Azorubine E122
synthetic — Primarily synthetic.
Disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)azo]-1-naphthalenesulfonate
CAS: 3567-69-9
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.
? Did You Know?
Beyond food, Azorubine is also used in cosmetics, medicine, industrial applications. Its versatility makes it one of the most multi-purpose chemical compounds in everyday life.
Regulatory opinions differ: Azorubine 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 ~2.4 litres of soft drink (at 100mg/kg max level) in a single day. (This is a mathematical illustration, not a safety recommendation.)
Regulatory Analysis
Azorubine's regulatory trajectory reveals how a single study can bifurcate global food color policy. The 2007 Southampton findings implicating E122 in childhood hyperactivity led the EU to mandate warning labels rather than ban the dye, creating a disclosure-based regime that contrasts sharply with the US approach of never authorizing it in the first place. The EU's choice of labeling over prohibition effectively created a natural experiment in whether informed consumer choice or regulatory gatekeeping is the more appropriate response to behavioral endpoints that fall short of classical toxicological harm.
Detailed Regulatory Assessment
European Union (EFSA)
Must carry warning: 'May have an adverse effect on activity and attention in children' (since 2010)
Official EFSA LinkUnited States (FDA)
Never authorized for use in foods, drugs, or cosmetics. Import of products containing E122 prohibited.
Japan (MHLW)
Approved as synthetic colour with purity specifications and maximum use levels
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
Synthesized through diazotization of naphthalene-4-sulfonic acid, followed by azo coupling with 1-naphthol-4-sulfonic acid. The resulting azo compound is converted to the disodium salt form, purified, and standardized to food-grade specifications.
Applications Beyond Food
Used in EU-approved cosmetics (lipsticks, eyeshadows) but restricted in some jurisdictions
Pharmaceutical tablet coatings and capsules
Historically used as textile dye before food applications