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2,868 results on '"Galli C"'

1. Evidence for the unique function of DHA during the evolution of the modern hominid brain

Author

Crawford M.A., Bloom M., Broadhurst C.L., Schmidt W.F., Cunnane S.C., Galli C., Gehbremeskel K., Linseisen F., Lloyd-Smith J., and Parkington J.

Subjects
arachidonic, brain, blood vessels, docosahexaenoic, evolution, lacustrine, marine foods, membranes, nutrition, Nyasa, Turkana, Australopithecus, H. erectus, H. sapiens, Oils, fats, and waxes, TP670-699
Abstract

The African savanna ecosystem of the large mammals and primates was associated with a dramatic decline in relative brain capacity. This reduction happened to be associated with a decline in docosahexaenoic acid (DHA) from the food chain. DHA is required for brain structures and growth. The biochemistry implies that the expansion of the human brain required a plentiful source of preformed DHA. The richest source of DHA is the marine food chain while the savannah environment offers very little of it. Consequently H. sapiens could not have evolved on the savannahs. Recent fossil evidence indicates that the lacustrine and marine food chain was being extensively exploited at the time cerebral expansion took place and suggests the alternative that the transition from the archaic to modern humans took place at the land\\water interface. Contemporary data on tropical lake shore dwellers reaffirms the above view. Lacustrine habitats provide nutritional support for the vascular system, the development of which would have been a prerequisite for cerebral expansion. Both arachidonic acid (AA) and DHA would have been freely available from such habitats providing the double stimulus of preformed acyl components for the developing blood vessels and brain. The w3 docosapentaenoic acid precursor (w3DPA) was the major w3 metabolite in the savanna mammals. Despite this abundance, neither it or the corresponding w6DPA were used for the photoreceptor nor the synapse. A substantial difference between DHA and other fatty acids is required to explain this high specificity. Studies on fluidity and other mechanical features of cell membranes have not revealed a difference of such magnitude between even a-linolenic acid (LNA) and DHA sufficient to explain the exclusive use of DHA. We suggest that the evolution of the large human brain depended on a rich source of DHA from the land\\water interface. We review a number of proposals for the possible influence of DHA on physical properties of the brain that are essential for its function.

Published
2004
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3. Dementia

Author

Galli, C.

Abstract

This music score was submitted for the Kaleidoscope 2020 Call for Scores, an open access collaboration with the UCLA Music Library.

Published
2020

5. The ART of bringing extinction to a freeze – History and future of species conservation, exemplified by rhinos

Author

Hildebrandt, Thomas B., Hermes, Robert, Goeritz, Frank, Appeltant, Ruth, Colleoni, Silvia, de Mori, Barbara, Diecke, Sebastian, Drukker, Micha, Galli, C., Hayashi, K., Lazzari, G., Loi, Pasqualino, Payne, J., Renfree, Marilyn, Seet, Steven, Stejskal, Jan, Swegen, A., Williams, Suzannah A., Zainuddin, Zainal Zahari, and Holtze, Susanne

Published
2021
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7. Optical modulation of excitation-contraction coupling in human-induced pluripotent stem cell-derived cardiomyocytes

Author

Vurro, V, Federici, B, Ronchi, C, Florindi, C, Sesti, V, Crasto, S, Maniezzi, C, Galli, C, Antognazza, M, Bertarelli, C, Di Pasquale, E, Lanzani, G, Lodola, F, Vurro V., Federici B., Ronchi C., Florindi C., Sesti V., Crasto S., Maniezzi C., Galli C., Antognazza M. R., Bertarelli C., Di Pasquale E., Lanzani G., Lodola F., Vurro, V, Federici, B, Ronchi, C, Florindi, C, Sesti, V, Crasto, S, Maniezzi, C, Galli, C, Antognazza, M, Bertarelli, C, Di Pasquale, E, Lanzani, G, Lodola, F, Vurro V., Federici B., Ronchi C., Florindi C., Sesti V., Crasto S., Maniezzi C., Galli C., Antognazza M. R., Bertarelli C., Di Pasquale E., Lanzani G., and Lodola F.

Abstract

Non-genetic photostimulation is a novel and rapidly growing multidisciplinary field that aims to induce light-sensitivity in living systems by exploiting exogeneous phototransducers. Here, we propose an intramembrane photoswitch, based on an azobenzene derivative (Ziapin2), for optical pacing of human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). The light-mediated stimulation process has been studied by applying several techniques to detect the effect on the cell properties. In particular, we recorded changes in membrane capacitance, in membrane potential (Vm), and modulation of intracellular Ca2+ dynamics. Finally, cell contractility was analyzed using a custom MATLAB algorithm. Photostimulation of intramembrane Ziapin2 causes a transient Vm hyperpolarization followed by a delayed depolarization and action potential firing. The observed initial electrical modulation nicely correlates with changes in Ca2+ dynamics and contraction rate. This work represents the proof of principle that Ziapin2 can modulate electrical activity and contractility in hiPSC-CMs, opening up a future development in cardiac physiology.

Published
2023

10. Precision genetics for complex objectives in animal agriculture

Author

Fahrenkrug, SC, Blake, A, Carlson, DF, Doran, T, Van Eenennaam, A, Faber, D, Galli, C, Gao, Q, Hackett, PB, Li, N, Maga, EA, Muir, WM, Murray, JD, Shi, D, Stotish, R, Sullivan, E, Taylor, JF, Walton, M, Wheeler, M, Whitelaw, B, and Glenn, BP

Subjects
Genetics, Zero Hunger, Animal Husbandry, Animal Welfare, Animals, Animals, Domestic, Animals, Genetically Modified, Food, Food Microbiology, Food Supply, Genetic Engineering, Genetic Techniques, Humans, Nutritional Status, cross-breeding, genetic engineering, genetic technology, hybridization, phenotypic diversity, selection, Biological Sciences, Agricultural and Veterinary Sciences, Dairy & Animal Science
Abstract

Indirect modification of animal genomes by interspecific hybridization, cross-breeding, and selection has produced an enormous spectrum of phenotypic diversity over more than 10,000 yr of animal domestication. Using these established technologies, the farming community has successfully increased the yield and efficiency of production in most agricultural species while utilizing land resources that are often unsuitable for other agricultural purposes. Moving forward, animal well-being and agricultural sustainability are moral and economic priorities of consumers and producers alike. Therefore, these considerations will be included in any strategy designed to meet the challenges produced by global climate change and an expanding world population. Improvements in the efficiency and precision of genetic technologies will enable a timely response to meet the multifaceted food requirements of a rapidly increasing world population.

