Agriculture, England PART 1 Introductory and general Title, application and commencement 1 These Regulations may be cited as the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015, apply in relation to England only and come into force on 6th April 2015. Interpretation and scope 2 1 In these Regulations — ... ... “Regulation 178/2002” means 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; “Regulation 1829/2003” means Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed ; “Regulation 1831/2003” means Regulation (EC) No. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition as last amended by Commission Regulation (EU) 2015/2294 amending Regulation (EC) No. 1831/2003 of the European Parliament and of the Council as regards the establishment of a new functional group of feed additives ; ... “Regulation 767/2009” means Regulation (EC) No. 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC , Commission Directive 80/511/EEC , Council Directives 82/471/ EEC , 83/228/EEC , 93/74/EEC , 93/113/ EC and 96/25/EC and Commission Decision 2004/217/EC ; “Regulation 2020/354” means Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC ; “the Agency” means the Food Standards Agency; “feed authority” means an authority identified in section 67(1) of the Agriculture Act 1970 as having the duty to enforce Part IV of that Act within its area or district as the case may be. 2 Any expression used in these Regulations and in Regulation 178/2002, Regulation 1831/2003 Regulation 767/2009 or Regulation 2020/354 has the meaning in these Regulations that it bears in the assimilated Regulation concerned. 3 Any reference to an ... instrument defined in paragraph (1) is a reference to that ... instrument as it may be amended from time to time. 4 These Regulations do not apply to any feed additive in category (d) or (e) of Article 6(1) of Regulation 1831/2003, with the exception of those in the functional groups listed in paragraph 4(a), (b) and (c) of Annex 1 to that Regulation . PART 2 Enforcement of Regulation 178/2002 Interpretation of this Part 3 In this Part any reference to a numbered Article is a reference to the Article so numbered in Regulation 178/2002. Offence of failing to comply with a specified provision of Regulation 178/2002 4 1 A person who contravenes or fails to comply with a provision specified in paragraph (2) commits an offence. 2 The specified provisions are — a Article 12, in so far as it relates to feed (conditions on export or re-export to third countries); b Article 15(1) (prohibition on the placing on the market or feeding to any animal of unsafe feed); c Article 16, in so far as it relates to feed (prohibition on misleading labelling, advertising or presentation); d Article 18(2) and (3) (requirements that operators must have traceability information and make such information available to competent authorities) in so far as they relate to feed business operators; and e Article 20 (responsibilities of feed business operators regarding feed that does not satisfy feed safety requirements). Competent authorities for the purposes of Regulation 178/2002 5 The competent authority — a for the purposes of Articles 15 and 18 is the feed authority in its area or district; and b for the purposes of Article 20 is the feed authority in its area or district or the Agency. PART 3 Enforcement of Regulation 1829/2003 Interpretation of this Part 6 In this Part any reference to a numbered Article is a reference to the Article so numbered in Regulation 1829/2003. Offence of failing to comply with a specified provision of Regulation 1829/2003 7 1 A person who contravenes or fails to comply with a provision specified in paragraph (2) commits an offence. 2 The specified provisions are — a Article 16(2) (prohibition on placing on the market, using or processing a product referred to in Article 15(1) unless it is covered by an authorisation and satisfies relevant conditions), as read with Article 20(6) ...; b Article 21(1) (requirement that the authorisation holder and the parties concerned must comply with conditions imposed in an authorisation for that product, and that the authorisation holder must comply with post-market monitoring requirements); c Article 21(3) ...; and d Article 25 (requirement for certain labelling indications). Competent authority for the purposes of Regulation 1829/2003 8 The national competent authority for the purposes of Chapter III of Regulation 1829/2003 is the Agency. PART 4 Enforcement of Regulation 1831/2003 Interpretation of this Part 9 In this Part any reference to a numbered Article is a reference to the Article so numbered in Regulation 1831/2003. Offence of failing to comply with a specified provision of Regulation 1831/2003 10 1 A person commits an offence if that person contravenes or fails to comply with a provision specified in paragraph (2) as read, in the case of subparagraph (a) or (e) with Article 2 (transitional provision) of Commission Regulation (EU) 2015/327 amending Regulation (EC) No. 1831/2003 of the European Parliament and of the Council as regards requirements for the placing on the market and conditions of use of additives consisting of preparations. 2 The specified provisions are — a Article 3(1) (prohibition on placing on the market, processing or using a feed additive unless it is covered by an authorisation and satisfies relevant conditions), as read with paragraph (2) (national authorisation for scientific experimental purposes), paragraph (4) (conditions on mixing of additives) and Article 10 (status of existing products); b Article 3(3) (restriction on the persons who may first place on the market certain additives); c Article 12(1) (requirement that any person using or placing on the market an additive, or a feed into which it has been incorporated, or any other interested party, must ensure that any conditions which have been imposed are respected); d Article 12(2) (requirement on the holder of an authorisation to observe monitoring obligations where they have been imposed, to inform the Food Safety Authority of any new information about a product which might affect the evaluation of the safety of its use in feed, or of any prohibition or restriction on the feed imposed by the competent authority in a third country); e Article 16(1),(3) and (4) (prohibition on the placing on the market of feed additives or premixtures unless labelled in the specified manner and with prescribed information), as read with paragraph (2) (derogation for certain flavouring compounds); and f Article 16(5) (requirement that additives and premixtures must be marketed only in closed packages or containers which must be closed in such a way that the fastener is damaged on opening and cannot be re-used). PART 5 Enforcement of Regulation 767/2009 Interpretation of this Part and Schedule 1 11 In this Part and in Schedule 1 any reference to a numbered Article or Annex is a reference to the Article or Annex so numbered in Regulation 767/2009. Offence of failing to comply with a specified provision of Regulation 767/2009 12 1 ) Subject to the transitional provisions contained in Article 32, a person who — a contravenes or fails to comply with a provision of Regulation 767/2009 specified in Schedule 1; or b places on the market or uses a feed that fails to comply with Article 6(1) or 8, commits an offence. 