The GRAS Substances (SCOGS) Database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The GRAS ingredient reviews were conducted by the Select Committee in response to a 1969 White House directive by President Richard M. Nixon.
α-Tocopherol acetate, tocopherols
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21 CFR Section
Tocopherols are a natural constituent of many foods. The average daily dietary intake of tocopherols in the United States is approximately 5 to 20 mg. The quantity of tocopherols added to foods as antioxidants is estimated to be equivalent to an average adult daily intake of 0.6 mg.
The several tocopherols used in foods as antioxidants are readily absorbed and metabolized. They are relatively non-toxic. LD50 values for acute oral toxicity of several animal species are in excess of 2000 mg per kg. Hypervitaminosis E has been reported in humans only at oral dosage levels in excess of 400 mg per day. Investigations on mutagenic, carcinogenic, and teratogenic effects of tocopherols have not revealed any deleterious or pathologic alterations, although some reproductive system effects have been observed in young animals fed or administered dosage levels that exceed by manyfold, the quantitites added to food or present in the daily diet.
The Select Committee has weighed the foregoing and concludes that:
There is no evidence in the available information on tocopherols and alpha-tocopheryl acetate that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.
*Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions and are available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.