In today’s market, clear food labeling is crucial for informing consumers about product ingredients, especially regarding food allergens. Recent legislative updates, such as the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act signed by President Biden in April 2021, have expanded the list of major food allergens to include sesame. These laws, including the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, mandate clear disclosure of allergens like milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame on product packaging. Additionally, the FASTER Act requires the Department of Health and Human Services to report on food allergy research within 18 months. In this article, we comprehensively discuss tips to better manage food allergens in your supply chain, vital for businesses navigating allergen labeling regulations and ensuring consumer safety.
FAQs for Food Allergen Regulations
As businesses adapt to the latest food allergen regulations, the FDA advises consumers to carefully scrutinize their food products, especially those distributed before 2023.
For businesses, assessing whether their recipes include sesame or other allergens is essential. Conducting thorough due diligence by contacting suppliers to clarify any ambiguous ingredients is paramount. Below, we address some frequently asked questions to assist food manufacturers in gaining a better understanding of food allergen regulations:
Tips for Managing Food Allergens Effectively
Understanding Precautionary Allergen Labeling
While the FDA provides clear guidance on labeling allergens in foods, what about precautionary statements? These voluntary statements, also known as precautionary allergen labeling, include phrases like "may contain (allergen)" or "produced in a facility with (allergen)" under the list of ingredients on food labels. While they may appear to be a simple solution for alerting consumers to potential cross-contact, the FDA emphasizes that these voluntary statements should not replace the implementation of good manufacturing practices. Manufacturers are required to take proactive measures to prevent allergen cross-contact before using advisory statements on their products. Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (CGMP & PC) rule, major food allergens are considered food hazards, and manufacturers must establish procedures, practices, and processes to significantly minimize or prevent allergen cross-contact. As the FDA conducts audits and investigations, they will continue to address cross-contact challenges and provide guidance to businesses based on industry best practices. Let’s explore some of these best practices in more detail.
Ensuring Accurate Allergen Labeling Through Ingredient Review
A critical aspect of adhering to allergen regulations is thoroughly examining your product’s ingredients and labels. Begin by conducting a comprehensive review, comparing supplier ingredient lists with your product labels to confirm proper allergen declaration. If any uncertainties arise, reach out to your suppliers for clarification.
It’s important to note that allergens can sometimes be concealed within ingredient lists. For instance, sesame, the most recent addition to the allergen list, is frequently found in spice mixes, seasonings, and international cuisine. It has various aliases, including tahini, ellu, geching, benne, or benniseed. Stay vigilant regarding potential allergen synonyms and ensure accurate allergen declaration using their common names on labels.
For instance, sesame might appear in your ingredient list as "spice mix (sesame)" and be declared as an allergen with "Contains: Sesame."
Maintaining Accurate Records for Compliance
Keeping thorough records of your ingredients, processes, and manufactured foods is crucial for several reasons. Businesses will soon be required to maintain traceability records for foods listed on the FDA’s Food Traceability List (FTL), as part of the FDA’s final rule on the Food Safety Modernization Act (FSMA) Section 204, with a compliance deadline of January 20, 2026. Many of the foods on the FTL are major allergens, indicating the FDA’s efforts to enhance traceability and recall management of potential food hazards, including allergens and foodborne illnesses.
By maintaining records, you not only ensure compliance with FSMA 204 but also better prepare yourself for an FDA audit or investigation. Your records may include, but are not limited to:
- Traceability Lot Codes (TLC), Critical Tracking Events (CTE), and Key Data Elements (KDE) as required for FSMA 204 compliance for foods on the FTL.
- Copies of labels and ingredient lists for products, along with supplier information.
- Detailed procedures for your traceability plan (required for FSMA 204 compliance), food safety audit plan, food recall plan, and Hazard Analysis and Critical Control Point (HACCP) plan.
- Copies of allergen testing, sample tests, and other relevant evaluations.
Understanding Allergen Management Protocols
In the FDA’s CGMP & PC rule (21 CFR part 117, Subpart B), current Good Manufacturing Practices (GMP) and sanitation standard operating procedures (SSOPs) are outlined to control disease, minimize risk, and reduce the chance of allergen cross-contact. Subpart B addresses various aspects, including food storage, washing procedures, employee cleanliness, and other measures.
Strategies to Minimize Cross-Contact
Manufacturers can implement several strategies to reduce the chances of allergen cross-contact:
- Keep allergens separated from non-allergens in facilities and utilize different storage containers, lines, and equipment for allergen-containing foods whenever possible.
- Schedule allergen-containing foods to be processed last on the production line before thorough cleaning and closure for the night or shift.
