This section gives general advice to food law enforcement officers on how to make sure food business operators understand the inherent hazards associated with vacuum packing and modified atmosphere packing as well as the control factors they should be using to prevent growth and toxin production by Clostridium botulinum in chilled foods.
This guidance is applicable to all vacuum packed and modified atmosphere packed chilled foods stored above 3ºC. Different food types will vary in their inherent risk with respect to Clostridium botulinum and therefore their priority for attention.
The table in Section 3 gives examples of foods that differ in their inherent risk with respect to Clostridium botulinum. For example, hot smoked fish would have a greater inherent risk relative to a hard cheese like cheddar. These examples of food types are given to aid enforcement officers when assessing any potential risk to public health.
Agency guidance recommends that the shelf-life applied to vacuum packed and modified atmosphere packed products should be restricted to a short period of time (i.e. no greater than ten days) unless the food business operator is able to demonstrate that appropriate key control measures are in place.
There are two recommended ways to ensure the safety of vacuum packed and modified atmosphere packed products. They should either be heated to a sufficient temperature to inactivate the spores of Clostridium botulinum, or be subject to a single or a combination of preservative control factors to prevent or inhibit the growth of Clostridium botulinum. These controlling factors need to be applied to foods with an assigned shelf-life of more than ten days.
The food business operator should see the decision tree in Module 3, Section 2. If the shelf-life is beyond ten days, the hazard analysis and critical control point (HACCP) plan should specify the relevant control measures to ensure safety within the allocated shelf-life.
Article 3.2, Annex II of EC Regulation 2073/2005: Microbiological Criteria for Foodstuffs describes the necessary practices and procedures that should be considered in establishing shelf-life. It is noted that this is set out specifically for Listeria monocytogenes and is not a general legal requirement for Clostridium botulinum. However, this information may assist in determining an appropriate approach.
See Article 3.2, Annex II of EC Regulation 2073/2005: Microbiological Criteria for Foodstuffs.
A business must be able to identify the hazards associated with their operation and the methods to control those hazards. Article 5 of Regulation (EC) No 852/2004 requires a permanent procedure based on HACCP principles.
A food business operator should be able to provide the local authority with evidence to demonstrate the way it controls the hazards, including that of Clostridium botulinum in relation to their vacuum packed and modified atmosphere packed products.
See Article 5 (4) (a) of Regulation (EC) No 852/2004 on the hygiene of foodstuffs.
In addition, depending upon the process, the business may also fall within the remit of Regulation (EC) No 853/2004, where there are additional requirements that the business has to meet over and above those for Regulation (EC) No 853/2004.
See Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin.
The extent and detail of the information in a hazard analysis and critical control point plan will depend on the shelf-life the business applies to their products.
If the shelf-life is ten days or less, the controls are simple and straightforward (i.e. a clear ’use by‘ date within ten days of packing and storing the product at 8ºC or less throughout its shelf-life).
The ‘use by’ date and required storage conditions should be clearly printed on the pack.
A HACCP procedure based on these principles is unlikely to be suitable, especially when the business wants to apply a shelf-life greater than ten days. In such circumstances, the business will need to set out their control measures, critical limits and monitoring procedures in more detail and will need to keep appropriate records.
Validation involves a confirmation that, if followed, the HACCP plan will result in the production of safe food. This is to ensure that the control measures and their associated limits are appropriate and can be applied in practice. The level and nature of the validation required will depend on the products and processes involved.
The most important things to validate are that the control measures at the critical control points are sufficient to achieve the objectives (for example, heat treatment of 90ºC for ten minutes; pH of 5 or less; minimum salt concentration of 3.5%; water activity of 0.97 or less). Note: these have previously been described in the text as ‘control factors’, but the correct term to be used in the context of HACCP is ‘control measures’.
The performance of some control measures will have already been validated by others, or they may be so well established in practice that validation can be considered to have been achieved (some examples are provided in this document).
However, when this is not the case (for example, when using different time temperature combinations) validation should be undertaken.
Food business operators should carry out validation – either themselves, if they have the expertise, or by someone else on their behalf. If the business is not using procedures that are already validated, they should be able to demonstrate how they have validated their HACCP plan – in particular, the effectiveness of the control measures.
The local authority should ensure that validation is undertaken by the business in meeting their obligation of complying with Article 5 of Regulation (EC) No 852/2004.
If control measures are being used that have not already been validated or are not accepted practice, then the authority should request evidence of the validation process, when it was undertaken, and who was involved (including their level of expertise).
