EUROPEAN COMMISSION Brussels, 10.1.2017 SWD(2017) 7 final COMMISSION STAFF WORKING DOCUMENT



IMPACT ASSESSMENT

Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work

{COM(2017) 11 final}

{SWD(2017) 8 final}



TABLE OF CONTENTS Introduction6 1The Problem and the policy context of EU intervention7 1.1Cancer is the first cause of work-related deaths in the EU7 1.2Legal context8 1.3How would the problem evolve9 2Why should the EU act?12 2.1Does the EU have the right to act?12 2.2Why is EU action needed and what is its added value?12 2.3Process for setting binding OELs and associated provisions under CMD.14 3What should be achieved?17 3.1What are the general policy objectives? What are the more specific objectives?17 3.2Are these objectives consistent with other EU policies and with the Charter for fundamental rights?18 3.2.1Consistency with the Charter for fundamental rights18 3.2.2Consistency with the REACH Regulation18 4What are the various options to achieve the objectives?21 4.1Complementary measures21

4.1.1Development of further guidance documents21 4.1.2Biomonitoring22 4.2Withheld actions22 4.2.1. Amending CMD in relation to Beryllium and inorganic beryllium compounds23 4.2.2. Amending CMD in relation to Hexachlorobenzene (HCB)23 4.2.3. Amending CMD in relation to diesel engine exhaust (DEE)24 4.2.4. Amending CMD in relation to rubber process dust and fumes (RPDF)25 4.2.5. Amending CMD in relation to 4,4'-Methylene-bis-(2 chloraniline) (MOCA)26 4.3Discarded options26 4.4Options and carcinogens retained for consideration27 5What are the impacts of the different policy options and how do they compare?29 5.1Study methodology29 5.1.1. Analytical challenges30 5.1.2. General remarks31 5.2Epichlorohydrine (ECH)32 5.3Ethylene dibromide (EDB)35 5.4Ethylene dichloride (EDC)38 5.54,4'-Methylenedianiline (MDA)42 5.6Trichloroethylene (TCE)45 5.7Complex polycyclic aromatic hydrocarbon (PAH) mixtures with benzo[a]pyrene as an indicator50

5.8Mineral Oils as Used Engine Oils54 5.9Summary of the retained options57 6Overall impact of the package of retained options59 6.1Impact on workers59 6.2Impact on businesses60 6.2.1Impact on SMEs60 6.2.2Impact on competition and competitiveness61 6.3Impact on Member States/national authorities61 6.4Impact on fundamental rights62 6.5Subsidiarity and proportionality62 6.6Budgetary implications63 7How would actual impacts be monitored and evaluated?63 7.1Monitoring arrangements63 7.2Evaluation arrangements64 8Annex 1 – Procedural Information65 8.1Lead DG65 8.2Consultation of the Regulatory Scrutiny Board (RSB)65 8.3Evidence used in the impact assessment66 8.3.1IARC Monographs66 8.4External expertise67

8.4.1Use of scientific expertise / Commission expert groups / SCOEL67 8.4.2Studies performed by external consultants67 8.4.3Study on chemical agents toxic to reproduction68 9Annex 2 - Stakeholder consultation69 9.1Social partner Consultation69 9.2Other consultation of stakeholders71 9.2.125 October 2006 - Workshop of setting OELs for Carcinogens71 9.2.2EU-OSHA - Exploratory survey of Occupational Exposure Limits (OELs) for Carcinogens, Mutagens and Reprotoxic chemical agents (CMRs) at EU Member States level (published in September 2009)71 9.2.3Consultation of the tripartite Working Party 'Chemicals at the Workplace' (WPCs) of the ACSH72 9.2.4September 2012 - Workshop in Berlin73 9.2.5Consultation of the members of the ACSH on existing national OELs for chemical agents subject to the amendments73 9.2.6Meetings with Industry and Workers representatives73 10Annex 3 – Who is affected by the initiative and how?75 11Annex 4 – Overview of the seven carcinogens77 11.1Sectors, types of cancer caused and estimated number of workers exposed77 11.2Legal and policy considerations specific for the proposal - Risk management measures under CMD81 11.2.1Annex I to the CMD – Process-Generated Substances (PGS)81 11.2.2Annex III to the CMD – OEL81 12Annex 5 – Analytical model used in preparing the Impact Assessment83 12.1Exposure estimation83

12.2Health impact – methodology for estimation of the current cancer burden (baseline) as compared with the policy intervention scenarios84 12.3Compliance costs92 12.4Analytical assumptions and challenges92 13Annex 6 – Carcinogenicity of the chemical agents94 14Annex 7 - Exposure Limit Values in EU Member States and some non-EU Countries95 14.1Annex 7 Table 1. OELs in EU MS95 14.2Annex 7 Table 2. OELs in EU MS – compared to levels recommended by the ACSH (option 2)97 14.3Annex 7 Table 3. OELs in some non-EU countries98 14.4Annex 7 Table 4. Exposures in Member States which have no OEL or an OEL higher that the retained option99 15Annex 8 - Relevant EU legislation99 15.1Existing EU-OSH framework99 15.1.1Directive 89/391/EEC99 15.1.2Directive 98/24/EC100 15.1.3Directive 2004/37/EC100 15.1.4Directive 2009/148/EC101 15.2Internal Market legislation101 15.2.1REACH Regulation101 15.2.2CLP Regulation102 15.2.3Comparison of high level CMD and REACH provisions in relation to occupational carcinogens102 16Annex 9 – general information about the Classification systems referred to in the document104

16.1Carcinogens104 16.1.1Classification according to the CLP Regulation104 16.1.2Classification according to IARC105 17Annex 10 – Additional Graphical Material106 17.1Epichlorohydrine106 17.2Ethylene dibromide107 17.3Ethylene dichloride108 17.44,4,'Methylenedianiline109 17.5Trichlorothylene110 17.6Complex PAH mixtures with benzo[a]pyrene as an indicator111 17.7Mineral Oils as Used Engine Oils112 18Annex 11 – Abbreviations used112



Introduction Exposure to some chemical agents in the workplace can cause cancer. To ensure workers' protection against such risks, in 1990 the EU (then EEC) adopted the Carcinogens Directive) as one of the first individual directives under the 1989 occupational safety and health (OSH) 'Framework Directive'. Over the following decade the CMD was updated and extended to become the Carcinogens and Mutagens Directive, which was consolidated in 2004. CMD obligations require employers to eliminate or otherwise minimise exposure of workers to cancer-causing ('carcinogenic') chemicals and elaborates the general requirement in the Framework Directive to eliminate all risks to workers. CMD establishes certain measures specific to given chemical carcinogens, including identification of 'process-generated' carcinogens (Annex I to the CMD), and limit values over which exposure of workers is not allowed (Annex III). Scientific knowledge about cancer and carcinogenic chemicals develops. At the same time technological progress brings new methods of measuring and controlling exposures. In order to ensure optimal protection of workers through the risk management measures established in the CMD, the Directive needs to keep abreast with the scientific and technological developments by updating the three Annexes. The Directive requires specifically that occupational limit values must be set out in respect of all those carcinogens or mutagens for which this is possible in the light of the available information, including scientific and technical data. The Commission has initiated a scientific and economic assessment of 25 priority chemical agents with a view to making appropriate updates to the CMD. Around 20 million EU workers are exposed to at least one of these carcinogens. For 13 of those 25 the evidence base and analysis were adequately advanced by 13 May 2016 for the European Commission to adopt a legislative proposal to amend the CMD, accompanied by a full impact assessment. For a further seven out of those 25 carcinogens policy options are analysed in this Staff Working Document. In the case of the five remaining substances, action through amendment of the CMD requires further consideration before proceeding and has been withheld at this stage. The aim of the further proposal under consideration remains to reduce exposure to these priority carcinogens with a consequential reduction in potential new cases of occupational cancer in the affected workers in the forthcoming 50 years. The proposal will increase protection and legal certainty for at least four million workers, reducing suffering, and improving the length, quality, and productivity of the working lives of European workers. It is a part of a longer-term process of updating and reviewing the CMD to ensure optimal protection from carcinogenic chemicals at work, with further proposals anticipated in the medium term. Given the level of scientific and technical knowledge required to identify measures, which at the same time adequately protect workers and are practically feasible for industries, the European Commission bases proposals in this area on opinions developed by the tripartite Advisory Committee on Safety and Health at Work (ACSH). The opinions of ACSH take into account advice developed by the Scientific Committee on Occupational Exposure Limits (SCOEL) as well as other sources of relevant scientific data. The purpose of this Impact Assessment is to verify, on the basis of available socioeconomic data, the robustness of ACSH opinions and, eventually to consider some complementary measures which could be proposed based on further scientific information.

Representatives of Member States authorities, employers' and workers' representative bodies within the framework of the tri-partite ACSH strongly anticipate a second Commission proposal. In its Resolution of 25 November 2015 on the EU Strategic Framework on Health and Safety at Work 2014-2020, the European Parliament 'firmly reiterates its call on the Commission to present a proposal for a revision of Directive 2004/37/EC on the basis of scientific evidence adding more binding occupational exposure limit values where necessary'. While this Staff Working Document sets out the case for further action, the supplementary analysis presented here should be read in conjunction with the earlier impact assessment (IA), which provided an exhaustive consideration of the CMD and the policy and legal context of the proposals. The most essential points are carried over and supplemented by additional information and analysis regarding these seven additional carcinogens. References to the full impact assessment document are given as appropriate. 1The Problem and the policy context of EU intervention 1.1Cancer is the first cause of work-related deaths in the EU 53% of annual occupational deaths are attributed to cancer, compared to 28% for circulatory diseases and 6% for respiratory diseases. Different forms of cancer may be initiated or promoted by the exposure to carcinogenic and/or mutagenic chemical agents at work. According to a 2016 report by the Netherlands National Institute for Public Health and the Environment (RIVM) 91,500-150,500 people were newly diagnosed with cancer in 2012, caused by past exposure to carcinogenic substances at work. 57,700 – 106,500 people died in 2012 as a result of a work-related cancer. That means that every hour in EU28, 7-12 people die of cancer because of past exposure to carcinogenic substances at work. The below problem tree summarises the main drivers behind this problem and the resulting consequences. A detailed description of those is provided in the previous IA.



