Food Safety (Products of Animal Origin) Regulations, 2017

27 FOOD SAFETY ORDINANCE, 2016 FOOD SAFETY (PRODUCTS OF ANIMAL ORIGIN) REGULATIONS, 2017 (Section 7) TABLE OF CONTENTS PART 1 PRELIMINARY AND INTERPRETATION 1. Citation and commencement 2. Application 3. Interpretation PART 2 OBLIGATIONS ON FOOD BUSINESS OPERATORS 4. General Obligation 5. Approval of premises 6. Identification marking 7. Products of animal origin from outside St Helena 8. Revocation and transitional provision Schedule I: Definitions 1. Meat 2. Eggs 3. Processed Products 4. Other Definitions Schedule II: Requirements Concerning Several Products of Animal Origin Part I: Identification Marking Part IL: Objectives Of Haccp-Based Procedures Schedule III: Specific Requirements Part I: Meat of Domestic Ungulates Part II: Meat from Poultry and Lagomorphs Part III: Minced Meat, Meat Preparations and Mechanically Separated Meat (MSM) Part IV: Meat Products Part V: Eggs Aad Egg Products Part VI: Raw Milk and Dairy Products PART 1 PRELIMINARY AND INTERPRETATION Citation and commencement 1. These Regulations may be cited as the Food Safety (Products of Animal Origin) Regulations, 2017, and come into force on 1st April 2017. Application 2. These Regulations do not apply to— (a) primary production for private domestic use; (b) the domestic preparation, handling or storage of food for private domestic consumption; or 28 (c) retail sale, except where the operations in paragraph (b) — (i) are carried out with a view to the supply of food of animal origin to another establishment; or (ii) include the slaughter of animals for sale for human consumption. Interpretation 3. Any word or expression to which a meaning has been assigned in the Ordinance, or any other subsidiary legislation made under it, bears the meaning so assigned and the words and expressions in Schedule 1 are defined for purposes of these Regulations. PART 2 OBLIGATIONS ON FOOD BUSINESS OPERATORS General Obligation 4. Food business operators must comply with the relevant provisions of Schedules II and III. Approval of premises 5. (1) Food business operators must place products of animal origin, for which Schedule III lays down requirements, on the market only if they have been prepared and handled exclusively in establishments which— (a) meet the relevant requirements of the Food Safety (General Food Hygiene Regulations), those of Schedules II and III and other relevant requirements of the laws relating to food safety: and (b) have been approved by the Regulatory Authority. (2) An establishment subject to approval in accordance with subsection (1) must not operate unless the Regulatory Authority has— (a) granted the establishment approval to operate following an on-site visit; or (b) provided the establishment with conditional approval. (3) Food business operators must co-operate with the Regulatory Authority and in particular, food business operators must ensure that an establishment ceases to operate if the Regulatory Authority withdraws or suspends its approval or, in the case of conditional approval, does not prolong it or fails to grant full approval. Identification marking 6. (1) Food business operators must not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Regulation 5, unless an identification mark is applied in accordance with Part 1 of Schedule II. (2) Food business operators may apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with these Regulations in establishments meeting the requirements of regulation 4. (3) Food business operators may not remove an identification mark from meat unless they cut or process it or work upon it in another manner. 29 Products of animal origin from outside St Helena 7. Food business operators importing products of animal origin for use in approved establishments must ensure that importation takes place only from countries approved by the Regulatory Authority. Revocation and transitional provision 8. (1) The Slaughterhouse Regulations, Cap. 49, and the Dairy Regulations, Cap. 49, are revoked. (2) Notwithstanding the provision of these Regulations, food business operators may continue to use stocks and equipment that they ordered before the entry into force of these Regulations until they are exhausted or require replacement. SCHEDULE I DEFINITIONS For the purpose of these Regulations— 1. MEAT 1.1. “meat” means edible parts of the animals referred to in items 1.2 to 1.8, including blood; 1.2. “domestic ungulates” means domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals; 1.3. “poultry” means farmed birds, including birds that are not considered as domestic but which are farmed as domestic animals, with the exception of ratites; 1.4. “lagomorphs” means rabbits and hares; 1.5. “carcass” means the body of an animal after slaughter and dressing; 1.6. “fresh meat” means meat that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere; 1.7. “offal” means fresh meat other than that of the carcass, including viscera and blood; 1.8. “viscera” means the organs of the thoracic, abdominal and pelvic cavities, as well as the trachea and oesophagus and, in birds, the crop; 1.9. “minced meat” means boned meat that has been minced into fragments and contains less than 1% salt; 1.10. “mechanically separated meat” or “MSM” means the product obtained by removing meat from flesh-bearing bones after boning or from poultry carcasses, using mechanical means resulting in the loss or modification of the muscle fibre structure; 30 1.11.“meat preparations” means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat; 1.12. “slaughterhouse” means an establishment accredited and certified used for slaughtering and dressing animals, the meat of which is intended for human consumption; 1.13. “cutting plant” means an establishment used for boning and/or cutting up meat. 2. EGGS 2.1. “eggs” means eggs in shell (other than broken, incubated or cooked eggs) that are produced by farmed birds and are fit for direct human consumption or for the preparation of egg products; 2.2. “liquid egg” means unprocessed egg contents after removal of the shell; 2.3. “cracked eggs” means eggs with damaged shell and intact membranes; 2.4. “packing centre” means an establishment where eggs are graded by quality and weight. 3. PROCESSED PRODUCTS 3.1. “meat products” means processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat; 3.2. “dairy products” means processed products resulting from the processing of raw milk or from the further processing of such processed products; 3.3. “egg products” means processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products; 4. OTHER DEFINITIONS 4.1. “products of animal origin” means— (a) food of animal origin, including honey and blood; (b) live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and (c) other animals destined to be prepared with a view to being supplied live to the final consumer. 31 SCHEDULE II REQUIREMENTS CONCERNING SEVERAL PRODUCTS OF ANIMAL ORIGIN PART I IDENTIFICATION MARKING When required in accordance with Regulation 6, and subject to the provisions of Schedule III, food business operators must ensure that products of animal origin have an identification mark applied in compliance with the following provisions. A. APPLICATION OF THE IDENTIFICATION MARK 1. The identification mark must be applied before the product leaves the establishment. 2. However, a new mark need not be applied to a product unless its packaging and/or wrapping is removed or it is further processed in another establishment, in which case the new mark must indicate the approval number of the establishment where these operations take place. 3. Food business operators must, in accordance with Regulation 6 of the Food Safety (General Food Hygiene) Regulations, have in place systems and procedures to identify food business operators from whom they have received, and to whom they have delivered, products of animal origin. B. FORM OF THE IDENTIFICATION MARK 4. The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities. 