CI 61565.

CI 61565 is a colorant, not an active ingredient, so the concept of 'dusting' related to insufficient active concentration is not applicable. While no general maximum concentration for cosmetics is specified, safety notes indicate potential concerns regarding toxicity and carcinogenicity at exceptionally high concentrations. Specific use cases, such as contact lenses (up to 0.03% by weight) and surgical sutures (up to 0.75% by weight), have defined limits.

The Cosmetic Ingredient Review (CIR) Expert Panel has deferred its evaluation of CI 61565, acknowledging that the U.S. Food and Drug Administration (FDA) has already assessed its safety. The FDA permits its use for coloring externally applied cosmetics, with the explicit exclusion of products intended for the lips or eye area, and externally applied drugs. All CI 61565 utilized in U.S. products undergoes mandatory FDA certification. Within the European Union, it is included in Annex IV of the Cosmetics Regulation, allowing its use in all cosmetic and personal care items under general provisions. However, specific global regulations or restrictions may apply, with some regions prohibiting its use in hair coloring products and others citing concerns about potential toxicity or carcinogenicity at high concentrations or through extended exposure. Low irritancy is noted by INCIDecoder.