Figure 1. Problem tree The carcinogens subject to this assessment have a direct impact on developing different types of cancer and are relevant to the sectors with high rates of cancer registrations. Their key characteristics are presented in a table in Annex 4. In total 12 million EU workers are exposed to at least one of the seven carcinogens (see Table 1 in Annex 4). Complex PAH mixtures with benzo[a]pyrene as an indicator, 4,4'-methylenedianiline, or oils that have been used before in internal combustion engines to lubricate and cool the moving parts within the engine (hereinafter, "mineral oils as used engine oils"), are among the top 10 carcinogenic substances to which the largest numbers of workers are currently exposed. 1.2Legal context Under CMD, 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 carcinogens cannot be substituted they must, so far as is technically possible, be manufactured and used in a closed system to prevent exposure. Where this is not technically possible either, worker exposure must otherwise be reduced to as low a level as is technically possible. This is the so-called minimisation obligation under Article 5 of the CMD. This is a more strict standard than for other hazardous chemicals, where the duty to control risks is always qualified by an assessment of risk by the employer. Those general provisions of the directive remain relevant. However, in the light of available scientific data concerning the covered carcinogenic chemicals, there are grounds for considering the update of Annexes of the CMD, which provide further clarification of employers' obligations with regard to protecting workers from carcinogenic chemicals: Annex I clarifies the scope of the directive. Annex I of CMD includes a list of identified 'process generated substances' (PGS). These are hazardous 'chemical agents' such as dust, fumes, and gases which may, for example, be generated as by-products during production processes, etc. The aim of this list is to clarify for workers, employers, and enforcers whether a given chemical agent, if it has not otherwise been classified according to the Regulation (EC) No 1272/2008 (CLP), is in scope of the CMD controls. Annex III establishes 'binding occupational exposure limit values' (OELs)

For some some chemical agents which fall under the scope of the Directive CMD provides that, in any case, exposure of workers must be kept below 'binding occupational exposure limit values' (OELs) as established in Annex III of the directive. An OEL addresses the inhalation route of exposure, describing a maximum airborne concentration level for a given chemical agent above which workers should not be exposed, on average, during a defined time period. OELs can further be annotated with appropriate indications of additional body burden resulting from non-inhalation routes such as, for example, a 'skin' notation where the dermal route of exposure is scientifically considered to be relevant. Under the CMD, OELs should be established for all those carcinogens and mutagens for which the available information make this possible and must also be revised whenever this becomes necessary in the light of more recent scientific data. As explained above, employers must prevent or minimise exposure to occupational carcinogens where risks occur. The principle of minimisation of the exposure is stated in article 5.3 of the CMD: 'the employer shall ensure that the level of exposure of workers is reduced to as low a level as is technically possible'. CMD OELs do not directly affect in theory the legal standard of control, which is in any case for minimised exposure. In practice, however, the existence of an OEL provides a clear benchmark that enables professionals to 'operationalise' the concept of minimised exposure, thereby allowing them to easily determine the level to which the exposure should at least be reduced. Further information about the Annexes of the CMD and their role is in Annex 8 of this report. When analysing options for amendments of CMD Annexes, the interface with the REACH Regulation needs to be taken into account as both CMD and the REACH Regulation are relevant for worker protection from carcinogens . Section 3.2.2 provides further information on the interface between REACH and CMD. 1.3How would the problem evolve Work-related cancer has a strong impact for workers and their families, for Member States and for the economy at large. The previous IA describes these impacts in more detail. Estimations on the numbers of deaths and health costs between 2010 and 2069 in case no action is taken regarding these carcinogens are, where available, summarised in the Table 1 below. Exposure to, for example, mineral oils as used engine oils, which potentially concern 1 million workers in Europe, is expected to cause 130,000 cases of cancers and 1200 deaths, with estimated health costs between € 445 m – and 2,815 m. These projections are made under the assumption that employers already comply with the CMD obligation to eliminate or minimise exposures to carcinogenic chemicals and that more detailed or more protective measures have been established by some Member States to complement the minimum requirements set at EU level. The general obligations set by CMD, employers' actions and measures adopted by Member States contribute overall to lowering exposures. As will be shown in section 5, exposure levels have generally been decreasing in the past years and this positive trend could continue in the future. Future forecasts in this area are however far from certain due to scarcity of relevant data and the fact that market forces such as raw material and energy prices, developing technology, as well as regulatory changes can drive decreases or increases in use which are not easy to predict. Even if trends were overall positive, under current circumstances, the existing employers practices as well as protective measures at Member State level, do not always reflect available scientific and technological knowledge. While the Commission does not receive information from Member States as for their intentions for developing their national legislation, national administrations are aware of the preparatory work at EU level and therefore it is likely they will await its results in order not to duplicate efforts. Table 1. Estimated current exposures and cancer deaths, cancer cases and related health costs in case no action is taken (baseline scenario), 2010-2069 Carcinogen including CAS numbers where relevant Classification No. of exposed workers Expected no. of deaths 2010 – 2069 Expected no. of cancer cases 2010 – 2069 Estimated health costs 2010 – 2069 CLP IARC Epichlorohydrine 106-89-8 (1-Chloro-2,3-epoxypropane) 1B 2A 39,372 2,400 2,600 € 1,362 m – 2,752 m Ethylene dibromide (EDB) 106-93-4 (1,2-Dibromoethane) 1B 2A < 7,691 - - - Ethylene dichloride (EDC) 107-06-2 (1,2-Dichloroethane) 1B 2B < 3,000 - - - 4,4'-Methylenedianiline (MDA) 101-77-9 1B 2B 3,942,581 - - - Trichloroethylene (TCE) 79-01-6 1B 1 74,076 3,300 4,800 € 1,582 m – 5,657 m 4,4'-Methylene-bis-(2-chloroaniline) (MOCA) 101-14-4 1B 1 2,500 100 280 € 45 m - 353 m Complex PAH mixtures with benzo[a]pyrene as an indicator 50-32-8 (for benzo[a]pyrene) 1B 1 7,505,211 10,000 13,000 € 6.2 b – 194 b Mineral Oils as Used Engine Oils (UEOs) n/a 1 1,050,127 1,200 130,000 € 445 m – 2,815 m Beryllium and inorganic beryllium compounds 7440-41-7 (for beryllium) 1B 1 64,734 390 390 € 203 mln - 529 mln Hexachlorobenzene (HCB) 118-74-1 1B 2B Insufficient data Insufficient data Insufficient data Insufficient data Diesel engine exhaust n/a 1 3,670,792 230,000 270,000 € 99,084 mln – 258,000 mln Rubber process dust and fume (RPDF) n/a 1 366,501 2,990 4,310 € 721 mln - 859 mln 2Why should the EU act? 2.1Does the EU have the right to act? Article 153 of the Treaty on the Functioning of the EU (TFEU) empowers the EU to support and complement the activities of the Member States as regards the protection of workers' health and safety. On this basis the CMD provides a specific basis for action. 2.2Why is EU action needed and what is its added value? Amending the CMD can only be done by action at EU level and it presents an EU added value in several respects.

Updated scientific basis of prevention and protection Scientific knowledge about carcinogenic chemicals is constantly developing and technological progress enables improvements in protection of workers. In order to ensure that the mechanisms for protecting workers from carcinogenic chemicals established in the CMD are as effective as possible, the directive needs to be kept more up to date with those developments. Available scientific evidence points to the need to establish new OELs in Annex III for a number of substances for inhalation exposures including for information on other routes of exposure (e.g. dermal) which could contribute significantly to the overall body burden of the workers . In addition, there is scientific information which could serve as a background to including mineral oils as used engine oils in Annex I of the CMD. Updating CMD to take account of newer scientific evidence is an effective way to ensure that preventive measures would be adjusted accordingly in all Member States. Improved clarity and enforcement Including substances in Annex I could contribute to the clarity for employers, workers and enforcement authorities as for what falls under the scope of the Directive, provided that the definitions make it possible to specifically identify the substance. Establishing new OELs in Annex III could provide a common reference point that can be used as a practical tool by employers, workers and enforcers to assess compliance with the general CMD requirements. OELs can also be used by process plant and machinery designers when planning new, or considering alterations, to existing process plant. Clear support for their continued use has been expressed from key stakeholders. Ensuring the same minimum level of protection across the EU In case of all carcinogenic chemical agents where OELs are proposed in this initiative at least half of the Member States have not yet established legally enforceable OELs or have less protective ones. For example, 17 Member States have set no limits or less protective ones for trichloroethylene – the same is true for 20 Member States in the case of EDB and 23 in the case of MDA. Also approaches to and definitions of the considered PGS differ significantly. Lack of EU action will most likely mean that there will remain Member States where no limit values exist for certain carcinogens or where those values are too high to ensure adequate worker protection. A minimum standard across the EU will not be ensured, to the detriment of worker protection. Contribution to level-playing field Additionally, while setting more stringent OELs at national level is in line with the minimum standard nature of the CMD, national OELs vary considerably in some cases – leading to significantly different levels of protection. For trichloroethylene, for example, the values range from 0.6 to 100 ppm (3.3 to 550 mg/m3). This can also have negative consequences for the internal market because businesses operating in Member States with less stringent levels or no exposure limit value at all would benefit from an undue competitive advantage. It may provide a potential incentive for companies to locate their production facilities in Member States with the lower standards. For example, for trichloroethylene producers and professional users in countries such as UK, Cyprus or France, it is sufficient to comply with exposure limits 10 times higher (i.e. less constraining) than in some other countries such as Belgium, Denmark, Spain or Finland among others.. Establishing common definitions in Annex I to the Directive and setting EU OELs in Annex III will not completely eliminate the differences between Member States, as they retain the possibility to adopt more protective measures. However, it will provide certainty that there is a core definition and/or enforceable exposure limit for all concerned carcinogens in all Member States. As illustrated in the graphs in Annex 10 it will also significantly minimise the scope for variation in OELs across the EU. The examples of the currently existing EU OELs (e.g. for hardwood dust, included in the 1st Commission proposal for amendment of the CMD) show that a majority of Member States in practice adopt the EU OEL directly. Assuming burdens at EU level related to derivation of limit values The process of establishing limit values is very complex and requires a high level of scientific expertise. An important advantage of setting OELs at EU level is that it eliminates the need for Member States to conduct their own scientific analysis. Since the establishment of SCOEL the onus for developing OELs for hazardous chemical agents in general, and carcinogens in particular, has shifted to the EU level and the European Commission. Accordingly this important activity to contribute to the protection of workers is now driven principally at EU level, forming important driving context for the present intiative. The annual budget for the operation of SCOEL in the year 2015-2016 is approximately €400,000, not including significant dedicated resources providing the administrative and scientific secretariat functions. The cost of undertaking the relevant scientific analysis at Member State level would differ as a result of different organisational requirements, prioritisation and resource allocation and other administrative decisions – making an extrapolation assuming the SCOEL resources are representative is therefore difficult. Assuming that a majority of Member States chose to establish or continue operating scientific committees to undertake equivalent work for all hazardous chemical agents (not just carcinogens and/or mutagens) would imply savings of between €6 000 000 and €12 000 000 at Member State level. Given the limited resources for OSH at national level, this could release funds currently spent on managing national scientific committees to be redirected into other OSH priorities.

