The Food Hygiene (Scotland) Regulations 2006

Scottish Statutory Instruments

2006 No. 3

FOOD

The Food Hygiene (Scotland) Regulations 2006

Made

9th January 2006

Laid before the Scottish Parliament

10th January 2006

Coming into force

11th January 2006

The Scottish Ministers, in exercise of the powers conferred by section 2(2) of the European Communities Act 1972(1) and of all other powers enabling them in that behalf, after consultation 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(2), hereby make the following Regulations:

PART 1 PRELIMINARY

Citation, commencement and extent

1.—(1) These Regulations may be cited as the Food Hygiene (Scotland) Regulations 2006 and shall come into force on 11th January 2006.

(2) These Regulations extend to Scotland only.

Interpretation

2.—(1) In these Regulations–

“the Act” means the Food Safety Act 1990(3);

“the Agency” means the Food Standards Agency;

“authorised officer”, in relation to an enforcement authority, means any person appointed by that authority under regulation 5(6);

“the Community Regulations” means Regulation 852/2004, Regulation 853/2004, Regulation 854/2004, Regulation 2073/2005 and Regulation 2075/2005;

“Directive 2004/41”, “Regulation 178/2002”, “Regulation 852/2004”, “Regulation 853/2004”, “Regulation 854/2004”, “Regulation 882/2004”, “Regulation 1688/2005”, “Regulation 2073/2005”, “Regulation 2074/2005”, “Regulation 2075/2005” and “Regulation 2076/2005” have the meanings respectively given to them in Schedule 1;

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

“food authority” means a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994(4);

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

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

“specified Community provision” means any provision of the Community Regulations that is specified in column 1 of Schedule 2 and the subject-matter of which is described in column 2 of 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 Community Regulations has the meaning it bears in Regulation 178/2002 or the Community Regulations, as the case may be.

(4) Where, apart from this paragraph, any period of less than 7 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 in Scotland under the Banking and Financial Dealings Act 1971(5),

that day shall be excluded from the period.

Presumptions that food is intended for human consumption

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 authority for the purposes of the Community Regulations

4.—(1) The competent authority for the purposes of the Community Regulations is the Agency.

(2) The Agency may, as respects any of its functions as competent authority under paragraph (1) which may be delegated in terms of the Community Regulations–

(a) delegate any of those functions to any person or persons; or

(b) arrange for any of those functions to be carried out by any person or persons.

(3) Before delegating or making an arrangement in accordance with paragraph (2), the Agency shall consult the person or persons to whom any delegation, or with whom any arrangement, is to be made and shall publish a notice containing the details and operative date of the delegation or arrangement in the Edinburgh Gazette at least 7 days before that operative date.

(4) Where, in accordance with paragraph (2), the Agency has–

(a) delegated any of its functions; or

(b) made an arrangement in relation to any of its functions,

the Agency may, subject to paragraph (5),–

(c) withdraw that delegation; or

(d) vary, suspend or cancel that arrangement,

in whole or in part.

(5) Paragraph (3) shall apply to any withdrawal of a delegation or variation, suspension or cancellation of an arrangement made by the Agency under paragraph (4) as it applies to a delegation or arrangement made by it in accordance with paragraph (2).

(6) The requirement to consult under paragraph (3) may be fulfilled by consultation begun under regulation 4(3) of the Food Hygiene (Scotland) Regulations 2005(6)

Enforcement

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 its operations may enforce and execute 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) subject to paragraph (5), the food authority in whose area the food business operator carries out its operations shall enforce and execute the Hygiene Regulations in so far as the operator concerned is carrying out operations which are not enforced and executed 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 enforce and execute 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; and

(b) subject to paragraph (5), the food authority in whose area the food business operator carries out its operations shall enforce and execute the Hygiene Regulations in so far as the operator concerned is carrying out operations in relation to any establishment or activity that is not specified in sub paragraph (a).

(3) Subject to paragraph (4) the food authority in whose area operations are carried out shall execute and enforce–

(a) the Hygiene Regulations in relation to 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;

(b) the Hygiene Regulations in relation to 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; and

(c) these Regulations in relation to the matters regulated by Schedules 3 to 6.

(4) The Agency may, if it considers it appropriate to do so, execute and enforce–

(a) the Hygiene Regulations in relation to any of the establishments, activities, operations or matters referred to in paragraphs (1)(b), (2)(b) and (3)(a) and (b); and

(b) these Regulations in relation to the matters regulated by Schedules 3 to 6.

(5) Before exercising its option to enforce and execute the Hygiene Regulations or these Regulations under paragraph (4), the Agency shall consult the enforcement authority which would otherwise have a duty to carry out such enforcement and execution.

(6) The Agency and any food authority may appoint as authorised officers such persons (whether or not officers of the Agency or the authority) as they consider necessary for the purpose of enforcing the Hygiene Regulations.

(7) In this regulation–

“cutting plant” means an establishment which is used for boning and, where appropriate, cutting up fresh meat for placing on the market and which–

(a)

is approved or conditionally approved under Article 31(2) of Regulation 882/2004; or

(b)

(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(7) or the Poultry Meat, Farmed Game Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995(8);

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

(a)

is approved or conditionally approved under Article 31(2) of Regulation 882/2004; or

(b)

(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(9); and

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

(a)

is approved or conditionally approved in accordance with Article 31(2) of Regulation 882/2004; or

(b)

(although lacking 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.

PART 2 MAIN PROVISIONS

Hygiene improvement notices

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, that officer may by a notice served on the food business operator (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 is guilty of an offence.

Hygiene prohibition orders

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 food business 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 paragraph (2)(a), a prohibition on the use of the process or treatment for the purposes of the business;

(b) in a case falling within paragraph (2)(b), 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 paragraph (2)(c), 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 food business 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 a hygiene prohibition order is guilty of an offence.

(6) A hygiene prohibition order shall cease 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 it is 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 shall issue a certificate under paragraph (6)(a) within 3 days of it being satisfied as mentioned in that paragraph; and on an application by the food business operator for such a certificate, the authority shall–

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

(b) if it determines that it is not so satisfied, give notice to the food business operator of the reasons for that determination.

(8) The court shall give a direction under paragraph (6)(b) 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 6 months of the making of the hygiene prohibition order; or

(b) within 3 months of the making by the food business operator of a previous application for such a direction.

(9) Where the sheriff makes an order under regulation 8(2) with respect to any food business, paragraph (1) of this regulation shall apply as if the food business operator had been convicted by the sheriff 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 10, paragraph (4) of this regulation 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 shall be construed accordingly.

Hygiene emergency prohibition notices and orders

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

(3) Such an officer shall not apply for a hygiene emergency prohibition order unless, at least 1 day before the date of the application, the officer has served notice on the relevant food business operator of the officer’s intention to apply for the order.

(4) Paragraphs (2) and (3) of regulation 7 shall 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 shall 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 a hygiene emergency prohibition notice is guilty of an offence.

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

(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 a hygiene emergency prohibition order is guilty of an offence.

(7) A hygiene emergency prohibition notice shall cease to have effect–

(a) if no application for a hygiene emergency prohibition order is made within the period of 5 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 shall cease to have effect on the issue by the enforcement authority of a certificate to the effect that it is 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 shall issue a certificate under paragraph (8) within 3 days of it being satisfied as mentioned in that paragraph; and on an application by the food business operator for such a certificate, the authority shall–

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

(b) if it determines that it is 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 shall compensate the food business operator in respect of any loss suffered by reason of compliance by the food business operator with the notice unless–

(a) an application for a hygiene emergency prohibition order is made within the period of 5 days beginning with the service of the notice; and

(b) the sheriff is 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 shall be determined by a single arbiter appointed, failing agreement between the parties, by the sheriff.

Remedial action notices and detention notices

9.—(1) Where it appears to an authorised officer of an enforcement authority that in respect of an establishment subject to approval under Article 4(2) of Regulation 853/2004–

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

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

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

(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 shall be served as soon as practicable and shall state why it is being served.

