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International audience; SCCS OPINION on water-soluble zinc salts used in oral hygiene products - Submission II - SCCS/1657/23 - Preliminary versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this Opinion by written procedure on 3 July 2023 (23 pages)Mise en ligne : 4 July 2023https://health.ec.europa.eu/publications/water-soluble-zinc-salts-used-oral-hygiene-products-submission-ii_enhttps://health.ec.europa.eu/system/files/2023-07/sccs_o_279.pdfDetailsPublication date : 4 July 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1657/23Adopted on: 3 July 2023Conclusion of the opinion:In light of the data provided and taking under consideration the aggregate exposure (including diet) and the concerns on the Tolerable Daily Upper Intake,(1) Does the SCCS consider that water soluble zinc salts are safe up to 1 % (as zinc) in toothpaste and 0.1% (as zinc) in mouthwash, for both adults and children? If not, the SCCS is requested to provide safe concentrations for each age group.The SCCS has calculated aggregate exposure to water-soluble zinc salts via toothpaste at the concentrations of 1% and from diet and concluded that the use of zinc in toothpaste is safe per se except for children under the age of 1 year because the intake exceeds the upper limit level. For children up to 1 year of age, the SCCS recommends a safe concentration of 0.72% for soluble zinc salts (as zinc) in toothpaste.The inclusion of zinc in mouthwash at 0.1% Zn is considered safe across all age groups.(2) Does the SCCS consider that the contribution of the cosmetic products among the overall/total exposure to zinc is still of concern?/SCCS, scientific opinion, water-soluble zinc salts, oral hygiene products, zinc acetate CAS: 557-34-6 EC: 209-170-2, zinc chloride CAS: 7646-85-7 EC: 231-592-0, zinc gluconate CAS: 4468-02-4 EC:/, zinc citrate CAS: 546-46-3 EC:/, zinc sulphate/zinc sulphate monohydrate/zinc sulphate heptahydrate CAS: 7733-02-0/7446-19-7/7446-20-0 EC:/, SCCS/1586/17, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on water-soluble zinc salts used in oral hygiene products - Submission II, preliminary version adopted on 3 July 2023, SCCS/1657/23.

International audience; SCCS OPINION on benzyl salicylate (CAS No. 118-58-1, EC No. 204-262-9) _ SCCS/1656/23– Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this document during its plenary meeting on 6-7 June 2023 2023 (68 Pages)Mise en ligne : 13 Juin 2023 https://health.ec.europa.eu/publications/benzyl-salicylate-cas-no-118-58-1-ec-no-204-262-9_enhttps://health.ec.europa.eu/system/files/2023-06/sccs_o_277.pdfDetailsPublication date : 13 June 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur), M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfentati, N. Cabaton (Rapporteur), E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1656/23Adopted on: 6-7 June 2023Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Benzyl Salicylate, does the SCCS consider Benzyl Salicylate safe when used up to the maximum concentrations provided in the dossier submission by the Benzyl Salicylate Consortium?Based on the data provided and assessed and taking under consideration the concerns related to potential endocrine disrupting properties, the SCCS considers Benzyl Salicylate safe when used up to the maximum concentrations provided in Table 1 of this Opinion.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Benzyl Salicylate in cosmetic products?/(3) Does the SCCS have any further scientific concerns with regard to the use of Benzyl Salicylate in cosmetic products?The available data on Benzyl Salicylate provide some indications for an endocrine mode of action, but there is no evidence that this results in potential endocrine effects.The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Benzyl Salicylate for the environment.Keywords:SCCS, scientific opinion, benzyl salicylate, Regulation 1223/2009, CAS No. 118-58-1, EC No. 204-262-9Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on benzyl salicylate (CAS No. 118-58-1, EC No. 204-262-9), preliminary version of 6-7 June 2023, SCCS/1656/23.

International audience; SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3) - SCCS/1646/22– Final OpiinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 6 June 2023 (75 Pages)Mise en ligne : 9 Juin 2023https://health.ec.europa.eu/publications/salicylic-acid-cas-no-69-72-7-ec-no-200-712-3_enhttps://health.ec.europa.eu/system/files/2023-06/sccs_o_268.pdfDetailsPublication date : 9 June 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfenati, N. Cabaton (Rapporteur), E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1646/22Adopted on: 6-7 June 2023Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Salicylic acid,a) does the SCCS consider Salicylic acid safe when used as a preservative in cosmetic products up to a maximum concentration of 0.5%?Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects:- the SCCS is of the opinion that salicylic acid (CAS 69-72-7) is safe when used as preservative at a concentration of 0.5 % in cosmetic products, considering its current restrictions in place. The provided information shows that salicylic acid is an eye irritant with the potential to cause serious damage to the eye.- this Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.b) does the SCCS consider Salicylic acid safe when used in cosmetic for purposes other than inhibiting the development of micro-organisms at a concentration up to:i. 3.0% for the cosmetic rinse-off hair products,ii. 2.0% for other products except body lotion, eye shadow, mascara, eyeliner, lipstick, non-spray deodorant, andiii. 0.5% for body lotion, eye shadow, mascara, eyeliner, lipstick, oral products and non-spray deodorantThe SCCS assessment has shown that:The use of salicylic acid as a restricted ingredient for purposes other than inhibiting the development of micro-organisms is safe at a concentration:- up to 3.0 % for the cosmetic rinse-off hair products,- up to 2.0 % for other products, except body lotion, eye shadow, mascara, eyeliner, lipstick, non-spray deodorant, and- up to 0.5% for body lotion, eye shadow, mascara, eyeliner, lipstick, oral products and non-spray deodorant.This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Salicylic acid in cosmetic products? / (3) Does the SCCS have any further scientific concerns with regard to the use of Salicylic acid in cosmetic products? In the absence of exposure data of Salicylic acid in cosmetic products for children, safety concerns have been noted for the younger age groups (between 3-10 years).Since the Cosmetic Regulation does not allow the use of salicylic acid in products for children under 3 years of age, this age category has not been considered in this Opinion.The conclusions of this Opinion refer only to Salicylic Acid as a cosmetic ingredient and not to other salicylates or salicylic acid salts.Keywords:SCCS, scientific opinion, salicylic acid, Regulation 1223/2009, CAS No. 69-72-7, EC No. 200-712-3Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3), preliminary version of 14 December 2022, final version of 6-7 June 2023, SCCS/1646/22.

International audience; SCCS OPINION on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7) - SCCS/1652/23– Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this document during its plenary meeting on 6-7 June 2023 2023 (95 pages)Mise en ligne : 8 Juin 2023https://health.ec.europa.eu/publications/methylparaben-cas-no-99-76-3-ec-no-202-785-7_enhttps://health.ec.europa.eu/system/files/2023-06/sccs_o_276.pdfDetailsPublication date : 8 June 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1652/23Adopted on: 6-7 June 2023Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Methylparaben, does the SCCS consider Methylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.4% (as acid) when used on its own and up to 0.8% (as acid) for mixtures of esters as indicated in entry 12 of Annex V to the Cosmetics Regulation?On the basis of the safety assessment of Methylparaben, and considering the concerns related to potential endocrine activity, the SCCS has concluded that Methylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.4% (as acid) when used on its own and up to 0.8% (as acid) for mixtures of esters as indicated in entry 12 of Annex V to the Cosmetics Regulation.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Methylparaben as a preservative in cosmetic products?/(3) Does the SCCS have any further scientific concerns with regard to the use of Methylparaben in cosmetic products?The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Methylparaben for the environment.Keywords:SCCS, scientific opinion, methylparaben, preservative, Regulation 1223/2009, CAS No. 99-76-3, EC No. 202-785-7Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7), preliminary version of 6-7 June 2023, SCCS/1652/23.

International audience; SCCS OPINION on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - SCCS/1651/23– Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this document during its plenary meeting on 6-7 June 2023 2023 (136 pages)Mise en ligne : 8 Juin 2023https://health.ec.europa.eu/publications/butylparaben-cas-no-94-26-8-ec-no-202-318-7_enhttps://health.ec.europa.eu/system/files/2023-06/sccs_o_275.pdfDetailsPublication date : 8 June 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1651/23Adopted on: 6-7 June 2023Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Butylparaben, does the SCCS consider Butylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %?On the basis of safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Butylparaben as a preservative in cosmetic products?/(3) Does the SCCS have any further scientific concerns with regard to the use of Butylparaben in cosmetic products?In the absence of solid exposure data for children to Butylparaben in cosmetic products, potential safety concerns have been noted by the SCCS.The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Butylparaben for the environment.Keywords:SCCS, scientific opinion, butylparaben, preservative, Regulation 1223/2009, CAS No. 94-26-8, EC No. 202-318-7Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on butylparaben (CAS No. 94-26-8, EC No. 202-318-7), preliminary version of 6-7 June 2023, SCCS/1651/23.

