EUROPEAN COMMISSION Brussels, 22.9.2020 SWD(2020) 183 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(2020) 571 final} - {SEC(2020) 302 final} - {SWD(2020) 184 final}



1.Introduction: Political and legal context 2.Problem definition 2.1.What is/are the problems? 2.2.What are the problem drivers? 2.3.How will the problem evolve? 3.Why should the EU act? 3.1.Legal basis 3.2.Subsidiarity: Necessity and added value of EU action 4.Objectives: What is to be achieved? 4.1.General objectives 4.2.Specific objectives 4.3.Consistency with other EU policies 5.What are the available policy options? 5.1.Process for setting binding OELs and associated provisions under CMD 5.2.Description of the retained policy options for establishing binding OELs under the CMD 6.What are the impacts of the policy options? 6.1.Acrylonitrile 6.2.Nickel compounds

6.3.Benzene 7.How do the options compare? 8.Preferred options 8.1.Summary of the preferred options 8.2.Overall impact of the package or preferred options 9.How will actual impacts be monitored and evaluated? 9.1.Monitoring arrangements 9.2.Evaluation arrangements Annex 1: Procedural information Annex 2: Stakeholder consultation Annex 3: Who is affected and how? Annex 4: Analytical methods Annex 5: National OELs Annex 6: Relevant sectors, uses and activities Annex 7: Route(s) of exposure, adverse health effects Annex 8 – Process for setting binding OELs and associated provisions under the CMD Annex 9 – Options discarded at an early stage Annex 10 – Consistency and synergies with the REACH RegulationDisclaimer. Unless otherwise specified, the information and views set out is this report refer to EU28 aggregated data collected before the 1st February 2020, date of the withdrawal of UK from the EU.Disclaimer. Unless otherwise specified, the information and views set out is this report refer to EU28 aggregated data collected before the 1st February 2020, date of the withdrawal of UK from the EU. Glossary

Term or acronym Meaning or definition ABS Acrylonitrile-Butadiene-Styrene ACSH Advisory Committee on Safety and Health at Work ASA Finnish Register of Workers Exposed to Carcinogens (altistuminen syöpäsairauden vaaraa aiheuttaville tekijöille (ASA-luettelo)) BLV Biological Limit Value CAD Chemical Agents Directive (Directive 98/24/EC) CAREX CARcinogen EXposure database CDB Current Disease Burden CEEMET Council of European Employers of the Metal, Engineering and Technology-based industries CEFIC European Chemical Industry Council CESI European Confederation of Independent Trade Unions CLP Classification, Labelling and Packaging Regulation (Regulation (EC) No 1272/2008) CMD Carcinogens and Mutagens Directive (Directive 2004/37/EC) COPD Chronic Obstructive Pulmonary Disease COWI SA Consulting Group CSRs Chemical Safety Reports DALY Disability-Adjusted Life Year DEEE Diesel Engine Exhaust Emission DNEL Derived No Effect Level DRR Dose Response Relationships ECEG European Chemical Employers Group ECHA European Chemicals Agency EFBWW European Federation of Building and Woodworkers EODS European Occupational Diseases Statistics EPSU European Public Service Union ERR Exposure Risk Relationship ETUC European Trade Union Confederation EU-OSHA European Agency for Safety and Health at Work FDB Future Disease Burden GDP Gross Domestic Product GDV General Dilution Ventilation IARC International Agency for Research on Cancer INRS Institut National de Recherche et Sécurité IMF International Monetary Fund Lat Latency LEV Local Exhaust Ventilation MaxEx Maximum Exposure MinEx Minimum Exposure MoR Mortality Rate NACE Nomenclature des Activités Économiques dans la Communauté Européenne NHS UK’s National Health Service OEL Occupational Exposure Limit (value) OSH Occupational Safety and Health PPE Personal Protective Equipment PROCs United Kingdom’s National Health Service PV Present Value R&D Research and Development RAC Risk Assessment Committee of ECHA REFIT Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (Regulation (EC) No 1907/2006) RMMs Risk Management Measures RMOA Regulatory Management Option Analysis RPE Respiratory Protective Equipment SAN Styrene-Acrylonitrile SDS Safety Data Sheet SLA Service Level Agreement SLIC Senior Labour Inspectors' Committee STEL Short Term Exposure Limit SVHC Substance of Very High Concern SWD Staff Working Document TFEU Treaty on the Functioning of the EU TWA Time-Weighted Average UEAPME European Association of Craft Small and Medium-sized Enterprises WTP Willingness to Pay 1.Introduction: Political and legal context Cancer, irrespective of whether it is related to work or not, is the second leading cause of mortality in the EU countries after cardiovascular diseases, accounting for about a quarter of all deaths. It is recognised as one of the major contributors to premature deaths in the European Union. It has an impact not only on individual health, family life, but also on the national health and social systems, the governmental budgets and the productivity and growth of the economy. Stepping up the fight against cancer is therefore an urgent priority for the EU. To that end, as announced by European Commission President von der Leyen in her Political Guidelines, the Commission will present before the end of 2020, a European plan to reduce the suffering caused by the disease and support Member States to improve cancer control and care in order to ensure more fair access to treatment across the EU. Fighting against occupational cancer is all the more necessary that occupational cancer remains the first cause of work-related deaths in the EU, as shown in the figure 1 below. 52% of annual occupational deaths in the European Union are currently attributed to cancer, compared to 24% to circulatory diseases, 22% to other diseases and 2% for injuries. Addressing occupational cancer will also be an integral part of the Europe’s Beating Cancer Plan. The initiative comes in the backdrop of an unprecedented crisis for the EU and the world. The Covid-19 pandemic has major health, economic and social consequences that will need to be addressed. The pandemic also sheds light on the importance of health and safety considerations in workplaces, especially for those in the front line of the response to crisis. It gives yet another incentive to redouble the efforts to protect workers and societies from all possible occupational risks, thereby having a positive impact on employment and economy. A strong social Europe calls for constant improvements towards safer and healthier work for all. As outlined in the Communication on “A strong social Europe for just transitions,” measures for the protection of workers need to keep up with a wide range of social, economic and technological developments while at the same ensuring continuous protection from traditional risks. In this Communication, the Commission has already committed to review the occupational safety and health (OSH) strategy to address among others the exposure to dangerous substances, with a view to maintain European’s high OSH standards. The European Pillar of Social Rights, jointly proclaimed by the European Parliament, the Council and the Commission at the Social Summit for Fair Jobs and Growth on 17 November 2017, enshrines workers' right to healthy, safe and well-adapted work environment, including protection from carcinogens. In its Communication on “Safer and Healthier Work for All,” the Commission emphasizes that European Union must continue investing in occupational safety and health and has committed to step up the fight against occupational cancer through legislative proposals. The recent extension of the Roadmap on Carcinogens covenant, which was signed in Helsinki on 28 November 2019, also proves that a significant number of stakeholders continue to be committed to improve the protection of workers from the exposure to carcinogenic substances. Reducing exposure to carcinogens and mutagens at the workplace by setting EU-wide occupational exposure limit values (OELs) effectively contributes to the prevention of cancer cases and deaths, as well as other significant non-cancer health problems caused by these substances. Consequently, it improves the protection of workers by increasing the length, quality and productivity of the working lives of European workers and ensuring a similar minimum level of protection across the EU, contributes to better productivity and competitiveness of the EU, and improves the level playing field for businesses. In order to further contribute to a better protection of workers, this Commission continues its process of updating the Carcinogens and Mutagens Directive (CMD) to keep abreast with the new scientific and technical developments and to take account of its stakeholders' views. This is in line with the Directive itself, which requires that OELs must be set for all those carcinogens or mutagens for which this is possible in the light of the available information. Consistency with the REACH Regulation is ensured in this respect. The finalised REFIT Occupational Safety and Health evaluation as well as the conclusions of the REACH REFIT evaluation have underscored and fed into this process. Updating and reviewing the CMD has now become a continuous process Over the last few years, the Commission proposed three directives amending the CMD. These three proposals have been adopted by the European Parliament and the Council . These three revisions, which addressed 26 substances, enabled among others to revise two existing OELs, introduce 22 new OELs and set a skin notation without any OELs for the remaining two. The REFIT OSH evaluation says that “following concerns raised by different stakeholders’ groups in the evaluation process and in the National Implementation Reports, the need to adopt limit values for more substances should be considered. These additional OELs should lead to a better chemical risk management in the future”. Therefore, the Commission will continue the process of updating and reviewing the CMD with the aim to propose new or revised OELs in Annex III to the CMD. It is not realistic 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. This prioritisation of the substances is based on a broad consultative approach, including opinions issued by the tri-partite Advisory Committee on Safety and Health at Work (ACSH), agreement in its Working Party on Chemicals (WPC), and formal two-stage social partners’ consultation (SPC). The selection of the specific three substances or groups of substances (hereafter “substances”) considered in this impact assessment, namely acrylonitrile, nickel compounds and benzene, folllowed the same path, including a formal two-stage consultation of the European Social Partners launched in July and November 2017, in accordance with Article 154 of the Treaty on the Functioning of the European Union (TFEU). It was agreed by all relevant stakeholders, taking into account factors such as the potential to cause adverse health effects, degree of evidence of such effects, as well as their severity, potency and reversibility, that these three substances are of high relevance for the protection of workers. The Commission's intention to prepare for the establishment or revision of OELs for those priority carcinogens was confirmed and encouraged by all the stakeholders. For the specific case of benzene, although an EU OEL of 3.25 mg/m³ already exists in the CMD since 2004, the most recent scientific and technical evidence indicates that this existing EU OEL should be updated. This is in line with the recital 13 of the CMD laying down that “limit values must be revised whenever this becomes necessary in the light of more recent scientific data”. Furthermore, the ACSH strongly recommended the Commission to adopt as soon as possible a revised OEL under the CMD for benzene. In order to carry out its impact assessement, the Commission contracted a study to COWI S/A (hereafter “COWI study”) in order to collect the most recent information for the three substances. According to the data arising from this study, more than 1 million EU workers are currently exposed to these hazardous substances. This impact assessment aims to assess whether there is a need to introduce new (for nickel compounds and acrylonitrile) or revised (for benzene) OEL for these substances, to address them with other legal or non-legal initiatives, or not to take any action.