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

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

(5) An authorised officer of an enforcement authority may, at an establishment subject to approval under Article 4(2) of Regulation 853/2004, by a notice in writing, in this regulation referred to as a “detention notice”, served on the relevant food business operator or the operator’s duly authorised representative, require the detention of any animal or food for the purposes of examination (including the taking of samples).

(6) An authorised officer of the enforcement authority whose officer served the original detention notice shall, 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 the operator’s duly authorised representative.

(7) Any person who fails to comply with a remedial action notice or a detention notice is guilty of an offence.

Offences due to fault of another person

10.  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 is guilty of 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 diligence

11.—(1) In any proceedings for an offence under these Regulations, it shall, subject to paragraph (2), be a defence to prove that 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 accused’s control.

(2) If in any case the defence provided by paragraph (1) involves the allegation that the commission of the offence was due to an 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 at the earlier of–

(a) a date 7 days before the trial diet (not being a notional trial diet); or

(b) a date 28 days after the first appearance of the accused before a court in connection with the alleged offence,

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

PART 3 ADMINISTRATION AND ENFORCEMENT

Procurement of samples

12.  An authorised officer of an enforcement authority may for the purpose of the performance by the authority of its functions under the Hygiene Regulations–

(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 14;

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

(d) take a sample of any article or substance which is found 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 samples

13.—(1) An authorised officer of an enforcement authority who has procured a sample under regulation 12 shall–

(a) if that 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;

(b) if that 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 or examination under this regulation, the food analyst or examiner is for any reason unable to perform the analysis or examination, the sample shall be submitted or, as the case may be, sent by the food analyst or examiner to such other food analyst or examiner as that person may determine.

(5) A food analyst or examiner shall analyse or examine as soon as practicable any sample submitted or sent to that person under this regulation, but may, except where–

(a) that person 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.

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

(7) Any certificate given by a food analyst or examiner under paragraph (6) shall be signed by the food analyst or examiner, but the analysis or examination may be made by any person acting under the direction of the food analyst or examiner.

(8) 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 (6); or

(b) of a document supplied to that party 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.

(9) In this regulation, where two or more public analysts are appointed for any area, any reference to the public analyst for that area shall be construed as a reference to either or any of them.

(10) The Food Safety (Sampling and Qualifications) Regulations 1990(10) shall apply in relation to a sample procured by an authorised officer of a food authority under regulation 12 as if it was a sample procured by an authorised officer under section 29 of the Act.

(11) The certificate given by a food analyst or examiner under paragraph (6) shall be in the form set out in Schedule 3 to the Food Safety (Sampling and Qualifications) Regulations 1990.

Powers of entry

14.—(1) An authorised officer of an enforcement authority other than the Agency shall, on producing, if so required, some duly authenticated document showing the officer’s authority, have 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;

(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 its functions under the Hygiene Regulations,

but subject to paragraph (3) admission to any premises used only as a private dwelling–house shall 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 shall, on producing if so required some duly authenticated document showing the officer’s authority, have 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;

(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,

but subject to paragraph (3) admission to any premises used only as a private dwelling–house shall not be demanded as of right unless 24 hours' notice of the intended entry has been given to the occupier.

(3) If the sheriff, a magistrate or 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 sheriff, magistrate or justice may by signed warrant 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 1 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 entered by virtue of such a warrant shall leave them as effectively secured against unauthorised entry as they were found.

(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) If any person who enters any premises by virtue of this regulation, or of a warrant issued under it, discloses to any person any information obtained on the premises with regard to any trade secret, that person is, unless the disclosure is made in the performance of that person’s duty, guilty of an offence.

(9) Nothing in this regulation authorises any person, except with the permission of the local authority under the Animal Health Act 1981(11), 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.

Obstruction etc. of officers

15.—(1) Any person who–

(a) intentionally obstructs any person acting in the execution of the Hygiene Regulations; or

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

is guilty of an offence.

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

(a) furnishes information which that person knows to be false or misleading in a material particular; or

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

is guilty of an offence.

(3) Nothing in paragraph (1)(b) shall be construed as requiring any person to answer any question or give any information if to do so might incriminate that person.

Time limit for commencement of prosecutions

16.—(1) No prosecution for an offence under these Regulations which is punishable under regulation 17(2) shall be begun after the expiry of–

(a) 3 years from the commission of the offence; or

(b) 1 year from the date on which evidence sufficient in the opinion of the prosecutor to warrant proceedings came to the knowledge of the prosecutor,

whichever is the earlier.

(2) For the purposes of this regulation, a certificate signed by or on behalf of the prosecutor and stating the date on which evidence sufficient in the prosecutor’s opinion to warrant the proceedings came to the knowledge of the prosecutor, shall be conclusive evidence of that fact.

(3) A certificate stating that matter and purporting to be so signed shall be deemed to be so signed unless the contrary is proved.

Offences and penalties

17.—(1) Subject to paragraph (4), any person who contravenes or fails to comply with any of the specified Community provisions is guilty of an offence.

(2) Subject to paragraph (3), 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 2 years, to a fine or to both.

(3) A person guilty of an offence under regulation 15 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.

(4) A person is not to be considered 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) if the requirements of Schedule 3 have been complied with.

Offences by bodies corporate

18.—(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 is to be deemed to be guilty of that offence and is liable to be proceeded against and punished accordingly.

(2) In paragraph (1)(a) “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 partnerships

19.  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 is to be deemed to be guilty of that offence and liable to be proceeded against and punished accordingly.

Right of appeal

20.—(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 regulation 7(6) or 8(8); or

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

may appeal to the sheriff.

(2) An appeal to the sheriff under paragraph (1) shall be by way of summary application.

(3) The period within which an appeal under paragraph (1) may be brought shall be–

(a) 1 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 regulation 6(1)(d).

(4) Where an appeal under paragraph (1)(b) is granted, the authority concerned shall give effect to the determination of the sheriff.

Appeal to Court of Session

21.  A person who is aggrieved by–

(a) the dismissal of an appeal under regulation 20(1), or

(b) a decision to make a hygiene prohibition order or a hygiene emergency prohibition order,

may appeal to the Court of Session.

Appeals against hygiene improvement notices and remedial action notices

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

(2) Where any period specified in a hygiene improvement notice pursuant to regulation 6(1)(d) 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 or is withdrawn.

Application of section 9 of the Food Safety Act 1990

23.  Section 9 of the Act (inspection and seizure of suspected food)(12) shall apply 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.

PART 4 MISCELLANEOUS AND SUPPLEMENTARY PROVISIONS

Power to issue codes of recommended practice

24.—(1) For the guidance of food authorities, the Scottish Ministers may issue codes of recommended practice as regards the execution and enforcement of the Hygiene Regulations and any such code shall be laid before the Scottish Parliament after being issued.

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

(3) In exercise of the functions conferred on it by or under the Hygiene Regulations, every food authority–

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

(b) shall comply with any direction which is given under this regulation and requires it 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 an order of the Court of Session under section 45 of the Court of Session Act 1988(13).

(5) The Agency shall consult the Scottish Ministers before making an application under paragraph (4).

(6) Before issuing any code under this regulation, the Scottish Ministers shall have regard to any relevant advice given by the Agency.

Protection of officers acting in good faith

25.—(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; and

(b) within the scope of the officer’s duties,

if the officer did that act in the honest belief that the officer’s duties under the Hygiene Regulations required or entitled the doing of it.

(2) Nothing in paragraph (1) shall be construed as relieving any enforcement authority from any liability in respect of the acts of its 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; but

(b) outside the scope of the officer’s duties,

the authority may indemnify the 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 it is satisfied that the officer honestly believed that the act complained of was within the scope of the officer’s duties.

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

Revocation and suspension of designations and appointments

26.—(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 that person 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 paragraph (5)(a).

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

(a) of that person’s 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 that person’s 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 an application for an opportunity to be heard may be made.

(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 (2) the Agency shall reconsider whether that person is unfit to perform any of the functions of the post they hold 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 paragraph (2)(b)–

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

(b) the person so nominated shall serve a notice on the person requesting 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 shall, within 21 days of the hearing, notify the person requesting the opportunity to be heard and the Agency of the determination made.

