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This study was commissioned by the Federal Office of Public Health, contract no. 06.003951.

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.

The Cosmetic Regulation (EC) No 1223/2009 specifically covers the risk of nanomaterials used in cosmetic products. If there are concerns regarding the safety of a nanomaterial, the European Commission refers it to the SCCS for a scientific opinion. The Commission mandated the SCCS to identify the scientific basis for safety concerns that could be used as a basis for identifying and prioritising nanomaterials for safety assessment, and to revisit previous inconclusive SCCS opinions on nanomaterials to identify any concerns for potential risks to the consumer health. The SCCS Scientific Advice identified the key general aspects of nanomaterials that should raise a safety concern for a safety assessor/manager, so that the nanomaterial(s) in question could be subjected to safety assessment to establish safety to the consumer. The Advice also developed a list of the nanomaterials notified to the Commission for use in cosmetics in an order of priority for safety assessment, and revisited three previous inconclusive opinions on nanomaterials to highlight concerns over consumer safety that merited further safety assessment.

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; 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.

International audience; Although the need for non-animal alternatives has been well recognised for the human health hazard assessment of chemicals in general, it has become especially pressing for cosmetic ingredients due to the full implementation of testing and marketing bans on animal testing under the European Cosmetics Regulation. This means that for the safety assessment of cosmetics, the necessary safety data for both the ingredients and the finished product can be drawn from validated (or scientifically-valid), so-called "Replacement methods". In view of the challenges for safety assessment without recourse to animal test data, the Methodology Working Group of the Scientific Committee on Consumer Safety organised a workshop in February 2019 to discuss the key issues in regard to the use of animal-free alternative methods for the safety evaluation of cosmetic ingredients. This perspective article summarises the outcomes of this workshop and reflects on the state-of-the-art and possible way forward for the safety assessment of cosmetic ingredients for which no experimental animal data exist. The use and optimisation of "New Approach Methodology" that could be useful tools in the context of the "Next Generation Risk Assessment" and the strategic framework for safety assessment of cosmetics were discussed in depth.

Introduction : A consistent body of literature highlights the importance of a broader approach to select medical school candidates both assessing cognitive capacity and individual characteristics. However, selection in a great number of medical schools worldwide is still based on knowledge exams, a procedure that might neglect students with needed personal characteristics for future medical practice. We investigated whether the personal profile of students selected through a knowledge-based exam differed from those not selected. Methods : Students applying for medical school ( N =311) completed questionnaires assessing motivations for becoming a doctor, learning approaches, personality traits, empathy, and coping styles. Selection was based on the results of MCQ tests. Principal component analysis was used to draw a profile of the students. Differences between selected and non-selected students were examined by Multivariate ANOVAs, and their impact on selection by logistic regression analysis. Results : Students demonstrating a profile of diligence with higher conscientiousness, deep learning approach, and task-focused coping were more frequently selected ( p =0.01). Other personal characteristics such as motivation, sociability, and empathy did not significantly differ, comparing selected and non-selected students. Conclusion : Selection through a knowledge-based exam privileged diligent students. It did neither advantage nor preclude candidates with a more humane profile. Keywords: selection; profile; medical students; undergraduate; personal characteristics; assessment (Published: 12 April 2016) Citation: Med Educ Online 2016, 21: 29705 - http://dx.doi.org/10.3402/meo.v21.29705

Created in 2010, the aim of the NERIS platform is to establish a forum for dialogue and methodological development among all organisations and associations taking part in decision-making of protective actions in nuclear and radiological emergencies and recovery in Europe. The objectives of the platform are to contribute to improving the effectiveness of current approaches for preparedness, promoting more coherent approaches, identifying gaps and need for further developments, addressing new and emerging challenges, and maintaining and improving know-how and technical expertise in this field. This paper describes the missions, the organisation and the activities of the platform as well as the key components of its strategic research agenda. © EDP Sciences 2016.

