GUIDANCE FOR BUSINESS ON REGULATIONS

The Food Safety (Temperature Control) Regulations 1995

TEMPERATURE CONTROL OF FOOD

This guidance is intended to help explain for both food businesses and enforcement authorities the new food temperature control requirements which will operate in England, and Wales. It contains advice on the types of foods which are required to be held under temperature control. It also gives guidance on the circumstances when the Regulations allow some flexibility from the temperature requirements.

While it is intended to be helpful, it does not provide an authoritative interpretation of the law and is no substitute for an understanding of the legal requirements. Any examples given are illustrative and not comprehensive.

Contents

• Introduction
• Product-Specific Food Hygiene Requirements
• Chill Control Requirements
• Variation upwards from 8 degrees Celsius maximum chill temperature
• Chill holding tolerance periods
• Hot Holding Controls
• The General Requirement
• Cooling of Food
• Annex: Variations from Maximum Chill Temperature

Guidance on The Food Safety (Temperature Control) Regulations 1995

I. Introduction

1. This guidance is intended to help explain for both food businesses and enforcement authorities the new food temperature control requirements which will operate in England, and Wales. It contains advice on the types of foods which are required to be held under temperature control. It also gives guidance on the circumstances when the Regulations allow some flexibility from the temperature requirements.

2. While it is intended to be helpful, it does not provide an authoritative interpretation of the law and is no substitute for an understanding of the legal requirements. Any examples given are illustrative and not comprehensive.

3. This guidance is intended to complement best practices in the food industry which might involve, for example, keeping foods at chill temperatures below the legal maximum and thereby providing additional assurances of food safety.

4. Advice on the approach to enforcement of the temperature control requirements of food hygiene Regulations is to be found in Food Safety Act Code of Practice No 10.

5. The Food Safety (Temperature Control) Regulations 1995 (referred to hereafter as "the Regulations") require foods which are likely to support the growth of pathogenic micro-organisms or the formation of toxins to be held at or below 8 degrees Celsius or above 63 degrees Celsius. The Regulations allow certain tolerances from the requirements (consistent with the need to ensure food safety), to take into account practical considerations relating, for example, to processing or handling.

6. Unlike previous food temperature control regulations, these Regulations do not list specific foods which need to be held under temperature control conditions. Food businesses themselves need to consider which foods should be held under temperature control.

Hazard Analysis

7. The temperature control requirements should be understood in the general context of the hazard analysis requirement contained in regulation 4(3) of the Food Safety (General Food Hygiene) Regulations 1995. This requires food businesses to identify food hazards and to ensure that controls are in place to eliminate or minimise risks to consumers.

8. Hazard analysis systems have an important part to play in helping to ensure that food is produced safely. Chill control, in particular, is very often critical to food safety. This means businesses should understand which foods need to be chill controlled, be aware of the relationship between temperature and the shelf-life of food, and be sure that any flexibility allowed by the Regulations is operated in a way which does not jeopardise the safety of food. Temperature monitoring and logging may be helpful in ensuring food safety. A need for monitoring is indicated for some food businesses by regulation 4(3) of the Food Safety (General Food Hygiene) Regulations 1995. Although logging is not a specific legal requirement, this may also help some food businesses to control food hazards. An understanding of the importance of chill control should be an element in the training of staff involved in food handling.

9. It is also important to remember that changes in food processing practices in recent years (eg, less use of preservatives) may mean that some products will no longer be safe when kept at ambient temperatures.

Industry Guides to Good Hygiene Practice

10. This guidance is expected to be complementary to more detailed sector-specific guidance in UK Industry Guides to good hygiene practice, and in any EC Industry Guides to good hygiene practice, which are recognized by the UK Government and the European Commission respectively as providing a guide to compliance with the Regulations and the EC Food Hygiene Directive respectively. Regulation 19 requires enforcers to give due consideration to recognised UK and EC Industry Guides in the enforcement of these Regulations.

Contents: Guidance on the food safety (temperature control) regulations 1995

II. Product-Specific Food Hygiene Regulations

11. A number of product-specific food hygiene Regulations contain requirements for foods to be kept at prescribed temperatures, or for the manufacturer to prescribe a temperature. Most of these product-specific regulations cover the food production chain from the primary producer to the manufacturer and often include the wholesaler as well. They do not, however, generally cover premises selling food direct to the final consumer; ie they do not usually apply to caterers and retailers. A list of product-specific Regulations is provided in regulation 3(2) of these Regulations.