Published
2010

12. SCCS OPINION on water-soluble zinc salts used in oral hygiene products - Submission II - SCCS/1657/23 - Preliminary version

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Benfentati, E., Cabaton, N., Corsini, E., Koutsodimou, A., Louro, H., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), and Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)

Subjects
SCCS, zinc acetate CAS: 557-34-6 EC: 209-170-2, zinc chloride CAS: 7646-85-7 EC: 231-592-0, zinc gluconate CAS: 4468-02-4 EC, Regulation 1223/2009, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], water-soluble zinc salts, zinc sulphate/zinc sulphate monohydrate/zinc sulphate heptahydrate CAS: 7733-02-0/7446-19-7/7446-20-0 EC, oral hygiene products, zinc citrate CAS: 546-46-3 EC, SCCS/1586/17, scientific opinion
Abstract

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

Published
2023

14. Oxidative Stress in Structural Valve Deterioration: A Longitudinal Clinical Study

Author

Galinanes, M, Casos, K, Blasco-Lucas, A, Permanyer, E, Manez, R, Le Tourneau, T, Barquinero, J, Schwartz, S, Roussel, T, Fellah-Hebia, I, Senage, T, Evangelista, A, Badano, L, Ruiz-Majoral, A, Galli, C, Padler-Karavani, V, Soulillou, J, Vidal, X, Cozzi, E, Costa, C, Galinanes M., Casos K., Blasco-Lucas A., Permanyer E., Manez R., Le Tourneau T., Barquinero J., Schwartz S., Roussel T. B. J. C., Fellah-Hebia I., Senage T., Evangelista A., Badano L., Ruiz-Majoral A., Galli C., Padler-Karavani V., Soulillou J. -P., Vidal X., Cozzi E., Costa C., Galinanes, M, Casos, K, Blasco-Lucas, A, Permanyer, E, Manez, R, Le Tourneau, T, Barquinero, J, Schwartz, S, Roussel, T, Fellah-Hebia, I, Senage, T, Evangelista, A, Badano, L, Ruiz-Majoral, A, Galli, C, Padler-Karavani, V, Soulillou, J, Vidal, X, Cozzi, E, Costa, C, Galinanes M., Casos K., Blasco-Lucas A., Permanyer E., Manez R., Le Tourneau T., Barquinero J., Schwartz S., Roussel T. B. J. C., Fellah-Hebia I., Senage T., Evangelista A., Badano L., Ruiz-Majoral A., Galli C., Padler-Karavani V., Soulillou J. -P., Vidal X., Cozzi E., and Costa C.

Abstract

The cause of structural valve deterioration (SVD) is unclear. Therefore, we investigated oxidative stress markers in sera from patients with bioprosthetic heart valves (BHVs) and their association with SVD. Blood samples were taken from SVD (Phase A) and BHV patients during the first 24 (Phase B1) and >48 months (Phase B2) after BHV implantation to assess total antioxidant capacity (TAC), malondialdehyde (MDA), and nitrotyrosine (NT). The results show that MDA levels increased significantly 1 month after surgery in all groups but were higher at 6 months only in incipient SVD patients. NT levels increased gradually for the first 24 months after implantation in the BHV group. Patients with transcatheter aortic valve implantation (TAVI) showed even higher levels of stress markers. After >48 months, MDA and NT continued to increase in BHV patients with a further elevation after 60-72 months; however, these levels were significantly lower in the incipient and established SVD groups. In conclusion, oxidative stress may play a significant role in SVD, increasing early after BHV implantation, especially in TAVI cases, and also after 48 months' follow-up, but decreasing when SVD develops. Oxidative stress potentially represents a target of therapeutic intervention and a biomarker of BHV dysfunction.

Published
2022

18. SCCS OPINION on benzyl salicylate (CAS No. 118-58-1, EC No. 204-262-9) _ SCCS/1656/23– Preliminary Opinion

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Benfentati, E., Cabaton, N., Corsini, E., Koutsodimou, A., Louro, H., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
[PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], SCCS, scientific opinion, benzyl salicylate, Regulation 1223/2009, CAS No. 118-58-1, EC No. 204-262-9
Abstract

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

Published
2023

19. SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3) - SCCS/1646/22– Final Opiinion

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Benfentati, E., Cabaton, N., Corsini, E., Koutsodimou, A., Louro, H., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
SCCS, Regulation 1223/2009, salicylic acid, CAS No. 69-72-7, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], EC No. 200-712-3, scientific opinion
Abstract

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

Published
2023

20. SCCS OPINION on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - SCCS/1651/23– Preliminary Opinion

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Benfentati, E., Cabaton, N., Corsini, E., Koutsodimou, A., Louro, H., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
SCCS, Regulation 1223/2009, preservative, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], butylparaben, EC No. 202-318-7, scientific opinion, CAS No. 94-26-8
Abstract

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

Published
2023

21. SCCS OPINION on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7) - SCCS/1652/23– Preliminary Opinion

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Benfentati, E., Cabaton, N., Corsini, E., Koutsodimou, A., Louro, H., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
SCCS, methylparaben, Regulation 1223/2009, preservative, EC No. 202-785-7, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], CAS No. 99-76-3, scientific opinion
Abstract

