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Ouvrages Année : 2020

SCCS OPINION ON Copper (nano) and Colloidal Copper (nano)

U. Bernauer
  • Fonction : Auteur
Q. Chaudhry
  • Fonction : Auteur
P.J. Coenraads
  • Fonction : Auteur
M. Dusinska
  • Fonction : Auteur
E. Panteri
  • Fonction : Auteur
M. Stepnik
  • Fonction : Auteur
S. Wijnhoven
  • Fonction : Auteur
W.H. De Jong
  • Fonction : Auteur
N. Von Götz
  • Fonction : Auteur

Résumé

"SCCS OPINION ON Copper (nano) and Colloidal Copper (nano)" SCCS/1621/20 - Preliminary Opinion U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, C. Rousselle, M. Stepnik, S. Wijnhoven, W.H. de Jong, N. von Götz The SCCS adopted this document at its plenary meeting on on 27-28 October 2020 (49 Pages) Mise en ligne le 9 Novembre 2020 https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_245.pdf SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven SCHEER member: W.H. de Jong (Rapporteur) SCCS external expert: N. von Goetz Contact: SANTE-C2-SCCS@ec.europa.eu On request from: European Commission SCCS Number: SCCS/1621/20 Adopted on: 27-28 October 2020 Conclusion of the opinion: 1. In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterials Copper and Colloidal Copper safe when used in leave-on and rinse-off dermal and oral cosmetic products including: skin, nail and cuticle, hair and scalp and oral hygiene products, at a maximum concentration of 1 % (for both Copper and Colloidal Copper) and with specifications as reported in the attached list, taking into account reasonably foreseeable exposure conditions? The SCCS has considered all the information provided by the Notifiers and is of the opinion that it is not possible to carry out safety assessment of the nanomaterials Copper and Colloidal Copper due to the limited or missing essential information. Much of the information provided on toxicity relates to copper as such, and in the absence of full study reports, it is not possible to determine the relevance of the data for nano-forms of copper under the current evaluation. Adequate information on various aspects both for the nanomaterial characterisation and the toxicological evaluation including experiment performance and experimental data obtained need to be provided (as summarised in Annex I). 2. Does the SCCS have any further scientific concerns with regard to the use of Copper and Colloidal Copper in nano form in cosmetic products? The information provided by the Notifiers, and obtained from scientific literature, suggests possible systemic uptake of Cu nanoparticle (and/or ionic Cu), which may lead to accumulation in certain organs - notably the liver and spleen. In addition, the available literature data indicate potential mutagenic/genotoxic and immunotoxic/nephrotoxic effects of copper nanomaterials. These indications raise an alert that warrants further safety evaluation of copper nanomaterials used as cosmetic ingredients. The SCCS concerns for consumer safety in this regard are detailed in Annex II. Annex I provides an overview of the information provided by the Notifiers compared to the data requirements as given in the SCCS checklists for Applicants submitting dossiers on Cosmetic Ingredients to be evaluated by the SCCS (SCCS/1588/17). Keywords: SCCS, scientific opinion, Copper (nano), Colloidal Copper (nano), CAS No 7440-50-8, EC No. 231-159-6, Regulation 1223/2009 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Copper (nano) and Colloidal Copper (nano), 27-28 October 2020, SCCS/1621/2020.
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Dates et versions

hal-02996911 , version 1 (09-11-2020)

Identifiants

  • HAL Id : hal-02996911 , version 1

Citer

U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, et al.. SCCS OPINION ON Copper (nano) and Colloidal Copper (nano). Scientific Committee for Consumer Safety (SCCS / EC). , 2020, Scientific Committee for Consumer Safety (SCCS, EC). ⟨hal-02996911⟩
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