Nanomaterials are chemicals that have features measured at a very small scale, in the range of 1-100 nanometers. These types of products exhibit novel characteristics compared to the same material without nanoscale-features. Nanomaterials often have unique optical, mechanical, or electronic properties, making them of interest in various fields. As nanomaterials become more commercialized, we are starting to see additional regulatory requirements to ensure their safe use.
The updated Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation annexes for the nanoforms of substances come into effect on January 1, 2020. The new requirements are of concern to companies that manufacture or import nanomaterials that are subject to registration under REACH in the European Union. The objective of the new information requirements is to ensure that companies are providing enough information to demonstrate safe use of nanoform substances for human health and the environment.
The revised Annex VI of REACH introduces the concept of “nanoform” into the Regulation. It establishes the principles that all the nanoforms of substances that are covered by the registration must be reported in the registration dossier. The revised Annex VI enables registrants to report several nanoforms together if certain conditions are met. These are called a “set of similar nanoforms”. The registrant must provide justification that the variation does not affect the hazard and risk assessment of the similar nanoforms in the set. A nanoform can only belong to one set of similar nanoforms.
The revised REACH annexes addressing nanoforms introduce clarifications and new provisions for:
- Characterisation of nanoforms or sets of nanoforms covered by the registration (Annex VI);
- Chemical safety assessment (Annex I);
- Registration information requirements (Annexes III and VII-XI); and
- Downstream user obligations (Annex XII)
Registrants must update existing dossiers with nanoform specific information by January 1, 2020.
Nanomaterial Guidance from ECHA
Two guidance documents for companies registering nanoform substances were updated in December 2019 by the European Chemicals Agency (ECHA). The documents aim to help companies fulfill the new legal requirements for nanomaterials.
The new Appendix for nanoforms to the Guidance on Registration and Substance Identification explains the term nanoform, provides advice on how to build and justify sets of similar nanoforms, and explains what characterisation information needs to be reported.
The Appendix for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals has been updated to reflect the advice of the guidance document mentioned above and clarify the differences between creating a set of nanoforms and read-across for justifying the use of hazard data between different (sets of) nanoforms of a substance.
ECHA has stated that they will keep updating existing guidance documents during 2020. An updated overview of available test guidelines and other recognised methods and standards is available on the European Union Observatory for Nanomaterials.
For assistance with REACH compliance, contact Nexreg today!