European Commission Focuses on Workplace Exposure to Acrylonitrile, Nickel Compounds and Benzene in 4th Revision of Carcinogens and Mutagens Directive

Last year [see edition 260 of BC Disease News (here)], we reported that the European Parliament and Council would soon be adopting a 3rd revision of the Carcinogens and Mutagens Directive (CMD) 2004/37/EC, which encompasses provisions intended to prevent or reduce workplace exposures to 26 carcinogenic and mutagenic substances falling under its scope. It eventually did so in June 2019.[1]

Earlier revisions of the CMD were adopted in December 2017 and January 2019.[2]

Last month, the European Commission proceeded to propose a 4th revision of the CMD, which would take the total number of regulated substances up to 28.

As part of this proposal, which marks the commencement of Europe’s Beating Cancer Plan initiative, new occupational exposure limit (OEL) values for acrylonitrile and nickel compounds, as well as adjusted limits for benzene, are established.[3]

Initial calculations suggest that improved safety measures comprised within the 4th revision would benefit 1,121,500 workers across the EU, in a wide range of sectors.

Below, we lay out individual profiles for acrylonitrile, nickel compounds and benzene, summarising the most pertinent information in the Commission’s Proposal 2020/0262 (COD)[4] and the accompanying Impact Assessment.[5]

N.B. The OELs proposed by the Commission in the latest iteration of the CMD are based on a consultation of the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) and the tripartite Advisory Committee on Safety and Health at Work (ACSH), as well as a two-phase consultation of the European Social Partners (workers’ and employers’ organisations).

ACRYLONITRILE

Industrial Uses

  • Acrylonitrile is widely used in the aircraft, defence, aerospace and automotive sectors. Other sectors where acrylonitrile is used includes industrial manufacturing, the manufacture of textiles, leather and fur, the manufacture of bulk, large scale chemicals (including petroleum products), the manufacture of fine chemicals, the formulation of preparations and/or repackaging (excluding alloys), the manufacture of rubber products, the manufacture of plastics products (including compounding and conversion), the manufacture of computer, electronic and optical products, electrical equipment, building and construction work, health services, professional use and scientific research and development.

Range of Exposure

  • The estimated number of workers exposed to acrylonitrile is between 10,000 to 33,000.

Routes of Exposure

  • Acrylonitrile exposure mostly occurs by way of inhalation, but also dermal.

Health Effects of Exposure

  • According to the IARC, acrylonitrile is classified as possibly carcinogenic to humans (Group 2B).
  • Acrylonitrile is associated with cancers of the brain, stomach, tongue, intestines and mammary gland, neurotoxic effects, irritation of the skin, nasal eyes and respiratory tract and sensitisation of the skin.
  • The latency of acrylonitrile-induced brain cancer is 30-years.
  • The minimum and maximum durations of acrylonitrile exposure to develop brain cancer are 2 and 40-years, respectively.
  • The minimum and maximum durations of acrylonitrile exposure to develop irritation are 0 and 2-years, respectively.

Existing OEL

  • There are 7 EU member states with no OEL for acrylonitrile.
  • The most lenient national binding OEL for acrylonitrile is 7 mg/m3 and this is the limit in 2 EU member states.
  • The strictest national binding OEL for acrylonitrile is 0.5 mg/m3 and this is the limit in 1 EU member state.

Proposed OEL

  • There will be an 8-hour TWA limit value of 1 mg/m³ (0.45 ppm) and a short-term limit value of 4 mg/m³ (1.8 ppm).
  • A transitional period of 4-years post-enforcement of the Directive should be introduced, after which the new limit applies.
  • There will also be a skin notation for acrylonitrile.

Impact Without 4th CMD Approval

  • Assessing the future health burden of acrylonitrile over a 60-year period, in the absence of any further action, it is predicted that there would be up to 12 new brain cancer and 408 nasal irritation cases resulting from future exposure at a cost of up to €7,446,000.

Impact With 4th CMD Approval

  • Over a 60-year period, an EU-wide OEL for acrylonitrile would bring about a monetised health benefit of up to €5,800,000, along with the prevention of 12 brain cancer and 408 nasal irritation cases.

BENZENE

Industrial Uses

  • Benzene is produced in petroleum refineries and chemical plant processes and is used as an intermediate in the production of a wide range of chemical substances. Benzene is also used in the manufacturing of some types of rubbers, lubricants, dyes, detergents, drugs, and pesticides. As such, exposure typically occurs in the petroleum industry, coking plants, petrochemical industry distribution of petrol, retail and petrol stations, maintenance and repair of motor vehicles, foundries, laboratories and other sectors such as paint, adhesive, traffic, fires, etc.

Range of Exposure

  • The estimated number of workers exposed to benzene is 1,012,500.

Routes of Exposure

  • Benzene exposure mostly occurs by way of inhalation, but also dermal and oral.

Health Effects of Exposure

  • According to the IARC, benzene is classified as carcinogenic to humans (Group 1).
  • Benzene is associated with leukaemia, leukocytopenia, lymphocytopenia, neutrocytopenia, thrombocytopenia, aplastic anaemia with pancytopenia, suppression of humoral and cellular immune responses, pulmonary oedema and haemorrhage.
  • The latency of benzene-induced leukaemia 5-years.
  • The minimum and maximum durations of benzene exposure to develop leukaemia are 2 and 20-years, respectively.
  • The minimum and maximum durations of benzene exposure to develop leukocytopenia are 0 and 6-years, respectively.

