What is FD&C Red No. 3, Aluminum Lake?
FD&C Red No. 3, Aluminum Lake (CAS Number 12227-78-0) is a synthetic azo dye colorant combined with aluminum substrate to create a lake form. Lake colorants are produced by adsorbing soluble dyes onto insoluble substrates, typically aluminum hydroxide or calcium carbonate. This process creates a more stable, insoluble pigment suitable for applications where water solubility of traditional dyes would be problematic. The aluminum lake form allows for better incorporation into solid food matrices and improved color stability.
Common Uses
Historically, FD&C Red No. 3, Aluminum Lake was used in a variety of food applications including confectionery, baked goods, beverages, and processed foods where red coloring was desired. The lake form was particularly valuable in dry applications and products where moisture could cause dye migration or color bleeding. It was also permitted for use in cosmetics and pharmaceuticals. However, following its delisting, these uses are no longer authorized in the United States.
Safety Assessment
According to FDA records, there have been zero adverse events reported associated with FD&C Red No. 3, Aluminum Lake, and zero FDA recalls linked to this additive. This suggests no documented safety incidents occurred during its permitted use period. The delisting of this colorant in 2024 reflects regulatory decision-making rather than a documented safety crisis or urgent health concern.
The safety profile of azo dyes has been subject to ongoing scientific review. Some azo dyes have been associated with concerns in animal studies, leading to the removal of certain colorants from the approved list over decades. The decision to delist FD&C Red No. 3, Aluminum Lake represents the FDA's determination that continued approval could not be justified under current regulatory standards, though the specific reasoning involved toxicology data review rather than consumer harm reports.
Regulatory Status
FD&C Red No. 3, Aluminum Lake was previously approved by the FDA as a food colorant but has been delisted as of 2024. This means it is no longer permitted for use in food, beverages, drugs, or cosmetics in the United States. The delisting followed a regulatory review process. Food manufacturers must reformulate products that previously contained this colorant using alternative approved colorants such as other FD&C-approved dyes or natural colorants like anthocyanins, carmine, or caramel coloring.
Other regulatory agencies may have different approval statuses. The European Union maintains its own approval processes for food additives, and the regulatory landscape for synthetic colorants varies internationally.
Key Studies
Regulatory decisions regarding synthetic food colorants are typically based on chronic toxicity studies, genotoxicity assessments, and reproductive/developmental toxicity evaluations. While specific recent studies on FD&C Red No. 3, Aluminum Lake were reviewed during the delisting process, the FDA does not routinely publish detailed study abstracts for individual colorants. The agency's decision reflects comprehensive toxicological review conducted as part of periodic safety reassessments mandated for color additives under 21 CFR Part 70-82.
Historical concerns about certain synthetic azo dyes led to the removal of FD&C Red No. 1 in 1976 and periodic reviews of remaining approved colorants. The delisting of FD&C Red No. 3, Aluminum Lake follows this pattern of ongoing regulatory scrutiny of synthetic colorants in the U.S. food supply.