EUROPEAN COMMISSION Brussels, 5.4.2018 SWD(2018) 88 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 on the protection of workers from the risk related to

exposure to carcinogens or mutagens at work {COM(2018) 171 final}

{SWD(2018) 87 final}



Table of contents 1.Introduction: Political and legal context 2.Problem definition 3.Why should the EU act? 4.Objectives: What is to be achieved? 5.What are the available policy options? 6.What are the impacts of the policy options and how do they compare? 7.Overall Impact of the Package of Retained options 8.How will actual impacts be monitored and evaluated? ANNEXES46 ANNEX 1: PROCEDURAL INFORMATION ANNEX 2: STAKEHOLDER CONSULTATION ANNEX 3: WHO IS AFFECTED AND HOW? ANNEX 4: ANALYTICAL METHODS ANNEX 5: OELS IN EU MEMBER STATES FOR THE SUBSTANCES SUBJECT TO THIS REPORT ANNEX 6: SELECTION PROCEDURE FOR PRIORITY SUBSTANCES ANNEX 7: RELEVANT SECTORS, USES AND ACTIVITIES

ANNEX 8: ROUTE(S) OF EXPOSURE, ADVERSE HEALTH EFFECTS ANNEX9: PROCESS FOR SETTING BINDING OELS AND ASSOCIATED PROVISIONS UNDER THE CMD ANNEX 10: CONSISTENCY AND SYNERGIES WITH THE REACH REGULATION



Glossary Term or acronym Meaning or definition ACSH Advisory Committee on Safety and Health at Work ANSES French Agency for Food, Environmental and Occupational Health & Safety As Arsenic ASA Finnish Register of Workers Exposed to Carcinogens (altistuminen syöpäsairauden vaaraa aiheuttaville tekijöille (ASA-luettelo)) BAuA Bundesanstalt für Arbeitsschutz und Arbeitsmedizin BeST Beryllium Science and Technology Association BLV Biological Limit Value BGV Biological Guidance Value CAD Chemical Agents Directive (Directive 98/24/EC) CAREX CARcinogen EXposure database CBD Chronic Beryllium Disease Cd Cadmium CLP Classification, Labelling and Packaging Regulation (Regulation (EC) No 1272/2008) CMD Carcinogens and Mutagens Directive (Directive 2004/37/EC) DALY Disability-Adjusted Life Year DMA Dimethylarsinic acid DNEL Derived No Effect Level ECHA European Chemicals Agency EIG Employers Interest Group EP European Parliament ERR Exposure Risk Relationship EU European Union EU-OSHA European Agency for Safety and Health at Work FinJem Finnish Job Exposure Matrix GIG Governments Interest Group HSE Health and Safety Executive IARC International Agency for Research on Cancer ICdA International Cadmium Association ICT Information and communication technology INRS Institut National de Recherche et Sécurité IOM Institute of Occupational Medicine LTCR Life Time Cancer Risk mg Milligram MEGA Messdaten zur Exposition gegenüber Gefahrstoffen am Arbeitsplatz MMA Monomethylarsonic acid MOCA 4,4'-Methylene-bis(2-chloroaniline) MSs Member States NACE Nomenclature des Activités Économiques dans la Communauté Européenne NAIC North American Industry Classification System Ni-Cd Nickel-Cadmium OEL Occupational Exposure Limit (Value) OJ Official Journal OSH Occupational Safety and Health ppm parts per million RAC Risk Assessment Committee of ECHA REACH Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (Regulation (EC) No 1907/2006) REGEX Registry of Subjects Occupationally Exposed to Carcinogens RIVM The Netherlands National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu) RMMs Risk Management Measures RPA Risk & Policy Analysts Ltd SCOEL Scientific Committee on Occupational Exposure Limits SEAC Socio- Economic Assessment Committee of ECHA SMEs Small and Medium Sized Enterprises STEL Short Term Exposure Limit SUMER Surveillance Médicale des Expositions aux Risques Professionnelles SVHC Substance of Very High Concern SWD Staff Working Document t tonnes TFEU Treaty on the Functioning of the EU TWA Time-Weighted Average µg Microgram UN United Nations UK United Kingdom US United States US-OSHA US-Occupational Safety and Health Administration WHO World Health Organisation WIG Workers Interest Group WPC Working Party 'Chemicals at the Workplace’ WTP Willingness to pay 1.Introduction: Political and legal context In the State of the Union Address 2017 President Juncker emphasized the need to avoid social dumping in Europe by joining efforts and delivering on the European Pillar on Social Rights. The Pillar - jointly proclaimed by the Commission, the European Parliament and the Council on 17 November 2017 at the Social Summit in Gothenburg - identifies workers' right to healthy, safe and well-adapted work environment, including protection from carcinogens, as one of the main principles. Protection of workers' health, by continuously reducing occupational exposures to carcinogenic and mutagenic substances, is a concrete action of the Juncker Commission to deliver on this key priority. This has been clearly stated in the Commission Communication on "Safer and Healthier Work for All". Cancer is the main work-related health problem in the EU-28, causing almost as much damage to workers' life and health as the two following combined (musculoskeletal disorders and circulatory diseases). Its negative impact is also far greater than that of work-related accidents. It brings about suffering to workers and their close ones, poor quality of life, undermined wellbeing and, in the worst case, death. Figure 1: Work-related health problems cause the highest DALY in the European Union Reducing exposure to carcinogens and mutagens at the workplace by setting EU-wide occupational exposure limit values (OELs) would effectively contribute to the prevention of cancer cases and death, as well as other significant non-cancer health problems caused by these substances. Consequently, it increases the length, quality and productivity of the working lives of European workers, contributes to better productivity and competitiveness of the EU, and improves the level playing field for businesses. For this reason this Commission has initiated a continuous process of updating the Carcinogens and Mutagens Directive (CMD) to keep abreast with the new scientific and technical developments, and taking 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 OSH evaluation as well as the preliminary conclusions of the REACH REFIT evaluation have underscored and fed into this process. Updating and reviewing the CMD has now become a continuous process: Two legislative amendments updating the CMD, of May 2016 and January 2017, addressing together 20 carcinogens, have been proposed. The first amendment was adopted by the co-legislators end 2017 and on the second the Council adopted a general approach on 15 June 2017. The European Parliament's first reading position is expected in the first quarter of 2018. For further amendments including the one at hand, the Commission follows the same process as for the two previous proposals; it has conducted a two-stage consultation of the European Social Partners , in accordance with Article 154 of the Treaty on the Functioning of the European Union (TFEU). Both workers' and employers' organisations confirmed that the five carcinogens selected for this amendment of the CMD are of high relevance for the protection of workers (see Annex 2 for more information) and encouraged the Commission to continue the preparatory work for the establishment of OELs for those priority carcinogens: ·Cadmium and its inorganic compounds under the scope of the CMD ·Beryllium and inorganic beryllium compounds under the scope of the CMD

·Arsenic acid and its salts, as well as inorganic arsenic compounds under the scope of the CMD ·Formaldehyde ·4,4'-Methylene-bis(2-chloroaniline) (MOCA) Estimates show that this proposal, when adopted, in longer term would improve working conditions for over1 000 000 EU workers and prevent over 22 000 cases of work-related ill health. Given the level of scientific and technical knowledge required to identify measures, which at the same time adequately protect workers and are practically feasible for industries, the European Commission bases proposals in this area on opinions developed by the tripartite Advisory Committee on Safety and Health at Work (ACSH). The opinions of ACSH take into account scientific basis, which is indispensable to underpin OSH legislation. With a view to mainstream scientific advice and in line with the Commission Communication on "Safer and Healthier Work for All", the Commission for this proposal sought advice from both, the Scientific Committee on Occupational Exposure Limits (SCOEL) and the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA). 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 framework of the tri-partite ACSH strongly anticipate the legal clarity and increased protection which would be the result of lower OELs on 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 five additional carcinogens. 2.Problem definition 2.1.What is/are the problems? Carcinogenic and mutagenic substances lead not only to cancers, but to also other important health problems. For example, exposure to beryllium, in addition to lung cancer, also causes incurable chronic beryllium disease. If effective measures are put in place to prevent high exposures of the five substances under consideration, their positive impact would be much broader than cancer prevention alone – in longer term the proposal would improve working conditions for over 1 000 000 EU workers and protect over 22 000 workers from significant health problems. Furthermore, ineffective prevention of the exposure to carcinogens would have negative consequences for business such as higher costs and reduced productivity due to absenteeism, lost expertise and distorted competition; and for Member States due 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: Figure 2: Problem tree 2.2.What are the problem drivers? 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, e.g. on estimated ranges, breakdown of relevant sectors etc., is provided in Annex 7. 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.

