EN 1 EN 1. INTRODUCTION

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2 . SECOND STAGE OF CONSULTATION OF THE SOCIAL PARTNERS ON THE PROTECTION OF WORKERS FROM RISKS RELATED TO EXPOSURE AT WORK TO CARCINOGENS, MUTAGENS AND SUBSTANCES TOXIC FOR REPRODUCTION 1. INTRODUCTION This document launches the second stage of consultation of the social partners at European level on Community action to protect workers from the risks related to exposure to carcinogens, mutagens and substances toxic for reproduction at work, pursuant to Article 138(3) of the Treaty establishing the European Community. On 6 April 2004, the Commission launched the first stage of the consultation of the social partners on the basis of a text describing the initiatives launched by the Community institutions to protect workers from exposure to carcinogens, mutagens and substances toxic for reproduction at work and asking the social partners to give their opinion on the possible direction of further Community action in this regard. By the end of the six-week consultation period the Commission had received nine replies. All the social partners who replied -Union of Industrial and Employers' Confederations of Europe (UNICE), European Centre of Enterprises with Public Participation and of Enterprises of General Economic Interest (CEEP), European Association of Craft, Small and Medium-Sized Enterprises (UEAPME), European Trade Union Confederation (ETUC), European Confederation of Executives and Managerial Staff (CEC), Confederation of National Associations of Tanners and Dressers of the European Community (COTANCE), Hotel, Restaurants and Cafes in Europe (HOTREC), European Federation of Trade Unions in the Food, Agriculture and Tourism Sectors and Allied Branches (EFFAT), Union Network International Europe Hair & Beauty (UNI-Europa Hair&Beauty) -confirmed the importance they attach to protecting workers from the health risks associated with exposure to carcinogens. While they all acknowledge the importance of the existing legislation, their views differ as to which strategy should be used and which factors should be taken into consideration. 2. BACKGROUND Occupational carcinogens, mutagens and reprotoxic substances are a major cause of concern not only because of the serious health effects on individual workers, but also because of the economic impact on businesses, and the social costs to European countries. Community action on prevention of exposure to occupational carcinogens began a long time ago. Thus, already in 1990, the Council adopted Directive 90/394/EEC on the protection of workers from the risks related to exposure to carcinogens at work EN 1 EN

3 (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391EEC) 1. Further developments were the adoption of Council Directive 97/42/EC 2 amending for the first time Directive 90/394/EEC, and Council Directive 99/38/EC 3 amending for the second time Directive 90/394/EEC and extending it to mutagens. In 2004, the existing legislation was codified as Directive 2004/37/EC of the European Parliament and of the Council 4. In its Communication "Adapting to change in work and society: a new Community strategy on health and safety at work ", the Commission announced its intention to propose extending the scope of the Directive on "carcinogenic agents". The Commission pointed out the need to adapt existing directives to reflect changes in scientific knowledge, technical progress and the world of work. In this regard, the Council, in its "Resolution on a new Community strategy on health and safety at work ( )", called on the Commission to submit to it any proposal needed for achieving the objectives set out in the new strategy and in particular those needed to consolidate, simplify and rationalise the existing legal framework and adapt it to technical progress, so that existing legislation can be better enforced 6. In its resolution on "the Commission communication: Adapting to change in work and society: a new Community strategy on health and safety at work ", the European Parliament welcomed the commitment taken by the Commission to extend the scope of the "Carcinogenic Agents Directive". However, the Parliament warned that a more comprehensive approach was required: legislation should set exposure limits on priority dangerous substances; substitutes should be used wherever possible and workers' interests should be reflected in environmental, commercial and other initiatives on chemical products 7. In its Action Plan on Environment and Health ( ), the Commission has committed itself to encouraging the restriction of smoking in all workplaces by exploring both legal mechanisms and health promotion initiatives at both European and Member State level. Social Partners replies to first phase consultation did not favour the inclusion of Environmental Tobacco Smoke (ETS) under the scope of the Carcinogens directive on the ground that ETS was not a process-generated substance. On the other hand, the framework directive 89/391/EEC imposes the obligation to evaluate all risks present in the work place and take any technical and/or organisational measure to eliminate or reduce them to a minimum. Based on these provisions Member States can already impose the banning of ETS exposure in work places. For these reasons and because ETS will automatically fall under the scope of directive 2004/37/EC, on Carcinogens and Mutagens, if classified at EU level as carcinogen category 1 or 2, the present document does not include ETS as a subject for further consultation OJ L 196, , p OJ L 179, , p OJ L 138, , p. 66. OJ L 158, , p. 50. COM(2002) 118 final. OJ C 161, , p. 1. A5-0310/2002 final. EN 2 EN

