Cosmetic ingredients
The looming European harmonisation of Nanomaterials regulations
As expected since 2014, the revised recommendation on the European definition of nanomaterials, C(2022) 3689, was published on Friday June 10, 2022, by the European Commission.
This update is the result of a long process to gather information and views from the various interested stakeholders, whether industrialists, professional unions, researchers or EU Member State authorities, European agencies or NGOs. The objective of this long revision process was toidentify points of clarification necessary to improve the understanding of the terms and concepts used and to better define the scope of application of the definition, to ultimately facilitate its implementation, particularly from the point of view of the analytical methodologies required.
Recommendation C(2022) 3689 was published to offer a harmonised definition of the term “nanomaterial” for subsequent inclusion in all European transversal or sectoral regulations.
Currently, Biocide Regulation (EU) 528/2012, Medical Devices Regulation (EU) 2017/745 and REACH Regulation 1907/2006/EC had already incorporated the first definition recommendation adopted in 2011, as well as the annual reporting obligation for substances in the nanoparticle state via the R-NANO register at the French level, which also uses an equivalent definition.
Other European sectoral regulations such as Novel Food Regulation (EU) 2015/2283 and Cosmetics Regulation 1223/2099/EC use specific definitions in relation to the definition recommendation. Options for revising these texts will be considered in light of the new definition recommendation.
Various webinars, including the latest webinar on REACH and nanomaterials, also provide indications to better understand this complex subject.
REACH and nanomaterials: take stock
Production and handling of powders: towards the assessment of powderiness to control risks
Nanomaterials and medical devices: taking into account the evolution of MD regulations
Source: lne.fr