Table 1: Summary of estimates taken forward for the assessment of options Carcinogen Exposed workforce (number of workers) Typical exposure levels Major occupational exposure route Cadmium and its inorganic compounds 10 000 Range of 2900 – 300 000 between different estimates 5 µg/m³ to 50µg/m³; with extreme values up to 400 µg/m³ Inhalation of cadmium-containing dusts and fumes. Incidental ingestion of dust at work from contaminated hands, cigarettes or food. Beryllium and inorganic beryllium compounds 54 000 Range of 14 000 – 74 000 (depending on which of the three datasets chosen Construction sector: 7 000 – 41 000 0.19 µg/m3 – 2.78 µg/m3 Inhalation of beryllium-containing dusts and fumes. Dermal exposure is relevant for non-carcinogenic ill-health effects. Arsenic acid and its salts, as well as inorganic arsenic compounds 7 900 –15 300 In addition: 18 000-102 000 potentially exposed below the lowest assessed OELs 0.1 µg/m3 – 45 µg/m3 with extreme values up to 312 µg/m3 in the domestic glass sector Inhalation of arsenic containing particulates. Ingestion (skin-to-mouth) exposure may be significant in specific situations. Formaldehyde 990 000 Range of 990 000 – 2 200 000 between different estimates 0.1 mg/m3 – 3 mg/m3 Higher values estimated for the hospitals, embalmers, veterinary activities (HEV sectors) Inhalation as the main route. Ingestion and absorption through the skin not negligible. 4,4'-Methylene-bis(2-chloroaniline) (MOCA) 350 1 200 workers may potentially be indirectly exposed 0.1 µg/m3 – 5 µg/m3, with extreme values up to 15 µg/m3 Absorption through the skin after contact with contaminated sites. Inhalation and ingestion represent minor sources. Total workforce assessed: ~ 1 070 000 Based on RPA (2018) Cadmium and its inorganic compounds under the scope of the CMD The data collected for this impact assessment estimates a number of 10 000 workers currently exposed to cadmium and its inorganic compounds. However, only limited extrapolation from the responses received to some of the sectors has been possible and some indications of exposure could not be confirmed. Occupations in which the highest potential exposures occur include cadmium production and refining, nickel-cadmium (Ni-Cd) battery manufacture, cadmium pigment manufacture and formulation, cadmium alloy production, mechanical plating, zinc and copper smelting, mining of non-ferrous metal ores, brazing with a silver-cadmium-silver alloy solder, and polyvinylchloride compounding. Recycling of scrap metal and Ni-Cd batteries may also involve some exposure. Beryllium and inorganic beryllium compounds under the scope of the CMD Ten industrial sectors such as foundries, glass and laboratories were identified in which workers are at risk of exposure to beryllium. RPA (2018) study used two compounds for this assessment, beryllium and beryllium oxide. Copper, aluminium, magnesium and nickel are widely alloyed with beryllium. These are a cause of worker exposure and are included in the assessment. Approximately 80% of all beryllium in the EU is used in copper beryllium alloys. The study concludes that further research and, in particular, survey data is required to establish whether there is an issue, and if yes - to what extent, with beryllium in construction. Arsenic acid and its salts, as well as inorganic arsenic compounds under the scope of the CMD The considered exposure data distinguishes between two groups: ·Workers for which available data shows that they are exposed at higher levels as demonstrated by measurements, modelling or from comparison to similar processes. ·Other workers who may potentially be occupationally exposed. The latter group either works in sectors and with processes where arsenic may be present in raw materials at considered relatively low levels, or they work in high-exposure sectors (as the copper sector), but likely are not routinely working with the high-exposure processes covered by the monitoring of workplace concentrations. Exposure to arsenic compounds occurs, for example, in copper and zinc production, as well as in the glass, electronics and chemical sectors. Formaldehyde In addition to formaldehyde manufacturing, it is used in a wide variety of products such as adhesives and sealants, coating products, polymers, biocides and laboratory chemicals; activities such as building and construction work; and in the manufacturing of leather and fur, pulp, paper and paper products, textile and wood and wood products. Formaldehyde is also used for tissue preservation in embalming fluids and as a disinfectant in pathology departments and autopsy rooms, usually in the form of formalin (i.e. mixture of formaldehyde, water, and methyl alcohol). 4,4'-Methylene-bis(2-chloroaniline) (MOCA) After the sunset date of 22 November 2017, as set by Annex XIV to REACH, MOCA can only be used by the downstream users in the supply chain of the only applicant for authorisation. However, the authorisation has not yet been granted. Exposed workers work in the plastics sector, where MOCA is used for moulding of polyurethane elastomer parts at 89 sites across the EU.

Exposure to the carcinogens addressed in this impact assessment leads to significant health consequences for workers. The table below shows the current and future burden of cancer and other health effects related to the occupational exposure to the five substances under consideration. Given the long latency period of the concerned illnesses, 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. First, the study quantified burden of only those cancers and other adverse health effects which are known to be caused by the lowest exposures (so-called most sensitive endpoints). However, workers may develop additional types of cancer and diseases at higher exposure levels that have not been quantified in the study (see table 2 below). When establishing an OEL at a certain level to prevent the most sensitive endpoints, the other diseases will be prevented as well. Second, the estimates relate only to sectors where exposure currently exists and therefore do not represent the total burden of possible past exposure. More information on limitations is given in chapter 6. Table 2: Current and future disease burden related to occupational exposure to carcinogens (number of cases) Carcinogen Health effects caused Current* disease burden (quantified) Future** disease burden (quantified) Cadmium and its inorganic compounds Lung cancer (quantified), bladder, kidney and prostatic cancer (not quantified) 11 6 Proteinurea (quantified), osteoporosis and respiratory effects (not quantified) 500 280 Beryllium and inorganic beryllium compounds Chronic beryllium disease (quantified), allergy or asthma symptoms, beryllium respiratory sensitisation, skin sensitisation, cardiovascular, renal, hepatic and haematological effects (not quantified) 3 807 4 602 Arsenic acid and its salts, as well as inorganic arsenic compounds Lung cancer (quantified) cancer in the skin, liver, lungs, bladder and kidney (not quantified) 17 20 Peripheral neuropathy (quantified), cardiovascular effects and immunotoxicity, skin changes and blackfoot disease (not quantified) 905 574 Formaldehyde Nasopharyngeal cancer (quantified), leukaemia, tumour induction (not quantified) 330 7 Sensory irritation (quantified), potential cancer precursor effects (not quantified) 19 200 19 200 4,4'-Methylene-bis(2-chloroaniline) (MOCA) Lung cancer, bladder cancer (quantified) 0 0 TOTAL 24 770 24 689 * The current disease burden is estimated over the past 40 years ** The future health burden is estimated over a 60 year period Based on RPA (2018) 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. The fact that OELs are established does not affect the underpinning obligations of the employer to comply with other obligations, including to reduce the exposure of his/her workers to carcinogenic and mutagenic substances to as low a level as is technically possible (minimised exposure). The existence of OELs provides clarity and 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 his/her risk management measures should aim to comply with the obligation to reduce the exposure to as low a level as is technically possible. They also support enforcement authorities in controlling that employers are putting in place the relevant risk management measures, including those that could contribute to 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, for none of which an EU OEL exists, the scientific advice has been provided by SCOEL (cadmium, beryllium, formaldehyde) and RAC (arsenic and MOCA). The tripartite ACSH has adopted opinions for all five. 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. 2.2.3.Diverging national OELs create different competing conditions and protection levels across the EU While no EU OELs have been established for the five carcinogens considered under this initiative, there is a diverse situation as for legal protection at national level. For each substance there is a range of national OELs and a number of Member States that have not set OELs. The table below summarises the divergences: Table 3: National OELs in EU Member States Carcinogen Lowest (strictest) national OEL (mg/m3) Highest (least strict) national OEL (mg/m3) Member States with no OEL Cadmium and inorganic compounds 0.002 BE, PL, PT, ES, SE 0.05 FR, LT 3 IT, LU, MT Beryllium and inorganic beryllium compounds 0.00005 PT (inhalable fraction) 0.05 AT, EL, SK, SI 4 IT, LU, MT, NL Arsenic acid and its salts, as well as inorganic arsenic compounds 0.01 CY, IE, LV, PT, RO, ES, SE 0.2 FR (As2O3) 3 IT, LU, MT Formaldehyde 0.15 NL 3 CY 5 BE, IT, LU, MT, ES 4,4'-Methylene-bis(2-chloroaniline) (MOCA) 0.005 IE, UK 0.22 FR, EL, RO 12 BG, CY, CZ, EE, DE, HU, IT, LV, LT, LU, MT, SE* * In Sweden working with this substance requires permission from the Swedish environmental authority before it can be used. Based on RPA (2018)

