Article 1 Objective
1. This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or mutagens at work. It lays down particular minimum requirements in this area, including limit values. 2. This Directive shall not apply to workers exposed only to radiation covered by the Treaty establishing the European Atomic Energy Community. 3. Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive. 4. As regards asbestos, which is dealt with by Directive 2009/148/EC of the European Parliament and of the Council ( 9 ), the provisions of this Directive shall apply whenever they are more favourable to health and safety at work.
Article 2 Definitions
For the purposes of this Directive, (a) ‘carcinogen’ means: (i) a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 10 ); (ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex; (a) ‘carcinogen’ means: (i) a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 10 ); (ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex; (b) ‘mutagen’ means: a substance or mixture which meets the criteria for classification as a category 1A or 1B germ cell mutagen set out in Annex I to Regulation (EC) No 1272/2008; (b) ‘mutagen’ means: a substance or mixture which meets the criteria for classification as a category 1A or 1B germ cell mutagen set out in Annex I to Regulation (EC) No 1272/2008; (c) ‘limit value’ means, unless otherwise specified, the limit of the time-weighted average of the concentration for a ‘carcinogen or mutagen’ in the air within the breathing zone of a worker in relation to a specified reference period as set out in Annex III to this Directive.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal This proposal aims to improve workers’ health protection by reducing occupational exposure to carcinogenic chemical agents, to increase the effectiveness of the EU legislation in this area and to provide more clarity and a better level playing field for economic operators. It is among the priority actions identified in the Commission Work Programme for 2016. With this initiative the Commission delivers on its commitment to improve the efficiency and effectiveness of an EU framework for protecting workers. The intention is also to continue this important work and to conduct further impact assessments with a view to propose limit values for additional carcinogens. Estimates of the recent and future burden of occupational diseases indicate that work-related cancer is a problem and will remain so in the future as a result of exposure of workers to carcinogens. Cancer is the first cause of work-related deaths in the EU. Annually, 53 % of occupational deaths are attributed to cancer, compared with 28% for circulatory diseases and 6% for respiratory diseases. 1 The Commission proposes to revise or to introduce exposure limit values for 13 chemical agents. According to the impact assessment, this is estimated to save around 100.000 lives by 2069. The limit values are proposed to be introduced in Directive 2004/37/EC of the European Parliament and of the Council on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (‘the Directive’). 2 In accordance with Article 16 of the Directive, the Council shall set such limit values on the basis of the available information, including scientific and technical data, in respect of all those carcinogens or mutagens for which this is possible. The provisions of the Directive apply to any chemical agent that meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 (CLP) 3 . This Regulation lists 'harmonised' (mandatory) classifications for 1017 chemical substances as Category 1 carcinogens (‘known or presumed human carcinogens’) on the basis of epidemiological and/or animal data. 4 Another important classification process, by the International Agency for Research on Cancer, has identified nearly 500 agents that are carcinogenic for humans (Group 1; 118 agents), probably carcinogenic to humans (Group 2A; 75) or possibly carcinogenic to humans (Group 2B; 288). 5 The provisions of the Directive also apply to any substance, mixture or process referred to in Annex I to that Directive, as well as to any substance or mixture released by a process referred to in that Annex. Annex I to the Directive currently includes a list of identified processes and process-generated substances. The aim is to clarify for workers, employers, and enforcers whether a given chemical agent or process, if it has not otherwise been classified according to Regulation (EC) No 1272/2008, is in the scope of the Directive. Currently, Annex I has five entries. The Directive sets a number of general minimum requirements to eliminate or reduce exposure for all carcinogens and mutagens falling under its scope. Employers must identify and assess risks to workers associated with exposure to specific carcinogens (and mutagens), and must prevent exposure where risks occur. Substitution to a non or less-hazardous process or chemical agent is required where this is technically possible. Where substitution is not technically possible chemical carcinogens must, as far as it is technically possible, be manufactured and used in a closed system to prevent exposure. Where this is not technically possible, worker exposure must be reduced to as low a level as is technically possible. This is the minimisation obligation under Article 5(2) and Article 5 (3) of the Directive. In addition to these general minimum requirements, t he Directive clearly indicates that the setting of occupational exposure limit values for the inhalation route of exposure for particular carcinogens and mutagens was an integral part of the mechanism for protecting workers. 6 Those values still need to be set for the chemical agents for which no such values exist and be revised whenever this becomes possible in the light of more recent scientific data. 7 Concrete exposure limit values for specific chemical agents are set in Annex III to the Directive. Currently, Annex III has three entries. Occupational exposure limit values set under the Directive should when appropriate be revised to take into account new scientific data, improvements in measurement techniques, risk management measures and other relevant factors. On this basis, it is proposed to take three specific measures: a. Include in Annex I to the Directive work involving exposure to respirable crystalline silica dust generated by a work process and establish a corresponding limit value in Annex III. The International Agency for Research on Cancer stated in Monograph 100C 8 , based on recent scientific evidence, that ‘crystalline silica in the form of quartz or cristobalite dust’ is carcinogenic to humans (Group 1). The Scientific Committee on Occupational Exposure Limits (SCOEL) evaluated the health effects of crystalline silica (respirable dust) on workers at work. The limit value to be introduced in Annex III proposed