EFSA 2021 re-evaluation: no numerical daily limit needed
The European Food Safety Authority completed a full re-evaluation of thaumatin in 2021. The Panel found no genotoxicity and no adverse effects in animal toxicity studies even at very high doses. It calculated a margin of safety of over 5,000 between the highest estimated human exposure and the lowest dose with no observed effects in animals, and concluded no numerical acceptable daily intake was needed.
No genotoxic potential was identified and no adverse effects were found in animal studies at doses up to 5,200 mg per kilogram of bodyweight per day in rats.
2021Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal
The Panel derived a margin of safety of 5,417 at the 95th percentile human exposure scenario and concluded there was no safety concern at regulatory maximum levels. No numerical ADI was set.
2021Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal 2021;19(12):e06884
Allergenicity: oral evidence is inconclusive
Because thaumatin is a protein, EFSA examined whether it could trigger allergic reactions when eaten. The Panel reviewed available human data but concluded no firm conclusion on oral allergenicity could be drawn from those data. Occupational inhalation of thaumatin powder has been linked to sensitisation in workers, but this is a different exposure route from eating it in food. No requirement to declare thaumatin as a food allergen currently exists under UK or EU food law.
EFSA concluded that no determination on oral allergenicity could be made from the available human data; inhalation allergenicity in occupational settings was noted but considered not relevant to dietary exposure.
2021Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal 2021;19(12):e06884
JECFA assessment: no ADI assigned
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) previously evaluated thaumatin and likewise did not assign a numerical acceptable daily intake, reflecting that exposure from food use is far below any level of concern identified in animal studies.
JECFA evaluated thaumatin and set no numerical ADI, considering it acceptable for use as a food additive at the levels required to achieve its sweetening effect.
RegulatoryJECFA (Joint FAO/WHO Expert Committee on Food Additives)