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Registration of Non Phase-in Substances

All non phase-in substances must be registered before they are manufactured or imported into the EU at a quantity of 1 tonne/year or more. Registration is the process in which a company submits to ECHA a dossier which details the phys-chemical and toxicological properties of a substance and provides guidance on hazard, risk and safe use.

In some instances some of this data will have already been submitted to ECHA by other companies, though it may not be freely available. To avoid duplication, particularly where studies concern vertebrates, ECHA have devised an Inquiry system in which every potential registrant must inquire from the Agency whether a registration has already been submitted for the same substance. This is to ensure that data are shared by the relevant parties.

An inquiry must be submitted before proceeding with substance registration, even in cases where the potential registrant possesses a full set of data for meeting the information requirements of the registration. If a potential registrant desires rapid access to the market it will be in his interest to submit an inquiry as early as possible.

When submitting an inquiry potential registrants are required to submit contact details, information on substance identity and identify the list of information requirements needed for their registration dossier as defined by the tonnage concerned. These are submitted to ECHA in an Inquiry Dossier.

On receipt of the inquiry dossier ECHA will perform a substance identification check in order to identify previous registrants or potential registrants. After performing the identification check, if ECHA concludes that the same substance has previously not been registered or if the information is not available (for instance, if the previous registrant referred to a lower tonnage band) the Agency will inform the potential registrant accordingly and he may proceed with his registration.

If the same substance has been registered less than 12 years earlier, ECHA will inform the potential registrant of the names and addresses of previous registrant(s), and of the availability of the relevant study summaries or robust study summaries already submitted to them. ECHA will also inform the previous registrant(s) of the name and address of the potential registrant and the data sharing process will be initiated.

Any study summaries or robust study summaries submitted at least 12 years previously can be freely used for the purposes of registration by another manufacturer or importer. These are provided by ECHA for inclusion in the new registration dossier being developed.

It is by using freely available data and negotiating access rights to data owned by others, that the registration dossier for a non phase-in substance is developed. However it should be noted that previous registrants only have a duty to share data if the study concerned involves testing on vertebrates.

After the new dossier has been created it is submitted to ECHA for registration. Once this is accepted and the appropriate registration fee is paid, the registration is formally recognised by the issue of a registration number. Manufacture/import of the substance may now begin.

If at a later date the tonnage concerned increases the registration dossier must be updated to include the information requirements of the new tonnage band.

 The registration tonnage bands are:

  • 1 - 10 tonnes/year
  • 10 - 100 tonnes/year
  • 100 - 1000 tonnes/year
  • >1000 tonnes/year 

ReFaC provides a complete service to assist companies introducing new substances, from the initial stages of the inquiry process through to registration. Contact ReFaC now for more information and assistance.

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