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November 12, 2018

SCCS Revised Guidance for Testing of Cosmetic Ingredients and Their Safety Evaluation Addresses Nanomaterials

Lynn L. Bergeson Carla N. Hutton

On November 7, 2018, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published the tenth revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation.  The guidance contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe.  The document states that it is designed to provide guidance to public authorities and to the cosmetic industry to improve harmonized compliance with the current cosmetic European Union (EU) legislation.  The guidance includes a section on special consideration for certain cosmetic ingredients that discusses nanomaterials, including:

  • Definition of nanomaterial: The guidance notes that Regulation (EC) No 1223/2009 specifically covers the use of nanomaterials in cosmetic products, providing a definition of nanomaterial, as well as a mechanism for notification, labeling, and safety evaluation of cosmetic products containing nanomaterials.  The Regulation covers mainly those nanomaterials that are intentionally produced and are insoluble/poorly-soluble or biopersistent (g., metals, metal oxides, carbon materials), and not those that are either completely soluble or degraded and are not persistent in biological systems (e.g., liposomes, oil/water emulsions);
  • Potential safety issues of nanomaterials: The guidance notes that SCCS has published “a more detailed specific Guidance on Risk Assessment of Nanomaterials (SCCS/1484/12) that is now being revised, a Memorandum on the Relevance, Adequacy and Quality of the Data Expected in Safety Dossiers on Nanomaterials (SCCS/1524/13, Revision of 27 March 2014), and a checklist for the applicants submitting dossiers on nanomaterials as cosmetic ingredients (SCCS/1588/17).”  The guidance lists special features of nanomaterials and suggests how the Responsible Person can address them when testing nanomaterials; and
  • Required information for nanomaterials: The information required by SCCS for the evaluation of nanomaterials as cosmetic ingredients is described in SCCS/1588/17 and SCCS/1484/12 (under revision).  The guidance states that the following aspects deserve special attention:
    • Although most analytical methods used routinely for chemical substances have not yet been validated for nanomaterials, a careful choice of mainstream method(s) should provide sufficient means to gather adequate characterization data for nanomaterials;
    • Where there is evidence for systemic absorption, further investigations are required to confirm whether the absorbed material was in a nanoparticle form or in solubilized/ionic/metabolized form. Where the absorption of nanoparticles cannot be ruled out either by experimental measurements or justified on the basis of solubility/degradation of the nanomaterial, the SCCS may apply a default approach and assume that 100 percent of the absorbed material was in nano form;
    • Surface modification/surface coating may bring about profound changes in a nanomaterial in regard to certain physicochemical properties and potentially the toxic effects; and
    • A full dataset would be preferable. As a minimum, in addition to safety data on the core nanomaterial, the SCCS would require:  information/data on each material used for surface modification/coating of the nanomaterial to indicate that it is safe for use in the intended cosmetic product; data on physicochemical properties of the surface-modified/coated nanomaterial to show that they have not significantly changed compared to either the same material when uncoated, or with a different surface modification/coating that has already been assessed safe by the SCCS; and data on dermal penetration, stability of the surface modification/coating, and (photo)catalytic activity, where relevant.