5. The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food. C. METHOD OF MARKING 6. The mark may, depending on the presentation of different products of animal origin, be applied directly to the product, the wrapping or the packaging, or be printed on a label affixed to the product, the wrapping or the packaging. The mark may also be an irremovable tag made of a resistant material. 7. In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary, however, if the process of opening destroys the packaging. When wrapping provides the same protection as packaging, the label may be affixed to the wrapping. 8. For products of animal origin that are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging. 32 9. When products of animal origin are placed in a package destined for direct supply to the final consumer, it is sufficient to apply the mark to the exterior of that package only. 10. When the mark is applied directly to products of animal origin, the colours used must be authorised. PART II OBJECTIVES OF HACCP-BASED PROCEDURES 1. Food business operators operating slaughterhouses must ensure that the procedures that they have put in place are in accordance with the general requirements of Regulation 5 of the Food Safety (General Food Hygiene) Regulations. 2. The procedures must guarantee that each animal or, if appropriate, each lot of animals accepted onto the slaughterhouse premises— (a) is properly identified; (b) does not come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health, except when the Regulatory Authority so permits; (c) is clean; (d) is healthy, as far as the food business operator can judge; and (e) is in a satisfactory state as regards welfare on arrival at the slaughterhouse. 3. In the event of failure to comply with any of the requirements listed under section 2, the food business operator must notify the authorised officer and take appropriate measures. SCHEDULE III SPECIFIC REQUIREMENTS PART I MEAT OF DOMESTIC UNGULATES Chapter I Transport of live animals to the slaughterhouse Food business operators transporting live animals to slaughterhouses must ensure compliance with the following requirements: 1. During collection and transport, animals must be handled carefully without causing unnecessary distress. 2. Animals showing symptoms of disease or originating in herds known to be contaminated with agents of public health importance may only be transported to the slaughterhouse when the Regulatory Authority so permits. Chapter II Requirements for slaughterhouses Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which domestic ungulates are slaughtered meet the following requirements: 33 1. (a) Slaughterhouses must have adequate and hygienic lairage facilities or, climate permitting, waiting pens that are easy to clean and disinfect. These facilities must be equipped for watering the animals and, if necessary, feeding them. The drainage of the wastewater must not compromise food safety. (b) They must also have separate lockable facilities or, climate permitting, pens for sick or suspect animals with separate draining and sited in such a way as to avoid contamination of other animals, unless the Regulatory Authority considers that such facilities are unnecessary. (c)The size of the lairage facilities must ensure that the welfare of the animals is respected. Their layout must facilitate ante-mortem inspections, including the identification of the animals or groups of animals. 2. To avoid contaminating meat, they must— (a) have a sufficient number of rooms, appropriate to the operations being carried out; (b) have a separate room for the emptying and cleaning of stomachs and intestines, unless the Regulatory Authority authorises the separation in time of these operations within a specific slaughterhouse on a case-by-case basis; (c) ensure separation in space or time of the following operations: (i) stunning and bleeding; (ii) in the case of porcine animals, scalding, depilation, scraping and singeing; (iii) evisceration and further dressing; (iv) handling clean guts and tripe; (v) preparation and cleaning of other offal, particularly the handling of skinned heads if it does not take place at the slaughter line; (vi) packaging offal; and (vii) dispatching meat; (d) have installations that prevent contact between the meat and the floors, walls and fixtures; and (e) have slaughter lines (where operated) that are designed to allow constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. If more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination. 3. They must have facilities for disinfecting tools with hot water supplied at not less than 82ºC or an alternative system having an equivalent effect. 4. The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination. 5. There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption. 6. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of means of transport for livestock. However, slaughterhouses need not have these places and facilities if the Regulatory Authority so permits and official authorised places and facilities exist nearby. 7. The access paths and roads to slaughterhouse must be kept clean and in good repair and adequately drained so as to minimise as far as is reasonably possible the entry into the slaughterhouse of soil and other contamination carried on the wheels of vehicles and the footwear of pedestrians. 34 8. They must have lockable facilities reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period. 9. If manure or digestive tract content is stored in the slaughterhouse, there must be a special area or place for that purpose. 10. They must have an adequately equipped lockable facility or, if needed, room for the exclusive use of the regulatory service. Chapter III Requirements for cutting plants Food business operators must ensure that cutting plants handling meat of domestic ungulates— (a) are constructed so as to avoid contamination of meat, in particular by— (i) allowing constant progress of the operations; or (ii) ensuring separation between the different production batches; (b) have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat; (c) have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V; (d) have equipment for washing hands with taps designed to prevent the spread of contamination, for use by staff engaged in handling exposed meat; and (e) have facilities for disinfecting tools with hot water supplied at not less than 82ºC, or an alternative system having an equivalent effect. Chapter IV Slaughter hygiene Food business operators operating slaughterhouses in which domestic ungulates are slaughtered must ensure compliance with the following requirements: 1. An occupier of a slaughterhouse must not permit an animal intended to provide meat for sale for human consumption to be slaughtered, unless— (a) the occupier has given an authorised officer at least 48 hours’ notice of the occupier’s intention to do so; or (b) the occupier has a written standing arrangement with an authorised officer to slaughter animals at an arranged time, and the occupier is slaughtering at that time; or (c) the animal is slaughtered in accordance with this Chapter. 2. An occupier of a slaughterhouse and any person engaged in the movement of lairaging of animals must ensure that— (a) every animal is unloaded as soon as possible after its arrival and, if delay in unloading is unavoidable, it is protected from adverse weather conditions and is provided with adequate ventilation; (b) when unloaded, every animal is protected from adverse weather conditions and is provided with adequate ventilation; (c) if any animal has been subjected to high temperatures in humid weather, it is cooled by appropriate means; (d) any animals which might injure each other on account of their species, sex, age or origin or for any other reason are kept and lairaged apart from each other; 35 (e) pending the slaughter or killing of any sick or disabled animal in the slaughterhouse, it is kept apart from any animal which is not sick or disabled. 