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Precautionary allergen labelling

Guidance for small food businesses on using precautionary allergen labelling such as ‘may contain’.
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To help consumers make safe and informed choices, food businesses may voluntarily provide information about the unintentional presence of allergens. This is called precautionary allergen labelling (PAL).

Allergen cross-contamination can happen unintentionally when there is a risk that the allergen has entered the product accidentally during the production process. This can sometimes happen when several food products are made on the same premises. 

However, precautionary allergen labelling should only be used when, following a thorough risk assessment, a real risk of allergen cross-contact within the supply chain is identified that cannot be removed through careful risk management actions.

Excessive use of precautionary allergen labels can unnecessarily limit consumer choice, and devalue the warning for consumers with a food allergy or intolerance. This can lead to risk-taking behaviours.

This guidance for food businesses outlines the process for deciding whether or not precautionary allergen labelling is appropriate to use. This will help to ensure that precautionary allergen labelling is applied appropriately and is as helpful as possible for the consumer.

Ensuring that risks of allergen cross-contamination have been mitigated and that good practices are in place offers protection for the business.

Tips

Our precautionary allergen labelling checklist provides more information on the steps food businesses should take when applying precautionary allergen labelling.

When precautionary allergen labelling should be used

Precautionary allergen labelling should only be used when a real risk of allergen cross-contact within the supply chain is identified that cannot be removed through careful risk management actions. This should be identified by a thorough risk assessment.

Allergen cross-contamination or cross-contact is when traces of allergens get into products accidentally. This can happen during the processing, manufacturing, handling, transport, or storage of foods. 
Your food business can choose wording such as:

  • “may contain x”
  • “not suitable for consumers with a x allergy”

General or blanket statements, such as “may contain allergens” could be deemed misleading to the consumer, because they are highly unlikely to be based on thorough risk assessments. 

Precautionary allergen labelling can also be used in combination with vegan or vegetarian labelling. Find out more about food labelling in your business through our online labelling training.

Precautionary allergen information from ingredient suppliers should be passed to the final consumer.

When precautionary allergen labelling should not be used

Precautionary allergen labelling should not be used in combination with a free-from statement for the same allergen. A food cannot carry both labels e.g. “free-from gluten” and “may contain gluten.”

PAL should not be used as a substitute for good food hygiene and safety practices. Excessive use of precautionary allergen labels can unnecessarily limit consumer choice, and devalue the warning for consumers with a food allergy or intolerance. This can lead to risk-taking behaviours to increase their food choice, resulting in unexpected adverse allergic reactions.. 

Whether a PAL is applied or not is a decision that should be made as the final step in a process of risk analysis of allergen cross-contact within the food supply chain. 

Voluntary food information must meet the requirements set out in food law: not to mislead the consumer and not to be ambiguous or confusing. The use of precautionary allergen labelling when no real risk to the consumer has been identified, could be considered to be misleading food information.

For non-prepacked foods precautionary allergen statements do not need to be included on a label, as information on the unintentional presence of allergens can be communicated by other means. This could be orally, by staff, or visually on signs at the premises.

Allergen cross-contamination

It is important to manage allergens effectively in your food business to ensure food is safe for customers with food allergies.

This involves including having good food preparation and hygiene practices in place to avoid cross-contamination in your kitchen.

Potential sources of allergen cross-contamination during food processing and preparation which should be considered as part of a thorough risk assessment include:

  • processing aids
  • raw material handling
  • storage
  • transport
  • people
  • cleaning
  • shared equipment
  • re-work
  • air particles in preparation area
  • supply chain
  • packaging.

Detailed guidance on how to manage allergens can be found in our Safer food, better business information packs for caterers (Safe catering in Northern Ireland).

Minimising risk of allergen cross-contamination

You can minimise the risk of allergen cross-contamination through a number of ways. 

Having an allergen notification system with suppliers and maintaining well labelled and segregated ingredient storage will support effective management of allergenic ingredients.

Exercising good personal hygiene and developing premises cleaning procedures, with dedicated areas and utensils, are all steps which will reduce the likelihood of allergen cross-contact.