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

Published
2023

22. The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation- 12th Revision - SCCS/1647/22

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Benfentati, E., Cabaton, N., Corsini, E., Koutsodimou, A., Louro, H., Uter, W., Goetz, N. Von, Krätke, R., CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
SCCS, SCCS/1647/22, 12th revision, SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci]
Abstract

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

Published
2023

23. SCIENTIFIC ADVICE – children exposure on Methyl salicylate,(methyl 2-hydroxybenzoate) - SCCS/1654/23 - Preliminary version

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Benfentati, E., Cabaton, N., Corsini, E., Koutsodimou, A., Louro, H., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
SCCS, methyl 2-hydroxybenzoate, Regulation 1223/2009, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], children exposure, scientific advice, methyl salicylate
Abstract

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

Published
2023

24. SCIENTIFIC ADVICE on HC Blue 18 (Colipa No. B122) - Submission II - SCCS/1653/23

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Benfentati, E., Cabaton, N., Corsini, E., Koutsodimou, A., Louro, H., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
hair dye, SCCS, Colipa No B122, CAS No. 1166834-57-6, HC Blue 18, Submission II, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], scientific advice
Abstract

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

Published
2023

26. Bortezomib, C1-Inhibitor and Plasma Exchange Do Not Prolong the Survival of Multi-Transgenic GalT-KO Pig Kidney Xenografts in Baboons

Author

Le Bas-Bernardet, S., Tillou, X., Branchereau, J., Dilek, N., Poirier, N., Châtelais, M., Charreau, B., Minault, D., Hervouet, J., Renaudin, K., Crossan, C., Scobie, L., Takeuchi, Y., Diswall, M., Breimer, M.E., Klar, N., Daha, M.R., Simioni, P., Robson, S.C., Nottle, M.B., Salvaris, E.J., Cowan, P.J., d’Apice, A.J.F., Sachs, D.H., Yamada, K., Lagutina, I., Duchi, R., Perota, A., Lazzari, G., Galli, C., Cozzi, E., Soulillou, J.-P., Vanhove, B., and Blancho, G.

Published
2015
Full Text
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27. SCCS OPINION on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) - SCCS/1645/22 - Final Version

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Koutsodimou, A., Uter, W., Goetz, N. Von, Cabaton, Nicolas J., CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
hair dye, SCCS, C186, Regulation 1223/2009, CAS No. 34722-90-2, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], sodium bromothymol blue, EC No. 252-169-7, scientific opinion
Abstract

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

Published
2023

28. SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final Opinion and Corrigendum

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Cabaton, N., Koutsodimou, A., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Commitee for Consumer Safety (SCCS, EC)

Subjects
SCCS, revision, Regulation 1223/2009, aluminium, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], scientific opinion, submission III
Abstract

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

Published
2023

29. SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final Opinion

Author

Eric GAFFET, Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P. J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Panteri, E., Rogiers, V., Ch. Rousselle, Stepnik, M., Vanhaecke, T., Wijnhoven, S., Cabaton, N., Koutsodimou, A., Uter, W., Goetz, N., Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Scientific Committee for Consumer Safety (SCCS) (SCCS), CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
SCCS, revision, Regulation 1223/2009, aluminium, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], scientific opinion, submission III
Abstract

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

Published
2023

31. Blood fatty acid composition in relation to allergy in children aged 2-9 years: results from the European IDEFICS study

Author

Mikkelsen, A, Galli, C, Eiben, G, Ahrens, W, Iacoviello, L, Molnár, D, Pala, V, Rise, P., Rodriguez, G., Russo, P., Tornaritis, M., Veidebaum, T., Vyncke, K., and Wolters, M.

Subjects
Allergy in children -- Physiological aspects, Blood -- Physiological aspects, Fatty acids -- Physiological aspects, Food/cooking/nutrition, Health
Abstract

Background/objectives: Blood polyunsaturated fatty acids (PUFA) are involved in allergy development, but the etiological role of n-6 and n-3 PUFA is still controversial. A European multicenter study of children (IDEFICS) provided the opportunity to explore the cross-sectional association between fatty acids (FA) and allergy. Subjects/methods: Blood FA levels were measured in 2600 children aged 2-9 years and were recorded as the percentage of weight of all FA detected. Logistic regression of allergy status on FA components was adjusted for age, sex, country, body mass index, family history of allergic disease, breast-feeding, and number of siblings. The results were given as odds ratios (OR) for current vs no allergy ever and an increase in FA by 1 s.d. Results: Overall, higher proportions of n-6 PUFA were associated with higher odds of allergy (OR=1.21 (1.05, 1.40)). Monounsaturated FA (MUFA) were associated with reduced risk for allergy (OR=0.75 (0.65, 0.87)), whereas saturated FA did not differ by allergy status. The strongest associations were observed in children Conclusions: Both PUFA subtypes were positively associated with allergy in an age-dependent manner, whereas MUFA was associated with less allergy. The observation of high proportions of n-3 PUFA in allergic children younger than 4 years might help to understand the nature of early onset of atopic disease., Author(s): A Mikkelsen [sup.1] [sup.2] , C Galli [sup.3] , G Eiben [sup.1] , W Ahrens [sup.4] , L Iacoviello [sup.5] , D Molnár [sup.6] , V Pala [sup.7] , [...]