3. After arrival of the animals in the slaughterhouse, their slaughter must not be unduly delayed. However, if required for welfare reasons, animals must be given a resting period before slaughter. 4. During slaughter, the operator of a slaughterhouse must ensure that an animal— (a) is brought or followed to the place of slaughter quietly; and (b) is adequately restrained so that it retains its composure and dignity; and (c) is slaughtered humanely using a stunning gun or electrolethaler; and (d) is released from its restraints as soon as possible after stunning; and (e) is bled efficiently as soon as it is suspended; and (f) commences dressing as soon as bleeding is completed; and (g) the above operations are not carried out in sight of another living animal. 5. (a) Meat from animals other than those referred to in paragraphs (b) and (c) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse. (b) Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of animals that have undergone emergency slaughter outside the slaughterhouse in accordance with Chapter VI; (c) Meat from animals that undergo slaughter following an accident in a slaughterhouse may be used for human consumption if, on inspection, no serious lesions other than those due to the accident are found. 6. The animals or, if appropriate, each batch of animals sent for slaughter must be identified so that their origin can be traced. 7. Animals must be clean. 8. Slaughterhouse operators must follow the instructions of the authorised officer appointed by the Regulatory Authority to ensure that ante-mortem inspection of every animal to be slaughtered is carried out under suitable conditions. 9. Animals brought into the slaughter hall must be slaughtered without undue delay. 10. Stunning, bleeding, skinning, evisceration and other dressing must be carried out without undue delay and in a manner that avoids contaminating the meat. In particular— (a) the trachea and oesophagus must remain intact during bleeding, except in the case of slaughter according to a religious custom; (b) during the removal of hides and fleece— (i) contact between the outside of the skin and the carcass must be prevented; and (ii) operators and equipment coming into contact with the outer surface of hides and fleece must not touch the meat; (c) measures must be taken to prevent the spillage of digestive tract content during and after evisceration and to ensure that evisceration is completed as soon as possible after stunning; and (d) removal of the udder must not result in contamination of the carcass with milk or colostrum. 11. Complete skinning of the carcass and other parts of the body intended for human consumption must be carried out, except for porcine animals and the heads and feet of ovine 36 and caprine animals and calves. Heads and feet must be handled so as to avoid contamination of other meat. 12. Porcine animals must have their bristles removed immediately. The risk of contamination of the meat with scalding water must be minimised. Only approved additives may be used for this operation. Porcine animals must be thoroughly rinsed afterwards with potable water. 13. The carcases must not contain visible faecal contamination. Any visible contamination must be removed without delay by trimming or alternative means having an equivalent effect. 14. Carcasses and offal must not come into contact with floors, walls or work stands. 15. Slaughterhouse operators must follow the instructions of the Regulatory Authority to ensure that post-mortem inspection of all slaughtered animals is carried out under suitable conditions. 16. Until post-mortem inspection is completed, parts of a slaughtered animal subject to such inspection must— (a) remain identifiable as belonging to a given carcass; and (b) come into contact with no other carcass, offal or viscera, including those that have already undergone post-mortem inspection. 17. Both kidneys must be removed from their fatty covering. In the case of bovine and porcine animals, the peri-renal capsule must also be removed. 18. If the blood or other offal of several animals is collected in the same container before completion of post-mortem inspection, the entire contents must be declared unfit for human consumption if the carcass of one or more of the animals concerned has been declared unfit for human consumption. 19. After post-mortem inspection— (a) the tonsils of bovine animals must be removed hygienically; (b) parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment; (c) meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption; and (d) viscera or parts of viscera remaining in the carcass, except for the kidneys, must be removed entirely and as soon as possible, unless the Regulatory Authority authorises otherwise. 20. After completion of slaughter and post-mortem inspection, the meat must be stored in accordance with the requirements laid down in Chapter VII. 21. When destined for further handling— (a) stomachs must be scalded or cleaned; (b) intestines must be emptied and cleaned; and (c) heads and feet must be skinned or scalded and depilated. 22. If establishments are approved for the slaughter of different animals, precautions must be taken to prevent cross-contamination by separation either in time or in space of operations carried out on the different species. 37 23. If the slaughterhouse does not have lockable facilities reserved for the slaughter of sick or suspect animals, the facilities used to slaughter such animals must be cleaned, washed and disinfected under official supervision before the slaughter of other animals is resumed. Chapter V Hygiene during cutting and boning Food business operators must ensure that cutting and boning of meat of domestic ungulates takes place in accordance with the following requirements: 1. Carcasses of domestic ungulates may be cut into half-carcases or quarters, and half carcasses into no more than three wholesale cuts, in slaughterhouses. 2. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that— (a) meat intended for cutting is brought into the workrooms progressively as needed; (b) during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the meat is maintained at not more than 3ºC for offal and 7ºC for other meat, by means of an ambient temperature of not more than 12ºC or an alternative system having an equivalent effect; and (c) if the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, if necessary by separation of the operations on the different species in either space or time. 3. However, meat may be boned and cut before it reaches the temperature referred to in section 2(b) in accordance with Chapter VII, section 3. 4. Meat may also be boned and cut prior to reaching the temperature referred to in section 2(b) when the cutting room is on the same site as the slaughter premises. In this case, the meat must be transferred to the cutting room either directly from the slaughter premises or after a waiting period in a chilling or refrigerating room. As soon as it is cut and, if appropriate, packaged, the meat must be chilled to the temperature referred to in section 2(b). Chapter VI Emergency slaughter outside the slaughterhouse Food business operators must ensure that meat from domestic ungulates that have undergone emergency slaughter outside the slaughterhouse may be used for human consumption only if it complies with all the following requirements: 1. An otherwise healthy animal must have suffered an accident that prevented its transport to the slaughterhouse for welfare reasons. 2. An authorised officer must carry out an ante-mortem inspection of the animal. 