REACh. Registration

Registration is the process under which EU-manufacturers/importers of chemical substances are obliged to send a registration containing safety data on substances to the European Chemicals Agency (ECHA). Non-EU manufacturers can use their importer for registration. They can also appoint an EU-based representative for the purpose of registration. The EU representative can be a subsidiary, a consultant, or any natural or legal person with experience in chemicals handling.

"One substance, one registration"

Each substance under REACH should have one registration. In order to avoid duplicate tests data should be submitted jointly by companies that manufacture and use the same substance. Hence, Substance Information Exchange Fora (SIEFs) will be formed to facilitate information sharing among manufacturers, importers and downstream users.

Data required for pre-registration and registration

Pre-registration is the prerequisite for phase-in chemicals to remain on the market while the REACH registration process is ongoing.

Pre-registration allows a potential registrant to benefit not only from the phased registration deadlines (depending on tonnage) but also from the participation in SIEF.

Once a chemical has been pre-registered, a Registration Dossier has to be prepared. The quantity of information included in the Registration Dossier depends on the hazard and the tonnage of the chemical. A Technical Dossier (TD) is obligatory. For chemicals manufactured/imported in amounts >10 t/a Chemical Safety Report (CSR) is required in addition. The CSR virtually contains the Chemical Safety Assessment (CSA) of a given chemical. The CSA evaluates risks arising from the manufacture and/or use of a substance. The "end product" Registration Dossier must be in IUCLID (International Uniform Chemical Information database) format.

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Explanations

European Chemicals Agency (ECHA)

http://echa.europa.eu/

Pre-registration

The required data for pre-registration are:

  • substance identification (name, CAS and EINECS/ELINCS numbers)
  • registrant's name and address
  • the anticipated deadline for the registration and the tonnage band
  • indication of substances for read-across

Registration Dossier

A registration for a substance is submitted to ECHA in form of registration dossier. The registration dossier contains:

  • technical dossier - provides information on the properties of the chemical as well as on safe handling
  • chemical safety report - description of measures for risk management (must be made if the annual tonnage exceeds 10 t)

Technical Dossier

TD includes the following:

  • the identity of the manufacturer/importer
  • the identity of the substance and information on its manufacture and use
  • classification and labelling
  • guidance for safe use
  • robust study summaries of the information on the intrinsic properties of the substance
  • an indication as to whether any of the information on the intrinsic properties of the substance - has been reviewed by an assessor
  • further testing proposals
  • exposure related information for substances manufactured/imported substance at 1-10

Chemical Safety Report includes:

Part A

  • summary of risk management measures
  • declaration that risk management measures are implemented declaration that risk management measures are communicated to downstream users

Part B

  • identity of the substance and physical and chemical properties

  • manufacture and uses
    • classification and labelling
    • environmental fate assessment (e.g. prediction of biodegradation rates, pathways and end products)
  • human health hazard assessment
  • physical hazard assessment (e.g. explosivity)
  • environmental hazard assessment
  • PBT and vPvB assessment
  • exposure assessment
  • risk characterisation

Chemical Safety Assessment

CSA contains a detailed summary of information on the

  • environmental-
  • human health-
  • physico-chemical-

persistent, bioaccumulative and toxic (PBT)/ very persistent and very bio-accumulative (vPvB)- hazard assessment. If the substance meets the criteria for classification as dangerous according to Directive 67/548/EEC or has PBT/vPvB properties, further steps in CSA are exposure assessment and risk characterisation.

IUCLID (International Uniform Chemical Information database)

http://ecbwbiu5.jrc.it/index.php? fuseaction=home.project&type=public