Precautionary allergen labelling

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 an allergen can enter the product accidentally during the production process. This can sometimes happen when several food products are made on the same premises. 

However, a precautionary allergen label should only be used when, following a risk assessment, a risk of allergen cross-contact within the supply chain is identified that cannot be removed through 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 risk of allergen cross-contact within the supply chain is identified that cannot be removed through risk management actions. This should be identified by a 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 unlikely to be based on an assessment of the risk of cross-contamination for each of the 14 regulated allergens. 

Precautionary allergen labelling can also be used in combination with vegan or vegetarian labelling.

Precautionary allergen information from ingredient suppliers should be passed to the final consumer, unless the food business risk assessment supersedes that information.

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 for example “free-from milk” and “may contain milk.”

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 genuine 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

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

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, for example 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 - 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 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

The main purpose of an allergen risk assessment is to understand the likelihood of unintentional allergen cross-contamination across the supply chain, from raw materials to your finished product. 

The risk assessment should consider the following as a minimum: 

What are the potential sources of allergens at your premises?

• Do any foods/ingredients that enter your premises intentionally contain allergens? For example, are peanuts, milk, eggs, sesame seeds or other allergens used in some of your products?
• Could any foods/ingredients that enter your premises unintentionally contain allergens?
• For example, are there any incoming foods/ingredients with a precautionary allergen label or has your supplier passed information to you which indicates that they may contain allergens? 
• Are there any other potential sources of allergens at your premises? (see Allergen cross-contamination)

How could allergen cross-contamination happen from the sources you have identified to foods at your premises that are not intended to contain allergens? 

• What are the routes through which this could happen?
• For example how could cross-contamination happen during handling, storage, preparation, production processes, packing or distribution? 
• The physical nature of the particular ingredients being used (e.g. liquid, powder or pieces) and geography of the manufacturing environment are important. For example, a liquid and a powder represent different types of risk. Milk powder may represent a greater risk in situations where air-borne contamination of products is possible, but liquid milk may be of less concern if there was sufficient separation (for example, by physical barriers, distance, timing or cleaning) between the products in which it is deliberately used and those where it is not
• The physical nature of the ingredients can also affect how evenly allergens may be spread in the food. For example, allergens in a powder are more likely to be evenly spread in a product than particles such as lumps, seeds and nuts which may appear as hot-spots that could deliver higher doses of allergen to the consumer
• How likely is it that cross-contamination will happen and in what amount? 

How effectively do your control measures reduce or eliminate the risk of allergen cross-contamination? 

• For examples of control measures, see the section on minimising the risk of allergen cross-contamination. (See Minimising risk of allergen cross-contamination)

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 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 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 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.