Given the level of scientific and technical knowledge required to identify measures ensuring adequate protection of workers while being practically feasible for industries, the Commission bases its proposals in this area on opinions developed by the ACSH. The opinions of ACSH take into account the scientific basis, which is indispensable to underpin OSH legislation. In order to establish this scientific basis for the ACSH, the Commission sought advice from the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA). This is in line with the REACH REFIT evaluation in which the Commission proposed to “enhance the role of ECHA’s RAC, involving also social partners, to provide scientific opinions under the OSH legislation while respecting the role of the ACSH” with the aim to clarify the interface between REACH and other pieces of EU legislation. 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. Member States authorities, employers' and workers' representative bodies within the tripartite ACSH strongly anticipate the legal clarity and increased protection which would be the result of new or revised OELs of these substances. The analysis presented in this document should be read in conjunction with the earlier impact assessment (IA) for the first proposal, which provided an exhaustive consideration of the CMD, the policy and legal context. The most essential points are carried over and supplemented by additional information and analysis regarding these three additional carcinogens. 2.Problem definition 2.1.What is/are the problems? As mentioned in section 1, 52% of annual occupational deaths in the EU are currently attributed to cancer. Furthermore, carcinogenic and mutagenic substances lead not only to cancers, but also to other important health problems. For example, exposure to benzene, in addition to leukaemia, also causes leukocytopenia, lymphocytopenia, neutrocytopenia and thrombocytopenia. More information about all the health effects for the three substances addressed in this initiative are available in table 1. As mentioned in the previous section, more than 1 million workers are currently exposed to acrylonitrile, nickel compounds or benzene. If no action is taken at the EU level, these workers will continue to run the risk of contracting a cancer or other severe health problems. Furthermore, ineffective prevention of the exposure to carcinogens entails negative consequences for business such as higher costs and reduced productivity due to absenteeism, lost expertise and distorted competition. For Member States, this also leads to increased social security costs and missed tax revenues. The problem tree below summarises the main drivers behind the problem and the resulting consequences for workers, business and Member States: 2.2.What are the problem drivers? 1. 2. 2.1. 2.2. 2.2.1.Exposure of workers to carcinogens represents a significant risk to workers’ health This section presents an overview of the estimated numbers of workers exposed to the substances subject to this initiative and a short explanatory summary for each substance. More detailed information is provided in annex 6.

Different sources compile different estimates of the total number of exposed workers. For the purpose of this impact assessment, for each substance the most reliable number has been taken forward for the baseline scenarios and for the cost-benefit assessments related to the retained options for establishing limit values. Carcinogen Exposed workforce (number of workers) Health effects caused Major occupational exposure route Acrylonitrile 10,000 – 33,000 -Brain, stomach, tongue, intestines and mammary gland cancer -Nasal irritation Primary route of exposure is through inhalation, although exposure can also occur through dermal contact. Nickel compounds ~87,500 -Lung and nasal cancer -Pulmonary morbidity and miscarriage Primary route of exposure is by dermal contact or by inhalation of aerosols, dusts, fumes of mists containing nickel. Dermal contact may also occur with nickel solutions. Benzene 1,012,500 -Leukaemia -Leukocytopenia, lymphocytopenia, neutrocytopenia and thrombocytopenia Benzene is readily absorbed by all routes (inhalation, dermal and oral), of which inhalation is the most important route of occupational exposure. Total workforce assessed: ~ 1,121,500 Based on COWI study (2019) Acrylonitrile Acrylonitrile is widely used in the aircraft, defence, aerospace and automotive sectors. This substance is particularly important to ensure a transition to technologies which are more environmentally friendly. More information is available at the annex 6. As shown in the table 1, between 10,000 and 33,000 workers are estimated to be exposed to acrylonitrile at their workplace. Such an exposure can lead to brain, stomach, tongue, intestines and mammary gland cancer, but also to other health problems like nasal irritation. Although inhalation is considered as the primary route of exposure, workers can also be exposed through dermal contact. Nickel compounds Nickel compounds are used in a wide variety of sectors and are usually supplied in granule, powder or liquid form. More information about the uses of nickel compounds can be found at annex 6. Table 1 shows that around 87,500 workers are currently estimated to be exposed to nickel compounds. This may have dramatic consequences as exposure to nickel compounds can lead to lung and nasal cancers but also pulmonary morbidity and miscarriage. The primary route of exposure is by dermal contact or by inhalation of aerosols, dusts, fumes of mists containing nickel. Benzene Benzene is produced in petroleum refinery and chemical plant processes and is used as an intermediate in the production of a wide range of chemical substances. Benzene is also used in the manufacturing of some types of rubbers, lubricants, dyes, detergents, drugs, and pesticides. More information about the production and the uses of benzene are available in annex 6. It is assumed that more than 1 million workers are still exposed to benzene and could therefore contract different hazardous diseases like leukaemia, as shown in the table 1. Benzene is readily absorbed by all routes (inhalation, dermal and oral). Inhalation is the most important route of occupational exposure. The table 2 below shows the current and future burden of cancer and other health effects related to the occupational exposure to the three substances under consideration. Given the long latency period of the illnesses considered in this impact assessment, the future health burden is estimated over a 60 year period. However, the disease burden on workers is likely to be underestimated due to several limitations of the data/calculations, which are further explained in the analytical challenges section of the annex 4. For instance, the COWI study does not quantify the burden of all cancers and other adverse health effects but only of those which are known to be caused by the lowest exposures (so-called most sensitive endpoints). When exposed to these substances, workers may develop additional types of cancer and other diseases which could be prevented by establishing an EU-wide OEL as mentioned in the RAC opinions for acrylonitrile, nickel compounds and benzene. The table 2 specifies the health effects which have been quantified and not quantified. As these three substances fall under the CMD, in order to prevent the whole range of health problems, an OEL can only be established under this directive. Furthermore, occupational cancers may develop decades after exposures – including during retirement – complicating the possibility of identifying a causal link, which could lead to underestimation of the disease burden. For the specific case of benzene, table 2 shows that even with an existing EU OEL, a high number of workers can still develop leukaemia and other serious illnesses in the absence of further EU action.

Carcinogen Health effects caused Current* disease burden (quantified) Future** disease burden (quantified) Acrylonitrile Brain cancer (quantified), stomach, tongue, intestines, mammary gland cancer (not quantified) 0.04 – 0.15 1 – 12 Nasal irritation (quantified) 1.6 – 9.4 73 - 408 Nickel compounds Lung cancer (quantified), nasal cancer (not quantified) 12 149 Pulmonary morbidity (quantified) 135 718 Miscarriage (quantified) 12 90 Benzene Leukaemia (quantified) 30 300 Leukocytopenia (quantified), lymphocytopenia, neutrocytopenia and thrombocytopenia (not quantified) 25 237 TOTAL 215.64 - 223.55 1568 - 1914 * Incidence in 2018 ** The future health burden is estimated over a 60 year period Based on COWI study (2019) 2.2.2.New scientific and technical evidence is available that could lead to updating of existing or establishment of new OELs Under the CMD, employers must identify and assess risks to workers associated with exposure to 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. For some chemical agents, the CMD establishes binding OELs at the EU level. The fact that OELs are established does not affect the obligations of the employer to comply with other rules, including to reduce the exposure of his/her workers to carcinogenic and mutagenic substances to as low a level as is technically possible (minimisation of the occupational exposure). The existence of OELs provides clarity and OELs are very relevant benchmarks for employers enabling them to know exactly the levels above which exposure cannot occur. OELs also allow employers to determine the level below which their risk management measures should aim to comply with the obligation to reduce the exposure to as low a level as is technically possible. To this end, Safety Data Sheets (SDS), and more especially their section 8.1, are very important for downstream users to identify and apply appropriate measures in order to adequately control the risk of the chemicals at their site. OELs also support enforcement authorities in controlling that employers are putting in place the relevant risk management measures, including those that could contribute to lower the exposure below the OELs. Under the CMD, the European Parliament and the Council shall set out limit values in Directives on the basis of the available information, including scientific and technical data, in respect of all those carcinogens or mutagens for which this is possible, and, where necessary, other directly related provisions. For the substances covered in this impact assessment, the scientific advice has been provided by RAC which adopted its three opinions on 9 March 2018 . The tripartite ACSH also adopted opinions for all three on 4 June 2019. It is therefore appropriate to consider updating the CMD based on the above-mentioned information. Further information on the scientific advice and ACSH opinions is provided in annexes 1 and 2, respectively. Among the three substances addressed in this impact assessment, only benzene has already an EU wide OEL of 3.25 mg/m³ dated from 2004. Although this EU OEL already provides among others clarity and support enforcement by authorities as explained above, the most recent scientific and technical evidence indicates that it should be updated. This is in line with the CMD obligation to revise OELs whenever this becomes necessary in the light of more recent scientific data. 2.2.3.Diverging national OELs create different competing conditions and protection levels across the EU The 2004 benzene OEL enabled to set a minimum common protection for all the workers dealing with this substance across the EU and limited the different competing conditions. The table 3 below, which lists among others the lowest and highest binding national OELs, shows that the Netherlands have set an OEL more than four times more stringent than the EU wide OEL. We can also deduce from this table that 10 countries adopted a level stricter than the EU OEL. Although differences in national OELs for benzene remain, this EU OEL limits the scope for divergences. If no EU OEL had been set, we cannot exclude that some Member States would not have established a national OEL yet. Although there is still no EU wide OEL for acrylonitrile, 21 Member States have already set a national OEL in their own legislation while 7 Member States have no OELs yet. These national OELs range from 0.5 mg/m³ in Latvia to 7 mg/m³ in Slovenia and Slovakia. In the absence of any EU wide OEL for nickel compounds, the table below shows that only a few Member States have already set an OEL. However, 19 out of the 23 Member States with no single national OEL for nickel compounds have a mix of OELs for some or all of these compounds. Moreover, the strictest OEL for nickel compounds is eight times lower than the highest limit value. Table 3 : National OELs in EU Member States Carcinogen Lowest (strictest) national binding OEL (mg/m3) Highest (least strict) national binding OEL (mg/m3) Member States with no OEL Acrylonitrile 0.5 LV 7 SI, SK 7 BG, CY, HR, IT, LU, MT, NL* Nickel compounds** (inhalable fraction) 0.03 DE 0.25 PL 23*** AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, HR, IE, IT, LT, LU, LV, MT, NL, PT, SI, SK, UK Benzene 0.7 NL 3.25 BE, BG, CY, ES, EL, FI, FR, HR, IT, LT, LU, LV, MT, PT, RO, SI, SK, UK 0 * In the Netherlands, in the absence of national OEL, industry is responsible for setting individual OELs. Among these substances with no national OEL is acrylonitrile. ** Single OEL for all the nickel compounds *** 19 Member States have OEL(s) for some or all nickel compounds Based on COWI study (2019) As shown in the table 3, the disparities between the existing national OELs for the three substances are high, which leads to different level of protection of the EU workers. In addition to this main consequence, such differences also cause complications for businesses operating in different Member States and bring confusion to cross-border companies which have to deal with highly diverging OELs. To a lesser extent, these disparities could also provide potential incentive for companies to locate their production facilities in Member States with the lower standards, which would prevent the smooth functioning of the internal market. Such disparities may also be a brake to the freedom of movements of workers, as they could renounce to accept a job in another Member State, for fear to receive weaker health and safety protection. Annex 5 provides an overview of all national OELs in EU Member States for the substances considered under this initiative. 2.2.4.Modern production technologies allowing lower exposure to carcinogens or mutagens are not fully exploited Although modern production technologies allow to reduce further the occupational exposure to carcinogenic and mutagenic substances in the workplace, their implementation is not yet generalised in all the companies dealing with the three substances addressed in this initiative. One possible reason is that decisions of business are often influenced by short-term cost assumptions rather than long-term benefits.

