In the new MS1514:2022 GMP, one of the new requirements added is allergen control. It is defined under clause 5.2.7 Allergenic Cross-Contact.

The clause specifies the following requirements for the control of allergenic cross-contact:

1. A system of allergen management shall be in place starting from receipt of materials that are, or that contain, known allergens, during processing and during storage of food products.
2. Controls to prevent cross contamination from foods containing allergens to other foods shall be implemented e.g., separation either physically, or by time, or cleaning and line change-over practices and/or production plan sequence.
3. Rework containing allergens shall be used only in products which contain the same allergens by design; or through a process which is demonstrated to remove or destroy the allergenic material.
4. Where cross contamination cannot be prevented despite well-implemented controls, consumers should be informed.

What is an Allergen?

An allergen is any normally harmless substance that causes an immediate allergic reaction in a susceptible person. Food allergens are almost always proteins although other food constituents, such as certain additives, are known to have allergenic (allergy-causing) properties.

An allergic reaction to food occurs when the immune system mistakes a normally harmless substance for one that it thinks could be dangerous. In an effort to combat allergens, the body secretes substances that manifest as respiratory, gastrointestinal, cutaneous, and cardiovascular problems. The severity of an allergic reaction varies from person to person, ranging from mild symptoms like itching and hives to life-threatening conditions like anaphylactic shock.

While allergies can be triggered by a wide variety of foods, the vast majority of them are actually caused by just 14 different food product groupings (and the items derived from them): Celery, Cereals containing gluten, Peanuts, Nuts (tree nuts), Milk, Eggs, Fish, Crustaceans, Molluscs, Mustard, Lupin, Sesame, Soybeans and Sulphur dioxide (sulphates).

Worldwide, allergens continue to be the leading cause of food product recalls. Therefore, it is crucial to pay close attention to the control and prevention of allergens throughout the entire food production process, from pre-production through post-production.

Here we’ll go through the five most crucial aspects of allergy control.

#1. Raw Material Management

Raw materials are the building blocks of all foods. Any company that uses raw materials must know everything there is to know about them. Make sure you don’t just ask your supplier for a list of allergens that are in the material. Ask your supplier if they use any allergens in the place where they make the product and take that into account as well. If there are allergens that don’t go well together, like nuts, peanuts, dairy, or eggs, and they’re not in your product, test them once a year to make sure your supplier is doing a good job.

Pay close attention to the manufacturers of raw materials with various ingredients to ensure that they, too, are adequately organized. You need to ensure that your allergy management standards are being met by your suppliers and that they fully comprehend and implement those criteria.

#2. Segregation during Transport, Storage and Handling

One of the most important concepts of allergy control is preventing cross-contamination. This is crucial how all raw materials, intermediates or finished products containing allergens are handled during transportation, storage, and handling. It is imperative to exercise extreme caution whenever raw materials are being transported, stored, or handled, as any of these actions could result in cross contamination. The only time this isn’t the case is if you can prove that none of your raw materials or their previous production procedures contained any allergens.

In a warehouse, allergen-containing materials must be physically separated from others. Separate warehouses or two storage areas in one are the best solutions due to despite all the packing materials around the product (bags/ boxes/ pallet foil), some product may be present on the packaging and may be blown off owing to air movements, landing on the packaging of a product with an incompatible allergy profile (i.e. not containing that specific allergen).

Cross-contamination can also occur during transportation. The way to control is transport allergen products separately. If this isn’t practicable, use a pallet cover (a large plastic bag to cover the entire pallet) to reduce cross-contamination.

#3. Product Labeling Management

The main way for a customer or consumer to find out if a food product contains allergens is to look at the label or information on the packaging of the finished product. Your allergen management program should have steps for making ingredient statements, giving advice on precautionary statements, and making sure that raw materials and formulation are correct.

#4. Production Segregation and Sequencing

If your products contain different types of allergens (like nuts vs. other allergens or products that contain allergens vs. products that don’t contain any allergens at all), it’s best to have separated production equipment for each type. If this is not practicable, another way is to control using production sequencing and start production with products that don’t have allergens.

#5. Employee Allergen Training

Allergen control can only be achieved if employees are aware of their part in preventing the allergen cross-contamination. The implementation of an allergy management plan will not be successful if employees do not grasp its underlying principles.

New hires, or those whose duties have expanded to include allergy management, should receive thorough training in allergen management. To ensure that all employees are up-to-date with the allergen control program and any updates or changes made to the allergen strategy, periodic refresher training should be conducted.

The Bottom Line

It is important to keep in mind that, like many other ideas, the concept of allergy prevention and management only works if all components are correctly regulated at all times. It’s possible that food safety problems, including a product recall, might arise if even one part of the allergen management system isn’t in place.

Source reference:

1. https://www.foodsafety-experts.com/food-safety/allergen-management-2/
2. MS1514:2022 Good Manufacturing Practice (GMP) for Food (Second Edition).

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