2018 revision of REACH technical annexes to specifically address nanomaterials

On 3 December 2018 the Commission adopted Commission Regulation (EU) 2018/1881 to modify REACH Annexes I, III and VI-XII, introducing nano-specific clarifications and new provisions in the chemical safety assessment (Annex I), registration information requirements (Annex III and VI-XI) and downstream user obligations (Annex XII).

The proposed amendments that entered into mandatory application on 1/1/2020 for the new as well as the existing registrations. Provisions include:

• Requirement to identify and characterise nanoforms of substance covered by the registration. They can be documented individually or jointly in sets of similar nanoforms by providing clear identification of size, shape, are and surface chemistry of particles of the nanoforms covered by the registration. Excerpt from the modified Annex VI of REACH:
  • On the basis of the Commission Recommendation of 18 October 2011 on the 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.
  • A nanoform shall be characterised in accordance with section 2.4 below. A substance may have one or more different nanoforms, based on differences in the parameters in points 2.4.2 to 2.4.5.
  • A 'set of similar nanoforms' is a group of nanoforms characterised in accordance with section 2.4 where the clearly defined boundaries in the parameters in the points 2.4.2 to 2.4.5 of the individual nanoforms within the set still allow to conclude that the hazard assessment, exposure assessment and risk assessment of these nanoforms can be performed jointly. A justification shall be provided to demonstrate that a variation within these boundaries does not affect the hazard assessment, exposure assessment and risk assessment of the similar nanoforms in the set. A nanoform can only belong to one set of similar nanoforms
• Compilation of basic information on volumes and uses of nanoforms
• Clarifications how obligations on substance apply to all nanoforms covered by the registration: performance of chemical safety assessment (and application of its conclusions when applying adequate risk management measures), documentation of information requirements on hazard assessment and application of adaptation possibilities etc.
• Introduction of requirements for adequate sample preparation, route of exposure and characterisation of test material when in nanoform, consideration of appropriate metrics when reporting the results and specific principal physico-chemical properties that can support the safety assessment of nanomaterials (dissolution rate, dispersion stability of nanoforms)

Qualification of existing adaptation possibilities to ensure their responsible application to nanoforms and modification of information requirement where the test method is not applicable/informative for nanoforms (e.g. KoW partition coefficient, genotoxicity AMES test).

Revision of REACH Annex II (Safety Data Sheet)

In a separate process, the Commission has also updated Annex II of REACH with Commission Regulation (EU) 2020/878. New provisions on Safety Data Sheets are complementing the new registration requirements for nanomaterials (see above) and ensuring that this same information is reflected also in the Safety Data Sheets.

Provisions came into force on 1 January 2021, with a transition period for the update of existing Safety Data Sheets extended to 31 December 2022.