New European Regulation to address nanoforms of substances

On 3 November, 2018,Commision Regulation 2018/1881 was published which address nanomaterials and nanoforms of substances falling under REACH.The regulation shall apply from 1 January 2020.

The regulation specifies what companies should provide with regards to nanoforms of substances falling under REACH. Nanoforms are substances that are nanomaterials according to the 2011 Commission nanomaterial definition. nanomaterial' means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm.

The new requirements will enable both companies and authorities to systematically assess the hazardous properties of nanomaterials, how they are used safely, and what risks they may pose to our health and the environment. This information will help authorities in the EU to identify if further risk management measures are needed.

Companies now have to assess whether the new information requirements apply to their substances. The changes are relevant for companies manufacturing or importing nanoforms of substances that fall within the scope of REACH. Nanoforms of substances are those covered by the European Commission's recommendation for a definition of a nanomaterial.

The European Chemicals Agency (ECHA) strongly encourages registrants of nanoform substances to familiarise themselves with the amendments and assess what action they need to take to comply. ECHA is also currently assessing the need to update existing guidance or issue new guidance to help registrants comply with the new requirements.

Under REACH, the EU's manufacturers and importers of chemicals have a general obligation to register in the European Chemicals Agency each substance manufactured or imported in quantities of 1 tonne or more per year per company. In the registration dossier, they must identify the risks linked to the substances they produce and market, and indicate how these risks are managed.

Ensuring that this safety assessment for substances in nanoform effectively captures and documents also the potential differences between the forms covered by the registration has been the principal objective of the modifications of the REACH annexes.

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