Allergen Management: Essential Guide for Food and Beverage Manufacturers

• The major allergens, often referred to as the Big 9 (Eggs, Fish, Crustacean shellfish, Tree nuts, Peanuts, Soybeans, Wheat, Milk, Sesame), necessitate a robust allergen management program in food businesses to protect consumers from potential harm. Integrating allergen management into food safety systems, such as an HACCP plan, is essential.

• In your food business, it is imperative to identify allergens and implement control measures to uphold food safety standards. Specifically addressing the Big 9 allergens in allergen management plans is crucial due to the varying effects these allergens can have on individuals, ranging from mild to severe, even life-threatening reactions. It is the responsibility of your team to inform customers about potential allergens in your products and rigorously enforce allergen control measures.

• In the United States alone, an estimated 32 million people are known to have food allergies, while globally, 1.1% to 10.8% of the population suffers from at least one food allergy. Given the prevalence of food allergies, prioritizing allergen control in your business is paramount. Failure to address these concerns can not only harm your reputation but may also lead to regulatory actions from food safety agencies.

• As per FDA's Reportable Food Registry, undeclared allergens are the leading cause of food recalls causing unnecessary financial and reputational challenges to food companies of every size and scale.

• However, there's no need to fret. A solid understanding of the Big 9 food allergens will empower you to establish and maintain an effective allergen management system, ensuring the safety of your products and the well-being of your customers.

How should major food allergens be listed in USA?

• In the United States, the listing of major food allergens is regulated by the Food Allergen Labeling and Consumer Protection Act (FALCPA). FALCPA, enacted in 2004, mandates clear and accurate labeling of major food allergens to ensure the safety of individuals with food allergies. The law identifies eight major food allergens that are responsible for the majority of allergic reactions: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Additionally, The Food Allergy Safety, Treatment, Education & Research (FASTER) Act became law in 2021 to include sesame as a major allergen, bringing the total to nine.

• According to FALCPA, food manufacturers must clearly state the presence of these major allergens on their product labels. This involves listing the specific allergen in plain and simple language within the ingredient list or through a separate "Contains" statement. The goal is to make it easy for consumers, including those with food allergies, to identify potential allergens in the foods they purchase.

• The consistency in how major food allergens are listed helps individuals with allergies make informed choices about the products they consume. This transparency not only aids consumers but also supports the broader efforts to prevent allergic reactions and promote public health. Compliance with FALCPA is crucial for food manufacturers to uphold safety standards and build trust with consumers in the highly regulated food industry.

Advisory Statement

• In certain instances, food businesses may opt to include a statement indicating that a product is processed in a facility that handles other allergens. While not explicitly mandated by the FDA, this precautionary claim serves as a proactive measure to alert individuals with allergies.

• Advisory statements, conveying similar information, can be incorporated into menu boards, functioning as restaurant menu disclaimers for specific food items. It's crucial to emphasize that an ingredient declaration should not serve as a food business's means to evade liabilities in the event of food allergy incidents related to their products. This declaration must not be misconstrued as a justification for permitting cross-contact within a food service establishment. Prioritizing rigorous allergen control measures remains imperative to uphold the safety and well-being of consumers with food allergies.

Allergen control measures by regulatory bodies

The FDA undertakes various initiatives to ensure that food businesses in the United States adhere to established regulations specifically focused on allergen control.

Food businesses have access to FDA-issued guidance documents, offering insights into the industry's current perspectives and approaches to allergen-related matters. Additionally, the FDA conducts inspections and audits to verify compliance with regulations such as the Current Good Manufacturing Practice (CGMP) and the Preventive Controls (PC) rule. This rule outlines mandatory preventive measures for allergens within the food industry.

Should issues like mislabeling, undeclared allergens, or instances of cross-contact in a food establishment be reported to the FDA, the agency may initiate regulatory actions against the implicated food business. Such actions could include product recalls, the seizure of goods, or, in extreme cases, the refusal of import permits. These measures underscore the FDA's commitment to enforcing allergen control standards and safeguarding the well-being of consumers.

What is Allergen Management System?

In a comprehensive food safety program, allergen management constitutes a meticulously documented system designed to identify, control, and prevent food safety issues related to food allergens within a food business.

