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

SCCS. Electronic address: SANTE-SCCS@ec.europa.eu; SCCS Members; SCHEER Member; SCCS External Expert

doi:10.1016/j.yrtph.2023.105365

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

Regul Toxicol Pharmacol. 2023 Mar:139:105365. doi: 10.1016/j.yrtph.2023.105365. Epub 2023 Mar 1.

Authors

SCCS. Electronic address: SANTE-SCCS@ec.europa.eu¹; SCCS Members; SCHEER Member; SCCS External Expert

Collaborators

Affiliations

¹ SCCS Secretariat at the European Commission, Directorate General for Health and Food Safety, Unit B3 - Drosbach Building, L-2920, Luxembourg.
² National and Kapodistrian University of Athens, School of Pharmacy, Division of Pharmaceutical Chemistry, Athens, Greece.
³ Federal Institute for Risk Assessment (BfR), Berlin, Germany.
⁴ Alternative Energies and Atomic Energy Commission (CEA), Saclay, France.
⁵ Institute of Food Science & Innovation, University of Chester, United Kingdom.
⁶ University Medical Center Groningen, Groningen, the Netherlands.
⁷ Norwegian Institute for Air Research (NILU), Kjeller, Norway.
⁸ Institute Jean Lamour (UMR 7198 CNRS Université de Lorraine), Nancy, France.
⁹ French Agency for Food, Environmental and Occupational Health & Safety (ANSES), Maisons-Alfort, France.
¹⁰ Qsar Lab Ltd., Gdańsk, Poland.
¹¹ RIVM, Centre for Safety of Substances and Products (VSP), Centre for Substances and Integrated Risk Assessment (SIR), Bilthoven, the Netherlands.
¹² Center for Health Protection, National Institute for Public Health (RIVM), Bilthoven, the Netherlands.
¹³ Federal Office of Public Health (FOPH), Switzerland.

PMID: 36868343
DOI: 10.1016/j.yrtph.2023.105365

Abstract

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%.

Keywords: CAS 919803-06-8; EC No. 485-100-6; HAA299; Nano; Regulation 1223/2009; SCCS; Scientific opinion.

Publication types

Review

MeSH terms

Consumer Product Safety*
Cosmetics* / toxicity
Humans
Piperazines
Risk Assessment
Skin

Substances

Cosmetics
Piperazines