|
FAO/WHO Reference Dose for Cereals
Containing Gluten
In early November, FAO/WHO held an Expert Consultation on gluten risk assessment and specifically discussed the establishment of a reference dose for gluten. The summary for that meeting has been released and is available here.
A reference dose differs from a gluten-free labeling threshold, such as the 20 parts-per-million (ppm) threshold used by the United States and countries following the Codex Alimentarius recommendations, or the 10 ppm threshold used by GFCO. A reference dose takes into account both the gluten concentration (which is expressed in milligrams per kilogram (mg/kg) and is equivalent to the ppm values in the regulatory thresholds mentioned above), as well as the expected serving size of the product. A reference dose is set as an upper limit on the total amount of gluten you would be expected to consume during an individual eating event of a single product.
The summary report is a recommendation, and any changes in labeling regulations would likely be many years away. But it is important to understand the main points that came from this consultation:
- This report does not recommend any change to the Codex 20 ppm threshold for gluten-free labeling (nor would it lead to a change to the GFCO definition of “gluten-free”).
- The report recommends a reference dose of 4 mg of gluten as the point at which precautionary allergen labeling (PAL) should be used on a product.
This reference dose recommendation is meant to provide specific criteria for when PAL should be used, and reduce unnecessary “may contain”, “shared equipment”, and “shared facility” statements. Per the recommendation, PAL should only be used when a product contains more than 4 mg of gluten in a serving.
As an example of how this would be employed, assume you make a product that contains no intentionally added gluten, but either by testing or risk assessment calculation, you know that it is expected to regularly contain about 40 ppm of gluten from cross-contact. This product would obviously not be eligible for gluten-free labeling, but do you need to use PAL?
- Remember that ppm is equivalent to mg/kg, so if the product regularly tests at ~ 40 ppm, that means that there are 40 mg of gluten in every 1 kg of the product
- If the serving size of your product is 50 grams, or 0.05 kilograms, and the gluten concentration is 40 mg/kg, then the expected total amount of gluten you would consume with one serving is 2 mg (40 mg/kg x 0.05 kg). In this case, even though the gluten concentration is twice the gluten-free labeling threshold, the recommendation would be NOT to use PAL for gluten on this product. However, if the serving size of this product is 100 grams or more, then PAL should be used.
| 
