What is FD&C Yellow No. 6, Calcium Lake?
FD&C Yellow No. 6, Calcium Lake is a synthetic azo dye colorant derived from FD&C Yellow No. 6 (also known as Sunset Yellow FCF or E110 in the European Union). The "lake" designation indicates that the dye has been converted into an insoluble form by combining it with a substrate, typically aluminum hydroxide or calcium salts. This process creates a pigment that is insoluble in water and oil, making it suitable for coloring applications in products where solubility characteristics differ from the dye's free acid form.
Common Uses
FD&C Yellow No. 6, Calcium Lake is used as a colorant in a variety of food products to impart yellow or orange hues. Common applications include:
- Baked goods and cake mixes
- Beverages and soft drinks
- Confectionery and candies
- Dairy products such as cheese and butter
- Processed meats and sausages
- Snack foods and crackers
- Seasonings and condiments
The lake form is particularly useful in dry food applications and products with low water content, where water-soluble dyes may not provide adequate stability or color distribution.
Safety Assessment
According to FDA records, there have been zero adverse events reported in association with FD&C Yellow No. 6, Calcium Lake, and zero recalls have been issued for this additive. The FDA has approved this colorant for use in food, though it is not classified as Generally Recognized as Safe (GRAS).
FD&C Yellow No. 6 (the parent compound) has been extensively studied for safety. The European Food Safety Authority (EFSA) evaluated FD&C Yellow No. 6 and established an acceptable daily intake (ADI) of 7.5 mg/kg of body weight. Some individuals, particularly those with sensitivities to azo dyes, have reported adverse reactions, though such occurrences are rare. The additive may cause allergic reactions in sensitive individuals, and certain jurisdictions require labeling when azo dyes are present.
The calcium lake form is considered chemically stable and is not expected to be absorbed significantly in the gastrointestinal tract due to its insoluble nature. However, the bioavailability and metabolism characteristics may differ from the soluble form of the dye.
Regulatory Status
FD&C Yellow No. 6, Calcium Lake is approved by the U.S. Food and Drug Administration (FDA) for use as a colorant in foods, beverages, and certain cosmetics. It is identified by CAS Number 977083-04-7 and is listed in the Code of Federal Regulations (CFR) under Title 21.
In the European Union, the equivalent colorant (E110 lake) is also approved, though labeling requirements may apply. The colorant is approved in many other countries including Canada, Australia, and Japan, though specific regulations and approved applications may vary by jurisdiction.
Key Studies
Research on FD&C Yellow No. 6 has included toxicological studies examining acute and chronic toxicity, genotoxicity, and reproductive effects. Long-term feeding studies in animals have been conducted to establish safety margins. A comprehensive assessment by regulatory bodies determined the compound to be safe at levels used in food applications.
Studies specifically examining the lake form are limited compared to research on the soluble dye, though the chemical inertness of the lake form suggests that systemic absorption would be minimal. Most safety data is derived from studies of FD&C Yellow No. 6 itself, with the assumption that the insoluble lake form presents lower bioavailability.