3. The slaughtered and bled animal must be transported to the slaughterhouse hygienically and without undue delay. Removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of the authorised officer. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to that animal. 38 4. If more than two hours elapse between slaughter and arrival at the slaughterhouse, the animal must be refrigerated. If climatic conditions so permit, active chilling is not necessary. 5. A declaration by the food business operator who reared the animal, stating the identity of the animal and indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, must accompany the slaughtered animal to the slaughterhouse. 6. A declaration issued by the authorised officer recording the favourable outcome of the ante mortem inspection, the date and time of, and reason for, emergency slaughter, and the nature of any treatment administered by a veterinarian to the animal, must accompany the slaughtered animal to the slaughterhouse. 7. The slaughtered animal must be fit for human consumption following post-mortem inspection carried out in the, including any additional tests required in the case of emergency slaughter. 8. Food business operators must follow any instructions that the authorised officer may give after post-mortem inspection concerning the use of the meat. 9. Food business operators may not place meat from animals having undergone emergency slaughter on the market unless it bears an identification mark. Chapter VII Storage and transport Food business operators must ensure that the storage and transport of meat of domestic ungulates takes place in accordance with the following requirements. 1. (a) Unless other specific provisions provide otherwise, post-mortem inspection must be followed immediately by chilling in the slaughterhouse to ensure a temperature throughout the meat of not more than 3ºC for offal and 7ºC for other meat along a chilling curve that ensures a continuous decrease of the temperature. However, meat may be cut and boned during chilling in accordance with Chapter V, section 4. (b) During the chilling operations, there must be adequate ventilation to prevent condensation on the surface of the meat. 2. Meat must attain the temperature specified in section 1 and remain at that temperature during storage. 3. Meat must attain the temperature specified in section 1 before transport, and remain at that temperature during transport. However, transport may also take place if the competent authority so authorises to enable the production of specific products, provided that— (a) such transport takes place in accordance with the requirements that the Regulatory Authority specifies in respect of transport from one given establishment to another; and (b) the meat leaves the slaughterhouse, or a cutting room on the same site as the slaughter premises, immediately and transport takes no more than two hours. 4. Meat intended for freezing must be frozen without undue delay, taking into account if necessary a stabilisation period before freezing. 39 5. Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat. Chapter VIII Slaughter of domestic ungulates on premises other than slaughterhouse Notwithstanding the provisions of this Part, food business operators may slaughter sheep, goats and pigs on premises other than a slaughterhouse only with authorisation of the Regulatory Authority and in compliance with the requirements prescribed by the authority from time to time. PART II MEAT FROM POULTRY AND LAGOMORPHS Chapter I Transport of live animals to the slaughterhouse Food business operators transporting live animals to slaughterhouses must ensure compliance with the following requirements: 1. During collection and transport, animals must be handled carefully without causing unnecessary distress. 2. Animals showing symptoms of disease or originating in flocks known to be contaminated with agents of public-health importance may only be transported to the slaughterhouse when permitted by the Regulatory Authority. 3. Crates for delivering animals to the slaughterhouse and modules, where used, must be made of non-corrodible material and be easy to clean and disinfect. Immediately after emptying and, if necessary, before re-use, all equipment used for collecting and delivering live animals must be cleaned, washed and disinfected. Chapter II Requirements for slaughterhouses Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which poultry or lagomorphs are slaughtered meet the following requirements: 1. They must have a room or covered space for the reception of the animals and for their inspection before slaughter. 2. To avoid contaminating meat, they must— (a) have a sufficient number of rooms, appropriate to the operations being carried out; (b) have a separate room for evisceration and further dressing, including the addition of seasonings to whole poultry carcases, unless the Regulatory Authority authorises separation in time of these operations within a specific slaughterhouse on a case-by-case basis; (c) ensure separation in space or time of the following operations: (i) stunning and bleeding; (ii) plucking or skinning, and any scalding; and 40 (iii) dispatching meat; (d) have installations that prevent contact between the meat and the floors, walls and fixtures; and (e) have slaughter lines (where operated) that are designed to allow a constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. If more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination. 3. They must have facilities for disinfecting tools with hot water supplied at not less than 82ºC or an alternative system having an equivalent effect. 4. The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination. 5. There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption. 6. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of— (a) transport equipment such as crates; and (b) means of transport. These places and facilities are not compulsory for item (b) if officially authorised places and facilities exist nearby. 7. They must have an adequately equipped lockable facility or, if needed, room for the exclusive use of the regulatory service. Chapter III Requirements for cutting plants 1. Food business operators must ensure that cutting plants handling meat from poultry or lagomorphs— (a) are constructed so as to avoid contamination of meat, in particular by— (i) allowing constant progress of the operations; or (ii) ensuring separation between the different production batches; (b) have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat; (c) have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V; (d) have equipment for washing hands used by staff handling exposed meat with taps designed to prevent the spread of contamination; and (e) have facilities for disinfecting tools with hot water supplied at not less than 82ºC, or an alternative system having an equivalent effect. 2. If the following operations are undertaken in a cutting plant: (a) the evisceration of geese and ducks reared for the production of "foie gras", which have been stunned, bled and plucked on the fattening farm; or (b) the evisceration of delayed eviscerated poultry, food business operators must ensure that separate rooms are available for that purpose. 