Ingredient register

Erythrosine

Avoid Carcinogen Food and drink E127 INS 127 CAS 16423-68-0

Decode Label flags Erythrosine as a high concern in food and drink (carcinogen). It appears in 2 of the 893 published products we have analysed (0.2%).

The concern

Synthetic red dye — US FDA revoked its food authorisation in 2025 after cancer in male rats; still permitted in India

Erythrosine (FD&C Red No. 3) is a synthetic xanthene dye used to give sweets, drinks and bakery items a bright cherry-red colour. On 15 January 2025 the US FDA revoked its authorisation for food and ingested drugs under the Delaney Clause, which bars any food additive shown to induce cancer in humans or animals — the petition cited studies showing it caused cancer in male rats. The FDA stated that the way it causes cancer in male rats does not occur in humans; the revocation followed from the law once the animal finding was established, and food manufacturers have until 15 January 2027 to reformulate. FSSAI still permits it (INS 127) at up to 100-200 ppm depending on the food category, so it remains legal and in circulation in India — including in strawberry milkshakes, candies and chewing gum.

Most relevant to

Anyone eating this regularly Children

Cited authority

US FDA order, 15 Jan 2025 (Delaney Clause revocation); FSSAI INS 127

Linked sources: FDA →

How common it is in this catalogue

Measured across every product Decode Label has analysed — not estimated, and not taken from anyone else's dataset.

2 of 893 published products 0.2%

By category

Oral Care 1
Food 1

Hazard classification

FDA FDA order (15 Jan 2025) — revoked under the Delaney Clause; induces cancer in male rats Carcinogen route: oral 2025-01-15 source →

A full revocation for food and ingested drugs, not a concentration limit. The Delaney Clause bars authorisation of any food additive shown to induce cancer in humans or animals, regardless of the human risk margin.

Identity

Canonical name
Erythrosine
CAS number
16423-68-0
E number
E127
INS number
127

Also appears on labels as

FD&C Red No. 3 Red 3 Red Dye 3 CI 45430

Questions

Is Erythrosine safe?

FDA: FDA order (15 Jan 2025) — revoked under the Delaney Clause; induces cancer in male rats. Why it is flagged: Synthetic red dye — US FDA revoked its food authorisation in 2025 after cancer in male rats; still permitted in India. Decode Label treats it as a high concern in food and drink. It appears in 2 of the 893 published products we have analysed (0.2%).

How common is Erythrosine in Indian packaged products?

Decode Label found Erythrosine in 2 of 893 published products (0.2%), most often in Oral Care, Food.

Which authorities have classified Erythrosine?

FDA — FDA order (15 Jan 2025) — revoked under the Delaney Clause; induces cancer in male rats.

Who should be most careful with Erythrosine?

Anyone eating this regularly; Children.

Products containing Erythrosine

2 published products, each with its own full analysis.

Related ingredients

Other entries in the register with the same kind of concern.

Method and limits

  • Prevalence counts published products whose decoded ingredient list matches this substance or one of its label synonyms, using the same matching the score itself uses. It describes our catalogue of 893 products, not the Indian market as a whole.
  • Presence is not dose. An ingredient list gives order, not quantity, unless the pack declares a percentage. Nothing here estimates how much of this substance any product contains.
  • A classification is not a verdict on a product. An agency classifies a substance under defined conditions of exposure; whether that matters in a given food or cosmetic depends on route, concentration and use.
  • No regulatory rows. This substance is not matched in our regulatory warehouse, so the concern above rests on the cited authority alone.
  • Last updated. This register entry was last changed on 7 October 2026.
  • Corrections. Every figure here is reproducible from the sources named. If something is wrong, tell us and we will correct it and say what changed.