- 7. Sådan bliver du klar til dossierajourføringer
- How to update your previously notified substance (NONS)
How to update your previously notified substance (NONS)
How to update your previously notified substance (NONS)
How to update your previously notified substances (NONS)
Substances notified under the Notification of New Substances (NONS) scheme of Directive 67/548/EEC – that was in place before REACH – are considered as registered.
Each notification under Directive 67/548/EEC was assigned a registration number in 2008. You could claim the registration number assigned to your NONS notification until July 2022.
If you did not claim your registration number, and want to restart manufacture or import, you must register your substance under REACH as a new registrant.
NONS registrants also have to update their registrations, and the REACH information requirements are different from those under Directive 67/548/EEC. However, updating does not necessarily mean that you need to provide all the information required under REACH. You can find which information you will need for updating such registrations in Annex 4 of the ECHA manual ‘How to prepare registration and PPORD dossiers’. This will depend on the situation you are in.
In any case, your registration update must include the classification and labelling in accordance with CLP, and it will undergo a completeness check in line with the situation you are in as described in the sections below.
For updates to increase the tonnage band or to become the lead of a joint submission the dossier must satisfy all information requirements under REACH.
The following steps explain how you can update the registration of your previously notified substance.
Your notification under Directive 67/548/EEC was included in ECHA’s database as an ‘individual registration’. However, as any registrant, you must submit jointly.
Therefore, before you update, check if there is a joint submission for the substance. If there is a joint submission, you need to join it.
If there is no joint submission for the substance, you should discuss with the other individual registrants and potential registrants about creating a joint submission and appointing a lead registrant. If there are no other (potential) registrants, you can either:
- create the joint submission yourself and become the lead registrant with your registration update, or
- update your individual registration. In this case, if another registrant later creates a joint submission for your substance, you will need to join the joint submission before the next update of your registration.
You can find more information on the steps you need to take to join a joint submission in phase 2 of the Registration phases ‘Finding your co-registrants’, or to create a joint submission in phase 3 ‘Get organised with your co-registrants’.
For a NONS registration update due to increase in tonnage band or for becoming a lead registrant of a joint submission, a complete dossier, containing all the data required by the REACH regulation for the given tonnage band in IUCLID 6 format must be submitted to ECHA.
If you are updating your registration to become a member registrant, then create a new IUCLID 6 dossier to provide all the information related to the update.
If you are updating your registration to become a lead registrant of a joint submission, then it is recommended that you complete one of the steps provided below:
- If you no longer have the SNIF file (file format used to exchange the data stored in summary notification dossiers), locate your registration in REACH-IT and open its latest submission. In case of a claimed, but never updated NONS, it will be the “Initial submission”. Once you have the submission opened in REACH-IT, you will be able to find and download the scientific dossier, migrated to the latest IUCLID format (“Download IUCLID file” button).
- If you have the SNIF file, you can use the SNIF migration plug-in tool available in the IUCLID website, to migrate it to IUCLID format.
The SNIF migration plug-in tool can only be used with IUCLID version 5.1. Then import the substance dataset to IUCLID 5.6 and finally do an import to IUCLID 6.
The information described above is useful for NONS notifiers whose dossiers are in IUCLID version 5.1. If your IUCLID file is of a later version than 5.1, it is recommended to use the IUCLID Cloud migration tool to update your IUCLID dossier.If you would require further assistance you can contact ECHA’s helpdesk.
The jointly submitted information on your substance needs to satisfy the REACH information requirements. The jointly submitted information for a standard (full) registration needs to cover as a minimum the requirements for registration in the 1-10 tonnes per year band.
If your tonnage band is higher, you can submit the additionally required information separately (as an opt-out). As a previous NONS notifier, the information you submit separately can contain derogations due to the substance being previously notified under Directive 67/548/EEC.
If a joint submission exists for your substance, you need to join as a member registrant. After that, you can submit an update as a member registrant.
If you will rely on the information jointly submitted by the lead registrant, you only need to update your own information, such as the composition of your substance, the quantities manufactured or imported and the uses of the substance in your supply chain.
If you will not rely on all or some of the information jointly submitted by the lead registrant, you will need to submit that information yourself (as an opt-out). If your current manufactured or imported quantities do not reach the next tonnage band threshold, you can make derogations to some of the information requirements due to the substance being previously notified under Directive 67/548/EEC.
You must update your registration if the quantity you manufacture or import of the substance reaches the next tonnage band threshold. You can find the timeline for updating from Respect the deadlines for updating.
The update must satisfy the information requirements under REACH and pass the standard completeness check for the new tonnage band. You can no longer make use of derogations due to the substance being previously notified under Directive 67/548/EEC.
Start by submitting an inquiry to ECHA and discussing with your co-registrants.
Review if the information in your notification for which confidentiality was accepted by the Member States under Directive 67/548/EEC still requires confidential treatment. If so, you need to indicate this in your update.
If you are requesting confidentiality on new information in your update, you will need to justify it and pay the fee as any other registrant.
Further information on confidentiality requests under REACH is available in the manual ‘Dissemination and confidentiality under the REACH Regulation’.
The following IUCLID tools are helpful in the preparation of your update:
- The Dissemination Preview tool simulates which information from your dossier will be published on the ECHA website;
- The Fee Calculator tool calculates the costs of your confidentiality requests and any other fees associated to your registration.
If you no longer manufacture or import a substance, you must notify the cease of manufacture or import to ECHA using the functionality ‘cease manufacture or import’ available in the ‘Reference number page’ of the substance in REACH-IT.
Ceasing manufacture or import is reversible – meaning that you can restart manufacture or import with the click of a button, without needing to register again – unless you ceased manufacture or import after having received a draft evaluation decision. More information is available in the practical guides ‘How to act in a substance evaluation’ and ‘How to act in a dossier evaluation’.
How to update your previously notified substance related
Registration - support - regulations p7-6
How to update your previously notified substance support
- ECHA's Questions and answers
- Dissemination and confidentiality under the REACH Regulation
- Guidance on registration
- How do I claim a registration number for a NONS
- How to act in dossier or substance evaluation
- How to cease manufacture
- How to prepare registration and PPORD dossiers
- How to submit and update your C&L notification
- Information on manual verification at completeness check
- National Helpdesks
- Technical completeness check