While global market demand for “free-from” food products is increasing, undeclared and mislabelled allergens, sulphites and gluten, throughout the supply chain, continue to be the number one cause of consumer product recalls. This is of major concern since the number of individuals affected by life-threatening allergies is on the rise, especially in children. Unfortunately, there is no cure for a food allergy; avoidance of allergenic food(s) is the only way to prevent an allergic reaction.

It is clear that allergen recalls negatively affect the consumer, however, they also result in huge financial implications and loss of brand credibility to all organizations involved. Businesses and brands may take a significant hit to their reputation since consumer perception plays a key role in the success of a business. With the increased use of the internet and social media, it is even more important to stay out of the spotlight and avoid recalls.

Among the reasons allergens hold the #1 position for product recalls may be lack of knowledge, insufficient supplier and raw material information, packaging errors, and accidental cross-contact. Cross-contact may be the result of poor cleaning practices, inadequate handling and storage procedures, employee traffic, and improper identification and assessments of risks. In addition, from a regulatory perspective, priority allergen lists and ingredient labeling laws vary from country to country, causing confusion for both manufacturers and consumers.

The good news is, implementing a strong allergen control plan can help to prevent recalls, protecting consumers and your business.

It starts with conducting a thorough risk assessment of each step in your process to determine where procedures and controls need to be implemented. A process flow diagram is very useful in understanding where allergenic ingredients and foods exist in the plant and where they are introduced into the process.

Control measures must be implemented even before raw materials enter the facility. The importance of understanding the incoming ingredients, inputs and suppliers cannot be overstated. The allergen status of every raw material handled or present in a food business needs to be identified and effective risk assessment tools applied. This involves identifying and documenting the food allergens present in each raw material, including non-food items like maintenance and cleaning chemicals. It’s imperative to recognize suppliers and backup suppliers’ vulnerabilities to ensure the success of the program. This should include identifying all allergens handled in the facility, as this might not be obvious based on ingredient declarations or product specification documents. Ensure supplier ingredient specification documents are current and routinely reviewed so accurate assessments can be made about the level of allergen risk.

Ensure there is segregation of allergenic foods or ingredients at every step of the process, from receiving raw materials through to shipping finished product. It is important to review labels at receiving to confirm the allergen status of raw materials. This serves as verification that ingredients have not been modified and the allergen status is still accurate. It also provides the basis upon which to determine storage and handling requirements. Visual tools are great for displaying the allergen status of each raw material. This can be done through applying color coded stickers or tape, unique tags or some other method, and should be done immediately at receiving. To avoid the potential for cross contamination from one ingredient to another, each allergen and/or group of allergens should have its own designated storage area or space. In addition, never store allergenic ingredients above ingredients that do not contain the same allergen.

Controlling allergen risk throughout processing can be a major challenge since there are so many opportunities for cross contact. Ideally, physically segregate production of foods containing allergens from the production of non-allergenic foods. When physical segregation is not possible, dedicated production lines and equipment is best practice. Barring this, scheduling production runs appropriately can reduce the risk of cross contact and minimize sanitation and changeover activities. Where possible, schedule non-allergenic production before processing allergen-containing products. In addition, dedicate and identify tools and utensils for allergenic ingredients and products. Providing a visual aide can help ensure appropriate practices, and one way to do this is through color coding. Similarly, use dedicated employees on non-allergenic production lines and/or allergenic production lines. Make the employees easy to identify by implementing colored uniforms, hairnets or smocks. Identify allergenic materials by labelling or color coding throughout the manufacturing process. This should include rework, which should only be added to work in progress containing the same allergens.

Control of allergens does not stop at processing; the Maintenance department also plays a big role. Sanitary design needs to be considered when purchasing any piece of equipment. The equipment must be easily and fully washable to ensure proper sanitation. Positioning of equipment is also important in terms of cleanability and the potential of cross contact from an allergenic production line to a non-allergenic production line. Airflow and the potential for contamination of air borne allergenic dust to non-allergenic ingredients, products and equipment also should to be considered. Lastly, maintenance procedures must be put in place to prevent cross contact. This includes processes for repairing or maintaining equipment, cleaning tools and changing work apparel between repairs, as appropriate.

Consumers rely heavily on ingredient declarations and allergen statements on packaging to make purchasing decisions. “For those living with the medical condition of food allergy, the simple act of eating is complicated; avoiding their allergen is the only tool they have to manage the risk of a potential allergic reaction. These consumers require accurate labeling information to help them stay safe while still having sufficient food choices,” states Jennifer Gerdts, executive director at Food Allergy Canada. As such, it is imperative that the information on finished product labels and packaging is accurate. A solid allergen control program includes processes for reviewing labels for new and modified products to ensure they are reflective of the ingredients in the product. Labels and packaging should also be verified for accuracy prior to receipt, and at the beginning of a production run or at changeover. Outdated labels and packaging should be discarded immediately to prevent the chance of accidental usage. Inventory control procedures and label/packaging reconciliation is imperative to ensure the correct labels/packaging have been applied to the appropriate finished product.

It is crucial to develop and implement robust procedures for effectively cleaning equipment, utensils, food contact surfaces and non-food contact surfaces. This must include cleaning between batches of allergenic and non-allergenic production and responding to allergen spills. Carefully consider the tools and cleaning chemicals used for each the task, as this can make a significant difference in the success of the sanitation program. Verification and validation of cleaning practices must be undertaken to confirm that cleaning activities are effective in removing the allergens in the facility. This can be done through visual inspections, swabbing after sanitation and trending results.

One of the most important tools for ensuring the success of any allergen control program is educated employees. All foods handlers, regardless of their position, should undertake training in food allergens. Employees are the eyes and ears of the plant floor, the more knowledgeable they are, the more likely proper procedures will be followed, and potential risks identified.

Complete regular reviews of the allergen management program to ensure that it remains current, effective, and continues to assist in the production of a safe and legal food product. The program should be reviewed, at a minimum, whenever a customer complaint is received regarding allergic reactions, there is a change to raw materials or suppliers, there is a change in manufacturing processes, there has been an introduction of new machinery, or there is a change to cleaning practices and procedures.

An important aspect of an allergen control program is allergen testing. Testing can be used to confirm the allergen status of raw materials at receipt, to verify cleaning processes, and to evaluate finished products. An array of test methods exist for this purpose, including but not limited to, immunochemical methods such as ELISA or lateral flow devices, DNA-based methods, such as Polymerase Chain Reaction (PCR), Mass spectrometry (MS), and other non-specific methods such as Protein tests, ATP and visual inspection to verify cleaning. The choice of test method is very important and depends on the purpose of the test, the type of sample, food matrix, processing effects, desired turn-around time, availability of equipment, skill level of person doing the analysis and cost. ELISA and lateral flow devices are often used on-site at the production facility because results can be obtained quickly, costs are relatively low, and personnel can be easily trained to use these tests. In some circumstances of highly processed samples, PCR may be a better choice. However, PCR testing requires specialized equipment and skilled technicians so is usually performed in a third-party testing lab. Mass spectrometry is yet another option but can be costly and like PCR, this method requires specialized equipment and skilled personnel to perform the analysis.

As you can see, there are many factors to consider when developing an effective allergen control program. While it may seem daunting, it is critical understand how to identify and assess all allergen risks and develop a plan to control, verify and validate each one. The upfront work may be challenging, however once implemented, an effective allergen control program will protect allergenic consumers from the potentially life-threatening effects of inadvertently consuming and allergenic product, and will protect your business from financial loss and a tainted brand reputation.