International audience; The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation- 12th Revision - SCCS/1647/22U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz, R. KrätkeThe SCCS adopted this guidance document by written procedure on 15 May 2023 (203 Pages)Mise en ligne : 16 May 2023https://health.ec.europa.eu/publications/sccs-notes-guidance-testing-cosmetic-ingredients-and-their-safety-evaluation-12th-revision_enDetailsPublication date : 16 May 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCHEER member: R. KrätkeSCCS external experts: E. Benfenati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1647/22Adopted on: 15 May 2023Conclusion of the opinion:The NoG have been revised and updated with emphasis on the following:• Importance of systematic literature review• Updating of animal-free alternative methods: NAM (New Approach Methodology), changes introduced for acute inhalation, skin irritation testing, eye irritation testing with DAL (Defined Approach for eye irritation, Liquid), DASS (Defined Approaches for Skin Sensitisation), new in vitro methods for genotoxicity testing (3D skin Comet; in vitro micronucleus)• Importance of AOP (Adverse Outcome Pathway), DAs (Defined Approaches), IATA (Integrated Approaches to Testing and Assessment), NGRA (Next Generation Risk Assessment) with definition of BER (Bioactivity/Exposure Ratio), TTC (Threshold of Toxicological Concern), iTTC (internal TTC)• Updating of in silico prediction possibilities• Exposure data reviewed (models, parameters specific for inhalation, aggregate exposure)• Exposure of children to different cosmetic product categories according to age• Sun protection by sunscreen products: rationale behind exposure data• Human biomonitoring (HBM) and differences with SCCS approach for risk assessment• CMRs reporting requirements• Endocrine active substances, introduction of non-monotonic dose response, reporting requirements• Templates for PBTK (Physiologically Based ToxicoKinetics) model description and parameter verification and analysisKeywords: SCCS, SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 12th revision, SCCS/1647/22Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 12th revision, 15 May 2023, SCCS/1647/22.

International audience; SCIENTIFIC ADVICE – children exposure on Methyl salicylate,(methyl 2-hydroxybenzoate) - SCCS/1654/23 - Preliminary versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 15 May 2023 (22 Pages)Mise en ligne : 16 May 2023https://health.ec.europa.eu/publications/sccs-scientific-advice-children-exposure-methyl-salicylate-methyl-2-hydroxybenzoate_enhttps://health.ec.europa.eu/system/files/2023-05/sccs_o_274.pdfDetailsPublication date : 16 May 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur), M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfenati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1654/23Adopted on: 16 May 2023Conclusion of the opinion:In the SCCS/1633/21 Opinion, the Committee concluded that Methyl Salicylate in toothpaste is safe for children under 6 years of age when used up to the maximum concentration of 2.52%.(1) In light of the data provided and taking under consideration the conclusions of SCCS/1633/21 and the aggregate exposure, does the SCCS consider Methyl Salicylate safe for children of age 0-3, when used up to a maximum concentration of 0.02% in all of the currently regulated cosmetic products included in Table 1 (except toothpaste in which up to 2.52% can be used)?In view of the conclusions of SCCS/1633/21 and the aggregate exposure, the SCCS considers the use of Methyl Salicylate as safe in cosmetic products intended for children of age 0.5-3 years when used up to a maximum concentration of 0.02% in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe.As no specific data were provided by the applicant for children below 6 months, the SCCS has not considered this age category in this safety assessment.(2) In light of the data provided and taking under consideration the conclusions of SCCS/1633/21 and the aggregate exposure, does the SCCS consider Methyl Salicylate safe for children of age 3-6, when used up to the allowed maximum concentrations for each of the currently regulated cosmetic products included in Table 1 (except toothpaste in which up to 2.52% can be used)?In Annex-1 of this Opinion, the SCCS has noted the basis for concerns over risks that the use of fullerenes, hydroxylated fullerenes and hydrated forms of hydroxylated fullerenes in cosmetic products may pose to the consumer. In brief, the SCCS has a concern in regard to:In view of the conclusions of SCCS/1633/21 and the aggregate exposure, the SCCS considers the use of Methyl Salicylate as safe in cosmetic products intended for children of age 3-6 years, when used up to a maximum concentration of 0.02% in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products, hair conditioner up to the allowed maximum concentrations indicated in Table 1. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe.Keywords:SCCS, scientific advice, methyl salicylate, methyl 2-hydroxybenzoate, children exposure, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Scientific Advice on methyl salicylate (methyl 2-hydroxybenzoate) – children exposure, preliminary version of 16 May 2023, SCCS/1654/23.

International audience; SCIENTIFIC ADVICE on HC Blue 18 (Colipa No. B122) - Submission II - SCCS/1653/23U. Bernauer, L. Bodin, Q. Chaudhry, .J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 27 April 2023 (24 Pages)Mise en ligne : 8 Mai 2023https://health.ec.europa.eu/publications/sccs-scientific-advice-hc-blue-18-colipa-no-b122-submission-ii_enDetailsPublication date 8 May 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von GoetzContact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1653/23Adopted on: 27 April 2023Conclusion of the opinion:1. In light of the data provided, does the SCCS consider HC Blue 18, safe when used in non-oxidative as well as in oxidative hair dye formulations up to a maximum on-head concentration of 0.35 %?In light of the new physicochemical data provided, SCCS considers that the use of HC Blue 18 as an ingredient in non-oxidative as well as in oxidative hair dye formulations up to a maximum on-head concentration of 0.35% is safe.2. Does the SCCS have any further scientific concerns with regard to the use of HC Blue 18 in cosmetic products?SCCS considers HC Blue 18 as a moderate sensitiser.Keywords:SCCS, scientific advice, hair dye, HC Blue 18, Colipa No B122, Submission II, CAS No. 1166834-57-6Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Scientific advice on HC Blue 18 (Colipa No. B122) – submission II, 27 April 2023, SCCS/1653/23.

International audience; SCCS Opinion on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0) - SCCS/1650/23 - Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri , V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 21-22 March 202 (36 Pages)Mise en ligne : 4 Avril 2023https://health.ec.europa.eu/publications/silver-zinc-zeolite-cas-no-130328-20-0-ec-no-603-404-0_enhttps://health.ec.europa.eu/system/files/2023-04/sccs_o_270.pdfDetailsPublication date : 4 April 2023Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson and Rapporteur), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact: SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1650/23Adopted on: 21-22 March 2023Conclusion of the opinion: (1) In light of the data provided and taking under consideration the classification as Toxic for reproduction Cat. 2, does the SCCS consider Silver Zinc Zeolite safe when used as a preservative in cosmetic products according to the specifications and concentration limits provided in the dossier submission?The SCCS considers that Silver Zinc Zeolite (CAS No. 130328-20-0) incorporating a maximum silver content of 2.5% is safe in spray deodorant and powder foundation when used at the proposed concentration of 1%.(2) Alternatively, what is, according to the SCCS, the maximum concentration considered safe for use of Silver Zinc Zeolite as a preservative in cosmetic products? /(3) Does the SCCS have any further scientific concerns with regard to the use of Silver Zinc Zeolite in cosmetic products? /Keywords:SCCS, scientific opinion, silver zinc zeolite, Regulation 1223/2009, CAS No. 130328-20- 0, EC No. 603-404-0Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on silver zinc zeolite (CAS No. 130328-20- 0, EC No. 603-404-0), preliminary version of 21 March 2023, SCCS/1650/23.

International audience; SCCS OPINION on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) - SCCS/1645/22 - Final VersionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 21 and 22 March 2023 (47pages)Mise en ligne 23 Mars 2023 https://health.ec.europa.eu/publications/sccs-sodium-bromothymol-blue-c186-cas-no-34722-90-2-ec-no-252-169-7_enhttps://health.ec.europa.eu/system/files/2023-03/sccs_o_267.pdfDetailsPublication date23 March 2023AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1645/22Adopted on: 21-22 March 2023Conclusion of the opinion:In light of the data provided, does the SCCS consider Sodium Bromothymol Blue safe when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5 %?Having considered the data provided, the SCCS is of the opinion that the safety of sodium bromothymol blue cannot be assessed because of the following reasons:- The Applicant used TTC approach to justify the safety of sodium bromothymol blue, but the SCCS estimate of the SED indicates that it exceeds the TTC threshold for Cramer class III substances.- The use of TTC on its own to justify the safety of the substances that are regulated under the EU Cosmetic Regulation is not sufficient to waive the information requirements on essential toxicological endpoints.2. Does the SCCS have any further scientific concerns with regard to the use of Sodium Bromothymol Blue in cosmetic products?While the use of TTC is acceptable to justify the safety of impurities and cosmetic ingredients that are added to a final product at sufficiently low concentrations, it is not acceptable on its own for the substances that ar regulated under the EU Cosmetic Regulation. Additional supporting data from NAMs that are scientifically-accepted for the purpose, and/or other acceptable in vivo data on systemic toxicity, are also required in an overall weight of evidence to assess safety.Keywords:SCCS, scientific opinion, sodium bromothymol blue, C186, hair dye, Regulation 1223/2009, CAS No. 34722-90-2, EC No. 252-169-7Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on sodium bromothymol blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7), preliminary version of 24-25 October 2022, final version of 21-22 March 2023, SCCS/1645/22

