Is Blue Dye 1 banned?

Countries where Blue Dye 1 is banned or restricted

Why Blue Dye 1 is flagged

Blue Dye 1 was historically banned in several European countries before EU harmonization permitted it (as E133). EFSA's 2010 comprehensive safety re-evaluation found no evidence of carcinogenicity in standard animal tests. The ADI was set at 6 mg/kg body weight. The most significant documented safety concern for Blue 1 involves intravenous/enteral administration rather than dietary intake. In 2003, the FDA issued a Public Health Advisory warning against using Blue 1 (used as a food coloring agent in enteral nutrition formulas to detect aspiration in critically ill patients) after multiple case reports — including deaths — documented that Blue 1 can be absorbed through damaged intestinal mucosa and cause cardiovascular instability, metabolic acidosis, and death. The FDA advisory specifically warned against this clinical use in intensive care patients. This is a medical use concern, not a dietary intake concern. For healthy consumers eating normally, EFSA found no significant safety concerns at food use levels. Blue 1 was not included in the 2007 Lancet hyperactivity study. However, it falls under the FDA's April 2025 announcement to phase out all petroleum-based synthetic food dyes, reflecting updated policy on the class as a whole rather than specific Blue 1 data. Historically, Blue 1 was banned in multiple European countries due to safety concerns, though EU harmonization later permitted it with E-number labeling requirements. This history suggests precautionary concern even when formal regulatory action was not sustained.