Upcoming Changes to the Carcinogens and Mutagens Directive

At the turn of 2019, various endorsements were made by European Union (EU) institutions, in respect of revisions to the Carcinogens and Mutagens Directive 2004/37/EC (CMD).[i] The EU Directive seeks to limit and/or eliminate workplace exposure to cancer, or mutation-causing chemical agents, generally through inhalation and dermal absorption. The European Commission has previously expressed that its objective is to reach a target of 50 CMD-regulated carcinogens by 2020.[ii]

We reported, in edition 198 of BC Disease News (here), that on 11 July 2017, the 2004 Directive[iii] was revised, setting broader and stricter 8-hour time-weighted (TWA) occupational exposure limits (OELs) for 13 carcinogenic substances:

  • 1,2-Epoxypropane;
  • 1,3-Butadiene;
  • 2-Nitropropane;
  • Acrylamide;
  • Bromoethylene;
  • Chromium (VI) Compounds;
  • Ethylene Oxide;
  • Hardwood Dust;
  • Hydrazine;
  • o-Toluidine;
  • Respirable Crystalline Silica (RCS);
  • Refractory Ceramic Fibres (RCF); and
  • Vinyl Chloride Monomer (VCM).

The OEL for Benzene, which was 1 of 3 carcinogenic substances (with VCM and hardwood dusts) to appear in the original CMD, was unchanged in the amendment (the 1st amendment).

Since, action has been taken by EU institutions to further revise the CMD for a 2nd and 3rd time.

The 2nd Amendment

We first alluded to the 2nd amendment in edition 198, when the European Commission was deciding whether to implement OELs in respect of 7 additional carcinogens.

In October 2018, the European Parliament’s Employment and Social Affairs Committee conducted negotiations with the Council of Ministers and struck a deal on the 2nd amendment.[iv]

This was formally adopted by the European Parliament and European Council on 11 December 2018 and 20 December 2018, respectively.[v]

OELs have been added for 8 additional carcinogens:

  • 4,4-methylenedianiline;
  • Epichlorohydrine;
  • Ethylene dibromide;
  • Ethylene dichloride;
  • Trichloroethylene;
  • Polycyclic aromatic hydrocarbons mixtures, particularly those containing benzo[a]pyrene, which are carcinogens within the meaning of the Directive;
  • Mineral oils that have been used before in internal combustion engines to lubricate and cool the moving parts; and
  • Diesel.

Implementing OELs for these particular substances is expected to have the most significant effect on:

  • Workers who regularly encounter chemicals;
  • Professional drivers;
  • Construction workers; and
  • Dock and warehouse workers.

Now, Member States have 2 years to transpose the latest iteration of the CMD into domestic law.

Having announced that the 2nd amendment was passed, EU Commissioner for Employment, Social Affairs, Skills and Labour Mobility, Marianne Thyssen, called for prompt agreement on the 3rd amendment.

To access the most up-to-date version of the CMD, which was published on 16 January 2019, click here.

The 3rd Amendment

In edition 226 (here), we reported that the European Commission was beginning work on a 3rd extension of the CMD, adding 5 more carcinogens to the list.

More recently, the Employment and Social Affairs Committee backed a draft report on this 3rd revision, which advises the following binding time-weighted OELs:

  • Cadmium and its inorganic compounds – 0.01 mg/m3;
  • Beryllium and inorganic beryllium compounds – 0.0002 mg/m3;
  • Arsenic acid and its salts, as well as inorganic arsenic compounds – 0.01 mg/m3;
  • Formaldehyde – 0.37 mg/m3 (and 0.738 mg/m3 short-term exposure); and
  • 4,4-Methylene-bis(2-chloroaniline) (MOCA) – 0.01 mg/m3.[vi]

Industries most affected by regulating these carcinogens would be those involved with:

‘... nickel-cadmium battery manufacture, zinc and copper smelting, laboratories, electronics, funeral and embalming, construction, healthcare, plastics and recycling sectors’.[vii]

Part of the Commission’s proposal ensures that both an airborne OEL and a biological limit value (BLV) for cadmium will be prescribed within 5 years of the latest CMD entering into force. A group of ministers have, however, expressed regret that the 3rd amendment does not put forward human biomonitoring (HBM) as an alternative measure of cadmium exposure. The UK’s deputy permanent representative to the EU, Katrina Williams, is part of this group, favouring ‘a wider range of monitoring techniques for cadmium’.

The 3rd amendment also allows Member States to impose more stringent OELs than the EU Directive instigates and allows States to impose different types of exposure levels, such as BLVs, where the EU does not.

Earlier this month, the Council of Ministers endorsed the European Commission’s 3rd amendment without objection, which the Committee adopted just 3 weeks prior.[viii]

Then, on Tuesday of this week, in the latest development, the European Parliament and the Commission reached a provisional agreement on the proposal, under the overarching governance of the European Council, in the wake of informal negotiations, or Trilogues.

All that remains for the 3rd amendment now is confirmation of the Council's Permanent Representatives Committee (COREPER) approval and a plenary vote of Parliament on the final text.


[i] <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004L0037R%2801%29> accessed 29 January 2019.

[ii] ‘Briefing: EU Legislation in Progress - Limits on exposure to carcinogens and mutagens at work: Third proposal’ (EPRS) <http://www.europarl.europa.eu/RegData/etudes/BRIE/2018/625121/EPRS_BRI(2018)625121_EN.pdf> accessed 22 January 2019.

[iii] <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004L0037-20180116> accessed 29 January 2019.

[iv] Nick Hazlewood, ‘European Parliament committee backs third revision to CMD’ (27 November 2018 Chemical Watch) <https://chemicalwatch.com/72327/european-parliament-committee-backs-third-revision-to-cmd?q=European+Council+of+Ministers+backs+third+revision+to+CMD> accessed 29 January 2019.

[v] Vanessa Zainzinger, ‘EU formally adopts carcinogens and mutagens Directive second revision’ (3 January 2019 Chemical Watch) <https://chemicalwatch.com/72992/eu-formally-adopts-carcinogens-and-mutagens-directive-second-revision?q=cmd> accessed 29 January 2019.

[vi] Nick Hazlewood, ‘European Parliament committee backs third revision to CMD’ (27 November 2018 Chemical Watch) <https://chemicalwatch.com/72327/european-parliament-committee-backs-third-revision-to-cmd?q=European+Council+of+Ministers+backs+third+revision+to+CMD> accessed 29 January 2019.

[vii] ‘Protecting workers against cancer-causing chemicals: Commissioner Thyssen welcomes third agreement between EU institutions’ (29 January 2019 European Commission) <http://europa.eu/rapid/press-release_STATEMENT-19-683_en.htm> accessed 31 January 2019.

[viii] Vanessa Zainzinger, ‘European Council of Ministers backs third revision to CMD’ (6 December 2018 Chemical Watch) <https://chemicalwatch.com/72628/european-council-of-ministers-backs-third-revision-to-cmd?additionalReg=true> accessed 29 January 2019.