Beyond Due Diligence: 10 “Musts” of Allergen Management

Identify, measure, minimize, control, eliminate: food allergen management isn’t easy, but it has to be done, all without interrupting production. Martin Candia of Romer Labs summarizes 10 essential aspects of food allergen management that no program can do without.

Since the declaration of allergen content in food products became 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 any allergic people is discouraged, or so all-encompassing that it is clear that no 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 exhaustive evaluation of the real risk of the presence of an allergen in the product. This evaluation should take into account a comprehensive 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, minimize, 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 these 10 recommendations to food producers:

1. 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 provide 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 that handle changes or substitutions must be in place.

2. Know how to handle and store raw materials and intermediate products

Pay special 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, for example, by the use of clear color-coded labels or containers. Furthermore, materials should be isolated in clearly demarcated areas. Where this is not possible, other measures to minimize cross-contact should be taken. For example, some can store allergenic materials on the floor to prevent them from spilling onto other materials. Another very important consideration is the nature of the materials: liquid, powder, granulate, etc. Measures should always be appropriate to the kind of material in use.

3. Use dedicated premises and equipment

Whenever possible, use dedicated premises for the storage, processing and production of goods with a defined allergen profile. Alternatively, you can have dedicated production lines. 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). Moreover, the design and layout of the premises and equipment, as well as the way in which they are employed, also have critical risk associated with them from an allergen management perspective. Open production lines are, for example, more prone to cross-contamination through spillage.

4. Check your recipe

This one is so simple that it’s often overlooked: all ingredients to be processed must be the same ones listed in the recipe. This requires some kind of check 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.

5. 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 and verification during and 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, you 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 of utmost importance regularly to 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.

6. Evaluate and declare any changes

If you need to change your product, 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: make sure you communicate these changes to the consumer through multiple channels. Some guides promote such communication through allergic consumer organizations. Since customers do not usually read the list of ingredients of products they are already familiar with, make sure you declare changes in the allergen profile in a clearly visible fashion on the package with labels such as “now contains…” or “new recipe”. Finally, any old packing material should be removed and destroyed to avoid using it by mistake.

7. Clean thoroughly and often

Your allergen management system rises or falls depending on the quality of your cleaning regimen. Validate and regularly test the cleaning of your facilities, equipment and production lines to confirm the effectiveness of your methods. Ideally, you would 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; with 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.

8. 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, you’ll need to keep records 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 you can offer proof about how you are managing risks if necessary. Regular audits will also ensure compliance with all protocols and procedures.

9. Inform your consumers with accurate, science-based labeling

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 infamous “may contain” statements. Labelling should not be misleading, ambiguous or confusing and should be based on relevant scientific data (see for example Art. 36.3, REG EU 1169/2011). Appropriate and informative labelling serves to establish your 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.

10. Get commitment from your 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! Your team members should be aware that cross-contamination could come from their own activities. Therefore, 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 your team the tools they need to do so with frequent training courses. 

Ensuring food safety is the collective responsibility of everyone in the organization. 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.