Safe food thanks to allergen management: What businesses need to know

Allergen management describes all measures that a food company must take to safely control allergy-triggering substances (allergens) throughout the entire production chain. Effective allergen management for food companies is not only a legal obligation, but also an expression of responsibility towards consumers. This is because consuming incorrectly labeled or contaminated food can be life-threatening for people with allergies. The aim of allergen management is to correctly identify and label allergenic ingredients in food and to prevent unwanted cross-contamination.

The legal basis for allergen management is the Food Information Regulation (LMIV 1169/2011), which stipulates throughout the EU that the 14 main allergens defined by the LMIV must be clearly and correctly labeled in prepackaged foods. In addition, the Food Information Implementation Regulation (LMIDV) in Germany regulates the information requirements for unpackaged foods. These legal requirements form the basis for any guidelines used in companies for the safe implementation of allergen management.

Which areas are part of comprehensive allergen management?

Allergen management covers all stages of the production process, from goods receipt and storage to manufacturing and marketing of products. In purchasing, it is crucial that allergen information is fully documented when ordering and receiving goods. Product specifications must be available and updated when changing suppliers or brands. This is the only way to ensure that the order, recipe, and actual goods received match.

Care must also be taken when storing allergenic ingredients: clear labeling and sealed storage of products are essential, as are measures to prevent allergen transfer (cross-contamination). In this regard, it has proven effective in practice to store substitute products, such as lactose-free milk or gluten-free baked goods, separately.

In production, spatial or temporal separation during the preparation of allergen-free foods is common practice. Checklists for special diets and consistent staff and hand hygiene help to minimize the risk of allergic reactions. Thorough cleaning of work surfaces and equipment is equally important, as even the smallest residues can be dangerous for allergy sufferers. Deviations from recipes and the use of leftovers must be documented so that they can be traced at any time.

When selling and serving food, the responsibility lies in the correct communication of allergen information. Trained staff must be informed about potential cross-contamination as well as possible emergency measures and possible recipe deviations. Food for allergy sufferers should be labeled separately and covered to avoid accidental contact with other products.

What are the most important allergens?

The Food Information Regulation requires the labeling of the 14 main allergens in prepackaged foods. These include:

1. Cereals containing gluten (such as wheat, rye, barley, spelt, or kamut)
2. Crustaceans
3. Eggs
4. Fish
5. Peanuts
6. Soybeans
7. Milk (including lactose)
8. Various nuts (e.g., almonds, hazelnuts, walnuts)
9. Celery
10. Mustard
11. Sesame seeds
12. Sulfur dioxide/sulfite
13. Lupins
14. Mollusks

The German Provisional Food Information Supplement Regulation (VorlLMIEV) also requires information about these allergens to be provided, especially for unpackaged foods. The LMIDV (Food Information Implementation Regulation) supplements these regulations at the national level and specifies the information requirements for food businesses, especially in out-of-home sales, catering, or retail. It specifies how and in what form consumers must be informed about food allergens contained in products (e.g., verbally, in writing, or electronically).

How is allergen management integrated into everyday production in practice?

Professional allergen management is based on HACCP analysis. Alongside microbiological, chemical, and physical influences, food allergens are among the key hazards in the HACCP concept, particularly as a chemical hazard.

Allergens must be identified as a potential hazard and recorded in the HACCP documentation. Allergens are assessed as chemical hazards and appropriate control measures are specified in the HACCP plan, for example as a critical control point (CCP) or operational preventive measure (oPRP). Careful planning and implementation are crucial to prevent unwanted allergen transfer and cross-contamination.

What are frequently asked questions in the practice of allergen management?

1) Can I label my food as ‘allergen-free’ if it contains allergens below the reference amounts?

No, labeling a product as ‘allergen-free’ is legally problematic. Even if allergens are only present in trace amounts below the scientifically defined reference doses, there is still a risk for particularly sensitive allergy sufferers.

The use of terms such as ‘allergen-free’, ‘lactose-free’ or ‘gluten-free’ is only permitted if these are clearly regulated by legal requirements (e.g. EU regulation for gluten-free products) and analytically verified.

A “free from...” claim requires:

• Appropriate process control (e.g., HACCP)
• Validated cleaning
• Analytical residue controls
• Proof that there is no cross-contamination

2) What measures must be taken to prevent cross-contamination of allergens?

To prevent cross-contamination, food companies must implement structured allergen management. Important measures include:

1. Spatial or temporal separation in production (e.g., first manufacture allergen-free products, then products containing allergens)
2. Risk assessment of raw materials and end products
3. Labeling and separate storage of allergenic raw materials
4. Supplier management (e.g., vehicle inspections)
5. Training for employees in production, cleaning, and service Training for employees in production, cleaning, and service (e.g., cleaning concepts, disinfection plans)
6. Separation of air flows and cleaning utensils
7. Storage conditions, production plans, and documented recipe compliance
8. Labeling and promotion of allergen-free products
9. Rework control (return of leftovers)
10. Control analyses of end products (e.g., ELISA or PCR)

These measures are also part of an HACCP system in which allergens are considered chemical hazards and are checked during audits.

3) What are the limits for allergens on prepackaged goods?

There are currently no legally defined limits for unintentional traces of allergens (e.g., due to cross-contamination) in the EU.

What applies:

• Labeling is only required if an allergen has been used as an ingredient (in accordance with LMIV).
• For traces, voluntary allergen labeling is possible, e.g., with statements such as “May contain traces of ...”.

4) Which methods should be used?

Cleaning is a key component of allergen management, as even the smallest amounts of allergens can trigger severe reactions in allergy sufferers. Recommended methods include:

• Wet cleaning (e.g., with cleaning agents, water, and disinfection) for protein-based allergens
• Dry cleaning (e.g., in grain processing or baked goods) to eliminate water as a risk factor

Validation of cleaning steps, e.g., through:

1. ELISA (enzyme-linked immunosorbent assay)
2. PCR (polymerase chain reaction)
3. Rapid protein tests (e.g., ATP measurement)

5) What are reference doses for food allergens and how are they determined?

Reference doses are quantities of an allergen that can trigger a reaction in a very small proportion (e.g., 1%) of the most sensitive allergy sufferers.

They are determined scientifically, primarily through controlled clinical studies with allergy sufferers. A well-known reference value is ED01 (Eliciting Dose 01): this is the dose at which 1% of allergy sufferers show a measurable reaction.

How can we help?

The Tentamus Group's laboratories support food businesses, producers, manufacturers, and start-ups in designing their allergen management systems in a practical, efficient, and legally compliant manner.

Our services range from laboratory analyses for food allergens and support with HACCP documentation to individual training courses, labeling checks, and audit preparation. In this way, we help to ensure the food safety of your products for allergy sufferers and secure consumer confidence in the long term.