Azorubine

Azorubine (E122), also known as Carmoisine, is a synthetic red azo dye used to produce dark red and purplish-red shades in food products. It is the disodium salt of 4-hydroxy-3-(4-sulfo-1-naphthalenyl)azo-1-naphthalenesulfonic acid, water-soluble with good stability across a wide pH range. Common applications include confectionery, marzipan, glacé cherries, packet soups, certain jams, and preserved fruit products where a deep red appearance is desired.

JECFA evaluated Azorubine in 1965 and established an ADI of 0–4 mg per kg body weight per day, equivalent to 240 mg daily for a 60 kg adult. This evaluation is among the earliest in JECFA food colour assessments and has not been substantially updated since. No EFSA ADI value for Azorubine is recorded in the EFSA OpenFoodTox 3.0 database.

Azorubine is one of the six food colours subject to the EU mandatory warning label under Regulation (EC) 1333/2008 Annex V — "may have an adverse effect on activity and attention in children" — following the 2007 Southampton study (McCann et al., The Lancet) which associated a mixture of azo food colours with increased hyperactivity in children. Azorubine is not permitted in the United States, Canada, or Japan, but is approved for use in the EU and Australia. Its use in Europe has declined as manufacturers reformulate to avoid the warning label obligation.