# The Food Safety and Hygiene (England) Regulations 2013

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U.K.

Statutory Instruments

# 2013 No. 2996

Food, England

# The Food Safety and Hygiene (England) Regulations 2013

Made

22nd November 2013

Laid before Parliament

3rd December 2013

Coming into force

31st December 2013

The Secretary of State makes the following Regulations in exercise of the powers conferred on him by section 2(2) of and paragraph                           1A of Schedule 2 to the European Communities Act 1972 F1.                        

The Secretary of State has been designated for the purposes of that section in relation to measures relating to food (including                           drink) including the primary production of food F2 and measures in the veterinary and phytosanitary fields for the protection of public health F3.                        

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears                           to the Secretary of State that it is expedient for any reference to an EU instrument defined in Schedule 1 to be construed in accordance with regulation 2(6) as a reference to that instrument as                           amended from time to time.                        

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 F4 there has been open and transparent public consultation during the preparation of the following Regulations.                        

F11972 c.68. Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (2006 c.51) and has been amended by section 3(3) of and the Schedule to the European Union (Amendment) Act 2008 (2008 c.7).

F2S.I. 2003/2901.

F3S.I. 1999/2027.

F4OJ No. L31, 1.2.2002, p.1, as last amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council adapting                              a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC                              with regard to the regulatory procedure with scrutiny: Adaptation to the regulatory procedure with scrutiny- Part Four (OJ                              No. L188, 18.7.2009, p.14).

## Title, application, commencement and extentU.K.

1.—(1) These Regulations                  

(a)may be cited as the Food Safety and Hygiene (England) Regulations 2013;                  

(b)apply in relation to England only, and                  

(c)come into force on 31st December 2013.                  

(2) Any amendment or revocation made by these Regulations has the same extent as the provision amended or revoked (but applies                     in relation to England only).                  

## InterpretationU.K.

2.—(1) In these Regulations —                  

“the Act” means the Food Safety Act 1990 F5;                  

“the Agency” means the Food Standards Agency;                  

“authorised officer”, in relation to an enforcement authority, means any person (whether or not an officer of the authority) who is authorised                     by them in writing, either generally or specially, to act in matters arising under the Hygiene Regulations and Regulation                     178/2002;                  

[F6”the EU Hygiene Regulations” mean Regulation 852/2004, Regulation 853/2004, Regulation 2073/2005, Regulation 2015/1375, Regulation                        2017/185 and Regulation 2017/625 and the Regulation 2017/625 package insofar as it and they apply to food;]                  

F7...                  

“enforcement authority” means the authority which, by virtue of regulation 5, is responsible for executing and enforcing the Hygiene Regulations                     and Regulation 178/2002;                  

“food authority” has the meaning that it bears by virtue of section 5(1) of the Act except that it does not include the appropriate Treasurer                     referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and Middle Temple);                  

“the Hygiene Regulations” means these Regulations and the EU Hygiene Regulations;                  

“premises” includes any establishment, any place, vehicle, stall or moveable structure and any ship or aircraft; and                  

[F8“the Regulation 2017/625 package” means Regulation 2017/625 and the other EU Regulations listed in Schedule 1 under the heading                        “The Regulation 2017/625 package”;]                   

“specified EU provision” means any provision of Regulation 178/2002 or the EU Hygiene Regulations that is specified in column 1 of Schedule 2 and                     whose subject-matter is described in column 2 of that Schedule.                  

[F9(1A)Any reference in these Regulations to Directives or Regulations referred to in Schedule 1 have the meanings respectively given                        to them in that Schedule.]                  

(2) Subject to paragraph (3), any expression other than one defined in paragraph (1) that is used both in these Regulations and                     in the Act has the meaning it bears in the Act.                  

(3) Unless the context otherwise requires, any expression used both in these Regulations and in Regulation 178/2002 or the EU                     Hygiene Regulations has the meaning that it bears in Regulation 178/2002 or the EU Hygiene Regulations.                  

(4) Where any functions under the Act are assigned —

(a)by an order under section 2 or 7 of the Public Health (Control of Disease) Act 1984 F10, to a port health authority;                  

(b)by an order under section 6 of the Public Health Act 1936 F11, to a joint board for a united district; or                  

(c)by an order under paragraph 15(6) of Schedule 8 to the Local Government Act 1985 F12, to a single authority for a metropolitan county,                  

any reference in these Regulations to a food authority is to be construed, so far as relating to those functions, as a reference                     to the authority to whom they are so assigned.                  

(5) Where, apart from this paragraph, any period of less than seven days which is specified in these Regulations would include                     any day which is —                  

(a)a Saturday, a Sunday, Christmas Day or Good Friday; or                  

(b)a day which is a bank holiday under the Banking and Financial Dealings Act 1971 F13,                  

that day is to be excluded from the period.

(6) In these Regulations, any reference to an EU instrument defined in Schedule 1 is a reference to that instrument as F14... amended from time to time.                  

F51990 c.16.

F6Words in reg. 2(1) substituted (14.12.2019) by The Official Feed and Food Controls (England) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/1476), regs. 1, **34(a)(i)**

F7Words in reg. 2(1) omitted (25.12.2020) by virtue of The Food and Feed Hygiene and Safety (Miscellaneous Amendments) (England) Regulations 2020 (S.I. 2020/1410), regs. 1(2), **5(2)(a)(i)**

F8Words in reg. 2(1) substituted (25.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments) (England) Regulations 2020 (S.I. 2020/1410), regs. 1(2), **5(2)(a)(ii)**

F9Reg. 2(1A) inserted (25.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments) (England) Regulations 2020 (S.I. 2020/1410), regs. 1(2), **5(2)(b)**

F101984 c.22; section 7(3)(d) was substituted by paragraph 27 of Schedule 3 to the Food Safety Act 1990.

F111936 c.49; section 36 is to be read with paragraph 1 of Schedule 3 to the Food Safety Act 1990.

F121985 c.51; paragraph 15(6) was amended by paragraph 31(b) of Schedule 3 to the Food Safety Act 1990.

F131971 c.80.

F14Words in reg. 2(6) omitted (14.12.2019) by virtue of The Official Feed and Food Controls (England) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/1476), regs. 1, **34(b)**

## Presumptions that food is intended for human consumptionU.K.

3.—(1) The following paragraphs apply for the purposes of these Regulations.                  

(2) Any food commonly used for human consumption shall, if placed on the market or offered, exposed or kept for placing on the                     market, be presumed, until the contrary is proved, to have been placed on the market or, as the case may be, to have been                     or to be intended for placing on the market for human consumption.                  

(3) The following, namely—

(a)any food commonly used for human consumption which is found on premises used for the preparation, storage, or placing on the                        market of that food; and                  

(b)any article or substance commonly used in the manufacture of food for human consumption which is found on premises used for                        the preparation, storage or placing on the market of that food,                  

shall be presumed, until the contrary is proved, to be intended for placing on the market, or for manufacturing food for placing                     on the market, for human consumption.                  

(4) Any article or substance capable of being used in the composition or preparation of any food commonly used for human consumption                     which is found on premises on which that food is prepared shall, until the contrary is proved, be presumed to be intended                     for such use.                  

## Competent authoritiesU.K.

4.—(1) The competent authority for the purposes of the EU Hygiene Regulations is the Agency except where it has delegated competences                     as provided for in those Regulations.                  

(2) The competent authorities for the purposes of the provisions of Regulation 178/2002 specified in paragraph (3) are the Agency                     and each food authority in its area or district.                  

(3) The provisions of Regulation 178/2002 are —

(a)Article 14(8) (power of competent authorities to take appropriate measures to impose restrictions on the placing of food on                        the market or to require its withdrawal from the market in certain circumstances);                  

(b)Article 18(2) and (3) (competent authorities to which food business operators must make information available on demand as                        to the traceability of food); and                  

(c)Article 19 (food business operators to inform and collaborate with competent authorities to avoid or reduce risks posed by                        a food).                  

## Enforcement authoritiesU.K.

5.—(1) In respect of any food business operator to whose operations Regulation 852/2004 applies but Regulation 853/2004 does not                     apply —                  

(a)the Agency or the food authority in whose area the food business operator carries out the operations shall execute and enforce                        the Hygiene Regulations in so far as the operator concerned is carrying out primary production and those associated operations                        listed in paragraph 1 of Part AI of Annex I to Regulation 852/2004 other than the associated operations described in sub-paragraphs                        (a) and (c) of that paragraph to the extent that they concern wild game; and                  

(b)the food authority in whose area the food business operator carries out the operations shall execute and enforce the Hygiene                        Regulations in so far as the operator concerned is carrying out operations which are not executed and enforced by the Agency                        or the food authority as provided for in sub-paragraph (a).                  

(2) In respect of any food business operator to whose operations both Regulation 852/2004 and Regulation 853/2004 apply —

(a)the Agency shall execute and enforce the Hygiene Regulations in so far as the operator concerned is carrying out operations                        in relation to —                  

(i)a slaughterhouse,                  

(ii)a game-handling establishment, or                  

(iii)a cutting plant;                  

(b)the Agency or the food authority in whose area the food business operator carries out the operations shall execute and enforce                        the Hygiene Regulations in so far as the operator concerned is carrying out operations in relation to any establishment that                        is not specified in sub-paragraph (a).                  

(3) In respect of —

(a)collection centres and tanneries supplying raw material for the production of gelatine intended for human consumption pursuant                        to paragraph 5 of Chapter I of Section XIV of Annex III to Regulation 853/2004; and                  

(b)collection centres and tanneries supplying raw material for the production of collagen intended for human consumption pursuant                        to paragraph 5 of Chapter I of Section XV of Annex III to Regulation 853/2004,                  

the food authority in whose area the collection centre or tannery concerned is situated shall execute and enforce the Hygiene                     Regulations.                  

(4) Each food authority shall execute and enforce these Regulations in its area in relation to the matters regulated by —

(a)Schedules 3 to 5; and                  

(b)Schedule 6 in so far as it applies in relation to raw milk intended for direct human consumption other than raw cows' milk.                  

(5) The Agency shall execute and enforce these Regulations in relation to the matters regulated by Schedule 6 in so far as it                     applies in relation to raw cows' milk intended for direct human consumption.                  

(6) Each food authority in its area or district shall execute and enforce the provisions of Regulation 178/2002 specified in Schedule                     2 and these Regulations in so far as they relate to those provisions.                  

(7) The Agency shall also execute and enforce Articles 14 and 19 of Regulation 178/2002 and these Regulations in so far as they                     relate to those Articles as regards relevant food.                  

(8) In paragraph (7) “relevant food” means food in respect of which the Agency is specified in regulations made pursuant to section 6(4) of the Act or made under                     the European Communities Act 1972 as being the enforcement authority.                  

(9) In this regulation —

“cutting plant” means an establishment which is used for boning and/or cutting up fresh meat for placing on the market and which —                  

is approved or conditionally approved under [F15Article 148 of Regulation 2017/625]; or                           

(although lacking the approval or conditional approval that it requires under Article 4(3) of Regulation 853/2004) was, on                              31st December 2005, operating as licensed cutting premises under the Fresh Meat (Hygiene and Inspection) Regulations 1995                              F16 or the Poultry Meat, Farmed Game Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995 F17;                           

“game-handling establishment” means any establishment in which game and game meat obtained after hunting are prepared for placing on the market and which                     —                  

is approved or conditionally approved under [F18Article 148 of Regulation 2017/625]; or                           

(although lacking the approval or conditional approval that it requires under Article 4(3) of Regulation 853/2004) was, on                              31st December 2005, operating as a licensed wild game processing facility under the Wild Game Meat (Hygiene and Inspection)                              Regulations 1995 F19;                           

“slaughterhouse” means an establishment used for slaughtering and dressing animals, the meat of which is intended for human consumption and                     which —                  

is approved or conditionally approved under [F20Article 148 of Regulation 2017/625]; or                           

(although lacking the approval or conditional approval that it requires under Article 4(3) of Regulation 853/2004) was, on                              31st December 2005, operating as a licensed slaughterhouse under the Fresh Meat (Hygiene and Inspection) Regulations 1995                              or the Poultry Meat, Farmed Game Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995.                           

