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Definition

Allergen management refers to the systematic approach to identifying, controlling, and minimising the risk of allergen cross-contact in food manufacturing. Its primary purpose is to safeguard allergic consumers by ensuring food products are safe, accurately labelled, and free from unintended allergenic contamination. This multidisciplinary process integrates risk assessment, operational controls, staff training, and continuous monitoring, supporting compliance with regulatory frameworks and fulfilling consumer expectations. In the UK and EU, allergen management must align with standards such as the Food Information for Consumers (FIC) Regulation and guidance from the European Food Safety Authority (EFSA).

Practical Application

Allergen management should be fully incorporated through operations. Pay particular attention to the following:

– Food Safety Plan – HACCP

Hazard Analysis:
This is a foundational step. The HACCP team must identify and document potential hazards associated with each product and process. Allergens are explicitly included as hazards.

• Information Management:
  This requires a thorough review of ingredients, recipes, and potential sources of cross-contamination. Supplier specifications are crucial here.
• Practical Actions:
• List all ingredients and raw materials, noting allergen exposure.
• Assess the likelihood and severity of allergen cross-contamination at each step.
• Document the hazard analysis clearly in the food safety plan.

HACCP Verification:
The HACCP plan, including allergen controls, must be verified to ensure it’s working effectively.

• Information Management:
  Verification activities generate data that confirms the effectiveness of allergen controls. This includes allergen testing results, audit findings, and customer complaints.
• Practical Actions:
• Regularly review the HACCP plan and allergen control measures.
• Conduct allergen testing of finished products and environmental swabs.
• Audit allergen control procedures.

– Food Safety and Quality Management System

Supplier Approval and Monitoring:
This addresses ensuring the safety and quality of incoming materials.

• Information Management:
  Requires documented supplier approval procedures. Specifications must be in place, and suppliers must be assessed for their ability to meet allergen control requirements.
• Practical Actions:
• Obtain detailed allergen information from suppliers for all ingredients.
• Implement a risk-based supplier approval program that includes allergen considerations.
• Regularly review supplier performance and audit supplier facilities.

Specifications:
Clear specifications are needed for raw materials, ingredients, and finished products.

• Information Management:
  All allergen-related information must be clearly stated in the relevant specifications.
• Practical Actions:
• Raw material specifications must declare all potential allergens present.
• Finished product specifications must accurately reflect the allergen content.
• Specifications must be reviewed and updated regularly.

Control of Non-Conforming Product:
This covers the handling of products that don’t meet specifications, including those with allergen-related issues.

• Information Management:
  Requires documented procedures for handling non-conforming products.
• Practical Actions:
• Establish procedures for identifying, segregating, and disposing of non-conforming products with allergen issues.
• Investigate the root cause of allergen-related non-conformities.

Product Labelling and Packaging Control:
Accurate labelling is crucial for communicating allergen information to consumers.

• Information Management:
  The labelling process must be controlled to ensure accurate and compliant allergen declarations.
• Practical Actions:
• Verify that labels accurately reflect the allergen content of the product.
• Implement procedures to prevent label mix-ups.
• Regularly review labels to ensure compliance with regulations.

Allergen Management:
Requires implementing an allergen management program to minimise the risk of allergen cross-contamination. This includes a risk assessment of raw materials, processing aids, and finished products.

• Information Management:
  Requires creating an allergen management plan that incorporates supplier management, recipe control, production scheduling, cleaning and sanitation procedures, and labelling practices.
• Practical Actions:
• Control raw materials and ingredients to prevent allergen contamination.
• Develop and implement recipe control measures to ensure accurate allergen information.
• Establish production scheduling practices to minimise allergen cross-contamination.
• Create cleaning and sanitation procedures to remove allergens effectively.
• Implement labelling practices that accurately reflect allergen content.

– Site Standards

Cleaning and Hygiene:
Effective cleaning and sanitation are essential to remove allergen residues.

• Information Management:
  Cleaning schedules and procedures must address allergen control. Validation data should demonstrate the effectiveness of cleaning methods.
• Practical Actions:
• Implement validated cleaning procedures for equipment and surfaces.
• Use dedicated cleaning equipment for allergenic and non-allergenic areas.
• Verify cleaning effectiveness with allergen testing.

– Personnel

Training:
Staff must be trained on allergen awareness and control procedures.

• Information Management:
  Training records must be maintained to demonstrate that staff have received adequate training.
• Practical Actions:
• Provide regular training on allergen awareness, cross-contamination prevention, and labelling requirements.
• Assess staff competency in allergen control procedures.