(6) The Agency shall establish and maintain a list of persons who may be nominated for the purposes of this regulation and shall 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 Regulations

27.—(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 documents

28.—(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 its secretary at its registered or principal office, or by sending the document in a prepaid letter addressed to its 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 that person at that person’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; or

(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 of raw sugar

29.  Schedule 3 (bulk transport in sea–going vessels of liquid oils or fats or of raw sugar) shall have effect.

Temperature control requirements

30.  Schedule 4 (temperature control requirements) shall have effect.

Direct supply by the producer of small quantities of meat from poultry and lagomorphs slaughtered on the farm

31.  Schedule 5 (direct supply by the producer of small quantities of meat from poultry and lagomorphs slaughtered on the farm) shall have effect.

Restrictions on the placing on the market of raw milk and raw cream intended for direct human consumption

32.  Schedule 6 (restrictions on the placing on the market of raw milk and raw cream intended for direct human consumption) shall have effect.

Consequential amendments

33.  The instruments specified in Schedule 7 are amended to the extent specified in that Schedule.

Revocations

34.  The instruments specified in column 1 of Schedule 8 are revoked to the extent specified in column 3 of that Schedule.

Savings

35.  For the purposes of these Regulations, any notice served or sample procured under the Food Hygiene (Scotland) Regulations 2005(14) is deemed to have been served or procured under these Regulations.

LEWIS MACDONALD

Authorised to sign by the Scottish Ministers

St Andrew’s House,

Edinburgh

9th January 2006

Regulation 2(1)

SCHEDULE 1 Definitions of Community legislation

• “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(15);

• “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(16) as amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council amending Regulation (EC) No. 178/2002 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(17);

• “Regulation 852/2004” means Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs(18) as read with Regulation 2073/2005;

• “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(19) as amended by Regulation 2074/2005 and Regulation 2076/2005 and as read with Directive 2004/41, Regulation 1688/2005, Regulation 2074/2005 and Regulation 2076/2005;

• “Regulation 854/2004” means Regulation (EC) No. 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption(20) as amended by Regulation 882/2004, Regulation 2074/2005 and Regulation 2076/2005 and as read with Directive 2004/41, Regulation 2074/2005, Regulation 2075/2005 and Regulation 2076/2005;

• “Regulation 882/2004” means Regulation (EC) No. 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(21) as read with Regulation 2074/2005 and Regulation 2076/2005;

• “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(22);

• “Regulation 2073/2005” means Commission Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs(23);

• “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(24);

• “Regulation 2075/2005” means Commission Regulation (EC) No. 2075/2005 laying down specific rules on official controls for Trichinella in meat(25); and

• “Regulation 2076/2005” means Commission Regulation (EC) No. 2076/2005 laying down transitional arrangements for the implementation of Regulations (EC) Nos. 853/2004, 854/2004 and 882/2004 of the European Parliament and of the Council and amending Regulations (EC) Nos. 853/2004 and 854/2004(26).

Regulations 2(1) and 17(1)

SCHEDULE 2 Specified Community provisions

Column 1	Column 2
Provision of Community Regulations	Subject-matter
Article 3 of Regulation 852/2004	Requirement that food business operators ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in Regulation 852/2004.
Article 4(1) of Regulation 852/2004	Requirement that food business operators carrying out primary production and specified associated operations comply with the general hygiene provisions laid down in Part A of Annex I to Regulation 852/2004 and any specific requirements provided for in Regulation 853/2004.
Article 4(2) of Regulation 852/2004	Requirement that food business operators carrying out any stage of production, processing and distribution of food after those stages to which Article 4(1) applies comply with the general hygiene requirements laid down in Annex II to Regulation 852/2004 and any specific requirements provided for in Regulation 853/2004.
Article 4(3) of Regulation 852/2004	Requirement that food business operators, as appropriate, adopt certain specific hygiene measures.
Article 5(1) of Regulation 852/2004	Requirement that food business operators (other than those excepted in Article 5(3)) put in place, implement and maintain a permanent procedure or procedures based on the HACCP (hazard analysis and critical control point) principles.
Article 5(2) of Regulation 852/2004	Requirement that when any modification is made in the product, process, or any step, food business operators review the procedure referred to in Article 5(1) and make the necessary changes to it.
Article 5(4)(a) of Regulation 852/2004	Requirement that food business operators provide the competent authority with evidence of their compliance with Article 5(1).
Article 5(4)(b) of Regulation 852/2004	Requirement that food business operators ensure that any documents describing the procedures developed in accordance with Article 5 are up to date.
Article 5(4)(c) of Regulation 852/2004	Requirement that food business operators retain documents and records for an appropriate period.
Article 6(1) of Regulation 852/2004	Requirement that food business operators co operate with the competent authorities in accordance with other applicable Community legislation or national law.
Article 6(2), first paragraph of Regulation 852/2004	Requirement that a food business operator notify the competent authority of each establishment under its control that carries out any of the stages of production, processing and distribution of food.
Article 6(2), second paragraph of Regulation 852/2004	Requirement that food business operators ensure that the competent authority has up to date information on establishments.
Article 6(3) of Regulation 852/2004	Requirement that food business operators ensure that establishments are approved by the competent authority when approval is required.
Article 3(1) of Regulation 853/2004	Requirement that food business operators comply with the relevant provisions of Annexes II and III to Regulation 853/2004.
Article 3(2) of Regulation 853/2004	Requirement that food business operators do not use any substance other than potable water or, when Regulation 852/2004 or Regulation 853/2004 permits its use, clean water, to remove surface contamination from products of animal origin unless use of the substance has been approved and any conditions for its use complied with.
Article 4(1) of Regulation 853/2004	Requirement that food business operators place products of animal origin manufactured in the Community on the market only if they have been prepared and handled exclusively in establishments– (a) that meet the relevant requirements of Regulation 852/2004, those of Annexes II and III to Regulation 853/2004 and other relevant requirements of food law; and (b) that the competent authority has registered or, where required in accordance with Article 4(2), approved.
Article 4(2) of Regulation 853/2004	Requirement that establishments handling those products of animal origin for which Annex III to Regulation 853/2004 lays down requirements do not operate unless the competent authority has approved them in accordance with Article 4(3).
Article 4(3) of Regulation 853/2004	Requirement that establishments subject to approval in accordance with Article 4(2) do not operate unless the competent authority has, in accordance with Regulation 854/2004– (a) granted the establishment approval to operate following an on-site visit; or (b) provided the establishment with conditional approval.
Article 4(4) of Regulation 853/2004	Requirement that food business operators co operate with the competent authorities in accordance with Regulation 854/2004 including ensuring that an establishment ceases to operate if it is no longer approved.
Article 5(1) of Regulation 853/2004	Requirement that food business operators do not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4(2) unless it has– (a) a health mark applied in accordance with Regulation 854/2004; or (b) when Regulation 854/2004 does not provide for the application of a health mark, an identification mark applied in accordance with Section I of Annex II to Regulation 853/2004.
Article 5(2) of Regulation 853/2004	Requirement that food business operators apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with Regulation 853/2004 in establishments meeting the requirements of Article 4.
Article 5(3) of Regulation 853/2004	Requirement that food business operators do not remove a health mark applied in accordance with Regulation 854/2004 from meat unless they cut or process it or work upon it in another manner.
Article 6(1) and (2) of Regulation 853/2004	Requirement that food business operators ensure that importation of products of animal origin only takes place where certain conditions are met.
Article 6(3) of Regulation 853/2004	Requirement that food business operators importing products of animal origin shall ensure that– (a) products are made available for control upon importation in accordance with Council Directive 97/78/EC(27); (b) importation complies with the requirements of Council Directive 2002/99/EC(28); and (c) operations under their control that take place after importation are carried out in accordance with the requirements of Annex III to Regulation 853/2004.
Article 6(4) of Regulation 853/2004	Requirement that food business operators importing food containing both products of plant origin and processed products of animal origin ensure that the processed products of animal origin satisfy the requirements of paragraphs (1) to (3) of Article 6.
Article 7 of Regulation 853/2004	Requirement that food business operators ensure that certificates or other documents accompany consignments of products of animal origin when required in accordance with Annex II or III to Regulation 853/2004.
Article 8 of Regulation 853/2004	Requirement that food business operators intending to place specified foods of animal origin on the market in Sweden or Finland comply with the rules set out in Article 8(2).
Article 7(1) of Regulation 2073/2005	Requirement that food business operators shall take the measures laid down in paragraphs (2) to (4) of Article 7 when the results of testing against the criteria set out in Annex 1 to Regulation 2073/2005 (microbiological criteria for foodstuffs) are unsatisfactory.
Article 9 of Regulation 2075/2005	Requirement that food business operators of holdings recognised as free from Trichinella shall inform the competent authority of any requirement as laid down in Chapter I and II(B) of Annex IV to Regulation 2075/2005 (detailed conditions for Trichinella free-holdings and regions with a negligible Trichinella risk) that is no longer fulfilled or of any other change that might affect holdings' Trichinella-free status.

