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Nanomaterials in REACH and CLP

REACH is the over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. Nanomaterials are covered by the definition of a "substance" in REACH, even though there is no explicit reference to nanomaterials. The general obligations in REACH, such as registration of substances manufactured at 1 tonne or more and providing information in the supply chain apply as for any other substance.

Information on the implementation of REACH for nanomaterials, including guidance and the application of the REACH evaluation processes, can be found on the ECHA website.


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:

 

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.



CLP

Nanomaterials that fulfill the criteria for classification as hazardous under Regulation 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures must be classified and labelled. This applies to nanomaterials as substances in their own right, or nanomaterials as special forms of the substance. Many of the related provisions, including safety data sheets and classification and labelling apply already today, independently of the tonnage in which the substances are manufactured or imported. Substances, including nanomaterials, meeting the classification criteria as hazardous should have been notified to ECHA by 3 January 2011. Any further update to the classification must also be notified without undue delay. It is perfectly possible that the classification is applied only to specific form(s) including nanoforms of the substance. Based on the information received under REACH registrations and CLP notifications, ECHA published a classification and labelling inventory.

Applicability of provisions of UNECE Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for nanomaterials is being assessed in the biennium 2015-2016 by the subcommittee of experts (see Program of Work). As appropriate, the outcomes will be reflected under CLP.

CARACAL and CARACAL Subgroup on Nanomaterials

In the years 2008-2017 the Commission prepared advice on how to manage nanomaterials in accordance with REACH and the CLP Regulation in close co-operation with the CARACAL subgroup on nanomaterials ("CASG Nano", composed of Member States and stakeholder experts). The first paper "Nanomaterials in REACH" provides an overview of how the provisions of REACH apply to nanomaterials. The second paper, Classification, Labelling and Packaging of Nanomaterials in REACH and CLP, focuses on the classification of nanomaterials in accordance with REACH and particularly the CLP Regulation. CASG Nano also recommended RIPoN reports as a preliminary advice and basis for ECHA in its further work on relevant guidance documents.

CARACAL, mainly through CASG Nano, has been following the development of major initiatives of the Commission on nanomaterials such as the revision of REACH, the assessment of impacts of EU registry of nanomaterials (also known as 'transparency measures') and served as the expert group and sounding board in the on-going review of Commission Recommendation on the definition of nanomaterial.

The last mandate of CASG Nano that expired in January 2018 has not been prolonged. CARACAL concluded that following the Commission proposal on modification of REACH Annexes in 2017, the principal discussion moved to the REACH committee while all the implementation aspects are now discussed in ECHA NanoMaterial Expert Group.

Nanomaterials however remain as a standing agenda point in every meeting of CARACAL.