The Food Hygiene (Wales) Regulations 2006

SCHEDULES

Regulation 2(1)

[F1SCHEDULE 1E+WDEFINITIONS OF EU LEGISLATION

“Decision 2006/766” (“Penderfyniad 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 as last amended by Decision 2011/131;

“Decision 2011/131” (“Penderfyniad 2011/131”) means Commission Decision 2011/131/EU amending Annexe II to Decision 2006/766/EC as regards the inclusion of Fiji in the list of third countries and territories from which imports of fishery products for human consumption are permitted;

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

“Regulation 178/2002” (“Rheoliad 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 596/2009;

“Regulation 852/2004” (“Rheoliad 852/2004”) means Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs as last amended by Regulation 219/2009 and as read with Regulation 2073/2005 [F2, 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 and with Commission Regulation (EU) No 2017/2158 establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food];

“Regulation 853/2004” (“Rheoliad 853/2004”) means Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin as last amended by Regulation 16/2012 and as read with Directive 2004/41, Regulation 1688/2005, Regulation 2074/2005, Regulation 2076/2005 [F3and Regulation 1020/2008];

“Regulation 854/2004” (“Rheoliad 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 as last amended by Regulation 739/2011 and as read with Directive 2004/41, Regulation 2074/2005, [F4Regulation 2015/1375], Regulation 2076/2005, Decision 2006/766 [F5and Regulation 1021/2008];

“Regulation 882/2004” (“Rheoliad 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 as last amended by Regulation 880/2011 and as read with Regulation 2074/2005 [F6and Regulation 669/2009];

“Regulation 1688/2005” (“Rheoliad 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 as last amended by Regulation 1223/2011;

[F7“Regulation 2073/2005” (“Rheoliad 2073/2005”) means Commission Regulation (EC) No. 2073/2005 on microbiological criteria for foodstuffs as last amended by Commission Regulation (EU) 2017/1495 amending Regulation (EC) No 2073/2005 as regards Campylobacter in broiler carcasses;]

[F8“Regulation 2074/2005” (“Rheoliad 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, as last amended by Commission Regulation (EU) 2017/1973;]

F9...

“Regulation 1020/2008” (“Rheoliad 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;

“Regulation 1021/2008” (“Rheoliad 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;

“Regulation 219/2009” (“Rheoliad 219/2009”) means Regulation (EC) No. 219/2009 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 Two;

“Regulation 596/2009” (“Rheoliad 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 as last amended by Regulation 1169/2011;

“Regulation 669/2009” (“Rheoliad 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 as last amended by Regulation 1277/2011;

F10...

“Regulation 739/2011” (“Rheoliad 739/2011”) means Commission Implementing Regulation (EU) No. 739/2011 amending Annex I 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;

F11...

“Regulation 880/2011” (“Rheoliad 880/2011 ”) means Commission Regulation (EU) No. 880/2011 correcting Regulation (EU) No. 208/2011 amending Annex VII to Regulation (EC) No. 882/2004 of the European Parliament and of the Council and Commission Regulations (EC) No. 180/2008 and (EC) No. 737/2008 as regards lists and names of EU reference laboratories;

“Regulation 1086/2011” (“Rheoliad 1086/2011”) means Commission Regulation (EU) No. 1086/2011 amending Annex II to Regulation (EC) No. 2160/2003 of the European Parliament and of the Council and Annex I to Commission Regulation (EC) No. 2073/2005 as regards salmonella in fresh poultry meat;

F12...

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

“Regulation 1223/2011” (“Rheoliad 1223/2011”) means Commission Implementing Regulation (EU) No. 1223/2011 amending Regulation (EC) No. 1688/2005 as regards sampling of flocks of origin of eggs and the microbiological examination of such samples and samples of certain meat intended for Finland and Sweden;

“Regulation 1277/2011” (“Rheoliad 1277/2011”) means Commission Implementing Regulation (EU) No. 1277/2011 amending Annex I to 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;

“Regulation 16/2012” (“Rheoliad 16/2012”) means Commission Regulation (EU) No. 16/2012 amending Annex II to Regulation (EC) No. 853/2004 of the European Parliament and of the Council as regards the requirements concerning frozen food of animal origin intended for human consumption;

F11...

