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 final conclusions. They were adopted at its plenary meeting on 21-22 March 2023.
Background
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).
The CSSC published its Preliminary Opinion in January 2023.
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
• Hydroxyapatite (nano): new preliminary Opinion of the SCCS, CosmeticOBS, 17 January 2023
The SCCS preliminary Opinion was subject to a commenting period of seven weeks after its initial publication (from 11 January to 1 March 2023). There were no comments received, therefore the final opinion was not changed comparing to its preliminary …
