View source for 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 [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:21994A0103(52):EN:HTML agreement] it is also applicable in the [[European Economic Area|EEA]], and compliance with the Directive will ensure compliance with the relevant [[Switzerland|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 [http://ecb.jrc.it/Legislation/1999L0045EC.pdf Directive 1999/45/EC].
The Directive does '''not''' apply to the following groups of substances and preparations (Art. 1):
* [[Medicine]]s
* [[Cosmetics]]
* [[Waste]]
* Foodstuffs for humans or animals
* [[Pesticide]]s
* [[Radioactivity|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.
* [[Explosive]]s ('''E''')
* [[Oxidizing agent]]s ('''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''')
* [[Irritant]]s ('''Xi''')
* [[Sensitizer]]s
* [[Carcinogen]]s ('''Carc.'''), classified into three categories
* [[Mutagen]]s ('''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 ==
{{seealso|European chemical hazard symbol|Dangerous goods}}

The danger symbols are defined in Annex II of the directive. A consolidated list with translations into other EU languages can be found in [http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:32001L0059:EN:HTML Directive 2001/59/EC].

== Standard phrases ==
{{seealso|Risk and Safety Statements}}

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 [[List of R-phrases|R-phrases]].  Annex IV defines phrases relating to ''Safety advice concerning dangerous substances and preparations'', often referred to as [[List of 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 [http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:32001L0059:EN:HTML Directive 2001/59/EC] provides a consolidated list in all EU languages.

== Packaging requirements ==
(Art. 22) {{Expand-section|date=January 2007}}

== 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|danger symbols]], if any;
* the [[#Standard phrases|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 [[material safety data sheet|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.
[http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:32001L0058:EN:HTML Directive 2001/58/EC] provides detailed guidance for the preparation of material safety data sheets.

== Transposition ==
A [[European Union directive|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 [http://www.legislation.hmso.gov.uk/si/si2002/20021689.htm The Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (S.I. 2002 No. 1689)] (CHIPS Regulations).

== See also ==
*[[Registration, Evaluation and Authorisation of Chemicals]]
*[[Dangerous goods]]
*[[Material safety data sheet]]
*[[Risk and Safety Statements]]

[[Category:European Union directives|67/548]]

[[fr:Signalisation des substances dangereuses]]

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