The decision is a compromise on the applicant Sabinsa Europe’s request to use the derivative of curcuminoids at a maximum dose of 300 mg/day for adults excluding pregnant and lactating women.
While EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) notes consumption of the NF is not “nutritionally disadvantageous,” the decision was made with results from a 90-day oral toxicity study firmly in mind.
The No-observed-adverse-effect level (NOAEL) from the study used a dose of 400 milligrams per kilogram body weight per day.
By applying an uncertainty factor of 200 (10 (interspecies variability) × 10 (intraspecies variability) × 2 (subchronic to chronic study duration)), the Panel derives a safe level of two milligrams per kilogram per bodyweight per day (mg/kg bw per day).
The Panel adds that for the adult target population that excludes pregnant and lactating women with a default body weight of 70 kg the safe level corresponds to 140 mg of the NF per day with the risk of allergenic reactions low.
Published in EFSA’s official journal, tetrahydrocurcuminoids has no history of use of the NF as a food. It is a white to pale yellow powder produced by hydrogenation of curcuminoids from rhizomes of C. longa L. The resultant product consists of more than 95% of tetrahydrocurcuminoids.
The source, C. longa rhizomes, that is used for the production of the NF has history of use as a spice to flavour and colour food.
Turmeric extract, produced by extraction of dried rhizomes using organic solvents, is a food additive, i.e. curcumin (E 100), authorised in the European Union.