Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth 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)

• Published date: 30 April 2004
• Subject Matter: Approximation of laws,Environment,Consumer protection
• Official Gazette Publication: Official Journal of the European Union, L 152, 30 April 2004

30.4.2004 EN Official Journal of the European Communities L 152/1

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COMMISSION DIRECTIVE 2004/73/EC

of 29 April 2004

adapting to technical progress for the twenty-ninth 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), and in particular Article 28 thereof,

Whereas:

(1) Annex I to Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling of each substance. That list needs to be updated to include further notified new substances and further existing substances as well adapting the existing entries to technical progress such as setting environmental concentration limits for certain substances. Accordingly it is also necessary to delete entries for certain substances and to split some entries because the classification no longer applies to all the substances under those entries. The labelling of substances containing 1,3-butadiene should be changed in order to reflect that that substance will be classified as a mutagen by the present Directive.

(2) Annex V to Directive 67/548/EEC lays down the methods for the determination of the physicochemical properties, toxicity and ecotoxicity of substances and preparations. It is appropriate to amend that Annex in order to obtain a reduction to a minimum of the number of animals used for experimental purposes, in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (2). The methods for sub-chronic oral toxicity in Chapters B.1, B.4, B.5, B.31 and B.35 should be revised accordingly. Furthermore, Chapter B.42 should be added to Annex V in order to make available a refined method on sub-chronic oral toxicity. Finally, Chapter A.21 on physico-chemical properties, Chapter B.43 on sub-chronic oral toxicity and Chapters C.21 to C.24 on environmental toxicity should be added in order to allow for the determination of properties which are not yet sufficiently covered by the methods in Annex V.

(3) The measures provided for in 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 with Dangerous Substances and Preparations,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 67/548/EEC is amended as follows:

(1) Annex I is amended as follows: (a) note K in the foreword is replaced by the text set out in Annex 1 A; (b) the entries corresponding to the entries set out in Annex 1B to this Directive are replaced by the text set out in that Annex; (c) the entries set out in Annex 1C to this Directive are inserted in accordance with the order of the entries set out in Annex I to Directive 67/548/EEC; (d) the entries with index numbers 604-050-00-X, 607-050-00-8, 607-171-00-6 and 613-130-00-3 are deleted; (e) the entry with index number 048-002-00-0 is replaced by the entries with index numbers 048-002-00-0 and 048-011-00-X set out in Annex 1D to this Directive; (f) the entry with index number 609-006-00-3 is replaced by the entries with index numbers 609-006-00-3 and 609-065-00-5 set out in Annex 1D to this Directive; (g) the entry with index number 612-039-00-6 is replaced by the entries with index numbers 612-039-00-6 and 612-207-00-9 as set out in Annex 1D.

(2) Annex V is amended as follows: (a) the text set out in Annex 2A to this Directive is added as Chapter A.21; (b) chapter B.1bis is replaced by the text set out in Annex 2B to this Directive; (c) chapter B.1tris is replaced by the the text set out in Annex 2C to this Directive; (d) chapter B.4 is replaced by the text set out in Annex 2D to this Directive; (e) chapter B.5 is replaced by the text set out in Annex 2E to this Directive; (f) chapter B.31 is replaced by the text set out in Annex 2F to this Directive; (g) chapter B.35 is replaced by the text set out in Annex 2G to this Directive; (h) the text set out in Annex 2H to this Directive is added as Chapter B.42 and B.43; (i) the text set out in Annex 2I to this Directive is added as Chapter C.21 to C.24.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 October 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 29 April 2004.

For the Commission

Margot WALLSTRÖM

Member of the Commission

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(1) OJ 196,16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 6.8.2001, p. 1)

(2) OJ L 358, 18.12.1986, p. 1. Directive as last amended by Directive 2003/65/EC of the European Parliament and of the Council (OJ L 230,16.9.2003, p. 32).

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ANNEX 1A

Note K:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0.1 % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the S-phrases (2-)9-16 should apply. This note applies to certain complex oil-derived substances in Annex I.