in this initiative and agreed by the Advisory Committee on Safety and Health at work (ACSH) reflects socio-economic feasibility factors, while maintaining the aim of ensuring the protection of workers' health. Crystalline silica placed on the market is subject to the classification obligation under Regulation (EC) No 1272/2008, while crystalline silica dust generated by a work process is not placed on the market and therefore is not classified in accordance with that Regulation. However, the Directive makes provisions for the inclusion in Annex I of substances or mixtures released by a process referred to in that Annex which, although not subject to the classification obligation in accordance with the said Regulation, meet the criteria for classification as a carcinogen. Respirable crystalline silica dust falls within this category. b. Establish in Annex III limit values for further 10 additional carcinogens. Available scientific evidence confirms the need to complete Annex III with limit values for 10 additional carcinogens. SCOEL submitted recommendations for all but two of these agents, ( o -toluidine and 2-nitropropane). For these, the Commission principally referred to scientific information available in the public domain, including to conclusions of national scientific committees that set occupational exposure limit values. The ACSH was consulted on all aspects of this proposal, in accordance with Article 2 (2) (f) of the Council Decision of 22 July 2003 9 . With regard to the values proposed, socio-economic feasibility factors have been taken into account further to the consultation of the ACSH. c. Revise the existing limit values for hardwood dusts and vinyl chloride monomer in the light of available scientific data. For two of the three existing limit values established in Annex III to the Directive, namely on work involving exposure to hardwood dust and vinyl chloride monomer, SCOEL adopted revised recommendations, in 2003 and 2004 respectively. These recommendations indicated a need to consider revising existing limit values for hardwood dusts and vinyl chloride monomer, which were estimated to be too high to properly protect workers. It is therefore appropriate to revise the current limit values for hardwood dusts and vinyl chloride monomer in the light of more recent scientific data.
Revised version (Article 2 Definitions):
For the purposes of this Directive, (a) ‘carcinogen’ means: (i) a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 2 ); (ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex; (b) ‘mutagen’ means: a substance or mixture which meets the criteria for classification as a category 1A or 1B germ cell mutagen set out in Annex I to Regulation (EC) No 1272/2008; (c) ‘limit value’ means, unless otherwise specified, the limit of the time-weighted average of the concentration for a ‘carcinogen or mutagen’ in the air within the breathing zone of a worker in relation to a specified reference period as set out in Annex III to this Directive.
Article 3 Scope — determination and assessment of risks
1. This Directive shall apply to activities in which workers are or are likely to be exposed to carcinogens or mutagens as a result of their work. 2. In the case of any activity likely to involve a risk of exposure to carcinogens or mutagens, the nature, degree and duration of workers' exposure shall be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken. The assessment shall be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to carcinogens or mutagens. The employer shall supply the authorities responsible at their request with the information used for making the assessment. 3. When assessing the risk, account shall be taken of all other routes of exposure, such as absorption into and/or through the skin. 4. When the risk assessment is carried out, employers shall give particular attention to any effects concerning the health or safety of workers at particular risk and shall, inter alia, take account of the desirability of not employing such workers in areas where they may come into contact with carcinogens or mutagens.
Article 4 Reduction and replacement
1. The employer shall reduce the use of a carcinogen or mutagen at the place of work, in particular by replacing it, in so far as is technically possible, by a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous to workers' health or safety, as the case may be. 2. The employer shall, upon request, submit the findings of his investigations to the relevant authorities.
Article 5 Prevention and reduction of exposure
1. Where the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, workers' exposure must be prevented. 2. Where it is not technically possible to replace the carcinogen or mutagen by a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous to health or safety, the employer shall ensure that the carcinogen or mutagen is, in so far as is technically possible, manufactured and used in a closed system. 3. Where a closed system is not technically possible, the employer shall ensure that the level of exposure of workers is reduced to as low a level as is technically possible. 4. Exposure shall not exceed the limit value of a carcinogen as set out in Annex III. 5. Wherever a carcinogen or mutagen is used, the employer shall apply all the following measures: (a) limitation of the quantities of a carcinogen or mutagen at the place of work; (b) keeping as low as possible the number of workers exposed or likely to be exposed; (c) design of work processes and engineering control measures so as to avoid or minimise the release of carcinogens or mutagens into the place of work; (d) evacuation of carcinogens or mutagens at source, local extraction system or general ventilation, all such methods to be appropriate and compatible with the need to protect public health and the environment; (e) use of existing appropriate procedures for the measurement of carcinogens or mutagens, in particular for the early detection of abnormal exposures resulting from an unforeseeable event or an accident; (f) application of suitable working procedures and methods; (g) collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures; (h) hygiene measures, in particular regular cleaning of floors, walls and other surfaces; (i) information for workers; (j) demarcation of risk areas and use of adequate warning and safety signs including ‘no smoking’ signs in areas where workers are exposed or likely to be exposed to carcinogens or mutagens; (k) drawing up plans to deal with emergencies likely to result in abnormally high exposure; (l) means for safe storage, handling and transportation, in particular by using sealed and clearly and visibly labelled containers; (m) means for safe collection, storage and disposal of waste by workers, including the use of sealed and clearly and visibly labelled containers.
