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 2012Version 3Revision of Guidance Part 3 Health Hazards, relating to specificconcentration limits (SCLs) for 4 hazard classes and the inclusionof a new AnnexThe update includes the following:- Revision of Part 3, by providing guidance on the setting oflower and higher SCLs for 4 health hazard classes in section3.2.2.5 Skin Corrosion/Irritation; section 3.3.2.5 Serious EyeDamage/Eye Irritation; section 3.7.2.5 Reproductive Toxicityand section 3.8.2.6 STOT-SE, in accordance with CLP Article10(7);- Inclusion of a new Annex (Annex VI) providing guidance onsetting SCLs for the reproductive toxicity hazard class basedon potency considerations.November 20124
Guidance on the Application of the CLP Criteria Version 3.0 - November 2012PREFACEThis document is the Guidance on the Application of the CLP Criteria. It is a comprehensivetechnical and scientific document on the application of Regulation (EC) No 1272/2008 on theclassification, labelling and packaging of substances and mixtures (CLP), which will replacethe Dangerous Substances Directive 67/548/EEC (DSD) and the Dangerous PreparationsDirective 1999/45/EC (DPD) in a staggered way. CLP is based on the Globally HarmonisedSystem of Classification and Labelling of Chemicals (GHS) and is implementing theprovisions of the GHS within the EU. The objective of this document is to provide detailedguidance on the application of the CLP criteria for physical, health and environmentalhazards. The guidance is developed to assist primarily manufacturers or importers applyingclassification and labelling criteria and it also includes practical examples. It is also assumedto be the guidance on classification and labelling for Competent Authorities in the MemberStates (MS CA), for the Commission services and the European Chemicals Agency (ECHA).In certain chapters, like for example the ones on carcinogenicity, mutagenicity andreproductive toxicity, the guidance includes to a larger extent scientific advice on how tointerpret different data used for classification. This additional guidance is based onexperience gained within the EU during the application of the classification criteria underDirective 67/548/EEC, and is written for the experts within the respective fields.This guidance document was developed as a REACH Implementation Project (RIP 3.6) at theInstitute for Health and Consumer Products (IHCP) of the Joint Research Centre in Ispra,with support from working groups consisting of experts on classification and labelling fromEU Member States and Industry. The project started in September 2007 and the differentworking groups had meetings and continuous discussions to discuss and develop the guidancetext until spring 2009. Finally all texts were consolidated and edited at the IHCP. RIP 3.6 wasfinancially supported with an administrative arrangement made with Directorate-GeneralEnterprise and Industry. The guidance was handed over to ECHA in summer 2009.At the time of the hand-over, it was clear that further work was necessary in relation to theguidance chapters on health hazards ( for example on setting of specific concentration limits(SCLs)), on the long-term aquatic hazard and in relation to labelling and packaging. Inaddition further drafting work was done in close collaboration with European experts, to takeaccount of a range of guidance aspects 1 following the 2 nd Adaptation to Technical Progress(ATP) to the CLP Regulation (Commission Regulation (EU) No 286/2011 2 ). In relation tolabelling and packaging, a new stand-alone guidance document was prepared (“Guidance onLabelling and Packaging in accordance with Regulation (EC) No 1272/2008”), warrantingthe deletion of Part 5 and of Annex V of the Guidance on the Application of the CLP Criteria.The Guidance on Labelling and Packaging in accordance with Regulation (EC) No1272/2008 is published on ECHA’s guidance website, underhttp://guidance.echa.europa.eu/guidance_en.htm.1 Further guidance on the criteria for respiratory and skin sensitisation, on the aspiration hazard and other humanhealth related points, as well as on the physico- chemical points that were revised following the 2 nd ATP to theCLP Regulation are not part of this update and are planned for a future update of this document in 2013. .2 Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation totechnical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Councilon classification, labelling and packaging of substances and mixtures.5
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ECHA - Guidance of the application of CLP criteria [November 2012]

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