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Dangerous Substances Directive (67/548/EEC)

The Dangerous Substances Directive (as amended) is one of the main European Union laws concerning chemical safety. 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 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.

Art. 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 symbols 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 of the Directive is maintained by the Institute for Health and Consumer Protection.

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.

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 (R-phrases). Annex IV defines phrases relating to Safety advice concerning dangerous substances and preparations, often referred to as S-phrases (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 last updated in 2001, and Directive 2001/59/EC provides a consolidated list in all EU languages.

Labelling: (Arts. 23-25). 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")

Art. 27 of the Directive imposes an obligation on suppliers to provide an MSDS, 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.

  • 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 EEC label.

http://en.wikipedia.org/wiki/Dangerous_Substances_Directive_%2867/548/EEC%29

EU dangerous substances directive

see 67/548/EEC dangerous substance directive