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March 23, 2022

EC Requests SCCS for a Scientific Opinion on “Hydroxyapatite (Nano)”

Lynn L. Bergeson Carla N. Hutton

On March 17, 2022, the European Commission (EC) requested that the Scientific Committee on Consumer Safety (SCCS) prepare a scientific opinion on “hydroxyapatite (nano).” As reported in our April 13, 2021, blog item, SCCS issued a final opinion in 2021 stating that having considered the data provided, and other relevant information available in scientific literature, it “cannot conclude on the safety of the hydroxyapatite composed of rod-shaped nanoparticles for use in oral-care cosmetic products at the maximum concentrations and specifications given in this Opinion.” This is because the available data and information are not sufficient to exclude concerns over the genotoxic potential of hydroxyapatite (nano). According to the EC, in February 2022, industry submitted additional information to support the safety of hydroxyapatite (nano) in oral products, specifically addressing its potential genotoxicity. The EC asks whether SCCS considers hydroxyapatite (nano) safe when used in oral cosmetic products according to the maximum concentrations and specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions. The EC also asks if SCCS has any further scientific concerns with regard to the use of hydroxyapatite (nano) in oral cosmetic products. The deadline for the scientific opinion is six months.