12. Where a product-specific Regulation applies, the provisions of the Food Safety (Temperature Control) Regulations 1995 generally do not apply. The exception is processed fishery products, which are covered by temperature requirements in these Regulations.

13. For eggs and poultrymeat, the EC Marketing Standards Regulations lay down temperature conditions which apply throughout the food chain, including the retail stage. Both the grading and labelling of eggs and the definitions of types of poultrymeat are affected by temperature rules. Therefore, in respect of these foods, businesses should refer to the EC Marketing Standards Regulations.

Contents: Guidance on the food safety (temperature control) regulations 1995

III.Chill Control Requirements

Which foods need to be kept at or below 8 degrees Celsius?

14. SUBJECT TO CERTAIN EXEMPTIONS, FOOD WHICH IS LIKELY TO SUPPORT THE GROWTH OF PATHOGENIC MICRO-ORGANISMS OR THE FORMATION OF TOXINS MUST NOT BE KEPT AT A TEMPERATURE ABOVE 8° C.

15. A maximum chill temperature of 8 degrees Celsius is the specific requirement for foods which, because of their inherent characteristics, require temperature control to prevent the development of harmful levels of pathogenic micro-organisms or toxin formation. The Regulations do, however, contain a number of specific exemptions which are described in paragraphs 21-24 below. The requirement is for the temperature of the food not the air in the storage facility.

16. The requirement applies to foods, including raw materials and ingredients, at all stages of transport, preparation, processing, storage and display for sale during manufacture, retail and catering.

17. Foods which are not likely to support the growth of pathogenic micro-organisms or the formation of toxins are not covered by the requirement. There may be other reasons to keep such foods cool, for example, yoghurts with a pH below 4.5, hard cheeses and butter may be held under chilled conditions for quality reasons, rather than for food safety reasons.

18. In any legal proceedings where food had not been kept at or below 8 degrees Celsius, the burden of proof would be on the food authority to demonstrate that a food is likely to support the growth of pathogenic micro-organisms or the formation of toxins. Paragraph 20 below details some foods which are seen as likely to fall into this category.

19. The requirement does not apply to cooked foods to be sold hot, which should be kept at or above 63 degrees Celsius.

Types of foods which require chilled storage

20. This paragraph gives some examples of various food types which, under normal conditions of storage and use, and in the absence of adequate preserving factors, should be kept chilled to help secure food safety. These examples are for general guidance only and are subject to the exemptions described in paragraphs 21 - 24.

a. Dairy Products

i. Soft or semi-hard cheeses ripened by moulds and/or bacteria.

The important safety factors for cheese relate primarily to its acidity and water activity. During the ripening process acidity declines until a point is reached where growth of pathogens such asListeria will no longer be inhibited. It is important that, from this point on, such cheeses are chill controlled. See also paragraph 24 (iii).

ii. Dairy-based desserts (including milk substitutes), examples include: Fromage frais, mousses, creme caramels, products containing whipped cream.

Where, however, the pH of these products would prevent the growth of pathogenic micro-organisms or the formation of toxins, (eg yoghurt with a pH below 4.5), or other effective preservative mechanisms are present, the food would not need to be subject to temperature control.

b. Cooked products

There will be a need for chill control of foods comprising or containing cooked products such as meat, fish, eggs (or substitutes for meat, fish, or eggs), milk, hard and soft cheese, cereals (including rice), pulses, and vegetables whether or not they are intended to be eaten without further re-heating.

