Review of latest US Allergen Guidance to Help with Risk Analysis and Control for Food Safety

Overview of the 5th edition of the US FDA Allergen Guidance

Overview

This blog compiles key points from three key sources: the US FDA’s Allergen Guidance (5th edition, 2025), the US FDA’s Preventive Controls for Human Food Guidance (2024), and the FSPCA PCHF V2 training curriculum (2024). Together, these resources support the development of food safety plans and the identification and control of chemical allergenic hazards. The discussion begins with the fifth edition of the FDA’s long-standing Q&A-style allergen guidance , finalized on January 6, 2025. This latest edition reflects the FDA’s most current interpretation of food allergen labeling regulations, incorporates public comments, and includes provisions from the FASTER Act, adding sesame as a major allergen as of January 1, 2023. It also builds upon the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, which established the framework for identifying major allergens.

Key Revisions in Edition 5 of the FDA Allergen Guidance

a) Expanded Scope of Allergen Definitions

• Major food allergens now include: milk, eggs, fish, crustacean shellfish, tree nuts (specified), peanuts, wheat, soybeans, and sesame.
• Tree nut list narrowed — coconut, chestnut, and shea nut are no longer considered allergens under FALCPA.
• Definitions broadened — “milk” includes milk from non-cow ruminants; “eggs” includes those from birds beyond chickens.

b) Ingredient Exemptions When Protein Is Absent

• Ingredients derived from allergens that do not contain any protein (e.g., highly refined oils, certain flavours or colours) are exempt from labeling.
• We advise manufacturers and importers to verify the absence of allergenic protein via:
  • Certificate of Analysis (C of A)
  • Supplier letter of guarantee
  • In-house allergen testing

Fish and Seafood Labeling: Precision Required

a) Species-Specific Labeling

• Under FD&C Act §403, labels must list the exact species (e.g., “salmon,” “cod,” “shrimp”), generic terms like “fish” or “shellfish” are not compliant.
• Use the FDA Seafood List for approved market names.

b) Crustaceans vs. Mollusks

• Crustacean shellfish (crab, lobster, shrimp) are major allergens under the FD&C Act.
• Mollusks (oysters, clams, scallops, mussels) are not classified as major allergens.

“May Contain” Advisory Statements: Voluntary & Genuine (understand “not misleading”)

Key Principles

1. “May Contain” statements are not substitute for GMP and Preventive Controls — Advisory labels cannot replace good sanitation, allergen segregation or preventive controls (labeling checks to ensure the right label is applied to the right package, changeover cleaning procedures).
2. Use only for real risk — Apply “may Contain” labels when allergen cross-contact cannot be prevented despite best sanitation and segregation practices.
3. Avoid contradictions — Never combine “Contains [allergen]” with “May contain [same allergen]” or use “allergen-free” alongside a “may contain” statement for that allergen. It may mislead consumers. We advise food manufacturers and importers to develop a strong supplier program to identify allergens in raw materials, ingredients and processing aids. We also advise sites to perform a thorough risk assessment of allergens present on site (i.e; vending machines, consumed in lunchrooms, present in maintenance lubricants).

Additional Notes

• Retail/Food Service Exemptions — Foods made-to-order for a customer are exempt from FALCPA labeling; prepackaged items in retail/food service are not exempt.
• Dietary Supplements — Must declare allergens unless exempted as protein-free ingredients.

FSMA Preventive Controls for Human Food (PCHF) Draft Guidance – Allergen Controls (Chapter 3)

We now turn to the PCHF guidance (Chapter 3) to review the FDA’s interpretation of chemical hazard identification and control in the context of the development and implementation of food safety plan.

Prevalence & Risk

• The FDA reports that ~15M Americans and >17M Europeans have food allergies.
• Reactions can occur from trace amounts, with symptoms ranging from oral tingling to anaphylaxis. Our review of epidemiological studies (Johns Hopkins Medicine) shows that 8% of children under the age of 5 have at least one diagnosed allergy.

Key points from the January 2024 PCHF Guidance (Chapter 3)

• Updates to Hazard Analysis and Risk-Based Preventive Controls under 21 CFR Part 117.
• Covers:
  • Food safety plans for Human Food
  • Hazard identification and risk assessment (evaluation of severity of food safety hazards and probability of occurrence of such hazards).
  • Preventive controls (Process, Allergen, Sanitation and Supply chain)
  • Management Components of Preventive Controls such as Monitoring, corrective action, verification, and recordkeeping procedures.