Published
2017
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33. ICHOSA (Intra Cerebral Hemorrage and Obstructive Sleep Apnea) project: first results

Author

Picchetto, L., primary, Pizza, F., additional, Bigliardi, G., additional, Giacobazzi, L., additional, Dell'Acqua, M., additional, Vandelli, L., additional, Ciolli, L., additional, Vandelli, G., additional, Rosafio, F., additional, Ricceri, R., additional, Galli, C., additional, Vitetta, F., additional, Zini, A., additional, Meletti, S., additional, and Plazzi, G., additional

Published
2022
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34. Alternative pre-analytical strategies for SARS CoV 2 RNA detection

Author

Martinelli, M, Molteni, C, Calcagno, G, Bubba, L, Galli, C, Musumeci, R, Giubbi, C, Perdoni, F, Castriciano, S, Pariani, E, Pellegrinelli, L, Pilla, L, Bonfanti, P, Malandrin, S, Cavallero, A, Cocuzza, C, MARTINELLI, M, MOLTENI, C, CALCAGNO, G, BUBBA, L, GALLI, C, MUSUMECI, R, GIUBBI, C, PERDONI, F, CASTRICIANO, S, PARIANI, E, PELLEGRINELLI, L, PILLA, L, BONFANTI, P, MALANDRIN, S, CAVALLERO, A, COCUZZA, CE, Martinelli, M, Molteni, C, Calcagno, G, Bubba, L, Galli, C, Musumeci, R, Giubbi, C, Perdoni, F, Castriciano, S, Pariani, E, Pellegrinelli, L, Pilla, L, Bonfanti, P, Malandrin, S, Cavallero, A, Cocuzza, C, MARTINELLI, M, MOLTENI, C, CALCAGNO, G, BUBBA, L, GALLI, C, MUSUMECI, R, GIUBBI, C, PERDONI, F, CASTRICIANO, S, PARIANI, E, PELLEGRINELLI, L, PILLA, L, BONFANTI, P, MALANDRIN, S, CAVALLERO, A, and COCUZZA, CE

Published
2021

35. Whole-blood fatty acids and inflammation in European children: the IDEFICS Study

Author

Gonzalez-Gil, E.M., Santabarbara, J., Siani, A., Ahrens, W., Sioen, I., Eiben, G., Gunther, K., Iacoviello, L., Molnar, D., Rise, P., Russo, P., Tornaritis, M., Veidebaum, T., Galli, C., and Moreno, L.A.

Subjects
Inflammation -- Physiological aspects, Fatty acids -- Health aspects, Children -- Health aspects, Food/cooking/nutrition, Health
Abstract

BACKGROUND/OBJECTIVES: Fatty acids are hypothesized to influence cardiovascular disease risk because of their effect on inflammation. The aim of this study is to assess the relationship between whole-blood fatty acids (WBFAs) and high- sensitivity C-reactive protein (hs-CRP) in European children. SUBJECTS/METHODS: A total of 1401 subjects (697 boys and 704 girls) aged between 2 and 9 years from the IDEFICS (/dentification and prevention of Dietary- and lifestyle-induced health Effects in Children and infantS) study were measured in this cross-sectional analysis. The sample was divided into three categories of hs-CRP. Associations between WBFA and hs-CRP were assessed by logistic regression models adjusting for body mass index (BMI), country, age, breastfeeding, mother's education and hours of physical activity. RESULTS: Linoleic acid (LA) (P = 0.013, 95% confidence interval (CI): 0.822-0.977) and sum of n-6 WBFA (P=0.029,95% CI: 0.866-0.992) concentrations were associated with lower concentrations of hs-CRP in boys. In girls, a high ratio of eicosapentaenoic acid (EPA)/arachidonic acid (AA) was associated (P=0.018, 95% CI: 0.892-0.989) with lower hs-CRP concentrations. In contrast, sum of blood n-6 highly unsaturated fatty acids (P = 0.012, 95% CI: 1.031-1.284), AA (P=0.007, 95% CI: 1.053-1.395) and AA/LA ratio (P = 0.005, 95% CI: 1.102-1.703) were associated (P < 0.05) with higher concentrations of hs-CRP in girls. CONCLUSIONS: The n-6 WBFAs (sum of n-6 FA and LA) were associated with lower hs-CRP in boys and with higher hs-CRP in girls (AA, sum of n-6 highly unsaturated and AA/LA ratio). More studies are needed to identify the optimal levels of WBFAs to avoid low-grade inflammation in children considering the differences by sex and BMI. European Journal of Clinical Nutrition (2016) 70, 819-823; doi: 10.1038/ejcn.2015.219; published online 13 January 2016, INTRODUCTION Low-grade chronic inflammation is related with obesity (1-3) and with the onset and development of atherosclerosis. (1,4) Athero-sclerosis development is characterized by an interaction between vascular endothelial cells and [...]

Published
2016
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36. SCCS OPINION on Genistein and Daidzein - SCCS/1641/22 Final version

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraad, P. J., Dusinska, M., Ezendam, J., Eric GAFFET, Galli, C. L., Granum, B., Panteri, E., Rogiers, V., Ch. Rousselle, Stepnik, M., Vanhaecke, T., Wijnhoven, S., Cabaton, N., Koutsodimou, A., Uter, W., Goetz, N., Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Direction des affaires européennes et internationales (DAEI), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Scientific Committee for Consumer Safety (SCCS, EC)

Subjects
SCCS, EC No 207-174-9), Regulation 1223/2009, daidzein (CAS No 486-66-8, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], EC No 207-635-4), scientific opinion, genistein (CAS No 446-72-0
Abstract

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.

Published
2022

37. SCCS OPINION ON the safety of presence of Bisphenol A in clothing articles - SCCS/16/2020 - Final Opinion

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Granum, B., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Koutsodimou, A., Uter, W., Goetz, N. Von, Comissariat à l'énergie atomique (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Publications Office of the European Union

Subjects
[PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci]
Abstract

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

Published
2022
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38. ADDENDUM to the scientific opinion SCCS/1613/19 on the safety of aluminium in cosmetic products (lipstick) - Submission II - SCCS/1626/20 - Addendum (lipstick) – Final version

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Granum, B., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Koutsodimou, A., Uter, W., Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Scientific Committee for Consumer Safety (SCCS), and Publications Office of the European Union

Subjects
[PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci]
Abstract

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

Published
2022
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39. SCCS OPINION on Methyl salicylate (methyl 2-hydroxybenzoate) - Submission I- SCCS/1633/21- Final Opinion

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraad, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Granum, B., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Koutsodimou, A., Uter, W., Goetz, N. Von, Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), and Publications Office of the European Union

Subjects
[PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci]
Abstract

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

Published
2022
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40. Being the Family Caregiver of a Patient With Dementia During the Coronavirus Disease 2019 Lockdown

