Revision of REACH technical annexes

The Commission Communication on the Second Regulatory Review on Nanomaterials (October 2012) as well as the REACH Review (February 2013) concluded that REACH and CLP offered the best possible framework for the risk management of nanomaterials when they occur as substances or in mixtures. However, within this framework more specific requirements for nanomaterials have proven necessary.

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 will enter into mandatory application by 1/1/2020 for the new as well as the existing registrations will significantly clarify REACH registration requirements with regard to nanomaterials. 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 definition of nanomaterial 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)

ECHA is presently working on the adaptation of REACH-IT submission tools and updating ECHA guidance [link to ongoing consultations here].

Procedure:

• October 2017: draft Commission proposal
• 25 April 2018: unanimous vote on the modified draft Commission proposal in the REACH committee
• 9 August 2018: end of EP scrutiny period
• 3 December 2018: adoption of Commission Regulation (EU) 2018/1881 of 3 December 2018
• Associated documents:
  • Impact Assessment Report SWD(2018) 474 final
  • Impact Assessment Summary SWD(2018) 475 final

Revision of REACH Annex II (Safety Data Sheet)

The Commission has not included the nanomaterial-related changes to Annex II to the common proposal described above, as it was decided that they are to be introduced jointly with other changes to Annex II that are required to ensure coherence with the work under UNECE Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Discussion was launched on an early draft in the meeting of the REACH Committee in September 2018. The work continues. Vote in the REACH committee is anticipated in 2019.