Who has to submit and what can be submitted in a notification?
You must notify a substance to the Classification and Labelling (C&L) Inventory within one month from being placed on the market and you:
- Manufacture the substance and it is subject to registration under the REACH Regulation; or
- Import the substance and it is subject to registration under the REACH Regulation; or
- Manufacture or import the substance and it is classified as hazardous, irrespective of the quantity; or
- Import a mixture which contains the substance that is classified as hazardous and is present above the relevant concentration limit, which results in the classification of the mixture as hazardous according to the CLP Regulation; or
- Import an article containing substances which are subject to registration under Article 7 of the REACH Regulation.
Only representatives (ORs) may submit the information needed for a notification to the C&L Inventory as part of a REACH registration dossier.
Where a separate notification to is necessary, the EU importers would normally have to submit the notification.
If, for confidentiality reasons, non-EU operators do not want to disclose the composition of their substances or mixtures to their EU importers, they may appoint one of the importers to notify on behalf of the other importers (notification as a group).
Alternatively, a third party who is not itself a manufacturer or importer (e.g. an OR who has already been appointed for the purposes of registration under REACH) may submit a group notification on behalf of the EU importers.
Such a third party can submit the notification, but cannot take over the obligations of the importers that are part of the group. If such a solution is used, the submitting entity must be able to document that it has been mandated to act on behalf and in the name of the manufacturers/importers that are part of the group and that the manufacturers/importers acknowledge that they remain solely and fully responsible to fulfil all their obligations associated with the notification.
The documentation related to the creation of this group of manufacturers/importers together with the data and information on which C&L are based may need to be made available to the competent authorities and to the relevant enforcement authorities.
As a first step, you should read the Practical guide 7: How to Notify Substances to the Classification & Labelling Inventory (see below) which helps you to identify whether you are obliged to notify your substance to the C&L Inventory.
The guide also provides an introduction on how to do the notification in practice.
Each notification should include the:
- Name and contact details of the notifier;
- Identity of the substance, including the name and other identifiers, information related to molecular and structural formula, composition, nature and amount of additives;
- Classification of the substance according to the CLP criteria;
- Reason for "no classification" if the substance is classified in some but not all hazard classes or differentiations indicating whether this is due to
- a lack of data,
- inconclusive data, or
- data which is conclusive for non-classification;
- Specific concentration limits or M-factors, where relevant, including a justification for setting them; and
- Label elements, including hazard pictograms, signal words, hazard statements and any supplemental hazard statements.
Companies may, under certain conditions, keep the IUPAC name of a substance confidential when notifying it to the C&L Inventory. The IUPAC name can be considered confidential and therefore not published in the C&L inventory for:
- non-phase-in substances;
- substances only used as one or more of the following:
- in scientific research and development; or
- in product and process-orientated research and development.
To keep the IUPAC name confidential, companies need to provide in their IUCLID dossier:
- A justification including a clear indication of whether the substance concerned is a non-phase-in substance, a substance used as a chemical intermediate, in scientific research and development or in product and process-orientated research and development.
- An alternative name for dissemination by ECHA.
Only IUCLID 5 can be used to make such confidentiality flags. How to do this is explained in Data Submission Manual Part 12.
There is no fee for the confidentiality flags in the C&L notification.
An alternative name provided in a C&L notification for dissemination cannot be used automatically for other purposes. An appropriate request is needed to use an alternative name for a substance in a mixture in a safety data sheet or on a label.