For example, as regards acrylonitrile, although a significant part of the companies have already a closed system in place, some companies having laboratories using this substance mainly use hoods as ventilation system. Moreover, it is assumed that companies operating at low concentration levels usually have full enclosure local exhaust ventilation (LEV) while the others have partial enclosure or open hood LEV. Companies working at higher levels of exposure should therefore invest in full enclosure LEV where possible. According to a consultation survey carried out in the framework of the COWI study, companies indicated in which types of risk management measures (RMMs) they would invest to comply with OELs of 0.01 and 0.03 mg/m³ for nickel compounds. As an example, 30% of the companies that replied to this survey would make investments in partial hoods to comply with an OEL of 0.03 mg/m³. This tends to prove that companies do not always use the most modern production technologies allowing to reduce the exposure to carcinogens or mutagens. A similar consultation survey was conducted for companies dealing with benzene. During this survey, several companies indicated that it was possible to reduce further the exposure of workers to benzene, meaning that they do not use the most modern production technologies yet. 2.3.How will the problem evolve? In the absence of EU action, it is estimated that workers exposed to these substances will continue to face the risk of contracting occupational cancer or other adverse health effects. Estimations on the numbers of cancer and other hazardous diseases cases and their associated health costs over a 60-years period in case no action is taken are contained in the table 4 below (baseline scenario). The general obligations set by the CMD, employers' actions and measures adopted by Member States contribute overall to lowering exposures. Exposure levels have generally been decreasing in the past years and this positive trend could continue in the future. Substitution may be possible for some carcinogens in the future, also the numbers of workers in the industries using these carcinogens may change, and technological developments could facilitate lower exposure concentrations. 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, as explained above, the existing employers' practices as well as protective measures at Member State level do not always reflect available scientific and technological knowledge. For that reason, assumptions are based on the legal provisions contained in the CMD, including the minimisation requirements, but also on other data including information gathered from the stakeholders. The objective has been to define a baseline scenario as close as possible to the future situation. However, it is very challenging to anticipate all the developments over such a long period. Further demographic changes increase the life expectancy of workers exposed and, therefore, the chances to develop the illnesses mentioned in table 2. More information about the past and future trends regarding the number of workers exposed and the exposure concentrations are available in Chapter 6. Member States usually do not inform the Commission on their intentions to revise existing or determine new OELs in their national legislation. However, national administrations represented in the ACSH 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. Carcinogen No. of exposed workers Expected no. of cancer cases Expected no. of cases of other adverse health effects Estimated health costs Possible underestimations (non exhaustive list) Acrylonitrile 10,000 - 33,000 1 - 12 73 - 408 291,000 – 7,446,000 Some health endpoints (neurotoxicity, cancer sites other than brain) could not be quantified Nickel compounds ~87,500 149 808 52,674,000 – 124,800,000 Some health endpoints (sinonasal cancer) could not be quantified Benzene 1,012,500 300 237 202,000,000 – 331,000,000 Some health endpoints (haematotoxic effects) could not be quantified Total ~ 1,121,500 450 - 461 1118 - 1453 254,965,000 – 463,246,000 Source: COWI study (2019) 3.Why should the EU act? 3.1.Legal basis Article 153 TFEU empowers the EU to support and complement the activities of the Member States as regards improvements, in particular of the working environment to protect workers' health and safety and to adopt, by means of directives, minimum requirements for gradual implementation, having regard to the conditions and technical rules obtaining in each of the Member States. On the basis of this provision, Article 16 (1) of the CMD provides a specific legal basis for action, allowing for adoption of limit values in respect of those carcinogens or mutagens for which this is possible, having regard to the available information, including scientific and technical data. 3.2.Subsidiarity: Necessity and added value of EU action 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 up to date with those developments. Updating the CMD to take account of newer scientific evidence is an effective way to ensure that preventive measures would be updated accordingly in all Member States. The ex-post evaluation of the European Union occupational safety and health Directives (REFIT evaluation) emphasizes that chemicals classified as carcinogens and mutagens continue to be manufactured across the EU and workers in manufacturing but also downstreams users continue to be exposed to them. The main conclusions of this evaluation indicates that the CMD is considered as of high relevance. Following concerns raised by different stakeholders’ groups in the evaluation process and in the National Implementation Reports, the need to adopt limit values for more substances should be considered. These additionals OELs should lead to a better chemical risk management in the future. This initiative is the fourth update of the CMD aiming to set additional OELs for all those carcinogens or mutagens for which this is possible in the light of the available information, as required by the article 16 of the CMD. In the future, the Commission will continue to evaluate the need to propose additional OELs in the CMD and to propose additional amendments when needed, in collaboration among others with the ACSH. Amending the CMD can only be done by action at EU level and it presents an EU added value in several respects:

Improved clarity and enforcement Establishing new OELs for acrylonitrile and nickel compounds will provide common reference points that are 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 plants. Clear support for establishing OELs for the substances subject to this initiative has been expressed from key stakeholders as it clearly results from the two phases of the consultation of the social partners and the opinions of the tripartite ACSH. Ensuring a similar minimum level of protection across the EU The CMD aims to improve workers’ health and safety by protecting them against risks arising or likely to arise from exposure to carcinogens or mutagens at work. This objective is in line with the European Pillar of Social Rights and the commitment of President von der Leyen to step up the fight against cancer in the context of a European plan against cancer. Limit values under the CMD are an important component of the general arrangements for the protection of workers. As laid down in Article 16 of the CMD, limit values should be established for all those carcinogens and mutagens for which the available information, including scientific and technical data, makes this possible. Such OELs should also be revised whenever this becomes necessary in the light of more recent scientific data. As mentioned in annex 8 related to the process for setting OELs under the CMD, it is not realistic to set an OEL for each hazardous chemical that may be used at the workplace. Therefore, the Commission identified acrylonitrile, nickel compounds and benzene as priority substances, following the procedure detailed in annex 8. This list of substances to be addressed in the 4th revision of the CMD has been approved by the Social Partners in the context of the formal two-stage consultation for which more information is provided in annex 2. As highlighted in section 2.2.3., the difference between the national OELs may be very high. For instance, national OELs for acrylonitrile range from 0.5 mg/m³ to 7 mg/m³, meaning that some Member States have set limit values fourteen times lower than others. And in addition to that, 7 Member States have no OELs yet to prevent workers’ exposure to this substance. 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. With regard to the specific case of benzene, although an EU OEL already exists, its revision will ensure a more appropriate minimum level of protection across the EU. Contribution to a level playing field Employers' organisations stressed in their response to the social partner consultation that setting EU OELs helps to provide a level playing field for industry. The costs of complying with lower national levels are generally higher and entail, therefore, a competitive advantage for enterprises operating in markets with no or less stringent national OELs. Setting EU OELs will not completely eliminate the differences between Member States. Indeed, they retain the possibility to adopt lower limit values as shown for benzene in table 3. However, it will limit (acrylonitrile and nickel compounds) or further limit (benzene) the scope for divergences and enhance certainty that there is a core definition and/or enforceable exposure limit for all concerned carcinogens in all Member States. 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 with likely substantial savings on administrative costs. These resources saved could instead be dedicated to improve further the occupational health and safety policies in each Member State. 4.Objectives: What is to be achieved? 4.1.General objectives The main general objective of this initiative is to ensure to the workers the right to a high level of protection of their health and safety at work, as laid down in the principle 10 of the European Pillar of Social Rights, and to prevent death caused by work-related cancer and other health problems as mentioned in the Commission Communication on “Safer and Healthier Work for All”. 4.2.Specific objectives The specific objectives are:

