Notification obligation to the classification and labelling inventory

Safety data sheet knowledge base – Notification obligations for the CLP classification and labeling inventory.

 

Information on the identification, classification and labeling of the substance shall be notified to the Agency.
The CLP notification is free of charge and it is obligatory to notify within one month of placing the substance on the market.

 

 

Who has obligation to notify to the classification and labelling inventory

Manufacturers and importers placing a substance on the market, in case one of the following criteria are met:

  • It is subjected to registration under REACH (≥ 1 tonne/year) and already placed on the market.
  • It is classified as hazardous under CLP and is already placed on the market, irrespective of the tonnage.
  • It is classified as hazardous under CLP and present in a mixture above the concentration limits specified in Annex I of CLP, which results in the classification of the mixture as hazardous.

*You do not need to notify separately a substance you have already registered under REACH when the information to be notified has already been provided as part of the REACH registration dossier. This also applies to certain substances contained in articles where Article 7 of REACH provides for their registration.

If you are a downstream user who formulates a mixture, a distributor or a producer of articles, you do not need to notify to the Agency, because the notification for your substance already has occurred at an earlier stage in the supply chain.

 

Updating the notified data

There is also an obligation to update the information sent for notification.
In case you have new information that leads to a revision of the classification and labelling elements of a substance.

 

Data to be notified to the CLP classification and labelling inventory

  • General data regarding the notifier
  • Identification of the substance
  • CLP classification of the substance
  • Where the substance has been classified in some but not all CLP hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which is conclusive for non-classification.
  • Where applicable, specific concentration limits, or M-factors related to the classification as hazardous for the aquatic environment, i.e. acute category 1 and chronic category 1, together with a justification for their use.
  • The labelling elements for the substance, including the supplemental hazard statements referred to in CLP Article 25 (1).

* Using the REACH-IT system, the range of data to be provided will be slightly different, and in practice, the process will look different.

 

Hazardous classification

The CLP Regulation actively engages the participants of the industries in identifying the hazard classes.
Of course, this may also mean that a substance is classified into several different hazard classes by individual notifiers.
In such a case the CLP Regulation orders the notifiers or registrants to make every effort to come to an agreed entry to be included in the inventory. However, you may classify your substance differently to another entry, provided you include the reasons in your notification.
In contrast, where your substance has a harmonised classification, you must classify it in accordance with the harmonised classification listed in Part 3 of Annex VI to CLP and include this classification in your notification.

 

The format of the notification sent to the CLP classification and labelling inventory

Your notification must be in the format specified by the Agency. The notification dossier can either be created online by use of the REACH-IT tool or it can be created in IUCLID 6 (International Uniform Chemical Information Database).

 

Submission of new information affecting classification and labeling in the C&L inventory

The manufacturer, importer or downstream user may also make proposals to the Agency to change the classification of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) or respiratory sensitization, if they can provide arguments justifying the need.

 

Labelling inventory

The classifications of all substances notified under CLP or registered under REACH are included (or will be included) in the classification and labelling inventory established at the Agency.
The inventory indicates whether a classification is harmonised or whether it has been agreed between two or more notifiers or registrants.

 

Information records

As a manufacturer of substances, an importer of substances or mixtures or as a downstream user, you need to assemble and keep available all the information that you used for the classification and labelling of your substance or mixture. This information must be kept for at least 10 years after you last supplied the substance or mixture.

As a distributor, you must in the same way assemble and keep available all the information that you used for the labelling.

 

Checking the information

The Competent Authority/ies or the enforcement authorities of the Member State where your company is established or ECHA may request all the information you used for the purpose of classification and labelling under CLP.

However, if the information requested by a Competent Authority is included in your notification under CLP, or your registration under REACH, this information will be available to ECHA, and the Competent Authority needs to address its request to ECHA.

 

Summary

The article discusses the obligations of manufacturers and importers to notify information about the identification, classification, and labeling of substances to the European Chemicals Agency (ECHA).

The CLP notification is free of charge and mandatory to submit within one month of placing the substance on the market. Manufacturers and importers are required to notify substances subjected to registration under REACH, classified as hazardous under CLP, or classified as hazardous and present in a mixture above the concentration limits specified in Annex I of CLP. Downstream users who formulate a mixture, distributors, or producers of articles are exempt from this notification requirement.

The notified data must be updated whenever new information leads to a revision of the classification and labeling elements of a substance.

The article also explains the required data to be notified to the CLP classification and labeling inventory, the format of the notification, and how to submit new information affecting classification and labeling.

The classifications of all substances notified under CLP or registered under REACH are included in the classification and labeling inventory established at the ECHA.

Lastly, manufacturers, importers, downstream users, and distributors must keep available all the information used for classification and labeling, which can be checked by the Competent Authority or enforcement authorities of the Member State.

 

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