Allergens Recognised in Europe

EU allergens as defined in Annex II of Regulation (EU) No 1169/2011, “Substances or products causing allergies or intolerances”:

1. Cereals containing gluten, namely: wheat (such as spelt and khorasan wheat), rye, barley, oats or their hybridised strains, and products thereof
2. Crustaceans and products thereof
3. Eggs and products thereof
4. Fish and products thereof, except:

(a) fish gelatine used as carrier for vitamin or carotenoid preparations;

(b) fish gelatine or Isinglass used as fining agent in beer and wine

5. Peanuts and products thereof
6. Soybeans and products thereof, except:

(a) fully refined soybean oil and fat;

(b) mixed tocopherols concentrate (E306), natural mixed tocopherols, D-alpha tocopherol acetate, D-alpha tocopherol succinate from soybean oil;

(c) vegetable oils derived from soybean sterols;

(d) soybean oil plant stanol ester, plant stanol ester produced from vegetable oil from soybean

7. Milk and products thereof (including lactose), except:

(a) whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks;

(b) lactitol

8. Nuts, namely: almonds *(*Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis (Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia nuts or Queensland nuts (Macadamia ternifolia), and products thereof
9. Celery and products thereof
10. Mustard and products thereof
11. Sesame seeds and products thereof
12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers
13. Lupin and products thereof
14. Molluscs and products thereof

This information is essential for food manufacturers to ensure accurate labelling and prevent potential harm to consumers with allergies. It’s important to note the specific exceptions for certain allergens, as these may not require labelling.

International allergen management

International efforts are underway to harmonise food safety standards regarding allergens, aiming for consistent food labelling and safety practices across countries. This is important for protecting public health and supporting the global food trade. When countries follow similar guidelines for allergen management, maintaining safe food supplies and ensuring proper labelling becomes more manageable.

Many countries have regulations requiring major food groups to be listed on food labels, including milk, eggs, soy, wheat, peanuts, tree nuts, fish, and shellfish. However, specific regulations can vary significantly from country to country.

Global Harmonization: The Food and Agriculture Organization (FAO) and the World Health Organization (WHO) are working to harmonize food allergen risk assessments, which could lead to updated guidelines in the Codex Alimentarius.

EU Regulations: The EU requires declaration of 14 major allergens. These include cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame seeds, sulphur dioxide and sulphites, lupin, and molluscs.

U.S. Regulations: In the United States, the Food and Drug Administration (FDA) recognises eight major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

Other Countries: Regulations in countries like Canada, Australia, and New Zealand also address a similar set of major allergens, with some regional variations.

Labelling Requirements: International regulations focus on ensuring that people with food hypersensitivities have clear information regarding allergenic ingredients.

Evolving Regulatory Requirements: Allergen regulations vary globally and are subject to change. For instance, sesame was added as a major allergen under US legislation in 2023, prompting updates to allergen management protocols. Manufacturers exporting to multiple regions must stay abreast of such changes.

Related Concepts

Effective allergen management does not operate in isolation but intersects with broader food safety and quality assurance systems. Key related concepts include:

• Allergen Risk Assessment: Systematically evaluating allergen hazards and identifying mitigation strategies at each stage of the supply chain and production process.
• Cross-Contact Prevention: Establishing robust physical and procedural controls to minimise the accidental introduction of allergens into allergen-free products.
• Allergen Labelling Compliance: Meeting regulatory requirements for allergen declarations across different jurisdictions, including the UK and EU, where 14 allergens (e.g., nuts, gluten, milk) must be declared.
• Food Safety Standards: Integrating allergen management into certification schemes like BRCGS, FSSC 22000, and SQF, which include allergen control as a core component.
• Supplier Assurance: Ensuring suppliers adhere to rigorous allergen control measures and provide detailed ingredient specifications.

Expert Insights

The complexity of allergen management extends beyond basic compliance, demanding attention to emerging trends, technologies, and consumer expectations.

– Beyond Compliance: Embrace a True Allergen Safety Culture

The Insight: Don’t just aim to “tick the boxes”. Cultivate a genuine culture of allergen awareness throughout the entire organisation. This means that every employee, from the CEO to the cleaning staff, understands the importance of allergen control and their role in preventing cross-contamination.

Why it Matters: A strong food safety culture directly reduces the risk of human error, which is a major cause of allergen incidents. It also fosters a proactive approach where potential problems are identified and addressed before they lead to a crisis.

Practical Action: Regularly communicate about allergen safety, celebrate successes, and openly discuss incidents (without blame) to foster continuous learning.

– The Power of Visual Management & Segregation

The Insight: Simple, visual cues can dramatically reduce the risk of allergen cross-contamination, particularly in busy production environments.

Why it Matters: Humans are visual creatures. Clear visual cues help to reinforce procedures and prevent mistakes.

Practical Actions:

• Use colour-coded containers, utensils, and equipment dedicated to specific allergens.
• Clearly mark storage locations for allergenic ingredients.
• Use signage to remind employees of allergen control procedures.

– Invest in Training & Competency

The Insight: Allergen training isn’t just about attending a course. It’s about ensuring that employees have the competency to perform their jobs safely.

Why it Matters: Poorly trained staff are more likely to make mistakes that can lead to allergen incidents.

Practical Actions:

• Provide hands-on training that simulates real-world scenarios.
• Assess employee competency through observation and testing.
• Provide ongoing refresher training to keep skills sharp.

Conclusion

Allergen management is a dynamic and integral aspect of food safety in the modern manufacturing landscape. Its success hinges on collaboration across departments, from procurement to production to quality assurance, and continuous dialogue with suppliers and regulators. By implementing comprehensive allergen controls, food manufacturers not only protect consumer health but also strengthen their market reputation for producing safe, high-quality products.

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