Article 6 Information for the competent authority
Where the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on: (a) the activities and/or industrial processes carried out, including the reasons for which carcinogens or mutagens are used; (b) the quantities of substances or mixtures manufactured or used which contain carcinogens or mutagens; (c) the number of workers exposed; (d) the preventive measures taken; (e) the type of protective equipment used; (f) the nature and degree of exposure; (g) the cases of replacement.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal This proposal aims to improve workers’ health protection by reducing occupational exposure to carcinogenic chemical agents, to increase the effectiveness of the EU legislation in this area and to provide more clarity and a better level playing field for economic operators. It is among the priority actions identified in the Commission Work Programme for 2016. With this initiative the Commission delivers on its commitment to improve the efficiency and effectiveness of an EU framework for protecting workers. The intention is also to continue this important work and to conduct further impact assessments with a view to propose limit values for additional carcinogens. Estimates of the recent and future burden of occupational diseases indicate that work-related cancer is a problem and will remain so in the future as a result of exposure of workers to carcinogens. Cancer is the first cause of work-related deaths in the EU. Annually, 53 % of occupational deaths are attributed to cancer, compared with 28% for circulatory diseases and 6% for respiratory diseases. 1 The Commission proposes to revise or to introduce exposure limit values for 13 chemical agents. According to the impact assessment, this is estimated to save around 100.000 lives by 2069. The limit values are proposed to be introduced in Directive 2004/37/EC of the European Parliament and of the Council on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (‘the Directive’). 2 In accordance with Article 16 of the Directive, the Council shall set such limit values on the basis of the available information, including scientific and technical data, in respect of all those carcinogens or mutagens for which this is possible. The provisions of the Directive apply to any chemical agent that meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 (CLP) 3 . This Regulation lists 'harmonised' (mandatory) classifications for 1017 chemical substances as Category 1 carcinogens (‘known or presumed human carcinogens’) on the basis of epidemiological and/or animal data. 4 Another important classification process, by the International Agency for Research on Cancer, has identified nearly 500 agents that are carcinogenic for humans (Group 1; 118 agents), probably carcinogenic to humans (Group 2A; 75) or possibly carcinogenic to humans (Group 2B; 288). 5 The provisions of the Directive also apply to any substance, mixture or process referred to in Annex I to that Directive, as well as to any substance or mixture released by a process referred to in that Annex. Annex I to the Directive currently includes a list of identified processes and process-generated substances. The aim is to clarify for workers, employers, and enforcers whether a given chemical agent or process, if it has not otherwise been classified according to Regulation (EC) No 1272/2008, is in the scope of the Directive. Currently, Annex I has five entries. The Directive sets a number of general minimum requirements to eliminate or reduce exposure for all carcinogens and mutagens falling under its scope. Employers must identify and assess risks to workers associated with exposure to specific carcinogens (and mutagens), and must prevent exposure where risks occur. Substitution to a non or less-hazardous process or chemical agent is required where this is technically possible. Where substitution is not technically possible chemical carcinogens must, as far as it is technically possible, be manufactured and used in a closed system to prevent exposure. Where this is not technically possible, worker exposure must be reduced to as low a level as is technically possible. This is the minimisation obligation under Article 5(2) and Article 5 (3) of the Directive. In addition to these general minimum requirements, t he Directive clearly indicates that the setting of occupational exposure limit values for the inhalation route of exposure for particular carcinogens and mutagens was an integral part of the mechanism for protecting workers. 6 Those values still need to be set for the chemical agents for which no such values exist and be revised whenever this becomes possible in the light of more recent scientific data. 7 Concrete exposure limit values for specific chemical agents are set in Annex III to the Directive. Currently, Annex III has three entries. Occupational exposure limit values set under the Directive should when appropriate be revised to take into account new scientific data, improvements in measurement techniques, risk management measures and other relevant factors. On this basis, it is proposed to take three specific measures: a. Include in Annex I to the Directive work involving exposure to respirable crystalline silica dust generated by a work process and establish a corresponding limit value in Annex III. The International Agency for Research on Cancer stated in Monograph 100C 8 , based on recent scientific evidence, that ‘crystalline silica in the form of quartz or cristobalite dust’ is carcinogenic to humans (Group 1). The Scientific Committee on Occupational Exposure Limits (SCOEL) evaluated the health effects of crystalline silica (respirable dust) on workers at work. The limit value to be introduced in Annex III proposed in this initiative and agreed by the Advisory Committee on Safety and Health at work (ACSH) reflects socio-economic feasibility factors, while maintaining the aim of ensuring the protection of workers' health. Crystalline silica placed on the market is subject to the classification obligation under Regulation (EC) No 