Allergen management; what does it involve?

Sound allergen management is an important part of ensuring food safety. Failure to list allergens can lead to severe allergic reactions and even life-threatening situations. Yet unfortunately it still goes wrong on a regular basis. For example, an overview from VMT.nl shows that in 2022 the NVWA published 54 safety warnings for incorrect labeling of allergens. This makes it the most frequent cause of recalls.

To ensure proper allergen management, a number of elements are necessary. The SimplyOK Foundation, which developed a certification to audit allergen management at companies, established the following five basic pillars in its Code of Practice:

1. up-to-date and complete resource information
2. continuous recipe management
3. accurate labelling
4. preventing mix-ups of raw materials, semi-finished products or labels
5. preventing cross-contamination.

Raw material information

Essential for allergen management is knowledge of (possible) allergens in raw materials. It is important that specifications are available for all raw materials, with clear communication with the supplier about which allergens need to be mentioned. Specifications of packaging materials that come into contact with raw materials and products used during the production process (such as spreading flour when baking bread) should also be requested. In addition, potential cross-contamination of raw materials should be requested. Once all specifications are together, it is not a matter of sitting back and relaxing. To prevent the information from becoming obsolete, it is necessary to check the specifications at least every year.

Recipe Management

In addition to raw material knowledge, it is also important to maintain good recipe management so that it is always clear which raw materials have been used in a product. But beyond raw materials, the recipe must also list previously produced products that are now being reprocessed, packaging materials and excipients. When the recipe changes, it is essential to redetermine the allergens present and possible cross-contamination. As a producer, you need to communicate these changes not only internally, but also on the labeling.

Labeling

Based on the raw material information and the recipe, a label is prepared. The labeling of allergens has been established at the European level since 2014 in Regulation 1169/2011. In addition, in July 2017, the European Commission adopted a communication further explaining some aspects on allergen labeling rules.
In the European Union, there are 14 allergens that must be highlighted on packaging:

1. Gluten-containing grains
2. Shellfish and shellfish-based products
3. Eggs and egg-based products
4. Fish and fish-based products
5. Peanuts (groundnuts) and peanut-based products
6. Soy and soy-based products
7. Milk and milk-based products (including lactose)
8. Nuts and nut-based products
9. Celery and celery-based products
10. Mustard and mustard-based products
11. Sesame seeds and sesame seed-based products
12. Sulfur dioxide and sulfites at concentrations greater than 10 mg/kg or 10 mg/l, expressed as total sulfur dioxide for a product as consumed
13. Lupin and lupin-based products
14. Molluscs and mollusc-based products

On pre-packaged foods, allergens must be listed in the ingredient list. In doing so, it is mandatory to highlight these allergens through different typography. In practice, allergens are often repeated outside the ingredient list, but the European Commission decided in its 2017 communication that this is not allowed. Ingredients derived from allergens should also be clearly named. This also applies, for example, to additives, flavorings and processing aids. Some exceptions to this rule are listed in Annex II of Regulation 1169/2011. In addition, no threshold has been set for the labeling of allergens. This means that no matter how little of the allergen is present in the product, it must still always be labeled. For sulfite and sulfur dioxide, the allergen only needs to be labeled if it is present in concentrations greater than 10 ppm.

Prevention of mix-ups

When raw materials, semi-finished products or labels are switched, allergen information no longer matches the actual composition of the product. To prevent this, identification of ingredients, packaging materials and labels during production and storage is essential. In this way, it is always possible to find out which allergens are present. It may seem unlikely, but a survey by VMT.nl shows that mislabeling of products, or filling the packaging with the wrong contents, are two major causes of product recalls. Residual batches of labels with outdated information should therefore be destroyed. Finally, it should be clear at all times which product is in a package or storage location.

Preventing cross-contamination

As of March 24, 2021, the European Commission has established in the Hygiene Regulation that cross-contamination in all links of the food chain must be prevented by thorough cleaning. Materials used in production and transport must be adequately cleaned after processing or moving an allergen. The effectiveness of this cleaning should be monitored. To prevent cross-contamination, separate materials can also be reserved for use with certain allergens. The processing of raw materials containing allergens should also take place as far as possible separately from the processing of non-allergenic raw materials, both in space and time. No European rules have yet been established for the listing of cross-contaminations, but harmonization is underway within Europe. For example, the FAO together with the WHO recently issued four opinions on priority allergens and their reference values, the labeling of cross-contaminations and the process for determining whether certain allergen-derived foods are exempt from the declaration requirement. Following the reference values prepared by FAO and WHO, the NVWA 's Risk Assessment & Research Bureau also reviewed the 2016 reference values. On the implementation of this advice, the Ministry of Health, Welfare and Sport is currently still in discussion with stakeholders.

Training employees

By training employees on allergens, they are aware of the specific allergens found in foods and learn how to prevent allergen contamination. Our e-learning dealing with allergens can help with this. Check out our training page for more information.

Want to know more?

Our Regulatory Affairs Support team is ready to assist you. For more information contact us at +31 (0)30 - 65 66 010 or email rasupport@precongroup.com.