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International audience; L’évaluation des risques décrite dans ce chapitre, au sens de Risk Assessment défini en 1983 par le National Research Council (NRC, 1983) est une analyse scientifique basée sur le recueil de données et la modélisation. Ses résultats sont des expressions qualitatives ou quantitatives de l’intensité et de la vraisemblance de dommages, causés par une exposition. L’évaluation s’effectue au niveau populationnel, car il ne s’agit pas de prédictions individuelles. Elle est la première composante de l’analyse des risques, qui comprend également la gestion et la communication des risques (OMS, 2021). Cet outil mobilise et organise les connaissances existantes pour aider à la décision publique, répondre à une question spécifique, guider la mise en œuvre de politiques publiques, ou la mise en place de réglementations protectrices de la santé.Si ce chapitre traite des composés chimiques, les concepts, principes et étapes de la démarche s’appliquent aussi aux risques physiques et biologiques. Après une présentation de ses objectifs, ce chapitre abordera les raisons d’être et les concepts de la démarche d’évaluation des risques sanitaires, puis en détaillera les étapes : formulation du problème, identification des dangers, établissement de la relation dose-réponse, évaluation des expositions et enfin caractérisation des risques et des incertitudes.

Current approaches for the assessment of environmental and human health risks due to exposure to chemical substances have served their purpose reasonably well. Nevertheless, the systems in place for different uses of chemicals are faced with various challenges, ranging from a growing number of chemicals to changes in the types of chemicals and materials produced. This has triggered global awareness of the need for a paradigm shift, which in turn has led to the publication of new concepts for chemical risk assessment and explorations of how to translate these concepts into pragmatic approaches. As a result, next-generation risk assessment (NGRA) is generally seen as the way forward. However, incorporating new scientific insights and innovative approaches into hazard and exposure assessments in such a way that regulatory needs are adequately met has appeared to be challenging. The European Partnership for the Assessment of Risks from Chemicals (PARC) has been designed to address various challenges associated with innovating chemical risk assessment. Its overall goal is to consolidate and strengthen the European research and innovation capacity for chemical risk assessment to protect human health and the environment. With around 200 participating organisations from all over Europe, including three European agencies, and a total budget of over 400 million euro, PARC is one of the largest projects of its kind. It has a duration of seven years and is coordinated by ANSES, the French Agency for Food, Environmental and Occupational Health & Safety. Open Access funding enabled and organized by Projekt DEAL. The European Partnership for the Assessment of Risks from Chemicals has received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No 101057014. Co-funding for the UK contribution via Innovate UK project ID 1752317 as part of the Horizon Europe Guarantee fund. Views and opinions expressed are, however, those of the author(s) only and do not necessarily refect those of the European Union or the Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them. Sí

International audience; SCCS (Scientific Committee on Consumer Safety), scientific opinion on Butylated hydroxytoluene (BHT), preliminary version of September 27, 2021, final version of December 2, 2021, SCCS/1636/21.

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; SCCS OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5) - Submission II - SCCS/1631/21 – Final 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, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 23 July 2021 (31 Pages)Mise en ligne le 26 Juillet 2021 https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_253.pdfConclusion of the opinion: (1) In light of the data provided, does the SCCS consider Acid Yellow 3, safe when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5 %?Based on the data provided in the dossier, the SCCS considers that Acid Yellow 3 is safe when used in non-oxidative hair colouring products at on-head concentrations of up to 0.5%.(2) Does the SCCS have any further scientific concerns with regard to the use of Acid Yellow 3 in cosmetic products?A detailed analytical report on the test substance in representative batches and results of the stability tests should be provided to exclude the possibility of the presence of any impurities that may be of concern.Keywords:SCCS, scientific opinion, Acid Yellow 3, hair dye, Regulation 1223/2009, CAS Number 8004-92-0, EC No 305-897-5Opinion 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 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 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 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; SCCS OPINION on Methyl salicylate (methyl 2-hydroxybenzoate) - Submission I - SCCS/1633/21- 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, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document at its plenary meeting on 24-25 June 2021 ( (80 pages)Mise en ligne le 9 Juillet 2021https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_255.pdfConclusion of the opinion: (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, except for mouth washes used below 10 years old.(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.Keywords:SCCS, scientific opinion, methyl salicylate, methyl 2-hydroxybenzoate, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on methyl salicylate (methyl 2-hydroxybenzoate), preliminary version of 24-25 June, SCCS/1633/21.