1272/2008, while crystalline silica dust generated by a work process is not placed on the market and therefore is not classified in accordance with that Regulation. However, the Directive makes provisions for the inclusion in Annex I of substances or mixtures released by a process referred to in that Annex which, although not subject to the classification obligation in accordance with the said Regulation, meet the criteria for classification as a carcinogen. Respirable crystalline silica dust falls within this category. b. Establish in Annex III limit values for further 10 additional carcinogens. Available scientific evidence confirms the need to complete Annex III with limit values for 10 additional carcinogens. SCOEL submitted recommendations for all but two of these agents, ( o -toluidine and 2-nitropropane). For these, the Commission principally referred to scientific information available in the public domain, including to conclusions of national scientific committees that set occupational exposure limit values. The ACSH was consulted on all aspects of this proposal, in accordance with Article 2 (2) (f) of the Council Decision of 22 July 2003 9 . With regard to the values proposed, socio-economic feasibility factors have been taken into account further to the consultation of the ACSH. c. Revise the existing limit values for hardwood dusts and vinyl chloride monomer in the light of available scientific data. For two of the three existing limit values established in Annex III to the Directive, namely on work involving exposure to hardwood dust and vinyl chloride monomer, SCOEL adopted revised recommendations, in 2003 and 2004 respectively. These recommendations indicated a need to consider revising existing limit values for hardwood dusts and vinyl chloride monomer, which were estimated to be too high to properly protect workers. It is therefore appropriate to revise the current limit values for hardwood dusts and vinyl chloride monomer in the light of more recent scientific data.
Revised version (Article 6 Information for the competent authority):
Where the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on: (a) the activities and/or industrial processes carried out, including the reasons for which carcinogens or mutagens are used; (b) the quantities of substances or mixtures manufactured or used which contain carcinogens or mutagens; (c) the number of workers exposed; (d) the preventive measures taken; (e) the type of protective equipment used; (f) the nature and degree of exposure; (g) the cases of replacement. The Member States shall take into account the information under points (a) to (g) of the first paragraph of this Article in their reports submitted to the Commission under Article 17a of Directive 89/391/EEC.
Article 7 Unforeseen exposure
1. In the event of an unforeseeable event or an accident which is likely to result in an abnormal exposure of workers, the employer shall inform the workers thereof. 2. Until the situation has been restored to normal and the causes of the abnormal exposure have been eliminated: (a) only those workers who are essential to the carrying out of repairs and other necessary work shall be permitted to work in the affected area; (b) the workers concerned shall be provided with protective clothing and individual respiratory protection equipment which they must wear; the exposure may not be permanent and shall be kept to the strict minimum of time necessary for each worker; (c) unprotected workers shall not be allowed to work in the affected area.
Article 8 Foreseeable exposure
1. For certain activities such as maintenance, in respect of which it is foreseeable that there is the potential for a significant increase in exposure of workers, and in respect of which all scope for further technical preventive measures for limiting workers' exposure has already been exhausted, the employer shall determine, after consultation of the workers and/or their representatives in the undertaking or establishment, without prejudice to the employer's responsibility, the measures necessary to reduce the duration of workers' exposure to the minimum possible and to ensure protection of workers while they are engaged in such activities. Pursuant to the first subparagraph, the workers concerned shall be provided with protective clothing and individual respiratory protection equipment which they must wear as long as the abnormal exposure persists; that exposure may not be permanent and shall be kept to the strict minimum of time necessary for each worker. 2. Appropriate measures shall be taken to ensure that the areas in which the activities referred to in the first subparagraph of paragraph 1 take place are clearly demarcated and indicated or that unauthorised persons are prevented by other means from having access to such areas.
Article 9 Access to risk areas
Appropriate measures shall be taken by employers to ensure that access to areas in which the activities in respect of which the results of the assessment referred to in Article 3(2) reveal a risk to workers' safety or health take place are accessible solely to workers who, by reason of their work or duties, are required to enter them.
Article 10 Hygiene and individual protection
1. Employers shall be obliged, in the case of all activities for which there is a risk of contamination by carcinogens or mutagens, to take appropriate measures to ensure that: (a) workers do not eat, drink or smoke in working areas where there is a risk of contamination by carcinogens or mutagens; (b) workers are provided with appropriate protective clothing or other appropriate special clothing; (c) separate storage places are provided for working or protective clothing and for street clothes; (d) workers are provided with appropriate and adequate washing and toilet facilities; (e) protective equipment is properly stored in a well-defined place and is checked and cleaned if possible before, and in any case after, each use; (f) defective equipment is repaired or replaced before further use. 2. Workers may not be charged for the cost of the measures set out in paragraph 1.
