Directive 67/548/EEC


Directive 67/548/EEC

EU directive
title=Directive on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
number=67/548/EEC
madeby=Council
madeunder=Art. 100 (EEC) [The old Art. 100 of the EEC treaty has since been renumbered to Art. 95.]
OJref=L196, 1967-08-16, pp. 1–98The official English version of the directive was published in the "OJEC English special edition, Series I, Chapter 1967", p. 0234. [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31967L0548:EN:HTML Text] ]
made=1967-06-27
commenced=1967-08-16
implementation=1970-01-01
CommProp=
ESCOpin=C11, 1966-01-20, pp. 143–66
ParlOpin=C209, 1965-12-11, pp. 3133–65
Reports=
replaces=—
amends=—
amendedby=" [http://eur-lex.europa.eu/Notice.do?val=9088:cs&lang=en&list=9088:cs,&pos=1&page=1&nbl=1&pgs=10&hwords= External list] "
replacedby=—
status=Current

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 one of the main European Union laws 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,Art. 23 and [http://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, 1992-05-02; came into force 1994-01-01.] and compliance with the Directive will ensure compliance with the relevant Swiss laws. [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] , [http://www.admin.ch/ch/d/sr/8/813.112.12.de.pdf German] , [http://www.admin.ch/ch/i/rs/8/813.112.12.it.pdf Italian] ). 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] , [http://www.admin.ch/ch/d/sr/8/813.1.de.pdf German] , [http://www.admin.ch/ch/i/rs/8/813.1.it.pdf Italian] ) 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] , [http://www.admin.ch/ch/d/sr/8/813.11.de.pdf German] , [http://www.admin.ch/ch/i/rs/8/813.11.it.pdf Italian] ).]

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: [http://ecb.jrc.it/Legislation/1999L0045EC.pdf Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations.] "OJEC" L200 of 1999-07-20, pp. 1–68.] these are very similar to the rules contained in Directive 76/548/EEC. [The European Court of Justice ruled in 1985 that Directive 76/548/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 1985-09-26. "European Court reports" [1985] 3013.] The Directive does not apply to the following groups of substances and preparations (Art. 1):
* Medicines
* Cosmetics, which are covered by the Cosmetics Directive
* Waste
* Foodstuffs for humans or animals
* Pesticides
* Radioactive materialsThe 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. [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:225:0001:0333:EN:PDF Commission Directive 2001/59/EC of 6 August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.] "OJEC" L225 of 2001-08-21, pp. 1–333.]

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) 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, 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 [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

References


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