This comprehensive system encompasses detailed documentation on various crucial aspects:

1. Allergen Labeling Laws: In-depth understanding of regulations governing allergen labeling practices.

2. Response Protocols: Defined measures to be taken in the event of an allergic reaction.

3. Risk Analysis: Identification and assessment of potential food allergens throughout the entire food supply chain.

4. Safe Handling and Storage: Protocols for the proper handling and storage of allergenic foods to prevent contamination.

5. Traceability System: Implementation of a traceability system to track the origin and movement of allergenic ingredients.

6. Employee Allergen Awareness Training: Training programs to equip staff with the knowledge necessary for handling allergenic foods, recognizing risks, and addressing potential issues.

Allergen management aims to empower food handlers with the expertise required to handle allergenic foods safely, understand associated risks, and mitigate potential problems. Additionally, it establishes a communication framework to effectively convey allergen risks to consumers. As an integral component of food safety systems, such as an HACCP plan, allergen management is vital for compliance with food safety regulations. It involves the systematic collection of information, implementation of control procedures, formulation of corrective actions, and utilization of monitoring techniques to effectively manage allergens in the food business.

What is allergen cross-contact?

Allergen cross-contact occurs when allergenic proteins from one food item unintentionally come into contact with another food, posing a risk to individuals with food allergies. This differs from cross-contamination, which generally involves the transfer of harmful bacteria or pathogens. Cross-contact is particularly critical for those with severe allergies, as even trace amounts of allergens can trigger adverse reactions.

How Cross-Contact Occurs in Food Processing?

• Cross-contact can transpire at various stages of food processing, from manufacturing to preparation. One common scenario is shared equipment or utensils inadequately cleaned between tasks involving allergenic and non-allergenic foods. Residual allergens on surfaces or equipment can inadvertently transfer to subsequent food items, leading to cross-contact. Additionally, the handling and processing of different foods in close proximity can result in cross-contact, especially if preventive measures are not rigorously implemented.

• In shared facilities where both allergenic and non-allergenic products are processed, there is an increased risk of cross-contact. Proper segregation, cleaning protocols, and allergen control measures are essential to minimize the likelihood of cross-contact in food processing environments. Robust allergen management practices, including clear labeling and employee training, play a pivotal role in preventing cross-contact and ensuring the safety of consumers with food allergies.

What are common examples of allergen cross-contact in food processing?

Understanding the potential scenarios where cross contact can occur is important for effective allergen management in food processing. Here are four examples highlighting common occurrences:

1. Cross-contact in supply chain:

When procuring raw materials, the risk of cross contact amplifies, especially when multiple bags are involved. Vigilance is crucial, as placing allergenic items alongside allergen-safe foods during transportation or storage can heighten the risk of cross contact. This risk extends to bulk deliveries from suppliers in container vans, emphasizing the need for stringent food handling procedures by suppliers to prevent cross contact.

2. Processing Area Challenges:

In an ideal scenario, having a designated processing area solely for allergenic foods is the best practice. However, practical constraints may impose limitations. Within the processing area, shared equipment, such as conveyors, mixers, and processing tools, can unintentionally transfer allergens between different food products. Proper cleaning and sanitization of equipment become important to mitigate these risks. Additionally, personnel handling ingredients and processing equipment should adhere to strict hygiene practices to prevent the inadvertent spread of allergen proteins within the processing environment.

3. Cross-contact during storage:

Storage practices play a critical role in preventing cross contact. For instance, gluten-containing foods like regular flour pose risks when stored alongside gluten-free items. Fine particles of regular flour, carried by air or cross-contaminated containers, can compromise the integrity of gluten-free products. Refrigerated storage introduces additional challenges, emphasizing the need for airtight, separate containers to prevent cross contact between allergenic and non-allergenic foods.

In food processing, meticulous attention to these scenarios is vital for developing robust allergen management strategies, ensuring the safety of consumers with food allergies.

Optimal Storage Practices for Allergenic Foods

For effective allergen management, it is imperative to establish clear guidelines on the storage of allergenic foods within a food processing facility.

1. Physical Segregation:

Preventative measures commence with the regular physical segregation of allergenic foods from non-allergenic raw materials. To mitigate the risk of cross-contact, allergenic foods should be stored in dedicated containers. Airtight containers, clearly labeled to denote their allergenic content, are the preferred choice.

2. Shelving Placement:

When arranging storage on shelves, a strategic placement approach is crucial. Positioning allergic foods on lower shelves is recommended to minimize the risk of cross-contact. This arrangement ensures that any potential allergen residues are less likely to fall onto non-allergenic items stored below.

