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1.This Directive, which is the fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, lays down minimum requirements for the protection of workers from risks to their safety and health arising, or likely to arise, from the effects of chemical agents that are present at the workplace or as a result of any work activity involving chemical agents.
2.The requirements of this Directive apply where hazardous chemical agents are present or may be present at the workplace, without prejudice to the provisions for chemical agents to which measures for radiation protection apply pursuant to Directives adopted under the Treaty establishing the European Atomic Energy Community.
3.For carcinogens at work the provisions of this Directive shall apply without prejudice to more stringent and/or specific provisions contained in Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens (sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(1).
4.The provisions of Directive 89/391/EEC shall apply fully to the whole field referred to in this Article, without prejudice to more stringent and/or specific provisions contained in this Directive.
5.As far as the transport of hazardous chemical agents is concerned, the provisions of this Directive shall apply without prejudice to more stringent and/or specific provisions contained in Directive 94/55/EC(2), in Directive 96/49/EC(3), in the provisions of the IMDG Code, IBC Code and IGC Code as defined in Article 2 of Directive 93/75/EEC(4), in the provisions of the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterway and of the Regulation for the Carriage of Dangerous Substances on the Rhine as incorporated in Community law and in the technical instructions for the safe transport of dangerous goods issued, at the date of entry into force of this Directive, by the International Civil Aviation Organisation.
For the purpose of this Directive, the terms used shall have the following meanings:
‘Chemical agent’ means any chemical element or compound, on its own or admixed, as it occurs in the natural state or as produced, used or released, including release as waste, by any work activity, whether or not produced intentionally and whether or not placed on the market;
‘Hazardous chemical agent’ means:
[F1any chemical agent which meets the criteria for classification as hazardous within any physical and/or health hazard classes laid down in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5) , whether or not that chemical agent is classified under that Regulation;]
[F2. . . . .]
[F1any chemical agent which, whilst not meeting the criteria for classification as hazardous in accordance with point (i) of point (b) of this Article may, because of its physico-chemical, chemical or toxicological properties and the way it is used or is present in the workplace, present a risk to the safety and health of workers, including any chemical agent that is assigned an occupational exposure limit value under Article 3;]
‘Activity involving chemical agents’ means any work in which chemical agents are used, or are intended to be used, in any process, including production, handling, storage, transport or disposal and treatment, or which result from such work;
‘Occupational exposure limit value’ means, unless otherwise specified, the limit of the time-weighted average of the concentration of a chemical agent in the air within the breathing zone of a worker in relation to a specified reference period;
‘Biological limit value’ means the limit of the concentration in the appropriate biological medium of the relevant agent, its metabolite, or an indicator of effect;
‘Health surveillance’ means the assessment of an individual worker to determine the state of health of that individual, as related to exposure to specific chemical agents at work;
‘Hazard’ means the intrinsic property of a chemical agent with the potential to cause harm;
‘Risk’ means the likelihood that the potential for harm will be attained under the conditions of use and/or exposure.
Textual Amendments
F1 Substituted by Directive 2014/27/EU of the European Parliament and of the Council of 26 February 2014 amending Council Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council, in order to align them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
F2 Deleted by Directive 2014/27/EU of the European Parliament and of the Council of 26 February 2014 amending Council Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council, in order to align them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
1.The Commission shall evaluate the relationship between the health effects of hazardous chemical agents and the level of occupational exposure by means of an independent scientific assessment of the latest available scientific data.
2.On the basis of the evaluation described in paragraph 1, the Commission, after first consulting the Advisory Committee on Safety, Hygiene and Health protection at Work, shall propose European objectives in the form of indicative occupational exposure limit values for the protection of workers from chemical risks, to be set at Community level.
[F3The Commission is empowered to adopt delegated acts in accordance with Article 12a in order to supplement this Directive by establishing or revising the indicative occupational exposure limit values referred to in the first subparagraph of this paragraph, taking into account the availability of measurement techniques.
Member States shall keep workers’ and employers’ organisations informed of indicative occupational exposure limit values set at Union level.
Where, in duly justified and exceptional cases involving imminent, direct and serious risks to workers’ and other persons’ physical health and safety, imperative grounds of urgency require action in a very short timeframe, the procedure provided for in Article 12b shall apply to delegated acts adopted pursuant to this Article.]
3.For any chemical agent for which an indicative occupational exposure limit value is established at Community level, Member States shall establish a national occupational exposure limit value, taking into account the Community limit value, determining its nature in accordance with national legislation and practice.
4.Binding occupational exposure limit values may be drawn up at Community level and, in addition to the factors considered when establishing indicative occupational exposure limit values, shall reflect feasibility factors while maintaining the aim of ensuring the health of workers at work. Such limit values shall be established in accordance with Article 118a of the Treaty and laid down in Annex I to this Directive.
5.For any chemical agent for which a binding occupational exposure limit value is established. Member States shall establish a corresponding national binding occupational exposure limit value based on, but not exceeding, the Community limit value.
6.Binding biological limit values may be drawn up at Community level on the basis of the evaluation described in paragraph 1 and of the availability of measurement techniques, and shall reflect feasibility factors while maintaining the aim of ensuring the health of workers at work. Such limit values shall be established in accordance with the procedure laid down in Article 118a of the Treaty and laid down in Annex II to this Directive, together with other relevant health surveillance information.
7.For any chemical agent for which a binding biological limit value is established, Member States shall establish a corresponding national binding biological limit value based on, but not exceeding, the Community limit value.
8.Where a Member State introduces or revises a national occupational exposure limit value or a national biological limit value for a chemical agent, it shall inform the Commission and other Member States thereof together with the relevant scientific and technical data. The Commission shall undertake the appropriate action.
9.On the basis of the reports provided by the Member States under Article 15, the Commission shall carry out an assessment of the way in which Member States have taken account of Community indicative limit values when establishing the corresponding national occupational exposure limit values.
10.Standardised methods for the measurement and evaluation of workplace air concentrations in relation to occupational exposure limit values shall be developed in accordance with Article 12(2).
Textual Amendments
F3 Substituted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).
Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (OJ L 319, 12.12.1994, p. 7). Directive as amended by Commission Directive 96/86/EC (OJ L 335, 24.12.1996, p. 43).
Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (OJ L 235, 17.9.1996, p. 25). Directive as amended by Commission Directive 96/87/EC (OJ L 335, 24.12.1996, p. 45).
Council Directive 93/75/EEC of 13 September 1993 concerning minimum requirements for vessels bound for or leaving Community ports and carrying dangerous or polluting goods (OJ L 247, 5.10.1993, p. 19). Directive as last amended by Commission Directive 97/34/EC (OJ L 158, 17.6.1997, p. 40).
[F1Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 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 ( OJ L 353, 31.12.2008, p. 1 ).]
Textual Amendments
F1 Substituted by Directive 2014/27/EU of the European Parliament and of the Council of 26 February 2014 amending Council Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council, in order to align them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.