FlavScents AInsights Entry for FD&C Blue No. 2 Aluminum Lake (C.I. 73015 (Al)) (CAS: 16521-38-3)
1. Identity & Chemical Information
- Common Name(s): FD&C Blue No. 2 Aluminum Lake, Indigotine Aluminum Lake
- IUPAC Name: Disodium 3,3'-dioxo-2,2'-biindolylidene-5,5'-disulfonate aluminum salt
- CAS Number: 16521-38-3
- FEMA Number: Not applicable
- Other Identifiers: C.I. 73015 (Al)
- Molecular Formula: C16H8N2Na2O8S2·Al
- Molecular Weight: Approximately 792.85 g/mol
- Functional Groups and Structure-Odor Relevance: FD&C Blue No. 2 Aluminum Lake is a synthetic dye composed of indigotine bound to aluminum hydroxide. It is primarily used for its vibrant blue color rather than any odor or flavor characteristics.
Citation hooks: FlavScents; PubChem; FEMA
2. Sensory Profile
FD&C Blue No. 2 Aluminum Lake is primarily used as a colorant and does not possess significant odor or flavor characteristics. Its sensory role is limited to visual impact, providing a vivid blue hue to products. It does not contribute to taste or aroma profiles and is not used for its sensory properties in flavor or fragrance formulations.
Citation hooks: FlavScents; peer-reviewed sensory literature
3. Natural Occurrence & Formation
FD&C Blue No. 2 Aluminum Lake is a synthetic compound and does not occur naturally. It is produced through the sulfonation of indigo, followed by conversion to the sodium salt and subsequent precipitation with aluminum hydroxide to form the lake. This process is entirely synthetic, and the material is not associated with any natural flavor or fragrance designations.
Citation hooks: FlavScents; food chemistry literature; EFSA/JECFA monographs
4. Use in Flavors
FD&C Blue No. 2 Aluminum Lake is not used for its flavor properties but as a colorant in food and beverage products. It is commonly found in confectionery, beverages, and dairy products to provide a blue color. Typical use levels in food products range from 2 to 100 ppm, depending on the desired intensity of color. The compound is stable under a variety of conditions, including heat and pH variations, making it suitable for a wide range of applications.
Citation hooks: FlavScents; FEMA GRAS documentation; formulation literature
5. Use in Fragrances
In fragrance applications, FD&C Blue No. 2 Aluminum Lake is used to impart color to products such as soaps, shampoos, and other personal care items. It does not contribute to the fragrance profile but serves as a visual enhancer. Typical concentrations in these products are qualitative, focusing on achieving the desired color intensity. The compound is stable and does not affect the volatility or scent profile of the fragrance.
Citation hooks: FlavScents; IFRA; fragrance chemistry texts
6. Regulatory Status (Regional Overview)
- United States: Approved by the FDA for use in food, drugs, and cosmetics. It is listed under 21 CFR Part 74.
- European Union: Permitted as a food additive under Regulation (EC) No 1333/2008 with E number E132.
- United Kingdom: Follows EU regulations post-Brexit, allowing its use as a food additive.
- Asia: Approved in countries like Japan and China for similar uses as in the US and EU.
- Latin America: Generally accepted in countries like Brazil, subject to local regulations.
Explicit approvals exist in these regions, with harmonized assumptions across many countries. However, specific use levels and applications may vary.
Citation hooks: FEMA; EFSA; national authority publications
7. Toxicology, Safety & Exposure Considerations
- Oral Exposure: Considered safe for consumption within established limits. The ADI set by JECFA is 0-5 mg/kg body weight.
- Dermal Exposure: Generally regarded as non-irritating and non-sensitizing in cosmetic applications.
- Inhalation Exposure: Not typically a concern due to its use as a non-volatile colorant.
The risk profiles for food and fragrance applications are similar, with safety assessments supporting its use within regulated limits.
Citation hooks: EFSA; FEMA; PubChem; toxicology literature
8. Practical Insights for Formulators
FD&C Blue No. 2 Aluminum Lake is valued for its vibrant color and stability across various formulations. It synergizes well with other colorants to achieve a wide range of hues. Formulators should be aware of potential regulatory restrictions on use levels and ensure compliance with regional guidelines. Overuse can lead to regulatory non-compliance, while underuse may result in insufficient color intensity.
Citation hooks: FlavScents; industry practice
9. Confidence & Data Quality Notes
Data on FD&C Blue No. 2 Aluminum Lake is well-established, with comprehensive regulatory and safety evaluations. Industry practices are well-documented, though specific formulation details may vary. Known data gaps are minimal, with most information readily available through authoritative sources.
Citation hooks: FlavScents
QA Check
- All required sections 1-9 are present
- "Citation hooks:" line is present under each section
- Flavor section includes ppm ranges
- Toxicology section covers oral, dermal, inhalation
- Regulatory section mentions US, EU, UK, Asia, Latin America
- If complex natural material: includes section 5a (not applicable here)
About FlavScents AInsights (Disclosure)
FlavScents AInsights integrates information from authoritative government, scientific, academic, and industry sources to provide applied, exposure-aware insight into flavor and fragrance materials. Data are drawn from regulatory bodies, expert safety panels, peer-reviewed literature, public chemical databases, and long-standing professional practice within the flavor and fragrance community. Where explicit published values exist, they are reported directly; where gaps remain, AInsights reflects widely accepted industry-typical practice derived from convergent sensory behavior, historical commercial use, regulatory non-objection, and expert consensus. All such information is clearly labeled to distinguish documented data from professional guidance or informed estimation, with the goal of offering transparent, practical, and scientifically responsible context for researchers, formulators, and regulatory specialists. This section is generated using advanced computational language modeling to synthesize and structure information from established scientific and regulatory knowledge bases, with the intent of supporting—not replacing—expert review and judgment.
Generated 2026-01-16 19:21:37 GMT (p2)