Safety grading ORANGE – SOME CONCERNS
Why ORANGE? Allura Red AC (E129), also known as FD&C Red No. 40 in the United States, is a bright red azo dye used extensively in beverages, confectionery, dairy desserts, baked goods, and pharmaceuticals. Major regulators, including the European Food Safety Authority (EFSA), the U.S. Food and Drug Administration (FDA), and WHO/JECFA, have reviewed the overall toxicology and determined that E129 is safe at permitted use levels. The established Acceptable Daily Intake (ADI) is commonly cited as 0–7 mg/kg body weight/day.
Nonetheless, Allura Red remains controversial for two main reasons. First, like several other synthetic colours, it was part of the 2007 “Southampton study,” which reported an association between mixtures of certain colours plus sodium benzoate and increased hyperactivity in children. While the study design limits firm conclusions about any single dye, the findings prompted the European Union’s precautionary warning label on foods containing these colours: “may have an adverse effect on activity and attention in children.” Second, a small fraction of consumers experience intolerance reactions – such as hives, rashes, or angioedema – especially among those with asthma or aspirin sensitivity. These reactions are uncommon but real, and they motivate some shoppers and brands to prefer natural colour alternatives.
Given the combination of broad regulatory approval and persistent debate – especially around child behaviour and rare allergic-type responses E129 is best graded ORANGE (some concerns) for this project. It is legally allowed and considered safe within current limits, yet many consumers intentionally moderate intake or choose products coloured with beetroot red (E162), carmine (E120), or paprika extract (E160c) to avoid synthetic dyes.
Should You Avoid Allura Red AC?
Most people do not need to avoid E129 when it is consumed within regulatory limits as part of a varied diet. Parents who are concerned about potential effects on behaviour may prefer to limit brightly coloured sweets and drinks or select products that use natural colourants. Individuals with a history of asthma, aspirin sensitivity, chronic hives, or known dye allergies may benefit from vigilance and label checking. If you suspect sensitivity, consider an elimination and re‑challenge approach with advice from a healthcare professional.
Common Uses
- Soft drinks, sports/energy drinks, powdered beverage mixes (vivid red hues).
- Confectionery: gummies, hard candies, chewing gum, icings, frostings.
- Baked goods and dessert mixes; gelatins and puddings.
- Dairy: flavoured milks, yoghurts, and ice creams.
- Savoury snacks and seasoning blends for red/orange shades.
- Pharmaceuticals and supplements: syrups, chewables, and capsule coatings.
- Cosmetics/personal care, e.g., bath products and occasional lip products.
Common names / Synonyms
- Allura Red AC
- E129; INS 129
- FD&C Red No. 40; Red 40 (US)
- C.I. 16035
What is Allura Red AC?
Chemistry: Allura Red AC is a water‑soluble, sulfonated azo dye. The colour arises from its azo bond (–N=N–) linking aromatic rings, which stabilises a conjugated electronic system that strongly absorbs visible light to produce a vivid red hue. In commercial form it is typically the disodium salt of 6‑hydroxy‑5‑[(2‑methoxy‑5‑methyl‑4‑sulfophenyl)azo]‑2‑naphthalenesulfonic acid. As with other synthetic dyes, the salt form improves solubility and handling in aqueous foods and syrups.
How it’s made: Industrial manufacture starts with petroleum‑derived aromatic precursors that are diazotised and then coupled to build the azo linkage. Subsequent neutralisation steps yield the disodium salt, followed by purification (filtration, decolorisation, deionisation) and spray‑drying to a standardised powder or granule. Modern specifications strictly limit impurities such as unreacted intermediates and subsidiary dyes to meet Codex/EFSA/FDA purity criteria.
Functional properties: E129 provides bright red to orange tones depending on concentration and matrix, and it blends well with yellows (e.g., tartrazine, E102) or blues (e.g., Brilliant Blue FCF, E133) to create a wide palette. It is generally stable to heat, light, and acidic pH, making it a go‑to for soft drinks, candies, and baked goods. Like many azo dyes, it performs less well in strongly alkaline environments and may fade in formulations with high reducing potential.
Biotransformation & exposure: After ingestion, intestinal microflora can reduce azo bonds, forming aromatic amine metabolites that are subsequently conjugated and excreted in urine/feces. Regulatory toxicology focuses on ensuring these metabolites do not present genotoxic or carcinogenic hazards at permitted exposure levels. Population exposure assessments typically find that average intakes are below the ADI, though high consumers of dyed beverages/sweets could approach it, especially in children – one reason for the EU’s warning requirement.
Safety landscape: Decades of studies (acute, subchronic, chronic, genotoxicity, and reproductive) underpin current approvals. EFSA’s 2009 re‑evaluation maintained the ADI at 7 mg/kg bw/day. The FDA also lists Red 40 as approved, with mandatory label declaration. While the totality of evidence does not demonstrate harm at authorised levels, the precautionary stance regarding child behaviour and rare hypersensitivity justifies consumer choice toward moderation or alternatives.
Where it’s allowed (EU vs US)
EU: Authorised as E129 with ADI 0–7 mg/kg bw/day, foods containing certain azo dyes (including Allura Red) must carry the warning about potential effects on children’s activity and attention.
US: Approved as FD&C Red No. 40, explicit declaration on labels is required.
Elsewhere: Historical national bans (e.g., in parts of Europe) have largely been harmonised. Today E129 is widely permitted with usage limits and purity specifications.
Further reading
- European Commission additive entry (direct): Allura Red AC — E129
- EFSA re‑evaluation (2009): Scientific Opinion on Allura Red AC
- Wikipedia overview: Allura Red AC
- PubMed search: allura red