F11...

F11...

[F13“Regulation 2015/1375” (“Rheoliad 2015/1375”) means Commission Implementing Regulation (EU) 2015/1375 laying down specific rules on official controls for Trichinella in meat.]]

Textual Amendments

Regulations 2(1) and 17

SCHEDULE 2E+WSPECIFIED COMMUNITY PROVISIONS

1. Provision of Community Regulations2. Subject matter
Article 3 of Regulation 852/2004Requirement 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 852/2004Requirement 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 852/2004Requirement 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 852/2004Requirement that food business operators, as appropriate, adopt certain specific hygiene measures.
Article 5(1) of Regulation 852/2004Requirement 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 852/2004Requirement 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 852/2004Requirement that food business operators provide the competent authority with evidence of their compliance with Article 5(1).
Article 5(4)(b) of Regulation 852/2004Requirement 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 852/2004Requirement that food business operators retain documents and records for an appropriate period.
Article 6(1) of Regulation 852/2004Requirement 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 852/2004Requirement 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 852/2004Requirement that food business operators ensure that the competent authority has up to date information on establishments.
Article 6(3) of Regulation 852/2004Requirement that food business operators ensure that establishments are approved by the competent authority when approval is required.
Article 3(1) of Regulation 853/2004Requirement that food business operators comply with the relevant provisions of Annexes II and III to Regulation 853/2004.
Article 3(2) of Regulation 853/2004Requirement 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 [F14European Union] 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 853/2004Requirement 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 the 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 853/2004Requirement 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 853/2004Requirement 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 853/2004Requirement 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 853/2004Requirement 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 M1;

(b)

importation complies with the requirements of Council Directive 2002/99/EC M2; 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 853/2004Requirement 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 853/2004Requirement 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 853/2004Requirement 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 2073/2005Requirement 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 [F15Regulation 2015/1375] [F16Requirement that food business operators of holdings officially recognised as applying controlled housing conditions must inform the competent authority of any requirement of Annex IV to Regulation 2015/1375 that is no longer fulfilled or of any other change that might affect the holdings’ Trichinella status.]

Textual Amendments

Marginal Citations

M1OJ No. L24, 30.1.1998, p.9.

M2OJ No. L18, 23.1.2003, p.11.

Regulation 29

SCHEDULE 3E+WBULK TRANSPORT IN SEA-GOING VESSELS OF LIQUID OILS OR FATS AND THE BULK TRANSPORT BY SEA OF RAW SUGAR

OffenceE+W

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

Liquid oils or fatsE+W

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 must 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 must 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 [F17Annex to Commission Regulation (EU) No. 579/2014 as amended from time to time].

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—E+W

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

(b)the three previous cargoes transported in the tank must 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 must 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.E+W

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 must 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.E+W

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

Raw sugarE+W

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 will be subject to the following conditions—E+W

(a)prior to loading the raw sugar, the receptacle, container or tanker must 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 must 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 must 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.E+W

10.  The documentary evidence must accompany the consignment of raw sugar during all stages of transport to the refinery and a copy must be retained by the refinery. The documentary evidence must 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”.E+W

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

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

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 must—E+W

(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.

InterpretationE+W

[F1814.  For the purposes of this Schedule any words or expressions used both in this Schedule and in Commission Regulation (EU) No 579/2014 granting derogation from certain provisions of Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council as regards the transport of liquid oils and fats by sea 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 will bear the same meanings as they respectively have in that Regulation or Directive.]

Regulation 17(5)

[F19SCHEDULE 3AE+WREQUIREMENTS REFERRED TO IN REGULATION 17(5)

Textual Amendments

The requirements are that—

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

(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 must 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 Community 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 examination for Trichinosis takes place at the slaughterhouse.

