COMMISSION DIRECTIVE 96/54/EC of 30 July 1996 adapting to technical progress for the twenty-second 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 (Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Commission Directive 94/69/EC (2), and in particular Article 28 thereof,
Whereas Annex I to Directive 67/548/EEC contains a list of dangerous substances, their classification, labelling and where appropriate, their characterization by concentration limits and other parameters enabling their risk to human health and the environment to be assessed; whereas the list of dangerous substances in Annex I needs to be adapted in the light of present scientific and technical knowledge; whereas in consequence it is necessary to amend the foreword to Annex I so as to include notes relating to the labelling of preparations and a new group of organic substances in table B; whereas the list of dangerous substances in Annex I contains substances for which specific temporary classification and labelling derogations have been granted to Austria and Sweden by the Act of Accession of Austria, Finland and Sweden; whereas the Act of Accession provides for the review of the classification and labelling requirements of those substances; whereas the classifications of some of those substances have been reviewed accordingly;
Whereas Annex III to Directive 67/548/EEC contains a list of phrases indicating the nature of special risks attributed to dangerous substances and preparations; whereas a phrase indicating the danger to health of certain substances and preparations on aspiration needs to be introduced;
Whereas Annex V to Directive 67/548/EEC lays down the methods for the determination of the physico-chemical properties, toxicity and ecotoxicity of substances and preparations; whereas the adaptation to technical progress of that Annex is necessary;
Whereas Annex VI to Directive 67/548/EEC contains general criteria for the classification and labelling of dangerous substances and preparations; whereas criteria for substances and preparations dangerous to health if aspirated need to be introduced; whereas the criteria for sensitizing substances and preparations need to be amended; whereas criteria for the labelling of gas containers intended for propane, butane or liquefied petroleum gas (LPG) need to be introduced;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 67/548/EEC is hereby amended as follows:
1. Annex I is amended as follows:
(a) nota 4 in the Foreword is replaced by the following text:
'Nota 4
Preparations containing these substances have to be classified as harmful with R65 if they meet the criteria in section 3.2.3 in Annex VI.`;
(b) the following nota 5 is added:
'Nota 5
The concentration limits for gaseous preparations are expressed as volume per volume percentage.`;
(c) the following special classification for organic substances is added to table B in the foreword to Annex I to Directive 67/548/EEC:
'647 Enzimas
Enzymer
Enzyme
¸íæõìá
Enzymes
Enzymes
Enzimi
Enzymen
Enzimas
Entsyymit
Enzymer`;
(d) the entries in Annex I to this Directive replace the corresponding entries;
(e) the entries in Annex II to this Directive are added for the first time;
(f) the entries with the following numbers are deleted:
008-002-00-3
612-045-00-9
648-011-00-5
648-025-00-1
648-157-00-X
648-158-00-5
648-159-00-0
649-192-00-3
(g) the entries shown in Annex III to this Directive are amended by replacing all references to 'R 22` by 'R 65`.
2. The following phrase is added to Annex III:
'R 65
ES: Nocivo: si se ingiere puede causar daño pulmonar.
DA: Farlig: kan give lungeskade ved indtagelse.
DE: Gesundheitsschädlich: kann beim Verschlucken Lungenschäden verursachen.
EL: ÅðéâëáâÝò: ìðïñåß íá ðñïêáëÝóåé âëÜâç óôïõò ðíåýìïíåò óå ðåñßðôùóç êáôÜðïóçò.
EN: Harmful: may cause lung damage if swallowed.
FR: Nocif: peut provoquer une atteinte des poumons en cas d'ingestion.
IT: Nocivo: può causare danni ai polmoni in caso di ingestione.
NL: Schadelijk: kan longschade veroorzaken na verslikken.
PT: Nocivo: pode causar danos nos pulmões se ingerido.
FI: Haitallista: voi aiheuttaa keuhkovaurion nieltäessä.
SV: Farligt: kan ge lungskador vid förtäring.`
3. Part B of Annex V is amended as follows:
(a) the text in Annex IV.A to this Directive replaces the heading and the general introduction to Part B: Methods for the Determination of Toxicity;
(b) the text in Annex IV.B to this Directive is inserted after chapter B.1 bis;
(c) the text in Annex IV.C to this Directive replaces chapter B.6;
(d) the text in Annex IV.D to this Directive replaces chapter B.7;
(e) the text in Annex IV.E to this Directive is added at the end.
4. Annex VI is amended by the texts set out in Annex V to this Directive, as indicated therein.
Article 2
1. Without prejudice to paragraph 2, not later than 31 May 1998, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission thereof.
2. Not later than 31 October 1997 the Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Annex V, points F, I and J of this Directive. Member States shall immediately inform the Commission thereof.
3. When Member States adopt the provisions referred to in paragraphs 1 and 2, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 30 July 1996.