·To further improve protection from occupational exposure to carcinogens and mutagens in the European Union; ·To increase the effectiveness of the EU legal 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 adopting minimum requirements at the European level. The existence of OELs provides clarity by determining among others the maximum level of exposure with which employers must comply. However, complying with the OELs does not prevent the employers from their other obligations pursuant to the CMD, including the reduction of the exposure as low a level as is technically possible. 4.3.Consistency with other EU policies Charter of Fundamental Rights of the EU 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. REACH Regulation The REACH Regulation, entered into force in 2007, establishes among others two distinct EU regulatory approaches that are restrictions and authorisations. Restrictions enable the EU to impose conditions on the manufacturing, placing on the market and/or use of substances, in mixtures or in articles, and authorisation is designed to ensure that risk of substances of very high concern (SVHCs) is properly controlled while promoting progressive substitution by suitable alternatives that are economically and technically viable. The applicable provisions of REACH authorisation and/or restriction of the chemical substances under consideration in this assessment, are as follows: ·Restriction: all uses of benzene and its mixtures with some exemptions, the use of nickel and its compounds in jewellery and articles which are intended to come into contact with the skin, the use of acrylonitrile and its mixtures supplied to the general public. ·Authorisation: none of these substances are subject to authorisation under REACH. More information about the REACH restrictions for the three substances is available in annex 10. Having an OEL under the CMD plays an important role in the reduction of worker exposure to benzene. Industrial processes covered by other EU legislations which set up specific quantity of emission of benzene, are indeed not subject to the REACH restriction for this substance. Setting an OEL for nickel compounds under the CMD will also enable to reduce the exposure of workers to this group of substances. As the REACH restriction for acrylonitrile does not concern the industrial uses, the setting of an OEL for this substance under the CMD will improve the protection of workers as they are not covered by the REACH restriction. Europe’s Beating Cancer Plan In her political guidelines for the next European Commission, President von der Leyen recognized that there is much more the European Union can do about cancer and committed to put forward a European plan to fight cancer. On 4 February 2020, the Commission launched an EU-wide public consultation on Europe’s Beating Cancer Plan on the occasion of a conference entitled “Europe’s Beating Cancer Plan: Let’s Strive for More”hosted in the European parliament. Europe’s Beating Cancer Plan will be structured around four pillars: prevention, early diagnosis, treatment and follow-up care. This proposal is fitted with the objectives of the prevention pillar such as measures to reduce environmental risk factors, for instance pollution and exposure to chemicals, and in particular the reduction of the exposure to carcinogens in the workplace. 5.What are the available policy options? 5.1.Process for setting binding OELs and associated provisions under CMD

A simplified outline of the process for the development of EU OELs for carcinogens and mutagens is set out here. A more detailed description is provided for in annex 8. As mentionned in Chapter 1, the selection of the specific three substances considered in this impact assessment was based on a consultative approach, including opinions issued by the tripartite ACSH and a formal two-stage consultation of the social partners. It was agreed by all relevant stakeholders, taking into account factors such as the potential to cause adverse health effects, degree of evidence of such effects, as well as their severity, potency and reversibility, that the three substances are of high relevance for the protection of workers. The Commission's intention to prepare for the establishment of OELs for those priority carcinogens was confirmed and encouraged by all the stakeholders. Figure 3: simple representation of typical EU OEL setting procedure (Source: ECHA website) 5.2.Description of the retained policy options for establishing binding OELs under the CMD The reference limit values per substance are presented below. In addition to the baseline scenario, options for OELs have been considered at the level proposed by the ACSH, including the transitional OELs, and at additional reference points (e.g. the strictest limit value observed among Member States, OELs derived by the RAC). It needs to be noted that the most stringent national OEL might not always be feasible as an EU standard for the following reasons: firstly, the substances subject to this proposal are used in many different industries, and for some industries it might be difficult to comply with strict OELs due to their specific production processes. Member States with the strictest OELs might not host the industries having problems to comply with the strictest OEL. Secondly, industries are at different stages in their maturity and use varying technologies and processes. Thus, in Member States and industries with more advanced and automated production processes it would be easier to reach a low OEL. However, this cannot prevent the European Union to set a similar and adequate minimum level of protection across the EU. These considerations are taken into account in the analysis substance by substance. All the OELs recommended by the ACSH, including the transitional limit values, as well as the OELs derived by the RAC, are covered by the different scenarios for each substance and are mentioned in the table 5 below. The OELs unanimously recommended by the three Interest Groups of the ACSH (Employers, Workers and Governments) have been established through scientific, technical and socioeconomic discussion. However, the costs and benefits of the combination of a targeting OEL and a transitional OEL have not been assessed in the COWI study. Therefore, it has not been possible to consider them as individual policy options. However, it is reasonable to consider that accompanying an OEL with transitional measures would have limited impacts on the benefits and relatively higher impacts on the costs. Furthermore, the OELs recommended by the ACSH as transitional OELs are covered by the policy options. For acrylonitrile, an OEL at the level of the lowest limit value in the Member States and another OEL two times higher the OEL recommended by the ACSH and the RAC have been retained as policy options . These two policy options for acrylonitrile are reference points aiming to establish whether the OEL recommended by the ACSH is appropriate to follow. As in the previous impact assessments, several other options than the retained policy options mentioned above have been discarded as they were considered as disproportionate or less effective in reaching the objectives of this initiative. More information about these discarded options is available in annex 9. Table 5: Options matrix of OELs Carcinogen Option 1 Baseline Other options Option 2 Option 3 Option 4 Acrylonitrile no EU OEL 0.5 mg/m3 1 mg/m3 (ACSH / RAC) 2 mg/m3 Nickel compounds (inhalable) no EU OEL 0.03 mg/m³ (RAC) 0.05 mg/m³ (ACSH) 0.1 mg/m³ (ACSH transition value) Benzene 1 ppm (3.25 mg/m³) (current EU OEL) 0.05 ppm (0.16 mg/m³) (RAC) 0.2 ppm (0.66 mg/m³) (ACSH) 0.5 ppm (1.62 mg/m³) ( ACSH transition value) 6.What are the impacts of the policy options? Different policy options presented in the options matrix in table 5 have been compared based on the methodology outlined in detail in annex 8. Other options than those supported by the ACSH in its opinions, such as the OEL recommended by RAC, are presented as reference points for the assessment of the ACSH options, to establish whether these are appropriate to follow. Analytical methodology The introduction of an OEL 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”. The baseline or "no policy change" option includes all relevant EU-level and national policies and measures which are assumed to continue being in force in the absence of further EU action. The baseline also takes into account as much as possible how the problem would evolve, considering legal provisions contained in the CMD but also all relevant societal, economic and technical developments that would probably occur in the following decades. For instance, the expected decrease of the use of petrol due to the gradual change to electric vehicles is taken into account. It also includes the existing national OELs, the current number of workers exposed and its evolution over time, the current and future exposure levels, the current risk management measures, the voluntary industry initiatives, the development of new technologies/growing use of substitutes, the future use of the substances and any other relevant factors. For a given reduction in exposure levels, it is then necessary to estimate the expected decrease in the incidence of cancer and non cancer cases over a given timeframe to the carcinogen in question. This requires estimates of the risks of carcinogenicity and other adverse health effects, which can be derived from the existing toxicological and epidemiological literature, as well as information about the current level of worker exposure (number of workers, level, duration and frequency of exposure).

