Public Consultation Begins on SCCS Scientific Advice on Safety of Nanomaterials in Cosmetics

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on October 5, 2020, on a preliminary opinion entitled Scientific Advice on the Safety of Nanomaterials in Cosmetics.  The EC requested that SCCS determine the nanomaterials, as published in the 2019 catalogue of nanomaterials, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article 16(4) Reg.1223/2009).  The EC asked that SCCS provide a description of the specific concerns that have been identified.  The preliminary opinion states that SCCS has identified certain aspects of nanomaterials that constitute a basis for concern over safety to consumers’ health when used in cosmetic products.  These include:

• Physicochemical aspects relating to: very small dimensions of the constituent particles; solubility/persistence/potential accumulation in the body; chemical nature and toxicity of the nanomaterial; physical/morphological features of the constituent particles; and surface chemistry and surface characteristics (surface modifications/coatings);
• Exposure aspects relating to: the frequency and the amounts used, whether the number/type of consumer product(s) used is relatively high; and whether there is a potential for systemic exposure of the consumer to nanoparticles; and
• Other aspects relating to: novel properties, activity, or function, and specific concern arising from the type of application.

Annex 1 of the preliminary opinion lists the nanomaterials included in the 2019 catalogue of nanomaterials in order of priority according to risk potential.  SCCS used a scoring system proposed by Brand et al. (2019) “that combines consideration of the key aspects of nanomaterials that can trigger a ‘signal’ for risk, which when combined with expert judgment can help assign an arbitrary score for prioritisation on the basis of risk potential for human health.”  The preliminary opinion notes that “the outcome of such a scoring system is not meant to be an alternative to evidence-based safety assessment, but to provide a means for prioritising nanomaterials so that they can be subjected to proper safety assessment.”  The nanomaterials listed in Annex 1 with the highest scores are methylene bis benzotriazolyl tetramethylbutyl phenol; colloidal silver; and silver.

The EC also requested that for nanomaterials with inconclusive SCCS opinions, SCCS assess if a potential risk can be identified according to Article 16(6) Reg.1223/2009.  The inconclusive SCCS opinions specified in the request include colloidal silver (nano) (SCCS/1596/18), styrene/acrylates copolymer (nano) + sodium styrene/acrylates copolymer (nano) (SCCS/1595/18), and silica, hydrated silica, and silica surface modified with alkyl silylates (nano form) (SCCS/1545/15).  According to the preliminary opinion, SCCS reviewed the previous inconclusive opinions (SCCS/1596/18, SCCS/1595/18, and SCCS/1545/15), in conjunction with any further relevant information available in published literature to identify whether there is a scientific basis for concern over their safety to consumers’ health when used in cosmetic products.  The preliminary opinion states that SCCS has identified certain aspects relating to each of the nanomaterials that raise a safety concern.  These have been detailed in three separate annexes to the preliminary opinion.  Comments on the preliminary opinion are due November 2, 2020.