On October 9, 2017, the European Commission (EC) began a public consultation on a draft regulation that would amend Annexes I, III, VI, VII, VIII, IX, X, XI, and XII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanoforms of substances.  The draft regulation states that:

  • Clarifications to requirements for the registration of substances with nanoforms and related downstream user obligations should be included in Annexes I, III, and VI to XII;
  • Manufacturers and importers should assess and, where relevant, generate the necessary information and document in the chemical safety report that the risks arising from the identified uses of the substance with nanoforms are adequately controlled;
  • As the majority of nanomaterials are expected to be nanoforms of phase-in substances, the conditions for the requirements for generation of new toxicological and ecotoxicological information on phase-in low volume substances should be elaborated to ensure that the assessment criteria are based also on the predicted properties of nanoforms;
  • All different nanoforms and sets of nanoforms should be considered by the registrant in the demonstration of safety;
  • To allow efficient assessment of the potential exposure for inhalable nanoforms, in particular in workplaces, information on dustiness should be provided for the different nanoforms or sets of nanoforms;
  • Although acute toxicity testing for the lowest tonnage is required via the oral route, for nanoforms, inhalation or in very specific cases the dermal route may be considered as a more appropriate route of exposure;
  • A number of specific physico-chemical properties, in addition to those used to identify the different nanoform or sets of nanoforms, may be considered relevant for scientific understanding of the properties of a nanomaterial, with the necessary parameters depending on the individual case. For reasons of workability and proportionality, only registrants for higher volume substances than 100 tonnes per year should be required to consider explicitly such further information in case other particle properties significantly influence hazard or exposure to those nanoforms; and
  • Compliance with the provisions of the proposed amendment should not be required immediately to allow all registrants and downstream users adequate time to adapt to the more specific requirements for substances with nanoforms. The amendment would apply from January 1, 2020.

Comments are due November 6, 2017.