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ECHA does not consider dossier updates during evaluation decision making


Once ECHA has sent a draft decision to registrants, it does not consider dossier updates during evaluation decision making. Registrants need to keep their registration dossiers up to date at all times.

Helsinki, 26 November 2019 – REACH is based on the principle that registrants must ensure that substances used and placed on the market do not adversely affect human health or the environment. Therefore, registrants are legally obliged to submit a registration dossier that complies with the REACH information requirements and to keep their dossiers up to date with the latest information to be validly on the market.

Consequently, under dossier evaluation, ECHA only takes into account dossier updates submitted before it issues a draft decision. If new information becomes available after that, registrants must submit this through their comments to the draft decision. The Agency will consider the information in the comments and may amend the decision accordingly.

Furthermore, ECHA does not take new information on tonnage, uses and exposure into account after it has sent the draft decision to registrants for comments. Registrants cannot retrospectively downgrade their tonnage band or remove certain uses from their registration to remove requests for information from ECHA’s decisions. This is because the registration dossier has to comply with the REACH information requirements for the registered tonnage band and uses at the time the dossier evaluation was opened.

ECHA’s website provides information for registrants on how to improve their dossiers: recommendations, a practical guide and questions and answers. These have been reviewed to reflect certain points made in a recent decision of the Board of Appeal.