At registration manufacturers and importers, of substances (including metals) supplied in quantities of 1 and more tonnes per year, are required to submit a dossier of information to the European Chemicals Agency (ECHA), in Helsinki, containing information on the substance properties and guidance on how to use the substance safely. Quantities starting at 10 tonnes additionally require submission of a Chemical Safety Report (CSR) to document the in-depth Chemical Safety Assessment (CSA) in order to demonstrate that the level of eventual risk a substance might pose to the environment or humans can be adequately controlled. Quantities produced or supplied at 1000 tonnes and above are priority substances for this assessment. The amount of information required in the dossier is related to the tonnage of substance manufactured/imported (the information required is also stipulated in the REACH annexes). The dossier must be submitted in IUCLID format and by the relevant deadline; failure to complete registration by the required deadline will result in loss of access to the EU market.
Further information on registration can be found on the ECHA website.
Joint registration and data sharing
One Substance One Registration (OSOR)
REACH is based on the principle ‘One Substance, One Registration’ whereby a single dossier is completed for each substance. Under this rule the registration dossier is completed, and submitted, by one company on behalf of the others a process which necessitates information to be shared between all manufactures and importers registering the same substance. The OSOR rule aims to increase efficiency, reduce cost, and to reduce testing on vertebrate animals. REACH also requires communication with ‘downstream users’ of chemicals to help ensure that any hazards, and risks, posed by a substance, are managed effectively throughout the supply chain.
Every manufacturer and importer that pre-registered a substance under the same substance identification parameters will automatically be admitted to a pre-SIEF within REACH-IT. Following the close of pre-registration, all pre-registrants of a substance are required to enter into substance sameness discussions to check, and agree, that they are all intending on registering the same substance under REACH. Once substance sameness has been agreed, pre-SIEF members enter into a Substance Information Exchange Forum (SIEF). REACH provides the formation of SIEFs to aid manufactures and importers of the same phase-in substances share information on the substances that they need to register; the aim of the SIEF is to increase efficiency, and reduce costs, and to prevent repeat testing (particularly on animals). SIEFs also allow for participation of downstream users and other stakeholders with a vested interest in the substance.
Joint Submission of Data
Potential registrants of the same substance are required to submit information jointly at registration. In this way a Lead Registrant of the SIEF will submit a dossier for, and on behalf of, the other SIEF members. This does not alleviate the other registrants from registering their substance; all registrants and manufacturers of substances supplied in quantities of one or more tonnes per year are required to submit a registration dossier to the Agency by the relevant deadline.
Information to be submitted jointly will include data on the hazardous properties of the substance including information on classification and labelling. The CSR can be submitted either jointly or separately.
Information to be submitted individually by each registrant will include substance and registrant identity, information on manufacture and use (and the CSR if not submitted jointly).
Further information on data sharing and joint submission can be found in the SIEF section of this website, or on the ECHA website.