Introductory Guidance on the CLP Regulation - ECHA - Europa

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Basic guidance to Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures As to non-EU sources, please find a second list below. Please note that this list is given for information purposes only; mention of a data source does not imply endorsement of its content: • ECHEM Portal from OECD: http://webnet3.oecd.org/echemportal/; • RTECS (Registry of Toxic Effects of Chemical Substances) available from the NIOSH (US National Institute of Occupational Safety and Health) website: http://www.cdc.gov/niosh/rtecs/; • USEPA (United States Environmental Protection Agency) website: http://www.epa.gov/; • IRIS (Integrated Risk Information System) available from the USEPA website: http://cfpub.epa.gov/ncea/iris/index.cfm; • OSHA (US Occupational Safety & Health Administration) website: http://www.osha.gov/; • NICNAS (National Industrial Chemicals Notification and Assessment Scheme - Australia) website: http://www.nicnas.gov.au/; • TOXNET website which include databases such as Toxline and HSDB: http://toxnet.nlm.nih.gov/; • IPCS (International Programme on Chemical Safety) INCHEM website: http://www.inchem.org/; and • scientific literature: the PubMed portal from the US National Library of Medicine searches 100’s of relevant journals, many of which are available free of charge. http://www.ncbi.nlm.nih.gov/entrez/. Testing Having reviewed other sources of information, you may need to consider testing. ( see section 11 of this guidance document). 46
Basic guidance to Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures 11. The role of testing in CLP Getting started Hazard classification 7. General features of classification 8. Using harmonised classifications 9. Using the translation tables 10. Sources of information 11. The role of testing in CLP 12. Classifying substances 13. Classifying mixtures Hazard communication Follow-up to classification REACH and EU downstream legislation The role of testing CLP requires a manufacturer, importer or downstream user to gather relevant and available information on all hazardous properties of a substance or mixture. This information should be rigorously assessed, in order to decide whether the substance or mixture should be classified. For physical hazards, you are obliged to generate new information for the purposes of classification and labelling, unless adequate and reliable information is already available. However, the obligation to test does not apply for health and environmental hazards, see also below. In general, if new data are generated, then certain quality conditions should be met to ensure the classification based on them is sound. Tests should be carried out on the substance or mixture in the form(s) or physical state(s) in which it is placed on the market and can reasonably be expected to be used, see also Part 1.2 of Module 2. Testing for physical hazards The physical hazards of substances and mixtures should be determined through testing based on the methods or standards referred to in part 2 of Annex I to CLP. These can be found for example in the UN Manual of Tests and Criteria, see the website http://www.unece.org/trans/danger/publi/manual/manual_e.html, which is normally used to classify substances and mixtures for transport. In case there are test results available which are based on other methods or standards, then these data may still be used, provided they are adequate for the purpose of hazard determination. To conclude on the adequacy you or the expert involved should check that there is sufficient documentation to assess the suitability of the test used, and whether the test was carried out using an acceptable level of quality assurance. In case you need to carry out new tests, please note that from 1 January 2014 at the latest, new testing should be carried out in compliance with a recognised quality system or by laboratories complying with a relevant recognised standard, such as EN ISO/IEC 17025 3 . Further guidance on this is provided in Part 2 of Module 2. 3 EN ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories. 47
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