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Which substances do I have to notify to the Inventory?


GHS / CLP Information

 

INTRODUCTION


This document is important for you if your company carries out one or more of the following activities and places the involved substances or mixtures (preparation) on the market:

 

  • Manufactures substances (including isolated intermediates) subject to registration in accordance with the REACH Regulation;
  • Imports substances (e.g. dye stuffs) subject to registration in accordance with the REACH Regulation;
  • Manufactures or imports substances which are classified as hazardous, irrespective of the quantity involved;
  • Imports mixtures containing hazardous substances, irrespective of the quantity involved;
  • Imports articles containing substances which are subject to registration under REACH Article 7.

 

Companies that manufacture substances or formulate mixtures outside the EU are not required to notify to the Classification & Labelling Inventory at the European Chemicals Agency (ECHA). Non-EU manufacturers and formulators who intend to import substances and mixtures into the EU should provide the relevant information (e.g. an IUCLID data set) to their EU importers who must submit the notification.

 

Which substances do I have to notify to the Inventory?

 

In general, the obligation to notify to the Classification & Labelling Inventory includes all hazardous substances within the scope of the CLP Regulation, either on their own or contained in a hazardous mixture above specified concentration limits, and which are imported or manufactured and placed on the market within the EU. Also non-classified substances subject to registration under the REACH Regulation, i.e. a substance manufactured or imported in volumes at or above 1 tonne per year, must be notified. This includes substances on their own, substances contained in mixtures and those substances contained in imported articles where Article 7 of the REACH Regulation provides for registration. Note that you must notify a substance even if its classification and labelling is (completely) harmonised and it is listed in Part 3 of Annex VI to the CLP Regulation.

The classification and labelling of active substances contained in plant protection products (PPPs) and biocidal products (BPs) is normally harmonised for all hazard classes and appears both in Tables 3.1 and 3.2 of Annex VI to the CLP Regulation. Notification to the Inventory must always be done for active substances when they are placed on the market.

Alloys are considered special preparations (CLP terminology: mixtures) under the REACH and CLP Regulations. The components of alloys need to be notified to the Inventory in case they are hazardous and contained in the alloy above specified concentration limits, see attachment 1 to this document.

Polymers must be notified to the Inventory if they are classified as hazardous and if they are imported or manufactured and placed on the market, on the basis of CLP Article 39(b) and 40.

However, the obligation to notify does not apply to a number of substances and mixtures 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.

Substances and mixtures for scientific research and development (R&D) are exempted from the CLP Regulation only if they are used under controlled conditions in accordance with Community workplace and environmental legislation and when they are not placed on the market. In situations where this is not the case, they would fall under the CLP Regulation irrespective of the tonnage, and they should be notified if they meet the criteria for classification as hazardous on the basis of the available information.

By contrast, monomers contained in such polymers are not considered as being placed on the market, and their notification is not necessary.

According to the CLP Regulation, importers of articles do not need to notify the classification and labelling of a substance contained in an article, unless the substance needs to be registered in accordance with Article 7 of the REACH Regulation.

You cannot submit a separate notification for a substance that you have placed on the market if you have already registered it under REACH and if the registration dossier contains the classification and labelling according to the CLP Regulation.

 

Tags:  CLPGHS


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