F15Words in reg. 5(9) substituted (14.12.2019) by The Official Feed and Food Controls (England) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/1476), regs. 1, **35(a)**

F16S.I. 1995/539, revoked by S.I. 2005/2059.

F17S.I. 1995/540, revoked by S.I. 2005/2059

F18Words in reg. 5(9) substituted (14.12.2019) by The Official Feed and Food Controls (England) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/1476), regs. 1, **35(b)**

F19S.I. 1995/2148, revoked by S.I. 2005/2059

F20Words in reg. 5(9) substituted (14.12.2019) by The Official Feed and Food Controls (England) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/1476), regs. 1, **35(c)**

## Hygiene improvement noticesU.K.

6.—(1) If an authorised officer of an enforcement authority has reasonable grounds for believing that a food business operator is                     failing to comply with the Hygiene Regulations, the officer may by a notice served on that person (in these Regulations referred                     to as a “hygiene improvement notice”) —                  

(a)state the officer's grounds for believing that the food business operator is failing to comply with the Hygiene Regulations;                  

(b)specify the matters which constitute the food business operator's failure to comply;                  

(c)specify the measures which, in the officer's opinion, the food business operator must take in order to secure compliance;                        and                  

(d)require the food business operator to take those measures, or measures which are at least equivalent to them, within such                        period (not being less than 14 days) as may be specified in the notice.                  

(2) Any person who fails to comply with a hygiene improvement notice commits an offence.

## Hygiene prohibition ordersU.K.

7.—(1) If —                  

(a)a food business operator is convicted of an offence under these Regulations; and                  

(b)the court by or before which the operator is so convicted is satisfied that the health risk condition is fulfilled with respect                        to the food business concerned,                  

the court shall by an order impose the appropriate prohibition.

(2) The health risk condition is fulfilled with respect to any food business if any of the following involves risk of injury to                     health (including any impairment, whether permanent or temporary), namely —                  

(a)the use for the purposes of the business of any process or treatment;                  

(b)the construction of any premises used for the purposes of the business, or the use for those purposes of any equipment; and                  

(c)the state or condition of any premises or equipment used for the purposes of the business.                  

(3) The appropriate prohibition is—

(a)in a case falling within sub-paragraph (a) of paragraph (2), a prohibition on the use of the process or treatment for the                        purposes of the business;                  

(b)in a case falling within sub-paragraph (b) of that paragraph, a prohibition on the use of the premises or equipment for the                        purposes of the business or any other food business of the same class or description; and                  

(c)in a case falling within sub-paragraph (c) of that paragraph, a prohibition on the use of the premises or equipment for the                        purposes of any food business.                  

(4) If —

(a)a food business operator is convicted of an offence under these Regulations; and                  

(b)the court by or before which the operator is so convicted thinks it proper to do so in all the circumstances of the case,                  

the court may, by an order, impose a prohibition on the food business operator participating in the management of any food                     business, or any food business of a class or description specified in the order.                  

(5) As soon as practicable after the making of an order under paragraph (1) or (4) (in these Regulations referred to as a “hygiene prohibition order”), the enforcement authority shall —                  

(a)serve a copy of the order on the relevant food business operator; and                  

(b)in the case of an order made under paragraph (1), affix a copy of the order in a conspicuous position on such premises used                        for the purposes of the food business as they consider appropriate,                  

and any person who knowingly contravenes such an order commits an offence.

(6) A hygiene prohibition order ceases to have effect —

(a)in the case of an order made under paragraph (1), on the issue by the enforcement authority of a certificate to the effect                        that they are satisfied that the food business operator has taken sufficient measures to secure that the health risk condition                        is no longer fulfilled with respect to the food business; and                  

(b)in the case of an order made under paragraph (4), on the giving by the court of a direction to that effect.                  

(7) The enforcement authority must issue a certificate under sub-paragraph (a) of paragraph (6) within three days of their being                     satisfied as mentioned in that sub-paragraph; and on an application by the food business operator for such a certificate,                     the authority must —                  

(a)determine, as soon as is reasonably practicable and in any event within 14 days, whether or not they are so satisfied; and                  

(b)if they determine that they are not so satisfied, give notice to the food business operator of the reasons for that determination.                  

(8) The court shall give a direction under sub-paragraph (b) of paragraph (6) if, on an application by the food business operator,                     the court thinks it proper to do so having regard to all the circumstances of the case, including in particular the conduct                     of the food business operator since the making of the order; but no such application shall be entertained if it is made —                  

(a)within six months of the making of the hygiene prohibition order; or                  

(b)within three months of the making by the food business operator of a previous application for such a direction.                  

(9) Where a magistrates' court makes an order under paragraph (2) of regulation 8 with respect to any food business, paragraph                     (1) shall apply as if the food business operator had been convicted by the court of an offence under these Regulations.                  

(10) Where the commission of an offence by a food business operator leads to the conviction of another person pursuant to regulation                     11, paragraph (4) shall apply in relation to that other person as it applies in relation to the food business operator and                     any reference in paragraph (5) or (8) to the food business operator is to be construed accordingly.                  

## Hygiene emergency prohibition notices and ordersU.K.

8.—(1) If an authorised officer of an enforcement authority is satisfied that the health risk condition is fulfilled with respect                     to any food business, the officer may by a notice served on the relevant food business operator (in these Regulations referred                     to as a “hygiene emergency prohibition notice”) impose the appropriate prohibition.                  

(2) If a magistrates' court is satisfied, on the application of such an officer, that the health risk condition is fulfilled with                     respect to any food business, the court shall, by an order (in these Regulations referred to as a “hygiene emergency prohibition order”), impose the appropriate prohibition.                  

(3) Such an officer may not apply for a hygiene emergency prohibition order unless, at least one day before the date of the application,                     the officer has served notice on the relevant food business operator of the intention to apply for the order.                  

(4) Paragraphs (2) and (3) of regulation 7 apply for the purposes of this regulation as they apply for the purposes of that regulation,                     but as if the reference in paragraph (2) to risk of injury to health were a reference to imminent risk of injury.                  

(5) As soon as practicable after the service of a hygiene emergency prohibition notice, an authorised officer of an enforcement                     authority must affix a copy of the notice in a conspicuous position on such premises used for the purposes of the food business                     as the officer considers appropriate, and any person who knowingly contravenes such a notice commits an offence.                  

(6) As soon as practicable after the making of a hygiene emergency prohibition order, an authorised officer of an enforcement                     authority must —                  

(a)serve a copy of the order on the relevant food business operator; and                  

(b)affix a copy of the order in a conspicuous position on such premises used for the purposes of the food business as the officer                        considers appropriate,                  

and any person who knowingly contravenes such an order commits an offence.

(7) A hygiene emergency prohibition notice ceases to have effect —

(a)if no application for a hygiene emergency prohibition order is made within the period of three days beginning with the service                        of the notice, at the end of that period; or                  

(b)if such an application is so made, on the determination or abandonment of the application.                  

(8) A hygiene emergency prohibition notice or a hygiene emergency prohibition order ceases to have effect on the issue by the                     enforcement authority of a certificate to the effect that they are satisfied that the food business operator has taken sufficient                     measures to secure that the health risk condition is no longer fulfilled with respect to the food business.                  

(9) The enforcement authority must issue a certificate under paragraph (8) within three days of their being satisfied as mentioned                     in that paragraph; and on an application by the food business operator for such a certificate, the authority must —                  

(a)determine as soon as is reasonably practicable and in any event within 14 days whether or not they are so satisfied; and                  

(b)if they determine that they are not so satisfied, give notice to the food business operator of the reasons for that determination.                  

(10) Where a hygiene emergency prohibition notice is served on a food business operator, the enforcement authority must compensate                     the operator in respect of any loss suffered by reason of complying with the notice unless —                  

(a)an application for a hygiene emergency prohibition order is made within the period of three days beginning with the service                        of the notice; and                  

(b)the court declares itself satisfied, on the hearing of the application, that the health risk condition was fulfilled with                        respect to the food business at the time when the notice was served,                  

and any disputed question as to the right to or the amount of any compensation payable under this paragraph is to be determined                     by arbitration.                  

## Remedial action noticesU.K.

9.—(1) Where it appears to an authorised officer of an enforcement authority that in respect of an establishment that Article 4(2)                     of Regulation 853/2004 requires to be approved —                  

(a)any of the requirements of the Hygiene Regulations is being breached; or                  

(b)inspection under the Hygiene Regulations is being hampered,                  

the officer may, by a notice in writing (in these Regulations referred to as a “remedial action notice”) served on the relevant food business operator or duly authorised representative —                  

(c)prohibit the use of any equipment or any part of the establishment specified in the notice;                  

(d)impose conditions upon or prohibit the carrying out of any process; or                  

(e)require the rate of operation to be reduced to such extent as is specified in the notice, or to be stopped completely.                  

(2) A remedial action notice must be served as soon as practicable and must state why it is being served.

(3) If it is served under paragraph (1)(a), it must specify the breach and the action needed to remedy it.

(4) An authorised officer of the enforcement authority whose authorised officer served the original remedial action notice must,                     as soon as satisfied that such action has been taken, withdraw the notice by a further notice in writing served on the food                     business operator or duly authorised representative.                  

(5) Any person who fails to comply with a remedial action notice commits an offence.

## Detention noticesU.K.

10.—(1) An authorised officer of an enforcement authority may, at an establishment that Article 4(2) of Regulation 853/2004 requires                     to be approved, by a notice in writing (in this regulation referred to as a “detention notice”) served on the relevant food business operator or duly authorised representative require the detention of any animal or                     food for the purpose of examination (including the taking of samples).                  

(2) An authorised officer of the enforcement authority whose officer served the original detention notice must, as soon as satisfied                     that the animal or food need no longer be detained, withdraw the notice by a further notice in writing served on the food                     business operator or duly authorised representative.                  

(3) Any person who fails to comply with a detention notice commits an offence.

## Offences due to the fault of another personU.K.

11.  Where the commission by any person of an offence under these Regulations is due to the act or default of some other person,                     that other person commits the offence; and a person may be convicted of the offence by virtue of this regulation whether or                     not proceedings are taken against the first-mentioned person.                  

## Defence of due diligenceU.K.

12.—(1) In any proceedings for an offence under these Regulations it shall, subject to paragraph (5), be a defence to prove that the                     person accused (“the accused”) took all reasonable precautions and exercised all due diligence to avoid the commission of                     the offence by the accused or by a person under the control of the accused.                  

(2) Without prejudice to the generality of paragraph (1), a person accused of an offence of contravening Article 12 or Article                     14(1) of Regulation 178/2002 who did not —                  

(a)prepare the food in respect of which the offence is alleged to have been committed; nor                  

(b)import it into the United Kingdom,                  

shall be taken to have established the defence provided by paragraph (1) if the requirements of paragraphs (3) or (4) are                     satisfied.                  

