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

International audienceSCCS OPINION on HAA299 (nano) - SCCS/1634/21 – Final OpinionU. 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 GoetzThe SCCS adopted this document at its plenary meeting on 26 and 27 October 2021 (60 Pages)Mise en ligne le 25/11/2021https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_256.pdfConclusion 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 and oral 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. The SCCS considers that HAA299 (nano) as covered within the provided characteristics (minimum purity equal to or above 97%, median particle size in terms of particle number equal to or above 50 nm) 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 exposure of the consumer’s lungs via inhalation.(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 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on HAA299 (nano), preliminary opinion 22 July 2021, final opinion 26-27 October 2021, SCCS/1634/2021

"Solubility of Synthetic Amorphous Silica (SAS)" - SCCS/1606/19 - Final Opinion"

The SCCS adopted this Opinion at the Plenary meeting on 20-21 June 2019 (43 pages)This Opinion has been subject to a commenting period of 9 weeks after its initial publication (from 15 March until 17 May 2018). Editorial comments received during this time were considered by the SCCS

SCCS OPINION ON Colloidal Silver (nano)” - SCCS/1596/18 Preliminary version

The SCCS adopted this document at its plenary meeting on 21/22 February 2018 – 36 pageshttps://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_219.pd

SCCS Opinion on Solubility of Synthetic Amorphous Silica (SAS)

Solubility of Synthetic Amorphous Silica (SAS)Link to opinionhttps://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_228.pdfWG on Cosmetic IngredientsSCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet (Rapporteur), E. Panteri, Ch. Rousselle, M. Stepnik, S. WijnhovenSCHEER members: P.H.M. Hoet, W.H. de JongSCCS external experts: N. von Götz, A. SimonnardContact: [email protected] request from: European CommissionSCCS Number: SCCS/1606/19Adopted on: 26 February 2019Conclusion of the opinion:1. Does the SCCS consider that Synthetic Amorphous Silica (SAS) are soluble (100 mg/L or higher) or degradable/non-persistent in biological systems, in light of the nanomaterial definition of the Cosmetic Regulation?Having considered the data provided in this dossier and that available in published literature, the SCCS concludes that:i) the solubility values for hydrophilic SAS materials have been reported to range from 22 mg/L to 225 mg/L for the solubility tests performed in aqueous media, or following the enhanced OECD TG 105 (0.5% ethanol). The latter protocol has been noted to increase the solubility by a factor of 10 for some hydrophilic SAS materials.ii) the solubility values of hydrophobic surface-treated SAS materials have been reported to range from 0.4 to 180 mg/L for solubility tests performed in aqueous media, or following a modified enhanced OECD TG 105 protocol (i.e. using 10% ethanol). The latter protocol has been noted to strongly increase the solubility of some hydrophobic SAS materials (by a factor up to 173).The hydrophilic and hydrophobic SAS materials can therefore be regarded as “insoluble” (i.e. below 100 mg/L) to “very slightly soluble” (i.e. 100 mg/L to 1000 mg/L) by the SCCS based upon the terminology used in USP38 and USP 38 NF33 (Table 1 corrected by the SCCS).In regard to the nanomaterial definition in the Cosmetic Regulation, none of the SAS materials (hydrophilic or hydrophobic) included in the dossier can be regarded as soluble. In fact, the Applicant had mistakenly interpreted the SAS materials as soluble on the basis of the solubility of some of the materials being 100 mg/L or higher. The threshold for regarding a material 'soluble' is 33.3 g/L (not 100 mg/L as claimed by the Applicant).No data were provided to help establish whether the SAS materials could be regarded degradable/non-persistent in biological systems.2. Can the SCCS indicate to which kind of Silica this solubility applies?The solubility values reported in the dossier are applicable when SAS materials are subject to the following conditions:- hydrophilic SAS: Silica and hydrated silica when solubilised in aqueous media containing up to 0.5% ethanol,- hydrophobic surface treated SAS: when solubilised in aqueous media containing up to 10% ethanol,- at temperatures between 19.5 to 20.5°C,- with a pH level of between 3 and 8,- over a period between 3 days (hydrophilic SAS) up to 49 days (hydrophobic SAS).3. Does the SCCS have any further scientific concerns with regard to solubility of Synthetic Amorphous Silica (SAS)?- The solubility values considered by the SCCS in this Opinion may not be valid in situations where the SAS materials are formulated/used under conditions that are different from those used in the solubility tests - e.g. when used in a less/non aqueous formulation, or at a different temperature.- In the context of the definition of nanomaterial under the Cosmetics Regulation, which relates to insoluble materials in conjunction with other size/particle related parameters, the question of solubility of a nano-structured material needs to be seen in perspective for use in cosmetics. For nano-structured materials, with the exception of the materials that are completely soluble, it is important to establish whether a proportion of these materials would still exist in undissolved form comprising nanoparticles, at the given use level in a cosmetic formulation.- The SCCS has noted that the protocols used for solubility tests have a strong influence on the solubility of SAS materials.Keywords:SCCS, scientific opinion, Synthetic Amorphous Silica (SAS), solubility, nanomaterials, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on solubility of Synthetic Amorphous Silica (SAS), 26 February 2019, SCCS/1606/2019

"SCCS ADDENDUM to the scientific Opinions on Climbazole (P64) - ref. SCCS/1506/13 and SCCS/1590/17" SCCS/1600/18 - Final version

International audienc

"SCCS OPINION ON Styrene/Acrylates copolymer (nano) and Sodium styrene/Acrylates copolymer (nano)"SCCS/1595/18 Final

International audienc

"SCCS ADDENDUM to the scientific opinion on o-Phenylphenol, Sodium ophenylphenate and Potassium o-phenylphenate (SCCS/1555/15) - Here: the use as preservative of Sodium o-phenylphenate, Potassium o-phenylphenate, MEA o-Phenylphenate (CAS n. 132-27-4, 13707-65-8, 84145-04-0)"

The SCCS adopted this document at its plenary meeting on 21-22 February 2018 https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_217.pd

"SCCS OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products - Submission II"SCCS/1591/17 - Final version

International audience"SCCS OPINION ON the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products - Submission II"SCCS/1591/17 - Final versionFor the Preliminary Opinion : SCCS Members ; U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stępnik (Rapporteur), T. Vanhaecke, S. WijnhovenFor the Final Opinion : SCCS Members : U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stępnik (Rapporteur), T. Vanhaecke, S. WijnhovenThe SCCS adopted this Opinion by written procedure on 10 May 2019 (68 pages)https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_213.pd