Fd&c Yellow No. 6, Aluminum Lake

FD&C Yellow No. 6, Aluminum Lake (CAS Number 15790-07-7) is a color additive created by combining FD&C Yellow No. 6 (also known as Sunset Yellow FCF or C.I. Food Yellow 3) with aluminum hydroxide. The aluminum lake format converts the water-soluble dye into a water-insoluble form, making it more stable and suitable for applications where water-soluble dyes would be unsuitable. Lake colorants are widely used in the food industry because they provide improved stability, better adherence to food matrices, and compatibility with oil-based products.

FD&C Yellow No. 6, Aluminum Lake is utilized in a variety of food and beverage applications. Primary uses include coloring in baked goods, cereals, confectionery products, desserts, and processed foods that require a stable yellow hue. The lake form is particularly advantageous in products with lower moisture content or those where water-soluble dyes might migrate or cause discoloration. The aluminum lake format also performs well in oil-based food systems and provides consistent color stability throughout the product's shelf life.

FD&C Yellow No. 6, Aluminum Lake has been subject to extensive safety evaluation. The FDA has not classified it as Generally Recognized As Safe (GRAS), meaning it remains a regulated color additive that requires pre-market approval. However, the FDA's database shows zero reported adverse events associated with this additive and zero recalls linked to it. The underlying dye, FD&C Yellow No. 6, has been extensively studied, and safety reviews have been conducted by multiple regulatory authorities including the FDA and the European Food Safety Authority (EFSA). While some consumers report sensitivities to azo dyes like Sunset Yellow FCF, these reactions are rare and typically occur in individuals with pre-existing sensitivities to synthetic dyes or salicylates.

The aluminum component in lake colorants has also been evaluated. The amount of aluminum in food-grade aluminum lakes is regulated and considered minimal relative to dietary aluminum exposure from other sources such as baking powder, antacids, and naturally occurring aluminum in foods.

FD&C Yellow No. 6, Aluminum Lake is approved for use as a color additive in the United States under FDA regulations (21 CFR 82.203). It is listed as an acceptable color for use in foods, drugs, and cosmetics. In the European Union, the equivalent colorant (E110 in its soluble form) is approved with labeling requirements that identify it as a color additive. The additive is also approved in other regulatory jurisdictions including Canada, Australia, and Japan.

As a regulated color additive, its use must comply with specific limitations on maximum levels in different food categories. Manufacturers are required to declare its presence on product labels, typically as "FD&C Yellow No. 6, Aluminum Lake" or "Yellow 6, Aluminum Lake."

Safety evaluations of FD&C Yellow No. 6 have been published in peer-reviewed literature and regulatory agency reports. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated this colorant, and acceptable daily intake (ADI) values have been established. Long-term toxicology studies in animal models have not identified significant safety concerns at approved usage levels. Post-market surveillance data continues to support the safety profile of this additive when used according to regulatory specifications.