International audience; SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final Opinion and CorrigendumU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 21 and 22 March 2023 (62 Pages)Mise en ligne : 23 Mars 2023https://health.ec.europa.eu/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_enhttps://health.ec.europa.eu/system/files/2023-03/sccs_o_266_0.pdfDetailsPublication date2 February 2023AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)Contact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1644/22Adopted on: 1 February 2023A corrigendum has been adopted on 21 March 2023 adding a note explaining that “AP” means “antiperspirant” under Table 6 of the Applicant.Conclusion of the opinion:1. In light of the new data provided, does the SCCS consider Aluminium compounds safe when used in cosmetic products other than deodorants, antiperspirants, lipsticks and toothpastes? In the event that the estimated exposure to Aluminium from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for each category.The SCCS considers that aluminium compounds are safe when used-in non-sprayable product categories at the maximum levels indicated in Tables 4 and 6; and- in sprayable products, at the maximum levels indicated in Table 4, provided that the percentage of particles/droplets with a diameter of less than 10 μm does not exceed 20% of the total aerosolised particles/droplets. Since the Applicant’s data submission indicated that aluminium is not used in sunscreen aerosol sprays, this Opinion does not cover sunscreen aerosol sprays.2. Does the SCCS have any further scientific concerns regarding the use of relevant Aluminium compounds in cosmetic products taking into account the newly submitted information on aggregate exposure to Aluminium from cosmetics, medicines (e.g. antacids) and food intake?As aluminium does not belong to substances classified as CMR 1A or B, only exposure from cosmetic uses was considered in this safety assessment with the exposure assessment based on maximum use levels for cosmetic ingredients.However, the submission also provided a scenario where realistic exposure from non-cosmetic sources of aluminium (food and pharmaceuticals) was aggregated along with exposure from cosmetics at use levels from the year 2016. From this scenario, it can be deduced that contribution to aluminium exposure from food may be at a similar order of magnitude to that from cosmetics used for the safety assessment. Considering the conservative nature of the estimates, the aggregate exposure to aluminium from cosmetic and non-cosmetic sources may exceed safe limits for consumers at the highest exposure ranges.Keywords:SCCS, revision, scientific opinion, aluminium, submission III, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products - Submission III, preliminary version of 6 May 2022, final version of 1 February 2023, Corrigendum 21 March 2023, SCCS/1644/22

International audience; SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 1st Februray 2023 (60 Pages)Mise en ligne : 2 February 2023https://health.ec.europa.eu/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_enhttps://health.ec.europa.eu/system/files/2023-02/sccs_o_266.pdfDetailsPublication date 2 February 2023Author Scientific Committee on Consumer Safety (SCCS)Description SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)Contact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1644/22Adopted on: 1 February 2023Conclusion of the opinion:1. In light of the new data provided, does the SCCS consider Aluminium compounds safe when used in cosmetic products other than deodorants, antiperspirants, lipsticks and toothpastes? In the event that the estimated exposure to Aluminium from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for each category.The SCCS considers that aluminium compounds are safe when used-in non-sprayable product categories at the maximum levels indicated in Tables 4 and 6; and- in sprayable products, at the maximum levels indicated in Table 4, provided that the percentage of particles/droplets with a diameter of less than 10 μm does not exceed 20% of the total aerosolised particles/droplets. Since the Applicant’s data submission indicated that aluminium is not used in sunscreen aerosol sprays, this Opinion does not cover sunscreen aerosol sprays.2. Does the SCCS have any further scientific concerns regarding the use of relevant Aluminium compounds in cosmetic products taking into account the newly submitted information on aggregate exposure to Aluminium from cosmetics, medicines (e.g. antacids) and food intake?As aluminium does not belong to substances classified as CMR 1A or B, only exposure from cosmetic uses was considered in this safety assessment with the exposure assessment based on maximum use levels for cosmetic ingredients.However, the submission also provided a scenario where realistic exposure from non-cosmetic sources of aluminium (food and pharmaceuticals) was aggregated along with exposure from cosmetics at use levels from the year 2016. From this scenario, it can be deduced that contribution to aluminium exposure from food may be at a similar order of magnitude to that from cosmetics used for the safety assessment. Considering the conservative nature of the estimates, the aggregate exposure to aluminium from cosmetic and non-cosmetic sources may exceed safe limits for consumers at the highest exposure ranges.Keywords:SCCS, revision, scientific opinion, aluminium, submission III, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products - Submission III, preliminary version of 6 May 2022, final version of 1 February 2023, SCCS/1644/22

International audience; SCCS OPINION on Genistein and Daidzein - SCCS/1641/22 Final versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 16 September 2022 (153 pages)Mise en ligne 23 Septembre 2022https://health.ec.europa.eu/publications/genistein-and-daidzein_enDetailsPublication date : 23 September 2022Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer (Rapporteur Daidzein), L. Bodin, Q. Chaudhry (Rapporteur Genistein), P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli (Rapporteur Genistein), B. Granum (former member), E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur Daidzein), M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1641/22Adopted on: 16 September 2022Conclusion of the opinion: (1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of phytoestrogens,(a) does the SCCS consider genistein safe when used in cosmetic products up to a maximum concentration of 0.007%?(b) does the SCCS consider daidzein safe when used in cosmetic products up to a maximum concentration of 0.02%?From the safety assessment based on the available relevant data on the aglycone form of genistein and daidzein, and in consideration of the potential endocrine disrupting properties of phytoestrogens, the SCCS considers that:a) the use of genistein (CAS No 446-72-0, EC No 207-174-9) in cosmetic products up to a maximum concentration of 0.007% is safe.b) the use of daidzein (CAS No 486-66-8, EC No 207-635-4) in cosmetic products up to a maximum concentration of 0.02% is safe. (2) Alternatively, according to the SCCS what is the maximum concentration of genistein and daidzein that is considered safe for individual and combined use in cosmetic products?/(3) Does the SCCS have any further scientific concerns with regard to the use of genistein and daidzein or other related phytoestrogens in cosmetic products?/Keywords:SCCS, scientific opinion, genistein (CAS No 446-72-0, EC No 207-174-9), daidzein (CAS No 486-66-8, EC No 207-635-4), Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Scientific opinion on genistein and daidzein, preliminary version of 12 January 2022, final version of 16 September 2022, SCCS/1641/22.

International audience; To review the available data on the presence and activity of Bisphenol A in clothing articles, taking into consideration the adopted opinions on tolerable intake limits and the legislative framework in other products (food contact materials, toys and printed paper) Regarding potential health effects of BPA, this Opinion is based on the information present in the most recent health risk assessments conducted by EFSA (2015) and ECHA (2015). SCCS is, however, aware of the fact that EFSA is currently re-evaluating the huge amount of data on BPA toxicity that came available since December 2012, i.e. the cut-off point for their latest assessment published in 2015. Hence, all outcomes and conclusions reported in this document with respect to human health might be subject of change in the near future. If this is the case, the Opinion should be updated accordingly. Exposure to BPA may occur from various sources, both dietary and non-dietary. In this Opinion, the assessment is based only on one source of BPA (i.e. textiles) and does not take into account the contribution of other sources, nor does it apply to BPA analogues. Only one study provides experimental migration rates of BPA from clothing into artificial sweat (Wang et al. 2019). Based on these reported migration rates, migration fractions were calculated under conservative assumptions, with a 2-hour chronic daily contact of the whole trunk to clothes fully soaked in sweat for men and women. As for children, exposure to sweaty clothes was considered with additional oral exposure due to sucking on clothes. From these calculations, it can be estimated that for adults the internal total BPA exposure due to clothing is between 1.56 - 9.90 ng/kg bw/d. For toddlers, exposure to total BPA via clothing is higher i.e. between 2.37 – 14.8 ng/kg bw/d. Compared to the dietary exposure previously assessed by EFSA (2015), the exposure to BPA through clothing is at least 25 times lower. Due to the many upper bound scenario decisions made in the exposure assessment, this difference may be much larger in reality. Moreover, taking into account that Wang et al. (2019) is the only study as yet available for BPA migration rates from clothes and that very large migration fractions have been determined, it has to be confirmed that migration of BPA from clothes is really that high. In future studies, reproducibility of the migration experiment should be investigated, and time-dependent and fabric-specific migration rates derived.

International audience; The SCCS concludes the following: 1. In light of the new data provided, does the SCCS consider Aluminium safe when used in lipsticks up to a maximum concentration of 14%? In the event that the estimated exposure to Aluminium from lipsticks of cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits. In the light of the new data provided, the SCCS considers that the use of aluminium compounds is safe at the following equivalent aluminium concentrations up to: · 6.25% in non-spray deodorants or non-spray antiperspirants · 10.60% in spray deodorants or spray antiperspirants · 2.65% in toothpaste and · 14% in lipstick 2. Does the SCCS have any further scientific concerns regarding the use of Aluminium substances in cosmetic products taking into account the newly submitted information on aggregate exposure from cosmetics? The SCCS considers that the systemic exposure to aluminium via daily applications of cosmetic products does not add significantly to the systemic body burden of aluminium from other sources. Exposure to aluminium may also occur from sources other than cosmetic products, and a major source of aluminium in the population is the diet. This assessment has not taken into account the daily dietary intake of aluminium.

