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
Modified by
  • Commission Directive 2001/60/ECof 7 August 2001adapting to technical progress Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(Text with EEA relevance), 32001L0060, August 22, 2001
  • Regulation (EC) No 1882/2003 of the European Parliament and of the Councilof 29 September 2003adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty, 32003R1882, October 31, 2003
  • Council Directive 2004/66/ECof 26 April 2004adapting Directives 1999/45/EC, 2002/83/EC, 2003/37/EC and 2003/59/EC of the European Parliament and of the Council and Council Directives 77/388/EEC, 91/414/EEC, 96/26/EC, 2003/48/EC and 2003/49/EC, in the fields of free movement of goods, freedom to provide services, agriculture, transport policy and taxation, by reason of the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, 32004L0066, May 1, 2004
  • Commission Directive 2006/8/ECof 23 January 2006amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(Text with EEA relevance)Corrigendum to Commission Directive 2006/8/EC of 23 January 2006 amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(Official Journal of the European Union L 19 of 24 January 2006), 32006L000832006L0008R(02), January 24, 2006
  • Council Directive 2006/96/ECof 20 November 2006adapting certain Directives in the field of free movement of goods, by reason of the accession of Bulgaria and Romania, 32006L0096, December 20, 2006
  • Regulation (EC) No 1907/2006 of the European Parliament and of the Councilof 18 December 2006concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC(Text with EEA relevance)Corrigendum to 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), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC(Official Journal of the European Union L 396 of 30 December 2006), 32006R190732006R1907R(01), December 30, 2006
  • Regulation (EC) No 1137/2008 of the European Parliament and of the Councilof 22 October 2008adapting a number of instruments subject to the procedure laid down in Article 251 of the Treaty to Council Decision 1999/468/EC, with regard to the regulatory procedure with scrutinyAdaptation to the regulatory procedure with scrutiny — Part One, 32008R1137, November 21, 2008
  • Regulation (EC) No 1272/2008 of the European Parliament and of the Councilof 16 December 2008on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006(Text with EEA relevance), 32008R1272, December 31, 2008
  • Council Directive 2013/21/EUof 13 May 2013adapting Council Directive 67/548/EEC and Directive 1999/45/EC of the European Parliament and of the Council in the field of environment, by reason of the accession of the Republic of Croatia, 32013L0021, June 10, 2013
Corrected by
  • Corrigendum 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, 31999L0045R(03), January 10, 2002
  • Corrigendum to Commission Directive 2006/8/EC of 23 January 2006 amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, 32006L0008R(02), February 15, 2007
  • Corrigendum to 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), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, 32006R1907R(01), May 29, 2007
Directive 1999/45/EC of the European Parliament and of the Councilof 31 May 1999concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations 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 of the CommissionOJ C 283, 26.9.1996, p. 1, and OJ C 337, 7.11.1997, p. 45.,Having regard to the opinion of the Economic and Social CommitteeOJ C 158, 26.5.1997, p. 76.,Acting in accordance with the procedure laid down in Article 251 of the TreatyOpinion of the European Parliament of 26 June 1997 (OJ C 222, 21.7.1997, p. 26), Council common position of 24 September 1998 (OJ C 360, 23.11.1998, p. 1) and Decision of the European Parliament of 10 February 1999(OJ C 150, 28.5.1999). Council Decision of 11 May 1999.,(1)Whereas Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparationsOJ L 187, 16.7.1988, p. 14. Directive as last amended by Commission Directive 96/65/EC (OJ L 265, 18.10.1996, p. 15). has been amended on several occasions; whereas on the occasion of further amendments, the said Directive should, for reasons of clarity, be recast;(2)Whereas, in spite of Community provisions, the rules applying to certain dangerous preparations in the Member States exhibit considerable differences as regards classification, packaging and labelling; whereas these differences constitute a barrier to trade, create unequal competition conditions and directly affect the functioning of the internal market; whereas it is therefore necessary to remove this barrier to trade by approximating the relevant legislation existing in the Member States;(3)Whereas measures for the approximation of the provisions of the Member States affecting the establishment and functioning of the internal market must, in so far as they concern health, safety and protection of man and the environment, adopt a high level of protection as a basis; whereas this Directive must, at the same time, ensure protection for the general public, and, in particular, persons who come into contact with dangerous preparations in the