Statutory Instruments
2022 No. 1351
Agriculture
Food
The Food and Feed (Miscellaneous Amendments) Regulations 2022
Coming into force
31st December 2022
The Secretary of State makes these Regulations in exercise of the powers conferred by section 8(1) of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018().
In accordance with paragraph 1(1) of Schedule 7 to that Act, a draft of these Regulations was laid before, 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(), there has been open and transparent public consultation during the preparation and evaluation of these Regulations.
PART 1Introductory
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 2Amendment 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() 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() 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() 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(), 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().
(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() 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() 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 3Amendment 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() 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()—
(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() 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()”;
(b)in paragraph 4, for “Directive 95/69/EC” substitute “Regulation (EC) No 183/2005()”.
(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()”.
(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()”;
(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 853/2004 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() 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() 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/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(), 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(), 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(), 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() 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()”;
(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/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()”;
(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()”;
(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()”;
(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(), 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() 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(); and
(c)in relation to Wales, the Animal Feed (Composition, Marketing and Use) (Wales) Regulations 2016().
‘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 450/2009 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() 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.(),”;
(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(), after “2012,” insert “in the case of products falling within Decision 2007/304/EC() or Decision 2007/308/EC(), 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.()—
(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() 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(), 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() is updated to authorise the novel food in accordance with Article 12(1) of this Regulation.”;
(c)omit paragraph 3.
Neil O’Brien
Parliamentary Under-Secretary of State,
Department of Health and Social Care
14th December 2022
Regulation 2(7)
SCHEDULE 1Insertion 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 5LIST 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.
First Part: Uncoated regenerated cellulose film
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 | |
Second Part: Coated regenerated cellulose film
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. ”. |
Regulation 3(10)
SCHEDULE 2Insertion 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 6EXTRACTION SOLVENTS WHICH MAY BE USED DURING THE PROCESSING OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD COMPONENTS OR OF FOOD INGREDIENTS
