What needs to be notified?
Notification is required for:
- All substances subject to
REACH Registration, whether they are hazardous or not. This includes isolated intermediates. Substances contained in articles
and subject to registration under REACH Article 7 also need to be notified
- Hazardous substances which are placed on the market,
in quantities of less than 1 tonne per year. There is no minimum quantity threshold for notification, so notification will
be required even if only a few grams are supplied.
- Hazardous substances present in mixtures placed on the market, where the amount
of the hazardous substance in the mixture is above the concentration limits specified in either CLP or the Dangerous Preparations
Directive (CHIP in the UK) and which results in the classification of the mixture as hazardous. A useful table of these concentration
limits is provided at the end of Practical Guide 7: How to notify substances to the classification and labelling inventory. Importers of mixtures which are classified as hazardous will therefore need to obtain
sufficient information from their suppliers to understand which components of the mixture are hazardous and above the relevant
on the market is defined as making a substance available either commercially or free of charge. For Importers, introducing
a substance into the territory of the EU is also considered placing on the market, so notification is required even if the
substance is imported for their own use.
Where a substance has been given a harmonised classification (i.e. in Annex VI of CLP), companies are still required
to submit a notification for that substance, however, in this case the task is simplified as they must use the harmonised
classification. Companies may however, identify additional hazards for a harmonised substance that has not been covered by
the harmonised classification.
is not required if the substance has already been registered, and the registration dossier includes the classification according
to both the DSD and CLP. Where a NONS dossier has been transferred into REACH then the registrant will need to update their
dossier with the CLP classification as soon as possible. Where a NONS dossier has not been transferred into REACH, e.g. because
the tonnage is less that 1 tonne per year, then a notification will still be required.
Substances in the finished state and
intended for the final user or for uses for which there is specific legislation in place, e.g. radioactive materials, medicinal
products, cosmetic products and food and feeding stuffs are exempted from the requirement to notify.
Substances for R&D may also be exempted provided
they are not placed on the market and are used under controlled conditions in accordance with Community workplace and environmental
legislation. Companies wishing to take advantage of this exemption need to take care however with the definition of not placing
on the market. Transfer of the substance between two different laboratories in a company is considered to be placing on the
market if the two laboratories are part of different legal entities.