Primary Allergen Sources The “Big Nine”

Responsible for >90% of U.S. food allergies (FALCPA 2004 + FASTER Act 2021)

1. Milk — caseins & whey proteins

2. Eggs — albumin in egg whites

3. Fish — cross-reactive allergens, heat stable

4. Crustacean shellfish — tropomyosin protein

5. Tree nuts — almonds, cashews, walnuts, etc.

6. Peanuts — albumins & globulins

7. Wheat — gluten proteins

8. Soybeans — globulin proteins

9. Sesame — oleosins & seed storage proteins

Undeclared Allergen Hazards

1. Incorrect Label Design
   • Missing allergen declarations, including from derivatives (e.g., casein from milk).
   • Flavourings, colourings, or incidental additives must also be declared.
2. Incorrect Label Application
   • Wrong packaging or misapplied labels (e.g., with/without nuts).
3. Allergen Cross-Contact
   • Unintended introduction during handling, storage, processing, or packaging.
   • Common causes:
     • Poor production scheduling
     • Inadequate cleaning including gowning protocols
     • Improper storage
     • Airborne allergen spread
     • Allergens present in process water and oil

Regulatory References

• FALCPA (2004) — Defines allergens & labeling rules.
• FD&C Act §403(w) — Mandatory declaration requirements.
• 21 CFR 117.130(b)(1)(ii) — Undeclared allergens as chemical hazards.

Allergen Hazard Identification in Preventive Control Plans for Human Food

• Chemical Hazard Recognition — Allergens are a primary chemical hazard in Appendix 1 of the PCHF Draft Guidance.
• Risk Analysis — Must assess:
  • Cross-contact during sourcing, storage, handling, and processing
  • Labeling accuracy and compliance
  • Supplier allergen management
• Verification & Monitoring — Label reviews, inspections, changeover checks, allergen testing. Validation of Allergen Preventive Controls is recommended but not mandatory.
• Training & Resources — Expanded glossary, PCQI training expectations, Codex HACCP guideline references.

Implications for Industry

The updated guidance reinforces that allergen control is not just a compliance box but a core food safety function. Preventive controls must be documented, verified, and incorporated into facility food safety plans with accountability extending across the supply chain.

FSPCA V2.0 Common Process-Related And Facility-Related Hazards

The “common process and facility related hazard document” published by FSPCA as part of the PCHF-PCQI V2 curriculum identifies the types of allergen risks to be identified, risk-assessed and controlled at an FDA-registered food manufacturing site.

Chemical Hazard Examples and Risk Considerations

Undeclared Food Allergens – Incorrect Labeling
Undeclared allergens due to labeling errors remain a leading cause of food recalls. Examples include:

• Labels printed with incorrect ingredient statements or allergen declarations.
• Failure to update labels after a formulation change introduces a new allergen.
• Applying the correct label to the wrong product, or vice versa, resulting in misleading allergen information.
• Failure to translate correctly the name of an imported food ingredient
  Risk Note: These hazards directly impact allergen-sensitive consumers, as even trace allergen exposure can cause severe or life-threatening reactions. Preventive controls must include label approval workflows, pre-label application checks, and end-of-line verification systems.

Unintended Food Allergen Presence – Allergen Cross-Contact

Cross-contact occurs when an undeclared allergen is unintentionally introduced into a food that should not contain it. Examples include:

• Shared equipment not adequately cleaned between runs of allergen-containing and allergen-free products.
• Accidental use of the wrong ingredient that contains an allergen.
• Poor application of GMP leading to allergen cross contact on the line (uniforms, gloves)
  Risk Note: Cross-contact risk is elevated in facilities with multiple product types, especially where airborne particles, shared utensils, or improper storage could allow contamination. Effective scheduling, validated cleaning, and dedicated equipment are key preventive measures.

Chemical Hazards Due to Misformulation (e.g., Sulfites, Yellow #5)

Misformulation hazards occur when chemical additives are unintentionally present or exceed safe levels. Sulfites added to a product that does not list them, due to production or ingredient handling errors.

• Sulfites are considered priority allergens in Canada. Health Canada mandates bilingual labeling of imported foods formulated with sulfites.
• Risk Note: These hazards can cause adverse health effects in sensitive individuals or exceed toxicological safety thresholds. Strong formulation controls, batching documentation, and verification testing can mitigate these risks.

References

• FSPCA PCHF Participant Manual V2.0 – PCQI certificate resource
• PCHF Final Rule (21 CFR Part 117) – Preventive controls mandate
• PCHF Draft Guidance (Jan 2024) – Updated hazard analysis and control expectations

Karine Lawrence, President of Sirocco Food and Wine Consulting Inc. is a food safety consultant and lead FSPCA instructor (PCHF). Since 2014, her team has helped small US and Canadian businesses comply with FSMA (PCHF rule) and SQF 9. Contact Sirocco for more information.