Directive 67/548/EEC
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (as amended) is the main European Union law concerning chemical safety. It was made under Art. 95 (ex Art. 100a) 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.
Scope of the Directive
The Directive applies to pure chemicals and to mixtures of chemicals (preparations) which 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 Directive 1999/45/EC. The Directive does not apply to the following groups of substances and preparations (Art. 1):
- Medicines
- Cosmetics
- Waste
- Foodstuffs for humans or animals
- Pesticides
- Radioactive materials
The Directive does not apply to the transport of dangerous substances or preparations.
Classification of dangerous substances
Art. 2 of the Directive lists the classes of substances or preparations which are considered to be dangerous. Some, but not all, of these classes are associated with a chemical hazard symbol and/or a code.
- Explosives (E)
- Oxidizing agents (O)
- Flammable substances or preparations, classified as extremely flammable (F+), highly flammable (F)
- Toxic substances or preparations, classified as very toxic (T+) or toxic (T)
- Harmful substances or preparations (Xn)
- Corrosive substances or preparations (C)
- Irritants (Xi)
- Sensitizers
- Carcinogens (Carc.), classified into three categories
- Mutagens (Mut.), classified into three categories
- Substances or preparations which are toxic for reproduction (Repr.), classified into three categories
- Substances or preparations which are dangerous for the environment (N)
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 European Chemicals Bureau.
Danger symbols
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.
Standard phrases
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 last updated in 2001, and Directive 2001/59/EC provides a consolidated list in all EU languages.
Packaging requirements
(Art. 22) Template:Expand-section
Labelling requirements
(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")
- 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.
Material safety data sheet
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.
Transposition
A Directive is only binding on EU member states, and cannot be enforced against individuals (or companies) until it has been transposed into the national law of the state concerned.
In the United Kingdom, the main text transposing the Directive is The Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (S.I. 2002 No. 1689) (CHIPS Regulations).