The requirement will include ready-to-eat products such as sandwiches, containing fillings, toppings, etc prepared with the foods mentioned in the previous paragraph.

c. Smoked or cured fish

There is a need for chill control whether the fish is whole or sliced. In the case of fresh fish, spoilage organisms, which are obviously detectable through appearance or smell, would render the product unfit for consumption before it became unsafe Because the preservative action of smoking or curing inhibits the growth of spoilage organisms, chill control is necessary for smoked or cured fish to ensure its safety.

d. Smoked or cured ready-to-eat meat which is not ambient shelf-stable

Examples may include sliced cured cooked meats such as hams, some salamis and other fermented sausages, depending on the method of curing.

e. Prepared ready-to-eat foods

Including prepared vegetables, vegetable salads containing fruit, or prepared salads, such as coleslaw, containing other products, and prepared products such as mayonnaise.

f. Uncooked or partly cooked pastry and dough products

Examples include products such as pizzas, sausage rolls, or fresh pasta, containing meat, fish or substitutes for meat or fish, or vegetables. These products often contain pre-cooked meat, fish or vegetables mixed or prepared with raw materials. The subsequent cooking process may be insufficient, in some cases, to ensure food safety, so temperature control will be necessary. Fresh pasta should normally be temperature controlled, whether or not it contains these products.

Exemptions from Chill Control Requirements

21. The Regulations provide exemption from the chill control requirement in defined circumstances for some foods even though they are inherently likely to support the growth of pathogenic micro-organisms or toxin formation. The exemptions recognize that a limited period of time outside of chill control would not have adverse consequences for human health. They recognize the link between time and temperature in the growth of micro-organisms. Some foods are stable, even for long periods, if kept at ambient temperatures within the prescribed shelf-life.

22. The Regulations also exempt foods which are intended to be processed in a way which should eliminate pathogenic micro-organisms or toxins.

23. In any legal proceedings, the burden of proof would be on the food business to demonstrate that a food, although likely to support the growth of pathogenic micro-organisms or the formation of toxins, should qualify for one of the exemptions listed in the Regulations. Food businesses are, therefore, responsible for satisfying themselves that a food may safely benefit from one of the exemptions.

24. The exemptions are:

i. FOOD WHICH, FOR THE DURATION OF ITS SHELF-LIFE, MAY BE KEPT AT AMBIENT TEMPERATURES WITH NO RISK TO HEALTH.

The inherent properties of the product or the way in which it has been treated or packed may be important in securing the stability of the product. Examples include certain pickles or jams, which may be safely kept at ambient temperatures, provided that their packing remains intact and they are within their shelf life. Some cured or smoked products, such as air-dried, cured hams with low water activity, may be safely kept at ambient temperatures under defined conditions and within their shelf life.

Other foods are normally sold to consumers within a short shelf life, as the quality of the product is not acceptable at a later stage. This would include certain bakery products and sandwiches, which are usually produced or prepared and sold on the same premises within a short period. For the food types described in paragraph 20, such periods under this exemption should not be longer than four hours after preparation, in line with the tolerance described at paragraphs 26-27, unless scientific evidence as part of a hazard analysis justifies a longer period. Under these circumstances, they can be safely sold to consumers without any need for chill control, even though they are not ambient shelf stable. Other examples might include certain types of cake, and products which have already undergone treatments, such as pasteurised milk. Pasteurised milk is usually kept chilled at retail level, but this is for quality reasons.

ii. 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.

Many foods may support the growth of pathogenic micro-organisms or the formation of toxins before processing, such as dehydration or canning, takes place. Once they are processed they may be ambient stable, until they are rehydrated or the seal of a can is broken. For example, fresh pasta, or rehydrated pasta, would be likely to support the growth of micro-organisms or toxin formation. Rehydrated pasta therefore normally needs chill control.

iii.FOOD WHICH MUST BE RIPENED OR MATURED AT AMBIENT TEMPERATURES; THIS EXEMPTION DOES NOT APPLY ONCE THE RIPENING OR MATURATION IS COMPLETED.

This exemption is intended to allow foods such as soft or mould-ripened cheeses to ripen at ambient temperatures. The exemption applies only where the ripening cannot take place at or below 8 degrees Celsius or a recommended higher temperature - see theAnnex below.

The exemption would not normally apply to soft or mould-ripened cheeses which are on retail display. Although the ripening process may not have stopped, the primary ripening which secures the quality of the product would be expected to have taken place at an earlier stage in manufacture.

iv. RAW FOOD INTENDED FOR FURTHER PROCESSING (INCLUDING COOKING) WHERE THAT PROCESSING WILL ENSURE THAT THE FOOD IS FIT FOR HUMAN CONSUMPTION.

