Carcinogens and Mutagens Directive Amended

Current worker protection from carcinogens in the workplace across the European Union is afforded under a combination of 24 EU Occupational Safety and Health directives, including, amongst others, Directive 89/391/EEC (the 'Framework Directive'), the Chemical Agents Directive 98/24/EC (CAD), and the Carcinogens and Mutagens Directive 2004/37/EC2 (CMD).[i] The latter of these, deals specifically with chemical risks to workers, generally through inhalation and dermal absorption. On 11 July, the Council's Permanent Representatives Committee (COREPER) approved the provisional agreement with the European Parliament, initially made on 28 June, to revise the 2004 CMD by, among many changes, setting broader and stricter exposure limits.

It is believed that, across the EU, 102,000 people die as a result of industrial exposure to carcinogens, representing 53% of the total number of deaths due to occupation, compared to 28% for circulatory diseases and 6% for respiratory diseases.[ii] In the preamble to the Carcinogens and Mutagens Directive and Article 16, it advises that ‘occupational exposure limit values’:

‘... must be revised whenever this becomes necessary in the light of more recent scientific [and technical] data’.

Therefore, in 2016, after more than 10 years of legislative inaction, the European Commission tabled a proposal to alter and create exposure limits of 13 cancer causing chemicals commonly found in labour environments. At the time, Marianne Thyssen, Commissioner of Employment, Social Affairs, Skills and Labour Mobility stated:

‘With this proposal we will save 100,000 lives in the next 50 years. Protection of workers is at the core of the Commission's commitment to a strong social Europe’.

Annex III to the first version of the CMD, in accordance with Article 16, suggested, as follows:
198 (17).png

However, in the second, approved iteration of the CMD, the table of occupational exposure limits (OELs) is set to be extended, as follows:[iii] [iv]

198 (18).png

As can be seen from the information displayed in the table above, various chemical agents, which have met the criteria for classification as carcinogenic, now have binding ‘limit values’. Meanwhile, the exposure levels, already in existence for vinyl chloride monomer (VCM) and hardwood dusts, will be tightened significantly, only to, in certain circumstances, be further constricted after a 5 year buffer, which serves as reactionary period, in order to ensure Member State compliance. Indeed, in the initial impact assessment, it was highlighted that:

 ‘In some cases, Member States either have no OELs or have ones that are less protective of worker health than the value recommended by Advisory Committee on Safety and Health at Work (ACSH)’.[v]

As a guide to comparison, in the table below, we present the UK’s workplace exposure limits for the 13 chemical agents subject to current EU regulatory amendment. These limits are ascribed to the Health and Safety Executive, many of which, when cross-referenced with the table above, are less stringent than the revised CMD would advocate:[vi]
198 (19).png

With Brexit on the horizon, it is uncertain as to how far the UK will be bound to transpose amendments into national law, since Article 2 of the CMD states:

‘Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than two years after the date of entry into force of this Directive. They shall forthwith communicate to the Commission the text of those provisions’.

Nonetheless, the British Occupational Hygiene Society has strongly welcomed the proposal, with Tracey Boyle, President of BOHS, stating:

These proposed changes plainly illustrate the importance of controlling exposure to carcinogens and mutagens. In terms of Britain’s Control of Substances Hazardous to Health (COSHH) regime, there is already a legal duty to reduce exposures to as low a level as reasonably practicable and certainly it would not be wise to aim to merely meet the occupational exposure limits for carcinogens, mutagens and sensitisers. For companies that are applying good practice in occupational hygiene, therefore, these proposals, if passed, will not represent the need for significant changes’.

Delving deeper into the implications of failing to implement domestic legislation prescribing OELs, the document inferred:

A lack of national Occupational Exposure Limits (OELs) for some carcinogens, and the high levels of others, not only leads to inadequate protection for EU workers but can also have negative consequences for the internal market. It leads to situations, where businesses located in Member States with less stringent levels (where there are no set occupational exposure limit values, or where they are set at a high level, allowing for greater worker exposure) may benefit from an undue competitive advantage ... From a more general perspective, therefore, OELs promote consistency by defining a 'level playing field' for all users and a common objective for employers, workers and enforcement authorities. The proposal therefore leads to a more efficient system of workers' health protection in the single market’.