Author

Zucca, M., Isella, V., Lorenzo, R. D., Marra, Camillo, Cagnin, A., Cupidi, C., Bonanni, L., Lagana, V., Rubino, E., Vanacore, N., Agosta, F., Caffarra, P., Sambati, R., Quaranta, Davide, Guglielmi, Valeria, Appollonio, I. M., Logroscino, G., Filippi, M., Tedeschi, G., Ferrarese, C., Rainero, I., Bruni, A. C., Gallo, E., Grassini, A., Marcinno, A., Roveta, F., Martino, P. D., Frangipane, F., Puccio, G., Colao, R., Mirabelli, M., Martellacci, N., Lino, F., Mozzetta, S., Busse, C., Camporese, G., Sacco, S., Lechiara, M. C., Carrarini, Claudia, Russo, M., Casalena, A., Sucapane, P., Tiraboschi, P., Caroppo, P., Redaelli, V., Fede, G. D., Coppa, D., Peluso, L., Insarda, P., Bartolo, M. D., Esposito, S., Iavarone, A., Orsini, A. V. M., Salvatore, E., Criscuolo, C., Sambati, L., Santoro, R., Gragnaniello, D., Pedriali, I., Ludovico, L., Chiari, A., Fabbo, A., Bevilacqua, P., Galli, C., Magarelli, S., Perini, M., Spalletta, G., Banaj, N., Porcari, D. E., Caruso, G., Cipollini, V., Casini, A. R., Ursini, F., Bruno, G., Rozzini, R., Brambilla, M., Magnani, G., Caso, F., Spinelli, E. G., Ramusino, M. C., Perini, G., Luzzi, S., Cacchio, G., Ciccola, A., Cionfrini, L., Giuli, C., Fabi, K., Guidi, M., Paci, C., Castellano, A., Petrucci, R., Accogli, M., Carapelle, E., Calabrese, G., Trevisi, G. N., Coluccia, B., Giuliano, A. V., Caggiula, M., Impagnatiello, V., Beretta, F., Milia, A., Pilia, G., Mascia, M. G., Putzu, V., Piccoli, T., Cuffaro, L., Monastero, R., Battaglia, A., Blandino, V., Lupo, F., Cumbo, E., Luca, A., Caravaglios, G., Vezzosi, A., Bessi, V., Tognoni, G., Calsolaro, V., Mossello, E., Amici, S., Trequattrini, A., Pezzuto, S., Mecocci, P., Fichera, G., Pradelli, S., Formilan, M., Coin, A., Togni, L. D., Sala, F., Nicolosi, V., Gallucci, M., Mazzarolo, A. P., Bergamelli, C., Zucca M., Isella V., Lorenzo R.D., Marra C., Cagnin A., Cupidi C., Bonanni L., Lagana V., Rubino E., Vanacore N., Agosta F., Caffarra P., Sambati R., Quaranta D., Guglielmi V., Appollonio I.M., Logroscino G., Filippi M., Tedeschi G., Ferrarese C., Rainero I., Bruni A.C., Gallo E., Grassini A., Marcinno A., Roveta F., Martino P.D., Frangipane F., Puccio G., Colao R., Mirabelli M., Martellacci N., Lino F., Mozzetta S., Busse C., Camporese G., Sacco S., Lechiara M.C., Carrarini C., Russo M., Casalena A., Sucapane P., Tiraboschi P., Caroppo P., Redaelli V., Fede G.D., Coppa D., Peluso L., Insarda P., Bartolo M.D., Esposito S., Iavarone A., Orsini A.V.M., Salvatore E., Criscuolo C., Sambati L., Santoro R., Gragnaniello D., Pedriali I., Ludovico L., Chiari A., Fabbo A., Bevilacqua P., Galli C., Magarelli S., Perini M., Spalletta G., Banaj N., Porcari D.E., Caruso G., Cipollini V., Casini A.R., Ursini F., Bruno G., Rozzini R., Brambilla M., Magnani G., Caso F., Spinelli E.G., Ramusino M.C., Perini G., Luzzi S., Cacchio G., Ciccola A., Cionfrini L., Giuli C., Fabi K., Guidi M., Paci C., Castellano A., Petrucci R., Accogli M., Carapelle E., Calabrese G., Trevisi G.N., Coluccia B., Giuliano A.V., Caggiula M., Impagnatiello V., Beretta F., Milia A., Pilia G., Mascia M.G., Putzu V., Piccoli T., Cuffaro L., Monastero R., Battaglia A., Blandino V., Lupo F., Cumbo E., Luca A., Caravaglios G., Vezzosi A., Bessi V., Tognoni G., Calsolaro V., Mossello E., Amici S., Trequattrini A., Pezzuto S., Mecocci P., Fichera G., Pradelli S., Formilan M., Coin A., Togni L.D., Sala F., Nicolosi V., Gallucci M., Mazzarolo A.P., Bergamelli C., Zucca, M, Isella, V, Di Lorenzo, R, Marra, C, Cagnin, A, Cupidi, C, Bonanni, L, Laganà, V, Rubino, E, Vanacore, N, Agosta, F, Caffarra, P, Sambati, R, Quaranta, D, Guglielmi, V, Appollonio, I, Logroscino, G, Filippi, M, Tedeschi, G, Ferrarese, C, Rainero, I, Bruni, A, Gallo, E, Grassini, A, Marcinnò, A, Roveta, F, De Martino, P, Frangipane, F, Puccio, G, Colao, R, Mirabelli, M, Martellacci, N, Lino, F, Mozzetta, S, Bussè, C, Camporese, G, Sacco, S, Lechiara, M, Carrarini, C, Russo, M, Casalena, A, Sucapane, P, Tiraboschi, P, Caroppo, P, Redaelli, V, Di Fede, G, Coppa, D, Peluso, L, Insarda, P, De Bartolo, M, Esposito, S, Iavarone, A, Orsini, A, Salvatore, E, Criscuolo, C, Sambati, L, Santoro, R, Gragnaniello, D, Pedriali, I, Ludovico, L, Chiari, A, Fabbo, A, Bevilacqua, P, Galli, C, Magarelli, S, Perini, M, Spalletta, G, Banaj, N, Porcari, D, Caruso, G, Cipollini, V, Casini, A, Ursini, F, Bruno, G, Rozzini, R, Brambilla, M, Magnani, G, Caso, F, Spinelli, E, Cotta Ramusino, M, Perini, G, Luzzi, S, Cacchiò, G, Ciccola, A, Cionfrini, L, Giuli, C, Fabi, K, Guidi, M, Paci, C, Castellano, A, Petrucci, R, Accogli, M, Carapelle, E, Calabrese, G, Trevisi, G, Coluccia, B, Vasquez Giuliano, A, Caggiula, M, Impagnatiello, V, Beretta, F, Milia, A, Pilia, G, Mascia, M, Putzu, V, Piccoli, T, Cuffaro, L, Monastero, R, Battaglia, A, Blandino, V, Lupo, F, Cumbo, E, Luca, A, Caravaglios, G, Vezzosi, A, Bessi, V, Tognoni, G, Calsolaro, V, Mossello, E, Amici, S, Trequattrini, A, Pezzuto, S, Mecocci, P, Fichera, G, Pradelli, S, Formilan, M, Coin, A, De Togni, L, Sala, F, Nicolosi, V, Gallucci, M, Mazzarolo, A, Bergamelli, C, Zucca, Milena, Isella, Valeria, Lorenzo, Raffaele Di, Marra, Camillo, Cagnin, Annachiara, Cupidi, Chiara, Bonanni, Laura, Laganà, Valentina, Rubino, Elisa, Vanacore, Nicola, Agosta, Federica, Caffarra, Paolo, Sambati, Renato, Quaranta, Davide, Guglielmi, Valeria, Appollonio, Ildebrando M., Logroscino, Giancarlo, Filippi, Massimo, Tedeschi, Gioacchino, Ferrarese, Carlo, Rainero, Innocenzo, and Bruni, Amalia C.

