The building blocks of a recall-proof allergen control plan
Food product recalls
A food recall is a high-impact event that could potentially cripple a company. Apart from the associated health risks and exorbitant costs, the ensuing brand and reputational damages can be severe and long-lasting. Despite a company’s best efforts, errors can occur, production processes can fail and controls can falter; meaning that an immediate recall could become a real and daunting eventuality. Evidence from several countries suggests that most products are recalled due to undeclared allergens.
Did you know?
Recalls: Undeclared allergen recalls retained their position as the primary reason for food recalls in 2023, as indicated by data from both the Food Standards Agency (FSA) and the Food and Drug Administration (FDA), and were ranked as the second-most frequent cause in Canada. Labelling errors, such as incorrect product information and mislabelled products, appear to be the primary root causes.
What is the risk of undeclared allergens to consumers?
Food allergies affect approximately 250 million people globally, leading to thousands of emergency room visits each year. Food allergens can trigger allergic reactions ranging from hives and swelling to severe, life-threatening anaphylaxis. Therefore, communicating allergen information accurately and effectively is crucial to safeguarding consumers and preventing adverse reactions.
Recap how to communicate allergen information
Allergen information is communicated primarily on product labels. Many countries define a list of priority allergens, and mandate their declaration if they are intentionally added as an ingredient.
Additionally, unindented allergen presence (allergens present due to cross-contact) should be communicated through precautionary allergen labelling (PAL); however, it is not always mandatory (it is in South Africa, however). Remind yourself of the South African allergen labelling requirements with this useful FACTS infographic.
Did you know?
Priority allergens: The first meeting of an ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens suggested the following priority allergen list to Codex:
• cereals containing gluten • crustaceans
• eggs • fish • milk • peanut • sesame
• tree nuts (almond, cashew, hazelnut, pecan, pistachio, walnut).
In conclusion, failure to correctly declare allergens violates the law and poses a health risk to consumers, leading to product recalls.
Consequences of undeclared allergens
In a heartbreaking incident on 11 January 2024, ballerina Órla Baxendale died from her peanut allergy after eating a mislabelled cookie. The root cause investigation pointed to a lack of communication in the supply chain, and possibly inadequate allergen control. This tragedy underscores the importance of robust allergen management protocols.
Building a robust recall-proof allergen control plan
The food industry’s allergen management responsibilities are well described in the regulations, food safety standards and retailer guidelines.
The risks that give rise to allergen recalls exist in almost every food manufacturing facility. Still, implementing robust, validated, verified allergen management plans can largely mitigate their effects.
The GFSI-benchmarked food safety standards have increasingly emphasised the importance of allergen management, highlighting validation, verification and monitoring of robust allergen controls.
Therefore, to prevent these catastrophic events, the effectiveness of allergen controls must periodically be confirmed through suitable allergen testing. Additionally, in the unfortunate event of a recall or consumer damage, allergen testing data will be a crucial component of root cause analyses or litigation.
TEST YOUR ALLERGEN PLAN
How many do you have?
☐ Supplier risk-review procedures
☐ Product risk-review procedures
☐ Material receipt procedures
☐ Dedicated storage
☐ Weighing and staging procedures
☐ Ventilation and extraction of dust
☐ Production scheduling
☐ Dedicated utensils & equipment
☐ Dedicated production areas
☐ Validated cleaning procedures
☐ Cleaning verification
☐ Visual line inspections
☐ Packaging material controls
☐ Product packing controls
☐ Rework control
☐ Work in progress control
☐ Product development controls
☐ Personnel movement control
☐ Validated handwashing procedure
☐ PPE control
☐ Staff training
Allergen control validation and verification
Allergen validation and verification are two distinct and different processes; both are required to prove effective control.
Methods used by commercial testing laboratories are ideal for validating allergen controls, because they are sensitive and accurate. However, they are also expensive, and must be performed by skilled analysts using specialised equipment and reagents.
Validation and verification of allergen controls strengthen risk mitigation. Each control reduces the likelihood of allergen cross-contact and undeclared allergens in your HACCP risk assessment. In turn, the strength of controls will determine whether a product should carry PAL for specific allergens.
Common allergen controls
This table summarises some common allergen controls, their purpose, and the type of samples that can be analysed during validation and verification.
| Allergen Control | Control Purpose | The Sample/s | |
| The Question | The Information | ||
| Raw ingredient risk assessment | Is the ingredient information truthful? | Prove whether an ingredient is ‘free-from’ or contaminated with specific allergens. | ☐ Ingredient |
| Handwashing procedure | Does the handwashing procedure remove allergen residues after meals and line changes? | Prove that handwashing procedures are adequate to prevent allergen cross-contact. | ☐ Hand Swabs |
| Cleaning-In-Place (CIP) | Does CIP remove allergen residue from shared food contact surfaces such as equipment? | Prove CIP effectively prevents allergen cross-contact from shared production lines/ equipment. | ☐ Surface swab ☐ Next product ☐ Rinse water |
| Manual cleaning | Does manual cleaning remove allergen residues from shared food contact surfaces such as equipment and utensils? | Demonstrate that cleaning prevents allergen cross-contact from loose production equipment. | ☐ Surface swab ☐ Next product ☐ Rinse water |
| Air handling system | Is the air extraction system effective in preventing allergen product dust cross-contact? | Demonstrate that the air extraction system prevents aerial allergen cross-contact (e.g. dust drift). | ☐ Air plate |
| Non-conformance /complaints | What went wrong? How did the product become contaminated? | Detect allergen cross-contact in ingredients or products as part of a corrective action, customer or consumer complaint, or root cause analysis. | ☐ Final product ☐ WIP ☐ Ingredients |
| Allergen information communication | Can we make an allergen-free-from claim? | Substantiate allergen ‘free-from’ claims (e.g. cow’s milk-free) and ensure regulatory compliance. | ☐ Final Product |
| Does the product need to carry a precautionary allergen labelling statement? | Gather supporting evidence to substantiate precautionary allergen labelling. | ||
We invite you to discuss your allergen controls and testing schedule with the FACTS Team. Together, we can ensure the integrity of your products and protect the allergic community.
As published in Food & Beverage Reporter, pages 18-20.