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
(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 2000/33/EC(2), 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. Present scientific and technical knowledge has shown that the list of dangerous substances in that Annex should be adapted to technical progress. Specifically, Tables A and B in the Foreword to Annex I require inclusion of the Finnish and Swedish nomenclature. Certain language versions of the Directive require technical corrections in specific sections of the Foreword to Annex I. It is useful to publish an updated and recast version of the Foreword to Annex I. Furthermore, the list itself should be updated to include notified new substances and further existing substances; the identity, nomenclature, classification, labelling and/or concentration limits for certain substances should be amended to reflect increased technical knowledge; the entries for three substances should be deleted from the list, since they are covered by other entries.
(2) Annex II to Directive 67/548/EEC contains a list of symbols and indications of danger for dangerous substances and preparations. Annex III to Directive 67/548/EEC contains a list of phrases indicating the nature of special risks attributed to dangerous substances and preparations. Annex IV to Directive 67/548/EEC contains a list of the phrases indicating the safety advice concerning dangerous substances and preparations. Annexes II, III and IV require inclusion of the Finnish and Swedish wordings. Certain language versions of the Directive require technical corrections in specific sections of Annexes II, III and IV. It is useful to publish updated and recast versions of Annexes II, III and IV.
(3) Article 1 of European Parliament and Council Directive 1999/33/EC(3) permitted Sweden from 1 January 1999 until 31 December 2000 to require the use of the additional R-phrase R340, not listed in Annex III, for substances classified as carcinogenic, category 3, instead of R-phrase R40. Member State experts have agreed to revise the text of R-phrase R40 to refer to carcinogenic, category 3 substances. A new R-phrase R-68 should be added to Annex III, containing the original text of R-phrase R40 for classification and labelling of mutagenic category 3 and harmful substances listed in Annex I. The classification and labelling and concentration limit references in Annex I that include R40 should therefore be revised for such mutagenic category 3 and harmful substances.
(4) 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 necessary to adapt that Annex to technical progress. It is appropriate to reduce to a minimum the number of animals used for experimental purposes, in accordance with Council Directive 86/609/EEC(4). Chapter B.1 should therefore be deleted, since alternative methods, using fewer animals, are available. Due regard should be given to methods recognised and recommended by competent international organisations. The methods for subchronic oral toxicity in Chapters B.26 and B.27 should be revised accordingly and Chapters C.14 to C.20, on environmental toxicity should be added to Annex V. Certain language versions require technical corrections to specific sections of Annex V.
(5) Annex VI to Directive 67/548/EEC contains a guide to the classification and labelling of dangerous substances and preparations. It is necessary to adapt that Annex to technical progress. Certain language versions of the Directive require technical corrections in specific sections of Annex VI. Specific sections require publication in Finnish and Swedish. It is useful to publish an updated and recast version of Annex VI, particularly including reference to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(5).
(6) In accordance with the provisions of Directive 67/548/EEC, any new substance placed on the market should be notified to the competent authorities of the Member States by means of a notification containing certain information including a technical dossier. For new substances supplied and then consumed in a chemical reaction which are strictly controlled (intermediates with limited exposure), it is technically justifiable and appropriate to define a reduced test package (RTP). Current technical progress can guarantee minimum exposure for man and the environment through rigorous containment of the process.
(7) The technical dossier should contain a test package for intermediates with limited exposure which would supply the information necessary to evaluate their foreseeable risk for man and the environment. Annex VII should specify the content of this technical dossier and Annex VIII should detail additional tests and studies that may be required for intermediates with limited exposure marketed in higher volumes.
(8) The criteria for the notification of intermediates with limited exposure may need to be revised in the light of technical progress and experience gained with such notifications made in accordance with the new specific requirements laid down in this Directive.
(9) 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 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) Tables A and B in the foreword to Annex I shall include the Finnish and Swedish nomenclature. Certain language versions of the Directive shall include technical corrections in specific sections of the Foreword and Tables A and B. The Foreword including Tables A and B is replaced by Annex 1A to this Directive.
(b) The corresponding entries are replaced by the entries in Annex 1B to this Directive.
