HACCP Allergen Management Program Development
Control Allergens. Prevent Cross-Contact. Protect Consumers & Your Brand.
Requirement Overview
Food allergens are one of the leading causes of product recalls in the United States. Regulatory agencies and GFSI standards require facilities to implement a comprehensive Allergen Management Program to prevent undeclared allergen cross-contact, mislabeling, and consumer risk.
Our Allergen Management Program Development Services provide a complete, audit-ready system to identify, control, verify, and document allergen-related hazards throughout your entire operation.
Why Allergen Control Matters
Robust allergen management is critical for regulatory compliance and consumer safety, as undeclared allergens cause more FDA recalls than pathogens.
An effective allergen program protects your facility and brand by ensuring:
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✓ Prevention of Consumer Illness
Proper labeling, ingredient control, and cross-contact prevention reduce the risk of allergen-related harm. -
✓ Compliance with Regulations
Adherence to FDA, USDA, and GFSI requirements ensures your operations meet all applicable allergen standards. -
✓ Reduced Recall Risk
Strong allergen controls minimize the likelihood of costly product recalls and associated disruptions. -
✓ Protection of Contracts and Business Relationships
Accurate allergen management maintains customer trust and prevents contract losses due to noncompliance. -
✓ Mitigation of Regulatory Enforcement
Documented allergen procedures and records help prevent enforcement actions and fines. -
✓ Brand Reputation Safeguards
Consistent allergen control demonstrates commitment to food safety, protecting your brand in the marketplace.
A comprehensive allergen program ensures your facility is compliant, safe, and audit-ready—while keeping consumers protected.
Digitizing your HACCP records improves traceability, reduces human error, and saves time while improving audit readinessOur Allergen Management Program Services
Allergen Hazard Assessment
Comprehensive allergen risk assessment is essential for preventing undeclared allergens and ensuring regulatory compliance.
Our allergen evaluation process ensures full visibility and control by including:
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✓ Ingredient and Formulation Review
All raw materials, recipes, and formulations are analyzed for potential allergen content. -
✓ Major and Minor Allergen Identification
All allergens are identified according to U.S., EU, or global regulatory lists. -
✓ Allergen Mapping Across Facility
Production lines, storage areas, and handling zones are assessed for allergen presence and movement. -
✓ Risk Assessment of Handling and Rework Practices
Employee handling, staging, and rework procedures are evaluated for potential allergen introduction. -
✓ Cross-Contact Scoring for Equipment and Tools
All processing equipment, tools, and packaging areas are scored for cross-contact risk.
Clients receive a detailed allergen risk analysis with step-by-step recommended controls—ensuring your facility mitigates allergen hazards effectively and remains compliant.
Label Review & Cross-Contact Prevention
Allergen labeling and cross-contact prevention are critical for avoiding recalls and protecting consumers.
Our label and packaging review ensures accuracy and compliance by providing:
- ✓ Allergen Declaration Verification
Ingredient statements and formulations are checked to confirm accurate allergen labeling. - ✓ Precautionary Label Review
Statements such as “may contain” or “processed on shared equipment” are evaluated for clarity and regulatory compliance. - ✓ Pre-Press Approval Workflows
Processes prevent mislabeling before printing and ensure only approved labels are used. - ✓ Label and Packaging Controls
Procedures for label storage, selection, verification, and packaging line checks ensure correct application. - ✓ Double-Verification Systems
Secondary checks confirm labels and packaging meet allergen requirements before product release.
We also implement cross-contact prevention practices, including:
- ✓ Physical Segregation Procedures
Separation of allergen-containing and allergen-free products reduces contamination risk. - ✓ Traffic Flow Controls
Defined movement patterns for personnel and materials minimize allergen exposure. - ✓ Allergen Color-Coding Systems
Visual identifiers for equipment, tools, and storage areas enhance segregation and reduce errors. - ✓ Line Scheduling to Minimize Risk
Production scheduling strategies reduce the likelihood of cross-contact between allergen and non-allergen products.
These measures ensure accurate labeling, prevent cross-contact, and maintain compliance with FDA, USDA, and GFSI standards.
Allergen Cleaning Validation
Validated allergen cleaning procedures are essential to ensure safe production and regulatory compliance between production runs.
