The regulatory framework for nanomaterials adapts to the continuous technological evolution.

The new Regulation 2018/1881 revises the requirements to be applied to substances developed intentionally as nanomaterials, as well as to those that may unintentionally contain nanomaterials in their formulation, for the purposes of a REACH Registration.

In particular, starting by January 1, 2020 the submission of additional data will be required both for substances currently registered and for new ones.

The new requirements concern:

  • characterisation of nanoforms or sets of nanoforms covered by the registration (Annex VI);
  • the chemical safety assessment (Annex I);
  • registration information requirements (Annexes III and VII-XI); and
  • downstream user obligations (Annex XII).

By employing read-across and robust scientific arguments, it will be possible to categorize nanomaterials into sets of similar nanomaterials in order to simplify the assessment of hazard and risk.

The European Union Observatory for Nanomaterials (EUON) has compiled a list of substances on the EU market that may have nanomaterials.

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