(3) The requirements of this paragraph are satisfied if it is proved that —

(a)the commission of the offence was due to the act or default of some other person who was not under the control of the accused,                        or to reliance on information supplied by such a person;                  

(b)either —                  

(i)the accused carried out all such checks of the food in question as were reasonable in all the circumstances, or                  

(ii)it was reasonable in all the circumstances for the accused to rely on checks carried out by the person who supplied the accused                        with that food; and                  

(c)the accused did not know and had no reason to suspect at the time the offence was committed that the act or omission would                        amount to an offence under these Regulations.                  

(4) The requirements of this paragraph are satisfied if the offence is one of placing on the market and it is proved that —

(a)the commission of the offence was due to the act or default of some other person who was not under the control of the accused,                        or to reliance on information supplied by such a person;                  

(b)the placing on the market of which the offence consisted was not a placing on the market under the name or mark of the accused;                        and                  

(c)the accused did not know and could not reasonably be expected to know at the time the offence was committed that the act or                        omission would amount to an offence under these Regulations.                  

(5) If in any case the defence provided by paragraph (1) involves the allegation that the commission of the offence was due to                     the act or default of another person, or to reliance on information supplied by another person, the accused shall not without                     leave of the court be entitled to rely on that defence unless —                  

(a)at least seven clear days before the hearing; and                  

(b)where the accused has previously appeared before the court in connection with the alleged offence, within one month of the                        first such appearance,                  

the accused has served on the prosecutor a written notice giving such information identifying or assisting in the identification                     of that other person as was then in the possession of the accused.                  

## Defence in relation to exportsU.K.

13.  In any proceedings for an offence of contravening or failing to comply with food law it shall be a defence for the accused                     to prove that —                  

(a)the item in respect of which the offence is alleged to have been committed was intended for export to a country that is not                        a member State and that the item could lawfully be exported there under Article 12 of Regulation 178/2002; or                  

(b)the item in respect of which the offence is alleged to have been committed was intended for export to a member State and that                        —                  

(i)the legislation applicable to that item in that member State is compatible with the relevant provisions of food law (except                        in so far as it relates to feed produced for or fed to food producing animals) at EU level, and                  

(ii)the item complies with that legislation.                  

## Procurement of samplesU.K.

14.  An authorised officer of an enforcement authority may —                  

(a)purchase a sample of any food, or any substance capable of being used in the preparation of food;                  

(b)take a sample of any food, or any such substance, which —                  

(i)appears to the officer to be intended for placing on the market or to have been placed on the market, for human consumption,                        or                  

(ii)is found by the officer on or in any premises which the officer is authorised to enter by or under regulation 16;                  

(c)take a sample from any food source, or a sample of any contact material, which is found by the officer on or in any such premises;                        and                  

(d)take a sample of any article or substance which is found by the officer on or in any such premises and which the officer has                        reason to believe may be required as evidence in proceedings under any of the provisions of these Regulations.                  

## Analysis etc. of samplesU.K.

15.—(1) An authorised officer of an enforcement authority who has procured a sample under regulation 14 shall —                  

(a)if the officer considers that the sample should be analysed, submit it to be analysed—                  

(i)by the public analyst for the area in which the sample was procured, or                  

(ii)by the public analyst for the area which consists of or includes the area of the authority; and                  

(b)if the officer considers that the sample should be examined, submit it to be examined by a food examiner.                  

(2) A person, other than such an officer, who has purchased any food, or any substance capable of being used in the preparation                     of food, may submit a sample of it —                  

(a)to be analysed by the public analyst for the area in which the purchase was made; or                  

(b)to be examined by a food examiner.                  

(3) If, in any case where a sample is proposed to be submitted for analysis under this regulation, the office of public analyst                     for the area in question is vacant, the sample shall be submitted to the public analyst for some other area.                  

(4) If, in any case where a sample is proposed to be or is submitted for analysis under this regulation, the food analyst determines                     that they are for any reason unable to perform the analysis or examination, the sample shall be submitted or, as the case                     may be, sent by them to such other food analyst as they may determine.                  

(5) If, in any case where a sample is proposed to be or is submitted for examination under this regulation, the food examiner                     determines that they are for any reason unable to perform the examination, the sample shall be submitted or, as the case may                     be, sent by them to such other food examiner as they may determine.                  

(6) A food analyst or examiner must analyse or examine as soon as practicable any sample submitted or sent to them under this                     regulation, but may, except where —                  

(a)the person to whom the sample was submitted or sent is the public analyst for the area in question; and                  

(b)the sample is submitted for analysis by an authorised officer of an enforcement authority,                  

demand in advance the payment of such reasonable fee as the food analyst or examiner may require.

(7) Any food analyst or examiner who has analysed or examined a sample must give to the person by whom it was submitted a certificate                     specifying the result of the analysis or examination.                  

(8) Any certificate given by a food analyst or examiner under paragraph (7) must be signed by the food analyst or examiner, but                     the analysis or examination may be made by any person acting under their direction.                  

(9) In any proceedings under these Regulations, the production by one of the parties —

(a)of a document purporting to be a certificate given by a food analyst or examiner under paragraph (7); or                  

(b)of a document supplied to him by the other party as being a copy of such a certificate,                  

shall be sufficient evidence of the facts stated in it unless, in a case falling within sub-paragraph (a), the other party                     requires that the food analyst or examiner shall be called as a witness.                  

(10) Where two or more public analysts are appointed for any area, any reference in this regulation to the public analyst for that                     area is to be construed as a reference to either or any of them.                  

(11) The Food Safety (Sampling and Qualifications) (England) Regulations 2013 F21 apply in relation to a sample procured by an authorised officer of an enforcement authority under regulation 14 as if it                     were a sample procured by an authorised officer under section 29 of the Act.                  

(12) The certificate given by a food analyst or examiner under paragraph (7) must be in the form set out in Schedule 3 to the Food                     Safety (Sampling and Qualifications) (England) Regulations 2013.                  

F21S.I. 2013/264.

## Powers of entryU.K.

16.—(1) An authorised officer of a food authority, on producing, if so required, some duly authenticated document showing authorisation,                     has a right at all reasonable hours —                  

(a)to enter any premises within the authority's area for the purpose of ascertaining whether there is or has been on the premises                        any contravention of the provisions of the Hygiene Regulations or Regulation 178/2002;                  

(b)to enter any premises, whether within or outside the authority's area, for the purpose of ascertaining whether there is on                        the premises any evidence of any such contravention within that area; and                  

(c)to enter any premises for the purpose of the performance by the authority of their functions under the Hygiene Regulations                        or Regulation 178/2002,                  

but admission to any premises used only as a private dwelling-house may not be demanded as of right unless 24 hours' notice                     of the intended entry has been given to the occupier.                  

(2) An authorised officer of the Agency, on producing if so required some duly authenticated document showing authorisation, has                     a right at all reasonable hours to enter any premises for the purpose of —                  

(a)ascertaining whether there is or has been on the premises any contravention of the provisions of the Hygiene Regulations or                        Regulation 178/2002;                  

(b)ascertaining whether there is on the premises any evidence of any such contravention; and                  

(c)the performance by the Agency of its functions under the Hygiene Regulations or Regulation 178/2002,                  

but admission to any premises used only as a private dwelling-house may not be demanded as of right unless 24 hours' notice                     of the intended entry has been given to the occupier.                  

(3) If a justice of the peace, on sworn information in writing, is satisfied that there is reasonable ground for entry onto any                     premises for any such purpose as is mentioned in paragraph (1) or (2) and either —                  

(a)that admission to the premises has been refused, or a refusal is apprehended, and that notice of the intention to apply for                        a warrant has been given to the occupier; or                  

(b)that an application for admission, or the giving of such a notice, would defeat the object of the entry, or that the case                        is one of urgency, or that the premises are unoccupied or the occupier is temporarily absent,                  

the justice may by warrant signed by the justice authorise the authorised officer to enter the premises, if need be by reasonable                     force.                  

(4) Every warrant granted under this regulation shall continue in force for a period of one month.

(5) An authorised officer entering any premises by virtue of this regulation, or of a warrant issued under it, may be accompanied                     by such other persons as the officer considers necessary, and on leaving any unoccupied premises which the officer has entered                     by virtue of such a warrant must leave them as effectively secured against unauthorised entry as the officer found them.                  

(6) An authorised officer entering premises by virtue of this regulation, or of a warrant issued under it, may inspect any records                     (in whatever form they are held) relating to a food business and, where any such records are stored in any electronic form                     —                  

(a)may have access to, and inspect and check the operation of, any computer and any associated apparatus or material which is                        or has been in use in connection with the records; and                  

(b)may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material                        to afford such assistance as the officer may reasonably require.                  

(7) Any officer exercising any power conferred by paragraph (6) may —

(a)seize and detain any records which the officer has reason to believe may be required as evidence in proceedings under any                        of the provisions of these Regulations; and                  

(b)where the records are stored in any electronic form, require the records to be produced in a form in which they may be taken                        away.                  

(8) Any person who enters any premises by virtue of this regulation, or of a warrant issued under it, commits an offence if they                     disclose to any other person any information obtained on the premises with regard to any trade secret, unless the disclosure                     was made in the performance of their duty.                  

(9) Nothing in this regulation authorises any person, except with the permission of the local authority under the Animal Health                     Act 1981 F22, to enter any premises —                  

(a)on which an animal or bird affected with any disease to which that Act applies is kept; and                  

(b)which is situated in a place declared under that Act to be infected with such a disease.                  

F221981 c.22.

## Obstruction etc. of officersU.K.

17.—(1) Any person who —                  

(a)intentionally obstructs a person acting in the execution of the Hygiene Regulations or Regulation 178/2002; or                  

(b)without reasonable cause, fails to give to any person acting in the execution of the Hygiene Regulations or Regulation 178/2002                        any assistance or information which that person may reasonably require of them for the performance of their functions under                        the Hygiene Regulations,                  

commits an offence.

(2) Any person who, in purported compliance with any such requirement as is mentioned in sub-paragraph (b) of paragraph (1) —

(a)furnishes information which they know to be false or misleading in a material particular; or                  

(b)recklessly furnishes information which is false or misleading in a material particular,                  

commits an offence.

(3) Nothing in sub-paragraph (b) of paragraph (1) is to be construed as requiring any person to answer any question or give any                     information if to do so might incriminate them.                  

## Time limit for prosecutionsU.K.

18.  No prosecution for an offence under these Regulations which is punishable under paragraph (2) of regulation 19 shall be begun                     after the expiry of —                  

(a)three years from the commission of the offence; or                  

(b)one year from its discovery by the prosecutor,                  

whichever is the earlier.

## Offences and penaltiesU.K.

19.—(1) Subject to paragraphs (4) to (8), any person who contravenes or fails to comply with any of the specified EU provisions commits                     an offence.                  

(2) [F23Subject to paragraphs (3) and (3A)], a person guilty of an offence under these Regulations is liable —                  

(a)on summary conviction to a fine not exceeding the statutory maximum; or                  

(b)on conviction on indictment to imprisonment for a term not exceeding two years, to a fine or to both.                  

(3) A person guilty of an offence under regulation 17 is liable on summary conviction to a fine not exceeding level 5 on the standard                     scale or to imprisonment for a term not exceeding three months or to both.                  

[F24(3A)A person guilty of an offence under paragraph 1A or 1B of Schedule 6 is liable on summary conviction to a fine not exceeding                        level 5 on the standard scale.]                  