The health benefits of avoided cancer and non-cancer diseases registrations and deaths can then be expressed in monetary terms by applying standard evaluation methods, in line with the Better Regulation Toolbox guidance. These health benefits of implementing new or revised OELs are calculated in terms of the costs of ill health avoided. 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 RMMs needed to comply with the proposed OEL, the costs of these RMMs for each company, the life span of the RMMs and the number of companies. The monetised health benefits are also compared to the other costs, including costs for public authorities, as well as to the potential effects on the market for the substance by the imposition of an OEL. The benefits and costs of possible OELs are measured against the baseline, meaning that only marginal costs and marginal benefits are taken into account (for example, additional costs added to the current costs to comply with REACH regulations). Given the complementarity between the regulation under REACH and the minimum requirements established through the CMD, the past and present REACH measures have been specifically taken into account in assessing the baseline and the impacts of the proposed CMD measures for all substances in this report. More information about the analytical methodology, but also some analytical challengens arising from this cost-benefit analysis, are further discussed in annex 4. 6.1.Acrylonitrile Acrylonitrile is not subject to authorisation according to Annex XIV of REACH but its use is restricted under Entry 28 of Annex XVII under the REACH Regulation. However, this restriction only concerns the general public and not workers. More information about this restriction can be found in annex 10 of this impact assessment. There is not yet any OEL for acrylonitrile at the EU level. In the absence of any further action, up to 12 new brain cancer and 408 nasal irritation cases resulting from future exposure are estimated to occur in the coming 60 years, which would cost respectively up to €5,692,000 and €1,754,000. With regard to brain cancer, a 30 years latency period and a mortality rate of 80% are assumed. It should be borne in mind that only two health endpoints (brain cancer and nasal irritation) have been used in this impact assessment, which could lead to underestimate even further the exact number of cancer cases and other adverse health effects. Table 6: Baseline scenario over 60 years for acrylonitrile Types of cancer caused Brain (quantified), stomach, tongue, intestines, mammary gland (not quantified) Other adverse health effects Nasal irritation (quantified) No. of exp. workers 10,000 to 33,000 Change exp. level Past: 3% Future: 0% Change no. of exp. workers Past: 0% Future: 0% Current disease burden (CDB) - no. of brain cancer cases 0.04-0.15 Future disease burden (FDB) - no. of brain cancer cases 1–12 CDB no. of other adverse health effects Nasal irritation: 1.6-9.4 FDB no. of other adverse health effects Nasal irritation: 73–408 Exp. no. of deaths FDB cancer 0.8 – 9.6 Exp. no. of deaths FDB other adverse health effects Presumed 0 Monetary value FDB brain cancer Method 1: €417,000–€5,692,000 Method 2: €269,000–€3,678,000 Monetary value FDB other adverse health effects Method 1: €22,000–€121,000 Method 2: €314,000–€1,754,000 Based on COWI study (2019) *Workforce turns over at 5% p.a. Impacts of the policy options The table 7 below shows the multi-criteria analysis, summarizing both the monetised impacts as well as those that are assessed qualitatively. In its opinion, RAC derives a limit value of 1 mg/m³ (0.45 ppm) which assumes a mode of action-based threshold for the carcinogenic effects of acrylonitrile. RAC also recognises that “there may be occupational tasks at industrial sites presenting a short term acute exposure risk”. For that reason, It also derives a short-term exposure limit (STEL) of 4 mg/m³ (1.8 ppm). The costs and benefits for STEL values could not be monetised for acrylonitrile. However, the three Interest Groups in the ACSH opinion recommended the same OEL and STEL as RAC accompanied with a 4-years transition period starting from the entry into force of the Directive revising the CMD. Although the main route of occupational exposure to acrylonitrile is by inhalation of the vapour, RAC noted that dermal exposure is also possible. Acrylonitrile can indeed readily penetrate the skin. For that reason, RAC recommended to set a skin notation. This skin notation has also been recommended by the ACSH. Compliance cost levels for companies generally depend on the extent to which exposures are currently close to the required OELs. The higher the difference between the current exposure levels and the required OEL is, the higher the investments in RMMs will be. Since the exposure levels in the different sectors using acrylonitrile are already very low, the compliance costs for companies should be very limited.

Complying with an OEL of 1 mg/m³ as recommended by the RAC and the ACSH would cost to the employers €28,000,000 over a 60 years period, which corresponds to between 0.02% and 0.07% of the turnover, depending on the current average exposure and the size of the company. This is not considered to be significant enough as to force companies to cease operating. However, these compliance costs have to be entirely considered as one-off costs which will be dedicated to investements in LEVs. A transition period could therefore be necessary to mitigate the adverse effects of such upfront effort by enabling companies to anticipate the changes, more gradually introduce improvements and plan the necessary investments. In the event of the introduction of an OEL of 0.5 mg/m³, compliance costs would represent up to 0.12% of the turnover and could, therefore, have more consequences for companies. Some of the costs included in the estimated compliance costs concern RMMs that may be required in any case to control exposure to other substances, leading to a possible compliance costs overestimation. Given their lower turnovers, SMEs usually encounter more difficulties to comply with lower OELs than the large companies. For an OEL of 1 mg/m³, it is estimated that SMEs will have to invest up to 0.07% of their 60-years turnover while larger companies could only need to invest 0.02% of their turnover. The estimated costs for this scenario therefore remain relatively low and no SMEs are expected to close down. However, as mentioned above these costs will be one-off costs and a transition period could be needed for companies, especially SMEs that might need more time to manage the investments. In the event that the OEL would be set at 0.5 mg/m³, SMEs could face compliance costs of up to 0.12% of their turnover. The impact of introducing any of the OELs on competitiveness are estimated to be relatively modest. Only a very limited number of companies interviewed mentioned that the introduction of an EU OEL could have a moderate or even significant impact. With regard to research and development (R&D) expenditures, even if the estimates of the costs arising from the implementation of the different OELs represent a relatively small percentage of overall turnover, they still represent an increase in costs compared to the current situation, which may slightly put the R&D expenditures under pressure. As no closures have been estimated for any of the OELs suggested in this impact assessment, it is likely that there would be low or very limited impacts on workers in terms of employment. With regard to environmental aspects, the impact of setting an OEL for acrylonitrile should also be very limited. People living close to acrylonitrile productions are indeed exposed to very low levels of acrylonitrile in the air and the introduction of an EU-wide OEL should not lead to higher levels. In addition to that, the overwhelming majority of the companies dealing with acrylonitrile already uses waste water treatments to avoid any contaminations by water. Administrative costs for Member States will depend on whether they already have a national OEL lower or equal to the proposed EU OEL for acrylonitrile. As mentioned in the table below, all Member States except Latvia would have to revise their national OEL in the event of option 2 or 3. According to the estimates, administrative costs would be of 50,000€ per Member State. In the event of option 4, only Latvia, Poland and Czech Republic would not need to transpose the new EU OEL. Table 7: Multi-criteria analysis on acrylonitrile (all impacts over 60 years and additional to the baseline) Impact Stakeholders affected OEL options Option 2 0.5 mg/m³ Option 3 1 mg/m³ (ACSH) Option 4 2 mg/m³ Economic impacts Compliance costs (one-off and recurrent) Companies €146,000,000 €28,000,000 €280,000 Compliance costs (one-off)* Companies €132,000,000 €30,000,000 €7,800,000 Compliance costs (recurrent)* Companies €13,300,000 -€2,000,000 -€7,500,000 Compliance costs as a percentage of turnover for an average company Companies 0.02%-0.12% depending company size and current exposure level 0.02%-0.07% depending company size and current exposure level Negligible Monitoring Companies €0 €0 €0 Administrative costs Public sector €1,350,000 €1,350,000 €1,250,000 Avoided costs** Companies € 340,000– € 1,100,000 € 340,000–€ 1,100,000 €0–€0 Avoided costs*** Public sector € 27,000– € 89,000 € 27,000– € 89,000 €0–€0 Single market: competition - No. of company closures Companies 0 0 0 Single-market: consumers Consumers Limited impacts expected Single market: internal market**** Companies Highest /lowest OEL from 9 to 1 Highest /lowest OEL from 9 to 2 Highest /lowest OEL from 9 to 4 International competitiveness Companies Limited***** N.A. N.A. Specific MSs/regions - MSs that would have to change OELs Public sector All Member States except LV All Member States except LV All Member States except CZ, PL and LV Social impacts No. of avoided cancer cases (brain cancer) Workers & families 1–12 1–12 0–1 No. of avoided cases (nasal irritation) Workers & families 73–408 73–408 28–176 Avoided costs of ill health, incl. intangible costs – METHOD 1 Workers & families € 440,000 - € 5,800,000 € 440,000 - € 5,800,000 € 110,000 - € 510,00 Avoided costs of ill health, incl. intangible costs – METHOD 2 Workers & families € 583,000 - € 5,430,000 € 583,000 - € 5,430,000 € 185,000 - € 1,050,000 Employment – Jobs lost Workers & families 0 0 0 Employment – Social cost Workers & families €0 €0 €0 Environmental impacts Environmental releases All Limited impact Based on COWI study (2019) * one-off and recurrent costs have been rounded in the COWI study so that the total of these two lines may not correspond to the total compliance costs. ** Including payments related to sick leave, absence from work, insurance premiums *** Including heathcare, loss of tax revenue **** Internal market shows the ratio of highest to lowest OEL before and after implementing the OEL option ***** Approximatively 20% of the companies surveyed in the framework of the COWI study are of the view that the introduction of an OEL of 0.03 mg/m³ would have a moderate or significant impact on their competitiveness outside the EU. This consultation has not been carried out for the two other scenarios. 6.2.Nickel compounds Around 87,500 workers in the EU are estimated to be exposed to nickel compounds in the sectors considered in this impact assessment, namely oil refineries, pigments, frits, catalysts, glass, metals and alloys, metal surface treatment, batteries, materials recovery and welding. Some sectors have not been considered in this impact assessment for the following reasons: ·Lack of source of information: agriculture; ·Marginal exposure or activity in the EU: mining and metal ores, manufacture of basic pharmaceutical products and pharmaceutical preparations, sewerage; ·Considered as covered by other sectors: manufacture of other inorganic base chemicals, manufacture of abrasive tools. Lung cancer is the main cancer endpoint due to an exposure to nickel compounds. The exposure to this group of substances can also lead to other adverse health effects like pulmonary morbidity and miscarriage. Exposure to nickel compounds can also lead to sinonasal cancer. However, this endpoint is supposed to occur at concentrations above those at which lung cancer occurred, and has not been considered in this impact assessment. Nickel compounds are not subject to authorisation according to Annex XIV of REACH. However, as indicated in Annex XVII of REACH (entry 27), the use of nickel and its compounds in jewellery (including watches) and articles that come into contact with the skin is restricted. More information about this restriction can be found in annex 10 of this impact assessment.In addition, all the nickel compounds and their mixtures cannot be supplied to the general public due to the restriction entry 28 of Annex XVII to REACH, similar to the previous case of acrylonitrile. The exposure levels used to estimate the current and future burdens of disease vary from a sector to another. It is assumed that the number of exposed workers remains constant both for the current and future burdens of disease. A mean latency period of 5 years for lung cancer (with a mortality rate of 80%) has been used for the calculations while it is assumed that there was no latency and a zero worker mortality rate for pulmonary morbidity and reproductive toxicity (miscarriage). The calculations enabling to estimate the number of miscarriage cases have been based on the workforce adjusted to represent those of reproductive age. In the absence of any further action, 149 lung cancer, 718 pulmonary morbidity and 90 miscarriage cases could occur over the next 60 years, which would correspond to a total health cost between 53 and 125 million EUR.