2 Where, pursuant to Article 17(2)(c), the name of a specific feed material may be replaced by the name of the category to which the feed material belongs, only the categories listed in Schedule 3 may be indicated. Competent authorities for the purposes of Regulation 767/2009 13 1 Each feed authority in its area or district is the competent authority for the purposes of — a Article 5(3), 13(1)(a) and 17(3) and Annex VII , Chapter 1, paragraph 8; and b Article 13(1)(b) as the competent authority that may request scientific substantiation of a claim and to whose attention purchasers have the right to bring doubts regarding the truthfulness of a claim. 2 The Agency is the competent authority for the purposes of — a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b Article 13(1)(b) as the competent authority that may submit to the appropriate authority doubts concerning the scientific substantiation of a claim. 3 The Agency and each feed authority in its area or district is a competent authority for the purposes of Article 5(2). PART 6 Undesirable substances in products intended for animal feed Interpretation of this Part 14 In this Part — a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b “undesirable substance” means any substance or product, not being a pathogenic agent, which is present in or on a feed and — i constitutes a potential danger to human or animal health or to the environment, or ii could adversely affect livestock production. Control of animal feeds containing undesirable substances 15 1 A person who — a places on the market any feed that is specified in column 2 of a table in Schedule 4 ; or b uses any such feed, commits an offence if it contains any undesirable substance listed in column 1 of that table in excess of the relevant maximum content specified in column 3. 2 A person who places on the market or uses any complementary feed commits an offence if — a having regard to the quantity of it recommended for use in a daily ration, it contains any undesirable substance listed in column 1 of a table in Schedule 4 in excess of the maximum content specified for it in column 3 in relation to complete feeds; and b there is no provision relating to any complementary feed in the corresponding entry in column 2 of that table . 3 A person who for the purpose of dilution mixes any feed with a feed that is specified in column 2 of a table in Schedule 4 and which contains any undesirable substance listed in column 1 of that table in excess of the maximum content specified for it in column 3 commits an offence. 4 A person who places on the market or uses any feed which is not sound and genuine and of merchantable quality commits an offence. 5 For the purposes of paragraph (4) a feed listed in column 2 of a table in Schedule 4 shall be deemed not to be sound, genuine and of merchantable quality if it contains any undesirable substance specified in column 1 of that table in excess of the maximum content specified in relation to it in column 3. 6 A person who has, for the purpose of a trade or business, possession or control of any of the feeds specified in paragraph (7) must, if required by an inspector, procure and produce to the inspector an analysis in order to demonstrate that the content of inorganic arsenic in the feed specified in that paragraph is less than 2 parts per million. 7 The feeds are — a palm kernel expeller; b feeds obtained from the processing of fish and other marine animals; c seaweed meal and feed materials derived from seaweed; ... d complete feeds for fish or for fur-producing animals; e peat; f leonardite. 8 A person who, without reasonable excuse, fails to comply with a requirement made under paragraph (6) commits an offence. 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. 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 assimilated direct legislation); b make different provision for different purposes. PART 7 Enforcement of Regulation 2020/354 Interpretation of this Part 16 In this Part, any reference to a numbered Article is a reference to the Article so numbered in Regulation 2020/354. Control of feed intended for particular nutritional purposes 17 A person who contravenes or fails to comply with Article 1 (conditions on marketing) as read with Article 2 (derogation for feed which complies with the provisions of Directive 2008/38/EC ) and Article 3 (transitional measures for feed labelled before 25 March 2022 in accordance with the rules applicable before 25 March 2020) commits an offence. PART 8 Administration and enforcement Penalties for offences under these Regulations 18 1 A person found guilty of an offence under regulation 4(1), 7(1), 10(1), 12(1), 15(1), (2), (3) or (4) or 17 is liable on summary conviction to a term of imprisonment not exceeding 3 months or to a fine not exceeding level 5 on the standard scale, or both. 2 A person found guilty of an offence under regulation 15(8) is liable on summary conviction to a fine not exceeding level 3 on the standard scale. Duties to enforce 19 It is the duty of each feed authority within its area or district to execute and enforce Regulation 178/2002, Regulation 1829/2003 , Regulation 1831/2003, Regulation 767/2009, Regulation 2020/354 and these Regulations. PART 9 Amendment and revocation Amendment of the Official Feed and Food Controls (England) Regulations 2009 20 1 The Official Feed and Food Controls (England) Regulations 2009 are amended in accordance with paragraph (2). 2 In Schedule 2 (definition of relevant feed law) — a omit paragraph (c); and b in paragraph (f), for the expression “the Animal Feed (England) Regulations 2010” substitute “the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015”. Revocations 21 The Regulations listed in the first column of Schedule 2 are revoked to the extent specified in the second column. Statutory review 22 1 The Food Standards Agency must from time to time — a carry out a review of the operation and effect of regulations 1 to 19; b set out the conclusions of the review in a report; and publish the report. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 The report must in particular - a set out the objectives intended to be achieved by the regulatory system established by these Regulations; b assess the extent to which those objectives are achieved; and c assess whether those objectives remain appropriate and, if they do, the extent to which they could be achieved with a system that imposes less regulation. 4 The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force. 5 Reports under this regulation are afterwards to be published at intervals not exceeding five years. Signed by authority of the Secretary of State for Health. Jane Ellison Parliamentary Under-Secretary of State Department of Health 25th February 2015