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More than 170 foods are known to cause averse or allergic reactions in some people, but only eight are included in the World Health Organization (WHO) list of foods and ingredients known to cause hypersensitivity that shall always be declared on a food label. Developed by WHO’s Codex Alimentarius Commission Committee on Food Labeling, the list is included in section 4.2.1.4 of General Standards for the Labeling of Prepackaged Foods.

Of the 10 major countries with allergen labeling requirements, only the U.S. and Brazil require labeling of those same eight foods and ingredients. Japan requires the fewest, with labeling mandated for only four (eggs, milk, peanut, and crustaceans), while Australia/New Zealand require the most, adding sesame, shellfish/mollusk, lupin, bee pollens, and royal jelly to their list for a total of 14 regulated allergens. (See Regulated Allergens Around the World, page 66, for allergens regulated by two or more countries; visit Kerry Health and Nutrition, https://bit.ly/2lDOmQ4, for the full list.)

With undeclared allergens being the #1 cause of food recalls for both USDA and FDA during the second quarter of 2019 — the eighth successive quarter that it is the top cause of FDA food recalls, and causing more than half all USDA recalls — avoidance of allergenic cross-contact is a critical issue for the food industry.

Additionally, while allergen controls were previously recommended by FDA as Good Manufacturing Practices (GMPs), controls are now mandated by FSMA. As stated in CFR 117.135(c)(2) Food Allergen Control: “Food allergen controls must include those procedures, practices, and processes employed for (i) Ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and (ii) Labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.”

ALLERGEN CONTROL PLAN. As such, an allergen control plan — which includes identification of allergenic foods and ingredients in the product and facility, and procedures for storage, handling, processing, packaging, and labeling — is an essential component of your food safety program.

Your plan should include information about how suppliers are vetted, the facility is kept clean, methods are proven effective, and internal testing is used, along with “if-then” statements, said Emport LLC President Emily Kaufman. For example, “If a supplier doesn’t provide XYZ documentation, then we will reject the item. If we test five spots on the line for environmental allergen residue and one test is positive, then we will take ABC steps to ensure the entire line is clean. And so on,” she said.

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Having a plan enables efficient, effective response should an issue occur. “Positive test results and consumer complaints are high stress situations; time is of the essence and emotions run high,” Kaufman said, explaining that a written allergen control plan has two main benefits:

  • It provides a set of next steps, so you can take action quickly and confidently and avoid making decisions under pressure.
  • As a documented framework of day-to-day activities, it provides written records to help trace product through the facility and supply chain to identify the source.
  • The allergen control plan also must be continually implemented, assessed, and updated. As discussed in “Components of an Effective Allergen Control Plan: A Framework for Food Processors” from the Food Allergy Research and Resource Program (FARRP) at the University of Nebraska-Lincoln, “Every time you make a change in a process or a product, assess your plan and update as needed. Every time you hire a new employee or change the responsibilities of an employee, make certain they understand their role in the allergen control plan through documented training. Every time you begin working with a new supplier, evaluate their Allergen Control plan and change yours as needed. If you change or add locations, a new allergen control plan should be developed specifically for that location.”

    Included in the FARRP publication are a number of recommendations for reducing the chance of cross contact when formulating products and sourcing suppliers. These include:

    • Avoid using allergenic ingredients in such low amounts that they have no or minimal functional effect in the finished product. There is not enough known about the specific amount or concentration of an allergenic protein that will elicit adverse reactions, said 3M Global Technical Service Specialist Gabriela Lopez Velasco. Because it is difficult to correlate threshold doses to allergen risk and safety levels, companies are more often applying precautionary allergen labeling statements out of an abundance of caution. But this may confuse consumers about the difference between a product that may, but likely doesn’t, contain a trace amount of an allergen from a residue on the production line to those that intentionally contain low levels of allergen in formulation. So, she said, “If a company can substitute other ingredients for allergens with little negative consequences, they minimize the possibility of adverse health consequences for their consumers and product recalls.”
    • Only add allergens to new products when they make a discernable difference in the taste or functionality of the product, and question ingredient suppliers on the functionality and necessity of allergens in their formulations. “Every allergen you introduce brings a new level of complexity to your allergen control plan,” Kaufman said. “It doesn’t matter whether the allergen is an afterthought or a main ingredient, it’s still a hazard and requires serious attention.”
    • Understand the existing allergens or lack of allergens in the manufacturing facilities when formulating new products, and create a process to review allergens in new products with the manufacturing facility prior to ordering ingredients. The introduction of a new allergen in the facility will require a reevaluation of the entire plan, additional monitoring of storage and cleaning protocols, and the incorporation of new testing. “So,” Kaufman said, “You'll want to ask yourself: Is it worth it?”

