Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency
Date: 2006-12-18
Institutions: Council of the European Union, European Parliament
Subjects: European Chemicals Agency, approximation of laws, chemical product, dangerous substance, labelling, marketing standard, packaging, scientific report

L 396/850 

EN 

Official Journal of the European Union 

30.12.2006 

DIRECTIVE 2006/121/EC OF THE EUROPEAN PARLIAMENT 

AND OF THE COUNCIL 

of 18 December 2006 

amending Council Directive 67/548/EEC 

on the approximation of laws, regulations and administrative 

provisions relating to the classification, packaging and labelling of 

dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 

concerning the Registration, Evaluation, Authorisation and Restriction 

of Chemicals (REACH) and establishing a European Chemicals Agency 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 95 

thereof, 

Having regard to the proposal from the Commission, 

Having regard to the Opinion of the European Economic and Social Committee1, 

After consulting the Committee of the Regions, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty2, 

1 
2 

OJ C 294, 25.11.2005, p. 38. 
Opinion of the European Parliament of 17 November 2005 (OJ C 280 E, 18.11.2006, 
p. 440), Council Common Position of 27 June 2006 (OJ C 276 E, 14.11.2006, p. 252) and 
Position of the European Parliament of 13 December 2006 (not yet published in the Official 
Journal).  

 
                                                 
30.12.2006 

EN 

Official Journal of the European Union 

L 396/851 

Whereas: 

In view of the adoption of Regulation (EC) No 1907/20061, Directive 67/548/EEC2 should be 

adapted and its rules on the notification and risk assessment of chemicals deleted, 

HAVE ADOPTED THIS DIRECTIVE: 

Directive 67/548/EEC is hereby amended as follows: 

Article 1 

1) 

2) 

3) 

in Article 1, paragraph 1, points (a), (b) and (c) shall be deleted; 

in Article 2, paragraph 1, points (c), (d), (f) and (g) shall be deleted; 

Article 3 shall be replaced by the following: 

"Article 3 

Testing and assessment of the properties of substances 

Tests on substances carried out within the framework of this Directive shall be conducted 

according to the requirements of Article 13 of Regulation (EC) No 1907/2006 of the 

European Parliament and of the Council of 18 December 2006 concerning the Registration, 

Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a 
European Chemicals Agency*. 

_____________________________ 

* 

OJ L"; 396, 30.12.2006, p. 1. 

1 
2 

See page 1 of this Official Journal. 
OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC 
(OJ L 152, 30.4.2004, p. 1). Corrected in OJ L 216, 16.6.2004, p. 3. 

 
                                                 
L 396/852 

EN 

Official Journal of the European Union 

30.12.2006 

4) 

Article 5 shall be amended as follows: 

(a) 

in paragraph 1, the first subparagraph shall be replaced by the following: 

"Member States shall take all the necessary measures to ensure that substances 

cannot be placed on the market on their own or in preparations unless they have been 

packaged and labelled in accordance with Articles 22 to 25 of this Directive and with 

the criteria in Annex VI of this Directive, and, for registered substances, in 

accordance with the information obtained through the application of Articles 12 

and 13 of Regulation (EC) No 1907/2006, save in the case of preparations where 

provisions exist in other Directives."; 

(b)  paragraph 2 shall be replaced by the following: 

"2.  The measures referred to in the first subparagraph of paragraph 1 shall apply 

until the substance is listed in Annex I or until a decision not to list it has been 

taken in accordance with the procedure laid down in Article 29."; 

5) 

6) 

7) 

8) 

Articles 7 to 15 shall be deleted; 

Article 16 shall be deleted; 

Articles 17 to 20 shall be deleted; 

Article 27 shall be deleted; 

 
30.12.2006 

EN 

Official Journal of the European Union 

L 396/853 

9) 

Article 32 shall be replaced by the following: 

"Article 32 

References 

References to Annexes VII A, VII B, VII C, VII D and VIII of this Directive shall be 

construed as references to the corresponding Annexes VI, VII, VIII, IX, X and XI of 

Regulation (EC) No 1907/2006."; 

10) 

Annex V shall be deleted; 

11) 

Annex VI shall be amended as follows: 

(a) 

in sections 1.6.2, 1.7.2, 1.7.3, 2.1, 2.2.1, 2.2.2, 2.2.2.1, 2.2.3, 2.2.4, 2.2.5, 3.1.1, 

3.1.5.1, 3.1.5.2, 3.2.1, 3.2.2, 3.2.3, 3.2.5, 3.2.6.1, 3.2.6.2, 3.2.7.2, 4.2.3.3, 5.1.3, 

9.1.1.1, 9.1.1.2, 9.3 and 9.5 of this Annex, the words "Annex V" and "Annex V to 

this Directive", shall be replaced by the words "the Commission Regulation on test 

methods as specified in Article 13(2) of Regulation (EC) No 1907/2006"; 

 
 
L 396/854 

EN 

Official Journal of the European Union 

30.12.2006 

(b) 

section 1.6.1, point (a) shall be replaced by the following: 

"(a)  as regards substances for which the information specified in Annexes VI, VII 

and VIII of Regulation (EC) No 1907/2006 is required, most of the necessary 

data for classification and labelling appear in the base set. This classification 

and labelling must be reviewed, if necessary, when further information is 

available (Annexes IX and X of Regulation (EC) No 1907/2006);"; 

(c) 

in section 5.1, the second paragraph shall be replaced by the following: 

"The criteria set out below follow directly from the test methods set out in the 

Commission Regulation on test methods as specified in Article 13(2) of 

Regulation (EC) No 1907/2006 in so far as they are mentioned. The test methods 

required for the base set referred to in Annexes VII and VIII of Regulation (EC) 

No 1907/2006 are limited and the information derived from them may be insufficient 

for an appropriate classification. Classification may require additional data derived 

from Annexes IX or X of Regulation (EC) No 1907/2006 or other equivalent studies. 

Furthermore, classified substances may be subject to review in the light of other new 

data."; 

 
30.12.2006 

EN 

Official Journal of the European Union 

L 396/855 

(d) 

in section 5.2.1.2, second paragraph, the second sentence shall be replaced by the 

following: 

"Such additional scientific evidence should normally be based on the studies required 

by Annex IX of Regulation (EC) No 1907/2006, or studies of equivalent value, and 

could include:"; 

12) 

Annexes VII A, VII B, VII C, VII D and VIII shall be deleted. 

Article 2 

1. 

Member States shall bring into force the laws, regulations and administrative provisions 

necessary to comply with this Directive with effect from 1 June 2008. They shall forthwith 

inform the Commission thereof. 

When Member States adopt these measures, they shall contain a reference to this Directive 

or shall be accompanied by such reference on the occasion of their official publication. The 

methods of making such reference shall be laid down by the Member States. 

2. 

Member States shall communicate to the Commission the text of the main provisions of 

national law which they adopt in the field covered by this Directive. 

 
L 396/856 

EN 

Official Journal of the European Union 

30.12.2006 

This Directive shall enter into force on the twentieth day following its publication in the Official 

Article 3 

Journal of the European Union. 

It shall apply from 1 June 2008. 

Notwithstanding the second paragraph of this Article, Article 1 point 6 shall apply from 1 August 

2008. 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels, 18 December 2006. 

For the European Parliament 

For the Council 

The President 

The President 

J. BORRELL FONTELLES 

M. VANHANEN 

_________________________