4 The Nice European Council approved the European Social Agenda 8, which identifies adapting existing standards on health and safety at work as a priority for action. The proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants} {SEC( } 9, presented by the Commission, proposes an authorisation for substances of very high concern including substances that are carcinogenic, mutagenic or toxic to reproduction (CMR); persistent organic pollutants; substances which are persistent, biocumulative and toxic; substances which are very persistent and very biocumulative; and endocrine disrupters. REACH shall apply without prejudice to Directive 2004/37/EC and will bring about improvements in the level of knowledge on the human health effects resulting from exposure to CMR substances. This will contribute to the more effective implementation of Directive 2004/37/EC, but should not restrict the need to adapt that Directive to reflect changes in scientific knowledge, technical progress and the changing world of work. The need to establish criteria for setting binding exposure limit values at European level is an issue that has been raised on various occasions. For this reason, the Commission, through the Advisory Committee on Safety and Health at Work, held on 25 October 2006 a workshop to discuss existing methodologies and criteria to assign binding limit values to carcinogens. The results of the workshop will contribute to the debate on better protection of workers from exposure to carcinogens, mutagens and reprotoxic substances. 3. THE SOCIAL PARTNERS All the social partners who replied during the first stage of the consultation process confirmed the importance they attach to protecting workers from the health risks associated with exposure to carcinogens, mutagens and reprotoxic substances. They all recognised the importance of existing legislation; however, while five organisations considered it to be appropriate to amend or update Directive 2004/37/EC, three other organisations felt that practical guidance documents and enhanced sectoral prevention should be given priority. In general, the social partner organisations representing employees were more in favour of a Community initiative to amend Directive 2004/37/EC. The social partner organisations representing employers, on the other hand, were less favourable to a Community initiative. Social partner organisations representing employers opposed the inclusion of reprotoxic substances within the scope of Directive 2004/37/EC, arguing that these substances are covered under Directive 98/24/EC on chemical agents, which requires a whole range of preventive measures. Furthermore, they consider that the non-inclusion of reprotoxic COM(2003) 644 final. EN 3 EN

5 substances in the scope of Directive 2004/37/EC will have no impact on current levels of protection if adequate non-binding guidelines at EU level for reprotoxic substances are established to complement the CAD Directive. Social partner organisations representing employees were more favourable to the inclusion of substances toxic to reproduction in Directive 2004/37/EC. They consider that, where training of workers and medical surveillance are concerned, the nature and the severity of the health effects resulting from exposure and the irreversibility of such effects are important factors to be taken into account. Therefore, such health effects have to be prevented rather than remedied. Consequently, levels of protection of workers should be raised by applying the more stringent provisions of the Carcinogens Directive to these substances. Employers and employees organisations agreed on the need to set new binding limit values for carcinogens and mutagens at EU level, to review the existing limit values, and to simplify the process of setting limit values for these substances by adopting appropriate criteria. It is hoped that this will help overcome the difficulties in setting binding limit values under the current Directive. Furthermore, employers' organisations stated that the setting of binding limit values should be based on clear new scientific evidence and should be subject to socio-economic impact assessment. Overall, respondents were broadly in favour of establishing new binding limit values on carcinogens and mutagens. Concerning the extension of the scope of Directive 2004/37/EC to cover substances toxic for reproduction, the opinion of the social partners was more qualified, although a majority of respondents supported a Community initiative in this area. At least four of the social partners highlighted the need to base any new policy development on sound scientific evidence and on an extended socio-economic impact assessment. They also mentioned the importance of taking into account the REACH initiative when developing Community policies in this area. 4. THE COMMISSION'S STANCE In view of the responses from the social partners, who are aware of the need to protect workers from the risks related to exposure to carcinogens, mutagens and reprotoxic substances at work, the Commission feels that the results of the first stage of the consultation process confirm its view that action must be taken at Community level in order to introduce better methods, standardised across the EU, for tackling situations involving exposure to these substances. The Commission considers that an amendment of Directive 2004/37/EC, in line with the position of most of the social partners, might bring the provisions of the Directive into line with new developments in scientific knowledge and technology. In view of the importance of this matter, the Commission shares the view of the social partners that every avenue should be explored to improve ways of protecting EN 4 EN

