How much allergen is too much? A primer on Action Levels

Do you know what food labels are really saying about allergens? Does anyone? How do food manufacturers differentiate between a product having “traces” of an allergen versus a product containing that allergen as an ingredient? In a perfect world, the answer would lie in action levels.

Action level is the fancy term for the threshold at which a food allergen needs to be declared in a product, which are different for each specific type of allergen. The calculation of the action level is based on LOAEL, the Lowest Observed Adverse Effect Levels that were recorded from clinical trials. LOAELs are the lowest concentration of allergenic food found in clinical trials that has a negative effect on allergic individuals.

Although there’s limited data on LOAELs for allergens, a set of action levels was created by VITAL (Voluntary Incidental Trace Allergen Labeling) using what data does exist. VITAL, an organization out of New Zealand with a sister branch in Europe (EU-VITAL), seeks to establish a system for food manufacturers to accurately and appropriately label allergens in their products. Accordingly, EU-VITAL has established a suggested standardized procedure for the declaration of allergens based on action levels. These proposed levels for food manufacturers remain as recommendations, since legislation has not been passed that specifically addresses allergen content.

There are three action levels for each allergen. Each level means something different for labeling and declaration.

  • Action level 1 requires no labeling or declaration.
  • Action level 2 requires labeling and declaration that the product “contains traces of” the specified allergen.
  • Action level 3 requires labeling as an ingredient and declaration that the product “contains allergen X as ingredient.”

In the following chart are the different action levels for each allergen:

Allergen Action Levels as proposed by VITAL

AllergenAction Level 1Action Level 2Action Level 3Published LOAELsLOD AlerTox SticksLOD AlerTox ELISA
Soy<2525-150>25088-5221ppm wet1.4ppm
Fish<100100-1000>10001-1000.35ppm dry / 1 ppm wet1.4ppm
Tree Nut<1010-100>1000.2-7.5n/a**n/a
Crustacean<1010-100>100analog peanut7ppm1ppb

*2.5ppm Casein or β-Lactoglobulin
**Specific allergens available: Hazelnut and Almond
***GlutenTox Pro LFD
Note! Action levels are measured in ppm, whereas LOAELs are measured in mg total protein

In addition to action levels, the LOD, or Limit of Detection, of both the AlerTox Sticks and AlerTox ELISA kits has been included in the chart. As you can see, the AlerTox Sticks test kits are quite sensitive to the allergens in question, with thresholds well under the suggested action levels. It is important to remember that since the thresholds of the kits are so low, a positive test result merely indicates that there is some degree of allergen contamination. A positive qualitative test result indicates that the sample should be shared with an outside lab for additional quantitative analysis.

As previously mentioned, VITAL is based in New Zealand and has a branch in the EU. While allergen regulations are still pending in both regions, the current standards of gluten detection between the two regions are set and are very different. They provide a helpful glimpse into what allergen labeling could mean for producers of allergen-free food.

In New Zealand and Australia a product labeled “gluten free” must have no traces of gluten when standard detection methods are used. On the other hand, in North America and Europe, products may be labeled “gluten free” if they have up to 20 ppm (.002%) of gluten detected. So, a product that has been slightly impacted by cross-contamination and tests to 7ppm may be called gluten-free in the US, Canada, and Europe – but not in Australia or New Zealand.

The stricter standards in Australia and New Zealand are of course more difficult for producers, and some people believe the no-detectable-gluten threshold leads to products being withheld from the gluten-free market despite being safe for all or most celiacs. Others believe that consumers buying food with any detectable gluten are putting themselves in harm’s way. For this reason, EU-VITAL uses the proposed actions levels to provide clear and consistent labeling levels, to identify food for people with allergies through the use of the “may be present” statement, and to inform producers on whether and how how to react to the possibility of minor cross contamination in their products.

The eventual development of action levels would be extremely important for food producers to know in order to label food accordingly. This is also important for consumers so they know approximately how much of an allergen they may be consuming, and can stay away from certain foods depending on the severity of their allergy.

Click on the links for more information on AlerTox Sticks and how they can help with the detection of potentially hazardous allergens in everyday foods.

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