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Cochineal Extract is permitted by the US FDA. Several countries restrict, warning-label, or have reviewed it for safety concerns. The US has more lenient additive rules than the EU, UK, Canada, and Japan, which is why this ingredient remains widely used here.
Cochineal extract and carmine are associated with potentially severe allergic reactions, including anaphylaxis. The FDA received multiple adverse event reports, and in 2009 issued a final rule requiring cochineal extract and carmine to be declared by name on food labels (rather than being permitted under 'artificial color'). EFSA confirmed its safety in 2015 but acknowledged allergic risk. Vegans and those following halal or kosher diets should avoid it as it is insect-derived.
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