(4) Provided the requirements of Schedule 3 are complied with, a person shall be considered not to have contravened or failed                     to comply with Article 4(2) of Regulation 852/2004 as read with paragraph 4 of Chapter IV of Annex II to that Regulation (bulk foodstuffs in liquid, granulate or powder form to be transported in receptacles and/or containers/tankers                     reserved for the transport of foodstuffs).                  

(5) Provided the requirements of Part 1 of Schedule 7 are complied with, a person shall be considered not to have contravened                     or failed to comply with Article 3(1) or 4(1)(a) of Regulation 853/2004 as read in either case with paragraph 5 of Chapter                     II of Section I of Annex III to that Regulation (food business operators to ensure that slaughterhouses in which domestic                     ungulates are slaughtered have lockable facilities for the refrigerated storage of detained meat and separate lockable facilities                     for the storage of meat declared unfit for human consumption).                  

(6) Provided the requirements of Part 2 of Schedule 7 are complied with, a person shall be considered not to have contravened                     or failed to comply with Article 3(1) or 4(1)(a) of Regulation 853/2004 as read in either case with paragraph 5 of Chapter                     II of Section II of Annex III to that Regulation (food business operators to ensure that slaughterhouses in which poultry                     or lagomorphs are slaughtered have lockable facilities for the refrigerated storage of detained meat and separate lockable                     facilities for the storage of meat declared unfit for human consumption).                  

(7) Provided the requirements of Part 3 of Schedule 7 are complied with, a person shall be considered not to have contravened                     or failed to comply with Article 3(1) or 4(1)(a) of Regulation 853/2004 as read in either case with paragraph 6 of Chapter                     II of Section I of Annex III to that Regulation (food business operators to ensure that slaughterhouses in which domestic                     ungulates are slaughtered have a separate place with appropriate facilities for the cleaning, washing and disinfection of                     means of transport for livestock unless the competent authority permits them not to have such places and official authorised                     places and facilities exist nearby).                  

(8) Provided the requirements of Part 4 of Schedule 7 are complied with, a person shall be considered not to have contravened                     or failed to comply with Article 3(1) or 4(1)(a) of Regulation 853/2004 as read in either case with paragraph 6(b) of Chapter                     II of Section II of Annex III to that Regulation (food business operators to ensure that slaughterhouses in which poultry                     or lagomorphs are slaughtered have a separate place with appropriate facilities for the cleaning, washing and disinfection                     of means of transport unless officially authorised places and facilities exist nearby).                  

F23Words in reg. 19(2) substituted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(2)(a)**

F24Reg. 19(3A) inserted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(2)(b)**

## Offences by bodies corporateU.K.

20.—(1) Where an offence under these Regulations which has been committed by a body corporate is proved to have been committed with                     the consent or connivance of, or to be attributable to any neglect on the part of —                  

(a)any director, manager, secretary or other similar officer of the body corporate; or                  

(b)any person who was purporting to act in any such capacity,                  

that person as well as the body corporate shall be deemed to commit that offence and is liable to be proceeded against and                     punished accordingly.                  

(2) In sub-paragraph (a) of paragraph (1) “director”, in relation to any body corporate established by or under any enactment for the purpose of carrying on under national ownership                     any industry or part of an industry or undertaking, being a body corporate whose affairs are managed by its members, means                     a member of that body corporate.                  

## Offences by Scottish partnershipsU.K.

21.  Where an offence under these Regulations which has been committed by a Scottish partnership is proved to have been committed                     with the consent or connivance of, or to be attributable to any neglect on the part of, a partner, that partner as well as                     the partnership shall be deemed to commit that offence and is liable to be proceeded against and punished accordingly.                  

## Right of appealU.K.

22.—(1) Any person who is aggrieved by —                  

(a)a decision of an authorised officer of an enforcement authority to serve a hygiene improvement notice;                  

(b)a decision of an enforcement authority to refuse to issue a certificate under paragraph (6) of regulation 7 or paragraph (8)                        of regulation 8; or                  

(c)a decision of an authorised officer of an enforcement authority to serve a remedial action notice,                  

may appeal to a magistrates' court.

(2) The procedure on an appeal to a magistrates' court under paragraph (1) shall be by way of complaint for an order, and the                     Magistrates' Courts Act 1980 applies to the proceedings.                  

(3) The period within which an appeal under paragraph (1) may be brought is —

(a)one month from the date on which notice of the decision was served on the person desiring to appeal; or                  

(b)in the case of an appeal against a decision to issue a hygiene improvement notice, the period specified in sub-paragraph (a)                        or, if it is shorter, the period specified in the notice pursuant to sub-paragraph (d) of paragraph (1) of regulation 6,                  

and the making of a complaint for an order shall be deemed for the purposes of this paragraph to be the bringing of the appeal.

## Appeals to the Crown CourtU.K.

23.  A person who is aggrieved by —                  

(a)the dismissal by a magistrates' court of an appeal to it under paragraph (1) of regulation 22; or                  

(b)any decision of such a court to make a hygiene prohibition order or a hygiene emergency prohibition order,                  

may appeal to the Crown Court.

## Appeals against hygiene improvement notices and remedial action noticesU.K.

24.—(1) On an appeal against a hygiene improvement notice or a remedial action notice, the court may cancel or affirm the notice and,                     if it affirms it, may do so either in its original form or with such modifications as the court may in the circumstances think                     fit.                  

(2) Where any period specified in a hygiene improvement notice pursuant to sub-paragraph (d) of paragraph (1) of regulation 6                     would otherwise include any day on which an appeal against that notice is pending, that day shall be excluded from that period.                  

(3) Any appeal shall be regarded as pending for the purposes of paragraph (2) until it is finally disposed of, is withdrawn or                     is struck out for want of prosecution.                  

## Application of section 9 of the Food Safety Act 1990U.K.

25.  Section 9 of the Act (inspection and seizure of suspected food) applies for the purposes of these Regulations with the modification                     that it shall apply in relation to an authorised officer of an enforcement authority as it applies in relation to an authorised                     officer of a food authority.                  

## Power to issue codes of recommended practiceU.K.

26.—(1) For the guidance of food authorities, the Secretary of State may issue codes of recommended practice as regards the execution                     and enforcement of the Hygiene Regulations and Regulation 178/2002 and any such code shall be laid before Parliament after                     being issued.                  

(2) The Agency may, after consulting the Secretary of State, give a food authority a direction requiring them to take any specified                     steps in order to comply with a code issued under this regulation.                  

(3) In exercise of the functions conferred on them by or under the Hygiene Regulations and Regulation 178/2002, every food authority                     —                  

(a)must have regard to any relevant provision of any such code; and                  

(b)must comply with any direction which is given under this regulation and requires them to take any specified steps in order                        to comply with such a code.                  

(4) Any direction under paragraph (2) shall, on the application of the Agency, be enforceable by mandatory order.

(5) The Agency must consult the Secretary of State before making an application under paragraph (4).

(6) Before issuing any code under this regulation, the Secretary of State must have regard to any relevant advice given by the                     Agency.                  

## Protection of officers acting in good faithU.K.

27.—(1) An officer of an enforcement authority is not personally liable in respect of any act done by that officer —                  

(a)in the execution or purported execution of the Hygiene Regulations or Regulation 178/2002; and                  

(b)within the scope of his employment,                  

if that act was done in the honest belief that the officer's duty under the Hygiene Regulations or Regulation 178/2002 required                     or entitled the officer to do it.                  

(2) Nothing in paragraph (1) is to be construed as relieving any enforcement authority of any liability in respect of the acts                     of their officers.                  

(3) Where an action has been brought against an officer of an enforcement authority in respect of an act done by that officer                     —                  

(a)in the execution or purported execution of the Hygiene Regulations or Regulation 178/2002; but                  

(b)outside the scope of the officer's employment,                  

the authority may indemnify that officer against the whole or a part of any damages which the officer has been ordered to                     pay or any costs which the officer may have incurred if they are satisfied that the officer honestly believed that the act                     complained of was within the scope of the officer's employment.                  

(4) A public analyst appointed by a food authority is to be treated for the purposes of this regulation as being an officer of                     the authority, whether or not the appointment is a whole-time one.                  

## Revocation and suspension of designations and appointmentsU.K.

28.—(1) Subject to paragraphs (2) and (3), the Agency may at any time revoke or suspend —                  

(a)the appointment of an official veterinarian;                  

(b)the designation of an approved veterinarian; or                  

(c)the appointment of an official auxiliary,                  

if it appears to the Agency that the person in question is unfit to perform any of the functions of that post under the Hygiene                     Regulations.                  

(2) Where the Agency revokes or suspends a designation or appointment under paragraph (1), the Agency shall, as soon as practicable,                     give to the person whose designation or appointment has been revoked or suspended a notice in writing of the reasons for the                     revocation or suspension and shall afford them an opportunity of —                  

(a)making representations in writing to the Agency with regard to the revocation or suspension; or                  

(b)being heard by a person nominated by the Agency for the purpose pursuant to sub-paragraph (a) of paragraph (5).                  

(3) A notice given under paragraph (2) shall inform the person to whom it is given —

(a)of their right to make representations in writing;                  

(b)of the manner in which and the time (not being less than 21 days from the giving of the notice) within which such representations                        may be made;                  

(c)of their right to be heard; and                  

(d)of the manner in which and the time (not being less than 21 days from the giving of the notice) within which they may apply                        for an opportunity to be heard.                  

(4) In the event of the person whose designation or appointment has been revoked or suspended making any representations (whether                     orally or in writing) under paragraph (3) the Agency must reconsider whether that person is unfit to perform any of the functions                     of the post held by them under the Hygiene Regulations and shall, as soon as practicable, reconsider its decision to revoke                     or suspend the designation or appointment under paragraph (1) in the light of those representations.                  

(5) Where a person requests the opportunity to be heard pursuant to sub-paragraph (b) of paragraph (2) —

(a)the Agency must nominate a person to determine the matter from the list established under paragraph (6);                  

(b)the person so nominated must serve a notice on the person who requested the opportunity to be heard and the Agency, informing                        them of the time (not being less than 21 days from the giving of the notice) of the hearing; and                  

(c)the person so nominated must, within 21 days of the hearing, notify the person who requested the opportunity to be heard and                        the Agency of the result of the determination.                  

(6) The Agency must establish and maintain a list of people who may be nominated for the purposes of this regulation and consult                     those organisations appearing to it to represent official veterinarians, approved veterinarians and official auxiliaries before                     including any person on the list.                  

## Food which has not been produced, processed or distributed in accordance with the Hygiene RegulationsU.K.

29.—(1) On an inspection of any food, an authorised officer of an enforcement authority may certify that it has not been produced,                     processed or distributed in compliance with the Hygiene Regulations.                  

(2) Where any food is certified as mentioned in paragraph (1) it shall be treated for the purposes of section 9 of the Act as                     failing to comply with food safety requirements.                  

(3) Where any food certified as mentioned in paragraph (1) is part of a batch, lot or consignment of food of the same class or                     description, all the food in the batch, lot or consignment shall, until it is proved that it has been produced, processed                     or distributed in compliance with the Hygiene Regulations, be treated for the purposes of paragraph (2) as having been so                     certified.                  