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

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; The SCCS concludes the following:1. In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterials Gold and Colloidal Gold, Gold Thioethylamino Hyaluronic Acid and Acetyl heptapeptide-9 Colloidal gold are safe when used in leave-on skin cosmetic products according to the maximum concentrations and specifications, taking into account reasonably foreseeable exposure conditions?The SCCS has considered all the information provided by the Notifiers and is of the opinion that it is not possible to carry out safety assessment of the nanomaterials (Gold, Colloidal Gold and Surface Modified Gold) due to limited or missing essential information. Much of the information provided on toxicity relates to gold as such, and it is not possible to determine the relevance of the data for nano-forms of any of the materials under the current evaluation due to the absence of full study reports.Detailed data and information need to be provided on physicochemical characterisation and toxicological evaluation, along with experiment performance to allow safety assessment of the nanomaterials.In regard to surface modified gold, all notifications relating to Acetyl heptapeptide-9 Colloidal gold (nano) were withdrawn by the Notifiers and therefore only Gold Thioethylamino Hyaluronic Acid has been considered in this Opinion.2. Does the SCCS have any further scientific concerns with regard to the use of materials A, B and C in nano form in cosmetic products?The information obtained from scientific literature suggests possible systemic uptake of gold nanoparticles which may lead to accumulation in certain organs - notably the liver and spleen. In addition, the available data from literature indicate potential mutagenic/genotoxic effects of gold nanomaterials. These indications raise an alert that warrants further safety evaluation of gold nanomaterials when used as cosmetic ingredients. In the absence of sufficient data to allow safety assessment, the SCCS has considered these aspects and has concluded that there is a basis for concern that the use of Gold (nano), Colloidal Gold (nano) and Surface Modified Gold (nano) materials in cosmetic products can pose a risk to the consumer. The SCCS concerns for consumer safety in this regard are detailed in Annex II. The SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.

International audience; . ABSTRACTThe SCCS concludes the following:(1) In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterials A (Platinum and Colloidal Platinum ) and B (Acetyl tetrapeptide-17 (and) Colloidal Platinum) are safe when used in leave-on cosmetic products according to the maximum concentrations and specifications reported in the attached list, taking into account reasonably foreseeable exposure conditions?Having considered all the information provided by the Notifiers, and that obtained from other sources, the SCCS is of the opinion that it is not possible to carry out a safety assessment of any of the notified platinum nanomaterials due to limited or missing essential information. The limited amount of data provided by the Notifiers also does not correspond to the requirements and data standards as indicated in the SCCS Guidance (SCCS 1611/19), and the SCCS Memorandum (SCCS/1524/13). To enable safety assessment by the SCCS, the Notifiers need to provide the necessary information, a summary of which is provided in Annex I.(2) Does the SCCS have any further scientific concerns with regard to the use of materials A and B in nano form in cosmetic products?In the absence of sufficient data to allow safety assessment, the SCCS has considered the different aspects of platinum nanomaterials that could raise a concern over consumer safety. As detailed in Annex II, the SCCS has concluded that there is a basis for concern that the use of platinum, colloidal platinum, and acetyl tetrapeptide-17 colloidal platinum (nano) in cosmetic products can pose a risk to the consumer. The SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.Keywords: SCCS, scientific opinion, Platinum, Colloidal Platinum, Acetyl tetrapeptide-17 Colloidal Platinum, nano, CAS No 7440-06-4, EC No. 231-116-1, Regulation 1223/2009Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano), final version of 24-25 June 2021, SCCS/1630/21