We develop and validate sanitation protocols using:
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✓ Allergen-Specific Test Kits
ELISA and lateral flow devices confirm the effective removal of allergenic proteins from surfaces and equipment. -
✓ ATP Pre-Checks and Visual Inspection Criteria
Quick assessments verify cleanliness before swab testing and full production. -
✓ Swab Testing for Protein Residue
Systematic sampling ensures allergen residues are within acceptable limits after cleaning. -
✓ Validation of Cleaning Agents and Tools
Chemicals, detergents, and equipment are verified to effectively remove allergens without leaving residues. -
✓ Documented Validation and Revalidation Processes
Cleaning procedures are formally validated, with records maintained for audits and regulatory review.
Clients receive fully validated cleaning procedures that are effective, defensible, and ready for verification by auditors and regulators.
Allergen Supplier Documentation Review
Supplier allergen management is the foundation of effective allergen control and regulatory compliance.
We strengthen your supplier program by reviewing and integrating critical documentation, including:
- ✓ Allergen Statements
Verification of declared allergens for all raw materials and ingredients provided by suppliers. - ✓ Ingredient Specifications
Detailed analysis of ingredient composition to confirm allergen content and suitability for your products. - ✓ Certificates of Analysis (COAs)
Review of supplier-provided COAs to validate allergen testing and quality compliance. - ✓ Cross-Contact Risk Statements
Assessment of potential allergen exposure during supplier production and handling. - ✓ Manufacturing Process Descriptions
Evaluation of supplier processes to identify allergen controls and potential contamination points. - ✓ Supplier Allergen Control Programs
Confirmation that suppliers maintain effective allergen prevention measures and documentation.
All supplier documentation is integrated into your HACCP, Preventive Controls, or FSVP programs—ensuring end-to-end allergen transparency and traceability throughout your supply chain.
Deliverables You Receive
Comprehensive allergen management provides end-to-end control, from hazard assessment to staff training and audit readiness.
Our services strengthen allergen control programs by delivering:
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✓ Full Allergen Management Program
A structured program covering all aspects of allergen control, from raw materials to finished products. -
✓ Allergen Hazard Assessment & Mapping
Identification of allergen risks and mapping across production lines, storage, and handling areas. -
✓ Labeling Control Procedures & Verification Forms
Processes and forms ensure accurate allergen declarations and compliance with labeling requirements. -
✓ Cleaning Validation Results & Protocols
Validated sanitation procedures demonstrate effective allergen removal between production runs. -
✓ Cross-Contact Control Measures
Physical segregation, scheduling, color-coding, and traffic flow controls reduce allergen exposure risks. -
✓ Supplier Allergen Documentation Checklist
Verified supplier documents ensure ingredient transparency and alignment with your allergen program. -
✓ Updated SOPs and Monitoring Logs
Standard operating procedures and records maintain consistent allergen control and regulatory compliance. -
✓ Staff Training Materials
Training resources and sessions ensure employees understand allergen hazards, documentation, and control measures.
This integrated approach ensures your allergen management program is comprehensive, defensible, and audit-ready—protecting consumers, maintaining compliance, and safeguarding your brand.
Who This Service Is Ideal For
Our services are suitable for:
- ✓ FDA- and USDA-regulated manufacturers
- ✓ GFSI-certified facilities (SQF, BRCGS, FSSC 22000)
- ✓ RTE, bakery, confectionery, dairy, and protein operations
- ✓ Importers needing allergen control aligned with FSVP
- ✓ Co-packers and private label manufacturers
- ✓ Facilities producing multi-allergen products or using shared equipment
Strengthen Your Allergen Controls Today
Allergen management errors are preventable — but only with a robust, well-designed program. Whether you are preparing for an audit, minimizing cross-contact risks, or implementing allergen controls for the first time, a science-based allergen management system ensures compliance, consumer safety, and operational confidence.
Allergen management errors are preventable — but only with a robust, well-designed program. Whether you are preparing for an audit, minimizing cross-contact risks, or implementing allergen controls for the first time, a science-based allergen management system ensures compliance, consumer safety, and operational confidence.
Start Your Allergen Management Program Now
Whether you are implementing a new allergen program, reviewing labeling accuracy, or validating cleaning procedures — we can help.
- ✓ Request an Allergen Program Proposal
- ✓ Schedule an Allergen Hazard & Label Review
- ✓ Validate Your Allergen Cleaning Procedures With Confidence
Protect consumers. Reduce risk. Strengthen your compliance.