3. Labeling and Container Usage:

Containers storing allergenic foods must be properly labeled, and utmost care should be taken to avoid using them for non-allergenic foods without thorough sanitation. This meticulous approach to container usage and labeling is instrumental in reducing allergen risks and mitigating the potential for cross-contact.

4. Special Considerations for Facilities with Allergenic Ingredients:

These storage conditions are particularly essential if your food offerings claim to be free from allergens. Moreover, it is crucial to inform customers if your processing facility handles finished products that incorporate allergenic ingredients. This transparent communication serves as a precautionary measure, ensuring that consumers are well-informed about potential allergen considerations in your food processing practices.

Explore an extensive list of best practices to effectively mitigate the risk of allergen cross-contact in your food processing facility by clicking here.

Crafting an effective allergen control plan

Developing an Allergen Control Plan is not a one-time effort but a continuous commitment. Regular audits, enforcement, and updates are important. Every process or product change warrants a reassessment of the plan. New employee hires or role changes demand documented training to ensure understanding. The plan should adapt to supplier changes, and if new locations emerge, tailored plans must be developed.

1. Components of an Effective Plan:

• Formation of Allergen Control Team: Include representatives from manufacturing, quality, labeling/regulatory compliance, research and development, engineering, sanitation, and food safety.

• Risk Assessment: Conduct a thorough risk assessment to determine specific allergen management procedures.

• Allergen Process Flow Diagram: Develop a visual representation to understand where allergenic ingredients are introduced into the process.

• Location-Specific Plans: Tailor Allergen Control Plans for each processing facility.

• Regular Review and Updates: Consistently review and update the plan, especially when introducing new ingredients, processes, or products.

2. Product Design (Research and Development):

• Selective Allergen Addition: Only include allergens in new products when essential for taste or functionality.

• Supplier Communication: Question suppliers on the necessity of allergens in formulations and understand allergen status in manufacturing facilities.

• Review with Manufacturing Facility: Collaborate with the manufacturing facility before ordering ingredients to review allergens in new products.

3. Segregation of Allergenic Foods or Ingredients:

• Label Review during Receiving: Scrutinize labels of incoming raw materials for allergen information.

• Tagging and Storage: Tag raw materials appropriately to ensure allergens are clearly identified during storage.

• Segregation Protocols: Use clean and closed containers, designate separate storage areas, and implement cleanup procedures for allergen spills.

4. Supplier Control Programs for Ingredients and Labels:

• Documented Allergen Control Plans: Require ingredient suppliers to have documented plans for allergen control.

• Guarantees from Suppliers: Request letters from suppliers guaranteeing allergen-free ingredients.

• Regular Supplier Audits: Periodically audit suppliers to assess the effectiveness of their Allergen Control Plans.

• Sanitation Procedures: Ensure suppliers have validated sanitation procedures, especially after changes that may affect allergen status.

5. Prevention of Cross-Contact During Processing:

• Scheduling: Schedule long runs of products containing allergens to minimize changeovers and segregate production areas.

• Dedicated Processing Equipment: Use dedicated equipment and lines to prevent cross-contact.

• Traffic Control: Limit traffic patterns during the manufacture of allergen-containing products to prevent cross-contact.

• Tools and Utensils: Dedicate tools and utensils for allergenic ingredients, employing color codes or clear markings.

• Processing Line Barriers: Use physical barriers to separate allergenic and non-allergenic production lines.

6. Product Label Review & Label/Packaging Usage and Control:

• Compliance with Regulations: Ensure packaged foods comply with allergen labeling regulations.

• Precautionary Labeling Guidelines: Adhere to guidelines and avoid arbitrary use of precautionary labeling.

• Label Approval Processes: Implement label approval processes for new products or changes to existing products.

• Inventory and Staging Control: Implement control procedures for inventory and staging of packaging materials.

• Training on Label Switching: Train personnel on techniques to ensure accurate label switching during production line changeovers.

7. Validated Allergen Cleaning Program:

• Plant Design: Construct processing equipment and plant structure with good sanitary features.

• Sanitation SOPs: Develop clear and easy-to-follow sanitation standard operating procedures.

• Cleaning Validation: Implement protocols for validating cleaning procedures and assess their efficacy regularly.