International audience; SCCS OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5) - Submission II - SCCS/1631/21 – 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 GötzThe SCCS adopted this document by written procedure on 7 May 2021 (32 Pages)Mise en ligne 10 Mai 2021 https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_253.pdfOn request from: European CommissionSCCS Number: SCCS/1631/21Adopted on: 7 May 2021Conclusion of the opinion: (1) In light of the data provided, does the SCCS consider Acid Yellow 3, safe when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5 %?Based on the data provided in the dossier, the SCCS considers that Acid Yellow 3 is safe when used in non-oxidative hair colouring products at on-head concentrations of up to 0.5%. (2) Does the SCCS have any further scientific concerns with regard to the use of Acid Yellow 3 in cosmetic products?A detailed analytical report on the test substance in representative batches and results of the stability tests should be provided to exclude the possibility of the presence of any impurities that may be of concern.Keywords:SCCS, scientific opinion, Acid Yellow 3, hair dye, Regulation 1223/2009, CAS Number 8004-92-0, EC No 305-897-5Opinion 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, SCCS/1631/21.

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 Resorcinol, does the SCCS consider Resorcinol safe when used as an oxidative hair dye in products intended for hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos?Keeping in view the evidence on endocrine disrupting properties of resorcinol, the SCCS assessment shows that resorcinol is safe when used as an oxidative hair dye in products intended for hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos.2/ Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of Resorcinol as an oxidative hair dye in products intended for hair and eyelashes and for hair lotions and shampoos?/3/ Does the SCCS have any further scientific concerns with regard to the use of Resorcinol in cosmetic products?Resorcinol is a moderate skin sensitiser based on data from animal studies. Clinical studies show that the frequency of contact sensitisation in humans is low.The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of resorcinol for the environment.Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Resorcinol (CAS No 108-46-3, EC No 203-585-2), preliminary version of 16 October 2020, final version of 30-31 March 2021, SCCS/1619/20

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; The European Commission and its Scientific Committee on Consumer Safety (SCCS) published the final Opinion on the safety of presence of BPA in clothing articles.A public consultation on the preliminary Opinion on the safety of presence of BPA in clothing articles was open on the website of the Scientific Committees from 16 October to 7 December 2020. Information about the public consultation was broadly communicated to national authorities, international organisations and other stakeholders. The SCCS received 25 comments from six different interested parties.Each comment and reference submitted during this time was carefully considered by the SCCS. Where appropriate, the text of the relevant sections of the Opinion was edited or explanations were added to pertinent comments. The literature list has been updated with relevant publications

