The Food Safety and Hygiene (England) Regulations 2013

Regulation 2(1) and (6)

SCHEDULE 1 Definitions of EU legislation

“Decision 2006/766” means Commission Decision 2006/766/EC establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted(1);

“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(2);

“Regulation 178/2002” means Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, as read with Commission Implementing Regulation (EU) No 931/2011 on the traceability requirements set by Regulation (EC) No 178/2002 of the European Parliament and of the Council for food of animal origin(3), and with Commission Implementing Regulation (EU) No 208/2013 on traceability requirements for sprouts and seeds intended for the production of sprouts(4).

“Regulation 852/2004” means Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs(5), as read with Regulation 2073/2005 and with Commission Regulation (EU) No 210/2013 on the approval of establishments producing sprouts pursuant to Regulation (EC) No 852/2004 of the European Parliament and of the Council(6);

“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(7), as read with Directive 2004/41, Regulation 1688/2005, Regulation 2074/2005, Regulation 1020/2008 and Regulation 1079/2013;

“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(8), as read with Directive 2004/41, Regulation 2074/2005, Regulation 2075/2005, Decision 2006/766, Regulation 1021/2008 and Regulation 1079/2013;

“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(9), as read with Regulation 2074/2005 and Regulation 669/2009;

“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(10);

“Regulation 2073/2005” means Commission Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs(11);

“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(12);

“Regulation 2075/2005” means Commission Regulation (EC) No. 2075/2005 laying down specific rules on official controls for Trichinella in meat(13);

“Regulation 1020/2008” means Commission Regulation (EC) No. 1020/2008 amending Annexes II and III to Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and Regulation (EC) No. 2076/2005 as regards identification marking, raw milk and dairy products, eggs and egg products and certain fishery products(14);

“Regulation 1021/2008” means Commission Regulation (EC) No. 1021/2008 amending Annexes I, II and III to 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 and Regulation (EC) No. 2076/2005 as regards live bivalve molluscs, certain fishery products and staff assisting with official controls in slaughterhouses(15);

“Regulation 596/2009” means Regulation (EC) No. 596/2009 of the European Parliament and of the Council adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny: Adaptation to the regulatory procedure with scrutiny – Part Four(16) as last amended by Regulation 1169/2011;

“Regulation 669/2009” means Commission Regulation (EC) No. 669/2009 implementing Regulation (EC) No. 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC(17);

“Regulation 1169/2011” means Regulation (EU) No. 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No. 1924/2006 and (EC) No. 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No. 608/2004(18);

“Regulation 28/2012” means Commission Regulation (EU) No 28/2012 laying down requirements for the certification for imports into and transit through the Union of certain composite products and amending Decision 2007/275/EC and Regulation (EC) No 1162/2009(19), as read with Regulation 853/2004.

“Regulation 1079/2013” means Commission Regulation (EU) No 1079/2013 laying down transitional measures for the application of Regulations (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council(20).

Regulation 2(1)

SCHEDULE 2 Specified EU provisions

1. Provision of EU Regulations	2. Subject matter
Article 12 of Regulation 178/2002, as it relates to food	Requirement that food exported or re-exported from the EU to third countries must comply with the relevant requirements of food law, except in certain specified circumstances.
Article 14(1) of Regulation 178/2002	Requirement that unsafe food must not be placed on the market.
Article 16 of Regulation 178/2002, as it relates to food	Requirement that the labelling, advertising and presentation of food must not mislead consumers.
Article 18(2) and (3) of Regulation 178/2002, as it relates to food business operators	Requirement that food business operators must ensure traceability of food, including having systems in place to identify businesses from which they have been supplied and to which they have supplied food.
Article 19 of Regulation 178/2002	Requirement that where there has been a breach of food safety requirements food business operators must, in specified circumstances, recall and/or withdraw the affected food and inform consumers and the competent authorities.
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 put in place, implement and maintain a permanent procedure or procedures based on the HACCP 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 EU 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.
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 of 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 1 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; (b) importation complies with the requirements of Council Directive 2002/99/EC; 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 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 I 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 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.

Regulations 19(4) and 31

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

Offence

1.  A person who contravenes or fails to comply with any of the requirements of this Schedule commits 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 cargoes on the vessel from which they were 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 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 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.

