Allergen control: requirements and how to apply it

Allergen control without the risks

The allergen control is one of the fundamental pillars of food safety in any company in the sector. Properly managing allergens is not just a legal obligation: it is a direct responsibility towards consumer health. A severe allergic reaction can have fatal consequences, and in most cases the root of the problem lies in failures of the management system within the production plant itself. In this article we explain what you must declare, what risks you must control and how a digital system like Solved can help you keep everything under control.

Which allergens must be declared and why

European regulations clearly and strictly establish which substances must be declared on food labelling. As set out in the Regulation (EC) No 178/2002 laying down the general principles and requirements of food law (Regulation [EC] 178/2002, 2002), food business operators are responsible for ensuring that the food they market is safe and correctly labelled, thereby protecting consumers' rights to receive accurate information.

In the European Union, 14 allergens are currently recognised as mandatory to declare:

• Cereals containing gluten (wheat, rye, barley, oats and their hybrid strains)
• Crustaceans
• Eggs
• Fish
• Peanuts
• Soybeans
• Milk (including lactose)
• Tree nuts (almonds, hazelnuts, walnuts, cashews, pecans, Brazil nuts, pistachios and macadamia nuts)
• Celery
• Mustard
• Sesame seeds
• Sulphur dioxide and sulphites at concentrations above 10 mg/kg or 10 mg/l
• Lupin
• Molluscs

The obligation to declare these allergens applies both to packaged food and to food sold loose or in collective catering. For quality managers at the food industry, knowing this list by heart is the first step, but managing it rigorously day to day is the real challenge.

Cross-contamination risks on the plant floor

One of the biggest challenges in food allergen control is cross-contamination. This phenomenon occurs when an allergen present in a product or ingredient comes into unintended contact with another product that should not contain it. The most common routes of cross-contamination on the plant floor are:

• Shared production lines: when products with and without allergens are manufactured in the same facilities without adequate separation measures.
• Poorly cleaned utensils and equipment: product residues left on surfaces, pipes, pumps or mixers can contaminate the next batch.
• Staff handling: operators can transfer allergens through their hands, clothing or footwear if they do not follow hygiene protocols correctly.
• Poorly segregated raw materials: storing allergenic ingredients next to allergen-free ingredients without the necessary physical barriers is a very common risk.
• Errors during format changes: during product changeovers on the line, if there is no clear verification protocol, it is easy for traces of the previous product to remain.

Cross-contamination is not always visible to the naked eye, which makes it particularly dangerous. Rigorous allergen management must take into account both direct and indirect contamination routes, and establish preventive controls for each of them.

Good control and cleaning practices

To minimize the risk of cross-contamination and ensure accurate, reliable allergen labeling, quality teams must implement a set of established good practices. These practices must be documented, reviewed periodically, and known to all personnel involved in production.

Among the most effective measures are:

• Allergen-specific risk analysis: integrated within the system APPCC, must identify all critical points where contamination can occur and set check limits and corrective actions.
• Physical and time separation: whenever possible, allergen-containing products should be manufactured on dedicated lines. If this isn't feasible, separate production shifts and validated cleaning procedures between them should be put in place.
• Validated cleaning procedures: cleaning alone isn't enough; it must be proven that cleaning effectively removes allergens. This means running surface tests (allergen tests) and documenting the results.
• Ongoing staff training: all operators must know what allergens are, why they're dangerous, and the protocols for their work area. Training must be recorded.
• Review of technical data sheets and supplier specifications: any change in formulation or supplier can introduce new, undeclared allergens. Supplier management is therefore an essential part of allergen control.
• Labeling checks: before each product launch, verify that labeling correctly reflects the actual composition, including “may contain traces of…” statements.

All these measures are part of the requirements set by the leading food safety certification standards. Schemes such as BRCGS Global Standards (BRCGS, n.d.) devote specific chapters to allergen management, precisely because it's one of the most heavily audited points and where non-conformities are most often found.

How to record and trace allergen checks in Solved

Having good practices in place is essential, but without an efficient record-keeping system it's very hard to demonstrate compliance during an audit or react quickly to an incident. This is where Solved makes the difference for quality managers.

Solved is quality software designed specifically for the food industry that lets you digitize and centralize all checks related to allergen management. Among its most valued features for this area are:

• Digital record of allergen checks: every check —from reviewing raw material data sheets to surface test results— is recorded with date, owner and result, instantly and without paper.
• Full batch traceability: gracias al módulo de trazabilidad, puedes rastrear qué materias primas con alérgenos entraron en cada lote de producción, en qué línea se fabricó y qué productos terminados se vieron afectados. Esto es crítico en caso de alerta o retirada de producto.
• Non-conformity and corrective action management: if a deviation is detected in allergen checks, Solved lets you open a non-conformity instantly, assign owners, and track corrective actions through to closure.
• Automatic alerts and notifications: the system alerts you when a check is due or when a result exceeds the set limits, so no verification is ever missed.
• Audit reports: all documentation related to allergen control can be exported in an organized way to present to external auditors, saving the quality team hours of work.

Digitizing allergen control doesn't just improve the quality team's efficiency: it reduces the risk of human error, supports data-driven decision-making, and, above all, protects consumers. In an increasingly demanding environment, having a tool like Solved is an investment in safety, reputation, and peace of mind.

If you want to learn more about how Solved can help you manage allergens in your plant, contact our team and we'll show you how it works, tailored to your production reality.

References

• BRCGS. (n.d.). BRCGS Global Standards. https://www.brcgs.com/
• Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law. (2002). https://eur-lex.europa.eu/eli/reg/2002/178/oj?locale=es