    VETTING SUPPLIERS. FARRP also recommends that suppliers be required to have a documented allergen control plan, and:

    • Letters that guarantee the ingredients do not contain undeclared allergens.
    • Notification of any changes to the allergen status of the ingredients they supply prior to any changes.
    • Sanitation cleaning procedures that are validated on a regular basis and whenever a change may affect the allergen status of the line (i.e., new or changed product, ingredient, equipment, etc.).
    • All allergenic ingredients in clearly marked, sealed, undamaged containers.

    Velasco agreed that manufacturers should require suppliers to guarantee against undeclared allergens, adding, “They should routinely audit the facilities and demand that they be alerted immediately to any changes to the allergen status of the ingredients they supply and handle as well as any important modifications to the allergen control plan.”

    The audit should assess the implementation and effectiveness of the allergen control plan; range of allergenic products produced, especially on shared equipment; cleaning program and protocols; and training records. “It’s not enough for a supplier to tell you that they test for allergens,” Kaufman said. “Find out more: How often do they test? How do they collect their samples? Do they test in-house, externally, or both? What do they do if they get a positive result?” It’s also important to know if they knowingly work or come into contact with any other allergens and to ensure you have allergen control information from all further upstream suppliers.

    “Food safety starts at the beginning of the chain — you want to make sure that you understand the state of the ingredients your company receives, before they enter your facilities,” Velasco said. “Suppliers must clearly declare allergens, but they must also have implemented controls to ensure that there is not unintentional contamination with undeclared allergens.”

    Thus, she said, food manufacturers should have a robust supplier verification program that includes the need for suppliers to have allergen control plans that consider risk assessment, risk verification, and risk communication:

    • Risk assessment involves a hazard analysis by a multifunctional team to identify potential sources of food allergens and map their path through each step of the manufacturing process. Once the path is identified, controls can be put in place in target areas. “It is important to periodically review and reassess the risk assessment as new products, formulation changes, or vendor changes may change production conditions,” she said.
    • Risk management is the development of work instructions and procedures to control the possibility of unintentional allergen contamination. “Risk management strategies implemented to control allergens must be constantly monitored and verified,” Velasco said. “In reality this is the only way to make sure that these strategies work and are effective.”
    • Risk communication ensures that information about potential allergen contamination is adequately communicated on the product label in compliance with applicable regulations.
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    “It is the duty of every food manufacturing facility to verify that their suppliers have a solid allergen control plan and that the plan complies with the risk management strategies implemented by their company to prevent unintended allergen contamination and to provide adequate risk communication — labeling — in your final product,” she said.

    “Hold your suppliers to the same high standards you hold yourself,” Kaufman said. “If they don’t have an allergen control plan of their own, if they can’t tell you in great detail how they are keeping you safe, you’ll have to assume that they are putting you at risk.”

    Training. Even with comprehensive supplier and labeling requirements and initiatives, the success of your program will be dependent on worker understanding and application of in-plant procedures. Thus, ongoing training should include:

    • Line personnel training on techniques for ensuring product labels are switched appropriately at product changeover.
    • General training on allergen awareness and control, handwashing and attire requirements, for employees at all levels.
    • Specific documented training as dictated by their job responsibilities, such as cleaning equipment, product formulation, and segregation activities.
    • Training for all employees on the reasons that protocols are required and the potential consequences of the plan not being followed.

    “The human aspect of allergen control cannot be understated,” Velasco said. “Continuous training and education to raise awareness about food allergy and food safety are critical.” And training should be appropriate for each group. For example, she said, “Food processors are wise to take into consideration such factors as the level of technical skills to understand specific terminology, the applicability of hands-on training versus classroom-style and the workers’ language skills.”

    It is critical that all employees understand the impact that an error in any step of the manufacturing process will have on an allergic consumer. “The most effective allergen control plan in the world won’t be effective if the people on the floor tracking supplies, making the product, and testing the facility are not following the established protocols,” Velasco said. “The presence of undeclared allergens is one of the most common causes for recalls, and if employees understand how their role relates to this issue, they are more likely to follow the protocol to a T.”

    The author is Editor of QA magazine. She can be reached at llupo@gie.net.