International audience; The SCCS adopted this Advice by written procedure on 8 January 2021 - Corrigendum of 8 March 2021 The SCCS concludes the following:1. The SCCS is requested to determine the nanomaterials, as published in the recent catalogue of nanomaterials of 2019, for which specific concerns can be identified and justified in order to establish a priority list of nanomaterials for risk assessment (Article 16(4) Reg.1223/2009). More specifically, the SCCS is requested to provide a description of the specific concerns that have been identified for the nanomaterials mentioned above. This process should be based on the currently available scientific literature and SCCS’ expert judgement.*Through a review of the available information and expert judgment, the SCCS has identified certain aspects of nanomaterials that constitute a basis for concern over safety to consumers’ health when used in cosmetic products. These include:• Physicochemical aspects relating to: very small dimensions of the constituent particles; solubility/persistence; chemical nature and toxicity of the nanomaterial; physical/morphological features of the constituent particles; surface chemistry and surface characteristics (surface modifications/coatings);• Exposure aspects relating to: the frequency and the amounts used, whether the number/type of consumer product(s) used is relatively high; and whether there is a potential for systemic exposure of the consumer to nanoparticles and potential accumulation in the body;• Other aspects relating to: novel properties, activity or function, and specific concern arising from the type of application.A detailed account of these aspects has been presented in this Advice. Also, the nanomaterials listed in the EC catalogue of nanomaterials of 2019 have been tabulated in an order of priority according to risk potential in Annex 1 of this Advice.2. For the nanomaterials with inconclusive SCCS opinions, such as [Colloidal Silver (nano) (SCCS/1596/18), Styrene/Acrylates copolymer (nano) + Sodium styrene/Acrylates copolymer (nano) (SCCS/1595/18) and Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form) (SCCS/1545/15)], the SCCS is requested to assess if a potential risk can be identified according to Article 16(6) Reg. 1223/2009. Such assessment, regardless of the data previously submitted by the respective applicants, should be based on the available scientific literature and SCCS’ expert judgement (i.e. systemic or local availability; harmful effects specifically related to nano-form; surface catalysed reactions in nano-form, absorption (or potential absorption) from dermal and inhalation routes, potential of nano-form to deliver ionic forms, etc.).*The SCCS has reviewed previous inconclusive opinions on three nanomaterials (SCCS/1596/18; SCCS/1595/18 and SCCS/1545/15), in conjunction with any further relevant information available in published literature to identify whether there is a scientific basis for concern over their safety to consumers’ health when used in cosmetic products. The SCCS has identified certain aspects relating to each of the nanomaterials that raise a safety concern. These have been detailed in three separate annexes (2, 3 and 4) to this Advice.

International audience; Copper (nano) and Colloidal Copper (nano)https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_245.pdfConclusion of the opinion:1. In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterials Copper and Colloidal Copper safe when used in leave-on and rinse-off dermal and oral cosmetic products including: skin, nail and cuticle, hair and scalp and oral hygiene products, at a maximum concentration of 1 % (for both Copper and Colloidal Copper) and with specifications as reported in the attached list, taking into account reasonably foreseeable exposure conditions?The SCCS has considered all the information provided by the Notifiers and is of the opinion that it is not possible to carry out safety assessment of the nanomaterials Copper and Colloidal Copper due to the limited or missing essential information.Much of the information provided on toxicity relates to copper as such, and in the absence of full study reports, it is not possible to determine the relevance of the data for nano-forms of copper under the current evaluation.Adequate information on various aspects both for the nanomaterial characterisation and the toxicological evaluation including experiment performance and experimental data obtained need to be provided (as summarised in Annex I).2. Does the SCCS have any further scientific concerns with regard to the use of Copper and Colloidal Copper in nano form in cosmetic products?The information provided by the Notifiers, and obtained from scientific literature, suggests possible systemic uptake of Cu nanoparticle (and/or ionic Cu), which may lead to accumulation in certain organs - notably the liver and spleen. In addition, the available literature data indicate potential mutagenic/genotoxic and immunotoxic/nephrotoxic effects of copper nanomaterials. These indications raise an alert that warrants further safety evaluation of copper nanomaterials used as cosmetic ingredients. The SCCS concerns for consumer safety in this regard are detailed in Annex II.Annex I provides an overview of the information provided by the Notifiers compared to the data requirements as given in the SCCS checklists for Applicants submitting dossiers on Cosmetic Ingredients to be evaluated by the SCCS (SCCS/1588/17).Keywords:SCCS, scientific opinion, Copper (nano), Colloidal Copper (nano), CAS No 7440-50-8, EC No. 231-159-6, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Opinion on Copper (nano) and Colloidal Copper (nano), preliminary version of 27-28 October 2020, final version of 5 March 2021, SCCS/1621/2020.

International audience; "SCCS OPINION ON Octocrylene"SCCS/1627/21- 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, A. Koutsodimou, W. Uter, N. von GoetzThe SCCS adopted this document by written procedure on 15 January 2021 (47 Pages)Mise en ligne 18 January 2021https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_249.pdfSCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (Rapporteur), 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 expert: A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)Contact: SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1627/21Adopted on: 15 January 2021Conclusion 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 (CAS No 6197-30-4), the SCCS considers that it is safe at concentrations of up to 10% when used individually or together as a UV-filter in cosmetic products, i.e. in sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick.Also, the use of sunscreen propellant spray is considered safe at concentrations of up to 10% when used individually but not safe when used together with face cream, hand cream, and lipstick.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.Keywords:SCCS, scientific opinion, Octocrylene, UV-filter, Regulation 1223/2009, CAS No 6197-30-4, EC No 228-250-8Opinion 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, SCCS/1627/21.

