EU Committee Publishes Revision of Guidance on the Safety Assessment of Nanomaterials in Cosmetics

On 6 June 2023, the Scientific Committee on Consumer Safety (SCCS) of the European Union adopted the second revision of its Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The guidance on nanomaterials should be used in conjunction with the general guidance for the submission of safety dossiers of cosmetic ingredients “The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 12th revision, SCCS/1647/22” or any future revision.

In the EU, the use of nanomaterials in cosmetics is specifically covered under the Cosmetic Regulation (EC) No 1223/2009, which provides a definition of a nanomaterial (NM) and requires premarket notification, safety evaluation, and labeling of cosmetics containing NM ingredients. If the European Commission has concerns regarding the safety of an NM, the Commission shall refer it to the SCCS for a scientific opinion.

This Guidance is an up-to-date revision of the existing Guidance (SCCS, 2019) and aims to provide an overview of the key issues and data requirements relating to the safety assessment of NMs in cosmetics. The revision contains a number of changes. New sections have been introduced covering aspects such as solubility and dissolution rate, solubility in non-aqueous media, evidence for the absence of nanoparticles, dispersion, aspect ratio, uptake into blood cells, reproductive toxicity, and endocrine disruption. The European Commission recommendation for a definition of nanomaterials published in 2022 has been incorporated. Key aspects triggering safety concerns over a nanomaterial based on the SCCS’s scientific advice on the safety of nanomaterials in cosmetic (SCCS/1618/2020) have been introduced, providing a clearer understanding of potential risks associated with nanomaterials. Additionally, Annex 1 and other sections of the Guidance have been updated based on recent literature, the section on read-across and grouping has been revised and a text explaining when historical/existing data can be used has been included.

The full text of the revised Guidance can be found here.