International audience; The SCCS concludes the following: 1. In light of the data provided and taking under consideration the RAC Opinion on Methyl salicylate and the expected new classification as Toxic for Reproduction Category 2 of Methyl salicylate (to be introduced by an update of Annex VI Reg. 1272/2008), does the SCCS consider Methyl salicylate safe when used up to the maximum concentrations provided in the dossier submitted by the applicant? The SCCS considers Methyl salicylate safe when used in cosmetic products up to the maximum concentrations provided in the dossier submitted by the applicant as detailed in Table 1. 2. Does the SCCS have any further scientific concerns with regard to the use of Methyl salicylate in cosmetic products, also in relation to the RAC recommended classification of Methyl salicylate as ‘Skin sensitizer Category 1B’? Methyl salicylate should be considered as a weak skin sensitiser in humans and eye irritant. Moreover the SCCS would like also to express other concerns related to the use of methyl salicylate: -Methyl salicylate can be used in consumer products other than cosmetic products, such as household cleaning products, air care products, biocides (e.g. disinfectants, pest control products), polishes and waxes which may increase the systemic exposure dose with a possibility to exceed the safe level. - Methyl salicylate will be metabolised in the body to salicylic acid which is also classified as a reprotoxicant and used in cosmetic products (see opinion SCCS/1601/18). Therefore the combined exposure to cosmetic products containing various salicylates may increase the systemic exposure dose with a possibility to exceed the safe level. The SCCS also notices that wintergreen oil that is used in cosmetic products may contain up to 99% methyl salicylate. Therefore when calculating the content of methyl salicylate in a cosmetic product, any fraction coming from wintergreen oil should also be considered.

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Acid Yellow 3 - C054 (CAS Number 8004-92-0, EC No 305-897-5), submission II, preliminary version of 7 May 2021, final version of 23 July 2021, SCCS/1631/21.

International audience; SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Preliminary OpinionU. 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. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 6 May 2022 (51 Pages)Mise en ligne 30 Mai 2022https://ec.europa.eu/health/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_enDescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)Contact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1644/22Adopted on: 6 May 2022Conclusion of the opinion:1. In light of the new data provided, does the SCCS consider Aluminium compounds safe when used in cosmetic products other than deodorants, antiperspirants, lipsticks and toothpastes? In the event that the estimated exposure to Aluminium from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for each category.The SCCS considers that aluminium compounds are safe when useda. in non-sprayable product categories at the maximum levels indicated in Table 4;andb. in sprayable antiperspirant products, provided that the maximum percentage of particles with 10 μm diameter does not exceed 20% of the total aerosolised particlesThe SCCS could not assess safety of aluminium compounds in sprayable applications other than antiperspirant. These applications (including eau de toilette, eau de parfum and hair spray) are therefore excluded from this Opinion.2. Does the SCCS have any further scientific concerns regarding the use of relevant Aluminium compounds in cosmetic products taking into account the newly submitted information on aggregate exposure to Aluminium from cosmetics, medicines (e.g. antacids) and food intake?As aluminium does not belong to substances classified as CMR 1A and B, only exposure from cosmetic uses was considered in this safety assessment.However, in a scenario provided by the Applicant, where exposure from non-cosmetic sources of aluminium (food and pharmaceuticals) was aggregated with exposure from cosmetics, food contributed in a similar order of magnitude as cosmetics. The aggregate exposure to aluminum from cosmetic and non-cosmetic sources may therefore exceed safe limits.Keywords:SCCS, revision, scientific opinion, aluminium, submission III, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products - Submission III, preliminary version of 6 May 2022, SCCS/1644/22

International audience; Publication date10 May 2022Author : Scientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, B. Granum, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1640/21Adopted on: 29 April 2022Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of 4-Methylbenzylidene camphor (4-MBC), does the SCCS consider 4-MBC safe when used as a UV-filter in cosmetic products up to a maximum concentration of 4%?The SCCS cannot conclude on the safety of 4-MBC, because the information provided is insufficient to fully evaluate potential genotoxicity.Moreover, there is sufficient evidence that 4-MBC may act as an endocrine disruptor and has effects on both the thyroid and estrogen systems. Effects on the androgen system are not so evident, as only in vitro evidence is available.Even if the genotoxic potential was excluded, the current re-evaluation of 4-MBC established a higher exposure level than in the previous Opinion. This would result in a lower MoS value, indicating that the use of 4-MBC at the maximum concentration of 4% in cosmetic ingredients would not be safe.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of 4-MBC as a UV-filter in cosmetic products?It is not possible to derive a maximum concentration for safe use of 4-MBC, because a genotoxicity potential cannot be excluded.(3) Does the SCCS have any further scientific concerns with regard to the use of 4-MBC in cosmetic products?The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of 4-MBC for the environment.Keywords:SCCS, revision, scientific opinion, 4-Methylbenzylidene camphor (4-MBC), CAS No 36861-47-9/38102-62-4, EC No 253-242-6, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on 4-Methylbenzylidene camphor (4-MBC), preliminary version of 22 December, final version of 29 April 2022, SCCS/1640/21.

International audience; SCCS OPINION on the safety of alpha-arbutin and beta-arbutin in cosmetic products - SCCS/1642/22 – Preliminary OpinionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 15 and 16 March 2022 (70 Pages)Mise en ligne 26 Mars 2022https://ec.europa.eu/health/publications/safety-alpha-arbutin-and-beta-arbutin-cosmetic-products_en DetailsPublication date25 March 2022AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1642/22Adopted on: 15-16 March 2022Conclusion of the opinion: (1) In light of the data provided, does the SCCS consider α-arbutin safe when used in face creams up to a maximum concentration of 2% and in body lotions up to a maximum concentration of 0.5 %?Having considered the data provided, and other relevant information available in scientific literature, the SCCS cannot conclude on the safety of alpha-arbutin when used in face creams up to a maximum concentration of 2% and in body lotions up to a maximum concentration of 0.5%. Relevant data on the degradation/metabolism of alpha-arbutin, exposed to the skin microbiome/enzymes, are not available and the release of hydroquinone and its final fate are not documented. These data are essentially required for safety assessment.(2) In the event that the estimated exposure to α-arbutin from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits.For the reasons given under question 1, the SCCS cannot recommend a safe concentration of alpha-arbutin.(3) In light of the data provided, does the SCCS consider β-arbutin safe when used in face creams up to a maximum concentration of 7%?No information was provided during the call for data. The SCCS has, therefore, considered the information available in scientific literature but regarded it insufficient to conclude on the safety of beta-arbutin when used in face cream up to a maximum concentration of 7%. Also, relevant data on the fate of beta-arbutin, when applied to human skin and its microbiome/enzymes, are not available and the release of hydroquinone and its final fate are not documented.(4) In the event that the estimated exposure to β-arbutin from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits.For the reasons given under question 3, the SCCS cannot recommend a safe concentration of beta-arbutin.(5) In light of the data provided, does the SCCS consider that the presence of hydroquinone in the cosmetic formulations must remain below 1 ppm for both α- and β arbutin containing products?Hydroquinone should remain as low as possible in formulations containing alpha-or beta arbutin and should not be higher than the unavoidable traces in both arbutins. In the new studies, submitted by the applicant, 3ppm was the LOQ/LOD of the methodology used.(6) Does the SCCS have any further scientific concerns regarding the use of a- and β arbutin in cosmetic products in relation to aggregate exposure from such substances in cosmetics?Safe concentrations for either of the arbutins in cosmetic products cannot be established without the data on the release of hydroquinone and their final fate.Keywords:SCCS, scientific opinion, alpha-arbutin, beta-arbutin, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of alpha- (CAS No. 84380-018, EC No. 617-561-8) and beta-arbutin (CAS No. 497- 76-7, EC No. 207-8503) in cosmetic products, preliminary version of 15-16 March 2022, SCCS/1642/22