Diverging national OELs not only lead to different workers protection levels across the EU but also distort competition. For example, PT firms need to comply with an OEL 1000 times smaller (i.e. stricter) than firms in AT, EL, SK and, therefore, their investments on protective measures/equipment would be higher. These national differences may lead to complications for businesses operating in different EU Member States. Annex 5 presents 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 are not fully exploited State-of-the-art industrial production processes allowing for the further reduction of occupational exposure to carcinogenic, mutagenic and other hazardous substances in the workplace exist but their adoption is not generalised. One possible reason is that decisions of business are often influenced by short-term cost assumptions rather than long-term benefits. For example, exposure to cadmium and MOCA could be further reduced by a higher degree of automation, e.g. in plating and coating processes and in the production of nickel-cadmium batteries, and regarding exposure to MOCA, also in the manufacture of rubber products. Risk management measures, such as improved local exhaust ventilation systems, would reduce exposure of workers to formaldehyde e.g. during the wood panel production, to arsenic acid and its salts in manufacturing of copper foils and in recycling facilities, and to beryllium in manufacturing of alloys and ceramics, to levels which would be more protective of workers health. 2.3.How will the problem evolve? In the absence of EU action, the consequences described above will continue. Estimations on the numbers of deaths and health costs in case no action is taken regarding the carcinogens covered in this report are, where available, described in the baseline scenario in section 6. 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. Further demographic changes increase the life expectancy of workers exposed and, therefore, the chances to develop the illnesses mentioned in table 2. Member States usually do not inform the Commission on their intentions to revise existing or determine new OELs in their national legislation; 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. 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. Addressing the social dimension of the European Union by putting forward a proposal for a Directive on the protection of workers from the risks related to exposure to carcinogens or mutagens is included in the Joint Declaration on the EU's legislative priorities for 2018-2019. The 2016-2019 "Roadmap on carcinogens" convenant initiated by the Dutch and Austrian governments as well as the European social partners supports and accompanies the process of regular CMD updates. 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 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. 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 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. Concerning formaldehyde, the employers' and workers' representatives in 2016 signed a common letter addressed to the Commission requesting to include it already in the second amendment to the CMD. Ensuring the same minimum level of protection across the EU In case of all carcinogenic chemical agents where OELs are proposed in this initiative at least 15 Member States have not yet established legally enforceable OELs for at least one of the substances. For example, 12 Member States have set no limits for MOCA – the same is true for 5 Member States in the case of formaldehyde. Lack of EU action will most likely mean that there will remain Member States where no limit values exist for certain carcinogens or where those values are too high to ensure adequate worker protection. A minimum standard across the EU will not be ensured, to the detriment of worker protection. Contribution to a levelplaying field Employers' orgnisations stressed in their response to the social partner consultation that setting EU OELs helps to provide a levelplaying field for industry. Setting EU OELs will not completely eliminate the differences between Member States, as they retain the possibility to adopt more protective measures. However, it will limit 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. The examples of the currently existing EU OELs (e.g. for benzene) show that a majority of Member States in practice adopt these values directly. Assuming burdens at EU level related to derivation of limit values The process of establishing limit values is very complex and requires a high level of scientific expertise. An important advantage of setting OELs at EU level is that it eliminates the need for Member States to conduct their own scientific analysis with likely substantial savings on administrative costs. Given the limited resources for OSH at national level, this could release funds to be redirected into other OSH priorities. 4.Objectives: What is to be achieved? 4.1.General objectives This initiative implements principle 10 of the European Pillar of Social Rights ("Healthy, safe and well-adapted work environment") directly contributing to a high level of workers' health and safety by eventually reducing the exposure to carcinogens and mutagens at the workplace. Modernising the legal framework setting updated OELs on exposure to carcinogens was also identified as the key priority in the OSH field by the Commission Communication 'Safer and Healthier Work for All' of 10 January 2017. 4.2.Specific objectives The specific objectives are: ·To reduce occupational exposure to carcinogens and mutagens in the European Union; ·To increase the effectiveness of the EU framework by updating it on the basis of scientific expertise; ·To achieve a more balanced protection of workers across the EU against carcinogens while ensuring more clarity and level playing field for economic operators.

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. Ensuring a safe and healthy work environment is a strategic goal for the European Commission as mentioned in the Communication above. REACH Regulation The REACH Regulation, adopted in 2006, consolidated and developed several parts of the EU chemicals legislation – principally those relating to risk assessment and the adoption of the risk management measures. The REACH Regulation established the 'registration' of all chemicals above 1 tonne produced or imported in the EU market and 'authorisation' and 'restriction' as risk management measures to control the exposures of chemicals, including substances of very high concern (SVHC), at the workplace or for industrial uses. Both the CMD and the REACH Regulation are relevant for worker protection for the majority of carcinogens considered in this legislative proposal. Restrictions of the presence of carcinogens, mutagens and reprotoxic substances in mixtures and in articles and their use in industrial processes, established under REACH, apply for two of the substances (arsenic compounds, cadmium and its inorganic compounds), subject of this legislative proposal, and two of these substances (arsenic acid and its salts and MOCA can only be used after an authorisation has been granted by the European Commission. Furthermore, cadmium and five other cadmium compounds have been identified as SVHC for possible inclusion in Annex XIV to REACH, the Authorisation list. A detailed description and the status of the five substances under REACH is presented in Annex 10. For the preparation of this impact assessment and for the development of the scientific opinions on the proposed limit values, data from the 'registration' dossiers prepared by manufacturers and importers, as well as data that became available to ECHA's Risk Assessment Committee (RAC) and to the Socio-Economic Assessment Committee (SEAC) during the development of opinions for the Commission to decide on authorisations for certain uses or in the restriction process under REACH have been used. This is a direct result of the REACH REFIT exercise focussing on streamlining the process of generating scientific advice. 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 is set out here. A more detailed description is provided for in Annex 9. Figure 3: Simplified workflow of preparation for EU OEL setting under CMD The selection of the specific five carcinogens / groups of carcinogens considered in this impact assessment was based on a consultative approach, including opinions issued by ACSH and 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 five substances are of high relevance for the protection of workers. Commission's intention to prepare for the establishment of OELs for those priority carcinogens was confirmed and encouraged by all the stakeholders.

Considering the occupational cancer burden, it is important to note that when identifying a priority substance, stakeholders look at the whole range of potential negative health effects (carcinogenic and non-carcinogenic) which could be prevented by establishing an EU level OEL. For example, concerning formaldehyde although an impact on cancer prevention is somewhat limited, it will have a major impact on prevention of other relevant non-cancer health problems such as sensory irritation (preventing around 19 200 cases) which otherwise would cause sufferings to these workers and compromise their quality of life. As formaldehyde (and the other four substances) falls under CMD, in order to prevent the whole range of health problems, an OEL can only be established under this directive. 5.2. Retained options for establishing binding OELs under the CMD The reference limit values per substances, for which explicit calculations have been made by RPA (2018), are presented below. In addition to the baseline scenario, OELs have been considered at the level proposed by the ACSH and at one or two additional reference points (e.g. the strictest limit value observed among Member States). 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 these 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. These considerations will be taken into account in the analysis substance by substance. Table 4: Options matrix of OELs (inhalable) Carcinogen Option 1 Baseline Other options Cadmium and its inorganic compounds no EU OEL 1 µg/m3 (ACSH) 4 µg/m3 (ACSH transition value) 10 µg/m3 Beryllium and inorganic beryllium compounds no EU OEL 0.1 μg/m3 0.2 μg/m3 (ACSH) 0.6 μg/m3 (ACSH transition value) Arsenic acid and its salts, inorganic arsenic compounds no EU OEL 10 µg/m3 (ACSH) 25µg/m3 50µg/m3 Formaldehyde no EU OEL 0.15 mg/m3 0.37 mg/m3 (ACSH) 0.6 mg/m3 4,4'-Methylene-bis(2-chloroaniline) (MOCA) no EU OEL 5 µg/m3 10 µg/m3 (ACSH) 20 µg/m3 5.3. Options discarded at an early stage Several other options have been discarded as they were considered disproportionate or less effective in reaching the objectives of this initiative. A.Banning the use of the carcinogenic chemical agents For most carcinogens even a very low OEL does not completely eliminate the risk of triggering a cancer. The risk could only be reduced to zero by eliminating the presence/use of the substance in the workplace. Indeed, substitution is the first option in the hierarchy of risk management measures under the CMD that an employer needs to consider. This means that if it were technically feasible, employers should already have replaced use of the concerned chemical agents with safer alternatives. Wherever substitution is a suitable alternative for use of the chemical agents in question the CMD already requires this, regardless of the existence of an OEL. As this legal standard already establishes that these carcinogens should not be used in the workplace where alternatives are available, establishing a more strict prohibition in the form of a ban would constitute a disproportionate measure with a strong negative impact on businesses. B.Providing industry-specific scientific information without amending CMD Another option could be for the Commission to collect and provide industry-specific scientific information to support employers in complying with the CMD obligations. Apart from the practical difficulties related to collection of relevant data for the multitude of sectors concerned, it is considered that this option would not be effective in achieving the objectives of the initiative for the following reasons: ·the way the information is used by employers would not be enforceable by surveillance authorities; ·such an option would not fit with the overarching legal framework of the CMD, which provides for general exposure management requirements to be specifically supplemented by EU-wide minimum standard OELs; ·in some cases, extensive industry- and chemical agent- specific information and guidance already exists and should be taken into account by employers during risk assessments – but this has not demonstrably addressed harmful exposures at EU level.