2.3Process for setting binding OELs and associated provisions under CMD. A simplified outline of the process for the development of EU Occupational Exposure Limit Values for carcinogens is set out here. After completion of these steps the Commission prepares and adopts the legislative procedure which then follows the ordinary legislative procedure for adoption and subsequent transposition and implementation at Member States level. Figure 2. Simple representation of typical EU OEL setting procedure Step 1: Social partners consultation TFEU Article 154 requires a formal two-stage consultation of the social partners at EU level (management and labour) prior to submitting proposals in the social policy field. As regards the present initiative this consultation took place in 2004 and 2007. Annex 2 (section 9.1.) provides further information on the outcomes of the consultation. Due to complex nature of this initiative, a further exchange of views between the Commission services and the social partners took place towards the end of the IA development stage of the overall process, once the policy options had been clarified. This ensured the continued active involvement of the social partners. Step 2: Priority setting It is neither realistic nor desirable to set an OEL for every hazardous chemical that may be used at the workplace. Instead it is appropriate to identify and target priority substances. The selection of the original 25 carcinogens considered in this and previous related Impact Assessment was based on a consultative approach including stakeholder engagement at member states and social partner levels, and taking into account general considerations such as the following: the potential to cause adverse health effects resulting from occupational exposure. Processes resulting in exposure or combined exposures to chemicals with the potential to cause adverse health effects resulting from a work activity for which markers of exposure are needed. Emerging specific issues on a basis of reported evidence and expert judgment. Degree of evidence for adverse effects. Characteristics of the adverse effects (severity, potency, reversibility, specificity). Estimated number of workers exposed.

Identified exposure patterns that pose difficulties for the control of exposures. Policy considerations, such as problematic disparities with or between other relevant threshold values, degree of stakeholders' interest in having an EU OELV, or other institutional priorities. The Commission is committed to continuing efforts to strengthen application of such criteria in the future. Step 3: Scientific evaluation and public consultation Article 16 of the CMD states that scientific/technical data should be included in the basis on which OELs are set. CMD does not determine which scientific body should be the source of such data – in practice the Commission and the ACSH principally seek the advice of SCOEL, but can also refer to scientific information sourced elsewhere as long as the data is adequately robust and is in the public domain (e.g. IARC monographs or conclusions of national OEL-setting science committees). SCOEL is an independent scientific committee, established by a Commission Decision and composed of 21 experts appointed in their personal capacity as leading experts in fields relevant for protection of workers from risks associated with workplace exposure to hazardous chemicals. SCOEL carries out scientific evaluation at EU level and as a result publish a single evaluation document (previously a 'SCOEL SUM', more recently a Recommendation or Opinion) for hazardous chemicals where there is priority concern for worker protection. The procedures for the adoption of a Recommendation by SCOEL include an external public consultation including directly informing a list of identified contact points in all of the Member States; this ensures scrutiny of the scientific evidence and methodological approach used by SCOEL and ensures transparency of the process. SCOEL has concluded opinions or recommendations on all the carcinogens analysed in chapter 5 – further details are provided in Annex 6. Step 4: Tripartite consultation of Member States and social partners While the aim of ensuring the protection of the health of workers is maintained, binding OELs set under CMD must also reflect other factors such as 'feasibility' and take into account the views of the social partners. For this reason the Opinion of the ACSH is requested. The ACSH is a tripartite body set up in 2003 by a Council Decision (2003/C 218/01) to streamline the consultation process in the field of occupational safety and health and rationalise the bodies created in this area by previous Council Decisions. The ACSH remit is to assist the Commission in the preparation, implementation and evaluation of activities in the fields of safety and health at work. The ACSH is composed of three full members per Member State, representing national governments, trade unions and employers' organisations, also organised in three separate interest groups within the Committee. The ACSH is supported by working parties of experts on given topics of interest according to mandates agreed by the plenary Committee. These working parties are also tripartite but usually with smaller selected expert membership. The ACSH Working Party on Chemicals (WPC) undertakes broader chemicals policy support for the ACSH and Commission and in particular detailed technical and policy negotiation of EU limit values. This process is informed by all available evidence regarding appropriate and achievable limit values including adopted SCOEL Recommendations and any national OELs It is during these, often complex, discussions that the level of ambition which is appropriate for a specific EU OEL for a carcinogen is established, taking into account the views of representatives from the government, workers, and employers interest groups. The ACSH discusses adopted SCOEL Recommendations (and/or other appropriate scientific evidence) and adopts a formal Opinion. In practice an OEL emerging from this process reflects a deep technical, socioeconomic, and political consideration of what is achievable by employers across the EU and also ensures that workers' health is adequately protected. These Opinions are also adopted taking into account that OELs for carcinogens exist within the broader context of the CMD elimination/minimisation obligation, which establishes an appropriate and exceptionally high legal standard for workplace- and process-specific risk control. Between 2009 and 2011 an external contractor evaluated, on behalf of the Commission, health, socio-economic and environmental aspects of the proposed amendments to CMD in order to inform impact assessment according to the regulatory procedures in place at that time. Between 2010 and 2013 the Working Party on Chemicals of the ACSH undertook detailed discussion on these issues in an increased work schedule, aiming to secure stakeholder engagement and agreement on values to propose for ACSH adoption. Step 5: Impact assessment

The impact assessment takes all of the above steps into consideration and the IA Report is presented to the Commission services Regulatory Scrutiny Board in accordance with the relevant internal rules for initiatives with foreseeable significant impacts. The options for action proposed by the ACSH are established through a thorough scientific, technical and socioeconomic discussion and in general the tripartite agreements reached in the Advisory Committee would be put forward in the eventual Commission's proposal. However, in line with the Better Regulation guidelines, an IA is conducted before presenting the proposal. In the IA the Commission verifies the ACSH opinions on the basis of a dedicated study. Other sources of information and data are duly taken into account at this stage. EU-OSHA provides input based on recent scientific research, concerned Commission services are asked for relevant data collected by the European Chemicals Agency (ECHA) and additional input from industries is requested with the help of DG Internal Market, Industry, Entrepreneurship and SMEs. Follow-up meetings with social partners are organised. As a result of the IA the ACSH-based options could be withheld, retained or complemented. A proposed action is withheld if the ACSH opinion has not been sufficiently consensual, and the Commission's assessment leads to concerns about the proposal (e.g. as regards legality or clarity). This does not mean that the Commission discards the option. Rather, important additional elements are needed before further assessing the option. An option is retained if the ACSH opinion has been clear and consensual, there are no concerns about legality and clarity of the option and the socioeconomic assessment confirms the robustness of ACSH opinions in terms of effectiveness, efficiency and coherence. An option may be further complemented if the ACSH opinion did not take into account an important scientific element, such as the need to establish a skin notation. Agreement of the RSB is a prerequisite before presenting the draft proposal for adoption by the college of Commissioners. Ensuring the active engagement of stakeholders during the overall process. The process of setting binding OELs under CMD actively engages the MSs and social partners during the key stages: Two stages consultation of the social partners' at EU level in accordance with TFEU. External consultation on SCOEL Recommendations before adoption. Development of Opinions of the tri-partite ACSH via its Working Party on Chemicals. A further advantage of an OEL is that it sets an objective to be achieved without being prescriptive in how this should be achieved. Therefore, it can accommodate technical developments in the world of work such as new or enhanced processes and is consistent with the policy objective of employers further lowering the level of exposure below the level of the OEL when, for specific processes, this can be achieved. In this context EU-OSHA plays an important role in facilitating the exchange on good risk management practices within and between industry sectors across the Member States. 3What should be achieved? 3.1What are the general policy objectives? What are the more specific objectives? The main general policy objective of this initiative is to ensure and maintain a high level of protection of worker's health and safety in the European Union. The specific objectives are: To further improve protection from occupational exposure to chemical carcinogens in the European Union;