Table 1: Extraction solvents to be used in compliance with good manufacturing practice for all uses
Name |
---|
|
|
Propane |
Butane |
Ethyl acetate |
Ethanol |
Carbon dioxide |
Acetone |
Nitrous oxide |
Table 2: Extraction solvents for which conditions of use are specified
Name | Conditions of use
(summary description of extraction)
| Maximum residue limits in the extracted foodstuff or food ingredient |
---|
|
|
|
|
Hexane | Production or fractionation of fats and oils and production of cocoa butter | 1 mg/kg in the fat or oil or cocoa butter |
Preparation of defatted protein products and defatted flours | 10 mg/kg in the food containing the defatted protein products and the defatted flours |
30 mg/kg in the defatted soya products as sold to the final consumer |
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 |
Production of sugar from molasses | 1 mg/kg in the sugar |
Ethylmethylketone | Fractionation of fats and oils | 5 mg/kg in the fat or oil |
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 | 0.009 mg/kg in the defatted animal protein products including gelatine |
Preparation of collagen and collagen derivatives, except gelatine | 3 mg/kg in the collagen and collagen derivatives, except gelatine |
Table 3: Extraction solvents for which conditions of use are specified
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.”. |
Regulation 4(9)
SCHEDULE 3Insertion 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 3Categories of feed materials which may be indicated in place of individual feed materials
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 |
Regulations 15 and 15A
SCHEDULE 4Maximum levels of undesirable substances
Table 1: INORGANIC CONTAMINANTS AND NITROGENOUS COMPOUNDS
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|
|
|
|
|
|
|
|
|
|
|
|
|
1. Arsenic | Feed materials | 2 |
| with the exception of: | |
| — meal made from grass, from dried lucerne and from dried clover, and dried sugar beet pulp and dried molasses sugar beet pulp; | 4 |
| — palm kernel expeller; | 4 |
| — peat; leonardite; | 5 |
| — phosphates, calcareous marine algae; | 10 |
| — calcium carbonate; calcium and magnesium carbonate ; calcareous marine shells; | 15 |
| — magnesium oxide; magnesium carbonate; | 20 |
| — fish, other aquatic animals and products derived from them; | 25 |
| — seaweed meal and feed materials derived from seaweed. | 40 |
| Iron particles used as tracer. | 50 |
| Feed additives belonging to the functional group of compounds of trace elements | 30 |
| with the exception of: | |
| — cupric sulphate pentahydrate; cupric carbonate; dicopper chloride trihydroxide; ferrous carbonate; dimanganese chloride trihydroxide | 50 |
| — zinc oxide; manganous oxide; cupric oxide. | 100 |
| Complementary feed | 4 |
| with the exception of: | |
| — mineral feed; | 12 |
| — complementary feed for pet animals containing fish, other aquatic animals and products derived from them and/or seaweed meal and feed materials derived from seaweed; | 10 |
| — long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed; | 30 |
| Complete feed | 2 |
| with the exception of: | |
| — complete feed for fish and fur animals; | 10 |
| — complete feed for pet animals containing fish, other aquatic animals and products derived from them and/or seaweed meal and feed materials derived from seaweed. | 10 |
2. Cadmium | Feed materials of vegetable origin | 1 |
| Feed materials of animal origin | 2 |
| Feed materials of mineral origin | 2 |
| with the exception of: | |
| — phosphates. | 10 |
| Feed additives belonging to the functional group of compounds of trace elements | 10 |
| with the exception of: | |
| — cupric oxide, manganous oxide, zinc oxide and manganous sulphate monohydrate. | 30 |
| Feed additives belonging to the functional groups of binders and anti-caking agents | 2 |
| Premixtures | 15 |
| Complementary feed | 0.5 |
| with the exception of: | |
| — mineral feed | |
| – – containing < 7 % phosphorus | 5 |