C.Market-based instruments Market-based instruments such as subsidies, tax breaks or reductions of social insurance contributions, are sometimes used by Member States to incentivise business to comply with health and safety rules. Such instruments can effectively support compliance with exposure limits. However, to be applied effectively in this context, such mechanisms would need to be linked (directly or indirectly) with the actual levels of exposure at firm level. This would require much improved data collection which would likely result in being extremely costly and cumbersome. It should also be noted that these instruments remain in the hands of Member States and the extent to which they are used vary significantly . This option alone would therefore not be effective in ensuring the same level of minimum protection across the EU. D.Industry self-regulation Certain industry initiatives like voluntary product stewardship programmes by companies and sectors, or autonomous social partner agreements, are not legally binding and not applied in all sectors or companies concerned. Such agreements are very useful tools to improve the situation over time, however, due to the fact that their rules and obligations for members are not always implemented and thus enforced by national authorities, these initiatives can only be considered as complementary tools. E.Regulation under other EU instruments (REACH) Both CMD and the REACH Regulation are relevant for worker protection from the majority of carcinogens considered in this assessment. The OSH Directives and REACH are complementary, and clear synergies between REACH and worker protection legislation can be seen – these are set out in more detail in section 4.3 of this report and in Annex 10. In the case of the present proposal, setting binding OELs under the CMD is the appropriate regulatory instrument. Among the reasons in support of this approach there is the fact that CMD covers worker exposure to carcinogenic agents released by any work activity, whether produced intentionally or not, and whether available on the market or not, such as process generated substances in the workplace. Furthermore, CMD is intended to set OELs, which are an important part of the wider OSH approach to managing chemical risks . F. Directly adopting the most stringent national OEL For most of the carcinogens some Member States adopted OELs more stringent than considered in this proposal. It could be argued that such OELs could be made binding across the EU based on an assumption that what is achievable in one Member State should be achievable in all. However, the EU sets minimum standards in this area and OELs need to be seen in the context of the minimisation principle. This means that industries have the obligation to minimise exposure below existing OELs if that is technically feasible. G. Guidance documents As non-regulatory alternatives, guidance documents or examples of good practice could be developed and disseminated in co-operation with the EU-OSHA and/or the ACSH and its relevant working party. This could also include the development of awareness raising campaigns for employers and workers alike on the prevention of risks arising from workers' exposure to categories 1A and 1B carcinogenic and mutagenic substances. However guidance documents by itself would not be considered effective enough in reaching the objectives of this initiative. They are complementary and provide an added value to setting OELs. H. Adapted solutions for SMEs SMEs should not be generally exempted from the scope of the initiative as their exclusion would mean that a very significant number of European workers would not be covered by health and safety at work legislation, with a clear distortion and inequality in the application of the EU legislative framework and with a risk of compromising the underlying social policy objectives and fundamental rights. 6.What are the impacts of the policy options and how do they compare? 6.1. Assessed options and how they compare This chapter provides an analysis of options per chemical agent, indicating first the baseline scenario, followed by a multi-criteria analysis of likely impacts and an assessment of the preferred option compared to the baseline. Finally, a summary assessment of the retained options is presented.

Different policy options presented in the options matrix in chapter 5.2 have been compared based on the methodology outlined in detail in Annex 4. Other options than those supported by the ACSH in its opinions, such as the most stringent OEL, are presented as reference points for the assessment of the ACSH options, to establish whether these are at reasonable levels and, therefore appropriate, to follow. The ACSH as a tripartite committee is an important body to establish consensus and to effectuate the preferences of governments, workers and employers. This consensus, as a result, ensures the effectiveness and enforcement of new OELs to be established. An OEL that is backed by governments, employers as well as workers has secured the acceptance by the three groups and therefore will be easier to implement and to enforce. 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 takes into account how the problem would evolve, considering all relevant societal, economic and technical developments that would probably occur in the following decades. It includes an assessment of how the situation is likely to change in terms of the number of people exposed, exposure concentrations, mortality, investment in Risk Management Measures (RMM), forthcoming changes in national OELs or protective regulation, self-regulatory initiatives, development of new technologies/growing use of substitutes, as well as any other relevant factors. Given the complementarity between the regulation under REACH and 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. Analytical methods and challenges For a given reduction in exposure levels, the expected decrease in the incidence of cancer cases and ill health is estimated over a given timeframe attributable to the carcinogen in question. The data in this section have been modelled over a period of 60 years using a static discount rate . The health benefits of avoided cancer cases and deaths are expressed in monetary terms by applying standard evaluation methods , in line with the Better Regulation Toolbox guidance. The cost assessment is largely based on consultations with companies in the specific sectors. The model calculates the costs for a group of similar companies incurred in reducing air exposure to a target OEL based on an assumed sequence of RMM implementation which is determined by suitability, effectiveness, and cost. The Better Regulation Toolbox guidance was followed for the cost calculations. 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). Concerning environmental impacts, it can be expected that, unless an OEL were to force companies to substitute the carcinogen for another substance or to discontinue production in the EU, such impacts would be minimal. Transposition and enforcement costs for the public sector for all substances are expected to be limited, taking into account that the transposition can be done for more substances at the same time. There are, however, significant challenges related to the presented analysis. First of all, the disease burden on workers is likely to be underestimated due to several limitations of the study. When considering the disease burden, only the most sensitive cancer endpoint and the most sensitive other adverse health effects have been considered. However, workers may develop additional types of cancer and diseases at higher exposure levels than the doses for the most sensitive endpoints. Those other cancers / adverse health effects, that will be prevented as well, could not be taken into account when calculating in particular the benefits of the proposed OELs, leading to an underestimation of the potential benefits. Furthermore, regarding occupational cancer, the available epidemiologic evidence is scarce and not always sufficiently robust, inevitably affecting the reliability of the derived estimates for the number of cancer registrations and deaths. It can therefore be difficult to establish a causal relationship between cancer cases and exposure to a specific carcinogen. Moreover, occupational cancers may develop decades after exposures – including during retirement – complicating the possibility of identifying a causal link. As a result, the health benefits presented in this report are likely to be underestimated. The 60 year-time frame of the assessment poses also a challenge of anticipating future industrial developments, technological progress, changes in work organisation, etc. It is difficult to predict future trends in the use of the substances under consideration and therefore in occupational exposures, and how these trends will impact the baseline. Similarly, the assessment of the impact on international competitiveness and innovation could only be based on consultations and the model assumptions of RPA (2018), but not substantiated with hard evidence. Finally, data on the number of workers exposed is generally scarce and unreliable, and data on the current exposure levels across EU Member States is not always available. Therefore, the baseline shows more modest figures than other recent studies that estimated past burdens of disease. Further methodological information is to be found in Annex 4. Assessment and comparison of options Regarding health considerations, health impacts could not be fully quantified and all methods using stated preference show uncertain components (e.g. the income and wealth of a person). Thus, a number of other qualitative considerations were taken into account on top of the quantitative calculations. Such considerations include the limitations of the data, and the uncertainty of health effects and scarce epidemiological evidence, as explained above. Moreover, the different timeframes for costs and benefits can also skew a purely quantified calculation. Often, significant parts of costs occur as capital expenditures in the years following the OEL setting, but health benefits, considering the long latency periods for cancer, can occur up to 50 years later. The rather high discount rate of 4% set by the Better Regulation guidelines thus reduces net present value of the benefits more importantly than that of the costs. This impact assessment aims to balance health considerations against economic impacts, by proposing OELs that are still economically feasible while protecting a maximum number of workers.

The study accompanying the impact assessment assessed the different 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. Concluding, the proposal aims to take a balanced approach and to prevent industries from closures or sever disadvantages in particular Member States due to e.g. adopting the most stringent OELs. Furthermore, the CMD lays down the minimum requirements and Member States are free to introduce more stringent provisions. 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. 6.1.1. Cadmium and its inorganic compounds Baseline At present, neither cadmium nor any cadmium compounds have been included in Annex XIV of REACH, the ‘Authorisation List’. However, a number of relevant compounds are at earlier stages of the process, which may lead to their eventual inclusion into Annex XIV. The exposure concentrations have been declining on average by 3% per year. Individual consultation responses, however, have not identified any significant decreases over time. For the future, 0% change in exposure levels and numbers of workers exposed are expected. In the absence of any further action a limited number of cases of cancer and up to 280 new cases of proteinuria are expected in the coming 60 years. This has been estimated to have a health cost of up to EUR 68 million. However, the fact that only one main cancer (lung) and one main non cancer health effect (elevated proteinuria ) have been quantified indicates that the estimated burden resulting from not preventing it can likely be higher. Table 5: Baseline scenario over 60 years for cadmium and its inorganic compounds Types of cancer caused Lung cancer (quantified), kidney and prostatic cancer (not quantified) Other adverse health effects Proteinurea (quantified), osteotoxic (toxic to the bones) and respiratory effects (not quantified) Number of exposed workers 10 000 Change exp. Level Past: -7% p.a. (level and workers) Future: 0% Change no. of exposed workers Past: -7% p.a. (level and workers)

Future: 0% Current disease burden (CDB) - no. of cancer cases 11 Future disease burden (FDB) - no. of cancer cases 5.8 CDB no. of other adverse health effects 500 FDB no. of other adverse health effects 180-280* Exp. no. of deaths FDB cancer 5 Exp. no. of deaths FDB other adverse health effects 6-8 Monetary value FDB cancer EUR 5 million Monetary value FDB other adverse health effects EUR 9-63 million Based on RPA (2018)

* Workforce turns over at 5% p.a. Impacts of the policy options The table below shows the multi-criteria analysis, summarizing both the monetised impacts as well as those that are assessed qualitatively. Compliance and administrative costs for companies are the largest cost burden across all options. There are between 100 and 150 mainly large companies with workforce exposed to significant levels of cadmium in the EU. The costs are estimated over a 60 year period, with capital expenditures of EUR 412 million and EUR 35 million operating expenditures discounted to a present value for an OEL of 1 µg/m3. If the strictest value were to be adopted without any transition period, it could be that a very limited number of companies or business units might relocate (the OELs in competitor countries are higher) or close down, with some associated job losses. This could have some negative consequences for competitiveness as well as innovation. However, a transition period with a higher initial value (as in option 3) would make it possible for companies to anticipate the changes, gradually introduce improvements and plan necessary investments. As a result it is not expected that any closures or job losses would occur. A transition period will also mitigate any negative impact on competitiveness and innovation. The companies in the key sectors are generally large enterprises, and only limited evidence of SMEs in the key sectors has been found . The increase in costs due to having to implement more or better RMMs is calculated to represent in the region of 1.4% of average turnover at the 1 µg/m3 OEL. There is no impact expected for consumers or the environment. The main benefits across all options come from avoided ill-health, in particular avoided lung cancer and elevated proteinurea cases vis-à-vis the baseline. RPA (2018) monetised the health benefits for cadmium for 181 cases of elevated proteinuria under the constant workforce scenario for the baseline, but up to 280 cases can be prevented under an assumed workforce turnover of 5% p.a. Options 2 and 3 are also associated with a significant positive effect on simplification and level playing field as currently 80% of Member States' OELs are above the option 2 value and 75% above the option 3 value. This is particularly relevant for this industry where a significant number of affected companies operate across borders. Table 6: Multi-criteria analysis for cadmium and its inorganic compounds