Some foods may support the growth of pathogenic micro-organisms or the formation of toxins, but this will have no adverse consequences for human health for products which will be thoroughly cooked or otherwise processed before consumption. Fresh meat and fish would fall into this category, unless the fresh meat or fish is intended to be eaten raw, for example as steak tartare, carpaccio, or sushi, when it would not be exempt from the 8 degrees Celsius requirement.

v. ANY FOOD WHICH IS BEING SENT AS PART OF A MAIL-ORDER TRANSACTION TO A CONSUMER.

Although such foods are exempt from the 8 degrees Celsius control they are subject to a general requirement that the product must be supplied by the mail-order business at a temperature, or temperatures, which are not likely to give rise to a risk to health. An industry code of practice is expected to include guidance on practices which would comply with this requirement.

Contents: Guidance on the food safety (temperature control) regulations 1995

IV. Variation upwards from the 8 degrees Celsius maximum chill temperature

25. TheAnnex to this guidance aims to help anyone using the facility for certain food businesses to recommend holding foods at temperatures higher than 8 degrees Celsius. It should help them to think through the steps to be considered in developing the necessary scientific assessment. It also provides guidance for food businesses holding foods at or below recommended temperatures higher than 8 degrees Celsius.

Contents: Guidance on the food safety (temperature control) regulations 1995

V. Chill holding tolerance periods

26. A FOOD BUSINESS MAY OFFER A DEFENCE AGAINST FAILURE TO OBSERVE THE REQUIREMENT FOR FOODS TO BE KEPT AT OR BELOW 8 DEGREES CELSIUS BY PROVING THAT:

- THE FOOD WAS DISPLAYED FOR A SINGLE PERIOD OF UP TO 4 HOURS TO ALLOW FOR SERVICE OR DISPLAY

27. This tolerance would allow, for example, for display outside chill control, in catering premises in respect of self service food, buffets, and cheese boards, and in retail premises for service and display. Such foods must not, however, have been displayed previously at a temperature above 8 degrees Celsius or above a recommended temperature as described in theAnnex below.

28. Foods displayed outside chill control under this tolerance should subsequently be placed under chill control until they are served, sold, or discarded. Alternatively, they should be discarded immediately after the tolerance period.

29. A DEFENCE AGAINST FAILURE TO OBSERVE THE REQUIREMENT FOR FOODS TO BE KEPT AT OR BELOW 8 DEGREES CELSIUS MAY ALSO BE OFFERED BY PROVING THAT THE FOOD WAS KEPT FOR A LIMITED PERIOD ONLY, THAT WAS CONSISTENT WITH FOOD SAFETY, AT A TEMPERATURE ABOVE 8 DEGREES CELSIUS OR ABOVE A RECOMMENDED HIGHER TEMPERATURE, AND -

THE FOOD WAS BEING LOADED OR UNLOADED FROM A VEHICLE FOR TRANSFER TO OR FROM FOOD PREMISES; OR

- THERE WERE UNAVOIDABLE CIRCUMSTANCES SUCH AS THE PRACTICALITIES OF HANDLING DURING AND AFTER PROCESSING AND PREPARATION; OR DEFROSTING OF EQUIPMENT; OR TEMPORARY BREAKDOWN OF EQUIPMENT.

30. The "limited periods" and permitted rises in food temperature for these purposes are not specified in the Regulations, but must be consistent with food safety. In normal circumstances, a single limited period of up to 2 hours outside temperature control is unlikely to be questioned. For longer periods, some justification, and a hazard analysis based on the principles of regulation (4)3 of the Food Safety (General Food Hygiene) Regulations 1995 would probably be expected.

31. As with other defence provisions, the burden of proof rests with the food business wishing to show that it can use these defences.

Contents: Guidance on the food safety (temperature control) regulations 1995

VI. Hot Holding Controls

32. FOOD WHICH HAS BEEN COOKED OR REHEATED AND NEEDS TO BE KEPT HOT TO CONTROL THE GROWTH OF PATHOGENIC MICRO-ORGANISMS OR THE FORMATION OF TOXINS MUST BE KEPT AT A TEMPERATURE AT OR ABOVE 63 DEGREES CELSIUS.