| – – containing ≥ 7 % phosphorus | 0.75 per 1 % phosphorus, with a maximum of 7.5 |
| — complementary feed for pet animals | 2 |
| — long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed; | 15 |
| Complete feed | 0.5 |
| with the exception of: | |
| — complete feed for cattle (except calves), sheep (except lambs), goats (except kids) and fish; | 1 |
| — complete feed for pet animals. | 2 |
3. Fluorine | Feed materials
with the exception of:
| 150 |
| — feed materials of animal origin except marine crustaceans such as marine krill; calcareous marine shells; | 500 |
| — marine crustaceans such as marine krill; | 3 000 |
| — phosphates; | 2 000 |
| — calcium carbonate; calcium and magnesium carbonate | 350 |
| — magnesium oxide; | 600 |
| — calcareous marine algae. | 1 250 |
| Vermiculite (E 561). | 3 000 |
| Complementary feed: | |
| — containing ≤ 4 % phosphorus; | 500 |
| — containing > 4 % phosphorus. | 125 per 1 % phosphorus |
| Complete feed
with the exception of:
| 150 |
| — complete feed for pigs; | 100 |
| — complete feed for poultry (except chicks) and fish; | 350 |
| — complete feed for chicks; | 250 |
| — complete feed for cattle, sheep and goats | |
| – – in lactation; | 30 |
| – – other. | 50 |
4. Lead | Feed materials | 10 |
| with the exception of: | |
| — forage ; | 30 |
| — phosphates, calcareous marine algae and calcareous marine shells; | 15 |
| — calcium carbonate; calcium and magnesium carbonate ; | 20 |
| — yeasts. | 5 |
| Feed additives belonging to the functional group of compounds of trace elements | 100 |
| with the exception of: | |
| — zinc oxide; | 400 |
| — manganous oxide, ferrous carbonate, cupric carbonate, copper (I) oxide. | 200 |
| Feed additives belonging to the functional groups of binders and anti-caking agents | 30 |
| with the exception of: | |
| — clinoptilolite of volcanic origin; natrolite-phonolite. | 60 |
| Premixtures | 200 |
| Complementary feed | 10 |
| with the exception of: | |
| — mineral feed; | 15 |
| — long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed. | 60 |
| Complete feed. | 5 |
5. Mercury | Feed materials | 0.1 |
| with the exception of: | |
| — fish, other aquatic animals and products derived from them intended for the production of compound feed for food producing animals; | 0.5 |
| — fish, other aquatic animals and products derived from them intended for the production of compound feed for dogs, cats, ornamental fish and fur animals; | 1.0 |
| — fish, other aquatic animals and products derived from them as canned wet feed material for direct feeding of dogs and cats; | 0.3 |
| — calcium carbonate; calcium and magnesium carbonate . | 0.3 |
| Compound feed | 0.1 |
| with the exception of: | |
| — mineral feed; | 0.2 |
| — compound feed for fish; | 0.2 |
| — compound feed for dogs, cats, ornamental fish and fur animals. | 0.3 |
6. Nitrite | Feed materials | 15 |
| with the exception of: | |
| — fishmeal; | 30 |
| — silage; | — |
| — products and by-products from sugar beet and sugarcane and from starch and alcoholic drink production. | — |
| Complete feed | 15 |
| with the exception of: | |
| — complete feed for dogs and cats with a moisture content exceeding 20 %. | — |
7. Melamine | Feed
with the exception of:
| 2.5 |
| — canned pet food | 2.5 |
| — the following feed additives: | |
| — guanidino acetic acid (GAA); | 20 |
| — urea; | — |
| — biuret. | — |
Table 2: MYCOTOXINS
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|
1. Aflatoxin B1 | Feed materials | 0.02 |
| Complementary and complete feed | 0.01 |
| with the exception of: | |
| — compound feed for dairy cattle and calves, dairy sheep and lambs, dairy goats and kids, piglets and young poultry animals, | 0.005 |
| — compound feed for cattle (except dairy cattle and calves), sheep (except dairy sheep and lambs), goats (except dairy goats and kids), pigs (except piglets) and poultry (except young animals). | 0.02 |