International audience; "SCIENTIFIC ADVICE ON the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products"SCCS/1643/22 - Scientific AdviceU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 15 and 16 March 2022 (51 Pages)Mise en ligne 26 Mars 2022https://ec.europa.eu/health/publications/safety-triclocarban-and-triclosan-substances-potential-endocrine-disrupting-properties-cosmetic_enDetailsPublication date25 March 2022AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1643/22Adopted on: 15-16 March 2022Conclusion of the opinion:In light of the information submitted via the call for data, the currently available scientific literature, relevant in silico tools and SCCS’ expert judgement and taking under consideration in particular the concerns related to potential endocrine disrupting properties, the SCCS is requested:1. to identify and justify specific concerns regarding the safe use of Triclocarban and Triclosan in cosmetic productsBased on the safety assessment carried out in consideration of all available information, including the potential endocrine effects, the SCCS is of the opinion that:- The use of Triclocarban as a preservative in cosmetic products is safe up to a maximum concentration of 0.2%.- In addition to the preservative function, the use of Triclocarban is also safe up to a maximum concentration of 1.5% in rinse-off products when used individually or in combination.- The use of Triclosan is safe as a preservative up to a maximum concentration of 0.03% in shower gel and hand soap, 0.2% in mouthwash, and 0.3% in toothpaste, deodorant stick, face powder and blemish concealer, when used individually or in combination.- The use of Triclosan is not considered safe as a preservative up to a maximum concentration of 0.3% in body lotion when used individually or in combination. The use of Triclosan in body lotion is considered safe when its concentration does not exceed 0.03% when used individually or combined with the above-mentioned products.The SCCS is not aware of the use of Triclocarban and Triclosan together in a single product, and therefore this has not been assessed.2. to highlight if there is a potential risk for human health from the use of Triclocarban and Triclosan in cosmetic products/Keywords:SCCS, scientific advice, Triclocarban, Triclosan, Regulation 1223/2009, CAS No. 101-20-2, EC No. 202-924-1, CAS No. 3380-34-5, EC No. 222-182-2Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Scientific advice, Request for a scientific advice on the safety of Triclocarban (CAS No. 101-20-2, EC No. 202- 924-1) and Triclosan (CAS No. 3380-34-5, EC No. 222-182-2) as substances with potential endocrine disrupting properties used in cosmetic products, preliminary version of 15-16 March 2022, SCCS/1643/22

International audience; SCCS Opinion on Kojic Acid - SCCS/1637/21 - Final versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 15 and 16 March 2022 (85 Pages)Mise en ligne 17 Mars 2022https://ec.europa.eu/health/publications/kojic-acid_enDescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. WijnhovenSCCS external experts: A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1637/21Adopted on: 15-16 March 2022Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Kojic acid, does the SCCS consider Kojic acid safe when used in cosmetic products up to a maximum concentration of 1 %?On the basis of the safety assessment, and considering the concerns related to potential endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that Kojic acid is not safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Kojic acid in cosmetic products?In the SCCS’s opinion, the use of Kojic acid as a skin lightening agent in cosmetic products is safe for the consumer up to a maximum concentration of 0.7% Kojic acid in the final product.(3) Does the SCCS have any further scientific concerns with regard to the use of Kojic acid in cosmetic products?As Kojic acid is sometimes added to peeling agents, a weakened skin barrier may be of additional concern because of greater dermal absorption.Only the topical use of Kojic acid in cosmetics has been considered in this Opinion. Other uses (e.g. food) of natural or synthetic sources have not been considered.As far as the derivatives of Kojic acid are concerned, e.g. esters of Kojic acid such as Kojic acid dipalmitate and Kojic acid isopalmitate, and derivatives such as chloro-Kojic acid, these have not been included in this Opinion as no data has been submitted.Keywords:SCCS, revision, scientific opinion, Kojic acid, CAS No 501-30-4, EC No 207-922-4, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on Kojic acid, preliminary version of 26-27 October 2021, final version of 15-16 March 2022, SCCS/1637/21.

International audience; SCCS OPINION on Prostaglandins and their analogues used in cosmetic products - SCCS/1635/21 - Final versionU. 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. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 3 February 2022 (41 pages)Mise en Ligne 4 February 2022https://ec.europa.eu/health/publications/prostaglandins-and-prostaglandin-analogues-used-cosmetic-products_enAuthorDirectorate-General for Health and Food SafetyDescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik (Rapporteur), T. Vanhaecke, S. WijnhovenSCCS external experts: A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1635/21Adopted on: 3 Februrary 2022Conclusion of the opinion: (1) In light of the data provided, does the SCCS consider Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide or DDDE (CAS 1185851-52-8) safe when used up to the concentrations provided in the respective dossiers (0.006% and 0.007% for Isopropyl cloprostenate and 0.018% for Ethyl Tafluprostamide)Having considered the limited data provided and the available information from published literature, the SCCS is not able to conclude on the safety of isopropyl cloprostenate and ethyl tafluprostamide when used up to the intended use concentrations indicated in the respective dossiers (0.006% and 0.007% for isopropyl cloprostenate and 0.018% for ethyl tafluprostamide).(2) Does the SCCS have any further scientific concerns with regard to the use of Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide / DDDE (CAS 1185851-52-8) in cosmetic products?The SCCS has noted concerns about the safety of isopropyl cloprostenate and ethyl tafluprostamide when used in cosmetic products - in particular those that are intended for use in the proximity of the eye. These concerns have been highlighted in more detail in Annex 1.(3) In light of the available data, does the SCCS consider that the use in cosmetic products of prostaglandins analogues (listed in Table 1) raises safety concerns and might pose a risk to human health?Prostaglandins and synthetic analogues are widely known to be potent pharmacologically active substances. Due to these effects, other regulatory authorities have advised against, or have prohibited, their use in eyelash growth-promoting cosmetics. In view of the potential for causing effects at very low concentrations, and the intended use in the proximity of the eye, the SCCS has noted concerns over the safety of prostaglandin analogues when used in cosmetic products. These have been highlighted in Annex 1 to this Opinion.Keywords:SCCS, scientific opinion, prostaglandins, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Prostaglandins and prostaglandin-analogues used in cosmetic products, preliminary version of 27 September 2021, final version of 3 February 2022, SCCS/1635/21.

International audience; SCCS OPINION on Genistein and Daidzein - SCCS/1641/22 - Preliminary versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 12 January 2022 (149 pages)Mise en ligne le 13 Janvier 2022https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_263.pdfSCCS members: U. Bernauer (Rapporteur Daidzein), L. Bodin, Q. Chaudhry (Rapporteur Genistein), P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli (Rapporteur Genistein), B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur Daidzein), M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact: SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1641/22Adopted on: 12 January 2022Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of phytoestrogens,(a) does the SCCS consider genistein safe when used in cosmetic products up to a maximum concentration of 0.007%?(b) does the SCCS consider daidzein safe when used in cosmetic products up to a maximum concentration of 0.02%?a) the use of genistein (CAS No 446-72-0, EC No 207-174-9) in cosmetic products up to a maximum concentration of 0.007% is safe.b) the currently available information is not sufficient to exclude the potential genotoxic effects of daidzein (CAS No 486-66-8, EC No 207-635-4). The SCCS is therefore not able to carry out risk assessment to conclude on the safety of the use of daidzein in cosmetic products. (2) Alternatively, according to the SCCS what is the maximum concentration of genistein and daidzein that is considered safe for individual and combined use in cosmetic products?/(3) Does the SCCS have any further scientific concerns with regard to the use of genistein and daidzein or other related phytoestrogens in cosmetic products?/Keywords: SCCS, revision, scientific opinion, genistein - (CAS No 446-72-0, EC No 207-174-9), daidzein - (CAS No 486-66-8, EC No 207-635-4), Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on genistein and daidzein, preliminary version of 12 January 2022, SCCS/1641/22.

International audience; SCCS REVISION of the scientific Opinion (SCCS/1576/16) on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate) - SCCS/1639/21- Final versionU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 24 – 25 October 2022 (45 pages)Mise en ligne le 26 Octobre 2022https://health.ec.europa.eu/publications/revision-scientific-opinion-sccs157616-vitamin-retinol-retinyl-acetate-retinyl-palmitate_enDescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)Contact:SANTE-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1639/21Adopted on: 24-25 October 2022Conclusion of the opinion:(1) In light of the data provided, does the SCCS consider that the contribution of the cosmetic products among the overall/total exposure to Vitamin A is of concern?The SCCS is of the opinion that vitamin A in cosmetics at the concentrations of 0.05% Retinol Equivalent (RE) in body lotion, and 0.3% RE for other leave-on and rinse-off products is safe.Regarding the contribution from cosmetics to overall/total exposure, no conclusion can be drawn due to inconsistencies in the presented model calculations. However, the probabilistic assessment regarding the contribution from food and food supplements shows that the exposure to vitamin A of the most exposed consumers (5% of the total population) may already exceed the upper limit. Compared to food, the contribution of vitamin A from cosmetics is lower. However, it will add to the overall consumer exposure and this may be of concern for consumers with the highest exposure (5% of the total population) to vitamin A from food and food supplements.(2) SCCS is invited to update accordingly opinion SCCS/1576/16 on Vitamin A notably as regards, as needed, the maximum concentration limits for the different categories of cosmetic products indicated in that Opinion.Since cosmetics alone do not exceed the upper limit, the allocation of contributions of different exposure sources is a risk management issue and cannot be addressed at the level of risk assessment.Therefore, it is beyond the scope of the SCCS to suggest maximum concentration limits that take into account contributions from other sources e.g. food, food supplements.Keywords:SCCS, revision, scientific opinion, vitamin A, Retinol, Retinyl Acetate, Retinyl Palmitate, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), revision of the scientific Opinion (SCCS/1576/16) on vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate), preliminary version of 10 December 2021, final version of 24-25 October 2022, SCCS/1639/21.

