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Tuesday, January 17, 2023SCCS

Hydroxyapatite (nano): new preliminary Opinion of the SCCS

Hydroxyapatite (nano) : nouvelle Opinion préliminaire du CSSC

Following an initial negative opinion from the SCCS, and the submission of new data by industry to defend its use in oral products, Hydroxyapatite (nano) has undergone a new safety assessment. The Scientific Committee has now published its conclusions, which are open for comment until 1 March 2023.

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In December 2021, the SCCS having considered the data submitted via the CPNP, additional data requested from the Responsible Persons and other relevant information available in scientific literature, could not conclude on the safety of the Hydroxyapatite (nano) composed of rod-shaped nanoparticles for use in oral cosmetic products at the maximum concentrations and specifications reported. Furthermore, the SCCS stressed that the available data/information is not sufficient to exclude concerns over the genotoxic potential of Hydroxyapatite (nano).
In February 2022, industry submitted additional information to support the safety of Hydroxyapatite (nano) in oral products, specifically addressing the potential genotoxicity of Hydroxyapatite (nano).

For an exhaustive background information, see the articles
Hydroxyapatite: Final Opinion of the SCCS, CosmeticOBS, 20 April 2021
Hydroxyapatite: new request for Opinion to the SCCS, CosmeticOBS, 21 March 2022


1. In view of the above, and taking into account the scientific data provided, does the SCCS consider 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?

Based on the data provided, the SCCS considers hydroxyapatite (nano) as safe when used at concentrations …

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