41 Chapter IV Slaughter hygiene Food business operators operating slaughterhouses in which poultry or lagomorphs are slaughtered must ensure compliance with the following requirements: 1. A food business operator must not permit an animal intended to provide meat for sale for human consumption to be slaughtered unless— (a) he has given an authorised officer at least 48 hours’ notice of his intention to do so; or (b) he has a written standing arrangement with an authorised officer to slaughter animals at an arranged time, and he is slaughtering at that time; or (c) the animal is slaughtered in accordance with Chapter VI. 2. The occupier of a slaughterhouse and any person engaged in the movement of lairaging of animals must ensure that— (a) every animal is unloaded as soon as possible after its arrival and, if delay in unloading is unavoidable, it is protected from adverse weather conditions and is provided with adequate ventilation; (b) when unloaded, every animal is protected from adverse weather conditions and is provided with adequate ventilation; (c) if any animal has been subjected to high temperatures in humid weather, it is cooled by appropriate means; (d) any animals which might injure each other on account of their species, sex, age or origin or for any other reason are kept and lairaged apart from each other; (e) pending the slaughter or killing of any sick or disabled animal in the slaughterhouse, such animal is kept apart from any animal which is not sick or disabled. 3. After arrival in the slaughterhouse, the slaughter of the animals must not be unduly delayed. However, if required for welfare reasons, animals must be given a resting period before slaughter. 4. During slaughter, the operator of a slaughterhouse must ensure that an animal— (a) is brought or followed to the place of slaughter quietly; and (b) is adequately restrained so that it retains its composure and dignity; and (c) is slaughtered humanely; and (d) is released from its restraints as soon as possible after stunning; and (e) is bled efficiently as soon as it is suspended; and (f) commences dressing as soon as bleeding is completed; and (g) the above operations are not carried out in sight of another living animal. 5. (a) Meat from animals other than those referred to in item (b) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse. (b) Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of delayed eviscerated poultry, geese and ducks reared for the production of "foie gras" and birds that are not considered as domestic but which are farmed as domestic animals, if slaughtered at the farm in accordance with Chapter VI. 6. Slaughterhouse operators must follow the instructions of the Regulatory Authority to ensure that ante-mortem inspection is carried out under suitable conditions. 42 7. If establishments are approved for the slaughter of different animal species precautions must be taken to prevent cross contamination by separation either in time or in space of the operations carried out on the different species. 8. Animals brought into the slaughter room must be slaughtered without undue delay. 9. Stunning, bleeding, skinning or plucking, evisceration and other dressing must be carried out without undue delay in such a way that contamination of the meat is avoided. In particular, measures must be taken to prevent the spillage of digestive tract contents during evisceration. 10. Slaughterhouse operators must follow the instructions of the Regulatory Authority to ensure that the post-mortem inspection is carried out under suitable conditions, and in particular that slaughtered animals can be inspected properly. 11. After post-mortem inspection— (a) parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment; (b) meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption; and (c) viscera or parts of viscera remaining in the carcass, except for the kidneys, must be removed entirely, if possible, and as soon as possible, unless otherwise authorised by the competent authority. 12. After inspection and evisceration, slaughtered animals must be cleaned and chilled to not more than 4ºC as soon as possible, unless the meat is cut while warm. 13. When carcasses are subjected to an immersion chilling process, account must be taken of the following: (a) Every precaution must be taken to avoid contamination of carcasses, taking into account parameters such as carcass weight, water temperature, volume and direction of water flow and chilling time. (b) Equipment must be entirely emptied, cleaned and disinfected whenever this is necessary and at least once a day. 14. Sick or suspect animals, and animals slaughtered in application of disease eradication or control programmes, must not be slaughtered in the establishment except when permitted by the Regulatory Authority. In that event, slaughter must be performed under official supervision and steps taken to prevent contamination; the premises must be cleaned and disinfected before being used again. Chapter V Hygiene during and after cutting and boning Food business operators must ensure that cutting and boning of poultry’s and lagomorphs’ meat takes place in accordance with the following requirements: 1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that— (a) meat intended for cutting is brought into the workrooms progressively as needed; (b) during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the temperature of the meat is maintained at not more than 4ºC by means of an ambient temperature of 12ºC or an alternative system having an equivalent effect; and 43 (c) if the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, if necessary, by separation of the operations on the different species in either space or time. 2. However, meat may be boned and cut prior to reaching the temperature referred to in section 1(b) when the cutting room is on the same site as the slaughter premises, provided that it is transferred to the cutting room either— (a) directly from the slaughter premises; or (b) after a waiting period in a chilling or refrigerating room. 3. As soon as it is cut and, if appropriate, packaged, the meat must be chilled to the temperature referred to in section 1(b). 4. Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat. Chapter VI Slaughter on premises other than slaughterhouse Food business operators may slaughter poultry referred to in Chapter IV, section 1(b), on premises other than a slaughterhouse only with the authorisation of the Regulatory Authority and in compliance with the following requirements: 1. The farm must undergo regular veterinary inspection. 2. The food business operator must inform the Regulatory Authority in advance of the date and time of slaughter. 3. The holding must have facilities for concentrating the birds to allow an ante-mortem inspection of the group to be made. 4. The holding must have premises suitable for the hygienic slaughter and further handling of the birds. 5. Animal welfare requirements must be complied with. 6. In the case of poultry reared for the production of "foie gras", the uneviscerated birds must be transported immediately and, if necessary, refrigerated to a slaughterhouse or cutting plant. They must be eviscerated within 24 hours of slaughter under the supervision of the Food Authority. 7. Delayed eviscerated poultry obtained at the farm of production may be kept for up to 15 days at a temperature of not more than 4ºC. 44 PART III MINCED MEAT, MEAT PREPARATIONS AND MECHANICALLY SEPARATED MEAT (MSM) Chapter I Requirements for production establishments Food business operators operating establishments producing minced meat, meat preparations or MSM must ensure that they— (a) are constructed so as to avoid contamination of meat and products, in particular by— (i) allowing constant progress of the operations; or (ii) ensuring separation between the different production batches; (b) have rooms for the separate storage of packaged and exposed meat and products, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat or products; (c) have rooms equipped to ensure compliance with the temperature requirements laid down in Chapter III; (d) have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent the spread of contamination; and (e) have facilities for disinfecting tools with hot water supplied at not less than 82ºC, or an alternative system having an equivalent effect. Chapter II Requirements for raw material Food business operators producing minced meat, meat preparations or MSM must ensure that the raw materials used satisfy the following requirements: 1. The raw material used to prepare minced meat must meet the following requirements: (a) it must comply with the requirements for fresh meat; (b) it must derive from skeletal muscle, including adherent fatty tissues; (c) it must not derive from— (i) scrap cuttings and scrap trimmings (other than whole muscle cuttings); (ii) MSM; (iii) meat containing bone fragments or skin; or (iv) meat of the head with the exception of the masseters, the non-muscular part of the linea alba, the region of the carpus and the tarsus, bone scrapings and the muscles of the diaphragm (unless the serosa has been removed). 