To increase the effectiveness of the EU framework by updating it on the basis of scientific expertise; To ensure more clarity, facilitate implementation, and contribute towards a better level playing field for economic operators by reducing divergences in national protection levels. 3.2Are these objectives consistent with other EU policies and with the Charter for fundamental rights? Promoting workers’ health is in line with the ambition for a Triple A Social Europe rating set by the Juncker Commission. It has a positive impact on productivity and competitiveness. 3.2.1Consistency with the Charter for fundamental rights The objectives of the initiative are consistent with article 2 (Right to life) and article 31 (Right to fair and just working conditions) of the EU Charter of Fundamental Rights. Ensuring a safe and healthy work environment is a strategic goal for the European Commission. 3.2.2Consistency with the REACH Regulation The REACH Regulation, adopted in 2006, is of particular relevance for worker protection from risks associated with the presence of hazardous chemicals at the workplace.REACH consolidated and evolved several parts of the EU chemical risk control system – principally those relating to risk assessment and internal market risk management measures. REACH further augmented these changes by establishing a new 'authorisation' risk management option. Both CMD and the REACH Regulation, are relevant for worker protection from the majority of carcinogens considered in this assessment. A chemical carcinogen may appear on both CMD Annex III and REACH Annex XIV without systematic conflict. The OSH Framework Directive – under which CMD is made – applies without prejudice to existing or future national and EU provisions which are more favourable to protection of the safety and health of workers at workʼ. REACH in turn applies without prejudice to worker protection legislation, including the CMD. Clear synergies between REACH and worker protection legislation can be seen – including in particular that REACH 'registration' should result in more information being available to inform chemicals risks assessment. REACH 'authorisation' also both establishes, for a given chemical agent, a clear and renewed pressure to substitute for safer alternatives, and can drive applicants to improve their worker protection risk assessments and controls. At the same time, adoption of EU OELs can be useful inputs for REACH risk characterisation. The applicable provisions of REACH authorisation and/or restriction, where relevant of the chemical agents under consideration in this report, are as follows: Out of scope of REACH: mineral oils as used engine oils, PAHs (where process generated), rubber process dust and fumes (collectively), DEE; Identified as a 'substance of very high concern' (SVHC) and candidate for being made subject to authorisation: benzo[a]pyrene Currently subject to authorisation: EDC, MDA, MOCA, TCE; Currently subject to restriction: benzo[a]pyrene as a member of the group entry for eight PAHs (Entry 50 of Annex XVII to REACH). Currently not subject to SVHC listing, authorisation, or restriction: Beryllium, EDB, ECH, HCB. Under REACH 'authorisation' certain chemicals with a specific hazard profile such as carcinogens (and others) may be identified as SVHCs and be subjected to an authorisation requirement. Such substances, which are listed in Annex XIV to REACH, may only be placed on the market and/or used if an authorisation has been granted for a specific use. The conditions for granting an authorisation are set out in Article 60 of REACH. An authorisation may only be granted for specific uses and operators who have demonstrated that the risks (including occupational risks, which is the main exposure scenario today for almost all the substances listed in Annex XIV) are either adequately controlled (the 'adequate control route') or are lower than the socio-economic benefits derived from the use (the 'socio-economic route') and there are no suitable alternatives. In the application for authorisation, and for each of the uses covered in the application, companies must include an assessment of the exposure of workers (and other populations, as well as of man via the environment, if relevant) to the substance(s), and the related risk, at individual workplaces concerned. If the risk management measures set out in the application are not judged (by the ECHA Committee on Risk Assessment) to be appropriate and effective, conditions and/or monitoring arrangements for the control of these risks can be imposed in the authorisation decision to reduce exposure and risks even further. REACH authorisation provisions are designed to dovetail and complement pre-existing EU regulatory approaches. In particular REACH Article 58(2) states that 'Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled.'

The meaning of the first set of conditions of this exemption ('on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance') is subject to consideration by the General Court in Case T-360/13 VECCO and Others v COM concerning chromium trioxide (a carcinogen mainly of concern for worker inhalation risks for which there is no EU OEL) and the legality of a Commission Regulation which included the substance in Annex XIV to REACH without granting an exemption for certain uses under Article 58(2). The case is currently subject to appeal. Some uses of substances are in any case exempted from the authorisation requirement. This is the case of 'intermediates'. Intermediates as defined by REACH are chemical substances which are manufactured for and consumed in or used for chemical processing in order to be transformed into another substance. Occupational exposure to intermediates may nevertheless occur for example during cleaning, maintenance, etc., where residues may be present and/or where process-streams are interrupted and containment may be compromised. INTERMEDIATES: AN EXAMPLE The chemical substance EDC is a carcinogen and as such is subject to CMD. Options relating to setting an inhalation OEL with a skin notation for EDC are considered in this IA. Further details relating to EDC are set out in section 5.3. EDC is also subject to REACH Authorisation. Applications for authorisation have been received for a range of industrial uses of EDC as a process/extraction/emulsifying solvent, reaction/crystallisation medium, or swelling agent. The main uses of EDC (more than 99% of the total volume) are however as an intermediate and are therefore outside the scope of authorisation. For example EDC is used as an intermediate in the manufacture of the chemical substance vinyl chloride monomer (VCM, or 'chloroethylene'). The chemical process used consists of continuous feeding of EDC to a dehydrochlorination reactor, where it is transformed into VCM, which is then distilled as an isolate from simultaneously-generated hydrogen chloride (HCl). EDC (1,2 dichloroethane) reacts according to the following reaction scheme Side reactions may take place during the manufacture that result in the formation of ethylene, 1 butene, 2 butene and 1,3 butadiene. These end up in the composition of the manufactured VCM (chloroethylene) as impurities. This use of EDC would not be subject to REACH authorisation, but workers are protected in EU legislation from potential exposure to EDC during this process and any associated work activity – for example decommissioning of a used dehydrochlorination reactor – by the provisions of the OSH Framework Directive, the CMD and in particular the duty to eliminate or minimise exposures, and would be supported by an EU OEL as considered in this assessment. REACH registration also contributes to worker protection by ensuring employers receive effective and timely advice regarding risk management from the supply chain. Unintended process-generated substances would also not be in scope of REACH authorisation. The co-existence of a CMD OEL alongside REACH authorisation provides several important benefits for the practice of both OSH and REACH worker protection provisions. CMD applies to all potential worker exposures – including those associated with intermediates, and process-generated substances, or resulting from unintended or misuse-related release. For non-threshold carcinogens the OEL-setting process provides a relatively thorough and robust process for establishing minimum standard exposure levels – ultimately passing through the co-legislator for adoption – based on a science and stakeholder consultation based process. This process can support Commission decision-making in implementing the REACH authorisation provisions – in particular whether the exposure of workers demonstrated in authorisation applications can be considered acceptable. The overall relationship between the REACH Regulation and OSH Directives (including some references specific to the CMD) has been subject of an opinion of the 'REFIT Platform' adopted on 27-28 June 2016. In this document the REFIT Platform recognises that the two sets of legislation are mutually reinforcing but points out that the interface between REACH and OSH legislation is complex and that further clarification is needed. The concerned Commission services share that analysis and are working on providing clarifications and on ensuring, in general, better interaction between both areas. In particular, DG Employment, Social Affairs, Skills and Labour Mobility, DG Environment, and DG Internal Market, Industry, Entrepreneurship and SMEs systematically share participation in technical and policy discussions, hold workshops to further explore how the two regulatory frameworks could interact, formalise cooperation between the REACH and OSH agencies to foster exchanges and avoid scientific conflict, and work in order to promote a better collaboration between the enforcement Authorities at national level.

Some examples of increased cooperation regarding the interaction between OSH and REACH are: the ECHA and the SCOEL have been mandated to create a Joint Task Force to further improve their mutual understanding and work towards agreed approaches. consideration is given to the OSH legislation during the process of identifying substances as possible candidates for authorisation and restriction under REACH during the so-called risk management option analysis process. the ECHA is working actively with stakeholders around safety data sheets in order to facilitate effective communication in the supply chains. the Commission plans to hold a workshop on the OSH-REACH interface during 2017. It is also worth noting that the links between REACH and OSH will be addressed in the ongoing OSH and REACH evaluations, which are expected to be completed in the course of 2017, and that the concerned Commission services are currently working on a Common Understanding Paper considering the interface between REACH and OSH legislation. 4What are the various options to achieve the objectives? 4.1Complementary measures 4.1.1 Development of further guidance documents During discussions in the ACSH and the social partners consultation the need for further guidance was expressed on several issues relating to the CMD. In order to meet this need, actions to develop, for example, additional guidance documents on particular questions raised, are ongoing or will be undertaken as complementary measures to this initiative. These are not alternative options to amending the CMD but are rather part of the baseline and will further reinforce potential positive effects of the considered options. 4.1.2 Biomonitoring Biomonitoring or biological monitoring is a way of assessing exposure to a certain hazardous chemicals by measuring the chemical or its breakdown products in a biological sample (usually urine, blood or breath). Biomonitoring provides very useful information for employers, workers, health practitioners, and enforcers to help them undertake effective and appropriate health surveillance in particular in cases where biomonitoring is considered to be an additional or sometimes the single most appropriate tool to evaluate the exposure of workers to a particular carcinogen (e.g. where chemicals can be significantly absorbed through the skin). Over the years, SCOEL has recommended biological monitoring values for a number of carcinogenic substances, some of them also part of this initiative. During this impact assessment, the Commission explored possibilities to introduce those SCOEL recommendations as part of an entry for a carcinogen in Annex III to the Directive. However, in accordance with Article 5 (4) CMD, a biological monitoring value established in Annex III would be 'binding', in the sense that employers would be under the obligation not to exceed that limit value. Such a regulatory approach does not appear legally possible due to the absence in the CMD of specific provisions concerning biological monitoring values. This analysis was confirmed by the Legal Service of the Commission. The Commission will consult the ACSH on approaches regarding biological monitoring. 4.2Withheld actions Commission's analysis led to a conclusion that action in relation to five carcinogens should be at this stage withheld. As described in section 2.3. a course of action proposed by the ACSH can be withheld from further assessment if the opinion has not been sufficiently consensual, and/or if there are concerns about legality or legal clarity of the proposal.