Recommendations and requirements for the management of foodstuffs including drinking water and feedstuffs (but not other commodities) contaminated after a nuclear accident or a radiological event have been developed by international bodies such as Codex Alimentarius Commission or European Union as well as by individual countries. However, the experience from severe nuclear accidents (Chernobyl, Fukushima) and less serious radiological events, shows that the implementation of such systems (based on criteria expressed in activity concentration) seems to be not fully suitable to prevent several difficulties such as, for instance, stigmatization and even rejection attitudes from consumers or retailers (anticipating the fears of consumers). To further investigate the possible strategies and stakeholder expectations to deal with this sensitive issue, a study has been launched within the European research project PREPARE-WP3. The overall objective of this work, coordinated is to contribute to the development of strategies, guidance and tools for the management of the contaminated products, taking into account the views of producers, processing and retail industries and consumers. For this purpose, 10 stakeholder panels from different European countries have been set up. In addition, feedback experience from the management of contaminated goods following the Fukushima accident has been provided by Japanese stakeholders. This paper highlights the key topics tackled by the different European stakeholders' panels. © EDP Sciences 2016.

International audience; During the Fukushima Daiichi nuclear power plant (FDNPP) accident, a dozen of high-altitude aerosol sampling stations, located between 850 and 3,454 m above sea level (a.s.l.), provided airborne activity levels across Europe (Fig. 1). This represents at most 5% of the total number of aerosol sampling locations that delivered airborne activity levels (at least one result) in Europe, in connection with this nuclear accident. High altitude stations are typically equipped with a high volume sampler that collects aerosols on filters. The Fukushima-labeled air mass arrival and the peak of airborne cesium-137 (137Cs) activity levels were registered in Europe at different dates depending on the location, with differences up to a factor of six on a regional scale. Besides this statement related to lowland areas, we have compared the maximum airborne levels registered at high-altitude European locations (850 m < altitudes < 3450 m) with what was observed at the closest lowland location. The vertical distribution of 137Cs peak level was not uniform even after a long travel time/distance from Japan. This being true at least in the atmospheric boundary layer and in the lower free troposphere. Moreover the relation '137Csmax vs. altitude' shows a decreasing trend (Fig. 2).

International audience; We evaluated a dog owner, participation-based, bait delivery system for the oral immunization of dogs against rabies. In a field study in a semirural area of northern Tunisia, dog owners were asked to come to temporary bait delivery sites. A total of 314 baits were given to 178 dog owners in four sites. The experimental baits used consisted of a freeze-dried core unit containing sulfadimethoxine (SDM) as a biological marker and an aromatized paraffin envelope. No vaccine was used. Preliminary tests had shown that by using a rapid commercial card test, positive SDM serum levels were detected in more than 95% of dogs up to two days after bait ingestion. During the two days following bait delivery, we visited more than 95% of all households in the study area and took blood samples from as many owned dogs as possible. Unconsumed baits were recovered and human contacts with the bait matrix were recorded. The campaign required 7.6 person-min per bait and 13.5 person-min per dog owner for providing baits, gloves, and instructions. The estimated average cost effectiveness ratio per dog accepting a bait was 1.7 US dollars. From the indications given by the dog owners and the results of the SDM test, it was concluded that 85-90% of the owned dogs in the study area had consumed a bait at least partially. Of 314 baits delivered, 78.7% were fully consumed by dogs and 4.1% were recovered during the household survey. The remaining baits (17.2%) that were not recovered were either not consumed or only partially consumed by the target dogs (3.7 baits per 100 inhabitants). These baits probably remained within the highly populated areas and were potentially accessible to other domestic animals and other nontarget species, including humans. Twenty-five unprotected human contacts with baits were recorded (1.7% of all inhabitants). Our study has demonstrated the potential of dog owner based bait delivery. This technique is simple and efficient, particularly if the human population is accustomed to mass immunization in defined centers. Before applying this method on a large scale with live vaccine loaded baits, further studies should focus on minimizing the number of human contacts with the vaccine bait, systematizing contact identification and establishing structures in ensuring proper treatment if exposure to vaccine should occur.