Impact Stakeholders affected Option 2 1 µg/m3 (ACSH) Option 3 4 µg/m3 (Lowest value, ACSH transition value) Option 4 10 μg/m3 (Highest value) Economic impacts Compliance and administrative costs Companies €447million assuming that no transition period is established €79–116 million €14-44 million Transposition & enforcement Public sector Limited costs Limited costs Limited costs Benefits from reduced ill health Reduction in cancer cases 6 6 4 Reduction in cases elevated proteinuria 181 176 92 Employers Moderate costs avoided: €1.0-€1.4 million Moderate costs avoided: €0.9-€1.3 million Limited costs avoided: €0.5-€0.7 million Public sector Moderate costs avoided: €4.6-€6.7 million Moderate costs avoided: €4.5-€6.5 million Moderate costs avoided: €2.4-€3.4 million Single-market: consumers Consumers No/very low impacts identified Simplification /level playing field Companies Significant positive impact % of MS currently above the OEL: 80% Significant positive impact % of MS currently above the OEL: 75% Significant positive impact % of MS currently above the OEL: 55% International competitiveness Companies Potential negative impact, if no transition period is established Moderate impact Specific MSs/regions MSs AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, EL, HU, IE, LV, LT, NL, PL, SI, ES, SE, UK AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, EL?, HU, IE, LV, LT, NL, PL, SI, ES, SE, UK AT, BG, HR, CY, CZ, DK?, FR, HU, IE, LV, LT, NL, SI, SE, UK Social impacts Ill health avoided Workers & families €9m-€59m €9m-€57m €5m-€30m Employment Jobs lost Limited impact Very limited impact Very limited impact Environmental impacts Environmental releases Environment No impact/limited impact Recycling – loss of business Recycling companies Negative impact if no transition period is established No impact/limited impact Based on RPA (2018); NB: a transition period was not considered in the analysis Comparison of the policy options Concerning the effectiveness, an OEL of 1 µg/m3 (Option 2) appears as the most effective option as it will prevent all the cases of cancer and proteinuria expected under the baseline. Moreover, the ACSH agreement on the Option 2 value has to be considered when looking at the effectiveness of option 2. This OEL is backed by employers as well as workers and would thus be easier to implement and to enforce. Concerning the efficiency, the costs of option 2 are significant. The Employers Interest Group noted in the ACSH opinion that a fundamental change to the OSH risk management strategy in the cadmium industry, along with the redesign and commissioning of more complex air cleaning systems, will be required by option 2. However, by combining the OEL of 1 μg/m3 with a transition period of 7 years at 4 μg/m3 the costs for employers and also the impact on employment are mitigated, thus the efficiency of this option is increased. Concerning coherence, establishing an OEL following option 2 also increases the coherence of the CMD with other EU policy objectives, including the Charter for fundamental rights. It also increases complementarity with REACH, as outlined in chapter 4. Moreover, establishing new OELs will increase legal clarity, provide a common reference point that can be used as a practical tool by employers, workers and enforcers to assess compliance with the general CMD requirements, and will also contribute to a level-playing field for businesses across the EU (see chapter 3). Coherence with general EU priorities and policies, as well as with the Charter of Fundamental Rights, is considered to be the highest for the strictest OEL, as it is the most protective of workers’ health. Option 2, with a transitional period of 7 years at the level of option 3, is therefore the preferred option. Table 7: Cadmium and its inorganic compounds – comparison of options Criteria Option 1: Baseline Option 2: 1 µg/m3 (ACSH opinion) Option 3: 4 µg/m3 Option 4: 10 μg/m3 Effectiveness 0 + + ≈ Efficiency 0 - - ≈ Coherence 0 ++ + + 6.1.2. Beryllium and inorganic beryllium compounds Baseline Around 54 000 workers in the EU are exposed to beryllium and its inorganic compounds. The sectors using beryllium that have been examined for this impact assessment are foundries, metal fabrication, transport, ICT, specialist manufacturers, medical devices, glass, construction, laboratories and recycling. The construction sector has been excluded from the baseline scenario, as there was little reliable data about exposed workers and affected enterprises in this sector. This exclusion might lead to an underestimation of the numbers of workers exposed to beryllium, in particular in light of the large workforce in this sector. In addition, there is a lack of published data for the monetisation of chronic beryllium disease. Beryllium is not on the authorisation list of REACH at present and there are no restrictions. As such, these regulatory mechanisms are not imparting any direct impact on worker exposures. For the current burden of disease, it is assumed that the numbers of workers in these sectors have decreased by 1% per year and the exposure concentrations have decreased by 3% per year. The estimates for the future burden of disease are based on the assumption that the number of workers exposed to beryllium and its inorganic compounds and the associated exposure concentrations will slightly decrease. The main significant end health point for exposure to beryllium is chronic beryllium disease. In the absence of any further action, further 4 602 new cases of chronic beryllium disease are expected in the coming 60 years. Further, the estimated latency period for the disease is as short as two years, whereas the estimated treatment period is as long as thirty years with fatality rate of 10%. This has been estimated to have a health cost between EUR 420 million and EUR 1.9 billion. The below table illustrates the baseline scenario for beryllium and its inorganic compounds. Table 8: Baseline scenario over 60 years for beryllium and inorganic beryllium compounds Types of health effect caused Chronic beryllium disease (quantified), allergy or asthma symptoms, beryllium respiratory sensitisation, skin sensitisation, cardiovascular, renal, hepatic and haematological effects (not quantified) No. of exp. workers 54 071 (excluding construction sector) Change in exposure levels Past: -3% per year Future: Expected 2% per year reduction Change number of exposed workers Past: -1% per year Future: Expected 3% per year reduction Current disease burden (CDB) - no. of chronic beryllium disease cases Exposure in sectors considered in this study over the past 40 years: 3 807 Future disease burden (FDB) - no. of chronic beryllium disease cases 3 068 -4 602* Exp. no. of deaths (FDB) from chronic beryllium disease 307 - 460* Monetary value FDB from adverse health effects EUR 290 million – EUR 1.9 billion Based on RPA (2018)

*Workforce turns over at 5% p.a.

