Select Committee on GRAS Substances (SCOGS) Opinion: Calcium stearate, and Hydrogenated tallow, Stearic acid, Tallow (packaging)

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.

Calcium stearate, and Hydrogenated tallow, Stearic acid, Tallow (packaging)

SCOGS Report Number: 54
NTIS Accession Number: PB262659*
Year of Report: 1975
GRAS SubstanceID Code

21 CFR Section

Calcium stearate1592-23-0181.29
Hydrogenated tallow (packaging)61789-97-7182.70
Stearic acid (packaging)57-11-4184.1090
Tallow (packaging)61789-97-7186.1555

SCOGS Opinion:

Tallow and stearic acid, one of its chemical components, are consumed as part of normal human diets primarily in meats and in smaller quantities as ingredients of shortening and oleomargarine. Calcium stearate appears to be a normal product of digestion of diets containing calcium and stearic acid. Hydrogenated tallow, including tallow flakes, is used to some extent in the manufacture of shortening.

Feeding tests with animals show a high utilization of tallow as an energy source, but a relatively low digestibility of hydrogenated tallow, stearic acid, and calcium stearate. None of the feeding tests involving amounts of these substances comparable to those estimated to be consumed as food additives showed any toxic effects. Furthermore, the toxicity of stearic acid at very high concentrations is markedly reduced by the presence in the diet of glycerides of substantially lower melting point, such as those containing unsaturated fatty acids. Carcinogenicity test of stearic acid have shown negative results.

This report is directed toward the GRAS status of tallow, hydrogenated tallow, and stearic acid as given in the Code of Federal Regulations 121.101(i) as substances migrating to food from cotton and cotton fabrics used in dry food packaging and calcium stearate as a GRAS substance (unpublished). Even at the levels estimated as being consumed by man from all added sources of these substances there is no evidence to demonstrate a hazard to the public.

In light of these observations, the Select Committee concludes that:

As a substances that may migrate to foods from cotton or cotton fabrics, there is no evidence in the available information on tallow, hydrogenated tallow, or stearic acid that demonstrates, or suggests reasonably 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.

There is no evidence in the available information on calcium stearate that demonstrates, or suggests reasonable grounds to suspect a hazard to the public, when it is used as a direct food additive 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.

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