Nanomaterials

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What is a nanomaterial?

In the EU, the European Commission set out the following recommendation in 2022 for a nanomaterial for use in legislation and policy making across all sectors (Official Journal of the EU C229/1,14.06.2022). This replaced their previous 2011 Recommendation (Official Journal of the EU L275, 20.10.2011, p. 40). The revised definition is an output under the EU’s Chemicals Strategy for Sustainability.

The term nanoform was introduced in the European Commission’s adopted Regulation (EU) 2018/1881 of 3 December 2018… ‘amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances’… states:

“On the basis of the Commission Recommendation of 18 October 2011 on the definition of nanomaterial ( 1 ), a nanoform is a form of a natural or manufactured substance 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, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm. For this purpose, “particle” means a minute piece of matter with defined physical boundaries; “agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components and “aggregate” means a particle comprising of strongly bound or fused particles.”

This amended Annex VI to Regulation (EC) No 1907/2006. [NOTE: As of August 2023, the 2022 Recommendation is not reflected within EU-REACH and UK-REACH legal texts].

What are the requirements under (EU/UK) REACH?

REACH registration requirements for nanoforms of a substance manufactured or imported above 1 tonne per annum came into force 1 January 2020. These apply to both existing and new registrations.

The requirements including specific information under Annexes VII-X are given in the adopted Regulation (EU) 2018/1881 of 3 December 2018… ‘amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances’. [Note: These amend those within Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).]

How many registration dossiers are required under (EU/UK) REACH?

Compliance requires one registration dossier per substance by the same registrant. Manufacturers and importers of a bulk substance with nanoform(s) must therefore submit information requirements for the bulk and its nanoform(s) within the same registration dossier. This can be done either by reporting your nanoforms individually or by reporting set(s) of nanoforms covering your nanoforms.

When can I group nanoforms into a set?

Under (EU/UK) REACH, two conditions apply: (i) Defined boundaries must be clearly reported in terms of characterisation parameters of the nanoform which are part of the set; and (ii) Justification must be given that the hazard, exposure and risk assessment of the nanoforms can be performed jointly.

How do I characterise a nanoform or set of nanoforms of a substance?

Characterisation information is required for both under (EU/UK) REACH. This is given under Section 2.4 of Regulation (EU) 2018/1881; Annex VI of the REACH legal text.

Where can I find further information?

Recommendations for complying with REACH for nanomaterials are provided on the European Chemical Agency’s website. These are also applicable to UK-REACH.

ECHA’s EU Observatory for Nanomaterials also contains lots of information.

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