Select Committee on GRAS Substances (SCOGS) Opinion: Thiamine hydrochloride and Thiamine mononitrate

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.

Thiamine hydrochloride and thiamine mononitrate

SCOGS Report Number: 109
NTIS Accession Number: PB288674*
Year of Report: 1978
GRAS SubstanceID Code

21 CFR Section

Thiamine hydrochloride67-03-8184.1875
Thiamine mononitrate532-43-4184.1878

SCOGS Opinion:

Thiamin† (thiamine) salts have been administered to man for months in daily doses up to 1 g or more without reported adverse effects, except hundred times the estimated intake of thiamin hydrochloride and thiamin monotrinate added to foods. Most cases of sensitivity were induced by previous topical or parenteral exposure to thiamin.

Similarly, mice and rats fed daily for three generations with several hundred times their normal requirements of thiamin showed no adverse effects.

Absorption of orally administered thiamin is regulated by a transport mechanism which offers an effective protection against overdosage. Excess thiamin in the tissues is rapidly excreted in the urine.

In view of the above considerations, the Select Committee concludes that:

There is no evidence in the available information on thiamin hydrochloride or thiamin mononitrate that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when it is used at levels that are now current or that might reasonably be expected in the future.

† This spelling has been recommended by the International Union of Nutrition Sciences and by the American Institute of Nutrition.

*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.

Page Last Updated: 10/16/2015
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