U.S. Food and Drug Administration (FDA)

The FDA lists TiO2 as an allowed color additive used in coloring products, including cosmetics and personal care products, provided it meets certain specifications. It is also an approved colorant for food, drugs and medical devices. In addition, the FDA includes it on a list of indirect food additives. For example, it may be used as a colorant in food contact packaging materials.

Sunscreens are regulated by the FDA as non-prescription, over-the-counter (OTC) drugs through a monograph system, which establishes various requirements for the product to be sold in the U.S. A monograph specifies the types of ingredients, dosage forms, testing methods, labeling requirements, and other related details for a product category, such as sunscreens. If a manufacturer follows the sunscreen monograph, its sunscreen products do not require separate FDA pre-approval before they can be sold in the U.S.

While the FDA proposed an Administrative Order on Sept. 27, 2021, that would amend conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE), the GRASE status for TiO2 is not expected to change once the proposed Administrative Order is finalized.

Because TiO2 is derived from minerals that are mined from the earth, it may contain small, trace amounts of heavy metals such as lead or cadmium. The levels of heavy metals in the TiO2 that is used in cosmetic and personal care products are tightly regulated by the FDA. Any tiny amount that may eventually be in cosmetics or personal care products does not pose a risk to human health.

Expert Panel for Cosmetic Ingredient Safety

The Expert Panel for Cosmetic Ingredient Safety (Expert Panel) has deferred evaluation of this ingredient because the safety has been assessed by the FDA. This deferral follows the Expert Panel’s procedures.

TiO2 is allowed as a cosmetics colorant without restrictions when purity requirements are fulfilled (Annex IV, entry 143). When used as a colorant in cosmetics products in the European Union, this ingredient is labelled as CI 77891. TiO2 is also approved as a sunscreen active ingredient (Annex VI, entries 27 and 27a).

Based on an opinion of the Scientific Committee on Consumer Safety (SCCS), in May 2021, Annex III, entry 321 of the EU cosmetics regulation was amended to restrict the use of powdered TiO2 in powder face products and in hair aerosol spray products. For all other product types, this form of TiO2 should not be used in applications that may lead to inhalation. A reference to these restrictions of titanium dioxide under Annex III was added in the relevant entries of TiO2’s Annex IV colorant and Annex VI sunscreen ingredient approved uses.