Barium Sulfate

Barium sulfate (CAS 7727-43-7) is permitted in the EU under Annex IV Entry 122 with no concentration cap and approved for all product types. In the US, it is delisted as a color additive but may be used under the opacifying agent function. CIR (2018) concluded it is safe in present practices of use and concentration when formulated to be non-irritating. The compound has negligible dermal absorption due to its water-insoluble nature. For spray and powder formulations, particle size control is critical (95-99% of particles should exceed 10 μm aerodynamic diameter). Cosmetic-grade material must be verified against heavy metal purity specifications for lead, arsenic, and chromium.

FDA delisted barium sulfate as a color additive and it is no longer authorized under color additive regulations (21 CFR Part 82). If used in US cosmetics, should be positioned under opacifying agent function rather than as a color additive to avoid regulatory conflict. CIR Final Report (June 2014, published IJT 2018) assessed it as safe at current use concentrations with the condition that formulation must be non-irritating.