Index No	chemical name	Notes related to substances	EC No	CAS No	Classification	Labelling	Concentration Limits	Notes related to preparations
006-005-00-4	thiram tetramethylthiuram disulphide		205-286-2	137-26-8	Xn; R20/22-48/22 Xi; R36/38 R43 N; R50-53	Xn; N R: 20/22-36/38-43-48/22-50/53 S: (2-)26-36/37-60-61	C ≥ 25 %: Xn, N; R20/22-36/38-43-48/22-50/53 20 % ≤ C
006-006-01-7	hydrogen cyanide...% hydrocyanic acid...%	B	200-821-6	74-90-8	T+; R26/27/28 N; R50-53	T+; N R: 26/27/28-50/53 S: (1/2-)7/9-16-36/37-38-45-60-61	C ≥ 25 %: T+, N; R26/27/28-50-53 7 % ≤ C
006-012-00-2	ziram (ISO) zinc bis dimethyldithiocarbamate		205-288-3	137-30-4	T+; R26 Xn; R22-48/22 Xi; R37-41 R43 N; R50-53	T+; N R: 22-26-37-41-43-48/22-50/53 S: (1/2-)22-26-28-36/37/39-45-60-61	C ≥ 25 %: T+, N; R22-26-37-41-43-48/22-50-53 20 % ≤ C
006-021-00-1	linuron (ISO) 3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea	E	206-356-5	330-55-2	Repr. Cat. 2; R61 Repr. Cat. 3; R62 Carc. Cat. 3; R40 Xn; R22-48/22 N; R50-53	T; N R: 61-22-40-48/22-62-50/53 S: 53-45-60-61
006-044-00-7	isoproturon 3-(4-isopropylphenyl)-1,1-dimethylurea		251-835-4	34123-59-6	Carc. Cat. 3; R40 N; R50-53	Xn; N R: 40-50/53 S: (2-)36/37-60-61	C ≥ 2,5 %: Xn, N; R40-50-53 1 % ≤ C
006-072-00-X	S-benzyl N,N-dipropylthiocarbamate prosulfocarb		401-730-6	52888-80-9	Xn; R22 R43 N; R51-53	Xn; N R: 22-43-51/53 S: (2-)24-37-61
006-089-00-2	chlorine dioxide		233-162-8	10049-04-4	O; R8 R6 T+; R26 C; R34 N; R50	O; T+; N R: 6-8-26-34-50 S: (1/2-)23-26-28-36/37/39-38-45-61	C ≥ 5 %: T+; N; R26-34-50 1 % ≤ C
006-089-01-X	chlorine dioxide ... %	B	233-162-8	10049-04-4	T; R25 C; R34 N; R50	T; N R: 25-34-50 S: (1/2-)23-26-28-36/37/39-45-61	C ≥ 25 %: T; N; R25-34-50 10 % ≤ C
007-001-00-5	ammonia, anhydrous		231-635-3	7664-41-7	R10 T; R23 C; R34 N; R50	T; N R: 10-23-34-50 S: (1/2-)9-16-26-36/37/39-45-61	C ≥ 25 %: T, N; R23-34-50 5% ≤ C
007-008-00-3	hydrazine	E	206-114-9	302-01-2	R10 Carc. Cat. 2; R45 T; R23/24/25 C; R34 R43 N; R50-53	T; N R: 45-10-23/24/25-34-43-50/53 S: 53-45-60-61	C ≥ 25 %: T, N; R45-23/24/25-34-43-50/53 10 % ≤ C
007-010-00-4	sodium nitrite		231-832-4	7758-09-0	O; R8 T; R25 N; R50	O; T; N R: 8-25-50 S: (1/2-)45-61	C ≥ 25 %: T, N; R25-50 5 % ≤ C
007-011-00-X	potassium nitrite		231-832-4	7758-09-0	O; R8 T; R25 N; R50	O; T; N R: 8-25-50 S: (1/2-)45-61	C ≥ 25 %: T, N; R25-50 5% ≤ C
007-013-00-0	1,2-dimethylhydrazine	E	-	540-73-8	Carc. Cat. 2; R45 T; R23/24/25 N; R51-53	T; N R: 45-23/24/25-51/53 S: 53-45-61	C ≥ 25 %: T, N; R45-23/24/25-51/53 3 % ≤ C
007-017-00-2	isobutyl nitrite	E	208-819-7	542-56-3	F; R11 Xn; R20/22 Carc. Cat. 2; R45 Muta. Cat. 3; R68	F; T R: 11-20/22-45-68 S: 53-45
007-027-00-7	1,6-bis(3,3-bis((1-methylpentylidenimino)propyl)ureido)hexane		420-190-2	-	Xn; R21/22-48/21 C; R34 R43 N; R50-53	C; N R: 21/22-34-43-48/21-50/53 S: (1/2-)7-26-36/37/39-45-60-61
008-003-00-9	hydrogen peroxide solution ... %	B	231-765-0	7722-84-1	R5 O; R8 C; R35 Xn; R20/22	O; C R:

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