In a diverse and evolving food landscape like India, food allergies are emerging as a serious public health concern. With increasing incidence of allergies and heightened consumer awareness, the onus is now on food manufacturers to implement robust allergen management systems. In India, the Food Safety and Standards Authority of India (FSSAI) plays a central role in defining allergen regulations, labeling standards, and preventive control measures.
Under FSSAI’s regulatory framework, allergen management is more than a best practice—it is a critical control measure that can significantly impact consumer safety and regulatory compliance.
Image Reference : www.nationalfoodinstitute.com.au
Understanding Food Allergens and the Indian Context
A food allergen is a naturally occurring protein in certain foods that can trigger abnormal immune responses in sensitive individuals. These reactions can range from mild (hives, rashes) to severe (anaphylaxis). While India lacks large-scale epidemiological data, anecdotal and hospital reports suggest rising cases of allergies due to milk, peanuts, tree nuts, eggs, soy, wheat, seafood, sesame, and others.
According to the FSSAI’s Packaging and Labelling Regulations (2011) and the Food Safety and Standards (Safe food and balanced diets) Regulations (2022), manufacturers are legally obligated to:
- Label allergens correctly.
- Prevent cross-contact during manufacturing.
- Ensure traceability and recall systems are in place for allergen-related issues.
FSSAI’s Key Regulations on Allergen Management
Food businesses operating under FSSAI must comply with several provisions, including:
1. Allergen Declaration in Labeling
According to FSS (Packaging and Labelling) Regulations, 2011, allergens must be:
- Declared in bold letters, preferably in a separate “Contains” statement.
- Included in the ingredient list if present, either directly or via derivatives (e.g., “casein” from milk).
Example:
Ingredients: Wheat flour, Sugar, Skimmed milk powder
Contains: Wheat, Milk
FSSAI has also issued advisories on common allergens and their mandatory declarations for various food categories.
Image Reference : www.foodsafetynews.com
2. Prevention of Cross-Contact in Manufacturing
Under Schedule 4 of the FSS (Licensing and Registration of Food Businesses) Regulations, 2011, all food processing facilities must:
- Maintain hygienic design and zoning to avoid contamination.
- Implement Good Manufacturing Practices (GMP) and Good Hygienic Practices (GHP) to reduce cross-contact risk.
- Ensure separate storage, utensils, and equipment for allergen-handling.
Allergen Management as a Critical Control Point (CCP)
Traditionally, CCPs are defined as points in the process where control is essential to prevent a food safety hazard. Given the life-threatening potential of allergens, their management often qualifies as a CCP—especially in shared facilities.
Key Components of Allergen Control as a CCP
1. Allergen Risk Assessment
Conduct a formal risk assessment to:
- Identify which allergens are present in raw materials, processing aids, or packaging.
- Assess the potential for cross-contact at each process stage.
2. Supplier and Ingredient Control
- Source only from FSSAI-licensed suppliers.
- Obtain allergen declarations for all ingredients.
- Regularly audit supplier facilities to ensure compliance with allergen control protocols.
3. Segregated Storage and Handling
- Store allergenic and non-allergenic materials separately.
- Use color-coded containers and tools for easy identification.
- Design workflows to prevent mixing or accidental transfer.
4. Production Line Scheduling
- Sequence production runs to start with allergen-free products, followed by products containing allergens.
- Schedule thorough cleaning and sanitation before switching between different product lines.
5. Cleaning and Sanitation Validation
- Implement validated cleaning protocols proven to remove allergen residues.
- Perform protein swab tests for allergens to verify cleaning effectiveness.
- Document cleaning schedules and test results.
6. Employee Training and Awareness
Train staff on:
- Recognizing allergens and understanding associated risks.
- Proper handling, hygiene, and use of PPE to prevent cross-contact.
- Emergency procedures in case of exposure or labeling errors.
Periodic refresher training is required as per FSSAI’s food safety training and certification (FoSTaC) guidelines.
7. Accurate and Legal Labelling
- Labels must comply with Section 2.2.2 (2) of the Labeling Regulations.
- Any allergen present must be:
- Mentioned in the ingredients list and under a clear “Contains” declaration.
- Accurately disclosed even if present via a compound ingredient.
Caution: “May contain” statements should only be used based on risk assessment, not as a default disclaimer.
8. Verification and Internal Audits
- Conduct internal audits to review allergen control procedures.
- Include allergen checks in finished product testing.
- Maintain records and traceability for all batches.
9. Allergen Recall Preparedness
FSSAI mandates food businesses to have a recall plan. In case of an undeclared allergen:
- Inform FSSAI and affected consumers immediately.
- Withdraw affected batches from market.
- Investigate root cause and update preventive actions.
Consequences of Non-Compliance
Non-compliance with allergen regulations can lead to:
- Product recalls
- Legal action and penalties under Section 26 & 27 of the FSS Act
- Loss of FSSAI license
- Consumer health crises, leading to lawsuits and brand damage
Conclusion
Effective allergen management is a critical responsibility for food manufacturers and must be treated as a key control point within the production process. As mandated by FSSAI, proper identification, segregation, labeling, and employee training are essential to prevent cross-contact and protect consumers with food allergies. By implementing robust allergen controls, businesses not only ensure compliance but also uphold consumer trust and food safety at every level.