  • For the purposes of this Schedule the “Community TSE Regulation” (“Rheoliad TSE y Gymuned”) means [F20Regulation (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, as last amended by Commission Regulation (EU) 2017/893] and as read with—

    (i)

    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,

    (ii)

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

    (iii)

    Commission Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programmes as amended by Commission Decision 2010/66/EU amending Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programmes.]

Regulation 17(6)

[F19SCHEDULE 3BE+WREQUIREMENTS REFERRED TO IN REGULATION 17(6)

The requirements are that—

(a)on 31 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 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 must 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.]

Regulation 17(7)

[F19SCHEDULE 3CE+WREQUIREMENTS REFERRED TO IN REGULATION 17(7)

The requirements are that—

(a)on 31 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 or she is to 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 or she may be required under animal health rules to cease operating at the slaughterhouse in the event of an animal disease outbreak.]

Regulation 17(8)

[F19SCHEDULE 3DE+WREQUIREMENTS REFERRED TO IN REGULATION 17(8)

The requirements are that—

(a)on 31 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 or she is to 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 or she may be required under animal health rules to cease operating at the slaughterhouse in the event of an animal disease outbreak.]

Regulation 30

SCHEDULE 4E+WTEMPERATURE CONTROL REQUIREMENTS

ScopeE+W

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 requirementsE+W

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 will be guilty of an offence.

(2) Sub-paragraph (1) will 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 may 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 requirementsE+W

3.  Sub-paragraphs (1) and (3) of paragraph 2 does 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 [F21Commission Regulation 543/2008 and Regulation 1308/2013 apply]; and

(g)food to which [F22Commission Regulation 589/2008 and Regulation 1308/2013 apply].

Upward variation of the 8°C temperature by manufacturers etc.E+W

4.—(1) In any proceedings for an offence consisting of a contravention of sub-paragraph (1) of paragraph 2, it will 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 must 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 periodsE+W

5.—(1) In any proceedings for an offence consisting of a contravention of sub-paragraph (1) of paragraph 2, it will 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 will 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 requirementsE+W

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,

will be guilty of an offence.

Hot holding defencesE+W

7.—(1) In any proceedings for an offence consisting of a contravention of paragraph 6, it will 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 will 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.

InterpretationE+W

8.  In this Schedule—

[F23“Commission Regulation 543/2008” (“Rheoliad y Comisiwn 543/2008”) means Commission Regulation (EC) No 543/2008 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 as regards the marketing standards for poultrymeat;]

[F24“Commission Regulation 589/2008” (“Rheoliad y Comisiwn 589/2008”) means Commission Regulation (EC) No 589/2008 laying down detailed rules for implementing Council Regulation (EC) No 1234/2007 as regards marketing standards for eggs;]

F25...

F25...

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

[F26“Regulation 1308/2013” (“Rheoliad 1308/2013”) means Regulation (EU) No 1308/2013 of the European Parliament and of the Council establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007;]

shelf life” (“oes silff”) means—

(a)

[F27in relation to food for which a date of minimum durability is required in accordance with Article 9(1)(f) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as read with Article 24(1) and (2) of that Regulation, the period up to and including the required date of minimum durability;]

(b)

[F27in relation to food for which a “use by” date is required in accordance with Article 9(1)(f) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council, as read with Article 24(1) and (2) of that Regulation, the period up to and including the required “use by” date; and]

(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 5E+WDIRECT SUPPLY BY THE PRODUCER OF SMALL QUANTITIES OF MEAT FROM POULTRY AND LAGOMORPHS SLAUGHTERED ON THE FARM

ScopeE+W

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 as fresh meat.

RequirementsE+W

2.—(1) Where a producer supplies meat in the manner described in paragraph 1, he or she must ensure that it bears a label or other marking clearly indicating the name and address of the farm where it 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 or her 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.

OffenceE+W

3.  A person who contravenes or fails to comply with any of the requirements of this Schedule will be guilty of an offence.

