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

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Guidance on the Application of the CLP Criteria Version 3.0 - November 2012 identification and examination of relevant available information regarding thepotential hazards of a substance or mixture; comparison of the information (data) with the classification criteria; and decision on whether the substance or mixture shall be classified as hazardous inrelation to the hazard classes or differentiations provided in CLP Annex I, and thedegree of hazard, where appropriate.Preliminary information on identification and review of relevant data is provided in section1.1.6 of this guidance document, while further guidance is provided in Part B of the ECHAGuidance document on Information Requirements and Chemical Safety Assessment(Chapters R.2 to R.4, IR/CSA), available on the ECHA Website(http://echa.europa.eu/web/guest/guidance-documents/guidance-on-information-requirementsand-chemical-safety-assessment).Classification according to CLP is based on intrinsic hazards, i.e. the basic properties of asubstance as determined in standard tests or by other means designed to identify hazards. AsCLP is hazard-based, it does not take exposure into consideration in arriving at either aclassification or appropriate labelling, unless for specific exceptions when a chemical can beconsidered as not being biologically available, such as the derogation not to label a metal inthe massive form.1.1.4 Who is responsible for the hazard classification and what is the timetableCLP and REACH places the responsibility for hazard classification and related provisionssuch as packaging, hazard communication and SDS on the suppliers of substances andmixtures.From 1 December 2010 to 1 June 2015 (CLP Article 61):Substances shall be classified in accordance with both DSD Directive and CLP Regulationin order to allow these classifications to be used in the classifications of mixtures.Classification and labelling information in accordance with both systems shall be includedin SDS (see the Guidance on the compilation of Safety Data Sheets, available on theAgency’s website). Labelling and packaging shall be in accordance with CLP Regulation.Mixtures shall be classified, labelled and packaged in accordance with DPD. They mayalso be classified, labelled and packaged in accordance with CLP. In that case they shallnot be labelled and packaged according to DPD. When a mixture is classified, labelled andpackaged according to CLP, classification and labelling information according to bothsystems shall be provided in SDS (see the Guidance on the compilation of Safety DataSheets, available on the Agency’s website).From 1 June 2015 (CLP Articles 60 and 61):Both substances and mixtures shall be classified, labelled and packaged in accordance withCLP. DSD and DPD are repealed from 1 June 2015 and classification according to thesedirectives is not allowed.However, substances classified, labelled and packaged in accordance with DSD and alreadyplaced on the market (“on the shelves”) before 1 December 2010, and mixtures classified,labelled and packaged in accordance with DPD and already placed on the market (“on theshelves”) before 1 June 2015, do not have to be relabelled and repackaged in accordance withCLP until 1 December 2012 and 1 June 2017, respectively.34
Guidance on the Application of the CLP Criteria Version 3.0 - November 20121.1.5 Which substances and mixtures should be classified (the scope)Substances and mixtures placed on the market fall within the scope of classification underCLP and should be evaluated in order to reach a decision as to whether they should beclassified or not. Substances are also subject to classification where they are subject toregistration or notification under REACH, even if they are not placed on the market.However, a number of substances and mixtures are exempted from the requirements of theCLP Regulation as a whole (CLP Article 1):– radioactive substances and mixtures (Directive 96/29/Euroatom 21 );– substances and mixtures which are subject to customs supervision, provided that they donot undergo any treatment or processing, and which are in temporary storage, or in a freezone or free warehouse with a view to re-exportation, or in transit;– non-isolated intermediates;– substances and mixtures used in scientific experimentation, analysis or chemical research,provided they are not placed on the market and they are used under controlled conditionsin accordance with EU workplace and environmental legislation;– waste, as defined in Directive 2006/12/EC 22 ; and– certain substances or mixtures in the finished state, intended for the final user:• medicinal products, as defined in Directive 2001/83/EC 23 ,• veterinary medicinal products, as defined in Directive 2001/82/EC 24 ,• cosmetic products, as defined in Directive 76/768/EEC 25 ,• medical devices as defined in Directive 90/385/EEC 26 (active implantablemedical devices) and 93/42/EEC 27 (medical devices in general), which areinvasive or used in direct physical contact with the human body, and in vitrodiagnostic medical devices (Directive 98/79/EC 28 ), and• food or feeding stuffs as defined in Regulation 178/2002 29 , including whenthey are used as food additives within the scope of Directive 89/107/EEC 30 , as21 Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of thehealth of workers and the general public against the dangers arising from ionizing radiation [OJ L 159,29.6.1996, p. 1]22 Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste [OJ L 114,27.4.2006, p. 9]23 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Communitycode relating to medicinal products for human use [OJ L 311, 28.11.2001, p. 67]24 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Communitycode relating to veterinary medicinal products [OJ L 311, 28.11.2001, p. 1]25 Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relatingto cosmetic products [OJ L 262, 27.9.1976, p. 169]26 Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member Statesrelating to active implantable medical devices [OJ L 189, 20.7.1990, p. 17]27 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ L 169, 12.7.1993, p. 1]28 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnosticmedical devices [OJ L 331, 7.12.1998, p. 1]29 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying downthe general principles and requirements of food law, establishing the European Food Safety Authority and layingdown procedures in matters of food safety [OJ L 31, 1.2.2002, p. 1]35
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ECHA - Guidance of the application of CLP criteria [November 2012]

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