What is FD&C Yellow No. 5, Calcium Lake?
FD&C Yellow No. 5, Calcium Lake (CAS Number: 977011-18-9) is a synthetic colorant derived from FD&C Yellow No. 5 (also known as Tartrazine). The "lake" designation indicates this is an insoluble pigment formed by combining the dye with a substrate, typically aluminum hydroxide or calcium salts. This formulation creates a more stable, insoluble colorant compared to the water-soluble dye form, making it suitable for applications where oil-based or dry systems are preferred.
Common Uses
FD&C Yellow No. 5, Calcium Lake is primarily used in food products where a yellow colorant is desired and the lake form offers technical advantages. Common applications include:
- Baked goods and cake mixes
- Dry beverage mixes
- Candy and confections
- Dry soup and seasoning mixes
- Coated tablets and supplements
- Pet foods
- Cosmetics and topical products
The lake form is particularly useful in products with limited water content or where oil-based systems are employed, as it maintains color stability better than water-soluble dyes in these conditions.
Safety Assessment
FD&C Yellow No. 5, Calcium Lake has been used in food and cosmetic applications for decades. The FDA has not classified it as Generally Recognized as Safe (GRAS), meaning it operates under FDA approval as a color additive rather than through GRAS status. However, this distinction does not indicate a safety concern; rather, it reflects the regulatory pathway established for synthetic colorants.
According to FDA records, there have been zero reported adverse events and zero recalls associated with FD&C Yellow No. 5, Calcium Lake. The water-soluble parent compound, FD&C Yellow No. 5, has been extensively studied and remains approved for use in the United States. Some individuals report sensitivity to tartrazine-based colorants, though the prevalence of true allergic reactions is relatively low in the general population.
The European Food Safety Authority (EFSA) permits tartrazine (E110) in the EU with specific use levels and labeling requirements. Products containing this colorant in the EU must display a warning label stating the presence of the additive.
Regulatory Status
In the United States, FD&C Yellow No. 5, Calcium Lake is approved by the FDA as a color additive for use in foods, drugs, and cosmetics, subject to specified limitations and purity requirements outlined in the Code of Federal Regulations (21 CFR Part 73).
The additive is permitted in the European Union as E110 (Tartrazine), though with mandatory labeling. Other countries including Canada, Australia, and Japan also permit tartrazine-based colorants under their respective regulatory frameworks.
Maximum use levels vary by country and product category. Manufacturers must comply with all applicable regulations in their target markets.
Key Studies
Research on tartrazine and its derivatives has examined potential effects including:
- Hypersensitivity reactions in sensitive individuals
- Behavioral effects, particularly in children (with mixed and inconclusive results)
- Genotoxicity and mutagenicity testing (concluded to be non-genotoxic at approved levels)
- Long-term safety studies supporting continued approval
The FDA and scientific advisory committees have consistently concluded that FD&C Yellow No. 5 and its formulations are safe at permitted use levels. However, individuals with known tartrazine sensitivity should avoid products containing this colorant. Those with concerns about synthetic colorants may opt for products colored with natural alternatives such as annatto, turmeric, or other plant-based colorants.