Allergen management and allergen labelling in the food industry

The labelling of allergens is one of the most critical aspects of food safety and, at the same time, one of the main sources of sanctions for food business operators. An error in this area is not only an administrative non-compliance, but a direct risk to consumer health and to the commercial viability of the product.

For this reason, allergen management cannot be limited to the design of the final label. It must be based on a robust internal procedure, integrated into the HACCP system, and aligned with the rest of the production process. Only in this way is it possible to guarantee truthful information to consumers and reduce the risk of alerts, withdrawals and penalties.

Allergen risk management within HACCP

Within the framework of HACCP, allergens are considered chemical hazards that must be identified, assessed and controlled systematically. This involves analysing not only the ingredients intentionally included in the recipe, but also any potential source of unintentional presence throughout the process.

The first step is to have a complete and up-to-date inventory of allergens present in raw materials, ingredients, additives and processing aids. This inventory must be reviewed whenever there are changes in suppliers, formulations or processes, as any modification may alter the product’s risk profile.

Based on this identification, the operator must assess at which stages of the process cross-contact may occur. Experience shows that the greatest risks usually arise from shared equipment, insufficient cleaning operations and errors resulting from handling or staff movement.

From a food safety perspective, the objective of HACCP is to prevent risk. Allergen labelling should not be understood as a corrective measure for system failures, but as an information tool when the risk cannot reasonably be eliminated.

Prevention of cross-contact and operational control

Preventing cross-contact is the cornerstone of any effective allergen management procedure. Food hygiene legislation requires operators to implement proportionate measures adapted to their activity, going beyond generic solutions.

Among the most common measures are proper segregation of raw materials, organising production to avoid unnecessary mixing, ensuring cleaning systems work effectively and providing continuous staff training. These measures must not only be documented in writing, but also applied in daily operations and be demonstrable during an inspection.

One of the most common mistakes is the systematic use of labelling as a preventive solution. The indiscriminate use of expressions such as “may contain” does not replace proper risk management and may be challenged by the competent authority if not duly justified.

The internal procedure must clearly define when the risk cannot be eliminated and when it can be better reduced by improving the process. To this end, the assessment must be based on real data, system checks and, where necessary, analytical results.

Allergen labelling and companies’ legal responsibility

Mandatory allergen labelling is regulated by Regulation (EU) No 1169/2011, which requires the clear and highlighted declaration of any substance causing allergies or intolerances when it is used in the manufacture of the food and is present in the final product.

Warning labelling should only be used when there is a real risk to allergic consumers and when this risk cannot be eliminated after applying all reasonable preventive measures. In addition, its use must be justified by a documented technical assessment and aligned with the HACCP system.

Excessive or unjustified labelling not only limits consumption options for allergic individuals, but may also be considered misleading information. In such cases, the company may be exposed to penalties and requirements to amend the labelling.

Regulatory framework

Allergen risk management and allergen labelling do not depend solely on the correct application of HACCP, but also on how the competent authorities interpret the applicable legislation. In this context, the procedure published by the Spanish Agency for Food Safety and Nutrition (AESAN) is particularly relevant, as it serves as a technical reference for operators and control authorities.

The document prepared by AESAN sets out a clear approach. Warning labelling for possible allergen presence is neither mandatory nor automatic, and should only be used when there is an unavoidable unintentional presence after all reasonable preventive measures have been applied. This approach is aligned with the principles of Regulation (EC) No 178/2002 on food safety and Regulation (EU) No 1169/2011 on food information to consumers, as previously indicated.

One of the most relevant aspects of the procedure is that it reinforces the idea that prevention must always be the first option. The use of warning labelling cannot become a generic solution to shortcomings in the production process, as this could mislead consumers and undermine the very foundations of the food safety management system.

AESAN also emphasises the importance of basing decisions on a documented risk assessment, supported by objective data, cleaning validations and a real understanding of the process. The aim is not to demonstrate zero risk, but to reasonably justify when a residual risk is technically unavoidable and when it can be reduced through operational improvements.

From the perspective of official control, this approach implies that authorities will assess not only the wording of the labelling, but also the consistency between the labelling, the internal allergen management procedure and the actual implementation of the HACCP system. A lack of such consistency may lead to requirements, mandatory label changes or even penalties.

For all these reasons, the AESAN document becomes a key tool for food business operators, as it provides clear criteria to justify the use of warning labelling and reinforces the need to integrate allergen management into an overall food safety and regulatory compliance strategy.

Risk of penalties and consequences for the company

Non-compliances related to allergen management and labelling are among the most common causes of food alerts, product withdrawals and administrative penalties. This is compounded by reputational impact and, in certain cases, potential civil liability for damage to consumers.

Control authorities do not assess only the final labelling, but the overall consistency of the management system in place. Correct labelling does not compensate for the absence of a robust internal procedure or a poorly documented risk assessment.

For this reason, having a well-structured allergen management procedure, integrated into the HACCP system and aligned with current legislation, is a key tool to protect consumers and reduce the operator’s legal risk.

As you know, at LegaleGo Regulatory Affairs we support companies in reviewing their allergen management procedures and labelling, helping them comply with legislation while minimising the risk of penalties and product withdrawals. Do you need help? Contact us!