Article 11 Information and training of workers
1. Appropriate measures shall be taken by the employer to ensure that workers and/or workers' representatives in the undertaking or establishment receive sufficient and appropriate training, on the basis of all available information, in particular in the form of information and instructions, concerning: (a) potential risks to health, including the additional risks due to tobacco consumption; (b) precautions to be taken to prevent exposure; (c) hygiene requirements; (d) wearing and use of protective equipment and clothing; (e) steps to be taken by workers, including rescue workers, in the case of incidents and to prevent incidents. The training shall be: — adapted to take account of new or changed risk, and — repeated periodically if necessary. 2. Employers shall inform workers of installations and related containers containing carcinogens or mutagens, ensure that all containers, packages and installations containing carcinogens or mutagens are labelled clearly and legibly, and display clearly visible warning and hazard signs.
Article 12 Information for workers
Appropriate measures shall be taken to ensure that: (a) workers and/or any workers' representatives in the undertaking or establishment can check that this Directive is applied or can be involved in its application, in particular with regard to: (i) the consequences for workers' safety and health of the selection, wearing and use of protective clothing and equipment, without prejudice to the employer's responsibility for determining the effectiveness of protective clothing and equipment; (ii) the measures determined by the employer which are referred to in the first subparagraph of Article 8(1), without prejudice to the employer's responsibility for determining such measures; (a) workers and/or any workers' representatives in the undertaking or establishment can check that this Directive is applied or can be involved in its application, in particular with regard to: (i) the consequences for workers' safety and health of the selection, wearing and use of protective clothing and equipment, without prejudice to the employer's responsibility for determining the effectiveness of protective clothing and equipment; (ii) the measures determined by the employer which are referred to in the first subparagraph of Article 8(1), without prejudice to the employer's responsibility for determining such measures; (b) workers and/or any workers' representatives in the undertaking or establishment are informed as quickly as possible of abnormal exposures, including those referred to in Article 8, of the causes thereof and of the measures taken or to be taken to rectify the situation; (c) the employer keeps an up-to-date list of the workers engaged in the activities in respect of which the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, indicating, if the information is available, the exposure to which they have been subjected; (d) the doctor and/or the competent authority as well as all other persons who have responsibility for health and safety at work have access to the list referred to in point (c); (e) each worker has access to the information on the list which relates to him personally; (f) workers and/or any workers' representatives in the undertaking or establishment have access to anonymous collective information.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal This proposal aims to improve workers’ health protection by reducing occupational exposure to carcinogenic chemical agents, to increase the effectiveness of the EU legislation in this area and to provide more clarity and a better level playing field for economic operators. It is among the priority actions identified in the Commission Work Programme for 2016. With this initiative the Commission delivers on its commitment to improve the efficiency and effectiveness of an EU framework for protecting workers. The intention is also to continue this important work and to conduct further impact assessments with a view to propose limit values for additional carcinogens. Estimates of the recent and future burden of occupational diseases indicate that work-related cancer is a problem and will remain so in the future as a result of exposure of workers to carcinogens. Cancer is the first cause of work-related deaths in the EU. Annually, 53 % of occupational deaths are attributed to cancer, compared with 28% for circulatory diseases and 6% for respiratory diseases. 1 The Commission proposes to revise or to introduce exposure limit values for 13 chemical agents. According to the impact assessment, this is estimated to save around 100.000 lives by 2069. The limit values are proposed to be introduced in Directive 2004/37/EC of the European Parliament and of the Council on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (‘the Directive’). 2 In accordance with Article 16 of the Directive, the Council shall set such limit values on the basis of the available information, including scientific and technical data, in respect of all those carcinogens or mutagens for which this is possible. The provisions of the Directive apply to any chemical agent that meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 (CLP) 3 . This Regulation lists 'harmonised' (mandatory) classifications for 1017 chemical substances as Category 1 carcinogens (‘known or presumed human carcinogens’) on the basis of epidemiological and/or animal data. 4 Another important classification process, by the International Agency for Research on Cancer, has identified nearly 500 agents that are carcinogenic for humans (Group 1; 118 agents), probably carcinogenic to humans (Group 2A; 75) or possibly carcinogenic to humans (Group 2B; 288). 