Lexikon
1272/2008 regulation 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.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF
directive on classification, packaging and labelling of dangerous substances. Commission Directive 2001/59/EC of 6 August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances: OJEC L225, 21.8.2001, pp. 1–333.
The danger symbols are defined in Annex II of the directive. A consolidated list with translations into other EU languages can be found in Directive 2001/59/EC.
The standard phrases are defined in Annexes III and IV of the Directive. Annex III defines phrases relating to the Nature of special risks attributed to dangerous substances and preparations, often referred to as R-phrases. Annex IV defines phrases relating to Safety advice concerning dangerous substances and preparations, often referred to as S-phrases.
The appropriate standard phrases must appear on the packaging and label of the product and on its MSDS (Material Safety data Sheet). Annex I specifies the standard phrases to be used for substances that are listed there: these are obligatory.
The lists of standard phrases were last updated in 2001, and Directive 2001/59/EC provides a consolidated list in all EU languages. In general, the label on the packaging of a dangerous substance or preparation must clearly indicate the following items:
- the name of the substance; for substances listed in Annex I, the name indicated must be one of those listed in the Annex (many substances appear in the Annex under different synonyms): otherwise, the name should be "internationally recognized"
- the name, full address and telephone number of the person or company which has placed the substance on the market (manufacturer, importer or distributor);
- the danger symbols, if any;
- the standard phrases, if any; (certain exemptions are permitted)
- the EINECS number or equivalent;
- for substances listed in Annex I, the words EC label.
On 20 January 2009 the new (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures entered into force. It aligns existing EU legislation to the United Nations Globally Harmonised System (GHS).
Source: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0059:EN:NOT and
http://en.wikipedia.org/wiki/Dangerous_Substances_Directive_%2867/548/EEC%29#cite_note-2001-59-EC-6
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulation and administrative provision relatingto the classification, packaging and labelling of dangerous substances.
Source: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31967L0548:EN:HTML
classification and labelling includes the evaluation of the hazard of a substance or preparation in accordance with Directive 67/548/EEC (substances) and 1999/45/EC (preparations) and a communication of that hazard via the label.
Classification is the process in which a given substance or preparation is assigned one of the 15 categories of danger depending on their intrinsic properties in accordance with the criteria for specified in directive 67/548/EEC. If the substance is not found to be dangerous, according to the said criteria, then it is not classified. Under GHS the substance or preparation will be assigned to hazard classes.
This evaluation must be made for any substance or preparation manufactured, imported or placed on the EU market for any tonnage level.
The classification of the substance and preparations as being dangerous is based on one or several endpoints concerning physical-chemical properties, health or environmental effects.
- explosive substances and preparations
- oxidising substances and preparations
- extremely flammable substances and preparations
- highly flammable substances and preparations
- flammable substances and preparations
- very toxic substances and preparations
- toxic substances and preparations
- harmful substances and preparations
- corrosive substances and preparations
- irritant substances and preparations
- sensitising substances and preparations
- carcinogenic substances and preparations
- mutagenic substances and preparations
- substances and preparations which are toxic for reproduction
- substances and preparations which are dangerous for the environment
Under REACH, any manufacturer or importer of a substance (regardless of quantity) will be required to submit all its classifications to the Agency, to be included in the classification and labelling Inventory. Classifications must be submitted by 1 December 2010 if the substance is put on the market and is either classified as dangerous (no tonnage threshold) or subject to registration.
The classification has to be included in all registration dossiers.
Classifications should also be communicated in the notifications which are required for substances for research and development (PPORD) and substances in articles.
The classification and labelling inventory is a database maintained by the European Chemical Agency (ECHA) containing the classification of all substances submitted either in registration dossiers or in notification of classification and labelling, including in PPORD notifications. Information from this inventory, which includes substance name and classification and labelling is made publicly available in accordance with the provisions of Article 119 of the REACH Regulation.
Source: REACH Glossary, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1999:200:0001:0068:EN:PDF
The CLP Regulation (Classification, Labelling and Packaging) ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through classification and labelling of chemicals.
Before placing chemicals on the market, the industry must establish the potential risks to human health and the environment of such substances and mixtures, classifying them in line with the identified hazards. The hazardous chemicals also have to be labelled according to a standardised system so that workers and consumers know about their effects before they handle them.
As a result of this process, the hazards of chemicals are communicated through standard statements and pictograms on labels and safety data sheets. For example, when a supplier identifies a substance as "acute toxicity category 1 (oral)", the labelling will include the hazard statement "fatal if swallowed", the word "Danger" and a pictogram with a skull and crossbones.
The CLP Regulation entered into force in January 2009, and the method of classifying and labelling chemicals it introduced is based on the United Nations' Globally Harmonised System (GHS).
The Regulation replaces over time two previous pieces of legislation, the Dangerous Substances Directive and the Dangerous Preparations Directive. There is a transition period until 2015.
Source: http://echa.europa.eu/web/guest/regulations/clp/understanding-clp
see 2001/59/EC directive on classification, packaging and labelling of dangerous substances