International audience; SCIENTIFIC ADVICE on the safety of nanomaterials in cosmeticsSCCS/1618/2020 Scientific AdviceU. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, C. Rousselle, M. Stepnik, S. Wijnhoven, W.H. de Jong, N. von GötzThe SCCS adopted this document by written procedure on 8 January 2021on line 11 January 2021 (49 pages)https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_239.pdfWG on Nanomaterials in Cosmetic ProductsSCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry (Rapporteur), P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle, M. Stepnik, S. WijnhovenSCHEER member: W.H. de JongSCCS external expert: N. von GoetzContact: SANTE-C2-SCCS@ec.europa.euOn request from: European CommissionSCCS Number: SCCS/1618/20Adopted on: 8 January 2021Conclusion of the opinion:1. The SCCS is requested to determine the nanomaterials, as published in the recent catalogue of nanomaterials of 2019, for which specific concerns can be identified and justified in order to establish a priority list of nanomaterials for risk assessment (Article 16(4) Reg.1223/2009). More specifically, the SCCS is requested to provide a description of the specific concerns that have been identified for the nanomaterials mentioned above. This process should be based on the currently available scientific literature and SCCS’ expert judgement.*Through a review of the available information and expert judgment, the SCCS has identified certain aspects of nanomaterials that constitute a basis for concern over safety to consumers’ health when used in cosmetic products. These include:- Physicochemical aspects relating to: very small dimensions of the constituent particles; solubility/persistence; chemical nature and toxicity of the nanomaterial; physical/morphological features of the constituent particles; surface chemistry and surface characteristics (surface modifications/coatings);- Exposure aspects relating to: the frequency and the amounts used, whether the number/type of consumer product(s) used is relatively high; and whether there is a potential for systemic exposure of the consumer to nanoparticles and potential accumulation in the body;- Other aspects relating to: novel properties, activity or function, and specific concern arising from the type of application.A detailed account of these aspects has been presented in this Advice. Also, the nanomaterials listed in the EC catalogue of nanomaterials of 2019 have been tabulated in an order of priority according to risk potential in Annex 1 of this Advice.2. For the nanomaterials with inconclusive SCCS opinions, such as [Colloidal Silver (nano) (SCCS/1596/18), Styrene/Acrylates copolymer (nano) + Sodium styrene/Acrylates copolymer (nano) (SCCS/1595/18) and Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form) (SCCS/1545/15)], the SCCS is requested to assess if a potential risk can be identified according to Article 16(6) Reg. 1223/2009. Such assessment, regardless of the data previously submitted by the respective applicants, should be based on the available scientific literature and SCCS’ expert judgement (i.e. systemic or local availability; harmful effects specifically related to nano-form; surface catalysed reactions in nano-form, absorption (or potential absorption) from dermal and inhalation routes, potential of nano-form to deliver ionic forms, etc.).*The SCCS has reviewed previous inconclusive opinions on three nanomaterials (SCCS/1596/18; SCCS/1595/18 and SCCS/1545/15), in conjunction with any further relevant information available in published literature to identify whether there is a scientific basis for concern over their safety to consumers’ health when used in cosmetic products. The SCCS has identified certain aspects relating to each of the nanomaterials that raise a safety concern. These have been detailed in three separate annexes (2, 3 and 4) to this Advice.* In the assessment of the above question and in order to avoid conflicting opinions with other bodies, SCCS is invited to consult SCHEER.________________________________________Keywords:SCCS, scientific advice, safety, nanomaterials, Regulation 1223/2009________________________________________Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Scientific advice on the safety of nanomaterials in cosmetics, preliminary version of 6 October 2020, final version of 8 January 2021, SCCS/1618/2020.

