The European Commission’s Scientific Committee on Consumer Safety (SCCS) published in November 2019 an up-to-date revision of the existing Guidance on the Safety Assessment of Nanomaterials (NMs) used in Cosmetic Products (SCCS/1484/12). The discussion to revise the Guidance on safety assessment of NMs started in May 2017 within a dedicated SCCS working group and aimed at providing key recommendations for safety of NM used in cosmetics including data requirements.
In Europe, the use of nanomaterials in cosmetics is specifically covered under the Cosmetic Regulation (EC) No 1223/2009, which provides a definition of a NMs and requires premarket notification, safety evaluation, and labelling of NMs intended for use in cosmetic products. Because of the specific concerns over the safety of NMs to human health and environment, the SCCS recommended a thorough risk assessment explained in their Guidance.
In 2012, the SCCS published a first Guidance on the safety assessment of NMs in cosmetics (SCCS/1484/12). This Guidance recommended minimum data requirements for the characterisation of nanomaterials intended for use in a cosmetic product. As a number of issues and questions have been identified by the SCCS regarding the types and quality of the information that must form part of the safety dossiers on NMs, the SCCS published a memorandum (SCCS/1524/13 revision of 27 March 2014) to highlight the importance of relevance, adequacy and quality of the data provided in a safety dossier on NMs. Lately, in May 2018 SCCS published the 1st revised version of the checklists for applicants submitting nanomaterial as cosmetics ingredients dossiers (SCCS/1588/17).
In line with the new scientific development, the SCCS published in November 2019 a revision of the Guidance on the Safety Assessment of Nanomaterials in Cosmetics (SCCS/1611/19). The SCCS clarified that the newly published Guidance is complementary to the SCCS general Notes of Guidance for specifically addressing safety aspects of NMs, and therefore must be considered in conjunction with the SCCS Notes of Guidance (SCCS/1602/18 or its most recent revision).
Key recommendations provided in this up-to-date Guidance are covering the main elements of the safety assessment including:
- Definition: This Guidance is applicable to any material meeting the criteria of a NM as outlined in the Cosmetic Regulation (EC) No. 1223/2009 Article 2 (1)(k), as “an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm”. Accordingly, the cosmetic regulation includes those nanomaterials that are intentionally produced and are insoluble/practically insoluble/very slightly soluble/slightly soluble/ sparingly soluble (according to the categorisation of solubility of substances as defined by US and European Pharmacopeias – European Pharmacopoeia 10th Edition (2019); USP38 and USP38 NF33) or biopersistent (e.g., metals, metal oxides, carbon materials, etc.), and not those that are either completely soluble or degraded and are not persistent in biological systems (e.g., liposomes, oil/water emulsions, etc.). It is further advisable that, when assessing the safety of a material consisting of small particles, Applicants should also take into account the Commission Recommendation (2011/696/EU). Material specifications such as particle size distribution, solubility, and persistence should provide a basis for deciding whether or not a cosmetic ingredient has to be considered a NM.
- Material characterization: A set of important parameters and methods needed to properly characterize a given NM was provided in the Guidance. The NM characterisation needs to be carried out at the raw material stage, in the cosmetic formulation, and during exposure for toxicological evaluations. A detailed description of the production processes, any surface modifications, and the preparatory steps carried out for integrating the NMs in the final cosmetic products may be asked for by the SCCS as input into the safety assessment process.
- Exposure assessment: While it is mentioned that the safety assessment of NMs follows the same procedure as for a non-nano ingredient, it is emphasized that special considerations of the nano-aspects will need to be taken into account. Safety assessment of NMs may, in the first instance, be driven by considerations of exposure. The SCCS is of the view that the method for calculating dermal and oral exposure to NMs will not be substantially different from the calculation of exposure to conventional cosmetic ingredients even if they are well aware of specific surface modifications of NMs that may stimulate dermal penetration. However, the committee did recognize that the calculation of exposure to aerosols containing NM may be more challenging.
- Hazard identification/dose-response characterization: Data from toxicological studies for local and — in case of systemic absorption — systemic effects will be required. Testing of nanomaterials for hazard identification/dose-response characterization must be carried out in consideration of the nano-related aspects. Also, the prohibition on animal testing and marketing of animal tested cosmetic ingredient/products under the Cosmetics Regulation must be observed in any toxicological testing. Since validated alternative methods that can be used in place of animal tests are not yet available for NMs, the SCCS can accept results from the methods that may not have been formally validated for NMs but can be demonstrated to be scientifically valid for hazard identification of NMs.
- Safety assessment: It is mentioned in the SCCS Guidance that, historically, the calculation of the margin of safety of a cosmetic ingredient has been based on a measured toxicological point of departure (POD), along with an estimate of internal exposure in terms of systemic exposure dose. In addition, the SCCS Guidance accepts that with the European Union’s ban on animal testing of cosmetic ingredients and/or products, derivation of PODsys for systemic adverse effects of a new cosmetic ingredient may not be possible, or possible only in exceptional cases. Still, data obtained to comply with other non-cosmetic regulations should be used and submitted when available. For other cases the applicant will need to assemble relevant information and data from different alternative (non-animal) methods and integrate the data to build an overall weight of evidence to support the safety of the cosmetic ingredient case by case basis. The Guidance also discussed about the need of additional uncertainty factors for NMs safety assessment when data provided are either insufficient or from inadequate tests.
Overall, the revised Guidance document for the Safety Assessment of Nanomaterial ingredients in Cosmetics is updated with available scientific knowledge in nanotechnology field. Also, this publication appears well planned along with recent prioritisation work of nanomaterial chemical registration dossier updates under the EU REACH Regulation by the European Chemical Agency (ECHA) and recent launch of new version of IUCLID updated with new data fields for reporting the characteristics of nanoforms and sets of nanoforms. It will be a challenging time ahead for manufacturers of nanomaterial to collate and generate reliable and relevant data for the safety assessment of nanomaterials.