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CLP Regulation and Notification for Classification and Labelling Inventory

(1)  Introduction

CLP Regulation is the new European Regulation on Classification, Labelling and Packaging of chemical substances and mixtures* ("CLP") which came into force on 20 January 2009.  The legislation introduces a new system for classifying and labelling chemicals throughout the European Union ("EU") based on the United Nations’ Globally Harmonised System (UN GHS). CLP replaces the Dangerous Substances Directive (DSD) 67/548/EEC and the Dangerous Preparations Directive (DPD) 1999/45/EC.

CLP lays down the rules on how to determine whether a substance or mixture displays properties that lead to a classification as hazardous and how to communicate such hazards to other players in the supply chain.  It is the responsibility of a company to establish what hazards their substances and mixtures have before they are placed on the market, and to package and label them in line with CLP.
There are specific timelines for industry to classify and label their substances and mixtures in line with the CLP rules. Also, industry must notify hazardous substances and mixtures which contain such substances to a central inventory ("C&L Inventory") established by the European Chemicals Agency ("ECHA").

*Note: “mixture” means the same as the term “preparation” which was used in previous chemical legislation.

(2) Industry's Roles and Obligations under CLP

The obligations placed on a supplier of substances or mixtures under CLP depend upon the role the supplier has in the supply chain towards a substance or mixture.  CLP distinguishes between:

  • Manufacturers of substances in the EU
  • Importers responsible for the physical introduction of substances or mixtures into the customs territory of the EU
  • Producers and importers of specific articles in the EU
  • Downstream users*, including formulators and re-importers in the EU
  • Distributors, including retailers within the EU, who only store and place on the market* a substance, on its own or in a mixture, for third parties.

It should be noted that suppliers of substances or mixtures may have more than one role under CLP:

  • Downstream users (including formulators of mixtures and re-importers), distributors or producers/importers of articles (if an article is not explosive as described in CLP Section 2.1 of Annex I and if the article does not contain substances which are subject to registration under REACH Articles 7 and 9) do not need to notify their classification and labelling to ECHA, but have to classify and label according to CLP.
  • Placing on the market means supplying or making available, whether in return for payment or free of charge, to a third party. Import is deemed to be placing on the market (ie including those importers who do not supply to third parties themselves need to notify).
  • Only Representatives ("ORs") are not entitled to submit a separate notification to the C&L Inventory as an OR has no role under CLP.  However, if an OR submits a Registration Dossier on behalf of the non-EU manufacturer and it contains information on classification and labelling of a substance, such information shall be regarded as sufficient for notification to C&L Inventory.

(3)  The Scope of Notification Duties to the C&L Inventory

The scope of which substances have to be notified to the C&L Inventory is provided in CLP Article 39 and, according to this Article, notification covers:

  • substances subject to registration in accordance with REACH
  • substances within the scope of CLP Article 1 which meet the criteria for classification as hazardous and are placed on the market either on their own or in a mixture above the concentration limits specified in CLP or the Dangerous Preparations Directive (Directive 1999/45/EC), where relevant, which results in the classification of the mixture as hazardous.

Therefore, where after evaluating hazard information under CLP no hazardous properties have been identified for a substance, there is no obligation to notify to C&L Inventory.  If, however, the substance is subject to registration under REACH, there is an obligation to notify ECHA after the substance is placed on the market.

(4) Deadlines for Submitting Notification for Substances to the C&L Inventory

Any hazardous substance (regardless of quantity) or non-hazardous substance subject to registration under REACH (ie ≥1 tonne per year) which is placed on the market on or after 1 December 2010 has to be notified to the Classification & Labelling Inventory (C&L Inventory) by 3 January 2011.   Separate notification is not necessary if information on classification and labelling has been submitted before this deadline as part of the registration of the substance under REACH.  However, if REACH registration is later than 3 January 2011, notification will have to be submitted before the substance has to be registered.

  • It should be noted that the duty to notify to the C&L Inventory applies to substances subject to registration under REACH irrespective of their registration deadline. Therefore, it is possible that notification will be necessary prior to the registration deadline.
  • For substances which are placed on the market on or after 1 December 2010, the deadline for notification to the inventory is one month after they have been placed on the market.
  • For substances placed on the market on 1 December 2010 itself, the notification is in practice due on 3 January 2011, because 1 January 2011 will be a Saturday and 2 January a Sunday. It is of course possible to voluntarily notify before 1 December 2010.
  • For substances placed on the market after 1 December 2010 (also when they have been placed before 1 December 2010, but not notified), the one month period has to be calculated from the date they are placed on the market after 1 December 2010.         

(5) CLP Requirements for Mixtures

The obligation to apply CLP to mixtures placed on the market will in most cases start on 1 June 2015.  The classification of mixtures is for the same hazards as for the substances [CLP Article 39(b)] and available data on a mixture as a whole will have to be used to determine the classification.  It should be noted that the physical hazard class to which the mixture belongs could be different from that of the substance(s) causing the hazard.  Expert judgment should be sought in case of doubt.

CLP requires that hazardous substances present in the mixture which led to the classification of the mixture have to be notified to the C&L Inventory.  Substances have to be present in the mixture above the concentration limits specified in Annex I of CLP (or as specified in Directive 1999/45/EC).

(6) Information to be Included in the C&L Notification

According to CLP Article 40(1), notification should contain the following information:

  • Company identity (name and contact details)
  • Identity of the substance (composition, structural formula, etc)
  • C&L classifications 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 a lack of data, inconclusive data or data which is conclusive yet insufficient for classification
  • Where applicable, specific concentration limits, or multiplying-factors (m-factors) related to the classification as hazardous for the aquatic environment, together with a justification for setting them
  • The labelling elements for the substance, such as hazard pictograms, signal words, hazard statements, appropriate precautionary statements, including the supplemental hazard statements.

Note: Information referred to in CLP Article 40(1) does not have to be notified if it has been submitted to ECHA as part of the registration pursuant to REACH or if it has already been notified by that notifier. 

(7) Submission of C&L Notification

A company can chose one of the following tools to prepare its classification and labelling notification:

  • via IUCLID (International Uniform Chemical Information Database) 5.2
  • via an online form on ECHA’s website when only a few substances need to be notified (especially useful for SMEs with reduced information notification needs)
  • directly to REACH-IT using an XML file containing more than one C&L notification (for bulk submissions).

(8) ECHA Guidance on CLP Notification

SIEF members who are obliged to submit C&L notification are recommended to visit, as the principal information source, the website of the European Chemicals Agency (ECHA) as it provides extensive guidance on CLP Regulation.

A description of the obligations related to the different roles of suppliers under CLP is available in section 2 of Introductory Guidance on the CLP Regulation and a copy of ECHA FQA re CLP.