Article 5(1) of Regulation (EC) No 852/2004 requires a food business operator to put in place, implement and maintain permanent procedures based on HACCP principles. Under Article 5(4)(a), a food business operator is also required to provide the competent authority with evidence of their compliance with Article 5(1), in the manner that the competent authority requires. Failing to meet those community provisions may constitute an offence under The Food Hygiene (England) Regulations 2006 (as amended). Parallel regulations apply in Scotland, Wales and Northern Ireland.
A hygiene improvement notice (HIN) may be appropriate to ensure either:
- validation is carried out, or
- evidence is provided of the result of the validation process
The use of enforcement powers is subject to the guidance in the Food Law Code of Practice and to the local food law enforcement policy.
Businesses should be able to provide scientific evidence that supports the shelf-life determination applied to their vacuum packed and modified atmosphere packed products. If a business is unable to provide this evidence, further investigation and action may be required to protect consumer safety.
General advice on enforcement is contained in the Food Law Code of Practice and associated practice guidance.
See Regulation 5(c) of the Food Labelling Regulations 1996 (SI No 1499: 1996) (as amended).
The first stage is to consider whether the FSA guidance on vacuum packed and modified atmosphere packed products is being followed. See the decision tree in Module 3, Section 2, developed on behalf of the ACMSF, summarising the key questions that need to be considered.
The ACMSF’s view is that businesses using vacuum packing and modified atmosphere packing should base their controls on the assumption that spores of Clostridium botulinum may be present in ingredients or foods.
Local authorities should ensure that these controls are in place to protect consumer safety. Local authorities should take a risk-based approach when prioritising enforcement activities (for example, focusing on businesses that use vacuum packing and modified atmosphere packing for food falling within the ‘high priority for attention’ category).
Examples are shown in the table in Module 3, Section 2.
There is no specific law in the EU, in the UK or in other member states that covers the use of vacuum packing and modified atmosphere packing technology.
In line with The Food Hygiene (England) Regulations 2006 (as amended) and equivalent legislation (as amended) in Scotland, Wales and Northern Ireland, a hygiene emergency prohibition notice can be issued where there is evidence that there is an imminent risk to consumers.
Before considering such action, the local authority should consider the advice in this document and seek further advice from an appropriate ‘expert’, who may be able to provide evidence in court on behalf of the authority if their action is challenged.
The seizure of food and the possibility of product recall would also need to be considered. In considering whether enforcement action is appropriate or necessary, it should be recognised that ACMSF advice is based on best scientific advice and industry practice.
If appropriate evidence is found, a hygiene emergency prohibition notice may be served on the food business operator, followed by an application to a Magistrates’ Court for a hygiene emergency prohibition order.
The following provides an example of circumstances where an authorised officer may consider the use of these prohibition powers because the health risk condition in regulation 7(2) or regulation 8(4) of the Food Hygiene (England) Regulations 2006 (as amended) is likely to be satisfied. That is, there is a risk of injury to health under regulation 7(2) or an imminent risk of injury to health under regulation 8(4). This example is, in no way, prescriptive or exhaustive and is for illustrative purposes only.
Equivalent legislation (as amended) applies in Scotland, Wales and Northern Ireland.
A food business operator is producing a vacuum packed product that falls within the category requiring ‘high priority for attention’ (see the table in Section 3). This product has shelf-life significantly more than ten days and there is a complete failure on the part of the company to demonstrate effective control of non-proteolytic Clostridium botulinum.
The food business operator is likely to have a general failure to satisfy relevant statutory obligations and a poor track record of compliance (i.e. a score of 15/20 in Part 2 of the food hygiene scoring system and a confidence in management score of 20/30 (see Annex 5 Food Law Code of Practice)).
Before considering such action, the local authority should consider the answers to previous questions in this module – in particular, the need for ‘expert’ evidence.
The food business operator should be provided with a copy of the ACMSF or Food Standards Agency guidance. Officers should consider whether the food business operator’s knowledge gap has resulted, or might result, in the production of food which is unsafe or otherwise non-compliant with food law.
The business should be given help and guidance, using a risk-based and proportionate enforcement approach in accordance with the advice contained in the Food Law Code of Practice.
Different foods will vary in their inherent risk with respect to Clostridium botulinum, and as a result their priority for enforcement attention (for example, hot smoked fish would have a greater inherent risk relative to a hard cheese like cheddar).
The 1992 ACMSF report contains further examples and details of inherent risk in respect of Clostridium botulinum. See an adapted version in Module 4, Section 3.
The ACMSF report identifies three categories of products in respect of inherent risk:
Enforcement activity would normally be focused on products that fall within the scope of ‘high priority for attention’.