Regulation 32

SCHEDULE 4 Temperature control requirements

Scope

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

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

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

Chill holding requirements

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

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

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

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

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

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

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

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

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

General exemptions from the chill holding requirements

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

(a) food which —

(i) has been cooked or reheated,

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

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

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

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

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

(ii) that container has been opened;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Chill holding tolerance periods

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

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

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

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

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

(a) was being transferred —

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

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

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

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

(ii) the defrosting of equipment, or

(iii) temporary breakdown of equipment,

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

Hot holding requirements

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

(a) has been cooked or reheated;

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

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

commits an offence.

Hot holding defences

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

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

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

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

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

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

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

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

Interpretation

8.  In this Schedule —

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

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

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

“shelf life” means—

(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(21) (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 33

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

Scope

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

Requirements

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

(2) The producer must —

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

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

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

Offence

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

Regulation 34

SCHEDULE 6 Restrictions on the sale of raw milk intended for direct human consumption

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

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

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

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

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

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

(b) to —

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

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

(iii) a distributor.

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

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

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

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

(d) direct to the final consumer.

5.  The raw milk must meet the following standards:

Plate count at 30°C (cfu per ml)	≤ 20,000
Coliforms (cfu per ml)	< 100

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

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

8.  In this Schedule —

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

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

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

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

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

Regulation 19

SCHEDULE 7 Derogations relating to low throughput establishments

PART 1 Requirements referred to in regulation 19(5)

1.  The requirements are that —

(a) on 31st December 2005 the slaughterhouse was licensed as a low throughput slaughterhouse under the Fresh Meat (Hygiene and Inspection) Regulations 1995(22);

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

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

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

(i) name and address of slaughterhouse of origin;

(ii) name and address of alternative detention facility;

(iii) number of carcases or cuts; and

(iv) species of animal; and

(e) no processing for human consumption of bovine animals that, in accordance with point 2 of Part I of Chapter A of Annex III to the EU TSE Regulation, require BSE testing at slaughter or of swine (domestic and farmed game), solipeds and other species susceptible to Trichinosis that, under Article 5 of Regulation 854/2004 as read with point 1 of Part C of Chapter IX of Section IV of Annex I to that Regulation, require that examination for Trichinosis takes place at the slaughterhouse.

2.  For the purposes of this Part the “EU TSE Regulation” means Regulation (EC) No. 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(23), as read with —

(a) Commission Decision 2007/411/EC prohibiting the placing on the market of products derived from bovine animals born or reared within the United Kingdom before 1 August 1996 for any purpose and exempting such animals from certain control and eradication measures laid down in Regulation (EC) No. 999/2001 and repealing Decision 2005/598/EC(24),

(b) Commission Decision 2007/453/EC establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk(25), and

(c) Commission Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programmes(26).

PART 2 Requirements referred to in regulation 19(6)

1.  The requirements are that —

(a) on 31st December 2005 the slaughterhouse was licensed as a low throughput slaughterhouse under the Poultry Meat, Farmed Game Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995(27);

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

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

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

(i) name and address of slaughterhouse of origin;

(ii) name and address of alternative detention facility;

(iii) number of carcases or cuts; and

(iv) species of animal.

PART 3 Requirements referred to in regulation 19(7)

1.  The requirements are that —

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

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

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

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

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

PART 4 Requirements referred to in regulation 19(8)

1.  The requirements are that —

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

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

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

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

Regulation 35

SCHEDULE 8 The Special Health Mark

1.  The special health mark shall consist of a square mark containing in legible form the following characters:

• on the upper part, the letters “UK”;

• in the centre, the approval number of the premises; and

• on the lower part, the letter “N”.

2.  When applied to carcases, the special health mark shall measure 5.5 cm by 5.5 cm and contain letters 0.8 cm high and figures 1 cm high. The dimensions and characters of the mark may be reduced for health marking of lamb, kids and piglets.