## Service of documentsU.K.

30.—(1) Any document which is required or authorised under the Hygiene Regulations to be served on a food business operator may be                     served —                  

(a)by delivering it to that person;                  

(b)in the case of an incorporated company or body, by delivering it to their secretary at their registered or principal office,                        or by sending it in a prepaid letter addressed to the secretary at that office; or                  

(c)in the case of any other food business operator, by leaving it or sending it in a prepaid letter addressed to the food business                        operator at the operator's usual or last known residence.                  

(2) Where a document is to be served on a food business operator under the Hygiene Regulations and it is not reasonably practicable                     to ascertain the name and address of the person on whom it should be served, or the premises of the food business operator                     are unoccupied, the document may be served by addressing it to the food business operator concerned in the capacity of occupier                     of those premises (naming them), and —                  

(a)by delivering it to some other person at the premises; and                  

(b)if there is no other person at the premises to whom it can be delivered, by affixing it or a copy of it to some conspicuous                        part of the premises.                  

## Bulk transport in sea-going vessels of liquid oils or fats and the bulk transport by sea of raw sugarU.K.

31.  Schedule 3 (bulk transport in sea-going vessels of liquid oils or fats and the bulk transport by sea of raw sugar) has effect.                  

## Temperature control requirementsU.K.

32.  Schedule 4 (temperature control requirements) has effect.                  

## Direct supply by the producer of small quantities of meat from poultry or lagomorphs slaughtered on the farmU.K.

33.  Schedule 5 (direct supply by the producer of small quantities of meat from poultry or lagomorphs slaughtered on the farm)                     has effect.                  

## Restrictions on the sale of raw milk intended for direct human consumptionU.K.

34.  Schedule 6 (restrictions on the sale of raw milk intended for direct human consumption) has effect.                  

## Special health markU.K.

F2535.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

F25Reg. 35 revoked (11.11.2014) by The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(3)**

## Consequential amendment to the ActU.K.

36.  In section 9(5)(a) of the Act F26, after “section 7” insert “ , regulation 19(1) of the Food Safety and Hygiene (England) Regulations 2013, so far as relating to the second entry in                        the list of specified EU provisions set out in column 1 of Schedule 2 to those Regulations ”.                  

F26Section 9(5)(a) was amended by S.I. 2004/3279.

## Amendments to the Official Feed and Food Controls (England) Regulations 2009U.K.

37.—(1) The Official Feed and Food Controls (England) Regulations 2009 F27 are amended in accordance with paragraphs (2) to (4).                  

(2) In regulation 2(1) (interpretation), for the definition of “the Import Provisions” substitute the following definition —

““the Import Provisions” means Part 3 of these Regulations, Article 14 of Regulation 882/2004 in so far as it applies to official controls to verify                           compliance with aspects of feed or food law not covered by Directive 97/78/ECF28, Articles 15 to 24 of Regulation 882/2004, Regulation 669/2009 and Commission Regulation (EU) No. 211/2013 on certification                           requirements for imports into the Union of sprouts and seeds intended for the production of sprouts F29;”.                     

(3) In regulation 41 (offences and penalties), after paragraph (1) insert the following as paragraph (1A) —

“(1A)Any person who imports into England or places on the market any sprouts or seeds intended for sprouting which do not comply                        with the certification requirements of Article 3 of Commission Regulation (EU) No. 211/2013 on certification requirements                        for imports into the Union of sprouts and seeds intended for the production of sprouts shall be guilty of an offence.”.                  

(4) In paragraphs (5) and (6) of regulation 3, paragraph (d) of Schedule 2 and paragraph (c) of Schedule 3, for the expression                     “the Food Hygiene (England) Regulations 2006” substitute “ the Food Safety and Hygiene (England) Regulations 2013 ”.                  

F27S.I. 2009/3255, amended by S.I. 2013/264.

F28Council Directive 97/78/EC laying down the principles governing the organisation of veterinary checks on products entering                              the Community from third countries (OJ No. L24, 30.1.1998, p.9).

F29OJ No. L68, 12.3.2012, p.26.

## Consequential amendments to the Animal By-Products (Enforcement) (England) Regulations 2013U.K.

38.  The Animal By-Products (Enforcement) (England) Regulations 2013 F30 are amended as follows —                  

(a)In [F31regulation 10(2)(a)], for “regulation 5(6) of the Food Hygiene (England) Regulations 2006” substitute “ regulation 5(9) of the Food Safety and Hygiene (England) Regulations 2013 ”;                  

(b)In [F32regulation 21(8)], for “regulation 5(2) of the Food Hygiene (England) Regulations 2006” substitute “ regulation 5(2) of the Food Safety and Hygiene (England) Regulations 2013 ”.                  

F30S.I. 2013/2952.

F31Words in reg. 38(a) substituted (15.10.2016) by The Food Safety and Hygiene (England) (Amendment) Regulations 2016 (S.I. 2016/868), regs. 1, **2(5)(a)**

F32Words in reg. 38(b) substituted (15.10.2016) by The Food Safety and Hygiene (England) (Amendment) Regulations 2016 (S.I. 2016/868), regs. 1, **2(5)(b)**

## Consequential amendment to the Trade in Animals and Related Products Regulations 2011U.K.

39.  In regulation 32(3)(b) of the Trade in Animals and Related Products Regulations 2011 F33, for “the Food Hygiene (England) Regulations 2006” substitute “ the Food Safety and Hygiene (England) Regulations 2013 ”.                  

F33S.I. 2011/1197.

## RevocationsU.K.

40.  In so far as they apply in relation to England, the instruments listed in the first column of Schedule 9 are revoked to the                     extent specified in the second column.                  

## ReviewU.K.

41.—(1) The Food Standards Agency must from time to time —                  

(a)carry out a review of the operation and effect of regulations 2 to 35;                  

(b)set out the conclusions of the review in a report; and                  

(c)publish the report.                  

(2) In carrying out the review the Agency must, so far as is reasonably practicable, have regard to how the EU instruments mentioned                     in paragraph [F34(1)] as read with paragraph [F35(6)] of regulation 2 are executed and enforced in other Member States.                  

(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 so, 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.

F34Word in reg. 41(2) substituted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(3)(a)**

F35Word in reg. 41(2) substituted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(3)(b)**

Signed by authority of the Secretary of State for Health.

Jane Ellison

 Parliamentary Under Secretary of State,

 Department of Health

Regulation 2(1)

## [F36SCHEDULE1U.K.DEFINITIONS OF LEGISLATION

F36Sch. 1 substituted (25.12.2020) by The Food and Feed Hygiene and Safety (Miscellaneous Amendments) (England) Regulations 2020 (S.I. 2020/1410), reg. 1(2), **Sch. 5**

“Directive 2004/41” means Directive 2004/41/EC of the European Parliament and of the Council repealing certain Directives concerning food hygiene and health conditions                        for the production and placing on the market of certain products of animal origin intended for human consumption and amending                        Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC;                  

“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 as read with Regulation 931/2011 and                        Regulation 208/2013;                  

“Regulation 852/2004” means Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs as read with Regulation 2073/2005 and Regulation                        210/2013;                  

“Regulation 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 as read with Directive                        2004/41, Regulation 1688/2005, Regulation 2074/2005 and 2017/185;                  

“Regulation 1688/2005” means Commission Regulation (EC) No. 1688/2005 implementing Regulation (EC) No. 853/2004 of the European Parliament and of the Council as regards special guarantees concerning salmonella for consignments to Finland                        and Sweden of certain meat and eggs;                  

“Regulation 2073/2005” means Commission Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs;                  

“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 and Regulation (EC) No. 882/2004 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 931/2011” means Commission Implementing Regulation (EU) No. 931/2011 on the traceability requirements set by Regulation                        (EC) No. 178/2002 of the European Parliament and of the Council for food of animal origin;                  

“Regulation 1169/2011” means Regulation (EU) No. 1169/2011 of the European Parliament and of the Council on the provision                        of food information to consumers, amending Regulations (EC) No. 1924/2006 and (EC) No. 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No. 608/2004;                  

“Regulation 208/2013” means Commission Implementing Regulation (EU) No. 208/2013 on traceability requirements for sprouts                        and seeds intended for the production of sprouts;                  

“Regulation 210/2013” means Commission Regulation (EU) No. 210/2013 on the approval of establishments producing sprouts pursuant to Regulation (EC) No. 852/2004 of the European Parliament and of the Council;                  

“Regulation 579/2014” means Commission Regulation (EU) No. 579/2014 granting derogation from certain provisions of Annex II to Regulation (EC) No. 852/2004 of the European Parliament and of the Council as regards the transport of liquid oils and fats by sea;                  

“Regulation 2015/1375” means Commission Implementing Regulation (EU) 2015/1375 laying down specific rules on official controls                        for Trichinella in meat;                  

“Regulation 2017/185” means Commission 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;                  

“Regulation 2017/625” means Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls and                        other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant                        health and plant protection products, amending Regulations (EC) No. 999/2001, (EC) No. 396/2005, (EC) No. 1069/2009, (EC) No. 1107/2009, (EU) No. 1151/2012, (EU) No. 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council                        Regulations (EC) No. 1/2005 and (EC) No. 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No. 854/2004 and (EC) No. 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC as read with Regulation 2074/2005, Regulation 2017/185 and the Regulation 2017/625 package;                  

*The Regulation 2017/625 package*                  

“Regulation 2019/478” means Commission Delegated Regulation (EU) 2019/478 amending Regulation (EU) 2017/625 of the European                        Parliament and of the Council as regards the categories of consignments to be subjected to official controls at border control                        posts;                  

“Regulation 2019/624” means Commission Delegated Regulation (EU) 2019/624 concerning specific rules for the performance of                        official controls on the production of meat and for production and relaying areas of live bivalve molluscs in accordance with                        Regulation (EU) 2017/625 of the European Parliament and of the Council;                  

“Regulation 2019/625” means Commission Delegated Regulation (EU) 2019/625 supplementing Regulation (EU) 2017/625 of the European                        Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals                        and goods intended for human consumption;                  

“Regulation 2019/626” means Commission Implementing Regulation (EU) 2019/626 concerning lists of third countries or regions                        thereof authorised for the entry into the European Union of certain animals and goods intended for human consumption, amending                        Implementing Regulation (EU) 2016/759 as regards these lists;                  

“Regulation 2019/627” means Commission Implementing Regulation (EU) 2019/627 laying down uniform practical arrangements for                        the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation                        (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No. 2074/2005 as regards official controls;                  

“Regulation 2019/628” means Commission Implementing Regulation (EU) 2019/628 concerning model official certificates for certain                        animals and goods and amending Regulation (EC) No. 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates;                  

“Regulation 2019/1012” means Commission Delegated Regulation (EU) 2019/1012 supplementing Regulation (EU) 2017/625 of the                        European Parliament and of the Council by derogating from the rules on the designation of control points and from the minimum                        requirements for border control posts;                  

“Regulation 2019/1013” means Commission Implementing Regulation (EU) 2019/1013 on prior notification of consignments of certain                        categories of animals and goods entering the Union;                  

“Regulation 2019/1014” means Commission Implementing Regulation (EU) 2019/1014 to lay down detailed rules on minimum requirements                        for border control posts, including inspection centres, and for the format, categories and abbreviations to use for listing                        border control posts and control points;                  

“Regulation 2019/1081” means Commission Delegated Regulation (EU) 2019/1081 establishing rules on specific training requirements                        for staff for performing certain physical checks at border control posts;                  

“Regulation 2019/1602” means Commission Delegated Regulation (EU) 2019/1602 supplementing Regulation (EU) 2017/625 of the                        European Parliament and of the Council concerning the Common Health Entry Document accompanying consignments of animals and                        goods to their destination;                  