course of their work or in the pursuit of a hobby, protection for consumers and for the environment;(4)Whereas containers containing certain categories of dangerous preparations offered or sold to the general public must be fitted with child-resistant fastenings and/or carry a tactile warning of danger; whereas certain preparations not falling within these categories of danger may nevertheless, owing to their composition, present a danger for children; whereas the packaging of such preparations should therefore be equipped with child-resistant fastenings;(5)Whereas it is necessary to provide concentration limits expressed as a volume/volume percentage in the case of preparations marketed in gaseous form;(6)Whereas this Directive contains special labelling provisions applicable to certain preparations; whereas, to ensure an adequate level of protection for man and the environment, special labelling provisions must also be introduced for certain preparations which, although not dangerous within the meaning of this Directive, may nevertheless present a danger to the user;(7)Whereas on 30 April 1992 the Council adopted Directive 92/32/EEC amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substancesOJ L 154, 5.6.1992, p. 1.; whereas on 27 April 1993 the Commission adopted Directive 93/21/EECOJ L 110, 4.5.1993, p. 20. adapting to technical progress for the 18th time Council Directive 67/548/EEC; whereas new criteria developed for classifying and labelling substances dangerous for the environment were introduced by those Directives, together with the appropriate symbols, indications of danger, risk phrases and safety advice required to appear on labelling; whereas provisions should be adopted at Community level on the classification and labelling of preparations to take account of their effects on the environment and whereas it is therefore necessary to introduce a method for assessing the hazards of a given preparation for the environment either by a calculation method, or by determining the ecotoxicological properties by test methods under certain conditions;(8)Whereas the number of animals used for experiments should be reduced to a minimum, in accordance with the provisions of 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 purposesOJ L 358, 18.12.1986, p. 1.; whereas Article 7(2) of that Directive stipulates that an experiment shall not be performed if another scientifically satisfactory method of obtaining the results sought, not entailing the use of an animal, is reasonably and practically available; whereas, therefore, this Directive makes use of the results of assessments of toxicological and ecotoxicological properties only when these are already known and entails no obligation to conduct further experiments on animals;(9)Whereas it is necessary to define what human experience might be considered for the evaluation of the health hazards of a preparation; whereas, if clinical studies may be accepted, it is taken as given that such studies comply with the Helsinki Declaration and OECD Guidelines for Good Clinical Practice;(10)Whereas the characteristics of alloys are such that it may not be possible accurately to determine their properties using currently available conventional methods; whereas it is therefore necessary to develop a specific method of classification which takes into account their particular chemical properties; whereas the Commission, in consultation with Member States, will examine this need and submit a proposal, if appropriate, before the implementation date of this Directive;(11)Whereas classification, packaging and labelling of plant protection products covered by Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides)OJ L 206, 29.7.1978, p. 13. Directive as last amended by Council Directive 92/32/EEC. need to be revised taking into account technical and scientific developments as well as regulatory developments following implementation of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the marketOJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 96/68/EC (OJ L 277, 30.10.1996, p. 25).;(12)Whereas Directive 91/414/EEC and Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the marketOJ L 123, 24.4.1998, p. 1., in contrast to the provisions applicable to chemical preparations covered by this Directive, provide for an authorisation procedure for each product on the basis of a dossier presented by the applicant and an assessment carried out by the competent authority in each Member State; whereas furthermore that authorisation procedure includes a control relating specifically to the classification, packaging and labelling of each product before it is placed on the market; whereas it is appropriate, as part of a clear and transparent information process, to classify and label plant protection products according to the provisions of this Directive, and also to provide instructions for use in accordance with the results of the evaluation carried out in the framework of Directive 91/414/EEC and to ensure that the labelling satisfies the high level of protection sought by both this Directive and Directive 91/414/EEC; whereas, in addition, a