Existing OEL

  • There are 0 EU member states with no OEL for benzene (this is a carcinogen already legislated for under the CMD).
  • The most lenient national binding OEL for benzene is 3.25 mg/m3 (CMD-established) and this is the limit in 18 EU member states.
  • The strictest national binding OEL for benzene is 0.7 mg/m3 and this is the limit in 1 EU member state.
  • The existing skin notation for benzene will also be kept.

Proposed OEL

  • There will be a revised 8-hour TWA limit value of 0.66 mg/m³ (0.2 ppm).
  • There will be a transitional period of 4-years post-enforcement of the Directive should be introduced, with a transitional limit value of 1.65 mg/m³ (0.5 ppm) applying from 2-years into this period.

Impact Without 4th CMD Approval

  • Assessing the future health burden of benzene over a 60-year period, in the absence of any further action, it is predicted that there would be up to 300 cancer and 237 leukocytopenia cases resulting from future exposure at a cost of up to €331,000,000.

Impact With 4th CMD Approval

  • Over a 60-year period, a revised OEL for benzene would bring about a monetised health benefit of up to €198,000,000, along with the prevention of 182 leukaemia and 189 leukocytopenia cases.

NICKEL COMPOUNDS

Industrial Uses

  • Nickel compounds can be found in oil refineries, as well as pigment, frit, catalyst, glass, metals and alloys, metal surface treatment, battery, material recovery and welding businesses. They are also present in agriculture, mining and metal ores industry, pharmaceutical manufacturing and preparations, sewerage, the manufacture of other inorganic base chemicals and the manufacture of abrasive tools.

Range of Exposure

  • The estimated number of workers exposed to nickel compounds is 87,500.

Routes of Exposure

  • Nickel compounds Are supplied in granule, powder and liquid form. Exposure is mostly dermal (nickel solutions), but also by way of inhalation (nickel-containing aerosols, dusts, fumes or mists).

Health Effects of Exposure

  • According to the IARC, nickel compounds are classified as carcinogenic to humans (Group 1).
  • Nickel compounds are associated with cancers of the lung and nose, pulmonary morbidity and miscarriage.
  • The latency of nickel compound-induced lung cancer 30-years.
  • The minimum and maximum durations of nickel compound exposure to develop lung cancer are 2 and 40-years, respectively.
  • The minimum and maximum durations of nickel compound exposure to develop pulmonary fibrosis are 1 and 22-years, respectively.
  • The minimum and maximum durations of nickel compound exposure to develop reprotoxic conditions are 0 and 0.25-years, respectively.

Existing OEL

  • There are 23 EU member states with no OEL for nickel compounds.
  • The most lenient national binding OEL for nickel compounds is 0.25 mg/m3  and this is the limit in 1 EU member state.
  • The strictest national binding OEL for nickel compounds is 0.03 mg/m3 and this is the limit in 1 EU member state.

Proposed OEL

  • There will be 8-hour TWA limit values of 0.01 mg/m³ (respirable fraction) and 0.05 mg/m³ (inhalable fraction).
  • There will be a transitional period until 17 January 2025 [aligned with OEL adoption for chromium (VI) compounds] should be introduced, with a transitional limit value of 0.1 mg/m³ (inhalable fraction) applying up to this date.
  • Notations will also be assigned to nickel compounds for dermal and respiratory sensitisation.

Impact Without 4th CMD Approval

  • Assessing the future health burden of nickel compounds over a 60-year period, in the absence of any further action, it is predicted that there would be up to 149 lung cancer, 718 pulmonary morbidity and 90 miscarriage cases resulting from future exposure at a cost of up to €124,800,000.

Impact With 4th CMD Approval

  • Over a 60-year period, an EU-wide OEL for nickel compounds would bring about a monetised health benefit of up to €92,000,000, along with the prevention of 133 lung cancer, 702 pulmonary morbidity and 80 miscarriage cases.

Progressing towards formal adoption of the updated CMD, the next step for the Commission's proposal involves negotiations between the European Parliament and the Council.

 

[1] ‘DIRECTIVE (EU) 2019/983 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 June 2019

amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to

carcinogens or mutagens at work’ (20 June 2019 Official Journal of the European Union) <https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019L0983&from=EN> accessed 7 October 2020.

[2] ‘DIRECTIVE (EU) 2017/2398 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 12 December 2017 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work’ (27 December 2017 Official Journal of the European Union) <https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017L2398&from=EN> accessed 7 October 2020.

‘DIRECTIVE (EU) 2019/130 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 January 2019 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work’ (31 January 2019 Official Journal of the European Union) <https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019L0130&from=EN> accessed 7 October 2020.

[3] ‘Beating cancer: Commission proposes improved protection for workers’ (22 September 2020 European Commission) <https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_1690> accessed 7 October 2020.

‘Beating cancer: Better protection of workers against cancer-causing chemicals’ (22 September 2020 European Commission) <https://ec.europa.eu/commission/presscorner/detail/en/IP_20_1691> accessed 7 October 2020.

[4] ‘Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.’ (22 September 2020 European Commission) <https://ec.europa.eu/social/BlobServlet?docId=23009&langId=en> accessed 22 September 2020.

[5] COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. (22 September 2020 European Commission) <https://ec.europa.eu/social/BlobServlet?docId=23008&langId=en> accessed 22 September 2020.