“Regulation 2019/1666” means Commission Delegated Regulation (EU) 2019/1666 supplementing Regulation (EU) 2017/625 of the                        European Parliament and of the Council as regards conditions for monitoring the transport and arrival of consignments of certain                        goods from the border control post of arrival to the establishment at the place of destination in the Union;                  

“Regulation 2019/1715” means Commission Implementing Regulation (EU) 2019/1715 laying down rules for the functioning of the                        information management system for official controls and its system components (the IMSOC Regulation);                  

“Regulation 2019/1793” means Commission Implementing Regulation (EU) 2019/1793 on the temporary increase of official controls                        and emergency measures governing the entry into the Union of certain goods from certain third countries implementing Regulations                        (EU) 2017/625 and (EC) No. 178/2002 of the European Parliament and of the Council and repealing Commission Regulations (EC) No. 669/2009, (EU) No. 884/2014, (EU) 2015/175, (EU) 2017/186 and (EU) 2018/1660;                  

“Regulation 2019/1873” means Commission Implementing Regulation (EU) 2019/1873 on the procedures at border control posts for                        a coordinated performance by competent authorities of intensified official controls on products of animal origin, germinal                        products, animal by-products and composite products;                  

“Regulation 2019/2007” means Commission Implementing Regulation (EU) 2019/2007 laying down rules for the application of Regulation                        (EU) 2017/625 of the European Parliament and of the Council as regards the lists of animals, products of animal origin, germinal                        products, animal by-products and derived products and hay and straw subject to official controls at border control posts and                        amending Decision 2007/275/EC;                  

“Regulation 2019/2074” means Commission Delegated Regulation (EU) 2019/2074 supplementing Regulation (EU) 2017/625 of the                        European Parliament and of the Council as regards rules on specific official controls on consignments of certain animals and                        goods originating from, and returning to the Union following a refusal of entry by a third country;                  

“Regulation 2019/2122” means Commission Delegated Regulation (EU) 2019/2122 supplementing Regulation (EU) 2017/625 of the                        European Parliament and of the Council as regards certain categories of animals and goods exempted from official controls                        at border control posts, specific controls on passengers’ personal luggage and on small consignments of goods sent to natural                        persons which are not intended to be placed on the market and amending Commission Regulation (EU) No. 142/2011;                  

“Regulation 2019/2123” means Commission Delegated Regulation (EU) 2019/2123 supplementing Regulation (EU) 2017/625 of the                        European Parliament and of the Council as regards rules for the cases where and the conditions under which identity checks                        and physical checks on certain goods may be performed at control points and documentary checks may be performed at distance                        from border control posts;                  

“Regulation 2019/2124” means Commission Delegated Regulation (EU) 2019/2124 supplementing Regulation (EU) 2017/625 of the                        European Parliament and of the Council as regards rules for official controls of consignments of animals and goods in transit,                        transhipment and onward transportation through the Union, and amending Commission Regulations (EC) No. 798/2008, (EC) No. 1251/2008, (EC) No. 119/2009, (EU) No. 206/2010, (EU) No. 605/2010, (EU) No. 142/2011, (EU) No. 28/2012, Commission Implementing Regulation (EU) 2016/759                        and Commission Decision 2007/777/EC;                  

“Regulation 2019/2126” means Commission Delegated Regulation (EU) 2019/2126 supplementing Regulation (EU) 2017/625 of the                        European Parliament and of the Council as regards rules for specific official controls for certain categories of animals and                        goods, measures to be taken following the performance of such controls and certain categories of animals and goods exempted                        from official controls at border control posts;                  

“Regulation 2019/2129” means Commission Implementing Regulation (EU) 2019/2129 establishing rules for the uniform application                        of frequency rates for identity checks and physical checks on certain consignments of animals and goods entering the Union;                  

“Regulation 2019/2130” means Commission Implementing Regulation (EU) 2019/2130 establishing detailed rules on the operations                        to be carried out during and after documentary checks, identity checks and physical checks on animals and goods subject to                        official controls at border control posts;                  

“Regulation 2020/466” means Commission Implementing Regulation (EU) 2020/466 on temporary measures to contain risks to human,                        animal and plant health and animal welfare during certain serious disruptions of Member States’ control systems due to coronavirus                        disease;                  

“Regulation 2020/1158” means Commission Implementing Regulation (EU) 2020/1158 on the conditions governing imports of food                        and feed originating in third countries following the accident at the Chernobyl nuclear power station.]                  

 Regulation 2(1)

## SCHEDULE 2U.K.Specified EU provisions

F37Full stop in Sch. 2 omitted (11.11.2014) by virtue of The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(5)**

F38Words in Sch. 2 added (11.11.2014) by The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(5)**

F39Words in Sch. 2 table substituted (15.10.2016) by The Food Safety and Hygiene (England) (Amendment) Regulations 2016 (S.I. 2016/868), regs. 1, **2(4)**

 Regulations 19(4) and 31

## SCHEDULE 3U.K.Bulk transport in sea-going vessels of liquid oils or fats and the bulk transport by sea of raw sugar

### OffenceU.K.

1.  A person who contravenes or fails to comply with any of the requirements of this Schedule commits an offence.                  

### Liquid oils or fatsU.K.

F402.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

F40Sch. 3 para. 2 omitted (11.11.2014) by virtue of The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(6)(a)**

F413.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

F41Sch. 3 para. 3 omitted (11.11.2014) by virtue of The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(6)(a)**

F424.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

F42Sch. 3 para. 4 omitted (11.11.2014) by virtue of The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(6)(a)**

F435.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

F43Sch. 3 para. 5 omitted (11.11.2014) by virtue of The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(6)(a)**

F446.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

F44Sch. 3 para. 6 omitted (11.11.2014) by virtue of The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(6)(a)**

### Raw sugarU.K.

7.  The bulk transport by sea of raw sugar which is not intended for use as food or as a food ingredient without a full and effective                     refining process is permitted in receptacles, containers or tankers that are not exclusively used for the transport of foodstuffs.                  

8.  The receptacles, containers or tankers referred to in paragraph 7 shall be subject to the following conditions —U.K.

(a)prior to loading the raw sugar, the receptacle, container or tanker shall be effectively cleaned to remove residues of the                        previous cargo and other soiling and inspected to establish that such residues have been removed effectively; and

(b)the immediate previous cargo prior to the raw sugar shall not have been a bulk liquid.

9.  A food business operator who is responsible for the transport of raw sugar by sea under paragraph 7 shall keep documentary                     evidence, accurately describing in detail the immediate previous cargo carried in the receptacle, container or tanker concerned,                     and the type and effectiveness of the cleaning process applied prior to the transport of the raw sugar.U.K.

10.  The documentary evidence shall accompany the consignment of raw sugar during all stages of transport to the refinery and a                     copy shall be retained by the refinery. The documentary evidence shall be marked as follows in a clearly visible and indelible                     fashion, in one or more Community languages: “This product must be refined before being used for human consumption”.U.K.

11.  On request, a food business operator responsible for the transport of the raw sugar or the refining process shall provide                     the enforcement authority with the documentary evidence referred to in paragraphs 9 and 10.U.K.

12.  Raw sugar which has been transported by sea in receptacles, containers or tankers which are not exclusively reserved for the                     transport of foodstuffs shall be subjected to a full and effective refining process before being considered suitable for use                     as food or as a food ingredient.U.K.

13.  In fulfilling the obligations under Article 5(1) of Regulation 852/2004 (hazard analysis and critical control points) in relation                     to the bulk transport of raw sugar by sea under paragraph 7, a food business operator who is responsible for the transport                     or refining of raw sugar shall —U.K.

(a)consider the cleaning process undertaken prior to the loading of the sugar for transport by sea to be a critical control point                        as referred to in Article 5(2)(b) of Regulation 852/2004; and

(b)take into account the nature of the previous cargo which has been transported in any receptacle, container or tanker used                        for the transport of the sugar.

### InterpretationU.K.

14.—(1) For the purposes of this Schedule any words or expressions used both in this Schedule and in F45... Commission Directive 98/28/EC granting a derogation from certain provisions of Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport by sea of bulk raw sugar shall bear the same meanings as they respectively                     have in those Directives.                  

F46(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .                  

F45Words in Sch. 3 para. 14(1) omitted (11.11.2014) by virtue of The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(6)(b)**

F46Sch. 3 para. 14(2) omitted (11.11.2014) by virtue of The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(6)(c)**

 Regulation 32

## SCHEDULE 4U.K.Temperature control requirements

### ScopeU.K.

1.—(1) This Schedule does not apply in relation to —                  

(a)any food business operation to which Regulation 853/2004 applies; or                  

(b)any food business operation carried out on a ship or aircraft.                  

### Chill holding requirementsU.K.

2.—(1) Subject to sub-paragraph (2) and paragraph 3, any person who keeps any food —                  

(a)which is likely to support the growth of pathogenic micro-organisms or the formation of toxins; and                  

(b)with respect to which any commercial operation is being carried out,                  

at or in food premises at a temperature above 8 °C commits an offence.

(2) Sub-paragraph (1) shall not apply in relation to any food which, as part of a mail order transaction, is being conveyed to                     the final consumer.                  

(3) Subject to paragraph 3, no person shall supply by mail order any food which —

(a)is likely to support the growth of pathogenic micro-organisms or the formation of toxins; and                  

(b)is being or has been conveyed by post or by a private or common carrier to the final consumer,                  

at a temperature which has given rise to or is likely to give rise to a risk to health.

### General exemptions from the chill holding requirementsU.K.

3.  Sub-paragraphs (1) and (3) of paragraph 2 shall not apply in relation to —                  

(a)food which —                  

(i)has been cooked or reheated,                  

(ii)is for service or on display for sale, and                  

(iii)needs to be kept at or above 63 °C in order to control the growth of pathogenic micro-organisms or the formation of toxins;                  

(b)food which, for the duration of its shelf life may be kept at ambient temperatures with no risk to health;                  

(c)food which is being or has been subjected to a process such as dehydration or canning intended to prevent the growth of pathogenic                        micro-organisms at ambient temperatures, but not where —                  

(i)after or by virtue of that process the food was contained in a hermetically sealed container, and                  

(ii)that container has been opened;                  

(d)food which must be ripened or matured at ambient temperatures, but not when the process of ripening or maturation is completed;                  

(e)raw food intended for further processing (including cooking) before human consumption, but only if that processing, if undertaken                        correctly, will render that food fit for human consumption;                  

(f)food to which Council Regulation 1906/90 applies; and                  

(g)food to which Council Regulation 1907/90 applied.                  

### Upward variation of the 8 degrees centigrade temperature by manufacturers etc.U.K.

4.—(1) In any proceedings for an offence consisting of a contravention of sub-paragraph (1) of paragraph 2, it shall be a defence                     for the accused to prove that —                  

(a)a food business responsible for manufacturing, preparing or processing the food, including, where relevant, the accused, has                        recommended that it is kept —                  

(i)at or below a specified temperature between 8 °C and ambient temperatures, and                  

(ii)for a period not exceeding a specified shelf life;                  

(b)that recommendation has, unless the accused is that food business, been communicated to the accused either by means of a label                        on the packaging of the food or by means of some other appropriate form of written instruction;                  

(c)the food was not kept by the accused at a temperature above the specified temperature; and                  

(d)at the time of the commission of the alleged offence, the specified shelf life had not been exceeded.                  

