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November 22, 2023

EC Asks SCCS to Assess Safety of Hydroxyapatite (Nano) in View of New Information

Lynn L. Bergeson Carla N. Hutton

On November 20, 2023, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) announced that the EC requested that it carry out a safety assessment on hydroxyapatite (nano) in view of new information provided. As reported in our March 24, 2023, blog item, according to SCCS’s March 2023 final opinion on hydroxyapatite (nano), based on the data provided, SCCS considers hydroxyapatite (nano) safe when used at concentrations up to ten percent in toothpaste, and up to 0.465 percent in mouthwash. The EC’s request for a scientific opinion states that following a regulatory proposal by the EC services to restrict the use of hydroxyapatite (nano) in cosmetics, “industry submitted evidence to demonstrate its safety at higher concentrations in oral products.” The EC asks SCCS to answer whether it considers hydroxyapatite (nano) safe when used in toothpaste up to a maximum concentration of 29.5 percent and in mouthwash up to a maximum concentration of ten percent according to the specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions; what is the maximum concentration considered safe for use of hydroxyapatite (nano) in cosmetic products; and whether SCCS has any further scientific concerns with regard to the use of hydroxyapatite (nano) in oral cosmetic products. The deadline for SCCS’s opinion is nine months.