Safety of S-acetyl glutathione as an novel food pursuant to Regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on S-acetyl glutathione (SAG) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of > 97% (w/w) SAG, which is an acetylated tripeptide (i.e. cysteine, glutamic acid and glycine) obtained through chemical synthesis. The information provided on the production process, composition and specifications of the NF did not raise safety concerns. The NF contains perchlorate, although its intake through this NF, added to the background dietary exposure, remains below the tolerable daily intake (TDI) established by EFSA, across the age groups. The NF is proposed to be used as a food supplement and as food for special medical purposes at a maximum dose of 300 mg NF/day, targeting the general population excluding individuals below 10 years of age, and pregnant or lactating women. A BMDL10 of 877 mg/kg bw per day was derived for the increase in the liver-to-body weight ratio from benchmark dose modelling, leading to a safe dose of 4.39 mg/kg bw per day after applying an uncertainty factor of 200. This corresponds to safe intake levels of 190, 269 and 307 mg/day for young adolescents (from 10 to < 14 years), older adolescents (from 14 to < 18 years) and adults, respectively. Human clinical data on orally administered glutathione support the safety of the NF in adults. The Panel concludes that the NF is safe at the proposed conditions of use of 300 mg/day for adults, excluding pregnant and lactating women. For young and older adolescents, the Panel considers that the NF is safe when consumed at intake levels up to 190 and 269 mg/day, respectively, assuming similar tolerance on a body weight basis as compared to adults.