2. Rye ergot (Claviceps purpurea) | Feed materials and compound feed containing unground cereals. | 1 000 |
Table 3: INHERENT PLANT TOXINS
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|
|
|
1. Free gossypol | Feed materials | 20 |
| with the exception of: | |
| — cottonseed, | 6 000 |
| — cottonseed cakes and cottonseed meal. | 1 200 |
| Complete feed | 20 |
| with the exception of: | |
| — complete feed for cattle (except calves), | 500 |
| — complete feed for sheep (except lambs) and goats (except kids), | 300 |
| — complete feed for poultry (except laying hens) and calves, | 100 |
| — complete feed for rabbits, lambs, kids and pigs (except piglets). | 60 |
2. Hydrocyanic acid | Feed materials | 50 |
| with the exception of: | |
| — linseed, | 250 |
| — linseed cakes, | 350 |
| — manioc products and almond cakes. | 100 |
| Complete feed | 50 |
| with the exception of: | |
| — complete feed for young chickens (< 6 weeks). | 10 |
3. Theobromine | Complete feed | 300 |
| with the exception of: | |
| — complete feed for pigs, | 200 |
| — complete feed for dogs, rabbits, horses and fur animals. | 50 |
4. vinyl thiooxazolidone (5-vinyloxazolidine-2-thione) | Complete feed for poultry | 1 000 |
| with the exception of: | |
| — complete feed for laying hens. | 500 |
5. Volatile mustard oil | Feed materials | 100 |
| with the exception of: | |
| — Camelina seed and products derived from it , products derived from mustard seed, rape seed and products derived from them. | 4 000 |
| Complete feed | 150 |
| with the exception of: | |
| — complete feed for cattle (except calves), sheep (except lambs) and goats (except kids); | 1 000 |
| — complete feed for pigs (except piglets) and poultry. | 500 |
Table 4: ORGANOCHLORINE COMPOUNDS (EXCEPT DIOXINS AND PCBs)
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|
|
|
|
CHB 26: 2-endo,3-exo,5-endo,6-exo,8,8,10,10-octochlorobornane, |
CHB 50: 2-endo,3-exo,5-endo,6-exo,8,8,9,10,10-nonachlorobornane, |
CHB 62: 2,2,5,5,8,9,9,10,10-nonachlorobornane. |
1. Aldrin | Feed materials and compound feed | 0.01 |
| with the exception of: | |
| — fats and oils, | 0.1 |
| — compound feed for fish. | 0.02 |
2. Dieldrin | Feed materials and compound feed | 0.01 |
| with the exception of: | |
| — fats and oils, | 0.1 |
| — compound feed for fish. | 0.02 |
3. Camphechlor (toxaphene) – sum of indicator congeners CHB 26, 50 and 62 | Fish, other aquatic animals and products derived from them | 0.02 |
| with the exception of: | |
| — fish oil. | 0.2 |
| Complete feed for fish. | 0.05 |
4. Chlordane (sum of cis- and trans-isomers and of oxychlordane, expressed as chlordane) | Feed materials and compound feed | 0.02 |
| with the exception of: | |
| — fats and oils. | 0.05 |
5. DDT (sum of DDT-, DDD- (or TDE-) and DDE-isomers, expressed as DDT) | Feed materials and compound feed | 0.05 |
| with the exception of: | |
| — fats and oils. | 0.5 |
6. Endosulfan (sum of alpha- and beta-isomers and of endosulfansulphate expressed as endosulfan) | Feed materials and compound feed | 0.1 |
| with the exception of: | |
| — cotton seed and products derived from its processing, except crude cotton seed oil | 0.3 |
| — soybean and products derived from its processing, except crude soybean oil | 0.5 |
| — crude vegetable oil | 1.0 |
| — complete feed for fish except for Salmonids | 0.005 |
| — complete feed for Salmonids | 0.05 |
7. Endrin (sum of endrin and of delta-ketoi-endrin, expressed as endrin) | Feed materials and compound feed | 0.01 |
| with the exception of: | |
| — fats and oils. | 0.05 |
8. Heptachlor (sum of heptachlor and of heptachlorepoxide, expressed as heptachlor) | Feed materials and compound feed | 0.01 |
| with the exception of: | |
| — fats and oils. | 0.2 |
9. Hexachlorobenzene (HCB) | Feed materials and compound feed | 0.01 |
| with the exception of: | |
| — fats and oils. | 0.2 |
10. Hexachlorocyclo-
hexane (HCH)
| | |
— alpha-isomers | Feed materials and compound feed | 0.02 |
| with the exception of: | |
| — fats and oils. | 0.2 |