Regulation 40

SCHEDULE 9 Revocations

Instrument	Provisions
The Food (Cheese) (Emergency Control) Order 1998 (S.I. 1998/1277)	The whole Order
The Food (Cheese) (Emergency Control) (Amendment) Order 1998 (S.I. 1998/1284)	The whole Order
The Food (Cheese) (Emergency Control) (Amendment) Order 1998 (S.I. 1998/1673)	The whole Order
The General Food Regulations 2004 (S.I.2004/3279)	Regulations 3, 4, 5, 6, 6A and 7
The Food Hygiene (England) Regulations 2006 (S.I. 2006/14)	The whole Regulations
The Food Hygiene (England) (Amendment) Regulations 2010 (S.I. 2010/534)	The whole Regulations
The Food Hygiene (England) (Amendment) Regulations 2012 (S.I. 2012/1742)	The whole Regulations

(1)

OJ No. L320, 18.11.2006, p.53. This instrument was last amended by Commission Regulation (EU) No.519/2013 (OJ No. L158, 10.6.2013, p.74).

(2)

OJ No. L157, 30.4.2004, p.33. The revised text of Directive 2004/41/EC is now set out in a Corrigendum (OJ No. L195, 2.6.2004, p.12).

(3)

OJ No. L242, 20.9.2011, p.2.

(4)

OJ No. L68, 12.3.2013, p.16.

(5)

OJ No. L139, 30.4.2004, p.1. The revised text of Regulation (EC) No. 852/2004 is now set out in a Corrigendum (OJ No. L226, 25.6.2004, p.3) which should be read with a further Corrigendum (OJ No. L204, 4.8.2007, p.26).

(6)

OJ No. L68, 12.3.2013, p.24.This instrument was last amended by Regulation (EC) No. 219/2009 of the European Parliament and of the Council (OJ No.87, 31.3.2009, p.109).

(7)

OJ No. L139, 30.4.2004, p.55. The revised text of Regulation (EC) No. 853/2004 is now set out in a Corrigendum (OJ No. L226, 25.6.2004, p.22) which should be read with a further Corrigendum (OJ No. L204, 4.8.2007, p.26). This instrument was last amended by Commission Regulation (EU) No. 786/2013 (OJ No. L220, 17.8.2013, p.14).

(8)

OJ No. L139, 30.4.2004, p.206. The revised text of Regulation (EC) No. 854/2004 is now set out in a Corrigendum (OJ No. L226, 25.6.2004, p.83) which should be read with a further Corrigendum (OJ No. L204, 4.8.2007, p.26).This instrument was last amended by Commission Regulation (EU) No. 517/2013 (OJ No. L158, 10.6.2013, p.1).

(9)

OJ No. L165, 30.4.2004, p.1. The revised text of Regulation (EC) No. 882/2004 is now set out in a Corrigendum (OJ No. L191, 28.5.2004, p.1) which should be read with a further Corrigendum (OJ No. L204, 4.8.2007, p.29). This instrument was last amended by Commission Regulation (EU) No. 517/2013 (OJ No. L158, 10.6.2013, p.1).

(10)

OJ No. L271, 15.10.2005, p.17.This instrument was last amended by Commission Implementing Regulation (EU) No. 1223/2011 (OJ No. L314, 29.11.2011, p.12).

(11)

OJ No. L338, 22.12.2005, p.1, as read with the Corrigenda at OJ No. L278, 10.10.2006, p.32 and OJ No. L283, 14.10.2006, p.62. This instrument was last amended by Commission Regulation (EU) No. 1086/2011 (OJ No. L281, 28.10.2011, p.7).

(12)

OJ No. L338, 22.12.2005, p.27. This instrument was last amended by Commission Implementing Regulation (EU) No. 1012/2012 (OJ No. L306, 6.11.2012, p.1).

(13)

OJ No. L338, 22.12.2005, p.60. This instrument was last amended by Commission Implementing Regulation (EU) No. 1109/2011 (OJ No. L287, 4.11.2011, p.23).

(14)

OJ No. L277, 18.10.2008, p.8.

(15)

OJ No. L277, 18.10.2008, p.15.

(16)

OJ No. L188, 18.7.2009, p.14.

(17)

OJ No. L194, 25.7.2009, p.11. This instrument was last amended by Commission Implementing Regulation (EU) No. 618/2013 (OJ No. L175, 27.6.2013, p.34).

(18)

OJ No. L304, 22.11.2011, p.18.

(19)

OJ No. L12, 14.1.2012, p.1.

(20)

OJ No. L292, 1.11.2013, p.10.

(21)

S.I. 1996/1499, to which there are amendments but none is relevant.

(22)

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

(23)

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

(24)

OJ No. L155, 15.6.2007, p.74.

(25)

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

(26)

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

(27)

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