Table 2. Overview of withheld actions Carcinogen Outcome of ACSH discussion/Commission's assessment Next steps Beryllium and inorganic beryllium compounds No ACSH opinion adopted to date. Will be examined once ACSH opinion available. Hexachlorobenzene (HCB) ACSH concluded an OEL would not be appropriate given the status of the substance. Substance banned in the EU. Use will be monitored to ensure that workers safety is not compromised. Diesel engine exhaust (DEE) ACSH opinion non conclusive – further research required. Lack of a clear agreed definition of the carcinogen – risk of legal unclarity and unintended effects. Further research and consultation required including on individual components, aiming for specific OELs. Rubber process dust and fumes (RPDF) Mixture complexity makes it difficult to establish a sufficiently clear definition. Lack of agreement on the most appropriate approach between workers and employers representatives in the ACSH.

Further research and consultation required including on individual components, aiming for specific OELs. 4,4'-Methylene-bis-(2 chloraniline) (MOCA) ACSH Opinion advised that the establishment of an airborne OEL is not useful to protect workers as this carcinogen has a high potential for dermal absorption. Further consideration of this substance is necessary before concluding on the best approach which may be a biological limit value together with a 'skin' notation, and possibly to complemented by an airborne OEL in order to improve consistency with REACH.

Further reasoning for withholding action at this stage for each of the five carcinogens is provided below. 4.2.1. Amending CMD in relation to Beryllium and inorganic beryllium compounds Exposure to beryllium and its compounds at the workplace occurs mainly via inhalation, which can cause lung cancer and may also cause beryllium sensitization and chronic beryllium disease, which is an incurable disease causing scarring of the lung tissue. Dermal exposure may also cause non-carcinogenic ill health effects. While beryllium is an important chemical for which an amendment of the CMD may be considered in the future, at this stage in the absence of ACSH opinion there is insufficient basis for such a decision. Consequently action on this carcinogen is withheld at this stage and an amendment of CMD in relation to Beryllium and inorganic beryllium compounds will be considered again once the SCOEL recommendation is finalised, ACSH position agreed and relevant data on impacts collected. 4.2.2. Amending CMD in relation to Hexachlorobenzene (HCB) HCB is a chlorinated aromatic hydrocarbon. It has been classified by the International Agency for Research on Cancer (IARC) as possibly carcinogenic to humans (Group 2b) and as a Category 1B carcinogen in the EU under CLP. HCB is listed under the UN Stockholm Convention on Persistent Organic Pollutants (POP) which entered into force on 17 May 2004. The Community ratified the Stockholm Convention on 16 November 2004. The Convention has been implemented at EU level by Regulation (EC) 2004/850. The Regulation bans production, placing on the market and use of the 10 intentionally produced POP substances listed in the Stockholm Convention (HCB is one of them). This Regulation entered into force on 20 May 2004 and is directly applicable in all EU Member States. HCB may still be formed as an unintentional by-product during the manufacture of other chlorine containing compounds or as an impurity formed as a result of various industrial processes. Assumptions that considerable exposure of workers to the substance can still occur in form of a unintentional by-product could however not be substantiated based on available data. ACSH in its opinion stated that 'No OEL is proposed due to the fact that the substance has already been prohibited globally under the Stockholm Convention and the Protocol on Persistent Organic Pollutants under the UN Convention on Long-Range Transboundary Air Pollution'. Given the legal status of the chemical, it is therefore not considered appropriate to include the substance in this amendment of the CMD. Use of the substance will be monitored to ensure that workers' safety is not compromised. 4.2.3. Amending CMD in relation to diesel engine exhaust (DEE) DEE contains a complex mixture of gases, vapours, liquid aerosols and particulate matter which are the products of combustion and can be hazardous to health. Some of these components are known carcinogens (e.g. PAHs, formaldehyde, 1,3-butadien, or benzene), others are not (e.g. carbon monoxide, carbon dioxide, or oxides of nitrogen). For some of the non-carcinogenic components, like nitrogen dioxide, SCOEL recommended an 8-hour TWA OEL. For DEE as a complex mixture, however, SCOEL in its opinion of June 2016 concluded, that 'an occupational exposure level that would be safe for workers could not or not yet be established. Both, toxicological information and human epidemiological data are further evaluated in order to derive such limits.' ACSH proposed an Annex I entry in the case of DEE but limited it to the emissions from older types of engine. Further investigations for newer engines would however be needed according to the ACSH opinion prior to decision regarding possible inclusion in Annex I. The principle of including an OEL for DEE in Annex III was agreed subject to taking into account, inter alia, feasibility in certain employment sectors, in particular mining and construction and taking environmental background levels into account in certain workplaces. Nevertheless, no potential concrete value has been proposed in the ACSH opinion. Differentiation between 'older' and 'newer' type of engines is relevant as the technological progress and EU emission standards have led over time to a considerable change in the composition of DEE emissions in general, and to its content of carcinogens in particular. IARC, in its recent monograph on 'Diesel and Gasoline Engine Exhausts and some Nitroarenes' classified diesel engine exhaust as 'carcinogenic to humans' (Group 1) but noted that the 'qualitative and quantitative composition of exhausts depends on the fuel, the type and age of the engine, the state of its tuning and maintenance, the emission control system, and pattern of use', and that 'in the past two decades, progressively tighter emission standards for on-road vehicles, introduced in North America, Europe, and elsewhere, have triggered advances in diesel technology that resulted in lower emission of particulate matter, nitrogen oxides, and hydrocarbons.' Taking the above mentioned considerations into account it is considered that the ACSH opinion has not been sufficiently consensual, and that there are concerns about legal clarity of the proposal. More specifically, the option of including DEE in Annex I is withheld at this stage because: 1) the definition of the substance with reference to 'older' or 'traditional' type of engines lacks necessary clarity from a legal point of view and would be very difficult, if not impossible, to implement. Furthermore, in formal terms, a reference to the European emissions standards based on Directive 70/220/EEC combined with a reference to a certain type of engines was not deemed as complying with the requirements for inclusion under Annex I of the CMD; 2) given the lack of clear distinction between 'new' and 'old' type of engines it would be impossible to evaluate the extent of the current use and consequently impacts that inclusion in Annex I and the resulting obligation to substitute would have on industry (especially mining and SMEs); 3) on 15th September 2016 a fourth list of indicative occupational exposure limit values was adopted in implementation of the Chemical Agents Directive (CAD, Council Directive 98/24/EC). This list includes indicative OELs for mono-nitrogen oxides (NOx), which are the most notable non-carcinogenic hazardous gases in DEE, and which will require an industry response to control emissions, which will have an additional beneficial effect in reducing exposure of workers to the carcinogenic components in DEE. Analysis of impacts of introducing an Annex I entry under CMD requires further consideration of these factors.

Without an Annex I entry defining the carcinogen, it is impossible to establish an OEL for a PGS such as DEE. Further noting SCOEL's conclusion that establishing a 'health-based' threshold for worker exposure to DEE is currently not possible, that no specific value has been reflected in the ACSH Opinion, and that there are practical difficulties with the measurement techniques suggested by the ACSH . Amending CMD in relation to DEE is withheld at this stage, pending further investigations into whether a legally clear definition can be proposed. In the meantime the Commission would support any relevant sectoral social dialogue – particularly noting the interest of social partners in the extractive industries – with a view to establish good practices and develop common definitions which could eventually feed into future amendments and complement legislative action. Individual components will be analysed with a view to introducing action in relation to them in further updates. 4.2.4. Amending CMD in relation to rubber process dust and fumes (RPDF) Working in rubber industry can cause leukaemia and cancers of the larynx and lung. Occupational exposure in the rubber manufacturing industry is classified as group 1 carcinogen by IARC. Because rubber process dust and fume are 'process-generated' and are not 'supplied' as such they are not subject to classification according to CLP. Rubber process fumes and dust are highly complex mixtures, the compositions of which varies considerably, but many studies have shown that they contain carcinogens. The presence and concentration of specific carcinogens depends on the production process and rubber mixture. The opinions of the social partners represented in the ACSH differ. The employers prefer to use a 'substance by substance' approach and not to include the rubber fumes and rubber process dust in Annex I, arguing that technological progress such as an increased use of closed processes, ventilation and increased automatisation has reduced the exposure levels. Industrial hygiene monitoring of separate substances have also contributed to lower exposure levels. The workers representatives favour inclusion of rubber fumes and dust in Annex I, and making certain processes exempt if it can be shown that those processes are free of carcinogens. Given the lack of an agreed ACSH position on the most appropriate approach as well as the fact that the complexity of the mixtures makes it difficult to establish a sufficiently clear definition, amending CMD in relation to rubber process dust and fumes is withheld at this time. At the same time, several known carcinogenic components of rubber process dust and fume – namely benzene and PAHs – are already subject to consideration for 'carcinogen specific' measures under CMD. 4.2.5. Amending CMD in relation to 4,4'-Methylene-bis-(2 chloraniline) (MOCA) MOCA has been classified by IARC as carcinogenic to humans (Group 1) and as a Category 1B carcinogen in the EU under CLP. It is also associated with occupational asthma and chronic obstructive pulmonary disease. In its pure form it is solid at room temperature and has low volatility. It is easily absorbed through the skin and the dermal route of exposure is the most important. SCOEL and ACSH have, due to the nature of the pattern of exposure, recommended a biological limit value and a skin notation and no airborne OEL. However, several Member States have established inhalation exposure limit values for MOCA, ranging from 0.005 to 0.22 mg/m3. Moreover, ECHA's RAC has considered and assessed the inhalation route and derived a dose-response curve for the chemical. This assessment will need to be taken into account in a future proposal for action with regard to the substance in order to ensure the maximum protection of workers and consistency between the approach under CMD and REACH. Finally, the use of biological limit value, in particular in the framework of the CMD, needs to be discussed and agreed and the Commission will explore the possibilities on how best to address this issue. 4.3Discarded options Several other options have been discarded as they were considered disproportionate or less effective in reaching the objectives of this initiative. These options are listed below. The reasons for discarding A, B and C are detailed in the previous IA. A. Banning the use of the carcinogenic chemical agents B. Providing industry-specific scientific information without amending CMD C. Market-based instruments D. Industry self-regulation A ‘Charter for the safe use of Trichloroethylene in metal cleaning’ established by the European Chlorinated Solvents Association 'represents a voluntary agreement open for signature by producers and importers' of TCE as a 'voluntary industry-wide commitment ensure adequate control of risks related to use of trichloroethylene' as identified in an earlier EU risk assessment with a view to 'safeguard the long-term sustainable use of trichloroethylene in closed-systems for metal cleansing'. The ECSA Charter stipulates that, since the end of 2010, trichloroethylene is only supplied by signatories for metal cleaning or degreasing if the user has an enclosed cleaning system and has confirmed that trichloroethylene will only and exclusively be used in enclosed cleaning equipment. It has been signed by all European Trichloroethylene producers and an importer.

