About
Ponceau 4R is a synthetic azo dye that imparts a bright red-to-scarlet colour to food and beverages. It is used in soft drinks, desserts, confectionery, sauces, seasonings, pickles, and flavoured dairy products.
Safety summary
EFSA lowered the ADI for Ponceau 4R from 4 mg/kg bw/day to 0.7 mg/kg bw/day in 2009, citing a NOAEL from a chronic mouse study and evidence that population intake at maximum permitted levels exceeded the ADI, especially in children. The 2007 Southampton study linked a mixture including Ponceau 4R to increased hyperactivity in 3-year-old children, prompting EU mandatory warning labelling. Recent in vitro genotoxicity studies in human lymphocytes found chromosomal damage at high concentrations, though regulators have not yet revised safety conclusions.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| MHLW (Ministry of Health, Labour and Welfare) (Japan) | Banned | Japan does not permit Ponceau 4R for use in food or drinks. Cited among countries that have prohibited synthetic azo dyes including Ponceau 4R to reduce potential health risks.source |
| FDA (Food and Drug Administration) (United States) | Banned | Ponceau 4R (C.I. Acid Red 18, C.I. 16255) has no certifiable equivalent in the USA and is explicitly listed by FDA as a colour additive not approved for use in food products in the United States. FDA has reported recalls for the presence of Ponceau 4R as an unapproved colour additive (e.g., in strawberry filling) and classifies it as 'non-permitted' on import alerts.source |
| EFSA (European Food Safety Authority) (European Union) | Restricted | Permitted in 31 food categories under Regulation (EC) No 1333/2008, Annex II. Following the 2009 EFSA opinion, 24 maximum permitted levels were withdrawn and 29 were reduced by factors of 1.2–200, with amendments applicable from 1 June 2013. Products containing E124 must bear the warning 'may have an adverse effect on activity and attention in children' per Regulation (EC) No 1129/2011. Maximum permitted levels range from 1 to 200 mg/kg depending on food category.source |
Who should approach with care
Research citations
- 1WHO. JECFA evaluation of Ponceau 4R – WHO Food Additives and Contaminants Database. apps.who.int
- 2PubMed. Do the azo food colorings carmoisine and ponceau 4R have a genotoxic potential?, 2025. pmc.ncbi.nlm.nih.gov
- 3PubMed. Food Safety and Health Concerns of Synthetic Food Colors: An Update, 2024. pmc.ncbi.nlm.nih.gov
- 4FDA. FDA Compliance Program Guidance Manual – Surveillance of Imported and Domestic Foods for Colour Additives, 2019. fda.gov
- 5EFSA. Refined exposure assessment for Ponceau 4R (E 124), 2015. efsa.europa.eu
- 6EFSA. Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive, 2009. efsa.europa.eu
