and animal derivatives	All the fleshy parts of slaughtered warm-blooded land animals, fresh or preserved by appropriate treatment, and all products and derivatives of the processing of the carcase or parts of the carcase of warm-blooded land animals
2.Milk and milk derivatives	All milk products, fresh or preserved by appropriate treatment, and derivatives from their processing
3.Eggs and egg derivatives	All egg products fresh or preserved by appropriate treatment and derivatives from their processing
4.Oils and fats	All animal and vegetable oils and fats
5.Yeasts	All yeasts, the cells of which have been killed and dried
6.Fish and fish derivatives	Fish or parts of fish, fresh or preserved by appropriate treatment, and derivatives from their processing
7.Cereals	All types of cereal, regardless of their presentation, or products made from the starchy endosperm
8.Vegetables	All types of vegetables and legumes, fresh or preserved by appropriate treatment
9.Derivatives of vegetable origin	Derivatives resulting from the treatment of vegetable products, in particular cereals, vegetables, legumes and oil seeds
10.Vegetable protein extracts	All products of vegetable origin in which the proteins have been concentrated by an adequate process to contain at least 50% crude protein, as related to the dry matter, and which may be restructured (textured)
11.Minerals	All inorganic substances suitable for animal feed
12.Various sugars	All types of sugar
13.Fruit	All types of fruit, fresh or preserved by appropriate treatment
14.Nuts	All kernels from shells
15.Seeds	All types of seeds as such or roughly crushed
16.Algae	Algae, fresh or preserved by appropriate treatment
17.Molluscs and crustaceans	All types of molluscs, crustaceans, shellfish, fresh or preserved by appropriate treatment, and their processing derivatives
18.Insects	All types of insects and their stages of development
19.Bakery products	All bread, cakes, biscuits and pasta products

SCHEDULE4

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