Statutory Instruments made by the National Assembly for Wales

(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.

(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 by the officer on or in any such premises; and

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

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

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

(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 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 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.

     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.

     6. Upon request, the captain of the vessel must 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 will be subject to the following conditions—

(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.

     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".

     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.

     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.

     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 —

(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.

(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 will be guilty of an offence.

    (2) Sub-paragraph (1) does 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 must 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 do 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 applies.

Upward variation of the 8°C temperature by manufacturers etc.
     4. —(1) In any proceedings for an offence consisting of a contravention of sub-paragraph (1) of paragraph 2, it is 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 periods
     5. —(1) In any proceedings for an offence consisting of a contravention of sub-paragraph (1) of paragraph 2, it is 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 is 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,

will be guilty of an offence.

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

(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.

(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 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 ultimate 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 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.

     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.

     8. In this Schedule —

"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;

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

"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.

(a) Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs (OJ No. L139, 30.4.2004, p.1. The revised text of Regulation 852/2004 is now set out in a Corrigendum (OJ No. L226, 25.6.2004, 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 (OJ No. L139, 30.4.2004, p.55. The revised text of Regulation 853/2004 is now set out in Corrigendum (OJ No. L226, 25.6.2004, p.22)) ("Regulation 853/2004"); and

(c) Regulation (EC) No. 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (OJ No. L155, 30.4.2004, p.206. The revised text of Regulation 854/2004 is now set out in a Corrigendum (OJ No. L226, 25.6.2004, p.83)) ("Regulation 854/2004"). Regulation 852/2004, Regulation 853/2004 and Regulation 854/2004 are referred to as "the Community Regulations".

     2. These Regulations —

(a) create certain presumptions that, for the purposes thereof, 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 except where it has delegated competencies (regulation 4);

(c) make provision for the enforcement and execution of these Regulations and of the Community Regulations (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 thereunder 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 thereunder it is a defence for the accused to prove that the accused took all reasonable precautions and exercised all due diligence to avoid the commission of the offence (regulation 11);

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

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

(i) provide for 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 Regulation 852/2004 or Regulation 853/2004 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 thereunder 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 thereunder 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 rights of appeal in respect of hygiene improvement notices, remedial action notices, hygiene prohibition orders and hygiene emergency prohibition orders (regulations 20 to 22);

(q) provide for the application of section 9 of the Food Safety Act 1990 (1990 c. 16) (regulation 23);

(r) provide for the issue of codes to food authorities by the National Assembly for Wales of recommended practice (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 the Hygiene Regulations, it must 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 that the requirements set out in the following Schedules has effect —



(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 sale of raw milk intended for direct human consumption (regulation 32);



(x) amend Regulation 31 of the Food Labelling Regulations 1996 (Raw Milk) (regulation 32); and

(y) provide for the revocation of specified instruments to the extent specified (regulation 33).

     3. A full Regulatory Appraisal on the effect that these Regulations will have on the costs of business has been prepared and placed in the Library of the National Assembly for Wales. Copies may be obtained from the Food Standards Agency, Southgate House, Wood Street, Cardiff CF10 1EW.