• Cleaning Verification: Define and follow protocols for verifying cleaning procedures after each cycle.

• Documentation and Compliance: Maintain detailed records for cleaning, validation, and verification, and conduct periodic evaluations.

8. Staff Training and Education:

• General Allergen Awareness Training: Provide general training on allergen awareness for all employees.

• Job-Specific Training: Offer specific training based on job responsibilities, emphasizing the importance of following protocols.

• Continuous Training Commitment: Ensure ongoing training for both new and experienced employees, emphasizing the reasons behind protocol requirements.

In crafting an effective Allergen Control Plan, meticulous attention to detail, ongoing vigilance, and a commitment to training are essential components. This plan not only safeguards consumers but also protects the financial health and reputation of the company.

What is Allergen Awareness Training?

Employee Allergen Awareness Training is a crucial aspect of ensuring food safety within a processing facility. This training equips staff at all levels with the necessary knowledge and understanding of allergens, enabling them to contribute actively to the implementation of an effective Allergen Control Plan. The primary goal of this training is to cultivate a heightened awareness among employees regarding the presence, risks, and management of allergenic ingredients throughout the food processing journey.

• During Employee Allergen Awareness Training, participants learn to identify common allergens, comprehend the potential consequences of allergen contamination, and recognize their role in preventing cross-contact. This training is not limited to specific departments; rather, it involves representatives from various sections, including manufacturing, quality control, sanitation, and food safety. By fostering a comprehensive understanding of allergens, employees become better equipped to handle their responsibilities in a manner that minimizes the risk of allergen-related incidents.

• The training sessions cover topics such as the importance of adhering to the Allergen Control Plan, recognizing allergen-containing ingredients in raw materials, and implementing proper storage and handling procedures. Employees also gain insights into the significance of clear labeling, preventing cross-contact during processing, and understanding the potential repercussions for both consumers and the company in the case of allergen-related issues.

• Continuous education is emphasized in Employee Allergen Awareness Training, ensuring that employees stay updated on any changes in processes, ingredients, or protocols. This ongoing commitment to training underscores the dynamic nature of allergen management within the food processing industry. By instilling a sense of responsibility and knowledge among employees, companies can establish a culture of vigilance and accountability, ultimately contributing to the creation of safer food products for consumers with allergies.

• If you are seeking allergen awareness training tailored for your employees in Spanish, you can access it here.

SUMMARY

1. The Food Allergen Labeling and Consumer Protection Act (FALCPA) provides specific guidelines for the identification of allergens in ingredient declarations. There are two approved methods:

Parenthetical Notation: Major allergens are indicated in parentheses immediately following the respective ingredient on the list. 

For instance: Flour (wheat) and butter (milk).

"Contains" Statement: Alternatively, a comprehensive "contains" statement can be used after the entire ingredient list. 

For example: Contains Milk and Wheat.

These methods offer flexibility for food manufacturers to communicate the presence of major allergens clearly and concisely, ensuring that individuals with food allergies can easily discern potential allergens within the product. Adhering to these FALCPA-approved practices is essential for regulatory compliance and reinforces transparency in food labeling.

2. An Allergen Management System is a meticulously documented framework integral to comprehensive food safety programs. Covering crucial aspects, it includes understanding allergen labeling laws, response protocols, risk analysis, safe handling and storage procedures, a traceability system, and employee allergen awareness training. This system empowers food handlers with the expertise to manage allergens effectively, from identification to safe handling, ensuring compliance with food safety regulations. As a vital component of safety systems like HACCP plans, allergen management involves systematic information collection, control procedures, corrective actions, and monitoring techniques.

3. Allergen cross-contact poses a risk when allergenic proteins unintentionally contact other foods, endangering individuals with allergies. Unlike cross-contamination involving harmful bacteria, cross-contact involves allergenic proteins. Shared equipment, inadequate cleaning, or processing different foods in close proximity can lead to cross-contact. In shared facilities, robust allergen management practices, including segregation, cleaning, labeling, and training, are crucial to prevent cross-contact and protect consumers.

4. Effective allergen management requires clear guidelines on allergenic food storage. Physical segregation, strategic shelving placement, and proper labeling and container usage are essential. Allergenic foods should be stored separately, in labeled containers, preferably on lower shelves to minimize cross-contact risks. Transparent communication with customers about allergenic ingredient handling is crucial, especially for facilities claiming allergen-free products.