Regulation 32

SCHEDULE 6E+WRESTRICTIONS 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 will be guilty of an offence.E+W

[F281A.  Any person who sells raw milk in contravention of paragraph 7A commits an offence.]E+W

[F281B.  Any person who sells raw milk in contravention of paragraph 7B commits an offence.]E+W

2.—(1) If any person other than the occupier of a production holding or a distributor sells raw cows' milk intended for direct human consumption that person will be guilty of an offence.E+W

(2) If the occupier of a production holding sells raw cows' milk intended for direct human consumption in contravention of paragraph 3 he or she will be guilty of an offence.

(3) If a distributor sells raw cows' milk intended for direct human consumption in contravention of paragraph 4 he or she will be guilty of an offence.

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

(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—E+W

(a)which he or she has bought pursuant to sub-paragraph (b)(iii) of paragraph 3;

(b)in the containers in which he or she 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:E+W

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 must 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.E+W

7.  In any case where the Agency carries out sampling, analysis and examination of raw cows' milk in accordance with paragraph 6, there will 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.E+W

[F297A.  Except in cases to which paragraph 7B applies, the container in which any raw milk is sold must be marked or labelled with the words “This milk has not been heat-treated and may therefore contain organisms harmful to health. The Food Standards Agency strongly advises that it should not be consumed by children, pregnant women, older people or those who are unwell or have chronic illness.”.]E+W

[F297B.  In the case of any raw milk which is not prepacked and is sold at a catering establishment there must appear—E+W

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

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

the words “Milk supplied in this establishment has not been heat-treated and may therefore contain organisms harmful to health. The Food Standards Agency strongly advises that it should not be consumed by children, pregnant women, older people or those who are unwell or have chronic illness.”.]

[F297C.  In addition to the English text that must be included by virtue of paragraph 7A, the mark or label may include the Welsh text “Nid yw’r llaeth hwn wedi ei drin â gwres a gall felly gynnwys organeddau sy’n niweidiol i iechyd. Mae’r Asiantaeth Safonau Bwyd yn cynghori’n gryf na ddylai gael ei yfed gan blant, merched beichiog, pobl hŷn neu’r rhai sy’n sâl neu â salwch cronig.”.]E+W

[F297D.  In addition to the English text that must be included by virtue of paragraph 7B, the label, ticket or notice may include the Welsh text “Nid yw’r llaeth a ddarperir yn y sefydliad hwn wedi ei drin â gwres a gall felly gynnwys organeddau sy’n niweidiol i iechyd. Mae’r Asiantaeth Safonau Bwyd yn cynghori’n gryf na ddylai gael ei yfed gan blant, merched beichiog, pobl hŷn neu’r rhai sy’n sâl neu â salwch cronig.”.]E+W

[F297E.  Nothing in this Schedule prevents the following being marked or labelled, as appropriate, with text corresponding to that which is required by virtue of paragraphs 7A and 7B in any other language in addition to Welsh and English—E+W

(a)the container in which raw milk is sold;

(b)in the case of raw milk which is not prepacked and is sold at a catering establishment—

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

(ii)a ticket or notice that is readily discernible by an intending purchaser at the place where the purchaser chooses that milk.]

8.  In this Schedule—E+W

[F30“catering establishment” (“sefydliad arlwyo”) means a restaurant, canteen, club, public house, school, hospital or similar establishment (including a vehicle or a fixed or mobile stall) where, in the course of a business, food is prepared for delivery to the final consumer and is ready for consumption without further preparation;]

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

farm premises” (“mangre fferm”) 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;

[F30“labelling” (“labelu”), in relation to a food, includes any words, particulars, trade mark, brand name, pictorial matter or symbol relating to the food and appearing on the packaging of the food or on any document, notice, label, ring or collar accompanying the food;]

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

[F30“prepacked” (“wedi ei ragbecynnu”), in relation to a food, means put into packaging before being offered for sale in such a way that the food, whether wholly or only partly enclosed, cannot be altered without opening or changing the packaging and is ready for sale to the final consumer or to a catering establishment;]

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

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

Regulation 32A

F31SCHEDULE 6AE+WTHE SPECIAL HEALTH MARK

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

Regulation 33

F32SCHEDULE 7E+WCONSEQUENTIAL AMENDMENTS

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