12 December 2020
20 January 2021
On January 11, 2021, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted a final 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 final 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; 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 potential accumulation in the body; and
- Other aspects relating to: novel properties; activity or function; and specific concern arising from the type of application.
Annex 1 of the opinion lists the nanomaterials included in the 2019 catalogue of nanomaterials in order of priority according to risk potential. SCCS states that it used a scoring system to assign a notional score to each listed nanomaterial to indicate the level of concern and listed the nanomaterials in descending order of the scores so that the nanomaterials requiring priority attention for safety assessment could be identified. The final opinion notes that “the scoring system is also not an alternative to safety assessment, and has only been used to prioritise nanomaterials for a subsequent evidence-based safety assessment.” The nanomaterials listed in Annex 1 with the highest scores are colloidal copper, methylene bis benzotriazolyl tetramethylbutylphenol, colloidal silver, and silver.
The EC also requested that for nanomaterials with inconclusive SCCS opinions, SCCS assess whether 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 opinion, SCCS reviewed the previous inconclusive opinions, 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 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.