Exiting The European Union PART 1 Introduction Citation and commencement 1 These Regulations may be cited as the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 and come into force on exit day. Interpretation 2 In these Regulations— “ Regulation (EC) 853/2004 ” means Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin; “ Regulation (EC) 854/2004 ” means Regulation (EC) No. 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption; “ Regulation (EU) 101/2013 ” means Commission Regulation (EU) No. 101/2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases; “ Regulation (EU) 2015/1474 ” means Commission Regulation (EU) 2015/1474 concerning the use of recycled hot water to remove microbiological surface contamination from carcases; “ Regulation (EU) 636/2014 ” means Commission Implementing Regulation (EU) No. 636/2014 on a model certificate for the trade of unskinned large wild game. “ Regulation 2074/2005 ” means Commission Regulation (EC) No. 2074/2005 laying down implementing measures for certain products under Regulation (EC) No. 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No. 854/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No. 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No. 853/2004 and (EC) No. 854/2004 ; “ Regulation 2015/1375 ” means Commission Implementing Regulation laying down specific rules on official controls for Trichinella in meat; “ Regulation 2016/759 ” means Commission Implementing Regulation (EU) 2016/759 drawing up lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down specific requirements, amending Regulation (EC) No. 2074/2005 and repealing Decision 2003/812/EC ; “ Regulation 2017/185 ” means Regulation (EU) 2017/185 laying down transitional measures for the application of certain provisions of Regulations (EC) No. 853/2004 and (EC) No. 854/2004 of the European Parliament and of the Council. PART 2 Amendment of retained direct EU legislation Amendment of Regulation (EC) 853/2004 3 Regulation (EC) 853/2004 is amended as follows. 4 In Article 1— a in paragraph 4, for “Member States” substitute “ The appropriate authority ” and, in both places in which it occurs, omit “national”; b in paragraph 5— i in point (b)(ii), omit “, in accordance with national law,”; ii in point (c)— aa for “Member States” substitute “ The appropriate authority ” ; bb omit “national” and “situated on their territory”. 5 In Article 2, at the end, insert new paragraphs 5, 6 and 7— 5 “ appropriate authority ” means— a in relation to England, the Secretary of State; b in relation to Wales, the Welsh Ministers; c in relation to Scotland, the Scottish Ministers; d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 “ prescribe ” means prescribe by regulations; 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 In Article 4— a in paragraph 1, omit “manufactured in the Community”; b in paragraph 5, in point (a), omit “Community”. 8 In Article 6— a in the heading, for “the Community” substitute “ Great Britain ” ; b in paragraph 1— i in point (a), in both places in which it occurs, omit “third”; ii in point (b) (ii), omit “or in approved Community establishments”; iii in point (c) (iii), omit “Community”. 9 Omit Article 8. 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 In Article 10— a for paragraph 1, substitute— 1 The appropriate authority may prescribe amendments to Annexes 2 and 3 to take account of— a the development of guides to good practice; b the experience gained from the implementation of HACCP-based systems pursuant to Article 5 of Regulation (EC) No 852/2004 ; c the technological developments and their practical consequences and consumer expectations with regard to food composition; d scientific advice, particularly new risk assessments; e microbiological and temperature criteria for foodstuffs; and f changes in patterns of consumption. ; b for paragraph 2, substitute— 2 Without prejudice to the general application of Article 10(1), the appropriate authority may, provided that they do not affect the achievement of the objectives of this Regulation, prescribe exemptions from Annexes 2 and 3. ; c for paragraph 3, substitute— 3 Nothing in this Regulation prevents the appropriate authority from using any power which the appropriate authority has to make subordinate legislation adapting the requirements set down in Annex 3 where that legislation does not compromise the achievement of the objectives of this Regulation and— a the adaptations have the aim of— i enabling the continued use of traditional methods, at any of the stages of production, processing or distribution of food; or ii accommodating the needs of food businesses situated in regions that are subject to special geographical constraints; b in cases not involving the matters at (a), the adaptations apply only to the construction, layout and equipment of establishments. ; d omit paragraphs 4, 5, 6 and 7; e for paragraph 8, substitute— 8 Nothing in this Regulation prevents the appropriate authority from using any power which the appropriate authority has to make subordinate legislation— a prohibiting or restricting the placing on the market raw milk or raw cream intended for direct human consumption; b permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex 3, Section 9 as regards plate count and somatic cell count of the manufacture of cheeses with an ageing or ripening period of at least 60 days, and dairy products obtained in connection with the manufacture of such cheeses, provided that this does not prejudice the achievement of the objectives of this Regulation. . 12 In Article 11— a at the beginning, for the first un-numbered paragraph, substitute— Without prejudice to the general application of Article 10(1), the appropriate authority may prescribe implementing measures or amendments to Annex 2 or 3— ; b . