SCCS OPINION on HAA299 (nano) - SCCS//1634/21 - Preliminary Opinion

SCCS OPINION on HAA299 (nano) - SCCS//1634/21 - Preliminary Opinion U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven, W.H. de Jong, N. von Goetz The SCCS adopted this document by written procedure on 22 July 2021 (60 Pages) Mise en ligne le 23 Juillet 2021 https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_256.pdf Conclusion of the opinion: (1) In light of the data provided, does the SCCS consider HAA299 (nano) safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10%? The available data indicate that HAA299 (nano) is a practically insoluble material, with very low dermal absorption. Due to the very low systemic availability, the material is unlikely to exert systemic genotoxic or reproductive effects. The NOAEL of 1000 mg/kg/day indicates that the material is of overall low toxicological concern. Given the low dermal penetration, and low systemic toxicity, the calculation of margin of safety (MoS) is not appropriate in this case, and the SCCS considers that HAA299 (nano) as covered within the provided characteristics (median particle size in terms of particle number above 50 nm with a similar particle size distribution) is safe when used as a UV-filter in dermally-applied cosmetic products up to a maximum concentration of 10%. Based on the inflammatory effects on the lung after the acute inhalation exposure, the SCCS has concerns regarding the repeated use of products containing HAA299 (nano) in applications that could lead to inhalation exposure. Therefore, the SCCS does not recommend the use of HAA299 (nano) in applications that could lead to inhalation exposure. (2) In view of the previous SCCS opinion (SCCS/1533/14) does the SCCS consider HAA299 non-nano and nano form safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10%? The data considered in this Opinion has not provided any new or additional concern that merits a revision of the previous SCCS opinion (SCCS/1533/14). Therefore, the SCCS considers HAA299, either as non-nano or nano form, safe when used as a UV-filter in dermally-applied cosmetic products up to a maximum concentration of 10%. The SCCS considers that the combined maximum concentration of non-nano and nano forms of HAA299 should not exceed 10% in a cosmetic product. (3) In case the SCCS finds HAA299 (nano) not safe, does it still uphold the conclusions of the SCCS/1533/14 opinion with regard to the safe use of HAA299 non-nano form? / (4) Does the SCCS have any further scientific concerns (on human health) with regard to the use of HAA299 (nano) in cosmetic products? This opinion is based on the currently available scientific evidence, which shows an overall very low or lack of dermal absorption of HAA299 (nano) in human skin. If any new evidence emerges in the future to show that HAA299 (nano) used as UV-filter in cosmetic products can penetrate human skin (healthy, compromised, sunburnt or damaged skin) to reach viable cells, in higher levels than demonstrated in this submission, then the SCCS may consider revising this assessment. Keywords: SCCS, scientific opinion, HAA299, nano, CAS 919803-06-8, EC No. 485-100-6, Regulation 1223/2009 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on HAA299 (nano), 22 July 2021, SCCS/1634/2021.