Publicação
SCCS - Scientific Opinion on Hydroxyapatite (nano) - Submission IV
| dc.contributor.author | European Commission. Scientific Committee on Consumer Safety (SCCS) | |
| dc.date.accessioned | 2026-02-09T15:48:11Z | |
| dc.date.available | 2026-02-09T15:48:11Z | |
| dc.date.issued | 2025-06-01 | |
| dc.description | SCCS External Experts: N. von Goetz, H. Louro. | |
| dc.description | Adopted on: 26 June 2025 | |
| dc.description.abstract | The SCCS concludes the following: (1) In view of the above, and taking into account the scientific data provided, does the SCCS consider Hydroxyapatite (nano) safe when used in toothpaste up to a maximum concentration of 29.5% and in mouthwash up to a maximum concentration of 10% according to the specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions? Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5% in toothpaste, and up to 10% in mouthwash. This conclusion is based on the available evidence, which shows that hydroxyapatite (nano) does not pose a mutagenic hazard or cytotoxicity or inflammatory effects even when tested at high concentrations in a buccal mucosa cell model. Any uptake of hydroxyapatite (nano) by buccal mucosa is considered negligible, and the epithelial cells with internalised particles will be shed out over time as they are continually replaced. Also, any unintentionally ingested HAP nanoparticles during the use of oral-care products will undergo rapid dissolution in the gastric fluid and therefore do not raise any nano-specific concern over safety. This safety evaluation only applies to the hydroxyapatite (nano) that have the following characteristics: - composed of rod-shaped particles of which at least 87% (in particle number) have aspect ratios equal to or less than 3, and the remaining 13% have aspect ratios not exceeding 9. - the HAP particles are not coated or surface modified. - the Opinion is related to HAP particles with max length of the HAP nanoparticles in the present Opinion, i.e. 122 ± 43 nm. 1. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Hydroxyapatite (nano) in cosmetic products? / 2. Does the SCCS have any further scientific concerns with regard to the use of Hydroxyapatite (nano) in oral cosmetic products? This Opinion is not applicable to any hydroxyapatite (nano) material that is composed of or contains needle-shaped particles. | eng |
| dc.identifier.citation | https://health.ec.europa.eu/publications/sccs-scientific-opinion-hydroxyapatite-nano-submission-iv | |
| dc.identifier.uri | http://hdl.handle.net/10400.18/10870 | |
| dc.language.iso | eng | |
| dc.peerreviewed | yes | |
| dc.publisher | European Commission | |
| dc.relation.hasversion | https://health.ec.europa.eu/publications/sccs-scientific-opinion-hydroxyapatite-nano-submission-iv | |
| dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
| dc.subject | Hydroxyapatite (nano) | |
| dc.subject | Environmental Genotoxicity | |
| dc.subject | Cosmetic Ingredients | |
| dc.subject | Safety Assessment | |
| dc.subject | Genotoxicidade Ambiental | |
| dc.title | SCCS - Scientific Opinion on Hydroxyapatite (nano) - Submission IV | eng |
| dc.type | report | |
| dspace.entity.type | Publication | |
| oaire.citation.endPage | 112 | |
| oaire.version | http://purl.org/coar/version/c_970fb48d4fbd8a85 |