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12A Omit Article 11A. 13 In Article 12— a for the heading, substitute “ Regulations and devolved powers ” ; b for the Article, substitute— 1 Any power to make regulations under this Regulation— a so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument; b so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument; c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 For regulations made under this Regulation by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments). 3 Any power to make regulations under this Regulation includes power— a to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); b to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient. 4 Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution— a in the case of England, of either House of Parliament; b in the case of Wales, of Senedd Cymru ; c in the case of Scotland, of the Scottish Parliament; d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 In this Regulation, any power— a of the Secretary of State to make regulations is limited to regulations which apply in relation to England only; b of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only; c of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only; d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 In Article 13— a in the heading, omit “European”; b for the Article, substitute— The appropriate authority must consult the Food Safety Authority on matters falling within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing to extend Annex 3, Section 3, to other animal species. . 15 Omit Article 14. 16 After Article 15, omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”. 17 In Annex 1, in paragraph 1, in point 1.5, omit “under the applicable law in the Member State concerned”. 18 In Annex 2— 1 In Section 1— a for Part B, substitute— 5 The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities. 6 The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food. 7 When applied in an establishment located in Great Britain, the mark must be oval in shape and include the abbreviation “UK” or “GB” or the words “United Kingdom”. Products imported into Great Britain from establishments located outside the United Kingdom must not be marked in anyway which indicates or suggests that they were produced in the United Kingdom. 8 When applied in an establishment located in Northern Ireland, the mark must be indicated as ‘UK(NI)’ or ‘United Kingdom (Northern Ireland)’. 9 When applied in an establishment located outside of the United Kingdom the mark must indicate the name of the country in which the establishment is located, which may be written out in full or as shown as a two-letter code in accordance with the relevant ISO standard. ; b in Part C, in paragraph 14, for “Community rules” substitute “ applicable legislation in force in the relevant constituent territory of Great Britain ” . 2 In Section 3, in paragraph 3, in point (a), for “Commission Regulation (EC) No 2075/2005 ”, substitute “ Commission Regulation (EC) No. 2015/1375 ” . 3 In Section 4, in paragraph 2, for “Directive 2000/13/EC ”, substitute “ Regulation (EU) 1169/2011 ” . 19 In Annex 3— 1 In Section 1, in Chapter 7, in paragraph 3, in point (b)(viii), in the first footnote reference, omit “of the Member State”. 2 In Section 2, in Chapter 6, in paragraph 9, for “in the same Member State as the farm of production”, substitute “ within the United Kingdom ” . 3 in Section 3— a in paragraph 3a, for point (a) substitute — a the holding is situated in a region which is not under health restrictions in accordance with legislation in force in the relevant constituent territory of Great Britain; ; b after paragraph 3a insert— 3b In paragraph 3a, “ region ” means that part of a constituent territory of Great Britain which is at least 2000km2 in area and which is subject to inspection by the competent authorities and includes at least one of the following administrative regions— a in England and Wales, a local government area as defined in section 270(1) of the Local Government Act 1972; b in Scotland, a local government area as defined in section 1 of the Local Government etc. (Scotland) Act 1994. ; 4 In Section 4, in Chapter 2— a at paragraph 4(a), in the fifth paragraph, omit “in the Member State”; b omit paragraph 8(b). 5 In Section 5, in Chapter 4, in paragraph 1, omit “if, and to the extent that, national rules in the Member State in the territory of which the product is placed on the market so require”. 6 In Section 7— a in Chapter 1, in paragraph 4, for the first sentence, substitute— The registration document must be in English or in English and Welsh and contain at least the information specified below. ; b in Chapter 7, in paragraph 2, for “Directive 2000/13/EC ”, substitute “ Regulation (EU) 1169/2011 ” . 7 In Section 8— a in paragraph 1, in the second unnumbered paragraph, for “Union legislation” substitute “legislation in force in the relevant constituent territory of Great Britain. b in Chapter 2, for paragraph 4, substitute— 4 Food business operators must cooperate with relevant competent authorities so as to permit them to carry out official controls in accordance with Regulation (EC) No. 854/2004 and notify the competent authority of where the fishery products are landed. ; c in Chapter 4, in Part B, omit paragraph 4. 8 In Section 9— a in Chapter 1, in point 3— i omit paragraph 1(b); ii in paragraph 2, omit “and with the existing national criteria referred to in point 1(b) in case of colostrum”; b in Chapter 4, in paragraph 1, for the first sentence, substitute— In addition to the requirements of Regulation (EU) No. 1169/2011, except in the cases envisaged in Article 16(1) and (2) of that Regulation, labelling must clearly show— ; c in Chapter 5, in paragraph 2, for “consigning country”, substitute “ United Kingdom ” . 