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Allergen risk assessment (RA) is a critical process in food safety management, aimed at identifying and mitigating risks associated with unintended allergen presence in food products. Below are the main aspects of allergen risk assessment based on current practices and guidelines:

Definition

Allergen RA involves estimating the likelihood and severity of adverse effects caused by allergens unintentionally present in food. This includes both proactive measures during normal production and reactive measures during incidents. It is integral to allergen risk management, supporting decisions about precautionary allergen labelling (PAL) and product recalls.

–Government Chemist contributes to food allergen guidance

–Allergen and allergy risk assessment, allergen management, and gaps in the European Food Information Regulation (FIR)

Key Steps in Conducting an Allergen Risk Assessment

Conducting an allergen risk assessment is essential for identifying and managing the risks of unintentional allergen cross-contact in food production. Below are the key steps involved:

1. Assemble a Multidisciplinary Team

Form a team with expertise in quality assurance, production, procurement, and new product development to ensure a comprehensive assessment. Engaging people from different functions allows for a well-rounded view of potential risks and control measures.

2. Identify Allergen Hazards

Start by listing all raw materials, ingredients, and processing aids used in production, noting their allergen profiles. It’s crucial to verify allergen information against supplier specifications and actual stock, as discrepancies can occur. Don’t overlook minor components like spices, seasonings, and additives, as they are common sources of undeclared allergens.

3. Map Allergen Risks

Creating an allergen map helps visually identify areas where allergens are stored and handled, highlighting potential cross-contact points. This includes all stages of the production process, from receiving raw materials to packaging the finished product. Pay close attention to shared equipment and adjacent storage areas where cross-contamination risks are higher.

4. Assess Cross-Contact Risks

Evaluate the likelihood of allergen cross-contact at each stage of production. Consider factors such as:

• Airborne Contamination: Particularly relevant for powdered allergens like wheat flour or milk powder.
• Shared Equipment: For example, slicers, mixers, or conveyors used for multiple products.
• Cleaning Protocols: Ineffective cleaning can leave behind allergenic residues.

This assessment should also include a review of employee practices, such as glove usage and hand washing, as human factors significantly impact allergen control.

5. Determine Hazard Ratings

Assign hazard ratings to each identified risk based on its likelihood and potential severity. This involves assessing the probability of cross-contact and the impact on allergic consumers if exposure occurs. The hazard rating helps prioritise risks, guiding where to focus mitigation efforts.

6. Evaluate Current Control Measures

Review existing procedures for handling allergens, such as:

• Segregation: Physically separating allergenic ingredients and products.
• Cleaning Protocols: Evaluating whether current cleaning methods effectively remove allergenic residues.
• Dedicated Equipment: Where practical, using equipment solely for allergen-free products.

Assess whether these measures are adequate or need enhancement. If gaps are identified, consider additional controls, like changing production schedules to separate allergen-containing products from allergen-free ones.

7. Develop Control Measures

If current measures are insufficient, implement additional controls. This may include:

• Product Reformulation: Eliminating or substituting high-risk allergens.
• Enhanced Cleaning Methods: Using validated cleaning techniques and allergen test kits for verification.
• Labelling Controls: Ensuring accurate allergen declarations on product labels.

Establish clear procedures for waste handling and storage to prevent cross-contact. Documentation of all control measures and related activities is crucial for traceability and auditing purposes.

8. Apply Precautionary Allergen Labelling (PAL)

If the risks cannot be fully mitigated, consider using precautionary allergen labelling to communicate the potential presence of allergens to consumers. However, PAL should be used judiciously and backed by a thorough risk assessment, as overuse can dilute its effectiveness and confuse consumers.

–Risk analysis and Precautionary Allergen Labelling research report

–National Guidelines on the Management and Labelling of Allergens from a Number of Countries

9. Document and Review

Maintain detailed records of the risk assessment process, including:

• Identified risks and corresponding hazard ratings.
• Control measures implemented and their effectiveness.
• Assigned responsibilities and timelines for review.