While the ECSA Charter is a welcome initiative, it should be noted that the effectiveness of self-regulation is hindered by the following: it does not apply to all uses of TCE; TCE importation the EU is not heavily represented; and it is not binding and cannot therefore be enforced by national authorities. Consequently, the ECSA Charter, while an important and valuable industry measure signalling positive intention, is not considered as effective as CMD amendments in setting and enforcing minimum protection for workers across the EU and in all sectors of industry. E. Regulation under other EU instruments (REACH) Both CMD and the REACH Regulation are relevant for worker protection from the majority of carcinogens considered in this assessment. REACH is a relevant regulatory instrument for protection of workers from hazardous chemicals, including in particular chemical carcinogens REACH and the OSH Directives are complementary, and clear synergies between REACH and worker protection legislation can be seen – these are set out in more detail in section 3.2.2 of this supplementary IA and sections 2.3 and 14.2 of the earlier full IA. In the case of the present proposal, CMD is the more appropriate regulatory instrument. Among the reasons in support of this approach there is the fact that CMD covers worker exposure to carcinogenic agents released by any work activity, whether produced intentionally or not, and whether available on the market or not, such as process generated substances in the workplace. Furthermore, CMD is intended to set OELs, which are an important part of the wider OSH approach to managing chemical risks. F. Directly adopting the most stringent national OEL For most of the carcinogens some Member States adopted OELs more stringent than considered in this proposal. It could be argued that workers' protection could be further improved if such OELs were to be made binding across the EU based on an assumption that what is achievable in one Member State should be achievable in all. However, a more stringent OEL may exist in a Member State where, for example, certain industries or industrial processes are less prominent or even not present or where the structure of the industry is different (e.g. relatively less SMEs). Also, there may be significant differences as for access to and affordability of new exposure control technologies. Such an assumption is therefore incomplete. The EU sets minimum standards in this area and OELs need to be seen in the context of the minimisation principle. This means that Member States are encouraged to establish limit values which are more protective than the EU OELs and that industries have the obligation to minimise exposure below existing OELs if that is technically feasible. 4.4Options and carcinogens retained for consideration Table 3 below summarises different policy options for each of the seven chemical agents, which are subject to further impact assessment. A baseline scenario of no further EU action is Option 1 for each chemical agent represented in this initiative. Directly reflecting the Opinion agreed by the ACSH, forms Option 2 for each chemical agent. Where appropriate and depending on specific characteristics of the agents, flanking options which, compared with the ACSH Opinion, provide for either lower (more stringent) or higher (less stringent) EU legal requirements, are presented as Option 3 and/or 4 respectively for each chemical agent. These flanking options are drawn from the IOM study, for which they were established by preference: i) from a SCOEL Recommendation if available; ii) as OEL values reflecting available data (for example taking account of existing national OELs); or iii) on the basis of recommendations from the contractor (for example taking into account non-EU OELs). Where available data do not support flanking options, these options are discounted. In addition, for each chemical agent where SCOEL has identified significant risk of adverse systemic effects from non-inhalation exposures the options are augmented with 'notations' indicating dermal risk in the form of a 'skin notation' ('sk.'). Table 3. Options matrix Carcinogen Option 1 (baseline) Option 2 (ACSH opinion) (mg/m3and ppm – parts per m),, Option 3 (more stringent) (mg/m3and ppm – parts per m) Option 4 (less stringent) (mg/m3and ppm – parts per m) Epichlorohydrine (ECH) n/a Annex III entry 1.9 mg/m3 Sk. n/a n/a Ethylene dibromide (EDB) n/a Annex III entry 0.8 mg/m3 (0.1 ppm) Sk. n/a n/a Ethylene dichloride (EDC) n/a Annex III entry 8.2 mg/m3 (2 ppm) Sk. Annex III entry 4.1 mg/m3 (1 ppm) Sk. Annex III entry 20.5 mg/m3 (5 ppm) Sk. 4,4'-Methylenedianiline (MDA) n/a Annex III entry 0.08 mg/m3 Sk. n/a Annex III entry 0.8 mg/m3 Sk. Trichloroethylene (TCE) n/a Annex III entry 8TWA 54.7 mg/m3 (10 ppm) STEL 164.1 mg/m3 (30 ppm) Sk. n/a Annex III entry 8TWA 273.5 mg/m3 (50 ppm) STEL 164.1 mg/m3 (30 ppm) Sk. Complex PAH mixtures with benzo[a]pyrene as an indicator n/a Annex III entry Sk. Annex III entry 0.002 mg/m3 Sk. n/a Mineral Oils as Used Engine Oils (UEO) n/a Annex I entry Annex III entry

Sk. n/a n/a

5What are the impacts of the different policy options and how do they compare? 5.1Study methodology Different policy options have been compared based on the following methodology: The introduction of a measure is expected to result in a reduction in the occupational exposure to the carcinogen concerned. The extent of such reduction depends on the current levels of exposure, as well as on the projected future levels of exposure in the absence of the proposed measure, i.e. the 'Baseline scenario', corresponding to Option 1. Depending on the specific situation with regard to each chemical (past trends, state of technological developments etc.), the baseline scenario taken from the IOM study foresees static baselines (i.e. where no changes in exposures were expected beyond 2010) or dynamic ones, where current trends (e.g. 4% annual reduction) is expected to continue till at least 2030. This projection of future exposure levels is obtained by extrapolating past declining trends in average exposure levels. It should be noted that any assumed exposure reductions refer to the geometric mean exposure levels (i.e. intensity of exposure) rather than the numbers of workers exposed. Further information on how baselines were defined in the study can be found in annex 5 (especially sections 12.1 and 12.2). For a given reduction in exposure levels, the expected decrease in the incidence of cancer cases is estimated over a given timeframe attributable to the carcinogen in question. This requires estimates of the risk of carcinogenicity, which can be derived from the existing toxicological and epidemiological literature, as well as information about the actual level of worker exposure (numbers, level, duration and frequency of exposure). The available epidemiologic evidence is however scarce and not always sufficiently robust, inevitably affecting the reliability of the derived estimates for the number of cancer registrations and deaths. The health benefits of avoided cancer registrations and deaths can then be expressed in monetary terms by applying standard evaluation methods. The valuation of health impacts was undertaken based on two approaches. In the low scenario, the estimate per incident is made of its Value of Life Years Lost and the related Cost of Illness (including in that case direct, indirect and intangible costs). In the alternative, high scenario the Willingness To Pay (WTP) approach was applied as the only value per incident case. The WTP approach typically reflects what people are willing to pay to avoid having cancer (both fatal and non-fatal). This under the assumption of the study includes such items as: lost wages, medical expenses, the monetary value of the disutility of illness and the impact of preventive expenditures. The WTP estimate for fatal cancers was used (1,793,776 EUR) in most cases. For the non-melanoma skin cancer a lower WTP was used (38,827 EUR). Those values were derived from the sources and guidance available at the time the study was undertaken. A more recent OECD study, summarising a four year-effort to compile and analyse the largest database to date containing all studies based on the States Preference method that have been prepared around the world, proposes a range of 1.8-5.4 million (2005 USD) for the average adult VSL for EU-27, with a base value of 3.6 million USD. In parallel, a study commissioned recently by the European Chemicals Agency (ECHA), found that the WTP values for a premature cancer death ranges between 3,500,000-5,000,000 EUR. This points to a possible underestimation of the benefits as computed under the IOM study. These monetised health benefits can in turn be compared to the expected monetary costs that would have to be incurred in order to comply with the proposed OEL. The estimate of the costs was made based on a literature research and data obtained from stakeholder contacts and take into account the following factors: the number of firms needing to apply the relevant Risk Management Measures (RMMs) and the costs of these RMMs over the considered period; the costs of administrative procedures of implementing the OELs (such as the costs of monitoring and audit); the potential effect on the market for the substance by the imposition of the OEL. 5.1.1. Analytical challenges As explained in more detail in the previous IA and in Annex 5 (section 12.4) the cost-benefit analysis poses numerous challenges, related, inter alia, to the long latency of cancers, scarcity of reliable data on exposures and effects of existing obligations on employers. Evolution in exposure Exposure estimates, derived from the IOM study, are based on the assumption that for many of the concerned chemical agents, past trends of declining exposures will continue. These trends were related to technological progress, changes in work organisation and relative weight of different industrial sectors but also to past legislative developments. It is difficult to predict whether such trends would indeed continue in the absence of further EU action. The 60-year time frame of the assessment poses also the challenge of anticipating future industrial developments. For each of the carcinogens several industry sectors are relevant, in total a high number of very diverse sectors are concerned (from e.g. car maintenance, through pharmaceutical industry, mining, steel production, asphalt production, textile manufacture, rubber and plastic industries). Analysing technological developments and making more detailed forecasts as for expected evolution for all these diverse sectors would pose a lot of challenges. As many and These industries are impacted by diverse developments impact these industries, such as technical inventions, oil prices, market structure etc., we cannot predict how all those things will impact the baseline.. The uses of the chemical agents under consideration could either decline or grow and potential new uses could lead to new workplace risks. In addition, even when declining trends in average exposure levels are observed, it may be misleading to regard these as exogenous. Recent reductions in exposure may have been precisely the result of OELs having been introduced or as an anticipation of those changes. Moreover, a 2016 report by the Netherlands National Institute for Public Health and the Environment (RIVM) indicates that, despite projected declining exposure levels, 'forecast impacts will probably not be lower than those of 2012' (p. 36). Period for estimation The period of estimation was set in order to take into account the long risk exposure period (REP) for specific types of cancer: for solid tumours a latency of 10-50 years was assumed and for haematopoietic neoplasms a latency of 0-20 years was assumed. The future cancer burden is estimated over a 60 years period. Reliable and timely data First of all, for most chemical agents under consideration, data on the number of workers exposed is scarce and unreliable (especially for some sectors and/or for some Member States), and data on the current exposure levels across EU Member States is generally not available. Member States record statistics relating to cancer in different ways which cannot be readily aggregated. Where exposure data is available, its use as an evidence base for regulatory decision-making is often confounded by the sensitive and sometimes confidential nature of the information, and the potential for source bias. This lack of data is recognized and in order to address this data gap the Commission initiated a study in 2013. The outcome of this work is expected to contribute to a better definition of the baseline situation for possible future initiatives.