- If allergen-containing foods must be stored near non-allergen foods, ensure they are placed below non-allergen foods to prevent potential condensation or packaging leakage from contaminating non-allergen foods.
- Establish comprehensive cleaning protocols for production lines after processing allergen-containing foods.
Effective Communication and Expectation Setting
It is crucial to communicate allergen management expectations and protocols with both employees and suppliers. While your facility may adhere to strict rules, suppliers may not, leading to potential cross-contact risks. Clear communication helps mitigate these risks and ensures alignment across the supply chain.
Training Employees in Allergen Awareness
After establishing an allergen management program and implementing measures to prevent allergen cross-contact, it is essential to provide comprehensive training to employees on these procedures. The FDA highlights three key concepts that should be covered in allergen training:
- Identification of Major Allergens: Employees should be able to identify the nine major allergens and understand the hazards they pose to individuals with sensitivities.
- Understanding Allergen Cross-Contact Prevention: Training should emphasize the importance of preventing allergen cross-contact, explaining why it matters and how even minimal amounts of allergens can have serious consequences for consumers and may necessitate a product recall.
- Familiarity with Allergen Processes and Protocols: Employees should be knowledgeable about allergen processes, prevention controls, and protocols in place at the facility. This includes understanding corrective actions and the required recordkeeping procedures that need to be maintained by the team.
Conducting Allergen Testing and Pursuing Ongoing Improvement
Manufacturers should conduct regular testing of their food products and production lines to prevent allergen cross-contact. Regular testing helps stay ahead of potential fines or recalls during FDA audits or inspections. Currently, the FDA has not established a threshold for allergens, so any presence of allergen in a food product necessitates proper labeling and declarations.
Furthermore, aim for continuous improvement as you test and analyze your processes. Develop protocols to address errors promptly or reinforce allergen protocols with employees. Remain open to making changes based on FDA guidance, industry updates, or insights gained from trial-and-error experiences.
The Nine Major Food Allergens and FALCPA requirements
To adhere to FALCPA requirements, food packages must indicate allergens by their common names and list them either:
- Within parentheses directly after the name of the ingredient within the ingredient statement. For example: Peanut butter (peanuts), casein (milk), spice (sesame)… Or
- In a separate “Contains” statement. For example: Contains peanuts, milk, and sesame.
Below we will discuss each of the U.S. allergens and their declaration requirements, including allowable synonyms and specific types/species.
Milk:
For single-ingredient products or those containing milk or milk protein, "milk" must be included in either the Contains statement or ingredient statement. No synonyms are applicable.
Egg:
Single-ingredient products or those containing egg or egg protein must include "egg" in either the Contains statement or ingredient statement. No synonyms are applicable.
Seafood (Fish & Crustacean Shellfish):
When labeling fish and crustacean shellfish, you must declare the specific species by using either the common name or acceptable market name. The scientific name (genus and species) is not acceptable.
To determine the appropriate labeling for seafood allergens, refer to The Seafood List, which contains nearly 2,000 records of fish and shellfish. This list is regularly updated and includes market names with asterisks (*) indicating species regulated by specific laws. For additional guidance, consult the Seafood List Guidance on the FDA website.
Note: Vernacular names for species are provided for cross-reference only and should not be listed on product packaging.
- Fish: For single-ingredient products or those containing fish or fish protein, it is required to declare the specific species of fish (e.g., bass, flounder, or cod) in either the Contains statement or ingredient statement. Here is an example of how salmon should be labeled:
- Crustacean Shellfish: For single-ingredient products or those containing crustacean shellfish or shellfish protein, it is required to declare the specific species of crustacean shellfish (such as crab, lobster, or shrimp) in either the Contains statement or ingredient statement. Exemptions apply to molluscan shellfish (such as oysters, clams, mussels, or scallops), which are not part of the Crustacean shellfish grouping. Examples of crustacean shellfish include:
Tree Nuts:
For single-ingredient products or those containing tree nuts or protein from a tree nut, it is mandatory to declare the specific type of tree nut (such as almonds, pecans, or walnuts) in either the Contains statement or ingredient statement. The common or usual name must be used, avoiding the scientific name. Tree nuts can be expressed in either singular or plural form (e.g., almond vs. almonds). Here is a list of specific tree nut types:
- Almond
- Beech nut
- Brazil nut
- Butternut
- Cashew
- Chestnut (Chinese, American, European, Seguin)
- Chinquapin
- Coconut
- Filbert/Hazelnut
- Gingko nut
- Hickory nut
- Lichee nut
- Macadamia nut/Bush nut
- Pecan
- Pine nut/Pinon nut
- Pili nut
- Pistachio
- Sheanut
- Walnut (English, Persian, Black, Japanese, California), Heartnut, Butternut
Wheat:
The term "wheat" encompasses any species within the genus Triticum. For single-ingredient products or those containing wheat or wheat protein, it is necessary to include "wheat" in either the Contains statement or ingredient statement. Specific genus does not need to be declared. Wheat includes grains such as:
- Common wheat (Triticum aestivum L.)