Regulation 29

SCHEDULE 3 Bulk transport in sea-going vessels of liquid oils or fats or of raw sugar

Offence

1.  Any person who contravenes or fails to comply with any of the requirements of this Schedule is guilty of an offence.

Liquid oils or fats

2.—(1) The bulk transport in sea-going vessels of liquid oils or fats which are to be processed, and which are intended for or likely to be used for human consumption, is permitted in tanks that are not exclusively reserved for the transport of foodstuffs, subject to the following conditions–

(a) where the oil or fat is transported in a stainless steel tank, or tank lined with epoxy resin or technical equivalent, the immediately previous cargo transported in the tank shall have been a foodstuff or a cargo from the list of acceptable previous cargoes for liquid oils or fats; and

(b) where the oil or fat is transported in a tank of materials other than those specified in sub paragraph (a), the three previous cargoes transported in the tanks shall have been foodstuffs or from the list of acceptable previous cargoes for liquid oils or fats.

(2) For the purposes of this paragraph, “list of acceptable previous cargoes for liquid oils or fats” means the list set out in the Annex to Commission Directive 96/3/EC.

3.  The bulk transport in sea-going vessels of liquid oils or fats which are not to be further processed, and which are intended for or are likely to be used for human consumption, is permitted in tanks that are not exclusively reserved for the transport of foodstuffs, subject to the following conditions–

(a) the tank shall be of stainless steel or lined with epoxy resin or technical equivalent; and

(b) the three previous cargoes transported in the tank shall have been foodstuffs.

4.  The captain of a sea-going vessel transporting, in tanks, bulk liquid oils or fats intended for or likely to be used for human consumption shall keep accurate documentary evidence relating to the three previous cargoes carried in the tanks concerned, and the effectiveness of the cleaning process applied between those cargoes.

5.  Where the cargo has been trans-shipped, in addition to the documentary evidence required by virtue of paragraph 4, the captain of the receiving vessel shall keep accurate documentary evidence that the transport of the bulk liquid oil or fat complied with the provisions of paragraph 2 or 3 during previous shipment and of the effectiveness of the cleaning process used between those previous cargoes on the vessel from which the bulk liquid oil or fat was trans-shipped.

6.  Upon request, the captain of the vessel shall provide the enforcement authority with the documentary evidence described in paragraphs 4 and 5.

Raw sugar

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–

(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.

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”.

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.

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.

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–

(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.

Interpretation

14.—(1) For the purposes of this Schedule, any words or expressions used both in this Schedule and in Commission Directive 96/3/EC or 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(29) shall bear the same meanings as they respectively have in those Directives.

(2) In this Schedule, “Commission Directive 96/3/EC” means Commission Directive 96/3/EC granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea(30) as amended by Commission Directive 2004/4/EC amending Directive 96/3/EC granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea(31).

Regulation 30

SCHEDULE 4 Temperature control requirements

Scope

1.—(1) Subject to sub-paragraph (2), this Schedule applies in relation to any person to whose food business operations Regulation 852/2004 applies but Regulation 853/2004 does not apply.

(2) This Schedule does not apply to food business operations on any ship or aircraft.

Chill and hot holding requirements

2.—(1) Subject to sub paragraph (2), any person who keeps food with respect to which any commercial operation is being carried out at or in food premises otherwise than–

(a) in a refrigerator or refrigerating chamber or in a cool ventilated place; or

(b) at a temperature above 63°C,

is guilty of an offence.

(2) Sub paragraph (1) shall not apply to any food–

(a) which is undergoing preparation for sale;

(b) which is exposed for sale or has been sold to a consumer whether for immediate consumption or otherwise;

(c) which, immediately following any process of cooking to which it is subjected or the final processing stage if no cooking process is applied, is being cooled under hygienic conditions as quickly as possible to a temperature which would not result in a risk to health;

(d) which, in order that it may be conveniently available for sale on the premises to consumers, it is reasonable to keep otherwise than as referred to in sub-paragraph (1);

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

(f) to which Council Regulation (EEC) No. 1906/90 on certain marketing standards for poultry(32), as last amended by Council Regulation (EC) No. 1101/98(33), applies; or

(g) to which Council Regulation (EEC) No. 1907/90 on certain marketing standards for eggs(34), as last amended by Council Regulation (EC) No. 2052/2003(35), applies.

Reheating of food

3.—(1) Food which in the course of a commercial operation has been heated and which is thereafter reheated before being served for immediate consumption or exposed for sale shall, on being reheated, be raised to a temperature of not less than 82°C.

(2) Any person who contravenes the provisions of sub paragraph (1) is guilty of an offence.

(3) In any proceedings for an offence under sub paragraph (2), it shall be a defence for the accused to prove that the food could not have been raised to a temperature of not less than 82°C without a deterioration of its qualities.

Interpretation

4.  In this Schedule, “shelf life” means–

(a) in relation to food with respect to which an indication of minimum durability is required in accordance with regulation 20 of the Food Labelling Regulations 1996(36) (form of indication of minimum durability), the period up to and including the date required to be included in that indication;

(b) in relation to food with respect to which a “use by” date is assigned in the form required in accordance with regulation 21 of the Food Labelling Regulations 1996 (form of indication of “use by” date), the period up to and including that date; and

(c) 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.

Regulation 31

SCHEDULE 5 Direct supply by the producer of small quantities of meat from poultry and lagomorphs slaughtered on the farm

Scope

1.  This Schedule applies 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.

Offence

2.  Any person who contravenes or fails to comply with any of the provisions of this Schedule is guilty of an offence.

Requirements

3.  No person shall sell meat from poultry or lagomorphs unless it bears a label or other marking clearly indicating the name and address of the farm where it was slaughtered.

4.  The producer shall–

(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, the producer’s premises during each week;

(b) retain the record for a period of 1 year; and

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

Regulation 32

SCHEDULE 6 Restrictions on the placing on the market of raw milk and raw cream intended for direct human consumption

1.  No person shall place on the market raw milk, or raw cream, intended for direct human consumption.

2.  Any person who contravenes paragraph 1 is guilty of an offence.

3.  In any proceedings for an offence in respect of a contravention of paragraph 1, it shall be a defence for the accused to prove that the raw milk or raw cream in respect of which the offence is alleged to have been committed was intended for export–

(a) to England, Wales or Northern Ireland or to a member state other than the United Kingdom and that the milk or cream complies with Regulation 853/2004 and with any national rules applicable to that part of the United Kingdom or to that member state, made pursuant to Article 10.8(a) of Regulation 853/2004;

(b) to a third country in accordance with Article 12 of Regulation 178/2002 as read with Article 11 of Regulation 852/2004.

Regulation 33

SCHEDULE 7 Consequential amendments

The Colours in Food Regulations 1995

1.  In the Colours in Food Regulations 1995(37) in regulation 4 (health marking etc. of certain meat and meat products), for “health marking as provided for in the Fresh Meat (Hygiene and Inspection) Regulations 1995” substitute “health mark referred to in Article 5 of Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin as amended by Regulation (EC) No. 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (38)”.

