In cosmetic products, 'nanomaterial' refers to an insoluble or biopersistent and intentionally manufactured material. A nanomaterial has one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. EU legislation provides a high level of protection of human health where nanomaterials are used in cosmetic products.
In the EU, responsible persons (i.e. manufacturers, importers or third persons appointed by them) are required to register cosmetic products on the cosmetic products notification portal (CPNP) (Regulation (EC) No 1223/2009, Art. 13 (1). The notification must specify whether the product contains nanomaterials, with their identification and the foreseeable exposure conditions. Questions and answers on the notification of cosmetic products containing nanomaterials.
In addition, cosmetic products containing nanomaterials other than colourants, preservatives and UV-filters and not otherwise restricted by Regulation (EC) No 1223/2009 are subject to an additional procedure. They require a specific notification on the CPNP 6 months before placement on the market (Art. 16 (3)). If the European Commission has concerns regarding the safety of a nanomaterial, it may request the scientific committee on consumer safety (SCCS) to perform a risk assessment.
Certain groups of substances, i.e. colourants, preservatives and UV-filters, including those that are nanomaterials, must be authorised by the European Commission prior to their use in cosmetic products. An opinion from the SCCS, which reviews submitted toxicological data, precedes this authorisation. Up until now, the Commission has authorised 4 UV-filters as nanomaterials: Methylene bis-benzotriazolyl tetramethylbutylphenol (MBBT), titanium dioxide, zinc oxide and tris-biphenyl triazine. It has also allowed carbon black (nano) for use as a colourant in cosmetic products.
Nanomaterials must be labelled in the list of ingredients with the word 'nano' in brackets following the name of the substance.
According to Regulation (EC) No 1223/2009 Article 16 (10a) the Commission has to publish a catalogue of all nanomaterials used in cosmetic products placed on the market. Nanomaterials used as UV-filters, colourants and preservatives must be specified in a different section. The catalogue should indicate the categories of cosmetic products and the foreseeable exposure conditions.
Responsible persons electronically notify the European Commission with information on nanomaterials in their products through the cosmetic products notification portal. The catalogue is based on this information.