33. Foods which should be kept hot in order to control the growth of pathogenic micro-organisms or the formation of toxins are broadly similar in nature to the food types described in paragraph 20 above.

A FOOD BUSINESS MAY OFFER A DEFENCE AGAINST FAILURE TO OBSERVE THIS REQUIREMENT BY PROVING-

(A) THAT A WELL FOUNDED SCIENTIFIC ASSESSMENT OF THE SAFETY OF THE FOOD AT A LOWER TEMPERATURE SHOWS THAT THE FOOD CAN BE KEPT SAFELY AT THAT TEMPERATURE FOR A SPECIFIED PERIOD; AND

(B) THAT THE FOOD WAS HELD IN A MANNER IN ACCORDANCE WITH THE SCIENTIFIC ASSESSMENT

34. Similar considerations apply as for scientific assessments of the safety of foods at chill temperatures, eg on the use of competent and expert advice, the use of generic recommendations, and the nature of the scientific assessment. However, unlike the chill temperature variation provisions, there is no requirement for written instructions.

35. As with other defence provisions, the burden of proof for those applicable to hot holding controls rests with the food business wishing to show that it can use the defence.

Hot Holding Tolerance Period

36. A FOOD BUSINESS MAY OFFER A DEFENCE AGAINST FAILURE TO OBSERVE THE REQUIREMENT TO KEEP FOODS AT OR ABOVE 63 DEGREES CELSIUS BY PROVING THAT THE FOOD HAS BEEN KEPT FOR SERVICE OR ON DISPLAY FOR SALE TO CONSUMERS FOR A SINGLE PERIOD OF LESS THAN 2 HOURS.

37. This tolerance would also apply to a recommended temperature for hot holding lower than 63 degrees Celsius. At the end of the period of up to 2 hours, the food should be as quickly as possible cooled to a temperature of 8 degrees Celsius or below, or discarded.

Contents: Guidance on the food safety (temperature control) regulations 1995

VII.The General Requirement

38. (A) NO PERSON SHALL KEEP RAW MATERIALS, INGREDIENTS, INTERMEDIATE PRODUCTS AND FINISHED PRODUCTS LIKELY TO SUPPORT THE GROWTH OF PATHOGENIC MICRO-ORGANISMS OR THE FORMATION OF TOXINS AT TEMPERATURES WHICH WOULD RESULT IN A RISK TO HEALTH.

(B) CONSISTENT WITH FOOD SAFETY, LIMITED PERIODS OUTSIDE TEMPERATURE CONTROL ARE PERMITTED WHERE NECESSARY TO ACCOMMODATE THE PRACTICALITIES OF HANDLING DURING PREPARATION. TRANSPORT, STORAGE, DISPLAY AND SERVICE OF FOOD.

(C) THE GENERAL REQUIREMENT AT (A) MAY IN SOME INSTANCES BE BREACHED, EVEN THOUGH THE REQUIREMENTS FOR A MAXIMUM CHILL TEMPERATURE OF 8 DEGREES CELSIUS OR FOR A MINIMUM HOT HOLDING TEMPERATURE OF 63 DEGREES CELSIUS HAVE BEEN OBSERVED. FOR EXAMPLE, KEEPING PERISHABLE FOODS ABOVE A MAXIMUM STORAGE TEMPERATURE RECOMMENDED IN ANY SPECIAL STORAGE CONDITIONS MAY BE ONE INSTANCE WHERE THE GENERAL REQUIREMENT AT (A) COULD BE BREACHED, EVEN THOUGH THE 8 DEGREES CELSIUS REQUIREMENT IS NOT BREACHED.

39. The general requirement applies to all forms of temperature control, including chill control and hot holding. Foods covered by product-specific Regulations are not covered by this requirement, (see paragraphs 11-13).

40. Like the 8 degrees Celsius requirement, the general requirement applies to all foods likely to support the growth of pathogenic micro-organisms or the formation of toxins. The specific exemptions from the 8 degrees Celsius requirement, set out at paragraph 20 above, do not apply here, but it is reasonable to follow broadly similar principles in applying this requirement. Temperatures will only "result in a risk to health" where temperature control is critical to the safety of food. For example, chill control will not be a requirement where food has been subject to a process, such as canning, which prevents the growth of pathogenic micro-organisms or the formation of toxins. Nor will it be a requirement where food, such as raw meat, will be cooked so as to ensure its fitness for consumption.

