REACH Metals Gateway

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REACH Pre-Registration FAQ

  • Could a Consortium make a pre-registration for its members?

    No, the pre-registration and the registration must be done by each Legal Entity. A Consortium can prepare the pre-registration and the registration of its members but neither pre-register nor register.

  • Does pre-registration finally decide on the status of the substance?

    Due to the high number of pre-registration dossiers, it is expected that the Agency will not have the capacity to check the status of the substance. Therefore, it is likely that the SIEF will be responsible to decide on the status of the substance.

  • Does the EU provide any documents /templates for pre-registration

    The pre-registration will be done via IUCLID 5 and REACH-IT.

  • How do we know into which tonnage band a substance we use or produce in the EU will fall?

    In the case of a phase-in substance that has been imported or manufactured for at least three consecutive years, the quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years. This value is to be used for the purpose of pre-registration, unless it is estimated that by the time of the pre-registration deadline the volume will be higher than the next tonnage band. In the case that the same registrant manufactures and/or imports the same substance in different sites (i.e. in different Member States) then the volume of substance to be registered is the total of the volumes of the substance manufactured and/or imported in the different sites, because the sites are not separate legal entities. In order to be able to calculate the amount of a substance in a preparation, the total volume of the preparation is multiplied by the fraction of the constituent substance. This value can for example be obtained from the safety datasheet of the preparation. When only a range of concentrations of a substance in a preparation is available then the highest value is chosen to be the content of that substance in that preparation for the purpose of calculating the volume of substance.

  • Should a substance that does not have to be registered (e.g. coal) be pre-registered?

    No.

  • What will happen if we miss pre-registration? Can we proceed straight to registration? Can a company still market the substance?

    If a company fails to pre-register within the applicable deadline, or does not wish to pre- register, it will have to suspend its activities involving the substances concerned and register the substances without delay prior to starting to manufacture or import this particular substance after 1 December 2008. If a company continues manufacturing or importing a substance after 1 June 2008 and if it did not pre-register by 1 December 2008, it would be in breach of the REACH Regulation. This also means that the downstream uses of these substances may be at risk.

  • Where and how do I need to pre-register?

    Pre-registration takes place when the company has submitted electronically to the ECHA the required information on a substance. This information includes:

    • The name(s) of the substance specified in section 2 of Annex VI, i.e.
      • the names in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature or other international chemical name(s);
      • other names (usual name, trade name, abbreviation);
      • European Inventory of Existing Commercial Chemical Substances (EINECS) number (if available and appropriate);
      • Chemical Abstract Service (CAS) name and CAS number (if available);
      • other identity code (if available);
    • The name and address of the pre-registrant and the name of the contact person and, where appropriate, the name and address of a third party representative whom the pre-registrant has selected to represent him for all the proceedings involving discussions with other manufacturers, importers and downstream users (Article 4);
    • The envisaged deadline for registration and tonnage band;
    • The name(s) of other substance(s) for which the available information is relevant for performing adaptations to the testing requirements, i.e. use of results from (Q)SAR models (section 1.3 of Annex XI) and read-across approach. The online submission must be done via the REACH IT system, i.e via a web tool or via the IUCLID 5 software.

Last page update: 1 October 2018