Background
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 introduced in 2008 the international globally harmonised system for classification and labelling of chemicals (GHS). GHS is a set of recommendations adopted by the United Nations Economic and Social Council in 2003 and intended to harmonise classification and labelling systems at global level. In Europe, the CLP Regulation has implemented the GHS system in 2008. The transition period with the pre-existing European system based on Directives Directives 67/548/EEC (substances) and 1999/45/EC (mixtures) ended in 2015. This legal act is a regulation thus applying directly in the Member States; no national implementing measures are required.
Objective
The purpose of this Regulation is to harmonise the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures. It also aims at establishing a classification and labelling inventory of substances.
This Directive shall not apply to non-isolated intermediates, waste, medicines, cosmetics, food and feeding stuffs, and substances and mixtures that are either radioactive, or subjects to custom supervision, or used for scientific research and are non-marketed.
This Regulation shall not apply to the transport of dangerous goods by air, sea, road, rail or inland waterways except for for labelling of outer packaging, inner packaging and single packaging.
Definitions
The Regulation defines terms: hazard class, hazard category, hazard pictogram, signal word, Danger, Warning, hazard statement, precautionary statement, substance, mixture, article, producer of an article, polymer, monomer, registrant, manufacturing, manufacturer, import, importer, placing on the market, downstream user, distributor, intermediate, non-isolated intermediate, the Agency, competent authority, use, supplier, alloy, UN RTDG, notifier, scientific research and development, cut-off value, concentration limit, differentiation, M-factor, package, packaging, intermediate packaging.
Contents
Title I sets general obligations to manufacturers, importers and downstream users to classify, label and package substances or mixtures. A hazardous substance/mixture must be classified in relation to its features (physical/health/environmental hazards) as in Annex I.
Title II deals with hazard classification (identification, examination and evaluation of information, and decision on classification).
Title III is about the hazard communication in the form of labelling (content of the label, hazard pictograms, signal words, location of the label)
Title IV orders that packaging has to be strong and solid enough to endure general handling. It must not adversely react with the content. The packaging should prevent leakage and should not look misleadingly.
Title V has as subject the harmonisation of classification and labelling of substances and the classification and labelling inventory. The content is closely linked to Regulation (EC) No 1907/2006.
Title VI is about competent authorities and enforcement.
Title VII (Common and final provisions) regulates advertisement, maintaining information and sets out special clauses. It also details the modifications of Directives 67/548/EEC, 1999/45/EC and Regulation (EC) No 1907/2006.
The Commission is empowered to adopt delegated acts to promote harmonisation of classification and labelling, emergency health response and preventive measures, and to adapt the Annexes according to technical and scientific progress.
Annexes
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Annex I: Classification and labelling requirements for hazardous substances and mixtures
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Annex II: Special rules for labelling and packaging of certain substances and mixtures
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Annex III: List of hazard statements, supplemental hazard information and supplemental label elements
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Annex IV: List of precautionary statements
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Annex V: Hazard pictograms
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Annex VI: Harmonised classification and labelling for certain hazardous substances
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Annex VII: Translation table from classification under Directive 67/548/EEC to classification under this Regulation
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Annex VIII: Harmonised information relating to emergency health response and preventative measures
Read the full text of the Regulation
Further information: ECHA website