International audience; DetailsPublication date13 June 2022AuthorScientific Committee on Consumer Safety (SCCS)DescriptionSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. WijnhovenSCCS external experts: A. Koutsodimou, W. Uter, N. von GoetzContact:SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1637/21Adopted on: 15-16 March 2022Corrigendum including changes in the abstract, in sections 3.2.4 calculation of SED/LED - 3.4 safety evaluation - 3.5 discussion and relevant conclusions 1 and 2. Adoption 10 June 2022.Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Kojic acid, does the SCCS consider Kojic acid safe when used in cosmetic products up to a maximum concentration of 1 %?On the basis of the safety assessment, and considering the concerns related to potential endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that Kojic acid is safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Kojic acid in cosmetic products?/ (3) Does the SCCS have any further scientific concerns with regard to the use of Kojic acid in cosmetic products?As Kojic acid is sometimes added to peeling agents, a weakened skin barrier may be of additional concern because of greater dermal absorption.Only the topical use of Kojic acid in cosmetics has been considered in this Opinion. Other uses (e.g. food) of natural or synthetic sources have not been considered.As far as the derivatives of Kojic acid are concerned, e.g. esters of Kojic acid such as Kojic acid dipalmitate and Kojic acid isopalmitate, and derivatives such as chloro-Kojic acid, these have not been included in this Opinion as no data has been submitted.Keywords:SCCS, revision, scientific opinion, Kojic acid, CAS No 501-30-4, EC No 207-922-4, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on Kojic acid, preliminary version of 26-27 October 2021, final version of 15-16 March 2022, Corrigendum of 10 June 2022, SCCS/1637/21.

International audience; In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Octocrylene, does the SCCS consider Octocrylene safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10% (as acid)? On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of Octocrylene, the SCCS is of the opinion that Octocrylene is safe as a UV-filter at concentrations up to 10% in cosmetic products when used individually. Octocrylene is also considered safe for a combined use of sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick at a concentration up to 10%. However, the use of Octocrylene at 10% or above in sunscreen propellant spray is not considered safe for the combined use.

International audience; SCIENTIFIC ADVICE ON the safety of Homosalate (CAS No 118-56-9, EC No 204-260-8) as a UV-filter in cosmetic products - SCCS/1638/21 - Scientific AdviceU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written proccedure on 2 December 2021Mise en ligne le 3 Décember 2021https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_260.pdfAbstractScientific Advice on the safety of Homosalate (CAS No 118-56-9, EC No 204-260-8) as a UV-filter in cosmetic productsSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: A. Koutsodimou, W. Uter, N. von GoetzContact: SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1638/21Adopted on: 2 December 2021Conclusion of the opinion:1. In light of the information provided and taking under consideration the concerns related to potential endocrine disrupting properties of Homosalate, does the SCCS consider Homosalate safe when used as a UV-filter in face products (face cream and pump spray) up to a maximum concentration of 7.34 %?On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of Homosalate, the SCCS is of the opinion that Homosalate is safe as a UV-filter at concentrations up to 7.34% in face cream and pump spray.2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Homosalate as a UV-filter in face products (face cream and pump spray)?/Keywords:SCCS, scientific advice, Homosalate, UV-filter, Regulation 1223/2009, CAS No 118-56-9, EC No 204-260-8Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Scientific advice on the safety of Homosalate (CAS No 118-56-9, EC No 204-260-8) as a UV-filter in cosmetic products in cosmetic products, final version of 2 December 2021, SCCS/1638/21.

International audience; Opinion on Dihydroxyacetone (DHA) CAS N° 96-26-4In light of the data provided, does the SCCS consider Dihydroxyacetone safe when used as hair colouring ingredient in leave-on applications up to a maximum concentration of 6.25 %? On the basis of data provided, the SCCS considers Dihydroxyacetone safe when used as hair colouring ingredient in leave-on applications (non-oxidative) up to a maximum concentration of 6.25%. Does the SCCS have any further scientific concerns with regard to the use of Dihydroxyacetone in cosmetic products? The use of Dihydroxyacetone as hair colouring ingredient in leave-on applications (nonoxidative) up to a maximum concentration of 6.25% together with the use of self-tanning lotion and face cream containing up to a maximum concentration of 10% Dihydroxyacetone is considered safe.

International audience; Opinion on titanium dioxide (TiO2) used in cosmetic products that lead to exposure by inhalationIn light of the data provided and of the possible classification as Carcinogen Cat. 2 (inhalation) in Annex VI to Regulation (EC) n.1272/2008, does the SCCS consider Titanium dioxide safe when used as a UV-filter (entry 27 Annex VI) in cosmetic products up to a maximum concentration of 25 %, as a colorant (entry 143 Annex IV) and as an ingredient in all other cosmetic products? On the basis of safety assessment, the SCCS is of the opinion that the use of pigmentary titanium dioxide (TiO2) up to a maximum concentration of 25% in a typical hair styling aerosol spray product is not safe for either general consumers or hairdressers. The safety assessment has shown that the use of pigmentary TiO2 in loose powder up to a maximum concentration of 25% in a typical face make-up application is safe for the general consumer. It needs to be noted that these conclusions are based on safety assessment of TiO2 in the context of possible classification as category-2 carcinogen (via inhalation). This means that the conclusions drawn in this Opinion are applicable to the use of pigmentary TiO2 in a cosmetic product that may give rise to consumer exposure by the inhalation route (i.e. aerosol, spray and powder form products). As such, the Opinion is not applicable to any pearlescent pigment because of the composite nature of such materials, of which TiO2 is only a minor constituent. Alternatively, if up to 25% use is not considered safe, what is according to the SCCS, the maximum concentration considered safe for use of Titanium dioxide as an ingredient in cosmetic products? In the SCCS’s opinion, the use of pigmentary TiO2 in a typical hair styling aerosol spray product is safe up to a maximum concentration of 1.4 % for general consumers, and 1.1 % for hairdressers. Does the SCCS have any further scientific concerns with regard to the use of Titanium dioxide in cosmetic products? It needs to be emphasised that the SCCS conclusions have been drawn from a very selected group of cosmetic products based on only one type of TiO2 material (pigmentary, anatase, surface-treated). In the absence of more information, it may not be clear whether these conclusions would be applicable to the use of pigmentary TiO2 materials in other similar types of cosmetic applications that may be on the market. In this regard, the SCCS is of the opinion that other applications of pigmentary TiO2 materials can also be considered safe if the MoS calculation is performed as detailed in the current Opinion, and if the resultant MoS for the combined use of different products is above 25 for general consumers and for hairdressers.

International audience; Scientific advice on the SCCS opinion on methyl-N-methylanthranilate (MNM) (SCCS/1455/11)We would like to request scientific advice on whether the sentence from the SCCS Opinion (SCCS/1455/11) "…the SCCS considers that for the use in sunscreen/sun care products or products (including fragrances) intended for use on areas exposed to light (especially face and neck), a risk cannot be excluded" means that methyl-Nmethylanthranilate should not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light, but is considered safe to be used up to 0.1% for leave-on and 0.2% for rinse-off products". In the SCCS’s opinion, Methyl-N-methylanthranilate should not be used in sunscreen products and products marketed for exposure to natural/artificial UV light. It is considered safe to be used up to 0.1% for leave-on and 0.2% for rinse-off products.

International audience; Opinion on hair dye Indigofera tinctoria (C170) CAS 84775-63-3 - Submission IIIIn light of the data provided, does the SCCS consider Indigofera tinctoria (C170) safe when used in non-oxidative conditions hair colouring products at on-head concentrations of up to 25%? In light of the data provided, the SCCS considers that Indigofera tinctoria is safe when used in non-oxidative condition hair colouring products at on-head concentrations of up to 25%. Does the SCCS have any further scientific concerns with regard to the use of Indigofera tinctoria (C170) in cosmetic products? A weak skin sensitisation potential cannot be excluded for Indigofera tinctoria.

International audience; Opinion on zinc pyrithione (ZPT) (CAS No 13463-41-7) - Submission IIIIn view of the conditions laid out in Article 15(d) of the Regulation (EC) No 1223/2009 and taking into account the scientific data provided, does the SCCS consider Zinc Pyrithione safe when used as an anti-dandruff in rinse-off hair products up to a maximum concentration of 1%? In line with the conditions laid out in Article 15(d) (i.e. ‘overall exposure from other sources’) of the Regulation (EC) No 1223/2009 and taking into account the scientific data provided, the SCCS considers Zinc Pyrithione (ZPT) as safe when used as an anti-dandruff in rinse-off hair products up to a maximum concentration of 1%.