Secondly, the available epidemiologic evidence is scarce and not always sufficiently robust, inevitably affecting the reliability of the derived estimates for the number of cancer registrations and deaths. Among the factors contributing to the scarcity of reliable data are the complexity of cancer development and also of workplace exposures. Different carcinogens can, for example, result in the same type of cancer (e.g. lung cancer), and occupational exposure to hazardous agents is characterised by simultaneous exposure to multiple chemical agents. It can therefore be difficult to establish a causal relationship between cancer cases and exposure to a specific carcinogen. Moreover, occupational cancers may develop decades after exposures – including during retirement – complicating the possibility of identifying a causal link. This also has a significantly negative impact on potential to improve evidence base for future proposals. As explained in more detail in the previous IA and in Annex 5 (section 12.4) these challenges and the fact that effects of diseases other than cancer which may be caused by the chemicals are not taken into account explain why health benefits are likely to be underestimated. 5.1.2. General remarks Analysis of impacts on Member States, competitiveness, and proportionality For each of the seven carcinogens, an analysis of possible policy options is presented by chemical agent in the following sub-sections. The IOM study identifies the number of EU workers exposed to each chemical agent and, in most cases, also identifies exposed working populations by Member States. An illustration of the OELs in place at national level is provided in Annex 10, as well as the estimated number of workers potentially exposed by Member State. Furthermore, Table 4 in Annex 7 identifies the population of workers occupationally exposed to each chemical agent in Member States having no OEL or less stringent OELs, and compares this to the overall EU population of exposed workers, resulting in the percentage of workers in the EU for whom legal protection would be improved by adoption at EU level of an OEL under CMD. In addition to consideration at section 6.2.2 of impacts on competition and competitiveness for the package of retained options, a brief reference to non-EU countries' OELs is given in each sub-section. Costs related to skin notations In order to effectively control total systemic exposure to chemicals at the workplace, it is necessary to take account not only of exposure by the inhalation route, but also of dermal exposure, which may lead to skin penetration and a consequent increase in the total body burden. It is therefore in some cases necessary to assign a ‘skin notation’ to some carcinogens in order to warn of the possible significant contribution of dermal absorption. A SCOEL recommendation for a skin notation is not related to CLP dermal hazard classification - it is not intended to give warning of, for example, direct effects on the skin such as corrosivity, irritation, and sensitisation. Nevertheless, of the seven carcinogens considered for the allocation of 'skin' notations in the retained options below, six are supplied in the EU bearing hazard warnings relating to dermal exposure. As a result of these hazard classifications employers should already be taking steps to manage risks to workers by avoiding dermal exposure – compliance costs for employers (if any) should therefore be minimal. The main positive effect of establishing a skin notation is that employers should thereby be alerted that a considerable part of the 'body burden' is the result of the uptake via the skin, and that biological monitoring would, if possible, be a valuable additional tool to ensure that adequate risk management measures are in place. Where the IOM study or this analysis have identified particular additional costs or benefits resulting from assigning a skin notation to a given carcinogen these are addressed in the appropriate sections below. A more detailed account of general OEL policy considerations, including skin notations, is given in Annex 4 at section 11.2.2. Comparison key The comparison tables used in the following sections apply the following ranking symbols: '0' – baseline, '≈' – similar to baseline, '+' more efficient/effective or coherent than baseline; '++' – much more efficient/effective or coherent than baseline; '-' – less efficient/effective or coherent than baseline; '- -' – much less efficient/effective or coherent than baseline. 5.2Epichlorohydrine (ECH)

Beside its probable carcinogenicity to humans, epichlorohydrine in liquid form has been found to cause skin burns and the vapour can cause irritation of the eyes, nose and throat. Workers’ inhalation and dermal exposures are controlled via the use of closed systems with engineering controls such as vapour return lines during product transfer, the dry disconnect style of fittings for transfer hoses and automated sampling systems. Personal protective equipment is also used to reduce exposure. Significant exposures are therefore likely to occur only during maintenance activities, or during accidental releases. There are 15 high volume (>1,000 tonnes per annum) producers or importers of epichlorohydrine within the European Union in the following member states: Germany (4), Netherlands (3), United Kingdom (2), Italy (2), Sweden (1), Finland (1), Austria (1) and Belgium (1). Annual production in the EU is estimated at around 360,000 tonnes per annum, while annual global production is estimated at around 900,000 tonnes. The total estimated number of exposed workers in the EU is 43,813. Table 4. Epichlorohydrine – Types of impacts Impact Option 1: Baseline Option 2: Annex III entry

1.9 mg/m3 (0.5 ppm)

Sk. Economic It is assumed that exposure levels remain the same and that firms will not incur costs to reduce exposure under the baseline scenario. It is estimated that, under the baseline scenario, firms are already achieving exposures less than 1.9 mg/m3. Therefore no significant additional costs are expected to meet the OEL, nor is negative impact on competitiveness anticipated. As per 'General remarks' skin notations should not result in additional cost as employers should already under the baseline be taking steps to manage risks to workers by avoiding dermal exposure. No impact on employment is expected. Social (incl. health) The total number of attributable deaths for 2010-2069 is estimated to 2430, including both lung and central nervous system (CNS) cancers. There is an estimated increase of the number of predicted attributable deaths throughout this period, entirely due to the increase in the longevity of the population. The corresponding health costs are estimated to be between €1362m and €2752m. YLLs are estimated to increase over the period, from 317 to 426 years per annum for lung cancer, and from 324 to 388 years per annum for CNS cancer. No significant health costs or benefits compared to the baseline are expected with the introduction of the OEL, as exposure is already estimated to be below the value. Skin notations may be expected to improve awareness and enforceability. Environmental No significant impact No significant impact Prevalence was estimated in the IOM study using the 2006 Labour Force Survey and the 2006 data from the Structural Business Statistics to estimate the proportion of employees in each industry. It was not possible to use CAREX data as epichlorohydrine was not included in the 2007 update. It is likely that all European facilities have already achieved a level of control equal or below 1.9 mg/m3. Table 5. Epichlorohydrine – Comparison of options Criteria Option 1: Baseline Option 2: Annex III entry

1.9 mg/m3 (0.5 ppm)

Sk. Effectiveness 0 ≈ (OEL likely already achieved in practice) Efficiency 0 ≈ (no significant additional costs) Coherence 0 + Scientific advice (SCOEL) (Adopted 2011) Epichlorohydrine is categorised into the SCOEL carcinogen group A as a non-threshold carcinogen. SCOEL strongly recommends avoiding occupational exposure to epichlorohydrine. SCOEL has also proposed a skin notation. SCOEL, in it is Recommendation (SCOEL SUM 169), concluded that it is not possible to derive a health based OEL. SCOEL makes reference to quantitative data on carcinogenicity as assessed by the Dutch Expert Committee on Occupational Standards (DECOS) on the estimated additional lifetime cancer risk ACSH An 8hr TWA of 1.9 mg/m3 is proposed. In the case of epichlorohydrine, in-depth discussions between the representatives of workers, employers and governments in the ACSH resulted in an agreement to propose an OEL as in option 2. No concerns about technical feasibility, overall costs or impact on competitiveness outside the EU have been raised by employers' representatives or government representatives. The fact that SCOEL could not, based on the available data, derive a health-based OEL has been taken into consideration in the discussions in the ACSH during which an agreement was reached on the numerical value of the proposed OEL. The impact assessment confirms that the option supported by the ACSH opinion (OEL of 1.9 mg/m3) is appropriate. According to the available data this exposure level is likely to have been achieved in practice. While no immediate health benefits are identified on the basis of current knowledge, introduction of an OEL with a skin notation as recommended by SCOEL would ensure legal protection for workers and enhanced clarity for enforcers and economic operators. Option 2 is therefore the preferred option. Impact on Member States, competitiveness, and proportionality In the case of epichlorohydrine, 15 Member States will need to introduce (7) or update (8) their OEL to bring it down to 1.9 mg/m3 (see table 2 of Annex 7 and Annex 10). Around 69% of exposed workers are estimated to work in those 15 Member States and would consequently benefit from improved legal protection as a result of the introduction of this OEL. Non-EU countries have established a wide range of exposure values. This OEL is equivalent to that in place in countries such as New Zealand and South Korea, although more stringent (China) and less stringent OELs (e.g. US, Australia, Singapore) are applied in some other third countries. As indicated above no significant impact on competitiveness is expected. 5.3Ethylene dibromide (EDB)