(2) A food business responsible for manufacturing, preparing or processing food shall not recommend that any food is kept —

(a)at or below a specified temperature between 8 °C and ambient temperatures; and                  

(b)for a period not exceeding a specified shelf life,                  

unless that recommendation is supported by a well-founded scientific assessment of the safety of the food at the specified                     temperature.                  

### Chill holding tolerance periodsU.K.

5.—(1) In any proceedings for an offence consisting of a contravention of sub-paragraph (1) of paragraph 2, it shall be a defence                     for the accused to prove that the food —                  

(a)was for service or on display for sale;                  

(b)had not previously been kept for service or on display for sale at a temperature above 8 °C or, where a recommendation has                        been made pursuant to sub-paragraph (1) of paragraph 4, the recommended temperature; and                  

(c)had been kept for service or on display for sale for a period of less than four hours.                  

(2) In any proceedings for an offence consisting of a contravention of sub-paragraph (1) of paragraph 2, it shall be a defence                     for the accused to prove that the food —                  

(a)was being transferred —                  

(i)from premises at which the food was going to be kept at or below 8 °C or in appropriate circumstances the recommended temperature                        to a vehicle used for the purposes of a food business, or                  

(ii)to such premises from such a vehicle; or                  

(b)was kept at a temperature above 8 °C or, in appropriate circumstances, the recommended temperature for an unavoidable reason,                        such as —                  

(i)to accommodate the practicalities of handling during and after processing or preparation,                  

(ii)the defrosting of equipment, or                  

(iii)temporary breakdown of equipment,                  

and was kept at a temperature above 8 °C or, in appropriate circumstances, the recommended temperature for a limited period                     only and that period was consistent with food safety.                  

### Hot holding requirementsU.K.

6.  Any person who in the course of the activities of a food business keeps at or in food premises at a temperature below 63 °C                     any food which —                  

(a)has been cooked or reheated;                  

(b)is for service or on display for sale; and                  

(c)needs to be kept at or above 63 °C in order to control the growth of pathogenic micro-organisms or the formation of toxins,                  

commits an offence.

### Hot holding defencesU.K.

7.—(1) In any proceedings for an offence consisting of a contravention of paragraph 6, it shall be a defence for the accused to prove                     that —                  

(a)a well-founded scientific assessment of the safety of the food at temperatures below 63 °C has concluded that there is no                        risk to health if, after cooking or re-heating, the food is held for service or on display for sale —                  

(i)at a holding temperature which is below 63 °C, and                  

(ii)for a period not exceeding any period of time specified in that scientific assessment; and                  

(b)at the time of the commission of the alleged offence, the food was held in a manner which was justified in the light of that                        scientific assessment.                  

(2) In any proceedings for an offence consisting of a contravention of paragraph 6, it shall be a defence for the accused to prove                     that the food —                  

(a)had been kept for service or on display for sale for a period of less than two hours; and                  

(b)had not previously been kept for service or on display for sale by that person.                  

### InterpretationU.K.

8.  In this Schedule —                  

“Council Regulation 1906/90” means Council Regulation (EEC) No. 1906/90 on certain marketing standards for poultry as last amended by Council Regulation (EC) No. 1101/98 amending Regulation (EEC) No. 1906/90 on certain marketing standards for poultry meat;                  

“Council Regulation 1907/90” means Council Regulation (EEC) No. 1907/90 on certain marketing standards for eggs as last amended by Council Regulation (EC) No. 2052/2003 amending Regulation (EEC) No. 1907/90 on certain marketing standards for eggs;                  

“recommended temperature” means a specified temperature which has been recommended in accordance with sub-paragraph (1)(a)(i) of paragraph 4; and                  

“shelf life” means—                  

[F47in relation to food for which a date of minimum durability is required in accordance with Article 9(1)(f) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as read with                                 Article 24(1) and (2) of that Regulation, the period up to and including the required date of minimum durability;                            

in relation to food for which a “use by” date is required in accordance with Article 9(1)(f) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council, as read with Article 24(1) and (2) of that Regulation, the period                                 up to and including the required “use by” date; and]                           

in relation to food which is not required to bear an indication of minimum durability or a “use by” date, the period for which                              the food can be expected to remain fit for sale if it is kept in a manner which is consistent with food safety.                           

F47Words in Sch. 4 para. 8 substituted (13.12.2014) by The Food Information Regulations 2014 (S.I. 2014/1855), **Sch. 7 para. 59**

 Regulation 33

## SCHEDULE 5U.K.Direct supply by the producer of small quantities of meat from poultry or lagomorphs slaughtered on the farm

### ScopeU.K.

1.  The requirements of this Schedule apply in relation to the direct supply by the producer of small quantities of meat from                     poultry or lagomorphs that have been slaughtered on the farm to the final consumer or to local retail establishments directly                     supplying such meat to the final consumer.                  

### RequirementsU.K.

2.—(1) Where a producer supplies meat in the manner described in paragraph 1, the producer must ensure that it bears a label or other                     marking clearly indicating the name and address of the farm where the animal from which it is derived was slaughtered.                  

(2) The producer must —

(a)keep a record in adequate form to show the number of birds and the number of lagomorphs received into, and the amounts of                        fresh meat despatched from, his premises during each week;                  

(b)retain the record for a period of one year; and                  

(c)make the record available to an authorised officer on request.                  

### OffenceU.K.

3.  A producer who fails to comply with any requirement of paragraph 2 commits an offence.                  

 Regulation 34

## SCHEDULE 6U.K.Restrictions on the sale of raw milk intended for direct human consumption

1.  Any person who sells raw milk intended for direct human consumption in contravention of paragraph 5 commits an offence.U.K.

[F481A.Any person who sells raw milk in contravention of paragraph 7A commits an offence.U.K.

F48Sch. 6 paras. 1A, 1B inserted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(4)(a)**

1B.Any person who sells raw milk in contravention of paragraph 7B commits an offence.]U.K.

F48Sch. 6 paras. 1A, 1B inserted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(4)(a)**

2.—(1) Any person, other than the occupier of a production holding or a distributor, who sells raw cows' milk intended for direct                     human consumption commits an offence.U.K.

(2) The occupier of a production holding who sells raw cows' milk intended for direct human consumption in contravention of paragraph                     3 commits an offence.                  

(3) A distributor who sells raw cows' milk intended for direct human consumption in contravention of paragraph 4 commits an offence.

3.  The occupier of a production holding may only sell raw cows' milk intended for direct human consumption —U.K.

(a)at or from the farm premises where the animals from which the milk has been obtained are maintained; and

(b)to —

(i)the final consumer for consumption other than at those farm premises,

(ii)a temporary guest or visitor to those farm premises as or as part of a meal or refreshment, or

(iii)a distributor.

4.  A distributor may only sell raw cows' milk intended for direct human consumption —U.K.

(a)which the distributor has bought pursuant to sub-paragraph (b)(iii) of paragraph 3;

(b)in the containers in which the distributor receives the milk, with the fastenings of the containers unbroken;

(c)from a vehicle which is lawfully used as a shop premises; and

(d)direct to the final consumer.

5.  The raw milk must meet the following standards:U.K.

6.  In the case where farm premises are being used for the sale of raw cows' milk intended for direct human consumption pursuant                     to sub-paragraph (a) of paragraph 3, the Agency shall carry out such sampling, analysis and examination of the milk as it                     considers necessary to ensure that it meets the standards specified in paragraph 5.U.K.

7.  In any case where the Agency carries out sampling, analysis and examination of raw cows' milk in accordance with paragraph                     6, there shall be due to the Agency from the occupier of the production holding who is selling the milk a fee of £63, which                     is payable by the occupier to the Agency on demand.U.K.

[F497A.Subject to paragraph 7C, and except in cases to which paragraph 7B applies, the container in which any raw milk intended for                        direct human consumption is sold must be marked or labelled with the words “This milk has not been heat-treated and may therefore                        contain organisms harmful to health.U.K.

F49Sch. 6 paras. 7A-7C inserted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(4)(b)**

7B.Subject to paragraph 7C, in the case of any raw milk intended for direct human consumption which is not prepacked and is sold                        at a catering establishment there must appear—U.K.

(a)on a label attached to the container in which that milk is sold, or

(b)on a ticket or notice that is readily discernible by an intending purchaser at the place where the purchaser chooses that                           milk,

the words “Milk supplied in this establishment has not been heat-treated and may therefore contain organisms harmful to health”.                  

F49Sch. 6 paras. 7A-7C inserted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(4)(b)**

7C.The provisions of paragraphs 7A and 7B do not apply to raw milk from buffaloes.]U.K.

F49Sch. 6 paras. 7A-7C inserted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(4)(b)**

8.  In this Schedule —U.K.

[F50“catering establishment” means a restaurant, canteen, club, public house, school, hospital or similar establishment (including                        a vehicle or a fixed or mobile stall) where, in the course of a business, food is prepared for delivery to the final consumer                        and is ready for consumption without further preparation;]                   

“distributor” means a person who sells raw cows' milk that has been produced on a production holding of which he is not the occupier;                  

“farm premises” means a farm occupied by the occupier of a production holding as a single farm and includes the production holding and any                     other building situated on that farm and occupied by the same occupier;                  

[F51“labelling”, in relation to a food, includes any words, particulars, trade mark, brand name, pictorial matter or symbol relating                        to the food and appearing on the packaging of the food or on any document, notice, label, ring or collar accompanying the                        food;]                   

“occupier” means any person carrying on the business of producing or handling raw cows' milk or his duly authorised representative;                  

[F52“prepacked”, in relation to a food, means put into packaging before being offered for sale in such a way that the food, whether                        wholly or only partly enclosed, cannot be altered without opening or changing the packaging and is ready for sale to the final                        consumer or to a catering establishment, and includes a food which is wholly enclosed in packaging before being offered for                        sale and which is intended to be cooked without opening the packaging and which is ready for sale to the final consumer or                        to a catering establishment;]                   

“production holding” means premises at which milk-producing cows are kept; and                  

“shop premises” means premises from which any food is sold to the final consumer.                  

F50Words in Sch. 6 para. 8 inserted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(4)(c)(i)**

F51Words in Sch. 6 para. 8 inserted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(4)(c)(ii)**

F52Words in Sch. 6 para. 8 inserted (13.12.2014) by The Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I. 2014/2885), regs. 1, **2(4)(c)(iii)**

 Regulation 19

## SCHEDULE 7U.K.Derogations relating to low throughput establishments

### **PART 1**U.K.Requirements referred to in regulation 19(5)

1.  The requirements are that —U.K.

(a)on 31st December 2005 the slaughterhouse was licensed as a low throughput slaughterhouse under the Fresh Meat (Hygiene and                        Inspection) Regulations 1995 F53;

(b)the condition of meat derived from domestic ungulates slaughtered at the slaughterhouse is only rarely such that it is necessary                        to detain such meat after post-mortem inspection for further inspection by the official veterinarian;

(c)where such further inspection is considered necessary by the official veterinarian, the meat concerned is destroyed or is                        detained at an alternative detention facility in the locality of the slaughterhouse;

(d)when meat is transported from the slaughterhouse to the alternative detention facility referred to in paragraph (c), it shall                        be marked ‘detained meat’ and accompanied by a document that has been signed by the official veterinarian, declares that the                        meat is detained meat and contains the following information—

(i)name and address of slaughterhouse of origin;

(ii)name and address of alternative detention facility;

(iii)number of carcases or cuts; and

(iv)species of animal; and

(e)no processing for human consumption of bovine animals that, in accordance with point 2 of Part I of Chapter A of Annex III                        to the EU TSE Regulation, require BSE testing at slaughter or of swine (domestic and farmed game), solipeds and other species                        susceptible to Trichinosis that, [F54under Article 18(2) of Regulation 2017/625 as read with Article 31 of Regulation 2019/627, require that examination for Trichinella                           takes place in accordance with Article 2 of Regulation 2015/1375].

