SCCS opinion on Hydroxyapatite (nano) - SCCS 1648/22 – Final Opinion
Résumé
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 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) safe when used
at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash.
This safety evaluation only applies to the hydroxyapatite (nano) with the following
characteristics:
- composed of rod-shaped particles of which at least 95.8% (in particle number) have an
aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9;
- the particles are not coated or surface modified.
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 hydroxyapatite (nano) composed of needle-shaped
particles.
Although the use of hydroxyapatite (nano) is indicated also for breath spray, no data were
provided to allow assessment of consumer safety from inhalation exposure. Therefore,
this Opinion is not applicable to sprayable products that might lead to exposure of the
consumer’s lungs to nanoparticles by inhalation.
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