CELEX: 32006L0121
Language: en
Date: 2006-12-18 00:00:00
Title: 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

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
        OJ C 294, 25.11.2005, p. 38.
2
        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).
 ---pagebreak--- 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:
                                                     Article 1
Directive 67/548/EEC is hereby amended as follows:
1)       in Article 1, paragraph 1, points (a), (b) and (c) shall be deleted;
2)       in Article 2, paragraph 1, points (c), (d), (f) and (g) shall be deleted;
3)       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
        See page 1 of this Official Journal.
2
        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.
 ---pagebreak--- 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)        Articles 7 to 15 shall be deleted;
6)        Article 16 shall be deleted;
7)        Articles 17 to 20 shall be deleted;
8)        Article 27 shall be deleted;
 ---pagebreak--- 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";
 ---pagebreak--- 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.";
 ---pagebreak--- 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.
 ---pagebreak--- L 396/856         EN               Official Journal of the European Union                     30.12.2006
                                                 Article 3
This Directive shall enter into force on the twentieth day following its publication in the Official
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
                                    _________________________