International audience

International audience; SCCS OPINION on Prostaglandins and their analogues used in cosmetic products - SCCS/1635/21 - Preliminary versionU. 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. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 27 September 2021Mise en Ligne 28 September 2021https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_258.pdfConclusion of the opinion: (1) In light of the data provided, does the SCCS consider Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide or DDDE (CAS 1185851-52-8) safe when used up to the concentrations provided in the respective dossiers (0.006% and 0.007% for Isopropyl cloprostenate and 0.018% for Ethyl Tafluprostamide)Having considered the limited data provided, and the available information from published literature, the SCCS is not able to conclude on the safety of isopropyl cloprostenate and ethyl tafluprostamide, when used up to the intended use concentrations indicated in the respective dossiers (0.006% and 0.007% for isopropyl cloprostenate and 0.018% for ethyl tafluprostamide).(2) Does the SCCS have any further scientific concerns with regard to the use of Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide / DDDE (CAS 1185851-52-8) in cosmetic products?The SCCS has noted serious concerns about the safety of isopropyl cloprostenate and ethyl tafluprostamide when used in cosmetic products - in particular those that are intended for use in the proximity of the eye. These concerns have been highlighted in more details in Annex 1.(3) In light of the available data, does the SCCS consider that the use in cosmetic products of prostaglandins analogues (listed in Table 1) raises safety concerns and might pose a risk to human health?Prostaglandins and synthetic analogues are widely known to be potent pharmacologically active substances. Due to these effects, other regulatory authorities have advised against, or have prohibited, their use in eyelash growth-promoting cosmetics. In view of the potential for causing effects at very low concentrations, and the intended use in the proximity of the eye, the SCCS has noted serious concerns over the safety of prostaglandin analogues when used in cosmetic products. These have been highlighted in Annex 1 to this Opinion.Keywords:SCCS, scientific opinion, prostaglandins, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Prostaglandins and prostaglandin-analogues used in cosmetic products, preliminary version of 27 September 2021, SCCS/1635/21.

International audience; SCCS OPINION on Butylated Hydroxytoluene (BHT) - SCCS/1636/21 - Preliminary versionU. 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. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 27 September 2021Mise en Ligne 28 September 2021 https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_257.pdfConclusion of the opinion: (1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of BHT (Butylated hydroxytoluene), does the SCCS consider BHT safe: (a) when used in mouthwash up to the maximum concentration of 0.001% and in toothpaste up to the maximum concentration of 0.1% ?On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties of BHT, the SCCS is of the opinion that BHT is safe as an ingredient up to a maximum concentration of 0.001% in mouthwash and 0.1% in toothpaste. (b) when used in other leave on and rinse-off products up to a maximum concentration of 0.8 % ?On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties of BHT, the SCCS is of the opinion that BHT is safe as an ingredient up to a maximum concentration of 0.8% in other leave-on and rinse-off products.BHT is also considered safe for a combined use of mouthwash at a concentration of 0.001%, toothpaste at a concentration of 0.1% and other leave-on and rinse-off products at the concentration of 0.8%.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of BHT (Butylated hydroxytoluene) in cosmetic products?/ (3) Does the SCCS have any further scientific concerns with regard to the use of BHT (Butylated hydroxytoluene) in cosmetic products?The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of BHT for the environment.Keywords:SCCS, scientific opinion, Butylated hydroxytoluene (BHT), CAS No 128-37-0, EC No 204-881-4, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on Butylated hydroxytoluene (BHT), preliminary version of 27 September 2021, SCCS/1636/21.

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International audience; Conclusion of the opinion:1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of homosalate, does the SCCS consider homosalate safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10 %?On the basis of safety assessment of homosalate, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that homosalate is not safe when used as a UV-filter in cosmetic products at concentrations of up to 10%.2. Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of homosalate as a UV-filter in cosmetic products?In the SCCS’s opinion, the use of homosalate as a UV filter in cosmetic products is safe for the consumer up to a maximum concentration of 0.5% homosalate in the final product.3. Does the SCCS have any further scientific concerns with regard to the use of homosalate in cosmetic products?It needs to be noted that the SCCS has regarded the currently available evidence for endocrine disrupting properties of homosalate as inconclusive, and at best equivocal. This applies to all of the available data derived from in silico modelling, in vitro tests and in vivo studies, when considered individually or taken together. The SCCS considers that, whilst there are indications from some studies to suggest that homosalate may have endocrine effects, the evidence is not conclusive enough at present to enable deriving a specific endocrine-related toxicological point of departure for use in safety assessment.Exposure to homosalate from other products than those in this Opinion has not been considered.Combined exposure to salicylic acid either formed by metabolic transformation from homosalate, other salicylates (e.g. methylsalicylate) or directly from salicylic acid itself has not been considered in this opinion.The use of Homosalate at the lower concentrations may have a bearing on efficacy as UV-filter, however this is outside the SCCS remit to assess the efficacy of cosmetic ingredients.Keywords: SCCS, scientific opinion, homosalate, UV-filter, Regulation 1223/2009, CAS No 118-56-9, EC No 204-260-8Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on homosalate (CAS No 118-56-9, EC No 204-260-8), preliminary version of 27-28 October 2020, final version of 24-25 June 2021, SCCS/1622/20.

International audience; Conclusion of the opinion:1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Octocrylene, does the SCCS consider Octocrylene safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10% (as acid)?On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of Octocrylene, the SCCS is of the opinion that Octocrylene is safe as a UV-filter at concentrations up to 10% in cosmetic products when used individually.Octocrylene is also considered safe for a combined use of sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick at a concentration up to 10%. However, the use of Octocrylene at 10% or above in sunscreen propellant spray is not considered safe for the combined use.2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Octocrylene as a UV-filter in cosmetic products?The use of Octocrylene in sunscreen propellant spray is considered safe when its concentration does not exceed 9% when used together with face cream, hand cream, and lipstick containing 10% Octocrylene.3. Does the SCCS have any further scientific concerns with regard to the use of Octocrylene in cosmetic products?The SCCS considers that, whilst there are indications from some in vivo studies to suggest that Octocrylene may have endocrine effects, the evidence is not conclusive enough at present to enable deriving a specific endocrine-related toxicological point of departure for use in safety assessment. Contact sensitisation to Octocrylene has been reported, however, taking into consideration the widespread use of Octocrylene in cosmetic products, the number of reported cases of allergic contact dermatitis appears to be negligible.It should be noted that occurrence of photoallergy to Octocrylene is strongly related to a previous photoallergy to topical ketoprofen. Exposure to Octocrylene from other products than those in this Opinion has not been considered.The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Octocrylene for the environment.Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Octocrylene (CAS No 6197-30-4, EC No 228-250-8), preliminary version of 15 January 2021, final version of 30-31 March 2021, SCCS/1627/21.

International audience; Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Benzophenone-3, does the SCCS consider Benzophenone-3 safe when used as a UV-filter in cosmetic products up to a maximum concentration of 6% and up to 0.5% in cosmetic products to protect product formulation?On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of benzophenone-3 (BP-3), the SCCS has concluded that:a. The use of BP-3 as a UV-filter up to a maximum concentration of 6% in sunscreen products, either in the form of body cream, sunscreen propellant spray or pump spray, is not safe for the consumer.b. The use of BP-3 as a UV-filter up to a maximum concentration of 6% in face cream, hand cream, and lipsticks is safe for the consumer.c. The use of BP-3 up to 0.5% in cosmetic products to protect the cosmetic formulation is safe for the consumer.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Benzophenone-3 as a UV-filter in cosmetic products?In the SCCS’s opinion, the use of BP-3 as a UV filter in the following sunscreen products is safe for the consumer up to a maximum concentration of:a. 2.2% in body creams, in propellant sprays and in pump sprays, provided that there is no additional use of BP-3 at 0.5% in the same formulation for protecting the cosmetic formulation.b. Where BP-3 is also used at 0.5% in the same formulation, the levels of BP-3 used as UV filter should not exceed 1.7% in body creams, in propellant sprays and in pump sprays.(3) Does the SCCS have any further scientific concerns with regard to the use of Benzophenone-3 in cosmetic products?It needs to be noted that the SCCS has regarded the currently available evidence for endocrine disrupting properties of BP-3 as inconclusive, and at best equivocal. This applies to all of the available data derived from in silico modelling, in vitro tests and in vivo studies, either considered individually or taken together. The SCCS considers that, whilst there are indications from some studies to suggest that BP-3 may have endocrine effects, the overall evidence is not conclusive enough at present for the SCCS to ascertain whether or not BP-3 is an ED substance, and this warrants further investigations.The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of BP-3 for the environment.Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5), preliminary version of 15 December 2020, final version of 30-31 March 2021, SCCS/1625/20.

International audience; Conclusion of the opinion:1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Propylparaben, does the SCCS consider Propylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %?On the basis of the safety assessment of Propylparaben, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that propylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %.2. Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of Propylparaben as a preservative in cosmetic products?/3. Does the SCCS have any further scientific concerns with regard to the use of Propylparaben in cosmetic products?The available data on Propylparaben provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment.The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of propylparaben for the environment.Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Propylparaben (CAS No 94-13-3, EC No 202-307-7), preliminary version of 27-28 October 2020, final version of 30-31 March 2021, SCCS/1623/20.

