The CLP Regulation stands for Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directive 67/548/EEC (Dangerous Substances Directive) and 1999/45/EC(Dangerous Preparations Directive).
With a view to facilitating worldwide trade and lowering the non-tariff barriers such as re-classification and re-labelling, Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS) have been developed within the United Nation structure.
Based on the 2nd revision of UN GHS, CLP Regulation implements into EU law and entered into force on 20th January 2009.
2- What is the relationship between CLP and REACH?
The CLP Regulation and REACH are closely interlinked. Both are hazard-based and both focus on collecting hazard data, with the aim of ensuring a high level of protection to humans and the environment. Both are related to classification of substances, which can be shared in SIEFs for the purpose of both regulations.
There are some differences when comparing these two regulations. CLP obligations to classify, label and package are generally linked to the supply of substances or mixtures. Classification for registration or notification under REACH is, however, is independent of supply.
The tonnage band threshold to register under REACH does not exist in CLP Regulation, namely, hazardous substances and mixtures have to comply with CLP regulation, irrespective of the tonnage.
The tool to communicate hazardous information in the supply chain under REACH is Safety Data Sheets (SDS); while hazard communication under CLP is in the form of labelling.
3- What is a self-classification? What is a harmonized classification?
CLP included provisions for two sorts of classification: self-classification and harmonized classification.
Self-classification is the decision of classification and labelling taken by a manufacturer, importer or downstream user on a particular hazardous substance or mixture, when there is no harmonized classification applied or where a harmonized classification is available for selected hazards only. Mixtures must always be self-classified.
Harmonised classification means the decision on classification for a particular hazard of a substance is taken at Community level. A harmonized classification must be applied by default by the suppliers of respective substances.
4- What main obligations does CLP trigger for EU manufacturers and importers of chemicals?
The main obligation imposed on manufacturers, importers, downstream users, including formulators of mixtures and re-importers of substances is to classify, label and package substances and mixtures in accordance with the CLP Regulation.
Manufacturers and importers who place a hazardous substance on the market, will also have to notify certain information, in particular the substance identity and the classification and labelling of that substance to ECHA, which will be included in the Classification and Labelling Inventory.
5- Which substances have to be notified to the Classification and Labelling (C&L) Inventory?
1) Substances subject to registration under REACH and placed on the market;
2) Substances classified as hazardous under CLP and placed on the market irrespective of the tonnage; [including volumes less than 1 T/y]
3) Substances classified as hazardous under CLP and present in a mixture above the concentration limits specified in Annex I of CLP or as specified in Directive 1999/45/EC, where relevant, which results in classification of the mixture as hazardous, and where the mixture is placed on the market.
6- What are the institutional fees for C&L submissions?
CLP FEES: Commission Regulation (EU) No 440/2010 of 21 May 2010 on the fees payable to the European Chemicals Agency pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures .
8- How can we assist you in complying effectively with CLP?
Article 40(3) states that from 1 December 2010, the classification and labelling of any substance must be notified in accordance with 40(1) within one month (30 days) after the placing on the EU market.
However, substances placed on the market before 1 December 2010 may be notified in accordance with paragraph 1 before that date.
The extend of our service on CLP compliance includes the following:
Regulatory Advice on CLP:
Assessing and clearing up hurdles for achieving CLP compliance for your company
Setting up timelines and case-by-case regulatory route for your business
Identification of roles and compulsory obligations under CLP and REACH
CLP training for the company staff
Technical Services on CLP:
Re-classification and re-labelling of your substances or mixtures
Generation of CLP compliant labels, in accordance with Articles 17, 25 of the CLP regulation
Generation/update of new Safety Data Sheets (SDS) in accordance with CLP and REACH
Notifications to the Classification & Labelling Inventory (Via: IUCLID 5, REACH-IT, or Bulk XML submissions)