Cleaning

Thorough cleaning that is effective in reducing the risks of allergen cross-contamination should be used where appropriate. 

Thorough cleaning requires careful management. This could include using dedicated, clean, or new sponges, cloths, and freshly prepared cleaning solutions. This is preferable to reusing cleaning solutions which have been used in areas where foods with allergens have been prepared. 

Where adequate cleaning is not possible, the risk of cross-contact should be assessed. Precautionary allergen labelling should be used when necessary.

Your business can minimise risk of allergen cross-contamination through cleaning processes, by:

  • establishing an appropriate cleaning regime.
  • focusing on hard to clean areas. 
  • where appropriate, consider dismantling equipment to remove allergen residues from powders, pastes, and seeds. 
  • cleaning thoroughly to remove microbiological hazards as well as allergens.
  • validating cleaning regimes with inspections to ensure there is no visible food, debris, or other residues.
  • monitoring that cleaning is done effectively by staff.
  • keeping records of cleaning.
  • making pest control providers aware of concerns around the allergen status of the site so they do not introduce additional allergens through their products.

Storage

You can avoid allergen cross-contamination by dedicating storage and production areas to specific allergenic products. 

However, food premises and product ranges vary significantly. Dedicated areas will not always be a feasible option, particularly in small and micro businesses. 

Where space is limited, there are a number of ways of minimising risk of allergen cross-contact. These include:

  • storing allergenic ingredients in different parts of the food preparation area.
  • storing allergenic ingredients below, rather than above non-allergenic ingredients, e.g. bread rolls with sesame seeds kept separate from ones without. If ingredients contain multiple allergens, consider how to store these appropriately.
  • using dedicated equipment and utensils when preparing allergenic ingredients. Colour coding can be helpful.
  • minimising unnecessary movement of foodstuffs.
  • being aware of decanting ingredients and air currents in the premises where this is practical, to avoid movement of lightweight ingredients via the air e.g. powdered ingredients such as flour.

Food preparation

Scheduling the food you are preparing is another method to reduce the risk of allergen cross-contamination. 

This can be done by preparing food in order of least allergenic to most allergenic. For example, gluten free products could be produced at the start of the day, followed by gluten containing products. 

Measures still need to be taken in food preparation because allergen cross-contact primarily occurs through:

  • food to food contact - by different foods touching or one food dripping onto another food.
  • food to hand to food contact - through food preparation staff using ingredients from multiple containers holding different allergens, without washing hands in between. This can also occur when assembling sandwiches, or putting toppings on food.
  • food to equipment/utensils/surface to food contact - through sharing of utensils without thoroughly washing and drying, or using the same cutting board for multiple ingredients.
  • food cooked in the same liquid - through shared fryers for cooking food containing different allergen content.

The different allergen cross-contamination risks should be considered as part of a thorough risk assessment.

Risk analysis for allergen cross-contamination

Undertaking a risk analysis will allow your business to identify the risk of allergen cross-contact, decide whether precautionary allergen labelling is appropriate, and agree next steps. 

Risk analysis is made up of 4 stages:

  1. Risk assessment – What is the risk?
  2. Risk management – Can the risk be managed? What actions could reduce the risk?
  3. Risk communication – How should the risk be communicated?
  4. Risk review – Has the risk changed? How frequently will you review your system?

Conducting a risk assessment for allergen cross-contamination

Before conducting a thorough risk assessment, consider where you can remove risk of allergen cross-contact. 

Identify where ingredients containing allergens could be removed or substituted in your processes. For example, if you use sesame seeds on products, can they be replaced with poppy seeds? 

For allergenic ingredients that cannot be substituted, or those you do not wish to remove, evaluate the likelihood of allergen cross-contact. You should consider the risk across the supply chain from raw materials through to the finished product. 

