August 8, 2018 by Rhiannon Smith
We have recently updated the REACH information on our website to reflect the need to focus on post-registration activity. This information also applies to NONS registrations.
Substances notified in accordance with Directive 67/548/EEC (NONS) are regarded as registered under REACH by the manufacturer or importer who submitted the notification. However, as discussed below, there are also some further aspects for NONS registrants to consider.
The REACH registration assigned from the NONS registration relates to the tonnage band referred to in the notification of the substance. Therefore, registrations should be updated without undue delay when the manufactured/imported quantity reaches the next tonnage threshold, including substances which were notified at <1 tpa where the manufacture/import tonnage has increased above 1 tpa. The registrants have to inform ECHA of the additional information that would be required to comply with the information requirements for the new tonnage level by submitting an inquiry dossier as soon as possible. ECHA will then put the company in contact with the other (pre)registrants for the substance.
The subsequent update to the registration dossier should not only contain the information required by REACH which corresponds to that higher tonnage threshold, but also any information which corresponds to lower tonnage thresholds but which was not yet submitted in the notification. When making a tonnage update, registrants of notified substances will also have to comply with all other REACH requirements and provisions (e.g. preparation of a CSR). Other reasons why a company may update their registration for a notified substance include becoming part of a joint submission and following a decision from ECHA.
Furthermore, for notified substances, as with new REACH registrations, it is the responsibility of the registrant to keep the information submitted to ECHA up to date. Registrants are required to report any new relevant available information concerning their registration (e.g. new tonnage band, new uses) to ECHA without undue delay. These updates, based on the registrant’s own initiative, may reflect changes in the company details (e.g. contact details, manufacturer/importer, registrant identity such as mergers or acquisitions), substance composition, tonnages, uses, classification, the CSR or guidance on safe use, data access rights, and/or new information on the risks.
It should be noted that for substances which have been registered under REACH (either notified or standard registrations), tonnage should be calculated on an annual basis (calendar year) so that as soon as the volume of a registered substance reaches the higher tonnage band, the information requirements of the registration dossier change. As such, companies should ensure that they have an appropriate registration in place for their requirements (i.e. they should upgrade their registration before they cross the tonnage threshold).
Registrants are also required to update registrations in response to decisions from ECHA, though ECHA will provide a timeline in the decision stating when the update needs to be submitted. Decisions taken according to Directive 67/548/EEC (NONS) are regarded as ECHA decisions (Article 135) and registrants should follow the standard process for submitting updates in response to these decisions. However, the update does not have to meet the full information requirements under REACH corresponding to the respective tonnage band, unless the quantity manufactured/ imported of the notified substance by the registrant reaches the next tonnage threshold.
wca can assist companies who decide or are obliged to update their notification registration under REACH. In order for update dossiers to be accepted during submission in REACH IT, it is necessary for the dossier to pass the technical completeness and business rules checks. wca are familiar with these checks and the requirements for the preparation of IUCLID dossiers and can assist companies with upgrading dossiers to make them fully compatible with the latest REACH guidance. Please contact us if wca can assist you in any of these areas.