The Animal By-Products (Identification) Regulations 1995

2.  The Animal By-Products (Identification) Regulations 1995(39) are amended as provided in paragraphs 3 to 11.

3.  In regulation 2(1) (interpretation)–

(a) for the definition of “animal by-products premises” substitute–

““animal by-products premises” means premises, other than a cold store, cutting plant, game-handling establishment or slaughterhouse, from which animal by-products are despatched to other premises;”;

(b) for the definition of “cold store” substitute–

““cold store” means any premises, not forming part of a cutting plant, game-handling establishment or slaughterhouse, used for the storage, under temperature controlled conditions, of fresh meat intended for sale for human consumption;”;

(c) after the definition of “the Community Regulation”, insert–

“Regulation 854/2004” has the same meaning as in Schedule 1 to the Hygiene Regulations”;

(d)

for the definition of “cutting premises” substitute–

““cutting plant” has the meaning given in regulation 5(7) of the Hygiene Regulations;”;

(e)

for the definition of “game processing facility” substitute–

““game-handling establishment” has the meaning given in regulation 5(7) of the Hygiene Regulations;”;

(f)

for the definition of “the Hygiene Regulations” substitute–

““the Hygiene Regulations” means the Food Hygiene (Scotland) Regulations 2006(40);”;

(g)

for the definition of “occupier” substitute–

““occupier” means a person carrying on the business of any cold store, cutting plant, game-handling establishment, slaughterhouse or animal by-products premises, or the duly authorised representative of such a person;”;

(h)

for the definition of “slaughterhouse” substitute–

““slaughterhouse” has the meaning given in regulation 5(7) of the Hygiene Regulations;”; and

(i)

for the definition of “wild game” substitute–

“wild game” means–

(i)

wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption, including mammals living in enclosed territory under conditions of freedom similar to those of wild game; and

(ii)

wild birds that are hunted for human consumption.

4.  In regulation 3(1)(iv) (meaning of “animal by product”) for “in accordance with the Hygiene Regulations” substitute “in accordance with the Hygiene Regulations and Regulation 854/2004”.

5.  In regulation 4(a) (scope) for “in accordance with the Poultry Meat, Farmed Game Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995” substitute “in accordance with the Hygiene Regulations and Regulation 854/2004”.

6.  In regulation 5(2)(c) (exemptions) for the words “cold store, cutting premises, slaughterhouse, game processing facility” substitute “cutting plant, game-handling establishment, slaughterhouse”.

7.  For regulation 6 (staining of animal by-products in cold stores, cutting premises, game processing facilities or slaughterhouses) substitute–

“Staining of animal by-products in cold stores, cutting plants, game-handling establishments and slaughterhouses

6.— (1) Subject to paragraph (2) below, it shall be the duty of the occupier of any cold store, cutting plant, game-handling establishment or slaughterhouse to ensure that any animal by-product is stained without undue delay.

(2) The duty imposed by paragraph (1) above shall not apply in relation to any animal by-product which–

(a) is–

(i) immediately moved to accommodation in the relevant cold store, cutting plant, game- handling establishment or slaughterhouse;

(ii) placed in a suitable, sufficient and lockable receptacle with closely fitting covers that is only used for holding meat rejected as unfit for human consumption and is clearly marked to that effect; and

(iii) stained by the operator concerned as soon as practicable after it has been placed in the receptacle; or

(b) is immediately moved, in the manner specified in paragraph (4), to an approved rendering plant for rendering there, or to an approved incineration plant which is adequately separated from the cold store, cutting plant, game-handling establishment or slaughterhouse concerned for incineration there.

(3) The occupier of any cold store, cutting plant, game-handling establishment or slaughterhouse shall ensure that any animal by-product which is placed in a receptacle in accordance with paragraph (2) above is removed from the relevant cold store, cutting plant, game-handling establishment or slaughterhouse as soon as is reasonably practicable.

(4) The manner is that the animal by-product is moved through a sealed and leak-proof pipe which connects the cold store, cutting plant, game-handling establishment or slaughterhouse concerned directly with the relevant approved rendering plant or, as the case may be, approved incineration plant.”.

8.  For regulation 8 (freezing of animal by-products in any animal by-products premises, cold store, cutting premises, game processing facility or slaughterhouse) substitute–

“Freezing of animal by-products in any animal by-products premises, cold store, cutting plant, game-handling establishment or slaughterhouse

8.— (1) Subject to paragraph (2) below, no person shall freeze any animal by-product in any animal by-products premises, cold store, cutting plant, game-handling establishment or slaughterhouse unless it has been stained in accordance with these Regulations.

(2) Paragraph (1) above shall not apply in the case of any animal by-product which is intended to be removed from the relevant animal by-products premises, cold store, cutting plant, game-handling establishment or slaughterhouse in accordance with regulation 10(2).”

9.  In regulation 9 (storage and packaging of animal by-products)–

(a) for paragraph (2) substitute–

“(2) The prohibition contained in paragraph (1) above shall not apply in relation to an animal by-product which is stored in a suitable, sufficient and lockable receptacle with closely fitting covers that is only used for holding meat rejected as unfit for human consumption and is clearly marked to that effect.”; and

(b) in paragraph (3) for “cutting premises, game processing facility” substitute “cutting plant, game-handling establishment”.

10.  In regulation 10 (restriction on movement of animal by-products)–

(a) in paragraph (1)–

(i) for “cutting premises, game processing facility” substitute “cutting plant,”; and

(ii) for “game processing facility” substitute “game-handling establishment”; and

(b) in paragraph (2), for “cutting premises, game processing facility” substitute “cutting plant, game-handling establishment”.

11.  In regulation 12 (enforcement)–

(a) in paragraph (a), for “in relation to premises licensed under the Hygiene Regulations” substitute “in relation to any cutting plant, game-handling establishment or slaughterhouse”; and

(b) for paragraph (b) substitute–

“(b) in relation to any other premises, by the Agency or the food authority within whose area the premises are situated.”.

The Food Labelling Regulations 1996

12.  The Food Labelling Regulations 1996(41) are amended as provided in paragraphs 13 to 18.

13.  In regulation 2 (interpretation), omit the definition of “raw milk”.

14.  In each of regulations 23(2)(b) (food which is not prepacked and similar food, and fancy confectionary products), 26(2) (small packages and certain indelibly marked bottles) and 27(2) (certain food sold at catering establishments), omit “and, if such milk is raw milk, the particulars required by regulation 5(e)(i)”.

15.  Omit regulation 31 (raw milk).

16.  In regulation 37 (milk)–

(a) in paragraph (1), omit “Subject to paragraph (2) of this regulation,”; and

(b) omit paragraph (2).

17.  In regulation 39 (field of vision), omit paragraph (d).

18.  In Schedule 3 (generic names in list of ingredients), Part I (general), in the entry for ““Meat” and the name of the animal species from which it comes, or a word which describes the meat by reference to the animal species from which it comes”, in column 2 for “any products covered by the European Community definition of “mechanically recovered meat” in Article 2(c) of Council Directive 64/433/EEC on health conditions for the production and marketing of fresh meat as last amended by Council Directive 95/23/EC” substitute–

• “the product obtained by removing the meat from flesh-bearing bones after boning or from carcases of farmed birds (including birds that are not considered as domestic but which are farmed as domestic animals, but not including ratites) using mechanical means resulting in the loss or modification of the muscle fibre structure”.

The Products of Animal Origin (Import and Export) Regulations 1996

19.  In the Products of Animal Origin (Import and Export) Regulations 1996(42), in regulation 1(1) (title, commencement, interpretation and extent) for the definition of “the Hygiene Regulations” substitute–

““the Hygiene Regulations” means the Food Hygiene (Scotland) Regulations 2006(43);”.

The Specified Risk Material Order 1997

20.  The Specified Risk Material Order 1997(44) is amended as provided in paragraphs 21 and 22.

21.  In article 2(1) (interpretation) after the definition of “specified solid waste” insert–

““Regulation 853/2004” has the same meaning as in Schedule 1 to the Food Hygiene (Scotland) Regulations 2006;”.