— beta-isomers | Feed materials | 0.01 |
| with the exception of: | |
| — fats and oils. | 0.1 |
| Compound feed | 0.01 |
| with the exception of: | |
| — compound feed for dairy cattle. | 0.005 |
— gamma-isomers | Feed materials and compound feed | 0.2 |
| with the exception of: | |
| — fats and oils. | 2.0 |
Table 5 (Part 1): DIOXINS AND PCBs
Undesirable substance | Products intended for animal feed | Maximum content in ng WHO-PCDD/F-TEQ/kg (ppt) relative to a feed with a moisture content of 12 % |
---|
|
|
|
|
|
1. Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005) ) | Feed materials of plant origin | 0.75 |
| with the exception of: | |
| — vegetable oils and their by-products. | 0.75 |
| Feed materials of mineral origin | 0.75 |
| Feed materials of animal origin: | |
| — Animal fat, including milk fat and egg fat, | 1.50 |
| — Other land animal products including milk and milk products and eggs and egg products. | 0.75 |
| — Fish oil, | 5.0 |
| — Fish, other aquatic animals, and products derived from them with the exception of fish oil, hydrolysed fish protein containing more than 20 % fat and crustacea meal, | 1.25 |
| — Hydrolysed fish protein containing more than 20 % fat; crustacea meal. | 1.75 |
| Feed additives belonging to the functional groups of binders and anti-caking agents | 0.75 |
| Feed additives belonging to the functional group of compounds of trace elements. | 1.0 |
| Premixtures | 1.0 |
| Compound feed | 0.75 |
| with the exception of: | |
| — compound feed for pet animals and fish, | 1.75 |
| — compound feed for fur animals. | — |
Undesirable substance | Products intended for animal feed | Maximum content in ng WHO-PCDD/F-PCB-TEQ/kg (ppt) relative to a feed with a moisture content of 12 % |
2. Sum of dioxins and dioxin-like PCBs (sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors), 2005) | Feed materials of plant origin | 1.25 |
| with the exception of: | |
| — vegetable oils and their by-products | 1.5 |
| Feed materials of mineral origin | 1.0 |
| Feed materials of animal origin: | |
| — Animal fat, including milk fat and egg fat | 2.0 |
| — Other land animal products including milk and milk products and eggs and egg products | 1.25 |
| — Fish oil | 20.0 |
| — Fish, other aquatic animals, and products derived from them with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat | 4.0 |
| — Fish protein, hydrolysed, containing more than 20 % fat | 9.0 |
| Feed additives belonging to the functional groups of binders and anti-caking agents | 1.5 |
| Feed additives belonging to the functional group of compounds of trace elements | 1.5 |
| Premixtures | 1.5 |
| Compound feed | 1.5 |
| with the exception of: | |
| — compound feed for pet animals and fish | 5.5 |
| — compound feed for fur animals | — |
Undesirable substance | Products intended for animal feed | Maximum content in μg/kg (ppb) relative to a feed with a moisture content of 12 % |
3. Non-dioxin-like PCBs (sum of PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180 (ICES – 6)) | Feed materials of plant origin | 10 |
| Feed materials of mineral origin | 10 |
| Feed materials of animal origin: | |
| — Animal fat, including milk fat and egg fat | 10 |
| — Other land animal products including milk and milk products and eggs and egg products | 10 |
| — Fish oil | 175 |
| — Fish, other aquatic animals and products derived from them with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat | 30 |
| — Fish protein, hydrolysed, containing more than 20 % fat | 50 |
| Feed additives belonging to the functional groups of binders and anti-caking agents | 10 |
| Feed additives belonging to the functional group of compounds of trace elements | 10 |
| Premixtures | 10 |
| Compound feed | 10 |
| with the exception of: | |
| — compound feed for pet animals and fish | 40 |
| — compound feed for fur animals | — |
Table 5 (Part 2): Table of TEF (toxic equivalency factors) for dioxins, furans and dioxin-like PCBs