Industry guidance, produced by Campden BRI, also contains a table of examples of inherent risks. See Table 1 in 'A code of practice for the manufacture of vacuum packed and modified atmosphere packed chilled foods' (Guideline No. 11) on the Campden BRI website via the link below. Please note that the publication is not free. Campden BRI members can buy the guidelines at a reduced (members) rate.
See Table 1 in 'A code of practice for the manufacture of vacuum packed and modified atmosphere packed chilled foods' (Guideline No. 11) on the Campden BRI website.
A food business operator must be able to identify the hazards associated with their business and the methods to control those hazards, reflecting these in their HACCP-based food safety management system.
The decision tree in Module 3, Section 2 will identify those factors that need to be taken into account when a vacuum pack or modified atmosphere pack product is repacked.
Under no circumstances should it be considered safe to use the same complex equipment, such as vacuum packing machines, slicers and mincers, for both raw and ready-to-eat foods.
The Agency has produced guidance, ‘E. coli O157: Control of Cross-Contamination – Guidance for food business operators and enforcement authorities’, that details the steps that food businesses need to take to control cross-contamination between raw foods and ready-to-eat foods where E. coli O157 is a hazard. The guidance includes advice on the dual use of equipment and machinery (including vacuum packing machinery), cleaning and disinfection procedures, and additional disinfection considerations for equipment and machinery, including vacuum packing machines.
The Agency’s advice is that there is a major risk of cross-contamination where the same item of equipment, such as vacuum packers, slicing machines and mincers, are used to process raw food and ready-to-eat food. E. coli O157 may contaminate the food contact surfaces of such equipment after use with raw foods. This contamination may not be adequately removed during the cleaning and disinfection process, which can result in any ready-to-eat foods, subsequently processed with the equipment, becoming contaminated.
The Agency’s guidance states that:
'Under no circumstances should it be considered safe to use the same complex equipment, such as vacuum packing machines, slicers and mincers, for both raw and ready-to-eat foods. Where, for example, vacuum packing of ready-to-eat foods is carried out, the vacuum packing machine for this purpose should be located in a designated clean area where there is no risk from cross-contamination via splashes, hands, clothing, packaging or other equipment, and should never be used for packing raw foods. Dual use of complex equipment for raw and ready-to-eat foods should never be regarded as a safe practice.'
The following is guidance on cleaning and disinfection of vacuum packing machines, and other machinery and equipment:
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Chemical disinfection – effective cleaning must use a combination of physical cleaning, i.e. using a detergent to physically remove all visible dirt, food debris, solids and grease from surfaces followed by a disinfectant used at the correct temperature, contact time and dilution. If a sanitiser is employed, it must be used in both stages of the cleaning and disinfection process, i.e. in general cleaning, to provide a clean surface, and then again to disinfect the surface. Single use of a sanitiser is not sufficiently effective to ensure thorough disinfection to microbiologically safe standards.
There are two officially recognised laboratory standards for assessing the effectiveness of disinfectants and sanitisers against a range of microorganisms.
These are BS EN 1276:2009 (or its predecessor BS EN 1276:1997) and BS EN 13697:2001. These standards demonstrate that a disinfectant is capable of reducing the levels of a range of bacteria, including E. coli, under a set of specified conditions (e.g. at a particular temperature, dilution and contact time).
- Non-chemical disinfection – the application of heat (thermal disinfection) is one of the most reliable ways of killing bacteria such as E. coli O157, but is not always practical, particularly in small food businesses. Where heat disinfection is being used, food businesses should ensure that the temperature and contact time is sufficient to destroy harmful bacteria. For instance, in certain non-retail establishments that require approval (such as meat cutting establishments), a water temperature of 82°C is legally required for the disinfection of tools (see Annex III, Section I, chapter II para 3 of Regulation (EC) No 853/2004).
The above guidance is suitable for smooth surfaces in good condition that can be fully inspected to ensure that they are visibly clean.
An additional disinfection consideration for all food equipment and machinery is that they should be hygienically designed.
Machinery supplied in 1995, or any time after that, for use at work should be CE marked to indicate that it was designed to comply with the European Machinery Directive. This includes requirements for hygienic design. Detailed guidance on hygienic design requirements of the Machinery Directive can be found in BS EN 1672-2:2005+A1:2009 Food Processing Machinery-Basic Concepts Part 2: Hygiene Requirements, BSI.
Additional requirements for some particular types of food machinery and packaging machinery are set out in more specific standards. Lists of type-specific standards are available for:
If an environmental health officer or a food business operator is concerned about the safety of a process, where can they get technical advice and opinion?
There are a number of food research organisations that can provide advice, including:
Trade associations may be able to provide opinion, including: