Date: Mar 18, 2009
Having survived the December 1, 2008 deadline for pre-registration under REACH, companies largely have turned their focus towards other matters unless of course they need to register their substances by November 30, 2010. But there is another important deadline under the new Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008) when most companies will need to notify for the Classification and Labeling (C&L) Inventory unless they have already submitted a registration under REACH before that date.
The C&L Inventory under the CLP replaces the one envisioned under Title XI of REACH. Article 40 of the CLP establishes an obligation for any manufacturer or importer, or group of manufacturers or importers, who place a covered substance on the market of the European Union (EU) to notify for the C&L Inventory.
Substances covered by the notification requirement are:
(1) All "substances subject to registration in accordance with" REACH; and
(2) All substances not subject to registration under REACH but which
(i) fall within the scope of Article 1 of the CLP Regulation;
(ii) meet the criteria for classification as hazardous; and
(iii) are placed on the market either on their own or in a mixture above the concentration limits specified in the CLP Regulation or the Dangerous Products Directive (1999/45/EC), where relevant, which results in the classification of the mixture as hazardous.
With respect to the first category of substances subject to notification, this applies to substances that do not fall under any of the exemptions from registration provided for in Article 2 of REACH.
A notification for this first category of substances is not required if all of the information called for has already been submitted to the European Chemical Agency (ECHA) as part of a registration under REACH before the notification deadline. Also, as substances notified under the 6th and 7th Amendments to the Dangerous Substances Directive, active plant protection substances and active biocidal substances, although regarded as registered are still subject to registration, there may be an obligation to provide at least some information in the notification for the C&L Inventory.
If a company has pre-registered a substance, but has not registered before the deadline, that EU manufacturer or importer will need to notify for the C&L Inventory. This situation will occur if the company manufactures or imports substances in quantities that do not trigger the first registration deadline of 30 November 2010.
With respect to the second category of substances noted above, a substance can be subject to notification for the C&L Inventory even if exempted from registration under REACH. This would occur where the substance is within the scope of the CLP and the other conditions apply (i.e., hazardous classification, placed on the market as such, or as part of a mixture in a sufficient concentration to cause the mixture to be classified as hazardous). The CLP excludes from its scope many of the substances that are outside of the scope of REACH, such as nuclear material, waste, non-isolated intermediates and substances under customs supervision but there are some differences. In particular, ingredients used to produce medicinal and veterinary medicinal products, many of the substances exempted under Annex V of REACH, and polymers are within the scope of the CLP and will be subject to notification if the other conditions apply (i.e., hazardous classification, placed on the market as such, or as part of a mixture in a sufficient concentration to cause the mixture to be classified as hazardous).
The specific information required in the Notification is as follows:
(a) the identity of the notifier(s) responsible for placing the substance or substances on the market;
(b) the identity of the substance or substances;
(c) the classification of the substance or substances;
(d) where a substance has been classified in some but not all hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which are conclusive although insufficient for classification;
(e) specific concentration limits or M-factors, where applicable, in accordance with Article 10 of the CLP Regulation together with a justification using the relevant Parts of sections 1, 2 and 3 of Annex I to REACH; and
(f) the pictograms, signal words and hazard statements specified in points (d), (e) and (f) of Article 17(1) of the CLP Regulation together with any supplemental hazard statements as determined in accordance with Article 25(1) of the CLP Regulation.
The notification must be in the format specified by the REACH-IT tool.
The ECHA will collate the information on classification and labelling into a C&L Inventory. Most of this inventory will be publicly accessible (in particular the classification and labelling of the substance); other parts will only be accessible to notifiers and potential registrants who have pre-registered the substance under REACH. This inventory will indicate the relevant registration number(s) (if available) and whether the classifications submitted for the same substance by different registrants or notifiers differ. In the latter case, the registrants and notifiers are required to make every effort to come to an agreed classification, and update their registrations/notifications as appropriate.