Opinion of the Scientific Committee on Consumer Safety (SCCS) - Revision of the Opinion on hydroxyapatite (nano) in cosmetic products.
Level 5 - mechanism / opinion, no new human data
Regulatory committee expert opinion and narrative safety assessment
PubMed 30125613 · doi:10.1016/j.yrtph.2018.07.018
What was done
The Scientific Committee on Consumer Safety (SCCS) conducted a safety assessment evaluating data from industry submissions and published scientific literature regarding the absorption, cellular entry, and potential toxicity of hydroxyapatite (nano) when used in oral cosmetic products.
What was found
The abstract reports no quantitative statistical metrics. SCCS determined that needle-shaped hydroxyapatite (nano) poses potential toxicological concerns and should not be used in cosmetic products. For non-needle shapes of hydroxyapatite (nano), the committee concluded that available evidence was insufficient to determine safety in oral cosmetic products at concentrations up to 10%.
Why it matters
This evaluation provides key regulatory guidance distinguishing the safety profile of specific nanoparticle morphologies in consumer dental and oral care formulations.
Limits
The abstract provides no quantitative exposure or toxicity thresholds, sample sizes, or specific toxicological endpoints evaluated. Conclusions for non-needle morphologies remain unresolved due to insufficient available data.
Cited by
- contradicts European safety regulators withheld approval of nanohydroxyapatite for approximately 12 years due to concerns regarding calcification buildup in arteries.