Impacts of the policy options The table below shows the multi-criteria analysis, summarizing both the monetised impacts as well as those that are assessed qualitatively in this report. Compliance and administrative costs for companies are the largest cost burden across all options. Beryllium is mostly used by SMEs. There are about 5 800 companies consisting of 92% small, 7% middle and 1% large enterprises in the EU (excluding the construction sector) with workforce exposed to beryllium. The costs for businesses are estimated over a 60-year period and discounted to present value. At an OEL of 0.1 µg/m3, the capital expenditures for all businesses are estimated to be EUR 875 million with operating expenditures of EUR 128 million. At an OEL of 0.2 µg/m3, the capital expenditures for all businesses are estimated to be EUR 87 million with operating expenditures of EUR 47 million. At an OEL of 0.6 µg/m3, the capital expenditures for all businesses are estimated to be EUR 26 million with operating expenditures of EUR 16 million. For small companies, the costs per firm are estimated to range for an OEL of 0.1 µg/m3 between EUR 21 425 to EUR 28 577, for an OEL of 0.2 µg/m3 between EUR 9 214 to EUR 14 904 and for an OEL of 0.6 µg/m3 between EUR 2 862 to EUR 4 940. The highest costs will be faced by small companies in the sectors foundries, metal fabrication and laboratories. For all of the three options the costs for a small company as a % of turnover is less than 0.25%. Stakeholders have expressed doubts about the feasibility for certain processes to achieve exposures below 0.2 μg/m3 and that these processes could move outside the EU if a lower OEL is set. Under the strictest OEL of 0.1 μg/m3, up to 4% of companies could potentially close due to technical difficulties achieving such a low OEL. Only the lowest OEL would have a likely negative impact on competitiveness due to companies exiting the market and (1) removing the provision of specialist services completely and (2) causing a concentration of the market into a small number of companies. Substitution is rarely an option for production with beryllium. However, companies are expected to be able to comply with OELs above 0.2 μg/m3 and international competitiveness should not be affected, taking into account a proposed transitional period. The aspects likely to be affected are innovation, research and development leading to new products in high technology areas where beryllium plays a key role such as electric cars and solar power. It is not possible though to determine the extent of these effects. Also, the global nature of the markets using beryllium means that companies using the substance outside of the EU will be at a competitive advantage where any regulatory requirements in force locally are lower than the proposed harmonised OELs. There is no impact on employment for an OEL starting with the lowest feasible OEL of 0.2 μg/m3. Moreover, there is no impact expected for consumers or the environment. The main benefits across all options come from avoided ill-health, in particular from avoided cases of chronic beryllium disease vis-à-vis the baseline and from improved level playing field for companies. Table 9: Multi-criteria analysis for beryllium and inorganic beryllium compounds, excluding construction Impact Stakeholders affected Option 2 <=0.1 μg/m3 (Lowest value) Option 3 0.2 μg/m3 (ACSH) Option 4 0.6 μg/m3 (Highest value, ACSH transition value) Economic impacts Compliance costs Companies > €1 billion €130 million €40 million Company closures Companies Significant impact No impact No impact Transposition and enforcement costs Public sector Limited costs 95% of MS would have to transpose Limited costs 80% of MS would have to transpose Limited costs 80% of MS would have to transpose Benefits from reduced ill health Reduction in CBD cases 2 800 -3 100 2 400 1 600 Employers Moderate > €17 million Moderate €15 million Moderate €10 million Public sector Moderate > €25 million Moderate €21 million Moderate €15 million Single-market: competition/ level playing field Companies Significant positive Reduction of highest OEL/lowest OEL ratio from 50 to ‘no difference’ Significant positive Reduction of highest OEL/lowest OEL ratio from 50 to 6 Significant positive Reduction of highest OEL/lowest OEL ratio from 50 to 6 Single-market: consumers Consumers Limited impact Simplification Companies Significant positive % of MS currently above the OEL: 95% Significant positive % of MS currently above the OEL: 80% Significant positive % of MS currently above the OEL: 80% Specific MSs/regions Member States Significant AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, EL, HU, IE, LV, LT, PL, RO, SK, SI, ES, SE, UK, plus IT, LU, MT, NL, PT Significant AT, BE, BG, HR, CY, CZ, DK, EE, FR, EL, HU, LV, LT, RO, SK, SI, SE, UK plus IT, LU, MT, NL, PT Significant AT, BE, BG, HR, CY, CZ, DK, EE, FR, EL, HU, LV, LT, RO, SK, SI, SE, UK plus IT, LU, MT, NL, PT Health and social impacts Deaths avoided Workers & families Significant 270 - 302 Moderate 223 Moderate 150 Ill health avoided including intangible costs Workers & families > €240 million €200 million < €140 million Employment – social cost (salary lost) Workers Moderate €17 – 180 million None None Environmental impacts Environmental releases All Neutral impact Based on RPA (2018);NB: a transition period was not considered in the analysis Comparison of the preferred policy option Concerning the effectiveness, option 2 would have the most positive effect on preventing deaths and ill health but option 3 is quite closely matched. Option 3 is also the result of in-depth discussions between the representatives of workers, employers and governments in the ACSH. This OEL, backed by stakeholders, would thus be easier to implement and to enforce. The workers noted that an OEL should in the future possibly go lower than 0.2 μg/m3 to optimally protect workers. Beryllium is a respiratory sensitiser. Beryllium and beryllium compounds can also cause allergic contact dermatitis or a granulomatous skin reaction in humans. Beryllium compounds have been shown to be skin sensitisers in animal experiments. A notation for dermal and respiratory sensitisation is therefore recommended. Concerning the efficiency, option 3 has the best cost-benefit ratio. The Employers Interest Group noted in the ACSH opinion that achieving an OEL of 0.2 μg/m3 is a very challenging target in terms of technical feasibility. Therefore, the impacts on companies can be further mitigated by combining the OEL of 0.2 μg/m3 with a transition period of 5 years at 0.6 μg/m3. Concerning the efficiency, the benefits outweigh the costs for option 3. Moreover, by combining the OEL of 0.2 μg/m3 with a transition period of 5 years at 0.6 μg/m3 the negative impact on companies created by possible additional costs can be further mitigated. Concerning coherence, establishing an OEL following option 3 also increases the coherence of the CMD with other EU policy objectives, including the Charter for fundamental rights. It increases complementarity with REACH, as outlined in chapter 4. It will 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 chapter 3). Coherence with general EU priorities and policies, as well as with the Charter of Fundamental Rights, is considered to be the highest for the strictest OEL, as it is the most protective of workers’ health. Option 3, with a notation 'Sensitisation (dermal and respiratory)', and with a transitional period of 5 years at the level of option 4, is therefore the preferred option.

Table 100: Beryllium and inorganic beryllium compounds – comparison of options Criteria Option 1: Baseline Option 2: 0.1 μg/m3 (Lowest value) Option 3: 0.2 µg/m3 (ACSH opinion) Option 4: 0.6 μg/m3 (ACSH transition value) Effectiveness 0 ++ + + Efficiency 0 - ++ + Coherence 0 ++ ++ + 6.1.3. Arsenic acid and its salts, as well as inorganic arsenic compounds Between 7 900 to 15 300 workers are estimated to be exposed to inorganic arsenic compounds, and 18 000 to 102 000 workers are potentially exposed at levels below the lowest OEL assessed. The calculations, by not including the larger number of workers (those potentially exposed), underestimates the total current burden of exposure. Moreover, the dose-response relationship (DRR) estimated as part of this study is based on limited available data. The estimate must be considered quite uncertain and to represent the order of magnitude only. Inorganic arsenic compounds are intentionally used in the glass sector, electronics sector and the primary zinc sector. Whereas a large number of workers a few decades ago were exposed at high levels to arsenic, the number of workers and exposure levels have decreased markedly due to restriction of some of the main uses of arsenic compounds and due to implementation of better RMMs. Unintentional use in raw materials occurs in the non-ferrous metal sector, the ferrous base metal sector, the energy sector and the chemical sector. Concerning the unintentional use, arsenic is present typically in concentrations below 0.1%. However, it cannot be excluded that some workers, e.g. in maintenance works in settings with arsenic-rich dusts, could be exposed at levels above the lowest of the assessed OELs. In the sectors with the major exposure to inorganic arsenic compounds, the arsenic is present as unintentional constituent of raw materials and it is anticipated that these exposures will not be influenced by any actions under REACH. For the major sectors, no significant trend in exposed workforce is observed, but where data is available the number of workers exposed at high levels shows a decrease. The future trend is set at -1%. As for the exposure concentrations, with expected increasing arsenic concentrations in the raw materials, as well as potential further exposures, for example in recycling, the exposure concentrations would increase if nothing else was done. However, this increase will likely be counterbalanced by RMMs. In the absence of any further action a limited number of cases of cancer and 574 cases of neurotoxic effects are expected in the coming 60 years. This has been estimated to have a combined health cost of EUR 39.6 million. Other related health effects such as cancer of skin, urinary bladder, kidney, liver and prostate have not been taken into account. The below table illustrates the baseline scenario. Table 11: Baseline scenario over 60 years for arsenic acid and its salts, as well as inorganic arsenic compounds Types of cancer caused Lung cancer (quantified) cancer in the skin, liver, lungs, bladder and kidney (not quantified) Other adverse health effects Peripheral neuropathy (quantified), cardiovascular effects and immunotoxicity, skin changes and black foot disease (not quantified) No. of exp. Workers 7 900-15 300 (assessed) 18 000 – 102 000 (potentially exposed at levels below the lowest OEL assessed) Change exp. Level Past: -8% Future: -1% Change no. of exp. Workers Past: -2% Future: 0 Current disease burden (CDB) - no. of cancer cases 17.2 * Future disease burden (FDB) - no. of cancer cases 20 Current disease burden (CDB) - no. of peripheral neuropathy cases 905 * FDB no. of other adverse health effects 574 Exp. no. of deaths FDB cancer 16 Exp. no. of deaths FDB, other adverse health effects None Monetary value FDB cancer EUR 16.356 million Monetary value FDB other adverse health effects EUR 23.31 million * Excludes burden of disease from exposure to prohibited applications; first of all the former use in CCA wood preservatives, CCA-preserved wood, other biocides and pesticides which have been major exposure sources. According to CAREX data, these applications accounted for half of the exposed workforce in 1993/97. Based on RPA (2018) Impacts of the policy options Overall, the estimated compliance costs are very small compared to industry activities. For an OEL of 10 μg/m3, one-off capital expenditures of businesses amount to EUR 11 million, and recurring operating costs to EUR 10 million. The estimated compliance costs over the 60 year period are below 0.5% of industry turnover per exposed worker. For a majority of affected companies, the measures needed to achieve compliance are respiratory protective equipment and therefore, the costs are more or less proportional to the number of workers. The highest impacts would be in the first year with relative high investment costs that need to be financed. The most affected sector is expected to be the copper sector. Comparing the compliance costs (CAPEX and OPEX) per exposed worker in the copper sector with that annual turnover, these represent a maximum of 5% of turnover in the first year. Although this could be challenging in case the affected company would have limited access to finance, it is still considered manageable. Overall, there is no indication of significant issues for SMEs in any of the affected sectors. While a few of the affected production sites/companies in the copper sector are relatively small, they are owned by larger companies and therefore they might not be formally SMEs. It means that they are likely to have access to technical expertise and financial resources that will ease the compliance with the considered OELs. The impacts of introducing any of the OELs on competition and competitiveness are estimated to be relatively modest and no significant impact on innovation is expected. Employment and the environment are also not expected to be affected by any of the options. The main benefits across all options stem from avoided ill-health, in particular from avoided cases of lung cancer and peripheral neuropathy disease vis-à-vis the baseline and from an increased level playing field for companies. The applications for authorisation under REACH for diarsenic trioxide have been studied for the preparation of this report. Increased releases to the environment are not expected from the application of lower OELs. Companies using arsenic acid and inorganic arsenic compounds have to comply with the Industrial Emissions Directive 2010/75/EU (integrated pollution prevention and control), as well as with site specific environmental permissions.