5 The provisions of the Directive also apply to any substance, mixture or process referred to in Annex I to that Directive, as well as to any substance or mixture released by a process referred to in that Annex. Annex I to the Directive currently includes a list of identified processes and process-generated substances. The aim is to clarify for workers, employers, and enforcers whether a given chemical agent or process, if it has not otherwise been classified according to Regulation (EC) No 1272/2008, is in the scope of the Directive. Currently, Annex I has five entries. The Directive sets a number of general minimum requirements to eliminate or reduce exposure for all carcinogens and mutagens falling under its scope. Employers must identify and assess risks to workers associated with exposure to specific carcinogens (and mutagens), and must prevent exposure where risks occur. Substitution to a non or less-hazardous process or chemical agent is required where this is technically possible. Where substitution is not technically possible chemical carcinogens must, as far as it is technically possible, be manufactured and used in a closed system to prevent exposure. Where this is not technically possible, worker exposure must be reduced to as low a level as is technically possible. This is the minimisation obligation under Article 5(2) and Article 5 (3) of the Directive. In addition to these general minimum requirements, t he Directive clearly indicates that the setting of occupational exposure limit values for the inhalation route of exposure for particular carcinogens and mutagens was an integral part of the mechanism for protecting workers. 6 Those values still need to be set for the chemical agents for which no such values exist and be revised whenever this becomes possible in the light of more recent scientific data. 7 Concrete exposure limit values for specific chemical agents are set in Annex III to the Directive. Currently, Annex III has three entries. Occupational exposure limit values set under the Directive should when appropriate be revised to take into account new scientific data, improvements in measurement techniques, risk management measures and other relevant factors. On this basis, it is proposed to take three specific measures: a. Include in Annex I to the Directive work involving exposure to respirable crystalline silica dust generated by a work process and establish a corresponding limit value in Annex III. The International Agency for Research on Cancer stated in Monograph 100C 8 , based on recent scientific evidence, that ‘crystalline silica in the form of quartz or cristobalite dust’ is carcinogenic to humans (Group 1). The Scientific Committee on Occupational Exposure Limits (SCOEL) evaluated the health effects of crystalline silica (respirable dust) on workers at work. The limit value to be introduced in Annex III proposed in this initiative and agreed by the Advisory Committee on Safety and Health at work (ACSH) reflects socio-economic feasibility factors, while maintaining the aim of ensuring the protection of workers' health. Crystalline silica placed on the market is subject to the classification obligation under Regulation (EC) No 1272/2008, while crystalline silica dust generated by a work process is not placed on the market and therefore is not classified in accordance with that Regulation. However, the Directive makes provisions for the inclusion in Annex I of substances or mixtures released by a process referred to in that Annex which, although not subject to the classification obligation in accordance with the said Regulation, meet the criteria for classification as a carcinogen. Respirable crystalline silica dust falls within this category. b. Establish in Annex III limit values for further 10 additional carcinogens. Available scientific evidence confirms the need to complete Annex III with limit values for 10 additional carcinogens. SCOEL submitted recommendations for all but two of these agents, ( o -toluidine and 2-nitropropane). For these, the Commission principally referred to scientific information available in the public domain, including to conclusions of national scientific committees that set occupational exposure limit values. The ACSH was consulted on all aspects of this proposal, in accordance with Article 2 (2) (f) of the Council Decision of 22 July 2003 9 . With regard to the values proposed, socio-economic feasibility factors have been taken into account further to the consultation of the ACSH. c. Revise the existing limit values for hardwood dusts and vinyl chloride monomer in the light of available scientific data. For two of the three existing limit values established in Annex III to the Directive, namely on work involving exposure to hardwood dust and vinyl chloride monomer, SCOEL adopted revised recommendations, in 2003 and 2004 respectively. These recommendations indicated a need to consider revising existing limit values for hardwood dusts and vinyl chloride monomer, which were estimated to be too high to properly protect workers. It is therefore appropriate to revise the current limit values for hardwood dusts and vinyl chloride monomer in the light of more recent scientific data.
Revised version (Article 12 Information for workers):
Appropriate measures shall be taken to ensure that: (a) workers and/or any workers' representatives in the undertaking or establishment can check that this Directive is applied or can be involved in its application, in particular with regard to: (i) the consequences for workers' safety and health of the selection, wearing and use of protective clothing and equipment, without prejudice to the employer's responsibility for determining the effectiveness of protective clothing and equipment; (ii) the measures determined by the employer which are referred to in the first subparagraph of Article 8(1), without prejudice to the employer's responsibility for determining such measures; (b) workers and/or any workers' representatives in the undertaking or establishment are informed as quickly as possible of abnormal exposures, including those referred to in Article 8, of the causes thereof and of the measures taken or to be taken to rectify the situation; (c) the employer keeps an up-to-date list of the workers engaged in the activities in respect of which the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, indicating, if the information is available, the exposure to which they have been subjected; (d) the doctor and/or the competent authority as well as all other persons who have responsibility for health and safety at work have access to the list referred to in point (c); (e) each worker has access to the information on the list which relates to him personally; (f) workers and/or any workers' representatives in the undertaking or establishment have access to anonymous collective information.
Article 13 Consultation and participation of workers
Consultation and participation of workers and/or their representatives in connection with matters covered by this Directive shall take place in accordance with Article 11 of Directive 89/391/EEC.