2. The following raw material may be used to prepare meat preparations: (a) fresh meat; (b) meat meeting the requirements of section 1; and (c) if the meat preparation is clearly not intended to be consumed without first undergoing heat treatment— (i) meat derived from the mincing or fragmentation of meat meeting the requirements of section 1 other than section 1(c)(i); and (ii) MSM meeting the requirements of Chapter III, section 3. 3. The raw material used to produce MSM must meet the following requirements: (a) it must comply with the requirements for fresh meat; (b) the following material must not be used to produce MSM: (i) for poultry, the feet, neckskin and head; and 45 (ii) for other animals, the bones of the head, feet, tails, femur, tibia, fibula, humerus, radius and ulna. Chapter III Hygiene during and after production Food business operators producing minced meat, meat preparations or MSM must ensure compliance with the following requirements: 1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that the meat used is— (a) at a temperature of not more than 4ºC for poultry, 3ºC for offal and 7ºC for other meat; and (b) brought into the preparation room progressively as needed. 2. The following requirements apply to the production of minced meat and meat preparations: (a) unless the Regulatory Authority authorises boning immediately before mincing, frozen or deep-frozen meat used for the preparation of minced meat or meat preparations must be boned before freezing. It may be stored only for a limited period. (b) when prepared from chilled meat, minced meat must be prepared— (i) in the case of poultry, within no more than 3 days of their slaughter; (ii) in the case of animal other than poultry, within no more than 6 days of their slaughter; or (iii) within no more than 15 days from the slaughter of the animals in the case of boned, vacuum-packed beef and veal. (c) immediately after production, minced meat and meat preparations must be wrapped or packaged and be— (i) chilled to an internal temperature of not more than 2ºC for minced meat and 4°Cfor meat preparations; or (ii) frozen to an internal temperature of not more than -18°C. These temperature conditions must be maintained during storage and transport. 3. The following requirements apply to the production and use of MSM produced using techniques that do not alter the structure of the bones used in the production of MSM and the calcium content of which is not significantly higher than that of minced meat: (a) raw material for deboning from an on-site slaughterhouse must be no more than 7 days old; otherwise, raw material for deboning must be no more than 5 days old. However, poultry carcases must be no more than 3 days old; (b) mechanical separation must take place immediately after deboning; (c) if not used immediately after being obtained, MSM must be wrapped or packaged and then chilled to a temperature of no more than 2°C or frozen to an internal temperature of no more than -18°C. These temperature requirements must be maintained during storage and transport. 4. The following requirements apply to the production and use of MSM produced using techniques other than those mentioned in section 3: (a) raw material for deboning from an on-site slaughterhouse must be no more than seven days old; otherwise, raw material for deboning must be no more than 5 days old. However, poultry carcasses must be no more than three days old; (b) if mechanical separation does not take place immediately after deboning the flesh bearing bones must be stored and transported at a temperature of no more than 2°C or, if frozen, at a temperature of no more than -18°C; 46 (c) flesh-bearing bones obtained from frozen carcases must not be refrozen; (d) if not used within one hour of being obtained, MSM must be chilled immediately to a temperature of not more than 2°C; (e) if, after chilling, MSM is not processed within 24 hours, it must be frozen within 12 hours of production and reach an internal temperature of no more than -18°C within six hours; (f) frozen MSM must be wrapped or packaged before storage or transport, must not be stored for more than three months and must be maintained at a temperature of not more than –18ºC during storage and transport; (g) MSM may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation. 5. Minced meat, meat preparations and MSM must not be re-frozen after thawing. Chapter IV Labelling 1. Packages intended for supply to the final consumer containing minced meat from poultry or meat preparations containing MSM must bear a notice indicating that such products should be cooked before consumption. PART IV MEAT PRODUCTS Chapter I Raw materials 1. Food business operators must ensure that the following items are not used in the preparation of meat products: (a) genital organs of either female or male animals, except testicles; (b) urinary organs, except the kidneys and the bladder; (c) the cartilage of the larynx, the trachea and the extra-lobular bronchi; (d) eyes and eyelids; (e) the external auditory meatus; (f) horn tissue; and (g) in poultry, the head – except the comb and the ears, the wattles and caruncles – the oesophagus, the crop, the intestines and the genital organs. 2. All meat, including minced meat and meat preparations, used to produce meat products must meet the requirements of these regulations. Chapter II Requirements for production establishments Food business operators operating establishments producing meat products must ensure that they— (a) are constructed so as to avoid contamination of meat and meat products, in particular by— (i) allowing constant progress of the operations; or (ii) ensuring separation between the different production batches; 47 (b) have rooms for the separate storage of packaged and exposed meat and meat products, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat or meat products; (c) have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent the spread of contamination; and (d) have facilities for disinfecting tools with hot water supplied at not less than 82ºC, or an alternative system having an equivalent effect. Chapter III Heat treatment The following requirements apply only to food placed on the market in hermetically sealed containers: (a) any heat treatment process used to process an unprocessed product or to process further a processed product is— (i) to raise every party of the product treated to a given temperature for a given period of time; and (ii) to prevent the product from becoming contaminated during the process; (b) to ensure that the process employed achieves the desired objectives, food business operators are to check regularly the main relevant parameters (particularly temperature, pressure, sealing and microbiology), including by the use of automatic devices; (c) the process used should conform to an internationally recognised standard (for example, pasteurisation, ultra-high temperature or sterilisation). Chapter IV Hygiene during and after production Food business operators producing meat products must ensure compliance with the following requirements: 1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that the meat used is— (a) at a temperature of no more than 4ºC for poultry, 3ºC for offal and 7ºC for other meat; and (b) brought into the preparation room progressively as needed. 