- Durum wheat (Triticum durum Desf.)
- Club wheat (Triticum compactum Host.)
- Spelt (Triticum spelta L.)
- Semolina (Triticum durum Desf.)
- Einkorn (Triticum monococcum subsp. monococcum L.)
- Emmer (Triticum turgidum L. subsp. dicoccon (Schrank) Thell.)
- Khorasan wheat (Triticum polonicum L.)
- Triticale (x Triticosecale ssp. Wittm.)
Peanuts:
For single-ingredient products or those containing peanuts or peanut protein, it is necessary to include "peanut" or "peanuts" in the Contains statement or ingredient statement. This may be expressed in either the singular or plural form (e.g., peanut or peanuts).
Soybeans:
For single-ingredient products or those containing soybeans or soybean protein, "soybean" (or one of the approved synonyms) must be included in the Contains statement or ingredient statement. However, "Soybeans" should be used as the common or usual name for packaged foods using soybeans as an ingredient or as part of a multi-component ingredient (e.g., miso or tofu). For example, miso ingredients would appear as: miso (fermented soybeans, salt, koji).
Synonyms: soybean, soy, and soya.
Sesame:
For single-ingredient products or those containing sesame or sesame protein, it is required to include "sesame" in the Contains statement or ingredient statement. No other synonyms apply.
Reducing the Risk of Undeclared Allergens
Businesses can take several steps to perform due diligence and reduce the chance of undeclared allergens in their food products. Here are some tips:
- Conduct a thorough review of ingredients: Review all ingredients thoroughly, and if any are unclear (such as “spice mix” without a detailed list), contact suppliers for more information. Consider conducting regular allergen testing on food products as an added precaution.
- Communicate with suppliers: If your facility is allergen-free, communicate with suppliers about the importance of preventing cross-contamination and mislabeled allergens. Ensure they understand any precautions your facility has in place.
- Train employees: Provide allergen awareness training to employees and instruct them to follow good manufacturing practices and sanitation standard operating procedures (SSOPs) to clean equipment and prevent cross-contamination during production.
- Maintain accurate records: Keep detailed records of ingredient sources, supplier communication, production procedures, and allergen testing results. This information will be essential for compliance with regulations such as FSMA 204.
- Review labels and packaging: Regularly review labels and packaging to ensure that allergen information is accurate and properly labeled. Consider using tools like Genesis R&D Foods for assistance in adding sesame allergen declarations.
- Aim for continuous improvement: Continuously evaluate procedures, conduct allergen tests, and monitor results to identify areas for improvement and ensure ongoing compliance with allergen regulations.
Shipping Allergen-Sensitive Goods
Shipping allergen-sensitive goods poses unique challenges. To meet customer expectations, businesses must prioritize product safety, regulatory compliance, and quality standards meticulously. Here are some essential tips to enhance the shipping process:
The Importance of Safety and Integrity
When it comes to shipping allergen-sensitive goods, safety and integrity are non-negotiable. Allergic reactions can range from mild discomfort to life-threatening situations, underscoring the critical need for stringent safety measures throughout the shipping process.
Proper Handling: From the moment allergen-sensitive goods are packed to their arrival at the customer’s doorstep, proper handling is essential. This includes minimizing cross-contamination risks by segregating allergen-containing products from allergen-free ones, using dedicated equipment and facilities, and implementing rigorous sanitation protocols.
Temperature Control: Many allergen-sensitive goods, such as perishable food items or pharmaceuticals, require temperature-controlled shipping to maintain their quality and safety. Cold chain logistics, which involve maintaining specific temperature ranges throughout transit, play a crucial role in preserving the integrity of these products.
Packaging Considerations: Choosing the right packaging materials is key to protecting allergen-sensitive goods during transit. Packaging should not only provide adequate protection against physical damage but also prevent exposure to allergens and maintain product freshness. Additionally, clear labeling with allergen information helps customers make informed choices and avoid potential risks.
Lashing, Loading, and Unloading
In addition to proper handling and packaging, lashing, loading, and unloading procedures are critical aspects of shipping allergen-sensitive goods safely and securely.
Lashing: During transportation by sea or land, proper lashing of cargo containers is essential to prevent shifting or movement that could damage or compromise the integrity of allergen-sensitive goods. Securely fastening containers using appropriate lashing techniques helps minimize the risk of damage and ensures the safe arrival of products at their destination.
