FD&C Yellow No. 6 Aluminum Lake is a synthetic yellow colorant derived from FD&C Yellow No. 6 (also known as Sunset Yellow FCF) by forming an insoluble salt with aluminum. This lake pigment is used in various applications, including food, pharmaceuticals, and cosmetics, due to its stability and bright yellow hue. It is approved for use by regulatory bodies like the U.S. Food and Drug Administration (FDA) when used within specified limits.
What is FD&C Yellow No. 6 Aluminum Lake made from?
FD&C Yellow No. 6 Aluminum Lake is manufactured by reacting FD&C Yellow No. 6 (Sunset Yellow FCF) with a soluble aluminum salt, such as aluminum chloride or aluminum sulfate [1]. This chemical process creates an insoluble pigment, meaning it does not dissolve in water. The resulting lake pigment inherits the color properties of FD&C Yellow No. 6, providing a distinct yellow shade.
Where is FD&C Yellow No. 6 Aluminum Lake used?
This colorant finds application in a range of products. In the food industry, it is used to color confectionery, baked goods, beverages, and dairy products [1]. For pharmaceuticals, it can be found in tablets, capsules, and liquid medications to aid in product identification and differentiation. Cosmetic products, such as makeup and personal care items, also utilize FD&C Yellow No. 6 Aluminum Lake for coloration [2].
What regulations govern FD&C Yellow No. 6 Aluminum Lake?
The use of FD&C Yellow No. 6 Aluminum Lake in food and drugs is regulated by the U.S. Food and Drug Administration (FDA). It is listed under 21 CFR 74.1706 as an approved color additive for food and drugs [3]. The FDA specifies purity criteria and allowable uses to ensure consumer safety. Similar regulations exist in other regions, such as the European Union, where it is permitted as a food additive (E110).
Are there any safety concerns associated with FD&C Yellow No. 6 Aluminum Lake?
While generally recognized as safe when used within approved limits, FD&C Yellow No. 6 and its derivatives have been subjects of research regarding potential effects, particularly in sensitive individuals. Some studies have explored links between artificial food colorings, including FD&C Yellow No. 6, and hyperactive behavior in children [4]. Regulatory bodies continuously review scientific data to assess safety.
What is the difference between FD&C Yellow No. 6 and FD&C Yellow No. 6 Aluminum Lake?
The primary difference lies in their solubility and stability. FD&C Yellow No. 6 is a water-soluble dye, whereas FD&C Yellow No. 6 Aluminum Lake is an insoluble pigment. This insolubility makes the lake form more stable in certain product matrices, such as those with fats or low water content, where the water-soluble dye might migrate or fade.
Can FD&C Yellow No. 6 Aluminum Lake be used in all food products?
No, its use is subject to specific regulations and limitations. The FDA permits its use in a variety of food categories but not all. The amount used must also comply with maximum permitted levels to ensure it remains within safe consumption guidelines [3].
Sources:
[1] https://www.drugpatentwatch.com/food-colorings/fdc-yellow-6-aluminum-lake
[2] https://www.drugpatentwatch.com/cosmetic-ingredients/fdc-yellow-6-aluminum-lake
[3] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=74.1706
[4] https://www.drugpatentwatch.com/food-additives/fdc-yellow-6