International audience; Conclusion of the opinion: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 lipstick2. 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.Keywords:SCCS, scientific opinion, aluminium, addendum, lipstick, Regulation 1223/2009Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Addendum to the scientific opinion SCCS/1613/19 on the safety of aluminium in cosmetic products - Submission II, preliminary version of 15 December 2020, final version of 30-31 March 2021, SCCS/1626/20.

International audience; SCCS SCIENTIFIC ADVICE ON on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances - SCCS/1632/21– Scientific adviceU. 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, N. von Götz, S. Wijnhoven, A. Koutsodimou, W. UterThe SCCS adopted this document by written procedure on 7 May 2021 (12 Pages)Mise en ligne 10 Mai 2021 https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_254.pdfOn request from: European CommissionSCCS Number: SCCS/1632/21Adopted on: 7 May 2021Conclusion of the opinion:1. In light of the data provided and taking under consideration the available scientific literature, does the SCCS consider the 0.05% threshold for labelling formaldehyde releasing substances adequate to protect consumers?The SCCS considers that the present threshold does not sufficiently protect consumers sensitised to formaldehyde from exposure to free formaldehyde from formaldehyde releasers.2. Does the SCCS consider necessary to change the 0.05% threshold and at which level?Reducing the present threshold by a factor of 50, that is, to 0.001% (10 ppm), will protect the vast majority of consumers sensitised to formaldehyde. This threshold applies to the total free formaldehyde irrespective of whether a product contains one or more formaldehyde releaser(s).Keywords:SCCS, scientific advice, formaldehyde, Regulation 1223/2009, CAS No. 50-00-0, EC No. 200-001-8, SCCS/1632/21Opinion to be cited as:SCCS (Scientific Committee on Consumer Safety), Scientific advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances, final version of 7 May 2021, SCCS/1632/21.

Dans le cadre de l’action W du Plan d’actions sur la qualité de l’air intérieur, lancé en octobre 2013 par les ministères chargés de l’écologie et de la santé, un état des connaissances sur l’exposition de la population aux moisissures est demandé. Ce plan liste les actions à engager pour l’amélioration de la qualité de l’air intérieur et constitue le volet sur l’air intérieur du troisième plan national santé environnement (PNSE 3 - 2015-2019) dans la continuité des précédents Plans nationaux santé environnement (PNSE 2004-2008 et 2009-2013).- par type de « bâti » en considérant les bâtiments individuels et/ou collectifs (privés et/ou publics), les habitats et/ou établissements recevant du public (ERP) : écoles, crèches, établissements hospitaliers, maisons de retraite ... ou encore l’année de construction (qui conditionne le type de construction et donc les matériaux utilisés) ; - par type de « population » : familles en situation précaire, enfants, personnes âgées,... ; - par « zone géographique » : zones humides, zones submersibles en lien avec l’impact du changement climatique ou en faisant un focus sur certaines régions à risque; - ou suivant le « contexte socio-économique » : par exemple les problèmes de contaminations fongiques dans les logements pouvant a priori être liés aux conditions de vie de certaines familles en situation précaire.

Opinion 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, corrigendum of 11 October 2022, SCCS/1641/22.; International audience; SCCS OPINION on Genistein and Daidzein - SCCS/1641/22 Final version and 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, N. Cabaton, A. Koutsodimou, W. Uter, N. von GoetzA corrigendum to correct the bioavailability oral route for daidzein has been adopted on 11 October 2022The SCCS adopted this document by written procedure on 11 October 2022 2022 (156 pages)Mise en ligne 13 October 2022https://health.ec.europa.eu/publications/genistein-and-daidzein_enPublication 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 2022A corrigendum to correct the bioavailability oral route for daidzein has been adopted on 11 October 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 1223/2009