Directive 67/548/EEC

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title: "Directive 67/548/EEC" type: doc version: 1 created: 2026-02-28 author: "Wikipedia contributors" status: active scope: public tags: ["european-union-directives", "packaging", "1967-in-law", "1967-in-the-european-economic-community", "hazardous-materials", "regulation-of-chemicals-in-the-european-union"] topic_path: "law" source: "https://en.wikipedia.org/wiki/Directive_67/548/EEC" license: "CC BY-SA 4.0" wikipedia_page_id: 0 wikipedia_revision_id: 0

::data[format=table title="Infobox EU legislation"]

Field	Value
type	Directive
number	67/548/EEC
title	Directive on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
EEA	yes
madeby	Council
madeunder	Art. 100 (EEC)
OJrefurl	https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31967L0548:EN:HTML
OJref	L196, 16 August 1967, pp. 1–98
EEATreaty	Chap. XV of Annex II
made	27 June 1967
commenced	29 June 1967
implementation	1 January 1970
ParlOpin	OJ 209, 11 December 1965, pp. 3133–40
amendedby	External list
replacedby	Reg. (EC) No 1272/2008
(from 1 June 2015)
status	Repealed
::

|type=Directive |number=67/548/EEC |title=Directive on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances |EEA=yes |madeby=Council |madeunder= Art. 100 (EEC) |OJrefurl= https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31967L0548:EN:HTML |OJref= L196, 16 August 1967, pp. 1–98 |EEATreaty=Chap. XV of Annex II |made= 27 June 1967 |commenced= 29 June 1967 |implementation= 1 January 1970 |CommProp= |ESCOpin= |ParlOpin= OJ 209, 11 December 1965, pp. 3133–40 |Reports= |replaces= |amends= |amendedby=External list |replacedby=Reg. (EC) No 1272/2008 (from 1 June 2015) |status=Repealed The Dangerous Substances Directive (as amended) was one of the main European Union laws concerning chemical safety, until its full replacement by the new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){{cite journal | last = European Commission | date = 29 December 2006 | title = European Union – Consolidated versions of the Treaty on European Union and the Treaty establishing the European Community | journal = Official Journal of the European Communities | issue = C 321E | pages = 1–331 | url = https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2006:321E:0001:0331:EN:PDF | format = pdf | access-date = 23 February 2009

Scope

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):

Cosmetics, which are covered by the Cosmetics Directive
Food for humans or animals
Medicines
Pesticides
Radioactive materials
Waste The directive does not apply to the transport of dangerous substances or preparations.

Classification of dangerous substances

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.

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)
Corrosive substances or preparations (C)
Harmful substances or preparations (Xn)
Irritants (Xi)
Sensitizers (R42 and/or R43)
Carcinogens (Carc.), classified into three categories
Mutagens (Mut.), classified into three categories
Substances or preparations that are toxic for reproduction (Repr.), classified into three categories
Substances or preparations that 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 is maintained by the Institute for Health and Consumer Protection.

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 Risk and Safety 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 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).

Packaging requirements

(Article 22)

Labelling requirements

(Articles 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

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.

References

''Full title'': Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances.
Art. 23 and [https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:21994A0103(52):EN:HTML Chapter XV of Annex II], [http://ec.europa.eu/world/agreements/downloadFile.do?fullText=yes&treatyTransId=1369 Agreement on the European Economic Area] signed in Oporto, 2 May 1992; came into force 1994-01-01.
Art. 2.1 of the Regulation of 28 June 2005 of the Federal Interior Ministry on the official classification and labelling of substances (SR/RS 813.112.12, text in [http://www.admin.ch/ch/f/rs/8/813.112.12.fr.pdf French] {{webarchive. link. (1 January 2007 , [http://www.admin.ch/ch/d/sr/8/813.112.12.de.pdf German] {{webarchive). link. (6 June 2011 , [http://www.admin.ch/ch/i/rs/8/813.112.12.it.pdf Italian] {{webarchive). link. (6 June 2011 ). See also the Swiss Federal Law on Chemical Products (SR/RS 813.1, text in [http://www.admin.ch/ch/f/rs/8/813.11.fr.pdf French] {{Webarchive). link. (15 March 2012 , [http://www.admin.ch/ch/d/sr/8/813.1.de.pdf German] {{Webarchive). link. (24 December 2012 , [http://www.admin.ch/ch/i/rs/8/813.1.it.pdf Italian] {{Webarchive). link. (15 March 2012 ) and the Swiss Federal Regulations on Chemical Products (SR/RS 813.11, text in [http://www.admin.ch/ch/f/rs/8/813.11.fr.pdf French] {{Webarchive). link. (15 March 2012 , [http://www.admin.ch/ch/d/sr/8/813.11.de.pdf German] {{Webarchive). link. (15 March 2012 , [http://www.admin.ch/ch/i/rs/8/813.11.it.pdf Italian] {{Webarchive). link. (15 March 2012 ).)
(16 August 1967). "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". Europa (web portal).
OJEC]]'' L200, 30 July 1999, pp. 1–68.
The [[European Court of Justice]] ruled in 1985 that Directive 67/548/EEC applies only to pure substances, not preparations: ''[http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:61984J0187:EN:HTML Re criminal proceedings against Giacomo Caldana]'' (Case 187/84 – Art. 177 (EEC) referral by the Pretore di Torino). Judgement 26 September 1985. ''European Court reports'' [1985] 3013.
OJEC]]'' L225, 21 August 2001, pp. 1–333.
[https://ec.europa.eu/environment/archives/dansub/home_en.htm The directive on dangerous substances] Includes Danger symbols)

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