22.  In Schedule 1 (foods and feeding stuffs requiring import certificates)–

(a) for paragraph 1 substitute–

“1.   Fresh meat, as defined in paragraph 1.10 of Annex I to Regulation 853/2004.”;

(b) for paragraph 2 substitute–

“2.   Minced meat and meat preparations as defined in paragraphs 1.13 and 1.15 respectively of Annex I to Regulation 853/2004.”;

(c) for paragraph 3 substitute–

“3.   Meat products and greaves as defined in paragraphs 7.1 and 7.6 respectively of Annex I to Regulation 853/2004.”;

(d) for paragraph 8 substitute–

“8.   Rendered animal fat as defined in paragraph 7.5 of Annex I to Regulation 853/2004.”.

The Beef Bones (Scotland) Regulations 1999

23.  The Beef Bones (Scotland) Regulations 1999(45) are amended as provided in paragraphs 24 and 25.

24.  In regulation 2(1) (interpretation)–

(a) after the definition of “carcase”, insert–

““cutting plant” has the meaning given in regulation 5(7) of the Hygiene Regulations;”;

(b) after the definition of “fresh meat”, insert–

““game-handling establishment” has the meaning given in regulation 5(7) of the Hygiene Regulations;

“the Hygiene Regulations” means the Food Hygiene (Scotland) Regulations 2006”; and

(c) after the definition of “occupier”, insert–

““official veterinarian” means a veterinarian who is qualified in accordance with Regulation 854/2004 to act in such a capacity and is appointed by the Agency;

“Regulation 854/2004” has the same meaning as in Schedule 1 to the Hygiene Regulations;

“slaughterhouse” has the meaning given in regulation 5(7) of the Hygiene Regulations; and”.

25.  In regulation 10 (enforcement)–

(a) for paragraph (1) substitute–

“(1) These Regulations shall be enforced–

(a) by the Agency in relation to any cutting plant, game-handling establishment or slaughterhouse; and

(b) in relation to any other premises, by the Agency or the food authority within whose area the premises are situated”; and

(b) in paragraph (2), for “an official veterinary surgeon (designated as such under regulation 8(1) of the Fresh Meat (Hygiene and Inspection) Regulations 1995” substitute “an official veterinarian”.

Amendments to the Cattle Identification Regulations 1998

26.  The Cattle Identification Regulations 1998(46) are amended as provided in paragraphs 27 to 29.

27.  In regulation 2(1), for the definition of “official veterinary surgeon” substitute “official veterinarian” means a person who is registered in the register of veterinary surgeons or the supplementary veterinary register provided for under sections 2 and 8 of the Veterinary Surgeons Act 1966(47), who is appointed by the Agency in accordance with regulation 5(6) of the Food Hygiene (Scotland) Regulations 2006 and is qualified in accordance with Regulation No. 853/2004;”.

28.  In regulation 2(1) after the definition of “official veterinary surgeon” insert–

• “Regulation 853/2004 has the same meaning as in Schedule 1 to the Food Hygiene (Scotland) Regulations 2006(48);”.

29.  In regulation 2(1), in the definition of “licensed slaughterhouse”, for “licensed under the Fresh Meat (Hygiene and Inspection) Regulations 1995” substitute “as defined in regulation 5(7) of the Food Hygiene (Scotland) Regulations 2006”.

The Bovine and Bovine Products (Trade) Regulations 1999

30.  The Bovine and Bovine Products (Trade) Regulations 1999(49) are amended as provided in paragraphs 31 to 34.

31.  In regulation 10(3) for sub-paragraph (a) substitute “(a) the establishment is a slaughterhouse as defined in regulation 5(7) of the Food Hygiene (Scotland) Regulations 2006”.

32.  In regulation 10(3)(b) for “in the OVS room (as defined in regulation 2(1) of the Fresh Meat (Hygiene and Inspection) Regulations 1995” substitute “in the room required to be provided for the use of the official veterinarian under paragraph 9 of Chapter II of Annex III to Regulation (EC) No. 853/2004”.

33.  In regulation 10 after paragraph 6 insert–

“(7) In this regulation, Regulation 853/2004 has the same meaning as in Schedule 1 to the Food Hygiene (Scotland) Regulations 2006”.

34.  In regulation 11(2)(a) for “the Fresh Meat (Hygiene and Inspection) Regulations 1995” substitute “the Food Hygiene (Scotland) Regulations 2006”.

The TSE (Scotland) Regulations 2002

35.  The TSE (Scotland) Regulations 2002(50) are amended as provided in paragraphs 36 to 42.

36.  In regulation 3(1) (interpretation)–

(a) after the definition of “The Community Transitional Measures” insert–

• “Regulation 854/2004 has the same meaning as in Schedule 1 to the Food Hygiene (Scotland) Regulations 2006;”;

(b) for the definition of “cutting premises” substitute–

• “cutting premises" means a cutting plant as defined in regulation 5(7) of the Food Hygiene (Scotland) Regulations 2006;

(c) in paragraph (b) of the definition of “inspector”, for “designated as an OVS or as a meat hygiene inspector in accordance with regulation 8(2) of the Fresh Meat (Hygiene and Inspection) Regulations 1995” substitute “appointed as an authorised officer in accordance with regulation 5(6) of the Food Hygiene (Scotland) Regulations 2006”;

(d) for the definition of “OVS” substitute–

““official veterinarian” means a veterinarian who is registered in the register of veterinary surgeons or the supplementary veterinary register provided for under sections 2 and 8 of the Veterinary Surgeons Act 1966, is appointed by the Agency in accordance with regulation 5(6) of the Food Hygiene (Scotland) Regulations 2006 and is qualified in accordance with Regulation 854/2004 ;”;

(e) for the definition of “occupier” substitute–

““occupier” means a person carrying on the business of any cutting plant, game-handling establishment, slaughterhouse or animal by-products premises, or the duly authorised representative of such a person;” and

(f) for the definition of “slaughterhouse” substitute–

““slaughterhouse” has the meaning given in regulation 5(7) of the Food Hygiene (Scotland) Regulations 2006;”.

37.  In regulation 43(1)(c), for “the Fresh Meat (Hygiene and Inspection) Regulations 1995” substitute “in accordance with Regulation (EC) No. 854/2004”.

38.  In regulation 55(4)(a) (licensing of premises), for “cutting premises” substitute “cutting plants”.

39.  In regulations 4(3), 10A(1) and (3), 41(3)(a) and (c) and (5), 42(1) to (4), 74 and 78(3), for “OVS” in each place where it occurs substitute “official veterinarian”.

40.  For regulation 49 (mechanically recovered meat) substitute–

“Mechanically separated meat

49.— (1) No person shall contravene or fail to comply with point 3 of Part A of Annex XI to the Community TSE Regulation.

(2) No person shall use any mechanically separated meat which is derived from a bovine, ovine or caprine animal in the preparation of any food for human consumption or any feedingstuff.”.

41.  In regulations 81(1), 88(2) and 89(1), for “premises licensed under the Fresh Meat (Hygiene and Inspection) Regulations 1995” in each place where it occurs substitute “a slaughterhouse”:

42.  In regulation 99 (enforcement), for paragraph (1) substitute–

“(1) Part II and Part IV of these Regulations shall be enforced–

(a) in relation to a slaughterhouse, by the Agency or by the Scottish Ministers; and

(b) in relation to any other premises, by the Local Authority.”.

The Condensed Milk and Dried Milk (Scotland) Regulations 2003 (2003/311)

43.  In the Condensed Milk and Dried Milk (Scotland) Regulations 2003(51), in note 4 of Schedule 1, omit “Without prejudice to the generality of Part V of the Dairy Products (Hygiene) (Scotland) Regulations 1995”.

The Animal By-Products (Scotland) Regulations 2003

44.  In the Animal By-Products (Scotland) Regulations(52), in regulation 49, for paragraph (1) substitute “These Regulations shall be enforced by the Scottish Ministers in relation to premises defined as a cutting plant, game-handling establishment or slaughterhouse by regulation 5(7) of the Food Hygiene (Scotland) Regulations 2006.”

