Do you want to place a cosmetic product containing nanomaterials on the market?
According to the Regulation (EC) no.1223/2009, nanomaterial is an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. The EU Regulation pretends to ensure a high level of protection of human health for every cosmetic product that contains nanomaterials, so these products shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market.
Is my product “nano”? What are the advantages and disadvantages of using nanoparticles in cosmetics? How to evaluate the penetration of nanomaterials?
There are many types of nanomaterials including liposomes, nanoemulsions, solid lipid nanoparticles (SLN), etc. Nanoparticles can be divided into two groups: i) soluble and/or biodegradable nanoparticles which disintegrate upon application on the skin into their molecular components (e.g. liposomes, microemulsions, nanoemulsions), and ii) insoluble particles (e.g. TiO2, fullerenes, quantum dots). The dimension, solubility and persistency dictate their classification as a nanomaterial according to the Regulation (EC) no.1223/2009.
The risk assessment of nanomaterials is a challenge. The Nano-Guidance (SCCS/1484/12) covers the essential elements that would be required in a safety dossier on manufactured nanomaterial, i.e. physicochemical characterization, toxicological evaluation, exposure assessment, and risk characterization. Further notes in relation to nanomaterials are provided in the SCCS Notes of Guidance (SCCS/1501/12). It is crucial when assessing possible risks associated with nanoparticles to consider their uptake. It is primarily for the insoluble particles that health concerns related to possible uptake may arise. Should they become systemically available, translocation/ transportation and eventual accumulation in secondary target organs may occur.
Presented by:Marta de Oliveira Ferreira