Brilliant Blue FCF

About

What it is and where it shows up.

Brilliant Blue FCF is a synthetic triarylmethane blue food dye approved for use in a wide range of processed foods including confections, beverages, cereals, frozen dairy desserts, frostings, and icings. It is one of the most widely used synthetic blue colorants in both food and cosmetic preparations worldwide.

Safety summary

The regulatory and scientific consensus.

EFSA (2010) and JECFA (2017) both established an ADI of 6 mg/kg bw/day, revised downward from earlier values of 10–12.5 mg/kg bw/day; dietary exposure is generally below this threshold for adults, but EFSA noted that 95th-percentile intake in children may exceed the ADI at Tier 2 estimates. In vitro studies have demonstrated cytotoxic and genotoxic potential, and the dye has been shown to inhibit nerve cell development and purinergic (P2) receptor activity in vitro, though no carcinogenicity has been found in animal models. Systemic absorption in critically ill patients receiving enteral feeding has been linked to toxicity and fatalities, though oral absorption is poor in healthy individuals.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FSSAI (Food Safety and Standards Authority of India) (India)	Restricted	Permitted in specified food categories only (custard powder, jelly crystals, ice candy, candies, wafers, soups/bouillons, and flavour emulsions for carbonated/non-carbonated beverages) at a maximum of 100 ppm. Not blanket-approved for all food categories. FSSAI also proposed allowing up to 10 ppm in non-edible ice (2020 draft amendment).source
EFSA (European Food Safety Authority) (European Union)	Approved	Permitted under EC Regulation No. 1333/2008 across a wide range of food categories. ADI was revised downward from 10 mg/kg bw/day (SCF, 1984) to 6 mg/kg bw/day based on a NOAEL of 631 mg/kg bw/day from a chronic rat toxicity study with an uncertainty factor of 100. EFSA noted that at Tier 2, 95th-percentile intake estimates for children may exceed the ADI.source
Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom)	Approved	Approved under Assimilated (Retained EU) Regulation EC No. 1333/2008, Annex III, as maintained in Great Britain post-Brexit. Conditions of use mirror former EU authorisation.source
FDA (Food and Drug Administration) (United States)	Approved	Certified color additive regulated under 21 CFR Part 74.101 (FD&C Blue No. 1). Requires FDA batch certification before use. Approved in 1993 for food use in confections, beverages, cereals, frozen dairy desserts, popsicles, frostings, and icings; approved in 1994 for externally applied drugs and nontherapeutic cosmetics. FDA does not publish a formal ADI for certified color additives; maximum use levels are set per food category.

Who should approach with care

Whose guidance would steer them away.

Children — EFSA (2010) found that at Tier 2 estimates, 95th-percentile intake in children exceeds the ADI of 6 mg/kg bw/day, suggesting high consumers among children face potential overexposure.

Ibd — Critically ill or immunocompromised patients with increased gastrointestinal permeability (e.g., IBD flares, sepsis) may absorb the dye systemically at higher rates, which has been associated with toxicity in enteral feeding cases.

Other — Individuals with aspirin sensitivity or salicylate intolerance may exhibit cross-reactive responses to synthetic triarylmethane dyes including Brilliant Blue FCF, including potential bronchial constriction as noted in published reviews.

Research citations

The sources behind this verdict.

1WHO. Brilliant Blue FCF – JECFA Food Additives & Contaminants Database. apps.who.int
2PubMed. Food Safety and Health Concerns of Synthetic Food Colors: An Update, 2024. pmc.ncbi.nlm.nih.gov
3PubMed. The Effects of Natural and Synthetic Blue Dyes on Human Health: A Review of Current Knowledge and Therapeutic Perspectives, 2021. pmc.ncbi.nlm.nih.gov
4PubMed. Brilliant Blue Dyes in Daily Food: How Could Purinergic System Be Affected?, 2016. pmc.ncbi.nlm.nih.gov
5FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations – Appendix A & B (Revised), 2011. fssai.gov.in
6EFSA. Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive, 2010. efsa.europa.eu

Independently researched6 citations