Ethylene dibromide (EDB) is classified as a Category 1B carcinogen according to CLP, and has been identified as a Group 2A carcinogen by IARC. EDB is categorised into the SCOEL carcinogen group A as a genotoxic carcinogen without a threshold. EDB is strongly irritant to the eyes, skin and respiratory tract, and acute exposure (200 mg/kg) is lethal to humans. EDB is currently used as a chemical intermediate in synthesis and as a non-flammable solvent for resins, gums and waxes. The major chemical made from EDB is vinyl bromide. EDB has also been used as an intermediate in the preparation of dyes and pharmaceuticals. An important use of EDB has been as a lead scavenger in 'antiknock' mixtures added to gasolines, although this use has decreased with banning the use of lead-containing fuels in many countries. In this context, it is important to notice, that ECHA, in its recent Risk Management Option Analysis (RMOA) for EDB of 16 July 2015 came to the conclusion, that 'The substance is registered for uses within the scope of authorisation (i.e. formulation of anti-knock additive into aviation fuels and potentially some non-intermediate use in fine chemicals/pharmaceutical manufacture). The substance could be proposed to be identified as a Substance of Very High Concern to be included in the Candidate List for potential prioritisation to Annex XIV. However, the European Commission considers that it is more appropriate to address the main non-intermediate use of the substance, i.e. additive in leaded aviation gasoline, at international level and/or under other EU legislation than REACH.' According to ECHA , this substance has three active registrations under REACH, one Joint Submission(s) and no Individual Submission(s). It is manufactured and/or imported in the European Economic Area in 1,000 – 10,000 tonnes per year. Under 8,000 EU workers are estimated to be potentially exposed to 1,2-dibromoethane. Out of them, about 100 workers employed in the chemical manufacturing sector would be confronted with potentially high levels of exposure. Table 6. Ethylene dibromide (EDB) – Types of impacts Impact Option 1: Baseline Option 2: Annex III entry

0.8 mg/m3 (0.1 ppm)

Sk. Economic A 7% annual decline in average exposure is assumed under the baseline. It is estimated that less than 1% of enterprises in the chemical manufacturing sector would be affected. The total cost of anticipating investment, which is assumed to take place gradually also under the baseline scenario, is in the range of €30-170k. A majority of companies will incur costs related either to appropriate use of respiratory equipment (€0.5k-2k, per company per year), possibly combined with a better use of ventilation systems (€3k-7k, per company per year). The additional costs for companies are in practice expected to be very low, as the vast majority of companies have appropriate risk management measures already in place. There is no risk of closures or competitiveness losses. Consequently, there are no risks for employment. As per 'General remarks' skin notations should not result in additional cost Social (incl. health) No health impact quantification possible. No health impact quantification possible. Better use of protective equipment and ventilation systems is expected to have a positive (although modest) impact on health. Skin notations may be expected to improve awareness and enforceability. Environmental No significant impact No significant impact According to the estimations performed in the IOM study about 8% of workers in chemical manufacturing are exposed to average levels above 0.1 ppm. Estimates of current exposure levels were obtained by extrapolating data from existing studies conducted in the 1990s, assuming an average annual reduction in exposure of 7%. Due to the limited epidemiological information regarding the carcinogenic effects of EDB, it is not possible to identify appropriate relative risks in order to quantify the health impacts of introducing new exposure limits. Even if majority of companies affected are micro- and small enterprises, compliance costs are expected to be very low and affordable, as the vast majority of companies have appropriate risk management measures already in place. It is therefore assumed that the introduction of an OEL of 0.8 mg/m3 would not imply any important costs associated with compliance, neither major social, macro-economic or significant environmental impact. All interest groups (employers, employees and governmental) of the ACSH agreed that the proposed OEL does not present a difficulty because the predicted costs of compliance are low. Table 7. EDB – Comparison of options Criteria Option 1: Baseline Option 2: Annex III entry

0.8 mg/m3 (0.1 ppm)

Sk. Effectiveness 0 ≈/+ (modest improvement of protection) Efficiency 0 ≈ (very low additional costs) Coherence 0 + Scientific advice (SCOEL) (Adopted 2011) SCOEL, in it is Recommendation (SCOEL SUM 166), concluded that EDB is both a local and systemic experimental carcinogen, its mode of action is clearly genotoxic, and it is categorised as carcinogen group A, meaning a non-threshold carcinogen. SCOEL strongly recommends avoiding occupational exposure to ECH. The quantitative data on carcinogenicity and the present state of toxicokinetic inter-species modelling do not permit a reasonable and reliable quantitative cancer risk assessment for humans to be derived and for this reason SCOEL did not propose a numerical value for an OEL. A 'skin' notation is justified. ACSH 0.8 mg/m3. The opinion of the workers group is that a reduction of the proposed value should be striven for within a review period of not more than three years. In the case of EDB, in-depth discussions between the representatives of workers, employers and governments in the ACSH resulted in agreement that the proposed OEL as in option 2 represents a pragmatic risk management measure. No concerns about technical feasibility, overall costs or impact on competitiveness outside the EU have been raised by employers' or governments' representatives. Workers' representatives indicated that the limit value should be further reduced at a future date. The fact that, based on the available data, SCOEL could not derive a reasonable and reliable quantitative cancer risk assessment for humans, has been taken into consideration in the discussions in the ACSH during which an agreement was reached on the numerical value of the proposed OEL.

The impact assessment confirms that the option supported by the ACSH opinion (OEL of 0.8 mg/m3) is appropriate. Introduction of an OEL with a skin notation as recommended by SCOEL could entail some health benefits (though quantification of those is not possible) and would ensure legal protection for workers and enhanced clarity for enforcers and economic operators. Option 2 is therefore the preferred option. This is also in line with the conclusions drawn in the RMOA of ECHA for EDB. Impact on Member States, competitiveness, and proportionality In the case of EDB, 20 Member States will need to introduce (11) or update (9) their OEL to bring it down to 0.8 mg/m3 (see annexes 7 and 10). 81% of exposed workers are estimated to work in those 20 Member States (see table 4 of Annex 7) and would consequently benefit from improved legal protection as a result of the introduction of this OEL. Few non-EU countries have established exposure values and for those who have, the values are higher than the retained option, except in one case for US-NIOSH (0.045 ppm). No concerns about impact on competitiveness outside the EU have been raised. 5.4Ethylene dichloride (EDC) Ethylene dichloride (EDC) is classified as carcinogen (IARC Group 2B and CLP Category 1B) for its carcinogenic effects at multiple sites in rats and mice, both by oral dosing and by inhalation. Next to its carcinogenic properties, EDC is a highly flammable liquid and vapour, is harmful if swallowed, causes serious eye irritation, causes skin irritation and may cause respiratory irritation. Additionally, it is toxic if inhaled. The substance is subject to REACH Authorisation based on its carcinogenic properties, and included as entry 26 in Annex XIV to the REACH Regulation. The so-called sunset date for the substance is 22 November 2017. The deadline for submitting applications for authorisation was 22 May 2016. 10 applications have been submitted by that deadline. For the purpose of analysis it is assumed that all uses of EDC which are in scope of REACH authorisation are subject to effective worker protection which has been duly considered by the European Chemicals Agency (ECHA) Committees and the European Commission. However, the main use of EDC (more than 95% of the total volume) is as an intermediate on site in the synthesis of vinyl chloride monomer (VCM). Use as an (transported) intermediate for VCM synthesis represents more than 4% of the total amount of EDC. In addition, small amounts are also used as an intermediate in the production of ethylenediamines, tri- and tetrachloroethylene and other chlorinated solvents and as a solvent in pharmaceutical processing. All these uses of EDC as intermediate (more than 99% of the total volume) are outside the scope of authorisation, and can therefore result in exposure of workers. According to registration information, the total amount of EDC manufactured in the EU is between 1,000,000 –10,000,000 t/y. Another 10,000 – 50,000 t/y are imported into the EU. There are at least 18 producers and importers in the EU making more than 10 million tonnes per annum. Less than 3,000 workers are potentially exposed in Europe (2009 data), most in the manufacture of VCM and about 500 exposed when 1,2-dichloroethane is used as a solvent in the pharmaceutical industry. The number of workers exposed outside of VCM manufacturing is small and the amounts of 1,2-dichloroethane used are also small, and it is likely to be well controlled as well. The IOM Study reports 2,264 workers exposed workers in EDC and vinyl chloride monomer (VCM) manufacturing facilities in the EU. An estimated 11% of EDC and/or vinyl chloride monomer manufacturing workers would be exposed above 4.1 mg/m3 (1 ppm) 8 TWA and 0.36% above an equivalent 20.5 mg/m3 (5 ppm.). Table 8. Ethylene dichloride (EDC) – Types of impacts Impact Option 1: Baseline Option 2: Annex III entry 8.2 mg/m3

(2 ppm)

Sk. Option 3: Annex III entry

4.1 mg/m3 (1 ppm)

Sk. Option 4: Annex III entry 20.5 mg/m3

(5 ppm)

Sk. Economic Calculated decline in exposure of 9% per year. Additionally the substance is now subject to REACH authorisation. Compliance costs have not been directly calculated for this option but are assumed to lie in between costs for options 3 and 4. As per 'General remarks' skin notations should not result in additional cost - employers should already under the baseline be taking steps to manage risks to workers by avoiding dermal exposure. Impact on employment unlikely. Compliance cost 2010-2069: 0-€43m (see text below for indication of costs per company) As per 'General remarks' skin notations should not result in additional cost - employers should already under the baseline be taking steps to manage risks to workers by avoiding dermal exposure. Impact on employment unlikely. Compliance cost 2010-2069: 0-€13m. (see text below for indication of costs per company) As per 'General remarks' skin notations should not result in additional cost - employers should already under the baseline be taking steps to manage risks to workers by avoiding dermal exposure. Impact on employment unlikely. Social (incl. health) No health impact quantification possible. Better use of personal protective equipment should have a positive health impact. Skin notations may be expected to improve awareness and enforceability. No health impact quantification possible. Better use of personal protective equipment should have a positive health impact. Skin notations may be expected to improve awareness and enforceability. No health impact quantification possible. Better use of personal protective equipment should have a positive health impact. Skin notations may be expected to improve awareness and enforceability. Environmental No significant impact No significant impact No significant impact No significant impact

Even if this substance is subject to REACH authorisation as of 22 November 2017, which will eventually phase out all non-essential uses, the impact of the introduction of an OEL on worker protection should not be underestimated. Less than 1% of the total production volume of this substance will be subject to REACH authorisation, and occupational exposure might still occur in the intermediate uses of the substance The IOM Study suggests existing pr