Regularly review and update the assessment to account for changes in ingredients, processes, equipment, or regulations. This ensures that allergen risk management remains current and effective.

10. Communicate Risks

Effective communication is crucial for successful allergen risk management. This includes:

• Sharing findings with relevant stakeholders, including staff, suppliers, and contract manufacturers.
• Training employees on allergen awareness and control practices.
• Engaging suppliers in allergen risk discussions to ensure they understand and comply with your requirements.

Clear and consistent communication across the supply chain minimises risks and helps maintain consumer trust.

Tools and Techniques

• Allergen Mapping: A visual representation of allergen handling areas to identify contamination risks.
• Analytical Methods: ELISA and PCR are widely used for detecting allergens, while mass spectrometry is emerging as a more advanced but costly alternative.
• Templates and Checklists: Standardise allergen risk assessment procedures.

Precautionary Allergen Labelling (PAL)

PAL should only be used when allergens are unavoidable and pose significant risks. Overuse can reduce its effectiveness in protecting allergic consumers.
Research indicates that many SMEs conduct limited or piecemeal allergen risk assessments, highlighting the need for improved practices.

Challenges

• Variability in individual allergic reactions complicates the establishment of universal thresholds.
• Ensuring compliance with evolving regulations and maintaining consumer trust require systematic and evidence-based approaches.

Regulatory Guidance

Organisations like FAO/WHO, Codex Alimentarius, and national bodies (e.g., UK Food Standards Agency) provide frameworks for conducting allergen RA, including guidance on labelling, threshold levels, and exemptions from mandatory declarations.

Related Concepts

• Precautionary Allergen Labelling (PAL): “May contain” statements should only be used when risk assessment demonstrates unavoidable cross-contact. Overuse of PAL diminishes its credibility and can confuse consumers.
• Validation and Verification: Regular testing of allergen control measures, such as cleaning protocols or segregation practices, ensures ongoing efficacy.
• Food Safety Culture: Embedding allergen awareness into the organisational culture fosters consistent application of control measures.
• Food Allergen Thresholds: Threshold levels for allergenic reactions vary by individual sensitivity and allergen type. These thresholds guide risk assessments and labelling strategies, though precise limits are still under scientific review.

Expert Insights

A Holistic Approach

Allergen risk assessment must extend beyond raw material evaluation to encompass the entire supply chain, production process, and finished product testing. Leadership commitment is essential to prioritising allergen management as a strategic objective, integrating it into broader food safety systems.

Legal and Regulatory Context

• UK Perspective: The Food Standards Agency (FSA) oversees allergen management compliance. Natasha’s Law (introduced in 2021) requires full ingredient and allergen labelling for all prepacked-for-direct-sale (PPDS) foods.
• EU Requirements: The FIC Regulation mandates clear allergen labelling for prepacked and non-prepacked foods, with enforcement by national authorities.
• Global Standards: Schemes such as BRCGS, FSSC 22000, and SQF incorporate allergen management into their certification criteria, ensuring compliance with global best practices.

Emerging Trends

1. Consumer Trends
   Growing demand for allergen-free and “free-from” products is driving manufacturers to innovate. This includes developing alternatives to common allergens, such as plant-based milks or egg substitutes.
2. Advances in Testing
   Enhanced analytical techniques, including mass spectrometry and next-generation sequencing, allow for more sensitive and accurate allergen detection, supporting improved risk management.
3. Digital Tools
   Software solutions are becoming integral to allergen management, integrating supplier data, risk assessments, and compliance tracking into a single platform for efficiency.

Conclusion

Food allergen risk assessment is a foundational element of food safety management, ensuring consumer protection and regulatory compliance. By systematically identifying and mitigating risks, food manufacturers can prevent allergen contamination, safeguard consumer trust, and enhance their competitive edge. As regulations evolve and consumer expectations grow, maintaining robust allergen risk assessment processes remains essential for public health protection and market success.

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