Congener | TEF value |
---|
Dibenzo-para-dioxins (‘PCDDs’) and Dibenzo-para-furans (PCDFs) | |
2,3,7,8-TCDD | 1 |
1,2,3,7,8-PeCDD | 1 |
1,2,3,4,7,8-HxCDD | 0.1 |
1,2,3,6,7,8-HxCDD | 0.1 |
1,2,3,7,8,9-HxCDD | 0.1 |
1,2,3,4,6,7,8-HpCDD | 0.01 |
OCDD | 0.0003 |
| |
2,3,7,8-TCDF | 0.1 |
1,2,3,7,8-PeCDF | 0.03 |
2,3,4,7,8-PeCDF | 0.3 |
1,2,3,4,7,8-HxCDF | 0.1 |
1,2,3,6,7,8-HxCDF | 0.1 |
1,2,3,7,8,9-HxCDF | 0.1 |
2,3,4,6,7,8-HxCDF | 0.1 |
1,2,3,4,6,7,8-HpCDF | 0.01 |
1,2,3,4,7,8,9-HpCDF | 0.01 |
OCDF | 0.0003 |
| |
‘Dioxin-like’ PCBs: Non-ortho PCBs + Mono-ortho PCBs | |
| |
Non-ortho PCBs | |
PCB 77 | 0.0001 |
PCB 81 | 0.0003 |
PCB 126 | 0.1 |
PCB 169 | 0.03 |
| |
Mono-ortho PCBs | |
PCB 105 | 0.00003 |
PCB 114 | 0.00003 |
PCB 118 | 0.00003 |
PCB 123 | 0.00003 |
PCB 156 | 0.00003 |
PCB 157 | 0.00003 |
PCB 167 | 0.00003 |
PCB 189 | 0.00003 |
Abbreviations used: ‘T’ = tetra; ‘Pe’ = penta; ‘Hx’ = hexa; ‘Hp’ = hepta; ‘O’ = octa; ‘CDD’ = chlorodibenzodioxin; ‘CDF’ = chlorodibenzofuran; ‘CB’ = chlorobiphenyl. |
Table 6: HARMFUL BOTANICAL IMPURITIES
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|
|
|
|
— the consignment is transported as a whole to the milling or crushing plant, and the milling or crushing plant is informed in advance of the presence of high levels of Ambrosia spp. seeds in order to take additional prevention measures to avoid dissemination into the environment, |
—solid evidence is provided that prevention measures are taken to avoid dissemination of Ambrosia spp. seeds into the environment during transport to the crushing or milling plant, and |
—the competent authority agrees to the transport, after having ensured that the abovementioned conditions are fulfilled. |
In case these conditions are not fulfilled, the consignment must be cleared before any transport into the country and the screenings must be appropriately destroyed. |
1. Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including | Feed materials and compound feed | 3 000 |
— Datura sp. | | 1 000 |
2. Crotalaria spp. | Feed materials and compound feed | 100 |
3. Seeds and husks from Ricinus communis L., Croton tiglium L. and Abrus precatorius L. as well as their processed derivatives , separately or in combination | Feed materials and compound feed | 10 |
4. Unhusked beech mast — Fagus sylvatica L. | Feed materials and compound feed | Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable |
5. Purghera — Jatropha curcas L. | Feed materials and compound feed | Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable |
6. Seeds from Ambrosia spp. | Feed materials | 50 |
| with the exception of: | |
| – Millet (grains of Panicum miliaceum L.) and sorghum (grains of Sorghum bicolor (L) Moench s.l.) not directly fed to animals | 200 |
| Compound feed containing unground grains and seeds | 50 |
7. Seeds from
— Indian mustard — Brassica juncea (L.) Czern. and Coss. ssp. integrifolia (West.) Thell.
— Sareptian mustard — Brassica juncea (L.) Czern. and Coss. ssp. juncea
— Chinese mustard — Brassica juncea (L.) Czern. and Coss. ssp. juncea var. lutea Batalin
— Black mustard — Brassica nigra (L.) Koch
— Ethiopian mustard — Brassica carinata A. Braun
| Feed materials and compound feed | Seeds may only be present in feed in trace amounts not quantitatively determinable |
Table 7: AUTHORISED FEED ADDITIVES IN NON-TARGET FEED FOLLOWING UNAVOIDABLE CARRY-OVER
Coccidiostat | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|
|
|
1. Decoquinate | Feed materials | 0.4 |
| Compound feed for | |
| — laying birds and chickens reared for laying (> 16 weeks); | 0.4 |
| — other animal species | 1.2 |
| Premixtures for use in feed in which the use of decoquinate is not authorised. | |
2. Diclazuril | Feed materials | 0.01 |
| Compound feed for | |
| — laying birds and chickens reared for laying (> 16 weeks), | 0.01 |
| — rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed), | 0.01 |
| — other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening, guinea fowl and turkeys for fattening. | 0.03 |