F53S.I. 1995/539, revoked by S.I. 2005/2059.

F54Words in Sch. 7 para. 1(e) substituted (14.12.2019) by The Official Feed and Food Controls (England) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/1476), regs. 1, **37**

2.  For the purposes of this Part the “EU TSE Regulation” means Regulation (EC) No. 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible                     spongiform encephalopathies F55, as read with —U.K.

(a)Commission Decision 2007/411/EC prohibiting the placing on the market of products derived from bovine animals born or reared within the United Kingdom before                        1 August 1996 for any purpose and exempting such animals from certain control and eradication measures laid down in Regulation                        (EC) No. 999/2001 and repealing Decision 2005/598/ECF56,

(b)Commission Decision 2007/453/EC establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk F57, and

(c)Commission Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programmes F58.

F55OJ No. L147, 31.5.2001, p.1. This instrument was last amended by Commission Regulation (EU) No. 630/2013 (OJ No. L179, 29.6.2013,                              p.60).

F56OJ No. L155, 15.6.2007, p.74.

F57OJ No. L 172, 30.6.2007, p. 84. This instrument was last amended by Commission Implementing Decision 2012/489/EU (OJ No. L231,                              28.8.2012, p.13).

F58OJ L 256, 29.9.2009, p. 35. This instrument was last amended by Commission Implementing Decision 2013/76/EU (OJ No. L35, 6.2.2013,                              p.6).

### **PART 2**U.K.Requirements referred to in regulation 19(6)

1.  The requirements are that —U.K.

(a)on 31st December 2005 the slaughterhouse was licensed as a low throughput slaughterhouse under the Poultry Meat, Farmed Game                        Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995 F59;

(b)the condition of meat derived from poultry or lagomorphs slaughtered at the slaughterhouse is only rarely such that it is                        necessary to detain such meat after post-mortem inspection for further inspection by the official veterinarian;

(c)where such further inspection is considered necessary by the official veterinarian, the meat concerned is destroyed or is                        detained at an alternative detention facility in the locality of the slaughterhouse; and

(d)when meat is transported from the slaughterhouse to the alternative detention facility referred to in paragraph (c), it shall                        be marked ‘detained meat’ and accompanied by a document that has been signed by the official veterinarian, declares that the                        meat is detained meat and contains the following information —

(i)name and address of slaughterhouse of origin;

(ii)name and address of alternative detention facility;

(iii)number of carcases or cuts; and

(iv)species of animal.

F59S.I. 1995/540, revoked by S.I. 2005/2059.

### **PART 3**U.K.Requirements referred to in regulation 19(7)

1.  The requirements are that —U.K.

(a)on 31st December 2005 the slaughterhouse was licensed as a low throughput slaughterhouse under the Fresh Meat (Hygiene and                        Inspection) Regulations 1995;

(b)the food business operator at the slaughterhouse only accepts domestic ungulates that have been transported direct from the                        holding of origin or from a market;

(c)the food business operator responsible for transporting the domestic ungulates undertakes in writing to the food business                        operator at the slaughterhouse that he will ensure that the means of transport are cleaned and, if necessary, disinfected                        after emptying;

(d)the food business operator at the slaughterhouse retains the undertaking referred to in paragraph (c) for one year; and

(e)the food business operator at the slaughterhouse acknowledges to the official veterinarian that he may be required under animal                        health rules to cease operating at the slaughterhouse in the event of an animal disease outbreak.

### **PART 4**U.K.Requirements referred to in regulation 19(8)

1.  The requirements are that —U.K.

(a)on 31st December 2005 the slaughterhouse was licensed as a low throughput slaughterhouse under the Poultry Meat, Farmed Game                        Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995;

(b)the food business operator at the holding of origin of the poultry or lagomorphs transports them from that holding direct                        to the slaughterhouse and undertakes in writing to the food business operator at the slaughterhouse that he will ensure that                        the means of transport are cleaned and, if necessary, disinfected after emptying;

(c)the food business operator at the slaughterhouse retains the undertaking referred to in paragraph (b) for one year; and

(d)the food business operator at the slaughterhouse acknowledges to the official veterinarian that he may be required under animal                        health rules to cease operating at the slaughterhouse in the event of an animal disease outbreak.

 Regulation 35

## F60SCHEDULE 8U.K.The Special Health Mark

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F60Sch. 8 revoked (11.11.2014) by The Official Feed and Food Controls (England) and the Food Safety and Hygiene (England) (Amendment) Regulations 2014 (S.I.                                 2014/2748), regs. 1, **3(7)**

 Regulation 40

## SCHEDULE 9U.K.Revocations

## Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations revoke and re-enact with some minor changes the Food Hygiene (England) Regulations 2006 (S.I. 2006/14) and                     certain provisions of the General Food Regulations 2004 (S.I. 2004/3279) as they apply in relation to England.U.K.

2.  These Regulations provide for the execution and enforcement in England 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 (OJ No L31, 1.2.2002, p.1), as read with Commission Implementing Regulation (EU) No 931/2011 on the traceability requirements                     set by Regulation (EC) No 178/2002 of the European Parliament and of the Council for food of animal origin (OJ No. L242, 20.9.2011, p.2), and with Commission                     Implementing Regulation (EU) No 208/2013 on traceability requirements for sprouts and seeds intended for the production of                     sprouts (OJ No. L68, 12.3.2013, p.16), (“Regulation 178/2002”).U.K.

3.  These Regulations also provide for the execution and enforcement of a number of EU instruments defined (*in regulation 2(1) as read with Schedule 1*) as “the EU Hygiene Regulations”. These are —U.K.

(a)Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs (OJ No. L139, 30.4.2004, p.1), as read with Regulation                        2073/2005 and with Commission Regulation (EU) No 210/2013 on the approval of establishments producing sprouts pursuant to                        Regulation (EC) No 852/2004 of the European Parliament and of the Council;

(b)Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin (OJ No. L139,                        30.4.2004, p.55), as read with Directive 2004/41, Regulation 1688/2005, Regulation 2074/2005, Regulation 1020/2008 and Regulation                        1079/2013;

(c)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 (OJ No. L139, 30.4.2004, p.206), as read with Directive 2004/41, Regulation                        2074/2005, Regulation 2075/2005, Decision 2006/766, Regulation 1021/2008 and Regulation 1079/2013;

(d)Commission Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs (OJ No. L338, 22.12.2005, p.1); and

(e)Commission Regulation (EC) No. 2075/2005 laying down specific rules on official controls for *Trichinella* in meat (OJ No. L338, 22.12.2005, p.60).

4.  These Regulations —U.K.

(a)create certain presumptions that, for the purposes of these Regulations, specified food is intended for human consumption                        *(regulation 3*);

(b)provide that the Food Standards Agency is the competent authority for the purposes of the EU Hygiene Regulations except where                        it has delegated competence as provided for in those Regulations, and that for the purposes of certain specified provisions                        of Regulation 178/2002 is the Food standards Agency and each food authority in its area or district (*regulation 4*);

(c)make provision for the execution of these Regulations, the EU Hygiene Regulations and Regulation 178/2002 (*regulation 5*);

(d)provide for the following enforcement measures to be available in respect of a food business operator —

(i)hygiene improvement notices (*regulation 6*);

(ii)hygiene prohibition orders (*regulation 7*);

(iii)hygiene emergency prohibition notices and orders (*regulation 8*);

(iv)remedial action notices (*regulation 9*), and

(v)detention notices (*regulation 10*);

(e)provide that where the commission of an offence under these Regulations is due to the act or default of another person, that                        other person commits the offence (*regulation 11*);

(f)provide that in any proceedings for an offence under these Regulations it is a defence for the accused to prove that they                        took all reasonable precautions and exercised all due diligence to avoid the commission of the offence (*regulation 12*);

(g)provide for defences in relation to food that is non-compliant with food law but is destined for export (*regulation 13*);

(h)provide for the procurement and analysis of samples (*regulations 14 and 15*);

(i)provide powers of entry for authorised officers of a food authority or the Food Standards Agency (*regulation 16*);

(j)create the offence of obstructing an officer (*regulation 17*);

(k)provide a time limit for bringing prosecutions (*regulation 18*);

(l)provide that anyone who contravenes or fails to comply with specified EU provisions commits an offence (*regulation 19(1) and Schedule 2*);

(m)provide penalties for offences (*regulation 19(2) and (3)*);

(n)provide that in relation to certain potential contraventions, no offence is committed provided certain conditions are met                        (*regulation 19(4) to (8) and Schedules 3 and 7*);

(o)provide that where an offence is committed by a corporate body or a Scottish partnership, officers of that body or partners                        of that partnership may be deemed to have also committed the offence (*regulations 20 and 21*);

(p)provide a right of appeal against a decision of an officer of an enforcement authority —

(i)to serve a hygiene improvement notice or a remedial action notice, or

(ii)to refuse to issue a certificate to the effect that the health risk condition no longer exists in relation to the food business                        concerned (*regulation 22*);

(q)provide for the application, for the purposes of section 9 of the Food Safety Act 1990, but with a specified modification                        (*regulation 25*);

(r)provide that the Secretary of State may issue codes of recommended practice to food authorities (*regulation 26*);

(s)provide for the protection of officers acting in good faith (*regulation 27*);

(t)provide for the revocation or suspension of the appointment or designation of specified officials (*regulation 28*);

(u)provide that when an authorised officer of an enforcement authority has certified that any food has not been produced, processed                        or distributed in accordance with these Regulations and the EU Hygiene Regulations, it is to be treated for the purposes of                        section 9 of the Food Safety Act 1990 as failing to comply with food safety requirements (*regulation 29*); and

(v)make provision for the service of documents (*regulation 30*).

5.  These Regulations, (*at regulations 31 to 35*) provide that the requirements in the following Schedules have effect —U.K.

(a)Schedule 3 (bulk transport in sea-going vessels of liquid oils or fats and the bulk transport by sea of raw sugar);

(b)Schedule 4 (temperature control requirements);

(c)Schedule 5 (the direct supply by the producer of small quantities of meat from poultry or lagomorphs slaughtered on the farm);

(d)Schedule 6 (restrictions on the sale of raw milk intended for direct human consumption); and

(e)Schedule 8 (the special health mark to be applied in the case of animals that have undergone emergency slaughter).

6.  These Regulations also —U.K.

(a)make a consequential amendment (which extends to Great Britain but applies in England only) to the Food Safety Act 1990 (*regulation 36*);

(b)amend the Official Feed and Food Controls (England) Regulations 2009 (S.I. 2009/3255) in order to enforce new EU requirements                        relating to sprouting seeds (*regulation 37*);

(c)make consequential amendments to the Animal By-Products (Enforcement) (England) Regulations 2013 and the Trade in Animals                        and Related Products Regulations 2011 (*regulations 38 and 39*);

(d)revoke specified legislation (*regulation 40 and Schedule 9*); and

(e)provide that the Food Standards Agency must carry out a periodic review of the operation and effect of these Regulations (*regulation 41*).

7.  A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is                     available from the Food Safety Group of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH and is annexed                     to the Explanatory Memorandum which is available at www.legislation.gov.uk.U.K.