Allergen Control in Manufacturing – FSMA & GFSI Compliance

Allergen control is one of the most scrutinized aspects of modern manufacturing compliance. Whether you’re producing food, dietary supplements, pharmaceuticals, or cosmetics, regulatory bodies like the FDA—and global schemes aligned with the Global Food Safety Initiative (GFSI)—expect a written, enforced allergen control strategy.

The Food Safety Modernization Act (FSMA) in the U.S. mandates allergen risk identification and preventive controls. GFSI benchmarks, including BRCGS, SQF, and FSSC 22000, raise the bar by requiring fully documented policies, validated cleaning procedures, and traceable recordkeeping.

This guide outlines exactly what FSMA and GFSI expect—and how V5 from SG Systems Global helps regulated manufacturers enforce allergen controls digitally, across every department and shift.

“Allergens are a leading cause of FDA recalls—and most are preventable. That’s why FSMA treats them like pathogens.”

– FDA Industry Guidance

FSMA Allergen Control Requirements

FSMA requires allergen control under the Preventive Controls for Human Food Rule (21 CFR Part 117). This includes identifying potential allergens during the hazard analysis stage and implementing preventive controls to ensure undeclared allergens are not introduced through:

• Cross-contact between materials
• Improper equipment cleaning
• Incorrect or missing labeling

Under FSMA, manufacturers must establish written food safety plans, verify cleaning procedures, train staff, and maintain audit-ready records of allergen handling. These expectations apply to food processors, contract manufacturers, copackers, and supplement companies.

What GFSI Schemes Require for Allergen Compliance

GFSI-benchmarked schemes go even further, requiring documented allergen control programs and policies. Specific requirements include:

• BRCGS: Section 5.3 – Allergen Management (ingredient checks, label reviews, risk assessments)
• SQF: Module 2.8 – Allergen Management Program (zoning, cleaning validation, verification)
• FSSC 22000: Prerequisite Programs – Risk-based allergen control and food safety documentation

Certification auditors typically request:

• Allergen risk assessments per SKU and line
• Written allergen management policies
• Allergen changeover documentation
• Training records for line operators and QA
• Product label verification logs

If any of these are missing or not enforced, your certification may be delayed, downgraded—or lost.

How V5 Digitally Enforces FSMA & GFSI Allergen Controls

While most manufacturers have written allergen plans, enforcement is often manual. V5 turns those plans into real-time system enforcement:

• Allergen Tagging: Ingredients and raw materials flagged by allergen class
• Label Verification: Digital label scans prevent packaging mismatches
• Cleaning Validation: Enforced cleaning steps with operator sign-off
• Audit Logging: Time-stamped QA and training data aligned with 21 CFR Part 11
• Zoning Enforcement: Allergen risk-based routing with visual workflows and access controls

These controls reduce human error, automate compliance reporting, and protect against undeclared allergen risk—without disrupting production throughput.

Industry-Specific Use Cases

• Dry Mixes: Shared line changeovers, allergen zoning, and rework prevention
• Supplements: Labeling for soy, nuts, shellfish, and dairy derivatives
• Food Plants: Real-time allergen segregation and label match enforcement

Many of these manufacturers started with clipboards—and upgraded to V5 when recalls, audits, or client demands pushed them to digitize.

Further Reading

• Allergen Control Resource Hub
• Allergen Control Program – Implementation Framework
• Allergen Management Policy – What to Include
• Manual vs. Digital Allergen Control Systems

Want to show auditors that allergen compliance is part of your live production process—not just paperwork? Request a demo of V5 today.

Frequently Asked Questions

What allergens are regulated under FSMA?

FSMA recognizes the major 9 allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Manufacturers must control cross-contact, verify labeling, and maintain traceable records.

Is allergen control mandatory for dietary supplements?

Yes. Under 21 CFR Part 111 and FSMA, supplement manufacturers must identify allergen risks and enforce preventive controls. Many use V5 to manage allergens across multiple SKUs and blended lines.

Can V5 integrate with LIMS or QMS for allergen swab testing?

Absolutely. V5 integrates with external LIMS systems to import swab results, trigger CAPAs, and link lab verification to specific changeovers and production runs.