41. Tolerances from the general requirement, as set out at paragraph 38(B), also apply on similar principles to those set out in paragraphs 26-31 and 34-37, although specific time periods have not been defined in the Regulations.

42. The substantive provision is regulation 10(1), summarised at paragraph 38(A) above. Paragraph 38(C) summarises regulation 10(3). This is drafted as a declaratory provision and, in effect, interprets an aspect of the requirements of regulation 10(1). To commit an offence, a food business must be in contravention of regulation 10(1). In most circumstances, food businesses complying with the more specific requirement for a maximum temperature of 8 degrees Celsius will also be complying with regulation 10(1). For regulation 10(1) to be breached, even where the food is kept at or below 8 degrees Celsius, a maximum chill temperature lower than 8 degrees Celsius would need to be critical to food safety. It would be necessary for an enforcement authority to prove a risk to health for any food alleged to be in breach of regulation 10(1). This may be demonstrated, for example, by scientific evidence. Observance of temperature recommendations in any special storage conditions on food labels, including recommendations for chill temperatures lower than 8 degrees Celsius, is not automatically mandatory. Many such recommendations are made for food quality rather than food safety reasons.

43. The general requirement should be taken into account by food manufacturers when specifying storage temperatures and shelf lives for products to be kept at chill temperatures, including temperatures below 8 degrees Celsius. For longer shelf life foods, for example, the practical difficulties of ensuring that the chill chain is not breached may mean that it is undesirable to rely on chill control at a recommended temperature of lower than 8 degrees Celsius as the only controlling factor for food safety.

44. The general requirement should also be taken into account by other food businesses storing such products. There will be some foods where the general requirement might require them to be stored at a chill temperature lower than 8 degrees Celsius for safety reasons, taking account of the allocated shelf life. Vacuum-packed, extended shelf life food such as sous vide products may be an example.

45. The advice in this section is intended to complement best practices in the food industry which might involve, for example, keeping foods at chill temperatures below the legal maximum and thereby providing additional assurances of food safety.

Contents: Guidance on the food safety (temperature control) regulations 1995

VIII. Cooling of Food

46. A FOOD BUSINESS RESPONSIBLE FOR COOLING FOOD WHICH MUST BE KEPT AT CHILL TEMPERATURES SHALL COOL THAT FOOD AS QUICKLY AS POSSIBLE TO THE REQUIRED CHILL TEMPERATURE FOLLOWING -

(A) THE FINAL HEAT PROCESSING STAGE; OR

(B) IF NO HEAT PROCESS IS APPLIED, THE FINAL PREPARATION STAGE

47. The cooling period for any food would not be regarded as unacceptable merely because other equipment, not present at the business, could have cooled the food more quickly. The time taken to achieve cooling must be consistent with food safety. Cooling will often be a step which is critical to food safety.

Contents: Guidance on the food safety (temperature control) regulations 1995

ANNEX

Variation upwards from the 8 degrees Celsius maximum chill temperature

1. This Annex aims to help anyone using the facility for certain food businesses to recommend holding foods at temperatures higher than 8 degrees Celsius to think through the steps that need to be considered in developing the necessary scientific assessment. It also provides guidance for food businesses holding foods at or below recommended temperatures higher than 8 degrees Celsius.
2. A FOOD BUSINESS MAY OFFER A DEFENCE AGAINST FAILURE TO OBSERVE THE REQUIREMENT FOR FOODS TO BE KEPT AT OR BELOW 8 DEGREES CELSIUS, BY PROVING THAT:

(A) THE FOOD BUSINESS MANUFACTURING, PREPARING, OR PROCESSING THE FOOD HAS RECOMMENDED THAT IT IS KEPT:

(I) AT A TEMPERATURE BETWEEN 8 DEGREES CELSIUS AND AMBIENT TEMPERATURES, AND

(11) FOR A SPECIFIED SHELF LIFE;

(B) THAT RECOMMENDATION -(UNLESS THE BUSINESS HAS ITSELF VARIED THE TEMPERATURE) -

HAS BEEN COMMUNICATED BY THE FOOD LABEL OR BY ANOTHER APPROPRIATE FORM OF WRITTEN INSTRUCTION; AND

(C) THE FOOD HAS NOT BEEN KEPT ABOVE THE RECOMMENDED TEMPERATURE; AND

(D) THE SPECIFIED SHELF LIFE HAS NOT BEEN EXCEEDED.

