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Determination of combined benzidine in FD&C Yellow No. 6 (Sunset Yellow FCF)
M D Peiperl1, M J Prival, S J Bell
1Genetic Toxicology Branch (HFS-236), Food and Drug Administration, Washington, DC 20204, USA.
Summary
Analysis of FD&C Yellow No. 6 revealed concerning levels of combined benzidine in many samples. Over half contained more than 10 ng/g, with one sample showing significantly higher contamination.
Area of Science:
- Food Science
- Analytical Chemistry
- Toxicology
Background:
- FD&C Yellow No. 6 (Sunset Yellow FCF) is a widely used synthetic food dye.
- Benzidine is a known human carcinogen, and its presence in food dyes is a significant safety concern.
- Regulatory bodies like the US Food and Drug Administration (FDA) monitor dye purity.
Purpose of the Study:
- To quantify the levels of combined benzidine in manufactured lots of FD&C Yellow No. 6.
- To assess the compliance of FD&C Yellow No. 6 with safety standards regarding benzidine contamination.
- To identify potential sources of benzidine contamination in the dye manufacturing process.
Main Methods:
- Samples of FD&C Yellow No. 6 from 67 manufactured lots were analyzed.
- Combined benzidine was reduced to free benzidine using dithionite.
- Quantification of total benzidine was performed using High-Performance Liquid Chromatography (HPLC) after diazotization and coupling with R salt.
Main Results:
- 34 out of 67 analyzed samples exceeded the 10 ng/g limit for combined benzidine.
- 30 of these contaminated samples originated from a single manufacturing company and its subsidiaries.
- Benzidine levels ranged from 11 to 104 ng/g, with one outlier at 941 ng/g.
Conclusions:
- A significant proportion of FD&C Yellow No. 6 lots analyzed contained unacceptable levels of combined benzidine.
- The findings suggest a potential issue with manufacturing processes at a specific company.
- Further investigation and stricter quality control measures are warranted to ensure food safety.