International audience; Background:The “Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation by the SCCS” is a document compiled by the members of the Scientific Committee on Consumer Safety (SCCS, replacing the former SCCP, SCCNFP and SCC). The document contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of this guidance is on cosmetic ingredients, although some guidance is also indirectly given for the safety assessment of finished products. It is designed to provide guidance to public authorities and to the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation. An important development in recent years was the full implementation of the cosmetic legislation, Regulation (EC) No 1223/2009, meaning that the animal testing and marketing bans fully apply from 2013 onwards: no in vivo testing of finished products after 11 March 2004; no in vivo testing for local toxicity after 11 March 2009 and no in vivo testing for repeated dose toxicity (including sensitisation) toxicokinetics and developmental toxicity from 11 March 2013 onwards for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made with regard to the development and validation of alternative methods, with emphasis on replacement methodology.The "Notes of Guidance" are regularly revised and updated in order to incorporate the progress of scientific knowledge in general, and the experience gained, in particular in the field of testing and safety evaluation of cosmetic ingredients.

International audience; SCCS OPINION on Butylated Hydroxytoluene (BHT) - SCCS/1636/21 - Final versionU. 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. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written proccedure on 2 December 2021Mise en Ligne le 3 Décembre 2021https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_257.pdfAbstractButylated Hydroxytoluene (BHT)SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: A. Koutsodimou, W. Uter, N. von GoetzContact: SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1636/21Adopted on: 2 December 2021Conclusion of the opinion: (1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of BHT (Butylated hydroxytoluene), does the SCCS consider BHT safe:(a) when used in mouthwash up to the maximum concentration of 0.001% and in toothpaste up to the maximum concentration of 0.1% ?On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties of BHT, the SCCS is of the opinion that BHT is safe as an ingredient up to a maximum concentration of 0.001% in mouthwash and 0.1% in toothpaste. (b) when used in other leave on and rinse-off products up to a maximum concentration of 0.8 % ?On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties of BHT, the SCCS is of the opinion that BHT is safe as an ingredient up to a maximum concentration of 0.8% in other leave-on and rinse-off products.BHT is also considered safe for a combined use of mouthwash at a concentration of 0.001%, toothpaste at a concentration of 0.1% and other leave-on and rinse-off products at the concentration of 0.8%.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of BHT (Butylated hydroxytoluene) in cosmetic products?/ (3) Does the SCCS have any further scientific concerns with regard to the use of BHT (Butylated hydroxytoluene) in cosmetic products?The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of BHT for the environment.Keywords:SCCS, scientific opinion, Butylated hydroxytoluene (BHT), CAS No 128-37-0, EC No 204-881-4, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on Butylated hydroxytoluene (BHT), preliminary version of 27 September 2021, final version of 2 December 2021, SCCS/1636/21.

The “SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 11 th Revision” (SCCS/1628/21) contains relevant and updated information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis is on cosmetic ingredients for which a concern has been expressed for human health. Indirectly, the Guidance also provides some advice on the safety of finished products. A general aim is to improve harmonised compliance with the current cosmetic EU legislation, Regulation (EC) No 1223/2009, for which animal testing and marketing bans fully apply from 2013 onwards. This means that no in vivo testing of ingredients or finished products is allowed in Europe for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made in regard to the development and validation of alternative replacement methods, also referred to as new approach methodology (NAM). The “SCCS Notes of Guidance” are regularly revised and updated in order to incorporate progress made and experience gained over time, in particular on the use of NAMs, and the new methods and data that became available since previous revision (SCCS/1602/18) formed the basis of the current (11 th) Revision. © 2021 Elsevier Inc.

International audience; Kojic acidSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. WijnhovenSCCS external experts: A. Koutsodimou, W. Uter, N. von GoetzContact: SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1637/21Adopted on: 26-27 October 2021Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Kojic acid, does the SCCS consider Kojic acid safe when used in cosmetic products up to a maximum concentration of 1 %?On the basis of the safety assessment, and considering the concerns related to potential endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that the concentration of 1% Kojic acid is not safe for the intended use in cosmetic products.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Kojic acid in cosmetic products?Without specific data on the different cosmetic products containing Kojic acid, the SCCS is unable to advice on the safe concentration of Kojic acid in individual cosmetic products. As an example, for the combined twice a day use of face cream and hand cream, the maximum concentration of Kojic acid should not exceed 0.04%.(3) Does the SCCS have any further scientific concerns with regard to the use of Kojic acid in cosmetic products?As Kojic acid is sometimes added to peeling agents, a weakened skin barrier may be of additional concern because of greater dermal absorption.Only the topical use of Kojic acid in cosmetics has been considered in this Opinion. Other uses (e.g. food) of natural or synthetic sources have not been considered.As far as the derivatives of Kojic acid are concerned, e.g. esters of Kojic acid such as Kojic acid dipalmitate and Kojic acid isopalmitate, and derivatives such as chloro-Kojic acid, these have not been included in this Opinion as no data has been submitted.Keywords:SCCS, revision, scientific opinion, Kojic acid, CAS No 501-30-4, EC No 207-922-4, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on Kojic acid, preliminary version of 26-27 October 2021, SCCS/1637/21.

International audience; 4-Methylbenzylidene camphor (4-MBC)SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, B. Granum, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. WijnhovenSCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzContact: SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1640/21Adopted on: 22 December 2021Conclusion of the opinion:(1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of 4-Methylbenzylidene camphor (4-MBC), does the SCCS consider 4-MBC safe when used as a UV-filter in cosmetic products up to a maximum concentration of 4%?The SCCS cannot conclude on the safety of 4-MBC, because the information provided is insufficient to fully evaluate potential genotoxicity.Moreover, there is sufficient evidence that 4-MBC may act as an endocrine disruptor and has effects on both the thyroid and estrogen systems. Effects on the thyroid and estrogen systems occur at oral exposure levels of 50 and 100 mg/kg bw/day or higher, respectively. Effects on the androgen system are not so evident, as only in vitro evidence is available.Even if the genotoxic potential was excluded, the current re-evaluation of 4-MBC established a higher exposure level than in the previous Opinion. This would result in a lower MoS value, indicating that the use of 4-MBC at the maximum concentration of 4% in cosmetic ingredients would not be safe.(2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of 4-MBC as a UV-filter in cosmetic products?It is not possible to derive a maximum concentration for safe use of 4-MBC, because a genotoxicity potential cannot be excluded.(3) Does the SCCS have any further scientific concerns with regard to the use of 4-MBC in cosmetic products?The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of 4-MBC for the environment.Keywords:SCCS, revision, scientific opinion, 4-Methylbenzylidene camphor (4-MBC), CAS No 36861-47-9/38102-62-4, EC No 253-242-6, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), scientific opinion on 4-Methylbenzylidene camphor (4-MBC), preliminary version of 22 December SCCS/1640/21.

In cosmetic products, the ingredient propylparaben (CAS No 94-13-3, EC No 202-307-7) with the chemical names Propyl 4-hydroxybenzoate and 4-Hydroxybenzoic acid propyl ester is currently regulated as a preservative in a concentration up to 0.14% (as acid) (Annex V/12a). In addition, a safe concentration was established for mixtures of parabens, where the sum of the individual concentrations should not exceed 0.8% (as acid). However, in such mixtures the sum of the individual concentrations of butyl- and propylparaben and their salts should not exceed 0.14%. Propylparaben was subject to different safety evaluations in 2005 (SCCP/0874/05), 2006 (SCCP/1017/06), 2008 (SCCP/1183/08), 2010 (SCCS/1348/10), 2011 (SCCS/1446/11), and in 2013 (SCCS/1514/13). On the basis of the safety assessment of propylparaben, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that propylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14%. The available data on propylparaben provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of propylparaben for the environment. Link to the Opinion (SCCS/1623/20): https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_243.pdf © 2021

International audience; SCCS OPINION ON Lawsonia inermis (Henna) - COLIPA n° C169 - SCCS/1511/13 CorrigendumU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this opinion at its 3rd plenary meeting on 19 September 2013 - Corrigendum of 12 November 2021 (45 pages)Mise en ligne le 15 Novembre 2021https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_140.pdf

International audience; Opinion on the safety of aluminium in cosmetic products Submission IIIn 2014, the SCCS was asked to review the safety of aluminium in cosmetic products. Aluminium containing ingredients were reported by cosmetic industry to be used in a lot of different categories of cosmetic products. Among them antiperspirants and deodorants, lipsticks and toothpastes were considered by the SCCS to be the main contributing sources of exposure via cosmetic products. The SCCS Opinion (SCCS/1525/14) concluded that due to the lack of adequate data on dermal penetration to estimate the internal dose of aluminium following cosmetic uses, risk assessment could not be performed, and asked for internal exposure to aluminium after skin application to be determined using a human exposure study under use conditions. The current SCCS Opinion is based on the new data and exposure assessment provided by the Applicant as part of Submission II.