EC Issues Comprehensive Paper on Nanomaterials
The European Commission, together with the University of West England (UWE), Bristol, published, in February, a new Thematic Issue called “Nanomaterials functionality”. In this paper, recent developments on nanomaterials applications are presented and the safety for humans and the environment is discussed.
As laid down in Regulation 1223/2009/EC, nanomaterial means an insoluble or bio-persistent, intentionally manufactured material with one or more external dimensions or an internal structure between 1 and 100 nm. The same Regulation considers that the use of these substances in cosmetic products may continue to increase with the development of technology and therefore a high level of consumer protection should be ensured.
At present, there is not enough information on the health risks associated to these ingredients, widely used in certain categories of cosmetics such as sun protection creams and lotions where Titanium Dioxide (NANO) is often included in the formulation as a UV-filter.
The safety of these ingredients has been studied in depth in the recent years by the Scientific Committee for Consumers Safety (SCCS) a body hosted by the European Commission and in charge of providing advice and scientific evidence to guide the debate and regulations at European level.
Though the European Commission committed to publishing the Nanomaterials Catalogue this has been considerably delayed due to a lack of proper information uploaded in the CPNP by users. The hope and belief is that this catalogue will clarify swiftly which nanomaterials can used and which will need further investigation and notification steps.
Advice and responsibility
The aim of the legislation is to guarantee a high level of safety for the final user. This will only be achieved by carefully monitored pre-market compliancy and in-market surveillance to ensure that no banned ingredients are included in the formulation of the cosmetic product.
It is the obligation of the EU Responsible Person to ensure compliance with Art. 16 of EC Regulation 1223/2009 on Nanomaterials. The Responsible Person is also charged with compiling the Product Information File, an essential step towards the compliance and marketing of a cosmetic product in the EU.
Are you confident that all the ingredients in your products are authorized in the EU? Would you like to know more about how to replace banned or restricted ingredients? Please contact us for in depth information about this and other steps in the EU compliance process. With more than 26 years of experience, we provide consultancy and regulatory advice to support your activities within the EU Market.