The multi-criteria analysis in the table below summarises the main impacts. Table 12: Multi-criteria analysis for arsenic acid and its salts, as well as inorganic arsenic compounds Impact Stakeholders affected Option 2 10 μg/m3 (ACSH) Option 3 25 μg/m3 (Mean value) Option 4 50 μg/m3 (Highest value) Economic impacts Compliance costs Companies exposing their workers €21.2 million €11 million €1.6 million Transposition costs Public sector Limited impact Limited impact Limited impact Benefits from reduced ill health Reduction in number of cancer cases 3 2 1 Reduction in numbers of peripheral neuropathy cases 574 468 393 Employers avoided costs €2.8 million €2.3 million €1.9 million Public sector avoided costs €1.3 million €1.1 million €0.9 million Single-market: competition Limited impact - no closures expected Single-market: consumers No impact No impact No impact Single-market: internal market Companies / Positive impact /level playing field Reduction of highest OEL/lowest OEL ratio from 71 to 4 Reduction of highest OEL/lowest OEL ratio from 71 to 9 Reduction of highest OEL/lowest OEL ratio from 71 to 18 International competitiveness No impact No impact No impact SMEs No or very limited impact No impact No impact Specific MS/regions MSs that would have to change OELs Companies that might be impacted AT, BG, HR, CZ, EE, FR, EL, HU, IT, LT, LU, MT, PT, SK, SI, UK AT, BG, HR, CZ, EE, FR, EL, HU, IT, LT, LU, MT, PT, SK, SI, UK AT, HR, CZ, FR, EL, HU, IT, LU, MT, PT, SK, SI, UK Social impacts Ill health avoided – lung cancer and peripheral neuropathy (incl. intangible costs) Workers & families €9 to €34 million €7 to €28 million €5to €23 million Other health points Workers & families Additional ill-health from other types of cancer and non-cancer endpoints not included in the assessment (expected to be lower than the assessed endpoints) Employment Workers No impact No impact No impact Environmental impacts Environmental releases No impact (expected that exhaust air from ventilation systems is filtered before released to the environment) Recycling – loss of business Recycling companies No impact Recycling – durability of consumer goods, etc. No impact Based on RPA (2018) Concerning effectiveness, option 2 will have the most positive impact on prevention of deaths and ill health compared to the baseline and other options. In addition, option 2 is a result of in-depth discussions between the representatives of workers, employers and governments in the ACSH and would thus be the easiest to implement and to enforce. Concerning efficiency, the benefits outweigh the costs for all options. This is also the case for the most stringent OEL under option 2, where the calculation shows that benefits of almost 26 million EUR (method 1) outweigh costs of some 21 million EUR over 60 years. However, the ACSH noted that the OEL could be technically challenging for the copper smelting sector, and a prolonged transitional period may be necessary. No other concerns about technical feasibility, overall costs or impact on competitiveness outside the EU have been raised by employers' representatives or government representatives. Concerning coherence, option 2 also increases the coherence of the CMD with other EU policy objectives, including the Charter for fundamental rights. It will increase the complementarity with REACH, as outlined in chapter 4. Moreover, it will provide a common reference point that can be used as a practical tool by employers, workers and enforcers to assess compliance with the general CMD requirements, and will also contribute to a level-playing field for businesses across the EU (see chapter 3). Coherence with general EU priorities and policies, as well as with the Charter of Fundamental Rights, is considered to be the highest for the strictest OEL, as it is the most protective of workers’ health. Option 2, with a transition period for copper smelting, is therefore the preferred option. Table 13: arsenic acid and its salts, as well as inorganic arsenic compounds –comparison of options Criteria Option 1: Baseline Option 2: 10 µg/m3 (ACSH opinion) Option 3 25 μg/m3 (Mean value) Option 4 50 μg/m3 (Highest value) Effectiveness 0 ++ + + Efficiency 0 + + + Coherence 0 ++ + + 6.1.4. Formaldehyde Baseline Around 990 000 workers are estimated to be exposed to formaldehyde. Formaldehyde is used in a wide array of economic sectors, ranging from agriculture, forestry and fishing, manufacturing of food products, manufacture of textiles, manufacture of leather and related products, manufacture of wood and products of wood and cork - except furniture, manufacture of paper and paper products, manufacture of chemicals and chemical products, manufacture of basic pharmaceutical products and pharmaceutical preparations, manufacture of rubber and plastic products, etc. to professional, scientific and technical activities, human health and funeral and related activities. Given the many and various economic sectors formaldehyde is used in, there is only limited availability and reliability of sector-specific data (i.e. exposed workers/companies; exposure concentrations and currently implemented RMMs). REACH is not expected to impact the baseline. Formaldehyde is registered under REACH. However, its intermediate use in resins and chemical synthesis is not covered under REACH , and formaldehyde-based resins are also not registered as they are considered as polymers. This includes resin manufacturing which is a major use of formaldehyde. Formaldehyde use is also covered under other regulations. For example, the use of formaldehyde in biocidal applications is covered by the Biocidal Product Regulation and wood-based panels are covered under EN standards. The current burden of disease has been estimated assuming that the number of workers in the relevant sectors has been decreasing by 3% per annum and the exposure concentrations have not changed. The number of cases expected to occur in the future is given below. It is assumed that the number of workers and exposure concentrations will remain stable in the future. In the absence of any further action a limited number of cancers and 19 200 cases of sensory irritation are expected in the coming 60 years. This has been estimated to have a combined health cost between EUR 1.4 billion and EUR 8 billion.

The below table illustrates the baseline scenario for formaldehyde. Table 14: Baseline scenario over 60 years for formaldehyde Types of cancer caused Nasopharyngeal cancer (quantified), leukaemia, tumour induction (not quantified) Other adverse health effects Sensory irritation (quantified), potential cancer precursor effects (not quantified) No. of exp. Workers 990 000 Change exp. Level Past: -5% p.a. (exp. level & workers) Future: 0% Change no. of exp. Workers Past: -3% p.a. (exp. level & workers) Future: 0% Current disease burden (CDB) - no. of cancer cases 330 per year (due to past exposure) Future disease burden (FDB) - no. of cancer cases 7* CDB no. of other adverse health effects 19 200 cases of sensory irritation FDB no. of other adverse health effects 19 200 cases of sensory irritation* Exp. no. of deaths FDB cancer 3 Exp. no. of deaths FDB other adverse health effects 0 Monetary value FDB cancer EUR 4 million to EUR 3 billion Monetary value FDB other adverse health effects EUR 1 billion to EUR 5 billion Based on RPA (2018) In case of formaldehyde due to the cumulative nature of cancer risk, the burden caused by the two modelled health endpoints is the same under both the worker ‘turnover’ and ‘no turnover’ scenarios. Impacts of the policy options SCOEL has derived an OEL of 0.37 mg/m3 with a corresponding short-term exposure limit (STEL) of 0.738 mg/m3 since sensory irritation is a concentration rather than a cumulative dose-driven effect . The costs and benefits for STEL values could not be monetised for formaldehyde. Formaldehyde is a well-known contact allergen to the skin (skin sensitiser). A notation 'sensitisation (dermal)' is therefore recommended by SCOEL. It is estimated that 133 926 small enterprises, 8 384 medium and 9 039 large enterprises have workers exposed to formaldehyde to some degree in the EU. EU MS with more than 10 000 enterprises using formaldehyde are France, Germany, Italy, Poland, Spain and the United Kingdom. No enterprises are expected to cease trading as a result of the introduction of any of the considered OELs. As a result, no impacts on competition are envisaged and also no significant impact on innovation is expected. All options are associated with compliance and administrative costs for companies. However, the compliance costs associated with meeting even the strictest OELs represent less than 1% of SMEs’ total turnover in the different sectors that would be affected. Consequently, workers are overall unlikely to lose their jobs as a result of the introduction of any of the OELs. Moreover, businesses may be able to absorb these cost increases without significant impacts on prices and, therefore on competitiveness or on consumers. For all small enterprises, an OEL of 0.37 mg/m3 would lead to estimated capital expenditures of EUR 21 million, but save the businesses operating costs of EUR 8 million, totalling costs at 13 million over 60 years. Similarly, medium enterprises would face capital expenditures of EUR 257 million and save operating expenditures of EUR 81 million over 60 years. Currently, businesses using formaldehyde face different OELs in different MS, with the ratio of the highest OEL to the lowest OEL being 20:1. In the event that an OEL of 0.6 mg/m3 is introduced, that ratio would reduce to 4:1, to approximately 2:1 under an OEL of 0.37 mg/m3. Greater harmonisation will also benefit those businesses which already, or might wish to, operate in multiple Member States. The main benefits across all options come from avoided ill-health, in particular from avoided cases of nasopharyngeal cancer and sensory irritation vis-à-vis the baseline. Moreover, there is a significant positive impact from increased competition and from a level playing field for companies. Table 13: Multi-criteria analysis for formaldehyde Impact Stakeholders affected Option 2 0.15 mg/m3 (Lowest value) Option 3 0.37 mg/m3 (ACSH) Option 4 0.6 mg/m3 (Highest value) Economic impacts Compliance costs Companies €10.34 billion €1.72 billion €0.07 billion Transposition costs Public sector Limited impact Limited impact Limited impact Benefits from reduced ill health Reduction in cases (lung cancer) 7 7 7 Reduction in cases (sensory irritation) 19 200 (on any given day) 19 200 (on any given day) 19 200 (on any given day) Reduction in DALYs 115 510 115 510 115 510 Employers (avoided costs) €0.03 million €0.03 million €0.03 million Public sector (avoided costs) €181 million €181 million €181 million Single market: competition No. of company closures 0 0 0 Single-market: consumers Consumers No impacts identified No impacts identified No impacts identified Single market: internal market Companies Significant positive impact Reduction of highest OEL/lowest OEL ratio from 20:1 to ‘no difference’ Significant positive impact Reduction of highest OEL/lowest OEL ratio from 20:1 to 2:1 Positive impact Reduction of highest OEL/lowest OEL ratio from 20:1 to 4:1 International competitiveness Companies Limited impact Limited impact Limited impact Specific MSs/regions MSs All except NL BE, BG, HR, CY, CZ, DK, EL, EE, HU, IT, LV, LT, LU, MT, PL, RO, SI, ES, UK BE, BG, HR, CY, EL, IT, LU, MT, RO, ES, UK Social impacts Ill health avoided (incl. intangible costs) Workers & families €1 billion or €5 billion (depending on method applied) Employment Jobs lost No impacts identified Social cost No impacts identified Environmental impacts Environmental releases Environment Limited impacts under all options Recycling – loss of business Recycling companies Limited impacts under all options Notes: All costs/benefits are incremental to the baseline (PV over 60 years). Based on RPA (2018) Concerning effectiveness, the positive effects on prevention of death and ill health are closely matched for all three options. All are expected to prevent 7 cases of cancer and 19 200 cases of sensory irritation compared to the baseline. However, option 3 is a result of in-depth discussions between the representatives of workers, employers and governments in the ACSH and the backing of all stakeholders will make it the easiest to implement and to enforce. Concerning the efficiency, option 2 is the most costly for business while not resulting in higher benefits in comparison to the remaining options. Benefits outweigh costs in both option 3 and 4, and in case of option 3 the Employers Interest Group in the ACSH did not note any difficulties in complying with the OEL of 0.37 mg/m3 other than for some specific processes. No transition measures were requested by Employers Interest Group with regard to this OEL. Concerning coherence, establishing an OEL following option 3 increases the coherence of the CMD with other EU policy objectives, including the Charter for fundamental rights. It increases complementarity with REACH, as outlined in chapter 4. It will provide a common reference point that can be used as a practical tool by employers, workers and enforcers to assess compliance with the general CMD requirements, and will also contribute to a level-playing field for businesses across the EU (see chapter 3). The stricter the adopted OEL, the more coherence is expected in general. However, in this case all options score similar in terms of coherence. Option 3, with a notation 'dermal sensitisation ' is therefore the preferred option. Table 146: Formaldehyde – comparison of options Criteria Option 1: Baseline Option 2: 0.15 mg/m3 (lowest value) Option 3: 0.37 µg/m3 (ACSH opinion) Option 4: 0.6 mg/m3 (Highest value) Effectiveness 0 + ++ + Efficiency 0 -- + + Coherence 0 ++ ++ ++

