ECHA - Guidance of the application of CLP criteria [November 2012]

Guidance on the Application of the CLP Criteria Version 3.0 - November 20121 PART 1: GENERAL PRINCIPLES FOR CLASSIFICATION ANDLABELLING1.1 INTRODUCTION1.1.1 The objective of the guidance documentThis document is a comprehensive technical and scientific guidance on the application ofRegulation (EC) No 1272/2008 on the classification, labelling and packaging of substancesand mixtures 13 , hereafter referred to as CLP.CLP amends the Dangerous Substance Directive 67/548/EEC 14 (DSD), the DangerousPreparations Directive 1999/45/EC 15 (DPD) and Regulation (EC) No 1907/2006 16 (REACH),and will replace DSD and DPD from 1 June 2015 (CLP Article 61). CLP is based on the 3 rdrevision of the United Nations’ Globally Harmonised System of Classification and Labellingof Chemicals (UN GHS) and is implementing the provisions of the GHS within the EU,without lowering the protection of human health and the environment, compared to theclassification, labelling and packaging system in DSD and DPD.A core principle of CLP is “self-classification” of a substance or mixture by the manufacturer,importer or downstream user (CLP Article 4(3) and Recital 17), which involves identificationof its hazards followed by classification as a result of the comparison of the hazardinformation with the criteria in CLP. This guidance will enable industry to self-classifychemicals and to provide appropriate hazard communication information to the targetpopulations potentially exposed. For substances of particular concern (carcinogens, mutagens,substances toxic for reproduction (CMRs) and respiratory sensitisers) or for other substanceswhere EU-wide action is needed, CLP sets out a system for formal harmonisation ofclassifications at EU level.Given that many provisions under REACH are linked to classification, the implementation ofREACH and CLP is interlinked and should be planned and applied in tandem. Further adviceon the implementation of CLP is available in the Agency 17 ’s Introductory Guidance on theCLP Regulation, available at ECHA website(http://echa.europa.eu/documents/10162/13562/clp_introductory_en.pdf ).The objective of this document is to provide detailed guidance on the application of the CLPcriteria for physical, health and environmental hazards.13 Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling andpackaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, andamending Regulation (EC) No 1907/2006 [ OJ L 353, 31.12.2008, p. 1]14 Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances,as amended [OJ 196, 16.8.1967, p. 1]15Directive 1999/45/EC as of 30 July 2002 of the European Parliament and of the Councilrelating to the classification, packaging and labelling of dangerous preparation, as amended[OJ L 200, 30.7.1999, p.1]16 Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration,Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency,amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and CommissionRegulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and omission of Directives 91/155/EEC,93/67/EEC, 93/105/EC and 2000/21/EC. [OJ L 396, 30.12.2006 p.1.] [Corrigendum: OJ L 136, 29.5.2007 p.3]17 'the Agency' means the European Chemicals Agency established by Regulation (EC) No 1907/2006(REACH).32