The Eggs (Marketing Standards) (Enforcement) Scotland Regulations 2005

45.  For regulation 4(3) (enforcement authorities) of the Egg (Marketing Standards) (Enforcement) (Scotland) Regulations 2005(53) substitute–

• “The Scottish Ministers shall execute and enforce the specified Community provisions insofar as they do not relate to the matters referred to in paragraph (1).”.

The Official Feed and Food Control (Scotland) Regulations 2005

46.  The Official Feed and Food Control (Scotland) Regulations 2005(54) are amended as provided in paragraphs 47 to 51.

47.  In regulation 2(1), for “and “Regulation 1688/2005”” substitute “, “Regulation 1688/2004”, “Regulation 2073/2005”, “Regulation 2074/2005” and “Regulation 2076/2005””.

48.  In regulation 15, for “the staff” substitute “a member of staff”.

49.  In regulation 43(2)(a), for “a 7 days” substitute “a date 7 days”.

50.  In regulations 4(5) and (6) and 13(7), Schedule 2, paragraph (e) and Schedule 3, paragraph (c), for “the Food Hygiene (Scotland) Regulations 2005(55)” in each place where it occurs substitute “the Food Hygiene (Scotland) Regulations 2006".

51.  For the definitions contained in Schedule 1, substitute–

““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(56);

“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 last amended by Regulation 1642/2003;

“Regulation 1642/2003” means Regulation (EC) No. 1642/2003 of the European Parliament and of the Council amending Regulation (EC) No. 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety;

“Regulation 852/2004” means Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs(57) as read with Regulation 2073/2005;

“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(58) as amended by Regulation 2074/2005 and Regulation 2076/2005 and as read with Directive 2004/41, Regulation 1688/2005, Regulation 2074/2005 and Regulation 2076/2005;

“Regulation 882/2004” means Regulation (EC) No. 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(59) as read with Regulation 2074/2005 and Regulation 2076/2005;

“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(60);

“Regulation 2073/2005” means Commission Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs(61);

“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(62); and

“Regulation 2076/2005” means Commission Regulation (EC) No. 2076/2005 laying down transitional arrangements for the implementation of Regulations (EC) No. 853/2004, (EC) No. 854/2004 and (EC) No. 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No. 853/2004 and (EC) No. 854/2004(63).”.

Regulation 34

SCHEDULE 8 Revocations

Column 1	Column 2	Column 3
Instruments	Reference	Extent of revocation
The Drinking Milk Regulations 1998	S.I. 1998/2424	Regulation 10(2) and (3)(a)
The Food Standards Act 1999 (Transitional and Consequential Provisions and Savings) (Scotland) Regulations 2000	S.S.I. 2000/62	Regulations 3(1), (2) and (3), 4(2) and (3), 5(1) to (3) and 6(1), (2) to (4), (6) and (7) and Schedule 1, Parts I and II, Schedule 2, Parts II and III, Schedule 3, Parts I to III and Schedule 4, Parts I to IV, VI and VIII
The Food Hygiene (Scotland) Regulations 2005	S.S.I. 2005/505	The whole Regulations

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which extend to Scotland only, revoke and re-enact with changes the Food Hygiene (Scotland) Regulations 2005 (S.S.I. 2005/505).

The Food Hygiene (Scotland) Regulations 2005 provided for the execution and enforcement of certain Community instruments, referred to in those Regulations as “the Community Regulations”. The Community instruments in question are those specified in paragraphs (a) to (c) below.

The Community instruments are–

(a) Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs (O.J. No. L 139, 30.4.04, p.1; the revised text of this Regulation is now set out in a Corrigendum, O.J. No. L 226, 25.6.04, p.3; “Regulation 852/2004”);

(b) Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin (O.J. No. L 139, 30.4.04, p.55; the revised text of this Regulation is now set out in a Corrigendum, O.J. No. L 226, 25.6.04, p.22);

(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 (O.J. No. L 155, 30.4.04, p.206; the revised text of this Regulation is now set out in a Corrigendum, O.J. No. L 226, 25.6.04, p.83);

Since then the Commission have published the following instruments which are also implemented by these Regulations–

(d) Commission Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs (O.J. No. L338, 22.12.05, p.1);

(e) Commission Regulation (EC) No. 2074/2005 laying down implementing measures for certain products under Regulation (EC) No. 853/2004, for the organisation of official controls under Regulations (EC) Nos. 854/2004 and 882/2004, derogating from Regulation (EC) No. 852/2004 and amending Regulations (EC) Nos. 853/2004 and 854/2004 (O.J. No. L 338, 22.12.05, p.27);

(f) Commission Regulation (EC) No. 2075/2005 laying down specific rules on official controls for Trichinella in meat (O.J. No. L 338, 22.12.05, p.60); and

(g) Commission Regulation (EC) No. 2076/2005 laying down transitional arrangements for the implementation of Regulations (EC) Nos. 853/2004, 854/2004 and 882/2004 of the European Parliament and of the Council and amending Regulations (EC) Nos. 853/2004 and 854/2004 (O.J. No. L 338, 22.12.05, p.83).

The effect of the instruments specified in paragraphs (d) to (g) above is to modify the Community instruments specified in paragraphs (a) to (c) above which require to be read along with them. The changes made by these Regulations are–

(a) to include definitions of the instruments specified in paragraphs (d) to (g) above (regulation 2(1) and Schedule 1);

(b) to change the enforcement arrangements (regulation 5);

(c) to extend the scope of Schedule 5 (direct supply by the producer of small quantities of meat form poultry or lagomorphs slaughtered on the farm) following Article 3 of Commission Regulation (EC) No. 2076/2005 laying down transitional arrangements for the implementation of Regulations (EC) Nos. 853/2004, 854/2004 and 882/2004 of the European Parliament and of the Council and amending Regulations (EC) Nos. 853/2004 and 854/2004 (O.J. No. L 338, 22.12.05, p.83); and

(d) consequential amendments to other instruments, including minor corrections.

These Regulations–

(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 Community Regulations and make provision for the Agency to delegate that function to, or enter into an arrangement concerning that function with, any other enforcement authority (regulation 4);

(c) make provision for the execution and enforcement of these Regulations and of the Community Regulations including the appointment of authorised officers (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), and

(iv) remedial action notices and detention notices (regulation 9);

(e) provide that where the commission of an offence under these Regulations is due to the act or default of some other person that other person is guilty of the offence (regulation 10);

(f) provide that in proceedings for an offence under these Regulations it is a defence for the accused to prove that all reasonable precautions were taken and all due diligence exercised so as to avoid the commission of the offence (regulation 11);

(g) provide for the procurement and analysis of samples (regulations 12 and 13);

(h) provide powers of entry for authorised officers of an enforcement authority (regulation 14);

(i) create the offence of obstructing an officer (regulation 15);

(j) provide a time limit for bringing prosecutions (regulation 16);

(k) provide that a person who contravenes or fails to comply with specified provisions of the Community Regulations set out in Schedule 2 is guilty of an offence (regulation 17(1));

(l) provide penalties for offences (regulation 17(2) and (3));

(m) provide that a person is considered not to have contravened or failed to comply with a specified provision of Regulation (EC) No. 852/2004 (requirement for bulk foodstuffs in liquid, granulate or powder form to be transported in receptacles and/or containers/tankers reserved for the transport of foodstuffs) provided the requirements of Schedule 3 are complied with (regulation 17(4));

(n) provide that 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, an officer of the body corporate or a person purporting to act as such that officer or person as well as the body corporate is deemed to be guilty of that offence and may be proceeded against and punished accordingly (regulation 18);

(o) provide that 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 is deemed to be guilty of that offence and may be proceeded against and punished accordingly (regulation 19);

(p) provide a right of appeal in respect of–

(i) the service of a hygiene improvement notice or a remedial action notice,

(ii) the refusal of an enforcement authority to issue a certificate under specified provisions to the effect that they are satisfied that a food business operator has taken measures to secure that the health risk condition is no longer fulfilled with respect to the food business concerned, and

(iii) the making of a hygiene prohibition order or a hygiene emergency prohibition order (regulations 20 to 22);