3. A FOOD BUSINESS MANUFACTURING, PREPARING OR PROCESSING FOOD SHALL NOT RECOMMEND -

• AN UPWARD VARIATION FROM THE MAXIMUM TEMPERATURE OF 8 DEGREES CELSIUS
• FOR A PERIOD NOT EXCEEDING A SPECIFIED SHELF LIFE

UNLESS THE RECOMMENDATION IS SUPPORTED BY A WELL-FOUNDED SCIENTIFIC ASSESSMENT OF THE SAFETY OF THE FOOD AT THE SPECIFIED TEMPERATURE AND SHELF-LIFE.

The requirement for food safety

4. A microbiologically unsafe food is one that contains levels of pathogens or their toxins which could harm consumers when the food is eaten. All foods must be held under conditions conducive to maintaining their safety. The scientific assessment must clearly demonstrate that the microbiological safety of the food will not be compromised by storage and handling at the higher temperature.

A maximum temperature higher than 8 degrees Celsius

5. he recommended temperature must be between 8 degrees Celsius and ambient temperatures. It must therefore be a temperature lower than estimated ambient temperatures. The recommended temperature will generally require some form of refrigeration if it is to be achieved over any extended period. Foods which are able to be kept safely at ambient temperatures are covered by the general exemptions described in Section III.

Which food businesses may recommend a temperature higher than 8 degrees Celsius?

6. The Regulations allow businesses manufacturing, preparing, or processing food to recommend a temperature higher than 8 degrees Celsius. The business involved in manufacture of the food should be best placed to know its microbiological and other safety characteristics, in the light of any processing it may have undergone. Businesses cooking or preparing food, for example catering businesses, may also make the recommendation for a higher temperature, but should check with a manufacturer first, where this is relevant, before deciding whether changes can be safely made.

Which businesses may use the defence?

7. Businesses only retailing and/or wholesaling may not themselves recommend a higher temperature. They may keep food at a temperature higher than 8 degrees Celsius, for a specified shelf life, where this is recommended by a manufacturer or processor. They can then rely on a defence, in any proceedings, that they had kept the food at or below the recommended temperature, and the specified shelf life had not been exceeded. Food businesses seeking to use this defence must comply with all parts of the provision to be able to use the defence. The burden of proof in any proceedings would be on the business wishing to show that it could use the defence.

What constitutes a scientific assessment?

8. A scientific assessment should include the microbiological analysis of a food under controlled conditions which represent expected real life conditions by a suitably qualified scientist and the evaluation by that scientist of the effects of time and temperature of storage, including distribution and retail display, on the safety of the food as it will be consumed. The use of a theoretically based modelling approach, eg MAFF MicroModel, may be helpful in defining the safety factors but is not considered in itself to provide a sufficient assurance of food safety.

9. It is common practice within businesses manufacturing foods to use a range of sources of raw material to allow for factors such as cost, availability, seasonal variation and quality so as to make the manufacturing process more cost effective. In some instances, the raw material may vary on a day-to-day basis. The justification for the use of a higher temperature than 8 degrees Celsius must take into consideration the effects of raw material variation on the microbiological status of the food so that the effects on safety can be fully evaluated.

10. The scientific justification must be fully developed for each product for which a higher storage and handling temperature than 8 degrees Celsius is proposed. That justification will need to be reviewed in the light of changes to any process (eg preparation of ingredients, cooking etc), any ingredients, product characteristics or the product life.

11. It is not possible, within this booklet, to list all the parameters which must be considered in a scientific assessment, as these will depend on the type of ingredients involved, the type of processing, the nature of the food itself, its packaging and the intended end-use by the consumer. In most cases, due consideration will need to be given to:

• pH;
• type of acidulants;
• water activity;
• type of solutes; and
• the combined effects of preservative factors.

But this is not an exhaustive list and each case must be given careful consideration.