9 In Section 14, in Chapter 3, in paragraph 1, in sub-paragraph (a), omit “Community”. Amendment of Regulation (EC) 2074/2005 19A Regulation (EC) 2074/2005 is amended as follows. 19B In Article 7— a in paragraph 1— i in the opening words, for “foods that, in the Member State in which they are traditionally manufactured, are:” substitute “ foods that are traditionally manufactured in Great Britain and are: ” ; ii in sub-paragraph (c), omit “a Community,” and “, regional or local”; b in paragraph 2, in the opening words, for “Member States” substitute “ The appropriate authority ” ; c omit paragraph 3. 19C After Article 10, omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”. 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Amendment of Regulation (EU) 101/2013 50 Regulation (EU) 101/2013 is amended as follows. 51 After Article 2, omit the words “This Regulation shall be binding in its entirety and directly applicable in all Member States.”. Amendment of Regulation 2015/1375 51A Regulation 2015/1375 is amended as follows. 51B In Article 1(3), omit “in a Member States,”. 51D In Article 3— a in paragraph 3— i in subparagraph (a) omit “in the Member State”; ii at the end of subparagraph (b) omit “or”; iii omit subparagraph (c); b for paragraph 4 substitute— 4 When carcasses and meat of domestic swine are exempt from Trichinella examination pursuant to a derogation under Article 3(3), the competent authority must collect the information referred to in Chapter 2 of Annex 4 and must maintain a list of holdings and compartments to which the derogation applies. . c in paragraph 5(a)(iii), for “the territory of the Member State” substitute “Great Britain”. 51E In Article 6(2), omit “or the EU reference laboratory”. 51F In the opening words of Article 7, for “The competent authorities of the Member States” substitute “ The competent authority ” . 51G Omit Article 8(2). 51H In Article 11, in the third paragraph, for “EU” substitute “ national ” . 51I Omit Article 12(2)(e). 51J In Article 13— a in paragraph 1, for “the Union”, substitute “ Great Britain ” ; b in the opening words of paragraph 2, for “Commission” substitute “ competent authority ” . 51K In Article 14— a omit paragraph 1; b in each place where it occurs, for “the Union” substitute “ Great Britain ” . 51L After Article 16, omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”. 51M In Annex 1— a in Chapter 1(3)(3) (positive or doubtful results), in the third paragraph omit “EU or”; b in Chapter 2(D)(3)(3) (positive or doubtful results), in the fourth paragraph omit “EU or”. 51N In Annex 4— a in Chapter 1(C), for “The competent authorities in Member States” substitute “ The competent authority ” ; b in Chapter 2, omit subparagraph (a). Amendment of Regulation (EU) 2015/1474 52 Regulation (EU) 2015/1474 is amended as follows. 53 After Article 2, omit the words “This Regulation shall be binding in its entirety and directly applicable in all Member States.”. Amendment of Regulation 2016/759 53A Regulation 2016/759 is amended as follows. 53B Omit Article 3. 53C In Article 4— a for paragraph 1, substitute— 1 The model certificate for the transit through Great Britain of raw materials and treated raw materials for the production of gelatine and collagen intended for human consumption bound for a third country, either by immediate transit or after storage in Great Britain, must be in the form published by the appropriate authority from time to time on its website. The appropriate authority may from time to time publish on its website guidance on the completion of the model certificate. References in other legislation which, on or after IP completion day, forms part of retained EU law to the model official certificate set out in Annex 3 to this Regulation are to be read as references to the form of certificate referred to in the first sentence of this Article. ; b in paragraph 2, for “at Union level” substitute “ in Great Britain ” . 53D Omit Article 5. 53E After Article 9, omit “This Regulation shall be binding in its entirely and directly applicable in all Member States.”. 53F Omit Annexes 3 and 4. General transitional provision relating to the presentation or other use of model official certificates 53G Where these Regulations amend any provisions of Regulation 2016/759 which, on or after IP completion day, forms part of retained EU law so as to enable the presentation or other use of a model official certificate in the form published by the appropriate authority from time to time, that amendment does not preclude a model official certificate in the form set out in Annex 3 of Regulation 2016/759, as it had effect immediately before IP completion day, from being presented or otherwise used on or after IP completion day in connection with the transit of the raw materials and treated raw materials through Great Britain instead of the equivalent model certificate, as published by the appropriate authority for a period after IP completion day for transitional purposes, until the appropriate authority publishes a notice that this is no longer permitted. Amendment of Regulation 2017/185 53H Regulation 2017/185 is amended as follows. 53I In Article 1, for “31 December 2020” substitute “ 21 April 2021 ” . 53J In Article 3, in both places it occurs, for “the Member State of import” substitute “ Great Britain ” . 53K In Article 5, in the second paragraph, after “2020” insert, “ except in relation to Article 3, which applies until 21 April 2021. ” . 53L After Article 5, omit “This Regulation shall be binding in its entirety and directly applicable in all Member States. PART 3 Revocation of retained direct EU legislation Revocation of Regulation (EU) 636/2014 54 Regulation (EU) 636/2014 is revoked. Signed by authority of the Secretary of State for Health and Social Care. Steve Brine Parliamentary Under-Secretary of State, Department of Health and Social Care