Ten musts of allergen management

Since the declaration of allergen content in food products has become mandatory in the food industry, consumers have witnessed a proliferation of allergen statements, formulations and formats that often cause effects opposite to those intended. Product labels turn out to be either so confusing that the consumption by people with allergies is discouraged, or so all-encompassing that users have to wonder if any real check was conducted on the products. In both cases, a detrimental effect is achieved – the consumers lose confidence in the information on the label.

Ideally, the information conveyed in the label should be the result of an evaluation of the real risk of the presence of an allergen in the product. This evaluation should take into account a risk assessment of the presence of allergens (comprising the whole production chain) and an appropriate allergen management plan.

Food allergen management is the name given to the collection of all documented measures and policies taken by a company to identify, minimise, control, or, if possible, eliminate the presence of allergens in all the levels and areas of a company involved in the supply chain. This includes the training of personnel and the internal and external communications of the risk and presence of said allergens.

There are guidance documents and many food safety certification programs that provide general guidelines on the aspects to take into account when putting a food allergen management plan in place. Though there may be some local variation, all of them share similar aspects.

Understand how your suppliers determine allergen status
It is essential to determine or verify the allergen status of the material suppliers provide and to understand their allergen risk and their allergen management practices.
There are different ways to accomplish this. The first and simplest is to require that providers give information about the measures they have taken to get the allergen status they declare. This inspection can include the testing of the material with allergen-specific analysis methods like ELISA. But that is just a starting point. Preferably, one should take more exhaustive measures that include requiring audits or certifying compliance via a food safety standard scheme. All information must be properly recorded and protocols must be in place on how to handle changes or substitutions.

Know how to handle and store raw materials and intermediate products
Pay attention to how raw materials and intermediate products are accepted, handled and stored. The main focus should be on clear identification and the avoidance of cross-contact, since this is the main risk that arises from handling such materials and products. Upon reception, the material should be sampled to verify its allergen status; this should be conducted in a controlled way to avoid dispersion with thoroughly cleaned (or disposable) sampling tools. Allergenic materials should be kept sealed whenever possible, and must be clearly marked at all stages, such as by the use of clear colour-coded labels or containers. Furthermore, materials should be isolated in clearly demarcated areas. Where this is not possible, other measures to minimise cross-contact should be taken. For example, store allergenic materials at floor level to prevent them from spilling on other materials. Another important consideration is the nature of the materials: liquid, powder, granulate, etc. Measures should always be appropriate to the kind of material in use.

Use dedicated premises and equipment
Whenever possible, use dedicated premises for the storage, processing and production of goods with a defined allergen profile. Alternatively, having dedicated production lines is ideal. Both options are seldom practical, so an effective segregation program should be in place along with a validated cleaning program. Whenever possible, equipment should be exclusively employed for specific materials (this also includes minor equipment like scales and scoops). Also, the design and layout of the premises and equipment, as well as the way in which they are employed, also have critical risk associated to them from an allergen management perspective. For example, open production lines are more prone to cross-contamination through spillage.

Check the recipe
This one is often overlooked – all ingredients to be processed must be the same ones listed in the recipe. This requires checking that verifies that the correct materials are used before manufacturing begins. Automated label verification systems are a good option. This complements measures from other points – correct and appropriate labeling at all times and segregating allergenic materials. Spatial segregation may not be enough. Temporal segregation can ensure that allergen-free materials enter production prior to materials with known allergen profiles.

Check your packaging and reworking processes
One of the major causes for food product recalls is incorrect packaging. This reflects the need for appropriate checks during and verification after packaging. The storage of packing materials and packed products is also important. Here again, temporal segregation is important. If they become contaminated at this point, all the earlier measures taken to avoid cross-contact are rendered useless. Ideally, processors would rework food only on the same product from which it originated. If this is not feasible, then the rework should be used only in products with the same allergen profile. Finally, it is important to regularly verify the effectiveness of the management plan by checking final products for the presence of allergens. Note that this is necessary but not sufficient to make “Free-from” claims – single assays do not supplant a whole food safety scheme.

Evaluate and declare any changes
If a change in product is needed, then be sure to evaluate the new materials and communicate relevant information to the consumer. If a change of material or formulation requires that new allergens be introduced, the allergen risk needs to be re-evaluated according to the management plan. Any change to the allergen profile should be addressed by appropriate measures to control the allergen.
Just as important is to make sure these changes are communicated to the consumer via multiple channels. Some guides promote such communication through allergic consumer organisations. Since customers do not usually read the list of ingredients of products they are already familiar with, make sure the changes are declared in the allergen profile in a clearly visible fashion on the package with labels such as “Now contains…” or “New formulation”. Finally, any old packing material should be removed and destroyed to avoid using it by mistake.

Clean thoroughly and often
An allergen management system rises or falls depending on the quality of the cleaning regimen. Validate and regularly test the cleaning of facilities, equipment and production lines to confirm the effectiveness of these methods. Ideally, the processor will use an analytical method specific to the allergens that represent a risk. If this is not possible, a surrogate allergen based on the allergen load of the materials might be effective. But when it comes to the cleaning process itself, there are other things worth considering – use single-purpose cleaning materials, adapt the layout of the plan to facilitate cleaning, and employ equipment whose design prevents the build-up of raw material and allows for easy access to all the parts that need cleaning. Wet cleaning, when possible, is preferable. When it comes to dry cleaning, avoid any method such as compressed air that could cause the unintentional spread of material that would increase the risk of cross-contamination.

Every record in its right place
There’s an old adage: “If it’s not documented, it didn’t happen”. It’s impossible to overestimate the importance of documentation in an allergen management plan. Every protocol and measure derived from the risk assessment to control the presence of allergens must be documented. Also, records need to be kept of the processes in place, such as checklists and records of cleaning, inspection, receipt and release of materials. Ideally, keep the risk assessment report with the documentation of the plan so that proof can be offered about how risks are being managed. Regular audits will also ensure compliance with all protocols and procedures.

Inform consumers with accurate, science-based labeling
As we’ve written elsewhere, the product label can be a either a powerful tool or a complete hindrance, depending on the information it contains and how it is conveyed. The main problems come from voluntary allergen labelling, as in the “may contain” statements. Labelling should not be misleading, ambiguous or confusing and should be based on relevant scientific data (see Art. 36.3, REG EU 1169/2011). Appropriate and informative labelling serves to establish a brand as trustworthy and informs the consumer about his or her options honestly. Labels that state every possible allergen are usually perceived as useless and protect the company more than the consumer.

Get commitment from the entire team
Finally, the human factor: everyone involved should be aware of the risk represented by food allergens and should be trained according to their responsibilities. Don’t forget that many employees could be allergic themselves. Team members should be aware that cross-contamination could come from their own activities, which means appropriate hygiene and GMP should be observed. Dedicated work clothes restricted to allergen-handling restricted areas should be provided. Ensure that all protocols are followed by giving the team the tools they need to do so with frequent training courses.

Ensuring food safety is the collective responsibility of everyone in the organisation. One component is crucial to setting the wheels in motion – the commitment of management. It’s up to them to ensure the development of a comprehensive risk-based allergen management plan, its effective application, and its continuous evaluation and improvement.

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