Table 8: Baseline scenario over 60 years for nickel compounds Types of cancer caused Lung cancer (quantified), nasal cancer (not quantified) Other adverse health effects Pulmonary morbidity, miscarriage (quantified) No. of exp. workers 87,488 Change exp. level Differs by sector Change no. of exp. workers Past: 0% Future: 0% Current disease burden (CDB) - no. of lung cancer cases 22 Future disease burden (FDB) - no. of lung cancer cases 149 CDB no. of other adverse health effects Pulmonary morbidity: 135 Miscarriage: 12 FDB no. of other adverse health effects Pulmonary morbidity: 718 Miscarriage: 90 Exp. no. of deaths FDB lung cancer 98 Exp. no. of worker deaths FDB other adverse health effects Pulmonary morbidity: 0 Miscarriage: 0 Monetary value FDB cancer Method 2: €43 million Method 1: €69 million Monetary value FDB other adverse health effects Pulmonary morbidity: ·Method 1: €9 million ·Method 2: €54 million Miscarriage: ·Method 2: €674,000 ·Method 1: €1.8 million Based on COWI study (2019) *Workforce turns over at 5% p.a. Impacts of the policy options In its opinion on nickel and its compounds, RAC derives an OEL for respirable fraction of 0.005 mg/m³ (to protect against lunger cancer) and an OEL for inhalable fraction of 0.03 mg/m³ (to protect against sinonasal cancer). RAC also recommends a skin and respiratory sensitisation notation as occupational exposure to nickel compounds may result in contact sensitisation and in rare cases also sensitisation of the respiratory tract. In the ACSH opinion, the three Interest Groups support the notations and, after considering also feasibility and socio-economic aspects, recommend both an OEL of 0.01 mg/m³ for the respirable fraction (which would apply from January 2025, after a transitional period) and an OEL of 0.05 mg/m³ inhalable fraction (with a transitional OEL of 0.1 mg/m³ for the inhalable fraction which would apply until January 2025). The multi-criteria analysis indicating impacts and stakeholders affected is summarised in the table 9 below. Unless otherwise specified, the limit value mentioned in this impact assessment is based on the inhalable fraction. Due to limited availability of relevant data, the impact of changes related to the respirable fraction could not be fully assessed. The compliance costs represent the needed investments in RMMs to comply with the proposed OEL. Complying with an OEL of 0.03 mg/m³ would cost €11 billion to the companies over the next 60 years. These compliance costs would decrease to €4.3 billion and €947 million for an OEL of 0.05 mg/m³ and 0.1 mg/m³ , respectively. The costs of compliance with an OEL of 0.05 mg/m³ and above represent a sustainable percentage of overall turnover, even for SMEs. Small companies operating in the oil refineries, welding and metals sectors would be the most affected and would have to invest 0.18%, 0.15% and 0.12% of their turnover over the next 60 years, respectively. However, these compliance costs would have to be entirely considered as one-off costs which would enable to invest in new RMMs. In the event of an OEL of 0.03 mg/m³, these compliance costs for companies in the oil refineries, welding and metal sectors would represent 0.37%, 0.31% and 0.31% of their turnover over the next 60 years, respectively. To prove their compliance with an OEL, companies have to monitor the exposure of their workers. In order to comply with the OELs recommended by the ACSH, the companies could be required to also measure the exposure of the respirable fraction. The average cost of measurement for both the inhalable and respirable fractions, irrespective of the OELs level, would be of €152,000 every five-years over the next 60 years for large companies, €76,000 for medium companies and €38,000 for small ones. For small companies operating in the metal surface treatment sectors, this could represent more than 0.3% of their turnover. Therefore, it is important to take into account both the compliance and monitoring costs when assessing the potential impacts of each scenario. As mentioned above, small companies operating in the oil refineries, welding and metals sectors would be the most affected in terms of compliance costs, as they would have to invest 0.18%, 0.15% and 0.12% (one-off costs), of their turnover in new RMMs to comply with an OEL of 0.05mg/m³, respectively. In addition to these compliance costs, these companies would also have to deal with monitoring costs representing 0.02%, 0.081% and 0.108% of their respective turnover over the next 60 years. Overall, the impact of both the compliance and monitoring costs may be higher for small companies in comparison with medium and large ones, especially as one-off costs will represent more than two thirds of the total costs. SMEs could therefore face problems when making the initial investments to comply with the new OELs. As requested by the Social Partners in the context of the two-phase consultation, socioeconomic considerations should be taken into account when adding or revising OELs. Therefore, the introduction of a transition period with a temporary higher initial value could be necessary to enable companies to anticipate the changes, gradually introduce improvements and plan the necessary investments. The number of companies which might be forced to fully or partially cease activities varies with the level of the OEL. The stricter the OEL is, the higher the number of closures would be. At the strictest OEL of 0.03 mg/m³, around 90 companies (out of around 60.000) could be forced to close down, among them 80% would be small companies. The main sector impacted would be oil refineries where 61 companies (out of which 51 are small companies), representing 6% of the number of companies operating in this sector, could not be able to make the necessary investmets to comply with this OEL. With OELs of 0.05 mg/m³ and 0.1 mg/m³, this number will be much lower, or even close to zero. In a letter to the European Commission dated 7 October 2019, the Nickel Institute encourages the Commission to follow the ACSH recommendation. Even if they recognised that these values (both inhalable and respirable fractions) are stringent and can be challenging, they remain committed to supporting their implementation. As indicated in the Better Regulation Tool #21, “all compliance costs divert resources from other purposes, potentially including research and innovation”. Although these compliance costs represent a small percentage of the overall turnover, they might still lead to a decrease in the R&D expenditures. This could especially be the case for catalysts and batteries sectors that would need to invest substantial amounts of money in order to position themselves in the Li-ion battery value chain. However, the companies of both these sectors should face low compliance costs compared to their turnover. Looking beyond the EU borders, the majority of the EU competitor countries have OELs for nickel compounds that are higher than 0.05 mg/m³ (including Australia, Canada, Japan South Korea, India, Brazil, USA and China for insoluble nickel compounds). The companies located in these countries could face lower costs due to the less strict measures to protect workers from the exposure to nickel compounds. Companies which also have plants in non EU countries with less stringent legal provisions could be tempted to relocate some of their operations located in the EU in these countries. However, these companies are often large companies for which complying with a new OEL for nickel compounds should be less challenging. Furthemore and as shown in the COWI study, the EU’s share in the global market for nickel metal dropped from more than 30% to less than 20% between 2008 and 2017 for the benefit of the Far East and particulary China. This seems to indicate that the level of the EU OEL will not be the only driver for the future trends for this global market. The impacts on consumers in terms of price should be very limited. Only the metal sector, which would face higher compliance costs, could pass on a part of these costs to the price. In the event of companies passing on a part of the increase of their costs to the prices, this could have an impact on consumers which could try to buy these products from outside the EU. The introduction of an OEL is estimated not to change the total environmental releases of nickel compounds significantly and is estimated not to have any significant environmental impact. However, two sectors in particular play a considerable role in the development of greener alternatives to fossil fuels, namely catalysts and batteries industries. Both these sectors require considerable R&D investments to satisfy, for example, the growing demand of Li-ion batteries for electric cars. The cost of complying with new OELs for nickel compounds at the levels below those recommended by the ACSH (i.e. option 3) might jeopardise this development. Setting an OEL of 0.1 mg/m³ and 0.05 mg/m³ would enable to reduce the number of lung cancer cases by about 56% and 89% over the next 60 years, the number of pulmonary morbidity cases by about 72% and 98% and the number of miscarriages by about 57% and 89%, respectively. The setting of any OELs would bring marginal benefits to the employers and the public authorities as indicated in the table 9 below. The impact on other cancer endpoints could not be quantified, resulting in an underestimation of the benefits. Only five Member States, namely Bulgaria, Finland, Germany, Poland and Romania, have one single OEL for all nickel compounds. Nine Member States have no OEL at all: Cyprus, Czech Republic, Estonia, Greece, Italy, Luxembourg, Malta, Portugal and Slovenia. The fourteen remaining Member States have a mix of OELs for different nickel compounds, which can complexify the transposition of a single EU OEL for nickel compounds in their own legislation. According to the estimates, Member States with one single already existing OEL for nickel compounds should not face major administrative costs in case they would have to revise their own limit value. Member States with an existing mix of OELs would have to invest €20,000 to transpose the EU wide single OEL in their own legislation while Member States with no OEL would have to incur costs of €50,000. Table 9: Multi-criteria analysis on nickel compounds (all impacts over 60 years and additional to the baseline)

