|European Union directive|
|Text with EEA relevance|
|Title||Directive on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances|
|Made under||Art. 100 (EEC)|
|Journal reference||L196, 16 August 1967, pp. 1-98|
|EEA Agreement||Chap. XV of Annex II|
|Date made||27 June 1967|
|Came into force||29 June 1967|
|Implementation date||1 January 1970|
|EP opinion||OJ 209, 11 December 1965, pp. 3133-40|
|Amended by||External list|
|Replaced by||Reg. (EC) No 1272/2008|
(from 1 June 2015)
The Dangerous Substances Directive (as amended) was one of the main European Union laws concerning chemical safety, until its full replacement by the new regulation CLP Regulation (2008), starting in 2016. It was made under Article 100 (Art. 94 in a consolidated version) of the Treaty of Rome. By agreement, it is also applicable in the EEA, and compliance with the directive will ensure compliance with the relevant Swiss laws. The Directive ceased to be in force on 31 May 2015 and was repealed by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and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 (Text with EEA relevance).
The directive applies to pure chemicals and to mixtures of chemicals (preparations) that are placed on the market in the European Union, therefore it does not apply directly to substances created purely for research purposes. Additional rules concerning preparations are contained in the Dangerous Preparations Directive (1999/45/EC): these are very similar to the rules contained in the Dangerous Substances Directive 67/548/EEC. The directive does not apply to the following groups of substances and preparations (Art. 1):
The directive does not apply to the transport of dangerous substances or preparations.
Article 2 of the directive lists the classes of substances or preparations that are considered to be dangerous. Some, but not all, of these classes are associated with a chemical hazard symbol and/or a code.
Substances or preparations falling into one or more of these classes are listed in Annex I of the directive, which is regularly updated. A public database of substances listed in Annex I is maintained by the Institute for Health and Consumer Protection.
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. Annex I specifies the standard phrases to be used for substances that are listed there: these are obligatory.
The lists of standard phrases were updated in 2001, and Directive 2001/59/EC provides a consolidated list in all EU languages.
The last update is European Regulation (EC) N°1272/2008, establishing the new CLP Regulation that implement the GHS system). See the current European chemical hazard symbols (CLP/GHS_hazard_statements).
(Articles 23-25) In general, the label on the packaging of a dangerous substance or preparation must clearly indicate the following items:
Article 27 of the directive imposes an obligation on suppliers to provide a material safety data sheet, on paper or electronically, at or before the first delivery of a dangerous substance or preparation. The supplier is also obliged to inform users of any relevant new information which becomes known. Directive 2001/58/EC provides detailed guidance for the preparation of material safety data sheets.