Erythrosine E127
synthetic — Primarily synthetic.
Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate monohydrate
CAS: 16423-68-0
Factual Regulatory Reference
This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.
What Is Erythrosine?
Erythrosine (E127) is a synthetic xanthene dye producing a bright cherry-pink color, notable for containing approximately 58% iodine by weight — making it unique among food dyes. It is manufactured by iodinating fluorescein and is used primarily as a food coloring in cocktail and glace cherries, certain confectionery, and in dental disclosing tablets. In the EU, erythrosine is authorized under Regulation (EC) No 1333/2008 with specified maximum use levels. The FDA permits erythrosine as FD&C Red No. 3 in food under 21 CFR 74.303, but since 1990 has banned its use in externally applied drugs and cosmetics based on a thyroid tumor study in male rats — a mechanism the FDA has acknowledged is not directly applicable to humans, though the cosmetics ban was implemented under the Delaney Clause.
? Did You Know?
Beyond food, Erythrosine is also used in cosmetics, medicine, industrial applications, household products. Its versatility makes it one of the most multi-purpose chemical compounds in everyday life.
Regulatory opinions differ: Erythrosine is approved in EU, JAPAN, CANADA but banned in USA. This reflects different risk assessment philosophies between regions.
To reach the Acceptable Daily Intake limit, a 60kg adult would need to consume approximately ~3 cocktail cherries (at 200mg/kg, ~10g each) in a single day. (This is a mathematical illustration, not a safety recommendation.)
Regulatory Analysis
Erythrosine presents one of the most striking examples of regulatory inertia in food safety history. The FDA banned it from cosmetics in 1990 under the Delaney Clause's zero-tolerance standard for animal carcinogens, yet allowed it in food for another 35 years before finally acting in January 2025. The delay exposes the tension between the Delaney Clause's bright-line rule and the risk-benefit balancing that governs food additive approvals, while the EU's decision to restrict it exclusively to cocktail cherries represents a third regulatory philosophy: containment through extreme use limitation rather than outright prohibition.
Detailed Regulatory Assessment
European Union (EFSA)
EXCLUSIVELY authorized for cocktail cherries, candied cherries, Bigarreaux cherries, and glacé cherries only. No other food uses permitted.
Official EFSA LinkUnited States (FDA)
FDA banned January 15, 2025; enforcement begins January 15, 2027 (food) and January 18, 2028 (drugs). Cosmetics/topical drugs banned 1990 (Delaney Clause - thyroid tumors in rats).
Japan (MHLW)
Approved as synthetic colour with purity specifications
Acceptable Daily Intake (ADI)
International Standard (JECFA)
mg/kg body weight per day
European Standard (EFSA)
Everyday Perspective
For a 60kg adult, this limit is roughly equivalent to consuming:
Natural Occurrence
This additive is not known to occur naturally in significant quantities.
Manufacturing
Resorcinol reacts with phthalic anhydride through condensation to form fluorescein. The fluorescein undergoes iodination to introduce four iodine atoms at positions 2, 4, 5, and 7, producing the bright cherry-red dye. It is then converted to the disodium salt (Erythrosin B) for water solubility.
Applications Beyond Food
BANNED in USA since 1990; limited EU use
Tablet/capsule coatings; diagnostic procedures
Textile dyeing (limited)
Dental disclosing tablets (plaque visualization)