Ponceau 4R | whatsinit

About

What it is and where it shows up.

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

The regulatory and scientific consensus.

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

What food-safety regulators have decided.

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 Following the 2009 EFSA opinion, 24 maximum permitted levels were withdrawn and 29 were reduced by factors of 1.2–200, with amendments applicable from 1 June 2013.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

Whose guidance would steer them away.

Children — The 2007 Southampton study (McCann et al.) linked a mixture including Ponceau 4R to significantly increased hyperactivity in 3-year-old children; the EU mandates a consumer warning on products containing E124 stating it 'may have an adverse effect on activity and attention in children', and EFSA found that intake in children aged 1–10 exceeded the ADI even after revised permitted levels.

Other — EFSA's ANS Panel noted that sensitive individuals — including those prone to hypersensitivity or intolerance reactions (e.g., asthma, urticaria) — may react to Ponceau 4R even at dose levels within the ADI, particularly when consumed in mixtures with other synthetic colours.

Research citations

The sources behind this verdict.

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

Independently researched6 citations