Article 14 Health surveillance
1. The Member States shall establish, in accordance with national laws and/or practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment referred to in Article 3(2) reveal a risk to health or safety. 2. The arrangements referred to in paragraph 1 shall be such that each worker shall be able to undergo, if appropriate, relevant health surveillance: — prior to exposure, — at regular intervals thereafter. Those arrangements shall be such that it is directly possible to implement individual and occupational hygiene measures. 3. If a worker is found to be suffering from an abnormality which is suspected to be the result of exposure to carcinogens or mutagens, the doctor or authority responsible for the health surveillance of workers may require other workers who have been similarly exposed to undergo health surveillance. In that event, a reassessment of the risk of exposure shall be carried out in accordance with Article 3(2). 4. In cases where health surveillance is carried out, an individual medical record shall be kept and the doctor or authority responsible for health surveillance shall propose any protective or preventive measures to be taken in respect of any individual workers. 5. Information and advice must be given to workers regarding any health surveillance which they may undergo following the end of exposure. 6. In accordance with national laws and/or practice: — workers shall have access to the results of the health surveillance which concern them, and — the workers concerned or the employer may request a review of the results of the health surveillance. 7. Practical recommendations for the health surveillance of workers are given in Annex II. 8. All cases of cancer identified in accordance with national laws and/or practice as resulting from occupational exposure to a carcinogen or mutagen shall be notified to the competent authority.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal This proposal aims to improve workers’ health protection by reducing occupational exposure to carcinogenic chemical agents, to increase the effectiveness of the EU legislation in this area and to provide more clarity and a better level playing field for economic operators. It is among the priority actions identified in the Commission Work Programme for 2016. With this initiative the Commission delivers on its commitment to improve the efficiency and effectiveness of an EU framework for protecting workers. The intention is also to continue this important work and to conduct further impact assessments with a view to propose limit values for additional carcinogens. Estimates of the recent and future burden of occupational diseases indicate that work-related cancer is a problem and will remain so in the future as a result of exposure of workers to carcinogens. Cancer is the first cause of work-related deaths in the EU. Annually, 53 % of occupational deaths are attributed to cancer, compared with 28% for circulatory diseases and 6% for respiratory diseases. 1 The Commission proposes to revise or to introduce exposure limit values for 13 chemical agents. According to the impact assessment, this is estimated to save around 100.000 lives by 2069. The limit values are proposed to be introduced in Directive 2004/37/EC of the European Parliament and of the Council on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (‘the Directive’). 2 In accordance with Article 16 of the Directive, the Council shall set such limit values on the basis of the available information, including scientific and technical data, in respect of all those carcinogens or mutagens for which this is possible. The provisions of the Directive apply to any chemical agent that meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 (CLP) 3 . This Regulation lists 'harmonised' (mandatory) classifications for 1017 chemical substances as Category 1 carcinogens (‘known or presumed human carcinogens’) on the basis of epidemiological and/or animal data. 4 Another important classification process, by the International Agency for Research on Cancer, has identified nearly 500 agents that are carcinogenic for humans (Group 1; 118 agents), probably carcinogenic to humans (Group 2A; 75) or possibly carcinogenic to humans (Group 2B; 288). 5 The provisions of the Directive also apply to any substance, mixture or process referred to in Annex I to that Directive, as well as to any substance or mixture released by a process referred to in that Annex. Annex I to the Directive currently includes a list of identified processes and process-generated substances. The aim is to clarify for workers, employers, and enforcers whether a given chemical agent or process, if it has not otherwise been classified according to Regulation (EC) No 1272/2008, is in the scope of the Directive. Currently, Annex I has five entries. The Directive sets a number of general minimum requirements to eliminate or reduce exposure for all carcinogens and mutagens falling under its scope. Employers must identify and assess risks to workers associated with exposure to specific carcinogens (and mutagens), and must prevent exposure where risks occur. Substitution to a non or less-hazardous process or chemical agent is required where this is technically possible. Where substitution is not technically possible chemical carcinogens must, as far as it is technically possible, be manufactured and used in a closed system to prevent exposure. Where this is not technically possible, worker exposure must be reduced to as low a level as is technically possible. This is the minimisation obligation under Article 5(2) and Article 5 (3) of the Directive. In addition to these general minimum requirements, t he Directive clearly indicates that the setting of occupational exposure limit values for the inhalation route of exposure for particular carcinogens and mutagens was an integral part of the mechanism for protecting workers. 