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REACH and Nanomaterials

Supporting compliance of nanomaterials under REACH


Regulation _200The European REACH Regulation places responsibility on industry to assess and manage the risks posed by chemical substances and provide appropriate safety information to their users. Although there are currently no provisions referring specifically to nanomaterials in REACH, nanomaterials meet the regulations’ substance definition and the general obligations of REACH therefore apply to nanomaterials as for any other substance.

One of the most significant developments to date is the adoption of a definition of the term “nanomaterial”, which states that a material is a nanomaterial if more than 50% of particles have at least one dimension between 1 – 100 nm.

The European Chemicals Agency (ECHA) has indicated that the scope of REACH registration dossiers should be clear and provide explicit information on all forms of the substance, including the nano-form. Recent compliance checks by ECHA have highlighted a lack of nano-specific information in many registration dossiers, with registrants being requested for additional data to ensure compliance.

A pro-active approach by industry to include nano-specific information in REACH dossiers, chemical safety reports and supply chain communications will help to promote responsible development, ensure regulatory compliance and prevent delays to commercialisation.

Having carried out extensive work with the European Commission, ECHA and industry to develop specific advice and guidance on the implementation of REACH for nanomaterials, including leading two of the REACH Implementation Projects on Nanomaterials (RIP-oNs), SAFENANO is ideally placed to support your needs in achieving regulatory compliance of nanomaterial substances.

Our range of services, which can be tailored specifically to meet your needs, include:

  • Scoping of REACH obligations;
  • Technical support to Lead Registrants & SIEFs;
  • Registration dossier preparation, pre-submission screening & gap analysis;
  • Chemical safety assessment;
  • Particle characterisation, including granulometry, in the context of the EU definition of nanomaterials;
  • Exposure assessment, including measurement, modelling & exposure scenario development;
  • Hazard assessment, including data gathering & development of testing proposals;
  • Material Safety Data Sheet preparation & review;
  • Training & awareness.

Please contact us to discuss your specific requirements for ensuring REACH compliance of nanomaterials.

Did you know?

0.335 nm is the theoretical thickness of graphene.