E486 - Calcium stearoyl fumarate

Origin

Calcium stearoyl fumarate is a synthetic compound produced by reacting stearic acid and fumaric acid, followed by neutralization with calcium hydroxide. Stearic acid can be derived from both vegetable and animal sources, so the origin can vary. The final product is a white to off-white powder.

Usage

Calcium stearoyl fumarate is primarily used as a dough conditioner and stabilizer in the baking industry. It improves dough handling properties, increases loaf volume, and enhances the texture of baked goods. It is also used as a conditioning agent in dehydrated potatoes and as a tableting aid in pharmaceutical formulations. Specifically, it functions as a lubricant, allowing powders to flow more easily during tablet manufacturing. Typical usage levels in food range from 0.2% to 0.5% by weight of the flour. In pharmaceuticals, it is used at similar or slightly higher concentrations depending on the formulation requirements.

Side Effects

Calcium stearoyl fumarate is generally considered safe for consumption at the levels typically used in food and pharmaceutical applications. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated calcium stearoyl fumarate and established an Acceptable Daily Intake (ADI) of "not specified," meaning that at the levels used in food, it does not pose a health risk. Some individuals may experience mild gastrointestinal discomfort if consumed in very large quantities, but this is rare. No significant adverse effects have been reported in scientific literature at normal consumption levels.

Regulatory Status

Calcium stearoyl fumarate is approved for use as a food additive in many countries, including the United States, Canada, and the European Union. In the EU, it is designated as E486. Regulatory bodies such as the European Food Safety Authority (EFSA) and the U.S. Food and Drug Administration (FDA) have reviewed its safety and established guidelines for its use. It is listed in the FDA's CFR 21 under various sections related to food additives and pharmaceutical ingredients.