6 Those values still need to be set for the chemical agents for which no such values exist and be revised whenever this becomes possible in the light of more recent scientific data. 7 Concrete exposure limit values for specific chemical agents are set in Annex III to the Directive. Currently, Annex III has three entries. Occupational exposure limit values set under the Directive should when appropriate be revised to take into account new scientific data, improvements in measurement techniques, risk management measures and other relevant factors. On this basis, it is proposed to take three specific measures: a. Include in Annex I to the Directive work involving exposure to respirable crystalline silica dust generated by a work process and establish a corresponding limit value in Annex III. The International Agency for Research on Cancer stated in Monograph 100C 8 , based on recent scientific evidence, that ‘crystalline silica in the form of quartz or cristobalite dust’ is carcinogenic to humans (Group 1). The Scientific Committee on Occupational Exposure Limits (SCOEL) evaluated the health effects of crystalline silica (respirable dust) on workers at work. The limit value to be introduced in Annex III proposed in this initiative and agreed by the Advisory Committee on Safety and Health at work (ACSH) reflects socio-economic feasibility factors, while maintaining the aim of ensuring the protection of workers' health. Crystalline silica placed on the market is subject to the classification obligation under Regulation (EC) No 1272/2008, while crystalline silica dust generated by a work process is not placed on the market and therefore is not classified in accordance with that Regulation. However, the Directive makes provisions for the inclusion in Annex I of substances or mixtures released by a process referred to in that Annex which, although not subject to the classification obligation in accordance with the said Regulation, meet the criteria for classification as a carcinogen. Respirable crystalline silica dust falls within this category. b. Establish in Annex III limit values for further 10 additional carcinogens. Available scientific evidence confirms the need to complete Annex III with limit values for 10 additional carcinogens. SCOEL submitted recommendations for all but two of these agents, ( o -toluidine and 2-nitropropane). For these, the Commission principally referred to scientific information available in the public domain, including to conclusions of national scientific committees that set occupational exposure limit values. The ACSH was consulted on all aspects of this proposal, in accordance with Article 2 (2) (f) of the Council Decision of 22 July 2003 9 . With regard to the values proposed, socio-economic feasibility factors have been taken into account further to the consultation of the ACSH. c. Revise the existing limit values for hardwood dusts and vinyl chloride monomer in the light of available scientific data. For two of the three existing limit values established in Annex III to the Directive, namely on work involving exposure to hardwood dust and vinyl chloride monomer, SCOEL adopted revised recommendations, in 2003 and 2004 respectively. These recommendations indicated a need to consider revising existing limit values for hardwood dusts and vinyl chloride monomer, which were estimated to be too high to properly protect workers. It is therefore appropriate to revise the current limit values for hardwood dusts and vinyl chloride monomer in the light of more recent scientific data.
Revised version (Article 14 Health surveillance):
1. The Member States shall establish, in accordance with national law or practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment referred to in Article 3(2) reveal a risk to health or safety. The doctor or authority responsible for the health surveillance of workers may indicate that health surveillance must continue after the end of exposure for as long as they consider it to be necessary to safeguard the health of the worker concerned. 2. The arrangements referred to in paragraph 1 shall be such that each worker shall be able to undergo, if appropriate, relevant health surveillance: — prior to exposure, — at regular intervals thereafter. Those arrangements shall be such that it is directly possible to implement individual and occupational hygiene measures. 3. If a worker is found to be suffering from an abnormality which is suspected to be the result of exposure to carcinogens or mutagens, the doctor or authority responsible for the health surveillance of workers may require other workers who have been similarly exposed to undergo health surveillance. In that event, a reassessment of the risk of exposure shall be carried out in accordance with Article 3(2). 4. In cases where health surveillance is carried out, an individual medical record shall be kept and the doctor or authority responsible for health surveillance shall propose any protective or preventive measures to be taken in respect of any individual workers. 5. Information and advice must be given to workers regarding any health surveillance which they may undergo following the end of exposure. 6. In accordance with national laws and/or practice: — workers shall have access to the results of the health surveillance which concern them, and — the workers concerned or the employer may request a review of the results of the health surveillance. 7. Practical recommendations for the health surveillance of workers are given in Annex II. 8. All cases of cancer identified in accordance with national law or practice as resulting from occupational exposure to a carcinogen or mutagen shall be notified to the competent authority. The Member States shall take into account the information under this paragraph in their reports submitted to the Commission under Article 17a of Directive 89/391/EEC.
Article 15 Record keeping
1. The list referred to in point (c) of Article 12 and the medical record referred to in Article 14(4) shall be kept for at least 40 years following the end of exposure, in accordance with national laws and/or practice. 2. Those documents shall be made available to the responsible authority in cases where the undertaking ceases activity, in accordance with national laws and/or practice.
Article 16 Limit values
1. The Council shall, in accordance with the procedure laid down in Article 137(2) of the Treaty, set out limit values in Directives on the basis of the available information, including scientific and technical data, in respect of all those carcinogens or mutagens for which this is possible, and, where necessary, other directly related provisions. 2. Limit values and other directly related provisions are set out in Annex III.
Article 17 Annexes
1. Annexes I and III may be amended in accordance only with the procedure laid down in Article 137(2) of the Treaty. 2. Purely technical adjustments to Annex II in the light of technical progress, changes in international regulations or specifications and new findings in the field of carcinogens or mutagens shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC.
Article 18 Use of data
The Commission shall have access to the use made by the competent national authorities of the information referred to in Article 14(8).
Article 19 Notifying the Commission
Member States shall communicate to the Commission the provisions of national law which they adopt in the future in the field governed by this Directive.
Article 20 Repeal
Directive 90/394/EEC, as amended by the Directives referred to in Annex IV, Part A of this Directive is repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition set out in Annex IV, Part B of this Directive. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex V.
Article 21 Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 22 Addressees
This Directive is addressed to the Member States.