- Fases do registo
- 7. Como organizar-se para as atualizações dos dossiês
- 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. ECHA has assigned registration numbers to all notifications made under Directive 67/548/EEC.
From July 2022 it is not possible to claim the registration numbers assigned to NONS notifications. From now on, you must follow the registration process set out under REACH if intend to manufacture or import a substance in quantities of 1 tonne per year or above. This does not affect the registration numbers already claimed before the process ended.
As the information requirements were different under Directive 67/548/EEC, updates of such registrations do not necessarily require that you provide all the information required under REACH. You can find which information you will need for updating such registration in the Annex 4 of the ECHA manual ‘How to prepare registration and PPORD dossiers’. Depending on the situation you are in, the information you will need to update will differ.
All registration updates undergo a technical completeness check according to the requirements of Article 20(2) of the REACH Regulation and must include the classification and labelling in accordance with CLP.
- For NONS notified below 1 tonne under Directive 67/548/EEC and for which no tonnage band update has been done, a separate notification to the Classification and Labelling Inventory will have to be made. Thus, the registration does not need to be updated.
- For NONS notified above 1 tonne under Directive 67/548/EEC, if you only need to provide a classification and labelling update and your tonnage band remains unaltered, you need to provide the minimum information requirements as explained in Annex 4 of the manual ‘How to prepare registration and PPORD dossiers’.
In updates indicated under Article 22(1) of the REACH Regulation and in updates following a decision made by the Member State Competent Authority according to Article ¬16(1) or 16(2) of Directive 67/548/EEC, the dossier does not need to include information under the REACH Regulation that was not required under previous legislation (i.e. Directive 67/548/EEC). However, 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 substances.
Once the registration number assigned to your notification is claimed, check if there is a joint submission available for the substance. If there is a joint submission available, in order to update your dossier, you will need to join. If there is none, you will be able to update your dossier. However, the moment a potential registrant creates a joint submission for the same substance, you will be prevented from updating your registration in REACH-IT: you will need to join the joint submission created in REACH-IT to update your registration.
If there is no joint submission available for the substance you should discuss with other potential registrants the creation of the joint submission and the appointment of the lead registrant.
You can find more information on the steps you need to take to join a joint submission in phase 2 ‘Finding your co-registrants’ of the Registration phases.
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 the steps provided below:
- If you have the SNIF file (file format used to exchange the data stored in summary notification dossiers), use the SNIF migration plug-in tool available in the IUCLID website, to migrate it to IUCLID 6.
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.
- If you do not have the SNIF file, request your notification migrated into IUCLID format (IUCLID substance dataset) from your relevant Member State Competent Authority.
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.
Jointly submitted information needs to comply with the REACH information requirements. This is because the jointly submitted information must cover the information requirements of new members joining, including members that did not notify under NONS. This means that the jointly submitted information needs to pass the completeness check and cannot contain derogations due to the substance being previously notified under Directive 67/548/EEC. This does not apply to information you submit separately as an opt-out.
If a joint submission exists for your substance, then you as a previous notifier will need to join it as a member registrant. This will need to happen at the latest when you update your registration.
You can join the joint submission and submit an update as:
- A regular member registrant if you rely on the information provided by the lead registrant.
- An opt-out member registrant if you intend to provide some or all the information required for your update by yourself without relying on the data available in the joint submission.
If you intend to update your registration dossier as a regular member of the joint submission relying on all the data submitted by the lead registrant, it is recommended to create a IUCLID 6 file and provide the information required for member registrants under REACH.
If you intend to update your registration dossier as an opt-out member, providing some or all the information by yourself, and your current manufactured or imported quantities does not reach the next tonnage threshold, you can make derogations to some of the information requirements due to the substance being previously notified under Directive 67/548/EEC.
Once the quantity of the substance reaches the next tonnage band threshold the dossier must fully be in line with the REACH requirements, and you cannot make use of the derogations under Directive 67/548/EEC.
You must update your registration as soon as the quantity you manufacture or import of the substance reaches the next tonnage band threshold.
If you are updating your registration to a higher tonnage band than the previously notified, then the update must satisfy all information requirements under REACH for the new tonnage band. This means that, in this case, the registration must meet all completeness check requirements.
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
See also under the Legislation section
How to update your previously notified substance support
- 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