Regulation (EC) No 1272/2008 - classification, labelling and packaging of substances and mixtures
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.
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.
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.
Entry into force, modifications and amendments have special time schedules, e.g. Titles II, III and IV shall apply in respect of substances from 1 December 2010 and in respect of mixtures from 1 June 2015 onwards.
Annex I: Classification and labelling requirements for hazardous substances and mixtures
Annex II: Special rules for labelling and packaging of certain substances and mixtures
Annex III: List of hazard statements, supplemental hazard information and supplemental label elements
Annex IV: List of precautionary statements
Annex V: Hazard pictograms
Annex VI: Harmonised classification and labelling for certain hazardous substances
Annex VII: Translation table from classification under Directive 67/548/EEC to classification under this Regulation
This legal act is a regulation thus applying directly in the Member States - no national implementing measures are required.