Classification and Labelling Notification

If you are a manufacturer or importer of hazardous substances or mixtures based in the EU or EEA you may have an obligation to notify substance classification and labelling information to ECHA. The duty does not apply to Downstream Users (e.g. formulators of mixtures), nor to Distributors and Producers of articles Notification applies to any legal entity which places on the market:

• a hazardous substance on its own,
• a hazardous substance present in a mixture above the concentration limits specified in Annex I of the CLP regulation which results in the classification of that mixture as hazardous,
• a substance subject to REACH Registration.

It’s not just commercial products which are in scope of notification; samples supplied free of charge and those provided to external laboratories for testing are also affected.

There are some exceptions to the notification requirement, for example for substances already registered under REACH, but they do not correspond to the exceptions for registration under REACH. For hazardous substances there is no lower tonnage threshold for the notification: notification is required for any quantity placed on the market. However, for non-hazardous substances the duty only applies if they are subject to REACH Registration, i.e. manufactured or imported at 1 tonne or more by the legal entity.

When notifying, you must identify the substance including any impurities and any additives necessary for stability; you must also provide information on its hazard classification and labelling elements. ECHA publishes the non-confidential information from notifications in its Classification and Labelling Inventory (CLI).

The obligation to notify began on 1 December 2010 and notifications to the CLI must be made within one month of first placing the substance on the EU/EEA market. They are submitted using an online form in REACH-IT, if a substance has been previously classified and labelled the process is relatively simple as subsequent notifiers can view existing notifications and indicate their agreement. Some information may be claimed confidential, but to do so the notifier must use IUCLID to prepare a notification dossier to be submitted through REACH-IT. Different manufacturers and importers of the same substance are obliged to make every effort to reach agreement on classification.

It is not currently possible to retire a C&L notification, even if you cease manufacture, import or onward supply. According to its Q&A [640], ECHA is currently investigating ways to indicate the date of the submission or latest update in the public C&L Inventory, which may help companies determine which notifications are still active.

It is expected that UK companies who had already notified to ECHA (or were otherwise covered by an existing notification in the EU or via an EU REACH registration) would not be expected to notify again. Under UK CLP, it is expected that the substances in scope of the notification requirements will be the same as those under the existing EU-requirements (Article 39 of EU CLP) and there will be no special arrangements. Notifications made by UK notifiers plus requirements to notify under UK CLP too.