6 the health of exposed workers, and therefore feels that a comprehensive approach, combining regulatory and non-regulatory elements, could be the best solution. 5. CONTENT OF ANY FUTURE INITIATIVE There is therefore a need to strengthen prevention and to adopt better measures to protect the health of European workers from exposure to carcinogens, mutagens and reprotoxic substances. Accordingly, the Commission intends to propose an extension of the scope of the "Carcinogens and Mutagens Directive" to include substances toxic for reproduction. In addition, it intends to propose a revision of the binding occupational exposure limits values (BOELVs) for carcinogens listed in the Directive, and to establish BOELVs for some carcinogens, mutagens and reproductive toxicants, not yet included in the Directive. Without prejudice to the principle of substitution enshrined in Article 4 of Directive 2004/37/EC, the adoption of BOELVs at EU level ensures a high level of protection of workers' health from the risks associated with exposure to chemical substances at the workplace. In this context, any future initiative should take into consideration the existing BOELVs under Directive 2004/37/EC. It should also take account any need to adapt these values to reflect changes in scientific knowledge or technical progress, whilst at the same time ensuring that BOELVs may be adopted for substances not yet included in the Directive. In addition, criteria should be developed to make it easier for BOELVs to be adopted and, as necessary, amended at European level. The revision of BOELVs for carcinogens listed in the Directive, together with the establishment of BOELVs for some carcinogens, mutagens and reproductive toxicants not yet included in the Directive, would be based on the scientific opinions given by the Scientific Committee for Occupational Exposure Limits to Chemical Agents (SCOEL) 10 and should take into account the results of the socio-economic impact assessment. Nevertheless, scientific, technical and socio-economic data alone will not be sufficient to enable binding limit values to be set for carcinogenic, mutagenic and reprotoxic substances. What is also needed is an appropriate definition by the political authority of the level of risk that can be accepted by society. The Commission is of the opinion that these criteria for setting BOELVs for carcinogenic, mutagenic and reprotoxic substances must be included in any future initiative. Regarding substances toxic for reproduction, Directive 2004/37/EC would be applicable to reprotoxicants in categories 1 and 2 included in Directive 67/548/EEC 11 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances or Directive OJ L 188, , p. 14. OJ 196, , p. 1.Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, , p. 36). EN 5 EN

7 1999/45/EC 12 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations. This would be in line with the coverage of category 1 and 2 carcinogens and mutagens by Directive 2004/37/EC and with the REACH proposal for substances of very high concern. The provision of training and information to the workers concerned is a key aspect of prevention policy. In implementing the existing EU legislation on health and safety at work, national authorities, and also employers, should set up strategies to raise awareness and to promote training schemes for workers exposed to CMRs. It is of essential importance that experience of training and best practice packages should be promoted and coordinated at national and EU levels. Sharing of information and training in SMEs could significantly contribute to the reduction and to the efficient management of the chemical risk. Such measures should be tailored to the type and level of risk concerned and should use a wide range of terms which are easily understandable. Workers should be made well aware of the risks to which they are or might be exposed; they should recognise the types of product which might contain carcinogens, mutagens and reprotoxic substances; and they should be provided with and be able to choose the most appropriate means of protection. Moreover, the Commission will invite the Senior Labour Inspectors Committee (SLIC) 13 to start a discussion on the enforcement of the national legislations transposing Directive 2004/37/EC with a view to identifying equivalent and efficient approaches to the effective application of the requirements of the Directive. SLIC may want to identify examples of good practice as regards controlling the risk and to foster the exchange of practical inspection methodologies. In addition, the Commission will encourage and support sectoral dialogue initiatives that may complement existing legislation in reducing the exposure of workers to carcinogens, mutagens and reprotoxic substances. Recent developments regarding crystalline silica, within the framework of the European social dialogue, are a good example of how the social partners can contribute to the health protection of workers. QUESTIONS FOR THE SECOND STAGE OF THE CONSULTATIONS WITH THE SOCIAL PARTNERS The Commission requests the social partners: to send to the Commission an opinion or, where appropriate, a recommendation on the objectives and content of the planned proposal pursuant to Article 138(3) of the Treaty establishing the European Community; to inform the Commission of their positions on other measures which might be envisaged, such as: (1) extending the scope of Directive 2004/37/EC to include category 1 and 2 reprotoxic substances, OJ L 200, , p. 1.Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, , p. 1). OJ L 188, , p. 11 EN 6 EN

8 (2) updating binding limit values for substances included in Annex III to Directive 2004/37/EC or (3) including binding limit values for more substances in Directive 2004/37/EC; (4) introducing objective criteria for setting binding occupational exposure limit values for carcinogenic, mutagenic and reprotoxic substances, explaining what these criteria should be, and indicating what should be the process for setting new limit values (5) training and information requirements (e.g. how existing measures could be implemented more effectively, examples of best practice, ways to improve coordination and sharing of information; to inform the Commission whether they wish to launch the negotiation procedure on the basis of the proposals described in this document pursuant to Articles 138(4) and 139 of the Treaty and, if so, to specify whether they wish to adopt an overall approach or focus on particular features. EN 7 EN