Loading: When loading allergen-sensitive goods onto vehicles or vessels, careful attention must be paid to placement and distribution to maintain balance and stability. Proper loading practices, including evenly distributing weight and securing cargo with straps or restraints, help prevent accidents and minimize the risk of damage during transit.
Unloading: Upon arrival at the destination, allergen-sensitive goods must be unloaded with care to avoid impact or mishandling. Using equipment such as forklifts or cranes, trained personnel can safely and efficiently remove cargo from vehicles or vessels, minimizing the risk of damage or contamination. Additionally, designated storage areas should be prepared to receive and store allergen-sensitive goods in a controlled environment.
Handle containers carefully to avoid cross-contamination with allergens. Implement strict hygiene protocols during loading and unloading.
During the loading and unloading process, it’s crucial to handle containers with care to prevent any potential cross-contamination with allergens. This includes ensuring that containers carrying allergen-sensitive goods are not exposed to allergens from other cargo. Implementing strict hygiene protocols, such as wearing gloves and using sanitized equipment, helps maintain the integrity of allergen-sensitive products throughout the shipping process. By prioritizing hygiene and careful handling, businesses can minimize the risk of allergen contamination and ensure the safety of their shipments.
Container Sanitization
Use containers that have been thoroughly cleaned and sanitized to prevent cross-contamination with allergens. Proper sanitation of shipping containers is essential to safeguard the integrity of allergen-sensitive goods throughout the transportation process.
Containers that have previously held allergenic products or have not been adequately cleaned pose a significant risk of cross-contamination, potentially compromising the safety of allergen-sensitive individuals. Therefore, it is crucial for shipping companies and manufacturers to implement rigorous cleaning protocols to eliminate any traces of allergens and ensure the sanitary condition of containers before loading allergen-sensitive goods.
Thorough cleaning and sanitation procedures should include the use of appropriate detergents and disinfectants to remove any residue or contaminants from previous shipments. Additionally, regular inspections and quality checks should be conducted to verify the cleanliness and suitability of containers for transporting allergen-sensitive products.
Furthermore, proper storage and handling of cleaned containers are essential to maintain their sanitary condition and prevent recontamination. Containers should be stored in designated areas away from potential sources of contamination and handled with care to avoid compromising their cleanliness.
Regulatory Compliance and Documentation
Navigating regulatory requirements is another essential aspect of shipping allergen-sensitive goods. Depending on the nature of the products and the regions they’re being shipped to, businesses may need to comply with various regulations and obtain necessary certifications and documentation.
Labeling Regulations: In many countries, strict labeling regulations govern the declaration of allergens in food products and other consumer goods. Businesses must accurately identify and disclose all allergenic ingredients on product labels to ensure transparency and compliance with regulatory standards.
Customs Documentation: When shipping allergen-sensitive goods internationally, businesses must adhere to customs requirements and provide accurate documentation. This may include certificates of origin, import permits, and compliance statements to facilitate smooth customs clearance and avoid delays or penalties.
Certifications and Quality Assurance
Maintaining high standards of quality and safety is essential for businesses involved in shipping allergen-sensitive goods. Obtaining relevant certifications and implementing robust quality assurance processes can instill confidence in customers and stakeholders while demonstrating a commitment to excellence.
Certifications: Certifications such as Hazard Analysis and Critical Control Points (HACCP) and ISO 22000 certify that a business has implemented food safety management systems and adheres to international standards for food safety and quality. Additionally, allergen-specific certifications, such as gluten-free or nut-free certifications, can help differentiate products and appeal to allergen-sensitive consumers.
Quality Assurance: Implementing comprehensive quality assurance measures, including regular testing for allergen contamination and strict adherence to Good Manufacturing Practices (GMP), is crucial for ensuring the safety and integrity of allergen-sensitive goods. Regular audits and inspections help identify potential risks and ensure compliance with regulatory requirements.
Customer Education and Support
In addition to ensuring the safe and compliant shipping of allergen-sensitive goods, businesses must also prioritize customer education and support. Providing clear information about allergens, offering personalized assistance, and addressing customer concerns promptly are essential for building trust and loyalty.
Allergen Information: Transparently communicating allergen information through product labels, online platforms, and customer service channels empowers consumers to make informed purchasing decisions and navigate their dietary restrictions safely. Providing detailed ingredient lists, allergen statements, and cross-contamination warnings helps customers assess potential risks and choose suitable products.
Personalized Support: Recognizing that each customer’s allergy or dietary restriction is unique, businesses can offer personalized support and guidance to address specific needs and concerns. This may include providing tailored product recommendations, answering inquiries about allergen policies and procedures, and accommodating special requests whenever possible.