| Premixtures for use in feed in which the use of diclazuril is not authorised. | |
3. Halofuginone hydrobromide | Feed materials | 0.03 |
| Compound feed for | |
| — laying birds, chickens reared for laying and turkeys (> 12 weeks), | 0.03 |
| — chickens for fattening and turkeys (< 12 weeks) for the period before slaughter in which the use of halofuginone hydrobromide is prohibited (withdrawal feed), | 0.03 |
| — other animal species. | 0.09 |
| Premixtures for use in feed in which the use of halofuginone hydrobromide is not authorised. | |
4. Lasalocid A sodium | Feed materials | 1.25 |
| Compound feed for | |
| — dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (> 16 weeks) and chickens reared for laying (> 16 weeks), | 1.25 |
| — chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of lasalocid A sodium is prohibited (withdrawal feed), | 1.25 |
| — pheasants, guinea fowl, quails and partridges (except laying birds) for the period before slaughter in which the use of lasalocid A sodium is prohibited (withdrawal feed), | 1.25 |
| — other animal species. | 3.75 |
| Premixtures for use in feed in which the use of lasalocid A sodium is not authorised. | |
5. Maduramicin ammonium alpha | Feed materials | 0.05 |
| Compound feed for | |
| — equine species, rabbits, turkeys (> 16 weeks), laying birds and chickens reared for laying (> 16 weeks), | 0.05 |
| — chickens for fattening and turkeys (< 16 weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed), | 0.05 |
| — other animal species. | 0.15 |
| Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised. | |
6. Monensin sodium | Feed materials | 1.25 |
| Compound feed for | |
| — equine species, dogs, small ruminants (sheep and goat), ducks, bovine, dairy cattle, laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 16 weeks), | 1.25 |
| — chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of monensin sodium is prohibited (withdrawal feed), | 1.25 |
| — other animal species. | 3.75 |
| Premixtures for use in feed in which the use of monensin sodium is not authorised. | |
7. Narasin | Feed materials | 0.7 |
| Compound feed for | |
| — turkeys, rabbits, equine species, laying birds and chickens reared for laying (> 16 weeks), | 0.7 |
| — other animal species. | 2.1 |
| Premixtures for use in feed in which the use of narasin is not authorised. | |
8. Nicarbazin | Feed materials | 1.25 |
| Compound feed for | |
| — equine species, laying birds and chickens reared for laying (> 16 weeks), | 1.25 |
| — other animal species. | 3.75 |
| Premixtures for use in feed in which the use of nicarbazin (alone or in combination with narasin) is not authorised. | |
9. Robenidine hydrochloride | Feed materials | 0.7 |
| Compound feed for | |
| — laying birds and chickens reared for laying (> 16 weeks), | 0.7 |
| — chickens for fattening, rabbits for fattening and breeding and turkeys for the period before slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed), | 0.7 |
| — other animal species. | 2.1 |
| Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised. | |
10. Salinomycin sodium | Feed materials | 0.7 |
| Compound feed for | |
| — equine species, turkeys, laying birds and chickens reared for laying (> 12 weeks), | 0.7 |
| — chickens for fattening, chickens reared for laying (< 12 weeks) and rabbits for fattening for the period before slaughter in which the use of salinomycin sodium is prohibited (withdrawal feed), | 0.7 |
| — other animal species. | 2.1 |
| Premixtures for use in feed in which the use of salinomycin sodium is not authorised | |
11. Semduramicin sodium | Feed materials | 0.25 |
| Compound feed for | |
| — laying birds and chickens reared for laying (> 16 weeks), | 0.25 |
| — chickens for fattening for the period before slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed), | 0.25 |
| — other animal species. | 0.75 |
| Premixtures for use in feed in which the use of semduramicin sodium is not authorised. | |