2. Immediately after production, meat products must be wrapped or packaged and, unless the processing, wrapping or packaging renders the meat product stable at ambient temperature, must be— (a) chilled to an internal temperature of no more than 5°C; or (b) frozen to an internal temperature of no more than -18°C. These temperature conditions must be maintained during storage and transport. PART V EGGS AND EGG PRODUCTS Chapter I Eggs 1. Eggs must be kept at the producer's premises, effectively protected from shocks and out of direct sunshine, clean, dry and free of extraneous odour until sold. 48 2. Eggs must be stored and transported at a temperature, preferably constant, that is best suited to assure optimal conservation of their hygiene properties. 3. Eggs must be delivered to the consumer within a maximum time limit of 14 days of laying. Chapter II Egg products A. REQUIREMENTS FOR ESTABLISHMENTS Food business operators must ensure that establishments for the manufacture of egg products are constructed, laid out and equipped so as to ensure separation of the following operations: 1. washing, drying and disinfecting dirty eggs, where carried out; 2. breaking eggs, collecting their contents and removing parts of shells and membranes; and 3. operations other than those referred to in sections 1 and 2. B. RAW MATERIALS FOR THE MANUFACTURE OF EGG PRODUCTS Food business operators must ensure that raw materials used to manufacture egg products comply with the following requirements: 1. The shells of eggs used in the manufacture of egg products must be fully developed and contain no breaks. However, cracked eggs may be used for the manufacture of egg products if the establishment of production or a packing centre delivers them directly to a processing establishment, where they must be broken as soon as possible. 2. Liquid egg obtained in an establishment approved for that purpose may be used as raw material. Liquid egg must be obtained in accordance with the requirements of sections 1, 2, 3, 4 and 7 of Part C. C. SPECIAL HYGIENE REQUIREMENTS FOR THE MANUFACTURE OF EGG PRODUCTS Food business operators must ensure that all operations are carried out in such a way as to avoid any contamination during production, handling and storage of egg products, in particular by ensuring compliance with the following requirements. 1. Eggs must not be broken unless they are clean and dry. 2. Eggs must be broken in a manner that minimises contamination, in particular by ensuring adequate separation from other operations. Cracked eggs must be processed as soon as possible. 3. Eggs other than those of hens, turkeys or guinea fowl must be handled and processed separately. All equipment must be cleaned and disinfected before processing of hens', turkeys' and guinea fowls' eggs is resumed. 4. Egg contents may not be obtained by the centrifuging or crushing of eggs, nor may centrifuging be used to obtain the remains of egg whites from empty shells for human consumption. 49 5. After breaking, each particle of the egg product must undergo processing as quickly as possible to eliminate microbiological hazards or to reduce them to an acceptable level. A batch that has been insufficiently processed may immediately undergo processing again in the same establishment, if this processing renders it fit for human consumption. When a batch is found to be unfit for human consumption, it must be denatured so as to ensure that it is not used for human consumption. 6. Processing is not required for egg white intended for the manufacture of dried or crystallised albumin destined subsequently to undergo heat treatment. 7. If processing is not carried out immediately after breaking, liquid egg must be stored either frozen or at a temperature of not more than 4 °C. The storage period before processing at 4 °C must not exceed 48 hours. However, these requirements do not apply to products to be de sugared, if de-sugaring process is performed as soon as possible. 8. Products that have not been stabilised so as to be kept at room temperature must be cooled to not more than 4 °C. Products for freezing must be frozen immediately after processing. D. ANALYTICAL SPECIFICATIONS 1. The concentration of 3-OH-butyric acid must not exceed 10 mg/kg in the dry matter of the unmodified egg product. 2. The lactic acid content of raw material used to manufacture egg products must not exceed 1g/kg of dry matter. However, for fermented products, this value must be the one recorded before the fermentation process. 3. The quantity of eggshell remains, egg membranes and any other particles in the processed egg product must not exceed 100 mg/kg of egg product. E. LABELLING AND IDENTIFICATION MARKING 1. In addition to the general requirements for identification marking laid down in Part I of Schedule II, consignments of egg products, destined not for retail but for use as an ingredient in the manufacture of another product, must have a label giving the temperature at which the egg products must be maintained and the period during which conservation may thus be assured. 2. In the case of liquid eggs, the label referred to in section 1 must also bear the words: “non-pasteurised egg products - to be treated at place of destination” and indicate the date and hour of breaking. PART VI RAW MILK AND DAIRY PRODUCTS Chapter I Raw milk – Primary production Food business operators producing or, as appropriate, collecting raw milk must ensure compliance with the requirements laid down in this Chapter. 50 A. HEALTH REQUIREMENTS FOR RAW MILK PRODUCTION 1. Raw milk must come from animals— (a) that do not show any symptoms of infectious diseases communicable to humans through milk; (b) that are in a good general state of health, present no sign of disease that might result in the contamination of milk and, in particular, are not suffering from any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognisable inflammation of the udder; (c) that do not have any udder wound likely to affect the milk; (d) to which no unauthorised substances or products have been administered; and (e) in respect of which, if authorised products or substances have been administered, the withdrawal periods prescribed for these products or substances have been observed. 2.(a) In particular, as regards brucellosis, raw milk must come from— (i) cows belonging to a herd which are free or officially free of brucellosis; (ii) sheep or goats belonging to a holding free or officially free of brucellosis; (iii) females of other species belonging, for species susceptible to brucellosis, to herds regularly checked for that disease under a control plan that the Regulatory Authority has approved. (b) As regards tuberculosis, raw milk must come from— (i) cows belonging to a herd which is officially free of tuberculosis; or (ii) females of other species belonging, for species susceptible to tuberculosis, to herds regularly checked for this disease under a control plan that the Regulatory Authority has approved. (c) If goats are kept together with cows, such goats must be inspected and tested for tuberculosis. 3. However, raw milk from animals that do not meet the requirements of section 2 may be used with the authorisation of the Regulatory Authority— (a) in the case of cows that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, after having undergone a heat treatment such as to show a negative reaction to the phosphatase test; (b) in the case of sheep or goats that do not show a positive reaction to tests for brucellosis, or which have been vaccinated against brucellosis as part of an approved eradication programme, and which do not show any symptom of that disease, either— (i) for the manufacture of cheese with a maturation period of at least two months; or (ii) after having undergone heat treatment such as to show a negative reaction to the phosphatase test; and (c) in the case of females of other species that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, but belong to a herd where brucellosis or tuberculosis has been detected after the checks referred to in section 2(a)(iii) or 2(b)(ii), if treated to ensure its safety. 