a a a | Display options

REACH Registration

The registration process requires manufacturers and importers of substances to gather information on the environmental and health properties of their substances, assess the risks arising from the uses of their substances and ensure that these risks are properly managed. In order to demonstrate that this has been achieved, a registration dossier must be submitted which contains:

  • A technical dossier for substances manufactured or imported at ≥ 1 tonne per annum;
  • A chemical safety report for substances manufactured or imported at ≥ 10 tonnes per annum

The technical dossier should contain:

  • the identity of the manufacturer/importer and the substance, and information on the manufacture and use;
  • the classification and labelling and guidance on the safe use of the substance;
  • (robust) study summaries of the information on the intrinsic properties of the substance as outlined in the Regulation;
  • proposals for further testing, if relevant;
  • or substances registered in quantities between 1 and 10 tonnes, exposure related information for the substance (main use categories, type of uses, significant routes of exposure);
  • an indication as to whether the information in the technical dossier and, if relevant, the chemical safety report, has been reviewed by an assessor;

The chemical safety report should contain:

  • human, physicochemical and environmental hazard assessments, including an assessment of whether the substance is Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB). This includes the establishment of Derived No Effect Levels (DNELs) for relevant routes of human exposure and Predicted No Effect Concentrations (PNECs) for the environment;
  • If the substance is classified as dangerous or fulfils the PBT or vPvB criteria:
    • Exposure assessment, including exposure scenarios and risk management measures
    • Risk characterisation - the exposure of humans and the environment is compared with the appropriate DNEL or PNEC. If the estimated exposure is higher than the DNEL or PNEC, then the Hazard or Exposure assessment must be refined until it can be demonstrated that the risks are adequately controlled.

Need assistance undertaking the registration process? IOM's REACH experts have the experience required to assist you, with our specialist registration services tailored to best suit your needs:

Timescale for registration

The timescale for submission of registration dossiers is different for 'phase-in' and 'non-phase-in' substances

'Non-phase-in' substances (i.e. new chemicals which have not been place on the market before) which have not been pre-registered must be registered before they can be manufactured, imported or used in the EU.

Registration for 'phase-in' substances (i.e. existing substances with an EINECs number) is based on tonnage and how hazardous the chemical is, with deadlines as follows:

  • 30th November 2010 for
    • substances manufactured or imported at ≥ 1000 tonnes per annum
    • substances classified as carcinogenic, mutagenic or reprotoxic (category 1 or 2) which are manufactured or imported at ≥ 1 tonnes per annum
    • substances classified as dangerous for the aquatic environment (R50/53) which are manufactured or imported at or above 100 tonnes per annum
  • 31st May 2013 for
    • substances manufactured or imported at 100 – 1000 tonnes per annum
  • 31st May 2018 for
    • substances manufactured or imported at 1 – 100 tonnes per annum