Subjects
Aging, medicine.medical_specialty, Cognitive Neuroscience, Population, Psychological intervention, Protective factor, Neurosciences. Biological psychiatry. Neuropsychiatry, burden, 03 medical and health sciences, stress, 0302 clinical medicine, stre, medicine, Dementia, caregiver, COVID-19, dementia, Psychiatry, education, Original Research, MED/26 - NEUROLOGIA, education.field_of_study, 030214 geriatrics, burden, caregiver, COVID-19, dementia, stress, Family caregivers, business.industry, medicine.disease, Mental health, Settore MED/26 - NEUROLOGIA, Anxiety, Caregiver stress, M-PSI/08 - PSICOLOGIA CLINICA, medicine.symptom, business, 030217 neurology & neurosurgery, Neuroscience, RC321-571
Abstract

Background: Family caregivers of patients with dementia are at high risk of stress and burden, and quarantine due to the coronavirus disease 2019 (COVID-19) pandemic may have increased the risk of psychological disturbances in this population. The current study was carried out during the national lockdown declared in March 2020 by the Italian government as a containment measure of the first wave of the coronavirus pandemic and is the first nationwide survey on the impact of COVID-19 lockdown on the mental health of dementia informal caregivers.Methods: Eighty-seven dementia centers evenly distributed on the Italian territory enrolled 4,710 caregiver–patient pairs. Caregivers underwent a telephone interview assessing classical symptoms of caregiver stress and concern for the consequences of COVID-19 infection on patient’s health. We calculated prevalence of symptoms and regressed them on various potential stress risk factors: caregivers’ sociodemographic characteristics and lifestyle, patients’ clinical features, and lockdown-related elements, like discontinuity in medical care.Results: Approximately 90% of caregivers reported at least one symptom of stress, and nearly 30% reported four or more symptoms. The most prevalent symptoms were concern for consequences of COVID-19 on patient’s health (75%) and anxiety (46%). The main risk factors for stress were identified as a conflicting relationship with the patient and discontinuity in assistance, but caregiver’s female sex, younger age, lower education, and cohabitation with the patient also had an impact. Availability of help from institutions or private individuals showed a protective effect against sense of abandonment but a detrimental effect on concern about the risk for the patient to contract COVID-19. The only protective factor was mild dementia severity, which was associated with a lower risk of feeling isolated and abandoned; type of dementia, on the other hand, did not affect stress risk.Conclusion: Our results demonstrate the large prevalence of stress in family caregivers of patients with dementia during the COVID-19 pandemic and have identified both caregivers and situations at a higher risk of stress, which should be taken into account in the planning of interventions in support of quarantined families and patients.

