What is FD&C Red No. 3 Calcium Lake?
FD&C Red No. 3 Calcium Lake is a synthetic azo dye and the calcium salt form of FD&C Red No. 3 (also known as Erythrosine). The "lake" designation indicates the dye is precipitated and adsorbed onto an insoluble substrate, typically aluminum hydroxide or similar compounds. This form creates a more stable, insoluble pigment suitable for certain food applications. The CAS number 977011-16-7 identifies this specific chemical compound.
Common Uses
Historically, FD&C Red No. 3 Calcium Lake was used as a colorant in food products, including candies, desserts, beverages, and other processed foods where a red or pink color was desired. The lake form was particularly useful in dry food applications where water-soluble dyes might not be practical. However, due to its delisted status, it is no longer permitted for use in foods under FDA regulations.
Safety Assessment
According to FDA records, there have been zero reported adverse events associated with FD&C Red No. 3 Calcium Lake and zero product recalls involving this additive. The lack of adverse event reports suggests no identified safety issues at the time of or after its use.
Historical toxicological studies on FD&C Red No. 3 and its derivatives were conducted before the ingredient's delisting. These studies examined potential concerns including genotoxicity, reproductive effects, and general toxicity. The delisting of FD&C Red No. 3 Calcium Lake was not primarily driven by new safety data but rather by regulatory decisions regarding the parent compound FD&C Red No. 3.
It is important to note that regulatory delisting does not necessarily indicate the ingredient is unsafe. Administrative, economic, or policy reasons often influence whether color additives remain on the approved list.
Regulatory Status
FD&C Red No. 3 Calcium Lake is currently delisted and no longer approved for use in food products in the United States. This means manufacturers cannot legally add this colorant to foods sold in the U.S. market. The delisting followed regulatory changes regarding FD&C Red No. 3 more broadly.
The FDA maintains detailed records of approved and delisted color additives under the Color Additives Status List. Manufacturers seeking to use food colorants must select from the current list of approved alternatives, which includes other synthetic dyes and natural colorants such as carmine, annatto, or beta-carotene.
Other jurisdictions may have different regulatory statuses for this additive. The European Food Safety Authority (EFSA) and other regulatory bodies maintain separate lists of permitted food colorants.
Key Studies
Specific published studies focused exclusively on the Calcium Lake form of FD&C Red No. 3 are limited in the scientific literature. Most research on FD&C Red No. 3 examines the free acid or sodium salt forms. Historical regulatory documentation from the FDA's color additives petition files contains safety assessments that were conducted during the approval process.
The absence of adverse event reports and recalls provides observational evidence that the ingredient did not generate public health concerns during its period of authorized use. Current food safety databases maintained by the FDA show no documented safety issues associated with this specific formulation.