Impact Stakeholders affected OEL options - inhalable Option 2 0.03 mg/m³ Option 3 0.05 mg/m³ (ACSH) Option 4 0.1 mg/m³ (ACSH transitional value) Economic impacts Compliance costs (one-off and recurrent) Companies €10 billion €4 billion €886 million Compliance costs (one-off)* Companies €11 billion €4.3 billion €947 million Compliance costs (recurrent)* Companies -€1.1 billion -€165 million -€ 61 million Monitoring Companies €2.5 billion €2.5 billion €2.5 billion Compliance and monitoring costs per company Companies €197,000 €108,000 €55,000 Administrative costs Public sector €730,000 €730,000 €730,000 Avoided costs** Companies €4 million €3.9 million €2.8 million Avoided costs*** Public sector €2.3 million €2.2 million €1.5 million Single market: competition – No. Of company closures Companies 93 46 3 Single-market: consumers Consumers Limited impacts expected Internal market**** Companies Highest /lowest OEL from 100 to 3 Highest /lowest OEL from 100 to 5 Highest /lowest OEL from 100 to 10 International competitiveness Companies Significantly negative for 38% of companies***** NA NA Specific MSs/regions – MSs that would have to change OELs Public sector All MS except BG, DE, FI, PL, RO All MS except BG, DE, FI, PL, RO All MS except BG, DE, FI, PL, RO Social impacts Reduction in cases – lung cancer Workers & families 147 133 84 Reduction in cases (pulmonary morbidity) Workers & families 712 702 517 Reduction in cases (reproductive toxicity) Workers & families 88 80 51 Avoided costs of ill health, incl. Intangible costs (M1 and M2) Workers & families €79 – 97 million €72 – 92 million €47-64 million Employment – Jobs lost Workers & families 19,000 10,000 1,500 Employment – Social cost Workers & families €1.6 billion €779 million €127 million Environmental impacts Environmental releases All No impact/limited impact Based on COWI study (2019) Notes: All costs/benefits are incremental to the baseline (PV over 60 years) * one-off and recurrent costs have been rounded in the COWI study so that the total of these two lines may not correspond to the total compliance costs. ** Including payments related to sick leave, absence from work, insurance premiums *** Including heathcare, loss of tax revenue ****Internal market shows the ratio of highest OEL to lowest OEL before and after implementing the OEL option. ***** 38% of the companies surveyed in the framework of the COWI study are of the view that the introduction of an OEL of 0.03 mg/m³ would have a significant impact on their competitiveness outside the EU. This consultation has not been carried out for the two other scenarios. 6.3.Benzene Approximatively 1,000,000 workers in the EU are exposed to benzene in the sectors that are included in this impact assessment, namely upstream and downstream petroleum industry, coking plants, petrochemical industry distribution of petrol, retail and petrol stations, maintenance and repair of motor vehicles, foundries, laboratories and other sectors such as paint, adhesive, traffic, fires, etc. Benzene is not subject to authorisation according to Annex XIV of REACH. However, according to entry 5 of Annex XVII of REACH, some uses of benzene are restricted. More information about these restrictions is available in annex 10. It is assumed for the current disease burden that the number of exposed workers in the relevant sectors has been decreasing in the past by 3% per year and the exposure concentration have been decreasing by 7% per year. These past trends are partly explained by the effects of the introduction of an EU OEL for benzene in the CMD in 2004. Annual declines of 2% for the number of workers exposed to benzene and 0% in exposure concentrations are assumed for the future disease burden. This null trend for the future exposure concentrations is based among others on information gathered from the relevant stakeholders in the context of the COWI study. The 2% annual decrease is explained by an estimated decrease in the use of petrol due to the gradual change to electric vehicles. For the estimates of the current and future burdens of disease, a mean latency of 5 years for leukaemia and 0 years for leukocytopenia as well as a mortality rate of 80% for leukaemia and 0% for leukocytopenia have been used. Without any medical treatment, leukocytopenia can lead to weakened immune defence and increased risk of contracting infectious diseases. The main cancer effect of benzene is leukaemia, a cancer of the blood system. Benzene also causes other hazardous effects on the bone marrow. However, due to lack of data, only leukocytopenia has been taken into account in the calculation of the burdens of disease. Other effects such as lymphocytopenia, neutrocytopenia and thrombocytopenia could not be quantified and monetised. In the absence of any further action, up to 300 cancer cases and 237 leukocytopenia cases are estimated to occur in the coming 60 years. This has been estimated to have a health cost between 202 and 331 million euro. Table 10: Baseline scenario over 60 years for benzene Types of cancer caused Leukaemia Other adverse health effects Leukocytopenia (quantified), lymphocytopenia, neutrocytopenia and thrombocytopenia (not quantifier) No. of exp. workers 1,012,500 Change exp. level Past: -7% Future: 0% Change no. of exp. workers Past: -3% Future: -2% Current disease burden (CDB) - no. of cancer cases 30 in 2018 Future disease burden (FDB) - no. of cancer cases 300 FDB - no. of leukocytopenia cases 237 Exp. no. of deaths due to FDB cancer 240 Exp. no. of deaths due to FDB leukocytopenia 0 Monetary value FDB cancer Method 1: €201 million Method 2: €329 million Monetary value FDB other adverse health effects Method 1: €1 million Method 2: €2 million Based on COWI study (2019) *Workforce turns over at 5% p.a. Impacts of the policy options In its opinion on benzene, RAC derived an OEL of 0.05 ppm (0.16 mg/m³) under which there should be no significant residual cancer risk or other adverse effects. It also recommends a skin notation for benzene as the dermal route can be an important contributor to total benzene exposure in certain situations. The table 11 below shows the multi-criteria analysis, summarizing both the monetised impacts as well as those that are assessed qualitatively. Compliance cost levels for companies generally depend on the extent to which exposures are currently close to the required OELs. The higher the difference between the current exposure levels and the required OEL is, the higher the investments in RMMs will be. For the purpose of adequately assessing the economic feasibility for companies to comply with the different OEL scenarios, the annualised compliance costs in percentage of the turnover were calculated. Overall, complying with an OEL of 0.05 ppm would cost to the employers 0.17% of their turnover every year over the next 60 years. Companies operating in the upstream petroleum sector, distribution and foundries would be the most impacted by facing higher compliance costs of about 0.24%, 0.64% and 0.29% of the turnover respectively. The average compliance costs related to an OEL of 0.2 ppm across all the sectors would be of about 0.07 % of the average turnover and relatively higher for the upstream petroleum sector (0.08%), as well as the distribution (0.35%). For the specific case of the foundry sector, employers would face relatively higher one-off compliance costs. Companies operating in this sector would have to initially invest 3.41% and 1.1% of their turnover to comply with an OEL of 0.05 ppm and 0.2 ppm, respectively. However, as mentioned in annex 3, one-off costs would represent one third of the total costs for companies. As requested by the several employers and workers’ representatives in the context of the two-phase consultation, socioeconomic considerations should be taken into account when adding or revising OELs. The introduction of a transition period with a temporary higher initial OEL could enable companies to anticipate the changes, gradually introduce improvements and plan the necessary investments, softening in this way the economic impact on them. As this industry is confronted with global competition, companies will not be able to pass on these costs to the users further down the value chain or consumers. At the strictest OEL, it is likely that companies operating in this sector would lose competitiveness, especially compared to China which represent the largest global suppliers in this sector (45% of the global market) and where companies have only to comply with an OEL of close to 2 ppm. Any other OELs equal or above the limit value recommended by the ACSH should not have any negative impacts on the competitiveness of this industry. The Member States with the highest number of companies operating with benzene across the EU are Germany, Italy, France, Poland and Spain. More information about the share of companies by Member States in each sector is available in annex 6.

The setting of a stricter EU wide OEL for benzene will have an impact on companies’ cost. The companies’ costs increase arising from the needed investments in RMMs in order to meet a stricter OEL could potentially weight negatively on the R&D expenditures. These impacts would depend on the level of the OEL and the sector in which the company is active. The impact of introducing any of the envisaged OELs on employment is very limited. Only the foundry industry, which could lose global market shares at the strictest OEL, could be concerned by potential consequences on the employment. With regard to the environmental impacts due to the introduction of a stricter OEL, it is estimated that it would result in positive impact due to reduced emissions to the environment by reducing the fugitive and diffuse emissions from a number of the main sources such as upstream and downstream petroleum sectors and the coking sector. Setting an OEL of 0.5 ppm and 0.2 ppm would enable to reduce the number of leukaemia cases by about 30% and 60% over the next 60 years respectively and the number of leukocytopenia cases by about 43% and 80% respectively. Concerning the two other envisaged scenarios, they would enable to reduce further the number of leukaemia and leukocytopenia, although to a lesser extent than for the two first scenarios discussed in this paragraph. The setting of any OELs below the current OEL (baseline scenario) would bring marginal benefits to the employers and the public sector as indicated in the table 11 below. A number of non-cancer health endpoints could not be quantified, resulting in an underestimation of the benefits. Although an EU wide OEL already exists for benzene, many Member States would need to revise their national OEL whatever the scenario. As indicated in the table 11, all the Member States would need to revise their OEL in the event of an EU OEL at the level of option 2. The Member States which would not need to revise their limit value for the two other scenarios are referenced in the table below. Considering that all Member States have already an OEL for benzene, the cost of transposing a revised OEL would be lower compared to the costs of transposing a new OEL. This cost has been estimated to €10,000 per Member State that would have to revise the national OEL. Table 11: Multi-criteria analysis on benzene (all impacts over 60 years and additional to the baseline) Impact Stakeholders affected OEL options Option 2 0.05 ppm Option 3 0.2 ppm (ACSH) Option 4 0.5 ppm (ACSH transitional value) Economic impacts Compliance costs (one-off and recurrent) Companies €23,526 million €7,610 million €884

million Compliance costs (one-off) Companies €11,329 million 2,461 million €740 million Compliance costs (recurrent) Companies €12,197 million 5,149 million 144 million Annualised compliance costs in % of turnover* Companies 0.17% 0.07% 0.01% Administrative costs Public sector €0.3