Published
2021

41. SARS-CoV-2 infection among asymptomatic homebound subjects in Milan, Italy

Author

Milani, G, Montomoli, E, Bollati, V, Albetti, B, Bandi, C, Bellini, T, Bonzini, M, Buscaglia, M, Cantarella, C, Cantone, L, Carugno, M, Casartelli, S, Cavaletti, G, D'Alessandro, S, De Chiara, F, Delbue, S, Dioni, L, Eberini, I, Favero, C, Ferrari, L, Ferraroni, M, Galastri, L, Galli, C, Hoxha, M, Iodice, S, La Vecchia, C, Macchi, C, Manini, I, Marchi, S, Mariani, J, Pariani, E, Pesatori, A, Rota, F, Ruscica, M, Schioppo, T, Tarantini, L, Trombetta, C, Valsecchi, M, Vicenzi, M, Zanchetta, G, Milani G. P., Montomoli E., Bollati V., Albetti B., Bandi C., Bellini T., Bonzini M., Buscaglia M., Cantarella C., Cantone L., Carugno M., Casartelli S., Cavaletti G., D'Alessandro S., De Chiara F., Delbue S., Dioni L., Eberini I., Favero C., Ferrari L., Ferraroni M., Galastri L., Galli C., Hoxha M., Iodice S., La Vecchia C., Macchi C., Manini I., Marchi S., Mariani J., Pariani E., Pesatori A. C., Rota F., Ruscica M., Schioppo T., Tarantini L., Trombetta C. M., Valsecchi M. G., Vicenzi M., Zanchetta G., Milani, G, Montomoli, E, Bollati, V, Albetti, B, Bandi, C, Bellini, T, Bonzini, M, Buscaglia, M, Cantarella, C, Cantone, L, Carugno, M, Casartelli, S, Cavaletti, G, D'Alessandro, S, De Chiara, F, Delbue, S, Dioni, L, Eberini, I, Favero, C, Ferrari, L, Ferraroni, M, Galastri, L, Galli, C, Hoxha, M, Iodice, S, La Vecchia, C, Macchi, C, Manini, I, Marchi, S, Mariani, J, Pariani, E, Pesatori, A, Rota, F, Ruscica, M, Schioppo, T, Tarantini, L, Trombetta, C, Valsecchi, M, Vicenzi, M, Zanchetta, G, Milani G. P., Montomoli E., Bollati V., Albetti B., Bandi C., Bellini T., Bonzini M., Buscaglia M., Cantarella C., Cantone L., Carugno M., Casartelli S., Cavaletti G., D'Alessandro S., De Chiara F., Delbue S., Dioni L., Eberini I., Favero C., Ferrari L., Ferraroni M., Galastri L., Galli C., Hoxha M., Iodice S., La Vecchia C., Macchi C., Manini I., Marchi S., Mariani J., Pariani E., Pesatori A. C., Rota F., Ruscica M., Schioppo T., Tarantini L., Trombetta C. M., Valsecchi M. G., Vicenzi M., and Zanchetta G.

Published
2020

44. SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Preliminary Opinion

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraads, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Granum, B., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Cabaton, N., Koutsodimou, A., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Scientific Committee for Consumer Safety (SCCS, EC), and Gaffet, Eric

Subjects
SCCS, revision, Regulation 1223/2009, aluminium, MESH: SCCS, revision, scientific opinion, aluminium, submission III, Regulation 1223/2009, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], [PHYS.COND.CM-MS] Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], scientific opinion, submission III
Abstract

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

Published
2022

45. SCCS OPINION on 4-Methylbenzylidene camphor (4-MBC) - SCCS/1640/21 - Final version

Author

Bernauer, U., Bodin, L., Chaudhry, Q., Coenraad, P.J., Dusinska, M., Ezendam, J., Gaffet, E., Galli, C. L., Granum, B., Panteri, E., Rogiers, V., Rousselle, Ch., Stepnik, M., Vanhaecke, T., Wijnhoven, S., Cabaton, N., Koutsodimou, A., Uter, W., Goetz, N. Von, CEA- Saclay (CEA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Scientific Committee for Consumer Safety (SCCS) (SCCS), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Scientific Committee for Consumer Safety (SCCS, EC), and Gaffet, Eric

Subjects
SCCS, revision, CAS No 36861-47-9/38102-62-4, EC No 253-242-6, Regulation 1223/2009, [PHYS.COND.CM-MS]Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], [PHYS.COND.CM-MS] Physics [physics]/Condensed Matter [cond-mat]/Materials Science [cond-mat.mtrl-sci], scientific opinion, 4-Methylbenzylidene camphor (4-MBC)
Abstract

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

Published
2022

46. Ethical Analysis of the Application of Assisted Reproduction Technologies in Biodiversity Conservation and the Case of White Rhinoceros (Ceratotherium simum) Ovum Pick-Up Procedures.

Author

Biasetti, P, Hildebrandt, TB, Göritz, F, Hermes, R, Holtze, S, Galli, C, Lazzari, G, Colleoni, S, Pollastri, I, Spiriti, MM, Stejskal, J, Seet, S, Zwilling, J, Ngulu, S, Mutisya, S, Kariuki, L, Lokolool, I, Omondo, P, Ndeereh, D, de Mori, B, Biasetti, P, Hildebrandt, TB, Göritz, F, Hermes, R, Holtze, S, Galli, C, Lazzari, G, Colleoni, S, Pollastri, I, Spiriti, MM, Stejskal, J, Seet, S, Zwilling, J, Ngulu, S, Mutisya, S, Kariuki, L, Lokolool, I, Omondo, P, Ndeereh, D, and de Mori, B

Abstract

Originally applied on domestic and lab animals, assisted reproduction technologies (ARTs) have also found application in conservation breeding programs, where they can make the genetic management of populations more efficient, and increase the number of individuals per generation. However, their application in wildlife conservation opens up new ethical scenarios that have not yet been fully explored. This study presents a frame for the ethical analysis of the application of ART procedures in conservation based on the Ethical Matrix (EM), and discusses a specific case study-ovum pick-up (OPU) procedures performed in the current conservation efforts for the northern white rhinoceros (Ceratotherium simum cottoni)-providing a template for the assessment of ART procedures in projects involving other endangered species.

Published
2022

47. Naïve-like pluripotency to pave the way for saving the northern white rhinoceros from extinction.

Author

Zywitza, V, Rusha, E, Shaposhnikov, D, Ruiz-Orera, J, Telugu, N, Rishko, V, Hayashi, M, Michel, G, Wittler, L, Stejskal, J, Holtze, S, Göritz, F, Hermes, R, Wang, J, Izsvák, Z, Colleoni, S, Lazzari, G, Galli, C, Hildebrandt, TB, Hayashi, K, Diecke, S, Drukker, M, Zywitza, V, Rusha, E, Shaposhnikov, D, Ruiz-Orera, J, Telugu, N, Rishko, V, Hayashi, M, Michel, G, Wittler, L, Stejskal, J, Holtze, S, Göritz, F, Hermes, R, Wang, J, Izsvák, Z, Colleoni, S, Lazzari, G, Galli, C, Hildebrandt, TB, Hayashi, K, Diecke, S, and Drukker, M

