Opinion of the FASFC: Reference Doses Allergens
According to Regulation 1169/2011, substances or products causing allergies or intolerances listed in Annex II must be labelled.
These substances include crustaceans, eggs, fish, peanuts, soy, milk, celery, mustard, sesame seeds, lupins, molluscs and some nuts.
In its opinion 24-2017, the Scientific Committee of the FASFC proposed to use the lower limit of the 95% confidence interval of ED05 (Dose triggering an allergic reaction in 5% of a sensitive population) as the reference dose for the risk assessment related to the ingestion of allergenic foods.
The following reference doses (expressed in mg of allergenic food protein) are proposed by the Scientific Committee for Risk Assessment:
| Allergenic foods | Proposed reference dose (mg allergenic food protein) | Allergen concentration based on proposed reference dose (mg allergenic food protein/kg) | |
| Serving 25g | Serving 400g | ||
| Groundnut | 1,1 | 44 | 2,8 |
| Milk | 1,2 | 48 | 3 |
| Egg | 0,3 | 12,4 | 0,8 |
| Hazelnuts | 0,5 | 20 | 1,3 |
| Nuts | 0,5 | 20 | 1,3 |
| Cashew nuts | 0,6 | 24 | 1,5 |
| Other nuts | 0,5 | 20 | 1,3 |
| Soy | 2,9 | 116 | 7,3 |
| Wheat (and all cereals containing gluten) | 1,3 | 52 | 3,3 |
| Mustard | 0,1 | 4 | 0,3 |
| Lupine | 4,5 | 180 | 11,3 |
| Sesame seeds | 0,4 | 16 | 1 |
| Shrimp | 12,1 | 484 | 30,3 |
| Other crustaceans | – | – | – |
| Molluscs | – | – | – |
| Fish | – | – | – |
| Celery | – | – | – |
Currently, there is insufficient bibliographic data to establish a reference dose for crustaceans other than shrimp, molluscs, fish and celery.
The reference doses proposed in this Notice do not apply to allergens that have been added as ingredients. In this case, the regulations impose their labelling.
These doses should not be used as limits to conclude that a product is “free” of a specific allergen.
Know that your Phytocontrol laboratory is able to look for the following allergenic food proteins: Milk, Egg, Soy, Cereals containing Gluten and Crustaceans.
You will find details of our COFRAC accreditations via our COFRAC technical appendix N°1-1904 available in your customer area or on the COFRAC website.
Full opinion of the FASFC:
Notice 24-2017: Reference doses for allergens listed in Annex II of Regulation (EU) No 1169/2011 of 25 October 2011.
For all technical, pricing and/or regulatory information, do not hesitate to contact your regional agency.