The specified shelf-life

12. The scientific assessment in support of the use of a higher temperature than 8 degrees Celsius must show how the safe product life has been established and provide the necessary evidence that the product will not be microbiologically compromised, if consumed within the Use-by period, allowing for reasonable handling by the consumer following retail sale. Consideration must be given to limited periods of exposure to temperatures higher than the new prescribed control temperature which may arise during loading and unloading of delivery vehicles or during defrosting periods of refrigeration equipment.

13. Shelf-life assessments may relate to quality as well as food safety. There are separate legal obligations relating to the deterioration of quality of food and the information which must be given about this to the consumer. The scientific assessment needed to justify a variation from the maximum temperature of 8 degrees Celsius relates only to safety issues.

Generic temperature recommendations

14. Generic recommendations may be made for variations of chill temperature, for example, a recommended temperature for a fully defined product made by a trade association, based on a scientific assessment of fully defined preparation and handling practices and defined storage conditions which provides evidence of safety for that product. The foods must be tightly defined in all aspects from raw materials to finished products. The handling and storage regimes must also be fully described and allow for the "worst case" scenario for the industry concerned.

15. It is most important that food businesses using such generic recommendations have access to the appropriate definitions of the product used for the scientific assessment, so that they can use the facility for a higher temperature correctly and follow the handling and storage regimes which are consistent with those used in the original scientific assessment. A food business making use of a generic recommendation when putting a temperature on a food label is responsible for ensuring that this is consistent with food safety.

16. Generic recommendations may be included in Industry Guides to good hygiene practice, which have been recognized as complying with the Regulations. A scientific assessment justifying such a recommendation, where this is included in a recognized Industry Guide, will normally be regarded as a sound scientific assessment.

Communication of the variation of temperature

17. The Regulations require the business manufacturing, preparing, or processing the food to communicate the variation of temperature either by means of the food label, or by another appropriate form of written instruction. Without one of these forms of communication, the variation of temperature cannot be used by a business other than one manufacturing, preparing or processing the food.

18. The two essential items of information are the new maximum temperature and the specified shelf life. Food items which are packaged will also be covered by the Food Labelling Regulations which require a "Use-by" or "Best-before" date to be shown on the food label. Where this is so, this information will be taken as the shelf-life for temperature control purposes, and should be calculated with this in mind. The new temperature must be stated clearly with an instruction to other food businesses in the food chain to store at or below this temperature.

19. The option of using the food label to communicate storage information will not apply in the case of unpackaged food. Written instructions must accompany each batch of food to which the variation applies. Most unpackaged food for which the variation of temperature might be employed would be expected to be short shelf-life products, in many cases manufactured and sold on the same premises. Where foods are manufactured and sold on the same premises, use of a general written instruction on storage temperature and shelf-life of a specified product would be good practice if the variation of temperature is to be employed, but is not a requirement.

Who can advise on scientific assessments and what constitutes a competent laboratory?

20. While large businesses may be able to undertake this type of scientific assessment in-house, it is unlikely that many small businesses would have the necessary technical competence to carry out such an exercise. In such cases, it will be necessary to seek outside advice and assistance, perhaps through a trade association. It is of the utmost importance that advice is sought from suitably qualified scientists or bodies employing such scientists who are in a position to provide sound, unbiased, and practical help.

21. Examples of bodies employing such people are Public Analysts, Food Examiners, Food Research Associations, the Public Health Laboratory Service and the Agricultural Development and Advisory Service. When seeking a competent laboratory, it is wise to select a facility which can demonstrate its competence through recognition by an independent accreditation body, eg, the National Measurement Accreditation Service. The area of competence recognised by the accreditation should be within a relevant field associated with the microbiological safety of food.

Further advice

22. Further advice on determining food shelf lives may be found in the following publications:

Shelf life of foods - Guidelines for its Determination and Prediction - Institute of Food Science and Technology (UK) - ISBN 0 905367 111 (Available from Institute of Food Science and Technology (UK), 5 Cambridge Court, 210 Shepherds Bush Road, London W6 7NL)

Evaluation of Shelf Life for Chilled Foods - Campden and Chorleywood Food Research Association, Technical Manual No 28 (Available from Campden Food Research Association, Chipping Campden, Gloucestershire, GL55 6LD)

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