6.1.5. 4,4'-Methylene-bis(2-chloroaniline) (MOCA) Baseline 350 workers are estimated to be exposed to MOCA in the EU across around 89 production sites. In addition, about 1 200 workers are indirectly exposed to MOCA via the dermal route. Exposure is not expected to change in the future. The key sector using MOCA is the plastics sector. The assessment of the baseline is done for two scenarios: under the assumption that the REACH authorisation is granted and the use of MOCA continues for a period of time, and the assumption that authorisation is not granted and the use of MOCA discontinues. Both the current burden on disease due to past exposure and the future burden of disease are estimated at relatively low numbers. The exposure risk relationships (ERR) based on workplace concentrations and urinary level, respectively, are both established by the RAC and considered to reflect the current knowledge about the lung cancer effects of the substance. Table 15: Baseline scenario over 60 years for MOCA Types of cancer caused Lung cancer (quantified), bladder cancer (not quantified) Other adverse effects No sufficient data available No. of exp. workers 350 Change exp. Level Past - 4% Future -1% Change no. of exp. workers Past - 3% Future 0% Current disease burden (CDB) - no. of cancer cases based on previous 50 years exposure 0.0005 Future disease burden (FDB) - no. of cancer cases 0.0036 Exp. no. of deaths FDB cancer 0.0019 Monetary value FDB cancer EUR 3 000 Based on RPA (2018) Impacts of the policy options The multi-criteria analysis indicating impacts and stakeholders affected is summarised below. The conclusions are drawn on the basis that the current levels of exposure is typically below the lowest of the OELs assessed and consequently the estimates are not sensitive to the number of exposed workers, the relationship between exposure and effects and the costs of cancer cases. The uncertainty is consequently related to the estimated exposure levels. All affected companies of a possible OEL for MOCA are SMEs. In the application for authorisation under ECHA, 20% are micro, 65% are small and 15% are medium size enterprises. Two thirds of estimated workers exposed to MOCA work in moulders at estimated 89 sites across the EU. The total costs of compliance will depend mainly on the number of workers affected, as the main cost is estimated to be costs of monitoring, thus operating costs. The frequency for monitoring is determined nationally. For this impact assessment, it is assumed that companies will be required to undertake one monitoring programme to demonstrate compliance. Capital expenditures for businesses are not expected. The unit cost of monitoring is found to be independent from the company size, as it mostly depends on the consultant and laboratory used , and is thus expected to be affordable for all businesses, including microbusinesses. The costs of monitoring are small and the economic impact on each company will be negligible. Thus, establishing a reference OEL of (Option 2) or above 5 μg/m3 (options 3 and 4) would not have any impact on competition, competitiveness, innovation, employment or consumer prices. Establishing the reference OELs would have some positive impact on the level playing field and legal clarity. 13 MS have an OEL higher than the lowest assessed OEL of 5 µg/m³ and 11 MS do not have any OEL. Only three MS have an OEL corresponding to the lowest assessed OEL of 5 µg/m³. The ratio of highest OEL/lowest OEL ratio is currently 44. As exposure via the dermal route makes a substantial contribution to body burden, a skin notation is warranted for this carcinogen. The applications for authorisation for MOCA under REACH have been studied for the preparation of this report. The operating conditions and the risk management measures that the applicants will have to comply with in case of a granted authorisation, will reduce workers exposure as well as releases to the environment. No releases to the environment are expected from the application of the proposed OEL. Table 16: Multi-criteria analysis for MOCA Impact Stakeholders affected Option 2 5 μg/m3 (Lowest value) Option 3 10 μg/m3 (ACSH) Option 4 20 μg/m3 (Highest value) Economic impacts Compliance and administrative costs Companies exposing their workers €701 000 €701 000 €701 000 Transposition and enforcement costs Public sector Limited costs Limited costs Limited costs Benefits from reduced ill health Employers Limited impact Limited impact No impact Public sector Limited impact Limited impact No impact Single-market: competition No impact identified for all options Single-market: consumers No impact identified for all options Single-market: internal market Limited impact of harmonisation effect of OEL International competitiveness Limited impact of harmonisation effect of OEL SMEs ** Monitoring costs are not significant Specific MSs/regions Public sector, Member States without an OEL or higher OELs. Companies (in MS with higher or without an OEL) AT, BE, BU, CZ, CY, DK, EE, EL, ES, DE, FI, FR, HU, IT, LV, LT, LU, MT NL, PL, PT, RO, SK, SI BE, DK, FR, EL, NL, PT, ES, HU, IT AT, BE, BU, CZ, CY, DK, EE, EL, ES, DE, FI, FR, HU, IT, LV, LT, LU, MT NL, PL, PT, RO, SK, SI BE, DK, FR, EL, NL, PT, ES, HU, IT BE, BU, CZ, CY, DK, EE, EL, ES, DE, FI, FR, HU, IT, LV, LT, LU, MT NL, PT, RO BE, DK, FR, EL, NL, PT, ES, HU, IT Social impacts Ill health avoided Workers & families Limited impact under all options Employment Workers No impacts under all options Environmental impacts Environmental releases Environment No impacts under all options Recycling – loss of business * Recycling companies No impacts under all options Recycling – durability of * consumer goods, etc. Manufacturers using secondary material No impacts under all options * MOCA is transformed by the use and not present at any significant concentration in recycled articles ** All affected companies are micro sized enterprises and SMEs Based on RPA (2018)

Comparison of the policy options Concerning effectiveness, all assessed OELs would bring similar health effects as the baseline. However, option 3 was agreed in the tripartite ACSH by all the Interest Groups. Thus, the endorsement by workers as well as employers will make it the easiest option to apply and enforce. Regarding efficiency, the very low costs associated with all three options make them comparable with the baseline. A substantial advantage of option 3 is its coherence and legal implications. Establishing an OEL following option 3 increases the coherence of the CMD with other EU policy objectives. In particular, it will significantly increase complementarity with REACH, especially that it is based on the same scientific advice. The new OEL will provide a common reference point that can be used as a practical tool by employers, workers and enforcers to assess compliance with the general CMD requirements. This is especially important in case of a substance like MOCA which is primarily used in SMEs. It will ensure legal stability and predictability for workers and companies irrespective of any potential changes in the future use of the substance. The OEL will also contribute to a level-playing field for businesses acro