4. Raw milk from any animal not complying with the requirements of sections 1 to 3, in particular, any animal showing individually a positive reaction to the prophylactic tests vis-à vis tuberculosis, must not be used for human consumption. 5. The isolation of animals that are infected, or suspected of being infected, with any of the diseases referred to in section 1 or 2 must be effective to avoid any adverse effect on other animals' milk. 51 B. HYGIENE ON MILK PRODUCTION HOLDINGS 1. Requirements for premises and equipment (a) Milking equipment, and premises where milk is stored, handled or cooled must be located and constructed so as to limit the risk of contamination of milk. (b) Premises for the storage of milk must be protected against vermin, have adequate separation from premises where animals are housed and, if necessary to meet the requirements laid down in Part 2, have suitable refrigeration equipment. (c) Surfaces of equipment that are intended to come into contact with milk (utensils, containers, tanks, etc. intended for milking, collection or transport) must be easy to clean and, if necessary, disinfect and be maintained in a sound condition. This requires the use of smooth, washable and non-toxic materials. (d) After use, such surfaces must be cleaned and, if necessary, disinfected. After each journey, or after each series of journeys when the period of time between unloading and the following loading is very short, but in all cases at least once a day, containers and tanks used for the transport of raw milk must be cleaned and disinfected in an appropriate manner before re-use. 2. Hygiene during milking, collection and transport (a) Milking must be carried out hygienically, ensuring in particular— (i) that, before milking starts, the teats, udder and adjacent parts are clean; (ii) that milk from each animal is checked for organoleptic or physico-chemical abnormalities by the milker or a method achieving similar results and that milk presenting such abnormalities is not used for human consumption; (iii) that milk from animals showing clinical signs of udder disease is not used for human consumption otherwise than in accordance with the instructions of a veterinarian; (iv) the identification of animals undergoing medical treatment likely to transfer residues to the milk, and that milk obtained from such animals before the end of the prescribed withdrawal period is not used for human consumption; and (v) that teat dips or sprays are used only if the Regulatory Authority has approved them and in a manner that does not produce unacceptable residue levels in the milk. (b) Immediately after milking, milk must be held in a clean place designed and equipped to avoid contamination. It must be cooled immediately to not more than 8 °C in the case of daily collection, or not more than 6 °C if collection is not daily. (c) During transport the cold chain must be maintained and, on arrival at the establishment of destination, the temperature of the milk must not be more than 10ºC. (d) Food business operators need not comply with the temperature requirements laid down in sections 2 and 3 if the milk meets the criteria provided for in Part C and either— (i) the milk is processed within 2 hours of milking; or (ii) a higher temperature is necessary for technological reasons related to the manufacture of certain dairy products and the competent authority so authorises. 3. Staff hygiene (a) Persons performing milking and/or handling raw milk must wear suitable clean clothes. 52 (b) Persons performing milking must maintain a high degree of personal cleanliness. Suitable facilities must be available near the place of milking to enable persons performing milking and handling raw milk to wash their hands and arms. C. CRITERIA FOR RAW MILK 1. A representative number of samples of raw milk collected from milk production holdings taken by random sampling must be checked for compliance with sections 2 and 3. 2. (a) Food business operators must initiate procedures to ensure that raw milk meets the following criteria: (i) for raw cows' milk: Plate count at 30 °C (per ml) Somatic cell count (per ml) ≤ 100 000 (*) ≤ 400 000 (**) (ii) for raw milk from other species: Plate count at 30 °C (per ml) ≤ 1 500 000 (*) (b) However, if raw milk from species other than cows is intended for the manufacture of products made with raw milk by a process that does not involve any heat treatment, food business operators must take steps to ensure that the raw milk used meets the following criterion: Plate count at 30 °C (per ml) ≤ 500 000 (*) (*) Rolling geometric average over a two-month period, with at least two samples per month. (**) Rolling geometric average over a three-month period, with at least one sample per month, unless the competent authority specifies another methodology to take account of seasonal variations in production levels. 3. When raw milk fails to comply with section 2, the food business operator must inform the Regulatory Authority and take measures to correct the situation. Chapter II Requirements concerning dairy products A. TEMPERATURE REQUIREMENTS 1. Food business operators must ensure that, upon acceptance at a processing establishment, milk is quickly cooled to not more than 6 °C and kept at that temperature until processed. 2. However, food business operators may keep milk at a higher temperature if— (a) processing begins immediately after milking, or within 4 hours of acceptance at the processing establishment; or (b) the Regulatory Authority authorises a higher temperature for technological reasons concerning the manufacture of certain dairy products. 53 B. REQUIREMENTS FOR HEAT TREATMENT 1. When raw milk or dairy products undergo heat treatment, food business operators must ensure that this satisfies the Food Authority sampling requirements. 2. When considering whether to subject raw milk to heat treatment, food business operators must have regard to the procedures developed in accordance with the HACCP principles. C. CRITERIA FOR RAW COWS' MILK 1. Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before processing— (a) raw cows' milk used to prepare dairy products has a plate count at 30ºC of less than 300 000 per ml; and (b) processed cows' milk used to prepare dairy products has a plate count at 30ºC of less than 100 000 per ml. 2. When milk fails to meet the criteria laid down in section 1, the food business operator must inform the Regulatory Authority and take measures to correct the situation. Chapter III Wrapping and packaging Sealing of consumer packages must be carried out immediately after filling in the establishment where the last heat treatment of liquid dairy products takes place, by means of sealing devices that prevent contamination. The sealing system must be designed in such a way that, after opening, the evidence of its opening remains clear and easy to check. Chapter IV Labelling 1. Labelling must clearly show— (a) in the case of raw milk intended for direct human consumption, the words "raw milk"; (b) in the case of products made with raw milk, the manufacturing process for which does not include any heat treatment or any physical or chemical treatment, the words "made with raw milk". 2. The requirements of section 1 apply to products destined for retail trade. The term "labelling" includes any packaging, document, notice, label, ring or collar accompanying or referring to such products. Chapter V Identification marking By way of derogation from the requirements of Part I of Schedule II, rather than indicating the approval number of the establishment, the identification mark may include a reference to where on the wrapping or packaging the approval number of the establishment is indicated.