Select Committee on GRAS Substances (SCOGS) Opinion: Silicon dioxides
- SCOGS-Report Number: 61*
- Type Of Conclusion: 1
- ID Code: 14808-60-7
- Year: 1979
- 21 CFR Section: There is no CFR citation.
Silicon dioxide and various silicates occur abundantly in the earth's crust, are present in practically all natural waters,animals, and plants, and are part of the normal human diet. The question of whether or not silicon is an essential human nutrient remains unresolved. Silicon compounds consumed as added food ingredients contribute only a minor proportion of the total dietary silicon intake. The estimated possible human intake of sodium aluminosilicate, the predominant silicate added to foods in this country, is approximately 0.3mg per kg body weight per day. Silicon compounds that are GRAS for use as direct food ingredient, except potassium and sodium silicates, are insoluble or very slightly soluble in water and appear to be biologically inert. The water-soluble silicates are also of low acute toxicity. The acute oral LD50 in rats of sodium aluminosilicate is >1g per kg. No significant tissue accumulation, pathology, or toxicity has been reported from the ingestion of those insoluble or very slightly soluble GRAS silicon compounds for which data are available. Of the five substances that were reported as added to foods in the NRC survey, biologic effects and safety data are available for all except sodium calcium aluminosilicate, and there is no reason to suspect that the toxicity of the latter would differ from those for which there are data. The results of two studies (1967-1970) in which various silicon compounds were fed to laboratory animals for 1 mo at a level of 0.8g per kg body weight (as silicon dioxide) and for 3 mo at levels of 6 to 30 mg per kg body weight suggests there may be a species-related susceptibility to renal damage from ingestion of sodium silicate, magnesium trisilicate, and finely ground quartz. No substantiating reports of these effects have appeared. Magnesium trisilicate was recognized as safe for prolonged use in human ingestion in large amount as a component of antacid preparations by the Advisory Review Panel on Over-the-Counter Drugs, and the available evidence on the acute toxicity of sodium silicate indicates that it is low. Consumption data are lacking for aluminum calcium silicate and tricalcium silicate, two compounds that are listed as GRAS for use as anticaking agents. However, their use in keeping with good manufacturing practice and in currently regulated amounts would be of the same order of magnitude as the other GRAS silicates. In addition, the Select Committee has limited information on the amounts of talc that are currently used in foods. However a major food use of talc is in the coating of rice. Assuming package label statements are ignored and coated rice is not washed prior to cooking and no other losses occur, maximun per capita intake of talc from this source appears to be 0.5g per day. With respect to paper and cotton food- packaging products, the possibility is remote that biologically significant amounts of talc, diatomaceous earth, or sodium silicate migrate to food from packaging, materials containing these substances. Perlite, a naturally occuring polysilicate substance, has an oral LD50 in the rat of >10g per kg body weight. Estimates of the maximun quantities of minerals that might be extracted from perlite and diatomaceous earth used as filteraids in food processing indicates no hazard to public health. There are no food grade specifications for aluminum calcium silicate, sodium calcium aluminosilicate, and talc. Such specifications for the substances used in foods are desirable. Specification for food grade talc should limit the content of asbestos fibers even though the potential hazard of ingested asbestos fibers even though the potential hazard of ingested asbestos is not clearly established. The Food and Drug Administration is sponsoring the development of an assay method for asbestos fibers. An upper limit for cadmium should be added to the specifications for food-grade perlite, and consideration should be given to the need for limitation of cadmium content of other silicates. In the light of all of the foregoing, the Select Committee concludes that: It is essential to establish food-grade specifications for aluminum calcium silicate, sodium calcium aluminosilicate, and talc, with provision for an upper limit of asbestos fibers in talc. There is no evidence in the available information on aluminum calcium silicate, calcium silicate, magnesium silicate, potassium silicate, sodium silicate, sodium aluminosilicate, sodium calcium aluminosilicate, tricalcium silicate, silica aerogel, and talc 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. There is no evidence in the available information on diatomaceous earth, silicon dioxides, sodium silicate, and talc that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used as ingredients of paper and paperboard products used in food packaging in accordance with current practice. There is no evidence in the available information on sodium silicate and talc that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used as ingredients of cotton and cotton fabrics used in dry food packaging in accordance with current practice. There is no evidence in the available information on diatomaceous earth and perlite that demonstrates or suggests reasonable ground to suspect a hazard to the public when they are used as filteraids in food processing at levels that are now current or that might reasonably be expected in the future.