safety data sheet has to be established for plant protectioon products in accordance with this Directive;(13)Whereas it is appropriate to provide, in relation to environmental labelling, that specific exemptions or specific provisions may be decided upon in specific cases where it can be demonstrated that the overall environmental impact of the product types in question is lower than that of corresponding product types;(14)Whereas, although munitions are not covered by this Directive, explosives marketed to produce an explosive or pyrotechnic effect may, through their chemical composition, present dangers to health; whereas it is therefore necessary as part of a transparent information process to classify them and assign to them a safety data sheet in accordance with the provisions of this Directive and also to label them in accordance with the international rules used for the transport of dangerous goods;(15)Whereas, in order to take account of certain preparations which, although they are not considered dangerous under this Directive, may nevertheless present a danger for users, it is necessary to extend certain provisions of this Directive to cover such preparations;(16)Whereas the label constitutes a basic tool for users of the dangerous preparations in so far as it provides them with the initial essential concise information; whereas it nevertheless needs to be supplemented by a two-fold system of more detailed information, consisting firstly of the safety data sheet, intended for professional users as defined by Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EECOJ L 76, 22.3.1991, p. 35. Directive as last amended by Commission Directive 93/112/EEC (OJ L 314, 16.12.1993, p. 38). and secondly of the bodies appointed by the Member States which are responsible for the provision of information solely for medical purposes, both preventive and curative;(17)Whereas, on the basis of information to be supplied by the Member States and the various parties concerned, the Commission will submit a report to the European Parliament and the Council within two years of the entry into force of this Directive on experience with the present overall approach to labelling of dangerous preparations and in particular on its understanding and application by users, experience with publicity campaigns and educational and training programmes; whereas, on the basis of this report, the Commission will, if appropriate, submit the necessary proposals;(18)Whereas it is necessary to require safety data sheets providing proportionate information on the dangers to man and the environment arising from preparations not classified as dangerous within the meaning of this Directive but containing substances classified as dangerous or having a Community exposure limit; whereas the Commission, on the basis of information submitted by Member States, will review Directive 91/155/EEC and submit proposals, if appropriate, before the expiry of the date for implementation of this Directive;(19)Whereas, in the case of preparations classified as dangerous within the meaning of this Directive, it is appropriate to permit Member States to allow certain derogations with respect to labelling where the packaging is too small, or otherwise unsuitable for labelling, or where such small packaging or such small quantities are involved that there is no reason to fear any danger to man or the environment; whereas in such cases appropriate consideration should also be given to the approximation of the relevant provisions at Community level; whereas the Commission will therefore examine the needs for harmonisation and, if appropriate, submit proposals;(20)Whereas the confidentiality of certain substances contained in the preparations should be guaranteed and whereas it is therefore necessary to institute a system which allows the person responsible for placing the preparation on the market to request confidentiality for such substances;(21)Whereas the provisions of this Directive will have regard to the commitment entered into by the Community and its Member States, in accordance with the goals for sustainable development set under Agenda 21, Chapter 19, at the UNCED conference held in June 1992 in Rio de Janeiro, to strive for the future harmonisation of systems for the classification of dangerous substances and preparations;(22)Whereas the Commission should be given the powers necessary to adapt all the Annexes to this Directive to technical progress;(23)Whereas the adoption of this Directive should not affect the obligations of the Member States concerning the deadlines for transposition into national law and for application of the Directives indicated in Annex VIII;(24)Whereas the Directives indicated in Annex VIII should be repealed, subject to certain conditions; whereas the conditions for repealing the Directives indicated in Annex VIII should be specified for Austria, Finland and Sweden in order to take account of the present level of their legislation, in particular as regards the protection of health and the protection of the environment,HAVE ADOPTED THIS DIRECTIVE:
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