SCCS scientific opinion on HAA299 (nano) - SCCS/1634/21.

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on HAA299 (nano), preliminary opinion July 22, 2021, final opinion 26-27 October 2021, SCCS/1634/2021. HAA299 is a UV filter active intended to be used in sunscreen products as skin protectant against UVA-1 rays. Its chemical name is '2-(4-(2-(4-Diethylamino-2 hydroxy-benzoyl)-benzoyl)-piperazine-1-carbonyl)-phenyl)-(4-diethylamino-2-hydroxyphenyl)-methanone' and INCI name 'Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine' (CAS 919803-06-8). This product was designed and developed to deliver to the consumer stronger UV protection on skin and is most effective as a UV filter when it is milled to a smaller particle size, a process we refer to as micronization. Currently HAA299 normal form and nano form is not regulated under the Cosmetic Regulation (EC) No. 1223/2009. In 2009, Commission' services received a dossier from industry to support the safe use of HAA299 (micronised and non-micronised) in cosmetic products, which was further substantiated with additional information in 2012. In its corresponding opinion (SCCS/1533/14), the SCCS concluded that "the use of non-nano HAA299 (micronised or non-micronised, with median particle size distribution around 134 nm or larger, as measured by FOQELS) at a concentration up to 10% as an UV-filter in cosmetic products, does not pose a risk of systemic toxicity in humans". In addition, SCCS stated that "[the Opinion] … covers the safety evaluation of HAA299 in non-nano form. The opinion does not cover the safety evaluation of HAA299 which is composed of nano particles' and highlighted that '[the Opinion] … does not apply to inhalation exposure of HAA299 since no information on chronic or sub-chronic toxicity after inhalation is provided". With the current submission, received in September 2020, and in view of the previous SCCS opinion (SCCS/1533/14) on the normal form of HAA299, the applicant requests to assess the safety of HAA299 (nano) intended to be used as UV-filter up to a maximum concentration of 10%.