(q) provide for the application, for the purposes of these Regulations, of section 9 of the Food Safety Act 1990 (1990 c. 16), but with a specified modification (regulation 23);

(r) provide for the issue to food authorities by the Scottish Ministers of codes of recommended practice as regards the execution and enforcement of these Regulations and the Community Regulations (regulation 24);

(s) provide for the protection of officers acting in good faith (regulation 25);

(t) provide for the revocation or suspension of the designation or as the case may be appointment of specified officials (regulation 26);

(u) provide that when an authorised officer of an enforcement authority has certified that any food has not been produced, processed or distributed in compliance with these Regulations and the Community Regulations, it shall be treated for the purposes of section 9 of the Food Safety Act 1990 as failing to comply with food safety requirements (regulation 27);

(v) provide for the service of documents (regulation 28);

(w) provide for the requirements set out in the following Schedules:

(i) Schedule 3 (bulk transport in sea–going vessels of liquid oils or fats and the bulk transport by sea of raw sugar) (regulation 29),

(ii) Schedule 4 (temperature control requirements) (regulation 30),

(iii) Schedule 5 (direct supply by the producer of small quantities of meat from poultry and lagomorphs slaughtered on the farm) (regulation 31), and

(iv) Schedule 6 (restrictions on the placing on the market of raw milk and raw cream intended for direct human consumption (regulation 32),

failure to comply with which is a criminal offence;

(x) make consequential amendments to specified instruments (regulation 33 and Schedule 7);

(y) provide for the revocation of specified instruments to the extent specified (regulation 34 and Schedule 8); and

(z) provide for the saving of notices served under the Food Hygiene (Scotland) Regulations 2005 (regulation 35).

A full Regulatory Impact Assessment which includes a compliance cost assessment of the effect which these Regulations will have on business costs has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency (Scotland), St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.

(1)

1972 c. 68 (“the 1972 Act”). Section 2(2) was amended by the Scotland Act 1998 (c. 46) (“the 1998 Act”), Schedule 8, paragraph 15(3). The function conferred on the Minister of the Crown under section 2(2) of the 1972 Act, so far as within devolved competence, was transferred to the Scottish Ministers by virtue of section 53 of the 1998 Act. In so far as not so transferred and in so far as relating to food (including drink) including the primary production of food, that function was transferred to the Scottish Ministers by the Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2005 (S.I. 2005/849).

(2)

O.J. No. L 31, 1.2.02, p.1 as amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (O.J. No. L 245, 29.9.03, p.4).

(3)

1990 c. 16.

(4)

1994 c. 39; section 2 was amended by the Environment Act 1995 (c. 25), Schedule 22, paragraph 232.

(5)

1971 c. 80.

(6)

2005/505.

(7)

S.I. 1995/539, to which relevant amendments were made by S.I. 1995/225, S.I. 1995/3189 and S.S.I. 2000/171.

(8)

S.I. 1995/540, to which relevant amendments were made by S.S.I. 2000/141.

(9)

S.I. 1995/2148.

(10)

S.I. 1990/2463, to which there are amendments not relevant to these Regulations.

(11)

1981 c. 22.

(12)

Section 9 was amended by the General Food Regulations 2004 (S.I. 2004/3279) and section 1(1) and (2) (definition of “food”) was substituted by the Food Safety Act 1990 (Amendment) Regulations 2004 (S.I. 2004/2990).

(13)

1988 c. 36.

(14)

S.S.I. 2005/505.

(15)

O.J. No. L 157, 30.4.04, p.33. The revised text of Directive 2004/41/EC is now set out in a Corrigendum (O.J. No. L 195, 2.6.04, p.12).

(16)

O.J. No. L 31, 1.2.02, p.1.

(17)

O.J. No. L 245, 29.9.03, p.4.

(18)

O.J. No. L 139, 30.4.04, p.1. The revised text of Regulation 852/2004 is now set out in a Corrigendum (O.J. No. L 226, 25.6.04, p. 3).

(19)

O.J. No. L 139, 30.4.04, p.55. The revised text of Regulation 853/2004 is now set out in a Corrigendum (O.J. No. L 226, 25.6.04, p.22).

(20)

O.J. No. L 139, 30.4.04, p.206. The revised text of Regulation 854/2004 is now set out in a Corrigendum (O.J. No. L 226, 25.6.04, p.83).

(21)

O.J. No. L 165, 30.4.04, p.1. The revised text of Regulation (EC) No. 882/2004 is now set out in a Corrigendum (O.J. No. L 191, 28.5.04, p.1).

(22)

O.J. No. L 271, 15.10.05, p. 17.

(23)

O.J. No.. L338, 22.12.05, p.1.

(24)

O.J. No. L 338, 22.12.05, p.27.

(25)

O.J. No. L 338, 22.12.05, p.60.

(26)

O.J. No. L 338, 22.12.05, p. 83.

(27)

O.J. No. L 24, 30.1.98, p.9.

(28)

O.J. No. L 18, 23.1.03, p.11.

(29)

O.J. No. L 140, 12.5.98, p.10.

(30)

O.J. No. L 21, 27.1.96, p.42.

(31)

O.J. No. L 15, 22.1.04, p.25.

(32)

O.J. No. L 173, 6.7.90, p.1.

(33)

O.J. No. L 157, 30.5.98, p.12.

(34)

O.J. No. L 173, 6.7.90, p.5.

(35)

O.J. No. L 305, 22.11.03, p.1.

(36)

S.I. 1996/1499, to which there are amendments not relevant to these Regulations.

(37)

S.I. 1995/3124, to which there are amendments not relevant to these Regulations.

(38)

O.J. No. L 139, 30.4.04, p.55. The revised text of Regulation 853/2004 is now set out in a Corrigendum (O.J. No. L 226, 25.6.04, p.22).

(39)

S.I. 1995/614, amended by S.I. 1995/1955, 1996/3124, 1997/2073, S.S.I. 2000/62, 2002/283, 2003/53 and 411 and 2005/470.

(40)

S.S.I. 2006/ 3 .

(41)

S.I. 1996/1499 amended by S.I. 1998/2424, 141 and 1398, 1999/747, 982, 1136, 1483, 1603 and 1540, S.S.I. 2000/83 and 309, 2001/38, 2002/524, 2003/145, 291, 293, 311, 527, 569 and 578, 2004/06, 133, 269, 395 and 472 and 2005/222 and 456.

(42)

S.I. 1996/3124.

(43)

S.S.I. 2006/3 .

(44)

S.I. 1997/2964.

(45)

S.S.I. 1999/186.

(46)

S.I. 1998/871.

(47)

1966 c. 36.

(48)

S.S.I. 2006/ 3 .

(49)

S.I. 1999/1103.

(50)

S.S.I. 2002/255.

(51)

S.S.I. 2003/311.

(52)

S.S.I. 2003/411.

(53)

S.S.I. 2005/332. Regulation 4(3) was substituted by S.S.I. 2005/505, regulation 33. These Regulations revoke and replace that amendment.

(54)

S.S.I. 2005/616.

(55)

S.S.I. 2005/505.

(56)

O.J. No. L 157, 30.4.04, p.33. The revised text of Directive 2004/41/EC is now set out in a Corrigendum (O.J. No. L 195, 2.6.04, p.12).

(57)

O.J. No. L 139, 30.4.04, p.1. The revised text of Regulation (EC) No. 852/2004 is now set out in a Corrigendum (O.J. No. L 226, 25.6.04, p.3).

(58)

O.J. No. L 139, 30.4.04, p.55. The revised text of Regulation (EC) No. 853/2004 is now set out in a Corrigendum (O.J. No. L 226, 25.6.04, p.22).

(59)

O.J. No. L 165, 30.4.04, p.1. The revised text of Regulation (EC) No. 882/2004 is now set out in a Corrigendum (O.J. No. L 191, 28.5.04, p.1).

(60)

O.J. No. L 271, 15.10.05, p.17.

(61)

O.J. No. L 338, 22.12.05, p.1.

(62)

O.J. No. L 338, 22.12.05, p.27.

(63)

O.J. No. L 338, 22.12.05, p.83.