Abstract

The northern white rhinoceros (NWR) is probably the earth's most endangered mammal. To rescue the functionally extinct species, we aim to employ induced pluripotent stem cells (iPSCs) to generate gametes and subsequently embryos in vitro. To elucidate the regulation of pluripotency and differentiation of NWR PSCs, we generated iPSCs from a deceased NWR female using episomal reprogramming, and observed surprising similarities to human PSCs. NWR iPSCs exhibit a broad differentiation potency into the three germ layers and trophoblast, and acquire a naïve-like state of pluripotency, which is pivotal to differentiate PSCs into primordial germ cells (PGCs). Naïve culturing conditions induced a similar expression profile of pluripotency related genes in NWR iPSCs and human ESCs. Furthermore, naïve-like NWR iPSCs displayed increased expression of naïve and PGC marker genes, and a higher integration propensity into developing mouse embryos. As the conversion process was aided by ectopic BCL2 expression, and we observed integration of reprogramming factors, the NWR iPSCs presented here are unsuitable for gamete production. However, the gained insights into the developmental potential of both primed and naïve-like NWR iPSCs are fundamental for in future PGC-specification in order to rescue the species from extinction using cryopreserved somatic cells.

Published
2022

48. Induced pluripotent stem cells and cerebral organoids from the critically endangered Sumatran rhinoceros.

Author

Zywitza, V, Frahm, S, Krüger, N, Weise, A, Göritz, F, Hermes, R, Holtze, S, Colleoni, S, Galli, C, Drukker, M, Hildebrandt, TB, Diecke, S, Zywitza, V, Frahm, S, Krüger, N, Weise, A, Göritz, F, Hermes, R, Holtze, S, Colleoni, S, Galli, C, Drukker, M, Hildebrandt, TB, and Diecke, S

Abstract

Less than 80 Sumatran rhinos (SR, Dicerorhinus sumatrensis) are left on earth. Habitat loss and limited breeding possibilities are the greatest threats to the species and lead to a continuous population decline. To stop the erosion of genetic diversity, reintroduction of genetic material is indispensable. However, as the propagation rate of captive breeding is far too low, innovative technologies have to be developed. Induced pluripotent stem cells (iPSCs) are a powerful tool to fight extinction. They give rise to each cell within the body including gametes and provide a unique modality to preserve genetic material across time. Additionally, they enable studying species-specific developmental processes. Here, we generate iPSCs from the last male Malaysian SR Kertam, who died in 2019, and characterize them comprehensively. Differentiation in cells of the three germ layers and cerebral organoids demonstrate their high quality and great potential for supporting the rescue of this critically endangered species.

Published
2022

49. Robust induction of primordial germ cells of white rhinoceros on the brink of extinction.

Author

Hayashi, M, Zywitza, V, Naitou, Y, Hamazaki, N, Goeritz, F, Hermes, R, Holtze, S, Lazzari, G, Galli, C, Stejskal, J, Diecke, S, Hildebrandt, TB, Hayashi, K, Hayashi, M, Zywitza, V, Naitou, Y, Hamazaki, N, Goeritz, F, Hermes, R, Holtze, S, Lazzari, G, Galli, C, Stejskal, J, Diecke, S, Hildebrandt, TB, and Hayashi, K

Abstract

In vitro gametogenesis, the process of generating gametes from pluripotent cells in culture, is a powerful tool for improving our understanding of germ cell development and an alternative source of gametes. Here, we induced primordial germ cell-like cells (PGCLCs) from pluripotent stem cells of the northern white rhinoceros (NWR), a species for which only two females remain, and southern white rhinoceros (SWR), the closest species to the NWR. PGCLC differentiation from SWR embryonic stem cells is highly reliant on bone morphogenetic protein and WNT signals. Genetic analysis revealed that SRY-box transcription factor 17 (SOX17) is essential for SWR-PGCLC induction. Under the defined condition, NWR induced pluripotent stem cells differentiated into PGCLCs. We also identified cell surface markers, CD9 and Integrin subunit alpha 6 (ITGA6), that enabled us to isolate PGCLCs without genetic alteration in pluripotent stem cells. This study provides a first step toward the production of NWR gametes in culture and understanding of the basic mechanism of primordial germ cell specification in a large animal.

Published
2022

50. Lombardia: la storia nel nome

Author

Testi di S.B. Galli, C. Azzara, G. Archetti, P. de Vingo, S. Gavinelli, F. Stroppa, A. Baronio, E. Percivaldi, Archetti, G., Archetti, Gabriele, Archetti, G. (ORCID:0000-0002-4706-8286), Testi di S.B. Galli, C. Azzara, G. Archetti, P. de Vingo, S. Gavinelli, F. Stroppa, A. Baronio, E. Percivaldi, Archetti, G., Archetti, Gabriele, and Archetti, G. (ORCID:0000-0002-4706-8286)

Abstract

Il saggio ripercorre la storia del significato del termine “Lombardia”, dalla sua formazione nell’alto medioevo alle differenti valenze del concetto storico-politico e geografico; usato inizialmente dai bizantini per indicare le popolazioni italiche sottratte al loro controllo dai longobardi, il termine si andò lentamente cristallizzando in riferimento agli abitanti della Langobardia maior che, dal tardo XII secolo, presero ad essere chiamati “lombardi”, anche in chiave anti imperiale, con un’accezione geografica per distinguerli dai longobardi delle Langobardia minor dei ducati di Spoleto e Benevento., The essay traces the history of the meaning of the term "Lombardy", from its formation in the early Middle Ages to the different values of the historical-political and geographical concept; initially used by the Byzantines to indicate the Italic populations removed from their control by the Lombards, the term slowly crystallized in reference to the inhabitants of Langobardia maior who, from the late 12th century, began to be called "Lombard", with a geographical meaning to distinguish them from the Lombards of the Langobardia minor of the duchies of Spoleto and Benevento.

Published
2022

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