million €0.3

million €0.3

million Avoided costs** Companies €3 million €2 million €1 million Avoided costs*** Public sector €3.8 million €2.5 million €1.2 million Single market: competition No. of company closures The foundry sector could see closures No closures No closures Single-market: consumers Consumers Limited impacts expected - small price increase for fuels Single market: internal market Companies Limited impacts expected as the currently even competition between EU companies will continue. Only a few Member States (MS) have OELVs lower than current EU value and will face lower costs. International competitiveness Companies Limited impacts - only foundries could face lower competitiveness No impacts No impacts Specific MSs/regions MSs that would have to change OELs All MS All MS except NL All MS except five MS**** Social impacts Reduction in cases (leukaemia cancer) Workers & families 281 182 88 Reduction in cases (leukocytopenia) Workers & families 233 189 103 Avoided costs of ill health, incl. intangible costs***** Workers & families €186 - 305 million €121 - 198 million €59 - 96 million Employment Jobs lost Few 0 0 Social cost No quantification €0 €0 Environmental impacts Environmental releases Environment Small positive impact of reduced fugitive and diffuse emissions Recycling – loss of business Recycling companies No impact expected Notes: All costs/benefits are incremental to the baseline (PV over 60 years). * Simple average of annualised compliance in % of turnover for all affected sectors ** Including payments related to sick leave, absence from work, insurance premiums *** Including heathcare, loss of tax revenue ****Denmark, Estonia, Germany and Sweden have an occupational exposure limit (OEL) of 0.5/0.6 and the Netherlands of 0.2. ***** Values relate to the two methods, method 1 and method 2 7.How do the options compare? The main objective is to balance health considerations against economic impacts, by proposing OELs that are still economically feasible while protecting a maximum number of workers. This impact assessment assessed the different OEL levels without any transitional period. However, the ACSH identified sectors that might find it initially difficult to comply with the OEL proposed, and thus suggested to include transitional periods. The duration of these periods was established by the governments, workers and employers, as they have the expert knowledge about technological development in different sectors. It is assumed that these transitional periods are necessary for companies to develop their production processes to be able to comply with the OELs proposed. They should attenuate short-term negative impacts, as the necessary investments in protective measures would be spread over a longer period of time. The aim is therefore to ensure a balanced approach and to prevent industries from closures or severe disadvantages in particular Member States due to e.g. adopting the most stringent OELs while providing an adequate protection of the workers at the EU level. The comparison tables used to compare the different options against the baseline scenario in terms of effectiveness, efficiency and coherence 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. With regard to the effectiveness, the options are analysed among others from the perspective of the prevention of deaths and other adverse health effects. With regard to the efficiency, the options are analysed among others on the basis of how balanced they will be between adequate protection of workers at the EU level and prevention of closures and other severe disadvantages for the industries. The efficiency is also analysed from the perspective of the costs/benefits ratios. However, although an option has the best costs/benefits ratio, it does not automatically mean that the protection it will bring to workers will be considered as sufficiently adequate or that the resulting costs for businesses will be disproportionate. With regard to the coherence, the options are analysed on the basis of how coherent they are with other EU policies (including the Charter for Fundamental Rights, the EU Pillar of Social Rights, the Europe’s Beating Cancer Plan and REACH). Coherence with general EU priorities and policies, as well as with the Charter of Fundamental Rights, goes hand in hand with the level of the OELs. The lower the OEL, the more protective for workers’ health. Furthermore, coherence will be also based on to what extent the opinion of the ACSH has been taken into account. Indeed, as laid down in the Council decision setting up an ACSH, this Committee “shall have the task of assisting the Commission in the preparation, implementation and evaluation of activities, in the fields of safety and health at work”. 3. 4. 5. 6. 7.

Acrylonitrile With regard to efficiency, all the options except option 1 have a costs/benefits ratio higher than 1. Option 4 has the lowest costs/benefits ratio, followed by option 3. Option 2 has a relatively high costs/benefits ratio compared to the previous two. However and as mentioned in introduction of this Chapter, the aim is to ensure a balanced approach between providing an adequate protection of workers at the EU level while preventing industries from closures or severe disadvantages. By recommending OELs and transitional measures through scientific, technical and socioeconomic discussion, the tri-partite ACSH is probably the best guarantee of such a balanced approach. Therefore, although all the options - except the baseline scenario - have costs/benefits ratios higher than 1, option 3 is considered as representing the best the balance between the adequate protection of workers and bearable costs for the companies. Nevertheless, as unanimously agreed by the ACSH, this balance would require a transition period of 4-years to make sure that companies could make the necessary investments. With regard to coherence, establishing an OEL following options 2 and 3 also increases the coherence of the CMD with other EU policy objectives, including the Charter for Fundamental Rights, the EU Pillar of Social Rights and the Europe’s Beating Cancer Plan. It increases complementarity with REACH, as outlined in section 4. It will also provide legal clarity and a common reference point that can be used as a practical tool by employers (particularly important for SMEs), workers and enforcers to assess compliance with the general CMD requirements, and will also contribute to a level-playing field for businesses across the EU (see section 3). For the specific case of acrylonitrile, the strictest OEL (option 2) does not bring more benefits to workers and their families and to employers than the ACSH’s recommended OEL. Based on the criteria explained above, option 3 is the most coherent as it ensures the same coherence with the other EU policies as option 2 while being coherent with the opinion of the ACSH. Option 3, with a STEL of 4 mg/m³ (1.8 ppm), a skin notation, and with a 4-years transitional period starting from the entry into force of the new Directive is therefore the preferred option. Table 12: Comparison of options for acrylonitrile (mg/m³) Criteria Option 1: Baseline Option 2: 0.5 Option 3: 1 (ACSH) Option 4: 2 Effectiveness 0 ++ ++ + Efficiency 0 -- + - Coherence 0 + ++ + Nickel compounds With regard to the effectiveness, option 2 and 3 would enable to drastically reduce the risks of work-related cancer and non-cancer diseases. Option 4 would result in a substantial reduction of the number of lung cancer, pulmonary morbidity and miscarriage cases. With regard to the efficiency, the costs outweight the benefits for all the envisaged options, except option 1. If option 4 has the lowest costs/benefits ratio, costs associated with option 3 are much lower than those that would result from adopting option 2. Furthemore, all the Interest Groups in their ACSH opinion strongly recommended the Commission to adopt a revised OEL, with a preference for option 3. This option will ensure a balanced approach between adequate protection of workers at the EU level and prevention of closures and other severe disadvantages for the industries. However, a transition at the level of option 4 has been considered as necessary to enable companies to more swiftly make the necessary investments for the purpose of reaching such a level of workers’ protection. For all these reasons, option 3 could be seen as an medium-term objective with a transitional value at the level of option 4. Option 2 is considered as less efficient. With regard to coherence, option 2 would be the most coherent with other EU policy objectives, including the Charter for Fundamental Rights and the EU Pillar of Social Rights, followed by option 3 and option 4. All the options increase complementary with REACH, as outlined in section 4. Taking into account the opinion of the ACSH (option 3 with a transition period at the level of option 4) increases also coherence as mentioned in introduction of this Chapter. Furthermore, as mentioned in the ACSH opinion, nickel compounds and chromium VI compounds are frequently occurring in the same sectors and, often, in the same processes. Therefore, aligning the measures for nickel compounds to those for chromium VI adopted in the context of the first revision of the CMD and that will apply in January 2025 would bring more coherence, both in terms of investments for companies and between the updates of the CMD. Option 3 (0.05 mg/m³ - inhalable fraction), with a corresponding OEL for respirable fraction of 0.01 mg/m³, a skin and respiratory sensitisation notation, and with a transitional value until the 17th January 2025 included at the level of option 4 (0.1 mg/m³ - inhalable fraction), is the preferred option. Table 13: Comparison of options for nickel compounds (mg/m³ - inhalable fraction) Criteria Option 1: Baseline Option 2: 0.03 Option 3: 0.05 (ACSH) Option 4: 0.1 (ACSH transition value) Effectiveness 0 ++ ++ + Efficiency 0 -- + + Coherence 0 + ++ + Benzene With regard to the effectiveness, option 2 will have the most positive impact on prevention of occupational exposure-related leukaemia and leukocytopenia compared to the baseline scenario. However, any other envisaged OELs would significantly reduce the number of leukaemia and leukocytopenia cases.. With regard to the efficiency, even if an EU-wide OEL for benzene is already set in the CMD, all the Interest Groups in their ACSH opinion strongly recommended the Commission to adopt a revised limit value. Option 3 has been considered as the most balanced option between adequate protection of workers at the EU level and prevention of closures and other severe disadvantages for the industries. However, the ACSH considered as important to foresee a transitional value at the level of option 4 from 2 up to 4 years after the entry into force of the Directive in order to give enough time to the companies to make the needed investments. Option 4 has the lowest costs/benefits ratio, followed by option 3. Option 2 is the less efficient option with much higher compliance costs than options 3 and 4. All these options have a costs/benefits ratio higher than 1.

With regard to coherence, option 2 will ensure the highest coherence of the CMD with other EU policy objectives, including the Charter for fundamental rights and the EU pillar of Social Rights, followed by option 3 and option 4. All the options increase complementary with REACH, as outlined in section 4. Coherence also depends on to what extent the opinion of the ACSH is taken into account, as explained in introduction of this Chapter., The ACSH agreed on an OEL at the level of option 3 as well as a transitional value at the level of option 4 which would enable companies to make the necessary investments. Option 3, with transitional value at the level of option 4 from two up to four years starting from the entry into force of the new Directive and the confirmation of the skin notation, is therefore the preferred option. Table 14: comparison of options for benzene (ppm) Criteria Option 1: Baseline Option 2: 0.05 Option 3: 0.2 (ACSH) Option 4: 0.5 (ACSH transition value) Effectiveness 0 ++ + + Efficiency 0 -- + + Coherence 0 + ++ + 8.Preferred options 8.1.Summary of the preferred options It has been shown in the previous sections that the impacts of the considered measures for the protection of workers vary significantly for the different substances assessed in this report.The table below summarises the preferred options. Table 15: Summary of the preferred options, by assessment criteria Name of chemical agent Retained option OEL (8h-TWA) and notation Acrylonitrile 8TWA: 1 mg/m³ (0.45 ppm) (4 years transition period*) STEL: 4 mg/m³ (1.8 ppm) (4 years transition period*) ------------