Nanomaterials – Know Your Registration Responsibilities
Nanomaterials are chemical substances with a particle size between 1 and 100 nanometres for 50% or more of the present particles in at least one dimension. As of 1 January 2020, explicit legal requirements under REACH apply for companies that manufacture or import nanomaterials within the EU. These new reporting obligations differ from conventional materials, addressing specific information requirements, namely:
- Characterisation of nanoforms or sets of nanoforms covered by the registration – substances may comprise different nanoforms due to variation in the physiochemical properties (size, shape, surface treatment), each of which needs to be addressed specifically within the registration dossier.
- Chemical safety assessment – nanoforms can be grouped based on physiochemical properties and reactive properties wherein a safety assessment will be required for each group.
- Registration information requirements – Registration requirements such as tonnage triggers still apply to nanoforms.
- Downstream user obligations – Downstream users are required to assess and document any risks arising from substances they use. The assessment shall cover the life-cycle of the substance, from its receipt by the downstream user and for identified uses further down the supply chain.
These new requirements apply to all new and existing registrations covering nanomaterials and are outlined in the corresponding revised annexes to the REACH regulation.
Enviresearch has many years of experience in regulatory compliance and is able to provide assistance in the registration of nanomaterials. A REACH registration package needs to be supported by a standard set of data on the substance, for which Enviresearch can assist for finding solutions for any data deficiency’s, offer strategic advice on compliance, and aid in technical dossier writing.