This will involve: 

  • passing on precautionary allergen information from ingredient suppliers 
  • risk assessing allergen cross-contact on your premises 
  • taking risk management actions, such as segregation and cleaning 

The outcome of the initial risk assessment could be either:

  • Probable – a likely chance of risk occurring
  • Remote – risks are unlikely to arise but are still possible. Low probability risks should not be ignored and should be eliminated and managed where appropriate.

Using precautionary allergen labelling is advisable where an unavoidable and real risk of allergen cross-contact has been identified.

Managing unintended allergens in food manufacturing

Food manufacturers must consider allergens when undertaking their Hazard Analysis and Critical Control Points (HACCP) assessment. This will identify whether an allergen can be eliminated, or inform the processes needed to manage the risk. 

A separate allergen risk assessment can also be undertaken, utilising the process flow from the HACCP to evaluate the allergen risks in isolation. It is important to establish both on-site risk points and risks from incoming ingredients. 

Good supplier management will usefully inform decisions on the appropriate frequency of checks on raw materials and specification checks.

Good Manufacturing Practice (GMP) requires a commitment to ensure products meet food safety, quality, and legal requirements. This relies on appropriate manufacturing operations, including effective food safety systems, hazard analysis principles and quality assurance systems. 

Appropriate and targeted GMP controls will also assist with allergen management, for example avoiding cross-contact by segregation of ingredients, cleaning, using separate utensils etc. However, it should be noted that unlike microbiological risks, food processing, for example heating, does not consistently destroy food allergens and may in some cases actually increase their potency, for example roasting peanuts.   

Precautionary allergen labelling should only be used where a real risk of allergen cross-contamination has been identified that cannot be removed. It should not be used as a substitute for good manufacturing practices.

An allergen cross-contamination HACCP based risk analysis for food manufacturers may include the following:

  • identifying incoming allergens through both raw and prepacked food suppliers
  • passing on precautionary allergen information from both raw and prepacked suppliers
  • identifying potential opportunities for cross-contact on the premises
  • assessing each potential issue for likelihood of cross-contact
  • determining the hazard rating of all allergen cross-contact points identified 
  • determining whether appropriate control measures are currently in place or can be implemented to prevent cross-contact. 
  • considering reformulating products in order to remove or reduce allergen risk.
  • applying a PAL to communicate to the consumer any real risk of allergens being unintentionally present.

Managing unintended allergens in the supply chain

Food businesses should establish a method for assessing the allergen status of incoming ingredients from suppliers. 

Any change in supplier should be accompanied by the appropriate checks. This could be through audits or a form asking suppliers to provide the required information. 

This should be undertaken for new ingredients prior to purchasing or coming on-site. This will ensure that the allergen status of your finished product remains unchanged.

You should manage the risk of allergen cross-contamination in the supply chain by:

  • checking the allergen status of all ingredients with suppliers and conduct a specification review on a regular basis.
  • asking suppliers to notify changes in the allergen status of the ingredients or materials that they supply.
  • carrying out appropriate checks on incoming goods. This includes identifying damaged packaging and checking that the delivery vehicle is clean and free from spillages.  
  • checking labels periodically to ensure the product matches specification and are appropriately labelled with correct allergen information.
  • clearly identifying allergenic raw materials and segregating ingredients where possible. 
  • ensuring the handling of allergenic ingredients does not cause contamination of other ingredients.
  • checking implications of any change of ingredient supplier, such as change of processing plant.
  • having a system in place that enables you to find out if your supplier changes any of their ingredients.

Allergen management resources for food businesses

Food allergy and intolerance online training

Our free food allergy and intolerance online training has six topic modules and a certificate on successful completion of the training.

We also offer labelling and root cause analysis training

Safer food, better business

The Safer food, better business pack contains guidance for food businesses, includes materials on ‘managing food allergen information’ and ‘customers - food allergies’. It also includes templates that staff can use. 

Safe catering 

The Safe catering pack contains guidance for food businesses in Northern Ireland.

Technical guidance

The Food allergen labelling and information requirements - Technical Guidance provides detailed guidance for businesses on allergen labelling requirements and legislation.

Food hypersensitivity team

If you have further queries, please contact our food hypersensitivity team.