Nanomaterials in cosmetics – The next priority of the Commission?

Since a number of new developments have taken place in the area of nanomaterial safety research, the EC Scientific Committee on Consumer Safety (SCCS) has updated its Guidance in October 2019 to ensure compliance of nanomaterials intended for use as cosmetic ingredients under the current EU legislation (EC No 1223/2009). We have provided a summary of the key elements in an earlier insight article. Elements like the ban of animal testing in 2013 under the Cosmetic Product Regulation (CPR) as well as the assessment of the first set of dossiers have highlighted a number of challenges in obtaining relevant data for the safety assessment of nanomaterials. The updated Guidance gives key recommendations for risk assessment of nanomaterials in relation to possible use as cosmetic ingredients.

On 5 February 2020, and in line with their recommendations, the SCCS working group on nanomaterials in cosmetic products jointly with the Scientific Committee on Health, Environment and Emerging Risks (SCHEER) were mandated by the Commission for a scientific advice on the safety of nanomaterials in cosmetics.

Thus far, the concern emitted by Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) to request the previous SCCS opinions was based on the intrinsic properties of nanomaterials, as a category, in light notable of their nano-scale dimension, bio-persistence and insolubility. In some recent cases, the SCCS was unable to establish or exclude the potential risk to human health of some nanomaterials due to insufficient or inconclusive data provided by the Applicants. Therefore, the Commission was not able to take potential regulatory measures in accordance with Article 16(6) of the CPR. The Commission seeks now advice on the establishment of the “minimum level of potential risk that could justify a restrictive regulatory measure”.

In order to do so, the SCCS is requested to:

1. 1. Establish a priority list of nanomaterials for risk assessment. Based on the recent published catalogue of nanomaterials used in cosmetic products on the EU market., the SCCS is requested to provide a description of the specific concerns that have been identified for the nanomaterials that will be listed as a priority.

1. 1. Assess if a potential risk can be identified according to Article 16(6) of  the CPR for the nanomaterials with inconclusive SCCS opinions, including nanoform colloidal silver (SCCS/1596/18); styrene/acrylates copolymer and sodium styrene/acrylates copolymer (SCCS/1595/18); and silica, hydrated silica, and with alkyl silylates surface modified silica (SCCS/1545/15). Such assessment should be based on the available scientific literature and SCCS expert judgement in view of evidences that may include, but are not limited to the following: systemic or local availability, harmful effects specifically related to the nanoform, surface catalyzed reaction in nanoform, absorption (or potential absorption) from dermal and inhalation routes, potential nanoform to deliver ionic forms.