(c) The entries in Annex 1C to this Directive are inserted.
(d) The entries in Annex 1D to this Directive are deleted.
(e) The entries shown in Annex 1E to this Directive are amended by replacing classification references to "Muta. Cat. 3; R40" by "Muta. Cat. 3; R68" and by replacing labelling references to R40 by R68.
(f) The entries shown in Annex 1F to this Directive are amended by replacing classification references to "Xn; R40" by "Xn; R68" and by replacing labelling references to R40 by R68.
(g) The entry shown in Annex 1G to this Directive is amended by replacing concentration limit references to "Xn; R40/20/21/22" by "Xn; R68/20/21/22".
(h) The entry shown in Annex 1H to this Directive is amended by replacing concentration limit references to "Xn; R20/21/22-40/20/21/22" by "Xn; R20/21/22-68/20/21/22".
(i) The entries shown in Annex 1I to this Directive are amended by replacing classification references to "Muta. Cat. 3; R40" by "Muta. Cat. 3; R68".
(j) The entries shown in Annex 1J to this Directive are amended by replacing classification references to "Muta. Cat. 3; R40" by "Muta. Cat. 3; R68" and by adding R68 to the label.
2. Annex II shall include the Swedish and Finnish versions and technical corrections to certain language versions. Annex II is therefore replaced by Annex 2 to this Directive.
3. Annex III shall include the Swedish and Finnish versions and technical corrections to certain language versions. Annex III is therefore replaced by Annex 3 to this Directive.
4. Annex IV shall include the Swedish and Finnish versions and technical corrections to certain language versions. Annex IV is therefore replaced by Annex 4 to this Directive.
5. Annex V is amended as follows:
(a) Chapter B.1 is deleted.
(b) The title of the English version of Chapter B13/14 is replaced by the text in Annex 5A.
(c) The last sentence of the French version of paragraph 1.4.2.2 of Chapter B.39 is replaced by the text in Annex 5B.
(d) The equation in the last sentence of section 1.7.1.6 of the English version of Chapter B.41 is replaced by the text in Annex 5C.
(e) The test method for subchronic oral toxicity tests in rodents is amended in accordance with Annex 5D to this Directive, which replaces Chapter B.26.
(f) The test method for subchronic oral toxicity tests in non-rodents is amended in accordance with Annex 5E to this Directive, which replaces Chapter B.27.
(g) The seven new test methods for environmental toxicity in Annex 5F to this Directive are included in Part C.
6. Annex VI shall include the Swedish and Finnish versions, technical corrections to certain language versions and further detailed technical updates. Annex VI is therefore replaced by Annex 6 to this Directive.
7. Annex VII.A shall include a technical dossier containing a test package for intermediates with limited exposure, supplying the information necessary to evaluate their foreseeable risk for man and the environment. Annex VII.A is therefore amended as follows:
(a) the text in Annex 7A to this Directive is inserted before section 0 of Annex VII.A;
(b) the text in Annex 7B to this Directive is inserted at the end of Annex VII.A.
8. Annex VIII shall include additional tests and studies that may be required for intermediates with limited exposure marketed in higher volumes. Annex VIII is therefore amended as follows:
(a) the text in Annex 8A to this Directive is inserted between "Level 1" and "Physicochemical studies" of Annex VIII;
(b) the text in Annex 8B to this Directive is inserted between "Level 2" and "Toxicological studies" of Annex VIII.
Article 2
1. Member States shall adopt and publish before 30 July 2002 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
2. Member States shall apply the laws, regulations and administrative provisions referred to in paragraph 1:
(a) as from 30 July 2002 or an earlier date for dangerous substances;
(b) as from 30 July 2002 for preparations not within the scope of Council Directive 91/414/EEC(6) or European Parliament and Council Directive 98/8/EC(7);
(c) as from 30 July 2004 for preparations within the scope of Directive 91/414/EEC or Directive 98/8/EC.
They shall forthwith inform the Commission thereof.
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.
3. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive and a correlation table between this Directive and the national provisions adopted.
Article 3
This Directive shall enter into force on the third 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, 6 August 2001.