Moreover, with respect to reprotoxic substances which cause impaired fertility or infertility, and have a negative impact on foetal development and lactation, the Commission plans to produce further proposals, by developing the current scope of the directive by the first quarter of 2019 at the latest. Interestingly, BC Disease News, in edition 180 (here), discussed instances where South Korea branded occupational exposure to chemicals in Samsung semi-conductor factories as an ‘occupational disease’, thus demonstrating the growing number of examples for which employers can be held liable.

As part of the next wave of exposure level limit evaluation, the Commission have also committed themselves to reviewing the restrictions (‘respirable fraction’) on respirable crystalline silica (RCS) fumes, of which 70% of construction employees face exposure.

Further, employers across the EU are currently obliged, by Article 4 and 5 of the CMD, to input measures, such as:

‘... in so far as it is technically possible, the replacement of the carcinogen or mutagen by a substance, mixture or process which is not dangerous or is less dangerous to worker's health, use of a closed system or other measures aimed at the reduction of the level of workers' exposure’.

Building on the duty to eliminate or reduce risks to a minimum, the newly amended piece of secondary EU legislation seeks to introduce obligatory health surveillance, per Article 14 of the CDM, additional to mandatory surveillance prior-to and during exposure periods, stressing that:

‘... it should be possible for appropriate health surveillance of workers [who] reveal a risk to health or safety to continue after the end of exposure following an indication by the doctor or authority responsible for the health surveillance’.

Championing the latest announcement that agreement between institutional bodies has been met, Commissioner Thyssen said:

‘Today's agreement therefore marks a milestone in the protection of workers' health and safety, in particular against cancer at the workplace. Protecting workers' health and safety in general, and the fight against work-related cancer in particular, are a top priority for this Commission’.[vii]

The EU has already, or intends in the future, to protect workers against a total of 25 priority carcinogenic, or mutagenic, agents, which equates to 5% of known carcinogens registered by the International Agency for Research on Cancer (IARC). In the CMD impact assessment, a SHEcan project discusses an Institute of Occupational Medicine report, insinuating that ‘at least 20 million workers in the EU are, to a lesser or greater extent, exposed to one or several of these 25 chemical agents’.

Consequently, research has already begun into a third CMD proposal, concerning 5 previously withheld carcinogenic agents for presentation in 2018, including beryllium and beryllium compounds, hexachlorobenzene, diesel engine exhaust emissions, rubber process fumes and dust, and 4,4'-methylene bis 2-chlororaniline. The next stage of the process for the Commission, however, will be to decide whether to establish ‘limit values and/or skin notations with regard to seven additional carcinogens’:[viii]
198 (20).png


[i] ‘DIRECTIVE 2004/37/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC)’ (Europa EU) <> accessed 15 August 2017.

[ii] ‘Impact Assessment: 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’ (10 January 2017 European Commission) <> accessed 15 August 2017.

[iii] ‘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: Analysis of the final compromise text with a view to agreement’ (29 June 2017 Council of the European Union) <> accessed 15 August 2017.

[iv] ‘Commission proposes better workers' protection against cancer-causing chemicals’ (13 May 2016 European Commission) <> accessed 15 August 2017.

[v] ‘Briefing: Initial Appraisal of a European Commission Impact Assessment: Protection of workers from exposure to carcinogens or mutagens: second proposal (CMD 2)’ (July 2017 European Parliament) <> accessed 15 August 2017.

[vi] ‘EH40/2005 Workplace exposure limits’ (2011 HSE) <> accessed 15 August 2017.

[vii] ‘Commission welcomes agreement by Parliament and Council to protect workers better against cancer-causing chemicals’ (11 July 2017 EU Commission) <> accessed 15 August 2017.

[viii] ‘Commission follows up on workers' protection from cancer-causing chemicals: frequently asked questions’ (10 January 2017 EU Commission) <> accessed 15 August 2017.