Select Committee on GRAS Substances (SCOGS) Opinion: Aluminum ammonium sulfate
Aluminum ammonium sulfate
- SCOGS-Report Number: 43*
- Type Of Conclusion: 1
- ID Code: 7784-26-1
- Year: 1975
- 21 CFR Section: 182.1127
Aluminum and its salts are found in varying amounts in nearly all foods. In addition to the aluminum occurring naturally in foods, man can be exposed to the aluminum added to foods, to that in aluminum antacids he may take, and to that from aluminum cooking vessels. It has been estimated that the daily aluminum intake for man from all dietary sources can range from 10 to 100 mg per day and that of this amount, the intake from aluminum compounds added to food may average about 20 mg per day, about 75 percent of which is in the form of sodium aluminum phosphate. In relation to body weight, these amounts are less than those needed to produce toxic responses in experimental animals. It should be noted, however, that this amount may be considerably increased by the consumption of aluminum-containing antacids. When aluminum salts are ingested in excessive amounts, their toxicity appears to be associated with interference in phosphorus metabolism resulting in rachitic or osteomalacic effects, kidney damage, and interference with glucose metabolism, apparently due to interference with phosphorylating enzymes. These effects are reduced and controlled by maintaining sufficient phosphorus in the diet and are exacerbated by kidney dysfunction. Clearly, dietary phosphorus level is a controlling factor, and care should be taken by patients with kidney disease when consuming food containg high levels of aluminum salts. The high intake of phosphorus in the American diet may provide a protective effects, especially in persons who consume large amounts of aluminum antacid preparations that do not contains phosphorus. However, since high phosphate intakes cannot be assured for specific individuals at all times, and since there is some evidence that persons with kidney disease may be at risk, appropriate labeling or other means to indicate the possibility of such hazards may warrant consideration. The Select Committee has found no relevant toxicologic studies on aluminum oleate, aluminum palmitate, sodium aluminate, and sodium phosphoaluminate (substances that may migrate to food from paper packaging materials). But the nature of the inorganic compounds at least does not suggest that, ingested in such small amounts, they would have a different effect than the other aluminum compounds considered in this report, all of which exhibit low orders of toxicity. Even in the absence of direct evidence, it cannot be concluded that the use of any of these compounds in packaging materials would have any likelihood of being hazardous. In the light of the foregoing, the Select Committee concludes that:
- There is no evidence in the available information on aluminum ammonium sulfate, aluminum potassium sulfate, aluminum sodium sulfate, aluminum sulfate, acidic sodium aluminum phosphate, basic sodium aluminum phosphate, and aluminum hydroxide 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.
- No consumption or biological information is available on aluminum oleate, aluminum palmitate, sodium aluminate, and sodium phosphoaluminate. However, there are no reasonable grounds to suspect a hazard to the public when they are consumed at the levels that are likely if these substances should migrate from paper and paperboard used as food packaging materials; or that might reasonably occur when they are used for this purpose in the future.