Upcoming Changes to Information Requirements for Chemical Registration Under REACH Announced

The European Commission has announced several forthcoming changes to information requirements under REACH. Updates focus on making such requirements more clear for businesses that submit REACH registration dossiers.

Key Information Requirement Changes

The announced changes to information requirements for registration of chemical substances under REACH include the following:

  • Requirements and rules for adapting:
    • aquatic toxicity studies (indicating, in particular, when long-term studies are necessary)
    • degradation and bioaccumulation studies (noting circumstances in which additional testing is required)
    • in vitro and in vivo mutagenicity studies (indicating whether mutagenicity concerns dictate the need for additional studies)
    • reproductive toxicity studies (noting preferred administration routes and animal species)
    • toxicity studies on terrestrial and sediment organisms (indicating when long-term vs. short-term studies are required)
  • Requirement that only representatives of non-EU manufactures provide details on the manufacturers

Information on substance identification, such as:

  • Requirements for describing compositions, nanoform or set of similar nanoforms for information submitted in fulfillment of information requirements under REACH Annex VII-X
  • Crystal structure reporting requirements, and requirements for reporting on substances with variable or unknown composition, complex reaction products, or biological materials
  • Clearer requirements for additives, analytical information, impurities, and reporting constituents

The planned changes to REACH information requirements are scheduled to commence on October 14th of this year. In anticipation of this, businesses should prepare for the impact that the changes will have on them. More information relative to these changes, including corresponding guidance documentation, will be made available by the European Chemicals Agency (ECHA) as this date approaches.

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