Regulations 15 and 15A
SCHEDULE 5Action thresholds triggering investigations: dioxins and PCBs
Table 1: DIOXINS AND PCBs
Undesirable substances | Products intended for animal feed | Action threshold in ng WHO-PCDD/F TEQ/kg (ppt) relative to a feedingstuff with a moisture content of 12 % | Comments and additional information (e.g. nature of investigations to be performed) |
---|
|
|
|
|
1. Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005) ) | Feed materials of plant origin | 0.5 | |
| with the exception of: | | |
| — vegetable oils and their by-products. | 0.5 | |
| Feed materials of mineral origin | 0.5 | |
| Feed materials of animal origin: | | |
| — Animal fat, including milk fat and egg fat, | 0.75 | |
| — Other land animal products including milk and milk products and eggs and egg products, | 0.5 | |
| — Fish oil, | 4.0 | |
| — Fish, other aquatic animals and products derived from them, with the exception of fish oil, hydrolysed fish protein containing more than 20 % fat and crustacea meal, | 0.75 | |
| — Hydrolysed fish protein containing more than 20 % fat; crustacea meal. | 1.25 | |
| Feed additives belonging to the functional groups of binders and anti-caking agents | 0.5 | |
| Feed additives belonging to the functional group of compounds of trace elements | 0.5 | |
| Premixtures | 0.5 | |
| Compound feed | 0.5 | |
| with the exception of: | | |
| — compound feed for pet animals and fish, | 1.25 | |
| — compound feed for fur animals. | — | |
2. Dioxin-like PCBs (sum of polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005) ) | Feed materials of plant origin | 0.35 | |
| with the exception of: | | |
| — vegetable oils and their by-products | 0.5 | |
| Feed materials of mineral origin | 0.35 | |
| Feed materials of animal origin: | | |
| — Animal fat, including milk fat and egg fat | 0.75 | |
| — Other land animal products including milk and milk products and eggs and egg products | 0.35 | |
| — Fish oil | 11.0 | |
| — Fish, other aquatic animals and products derived from them, with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat | 2.0 | |
| — Fish protein, hydrolysed, containing more than 20 % fat | 5.0 | |
| Feed additives belonging to the functional groups of binders and anti-caking agents | 0.5 | |
| Feed additives belonging to the functional group of compounds of trace elements | 0.35 | |
| Premixtures | 0.35 | |
| Compound feed | 0.5 | |
| with the exception of: | | |
| — compound feed for pet animals and fish | 2.5 | |
| — compound feed for fur animals | — | |
Table 2: Table of TEF (toxic equivalency factors) for dioxins, furans and dioxin-like PCBs
Congener | TEF value |
---|
Dibenzo-para-dioxins (‘PCDDs’) and Dibenzo-para-furans (PCDFs) | |
2,3,7,8-TCDD | 1 |
1,2,3,7,8-PeCDD | 1 |
1,2,3,4,7,8-HxCDD | 0.1 |
1,2,3,6,7,8-HxCDD | 0.1 |
1,2,3,7,8,9-HxCDD | 0.1 |
1,2,3,4,6,7,8-HpCDD | 0.01 |
OCDD | 0.0003 |
| |
2,3,7,8-TCDF | 0.1 |
1,2,3,7,8-PeCDF | 0.03 |
2,3,4,7,8-PeCDF | 0.3 |
1,2,3,4,7,8-HxCDF | 0.1 |
1,2,3,6,7,8-HxCDF | 0.1 |
1,2,3,7,8,9-HxCDF | 0.1 |
2,3,4,6,7,8-HxCDF | 0.1 |
1,2,3,4,6,7,8-HpCDF | 0.01 |
1,2,3,4,7,8,9-HpCDF | 0.01 |
OCDF | 0.0003 |
| |
‘Dioxin-like’ PCBs: Non-ortho PCBs + Mono-ortho PCBs | |
| |
Non-ortho PCBs | |
PCB 77 | 0.0001 |
PCB 81 | 0.0003 |
PCB 126 | 0.1 |
PCB 169 | 0.03 |
| |
Mono-ortho PCBs | |
PCB 105 | 0.00003 |
PCB 114 | 0.00003 |
PCB 118 | 0.00003 |
PCB 123 | 0.00003 |
PCB 156 | 0.00003 |
PCB 157 | 0.00003 |
PCB 167 | 0.00003 |
PCB 189 | 0.00003 |
Abbreviations used: ‘T’ = tetra; ‘Pe’ = penta; ‘Hx’ = hexa; ‘Hp’ = hepta; ‘O’ = octa; ‘CDD’ = chlorodibenzodioxin; ‘CDF’ = chlorodibenzofuran; ‘CB’ = chlorobiphenyl.”. |
EXPLANATORY NOTE
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/EC relating 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/EC of 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/EEC laying 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/EC of 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.