Radioactive emissions into the atmosphere from the damaged reactors of the Fukushima Dai-ichi nuclear power plant (NPP) started on March 12th, 2011. Among the various radionuclides released, iodine-131 ( 131I) and cesium isotopes ( 137Cs and 134Cs) were transported across the Pacific toward the North American continent and reached Europe despite dispersion and washout along the route of the contaminated air masses. In Europe, the first signs of the releases were detected 7 days later while the first peak of activity level was observed between March 28th and March 30th. Time variations over a 20-day period and spatial variations across more than 150 sampling locations in Europe made it possible to characterize the contaminated air masses. After the Chernobyl accident, only a few measurements of the gaseous 131I fraction were conducted compared to the number of measurements for the particulate fraction. Several studies had already pointed out the importance of the gaseous 131I and the large underestimation of the total 131I airborne activity level, and subsequent calculations of inhalation dose, if neglected. The measurements made across Europe following the releases from the Fukushima NPP reactors have provided a significant amount of new data on the ratio of the gaseous 131I fraction to total 131I, both on a spatial scale and its temporal variation. It can be pointed out that during the Fukushima event, the 134Cs to 137Cs ratio proved to be different from that observed after the Chernobyl accident. The data set provided in this paper is the most comprehensive survey of the main relevant airborne radionuclides from the Fukushima reactors, measured across Europe. A rough estimate of the total 131I inventory that has passed over Europe during this period was \textless1% of the released amount. According to the measurements, airborne activity levels remain of no concern for public health in Europe. © 2011 American Chemical Society.

Unauthorised GMOs (UGM) and derived materials are not uncommon in products found on the European market. At present there is zero tolerance for UGM in the EU. In most documented cases, the UGM concentration relative to the product in which the UGM material is found, was low. Low level presence will always represent a challenge to analytically based detection, in particular if the UGM is obscured by other GM material. Analytical ad hoc implementation of the zero tolerance for particular UGMs in feed is described in Regulation (EU) No 619/2011. In Europe, GM detection is predominantly achieved with polymerase chain reaction (PCR) derived methods targeting the transgenic construct and insertion site DNA sequences. The increase in number and divergence of GMOs developed and commercialised has gradually forced the GM detection laboratories to rationalise their analytical work, and most laboratories now apply initial PCR based screenings followed by (when appropriate) more specific PCR based identification and quantification. The detection of any GM is dependent on availability of suitable detection method(s) and control materials to verify the performance of the method(s). Other information, e.g. describing the novel trait, introduced genetic elements, etc. may also facilitate detection, verification and identification of the GM. For UGM, this is a major challenge, and the GMOs are therefore classified into four knowledge groups in the present document. This classification may facilitate stakeholder communication and decision making in analytical laboratories. A decision tree is presented, summarising the recommended principles of GM and UGM detection. Notably, the state-of-the-art of GMO analysis is not static, and it is expected that the guidelines and recommendations presented in this document will have to be modified on a regular basis. Finally, the document highlights a number of R&D priorities and points out the need for reinforced information sharing at the global level.

International audience; A 15-Country collaborative cohort study was conducted to provide direct estimates of cancer risk following protracted low doses of ionizing radiation. Analyses included 407,391 nuclear industry workers monitored individually for external radiation and 5.2 million person-years of follow-up. A significant association was seen between radiation dose and all-cause mortality [excess relative risk (ERR) 0.42 per Sv, 90% CI 0.07, 0.79; 18,993 deaths]. This was mainly attributable to a dose-related increase in all cancer mortality (ERR/Sv 0.97, 90% CI 0.28, 1.77; 5233 deaths). Among 31 specific types of malignancies studied, a significant association was found for lung cancer (ERR/Sv 1.86, 90% CI 0.49, 3.63; 1457 deaths) and a borderline significant (P = 0.06) association for multiple myeloma (ERR/Sv 6.15, 90% CI

International audience; Radiation protection standards are based mainly on risk estimates from studies of atomic bomb survivors in Japan. The validity of extrapolations from the relatively high-dose acute exposures in this population to the low-dose, protracted or fractionated environmental and occupational exposures of primary public health concern has long been the subject of controversy. A collaborative retrospective cohort study was conducted to provide direct estimates of cancer risk after low-dose protracted exposures. The study included nearly 600,000 workers employed in 154 facilities in 15 countries. This paper describes the design, methods and results of descriptive analyses of the study. The main analyses included 407,391 nuclear industry workers employed for at least 1 year in a participating facility who were monitored individually for external radiation exposure and whose doses resulted predominantly from exposure to higher-energy photon radiation. The total duration of follow-up was 5,192,710 person-years. There were 24,158 deaths from all causes, including 6,734 deaths from cancer. The total collective dose was 7,892 Sv. The overall average cumulative recorded dose was 19.4 mSv. A strong healthy worker effect was observed in most countries. This study provides the largest body of direct evidence to date on the effects of low-dose protracted exposures to external photon radiation. © 2007 by Radiation Research Society.