EurWORK European Observatory of Working Life

Carcinogens directive revision


Exposure to certain substances is linked to the risk of developing occupational diseases, particularly cancers. Recognising this link, the European Union adopted a directive in 2004 to protect workers against risks related to exposure to carcinogens or mutagens at work. In line with scientific advances, since 2016 the European Commission has undertaken three sets of revisions (referred to as batches) to this directive to adjust the maximum exposure limits or add new dangerous agents to those already covered.

Background and status

According to the European Working Conditions Survey 2015, 17% of EU workers are exposed to chemical products or substances at least a quarter of the time they are at work. Unlike physical risks, such as exposure to noise or vibration, it is not scientifically possible to identify levels below which exposure to most carcinogens and mutagens would not lead to adverse effects. Therefore, setting limit values in relation to carcinogens and mutagens does not completely eliminate risks to the health and safety of workers arising from exposure at work (known as ‘residual risk’).

On 14 January 2020, the Commission unveiled its social affairs road map for its term of office, in a communication on a ‘strong Social Europe for Just Transitions’. The communication stated that risks and exposure to dangerous substances will be addressed in a new strategy, but an adoption date was not specified.

Regulatory aspects

First batch

In May 2016, the European Commission proposed to extend the protection provided by the 2004 directive (that covered only three substances) to 11 new agents. The proposal includes giving exposure limit values to set a maximum concentration for the presence of a chemical carcinogen in the workplace air.

In addition, it was proposed to extend the protection to work involving exposure to respirable crystalline silica dust generated by a work process. (In 2006, this chemical was the subject of the first European multi-sectoral agreement.) As part of the 2016 proposal, the Commission set an exposure limit value to protect the estimated 5.3 million employees exposed to this substance.

The proposal also established limit values for 10 additional carcinogens and revised the limit values for hardwood dusts and vinyl chloride monomer.

On 12 December 2017, the European Parliament and the Council adopted the directive. The text was required to be transposed into the national legislations of the Member States by 20 January 2020.

Second batch

On 10 January 2017, the Commission initiated the process to revise European legislation on occupational safety and health. It also proposed new occupational exposure limits for a further six cancer-causing chemical agents, along with mineral oils and diesel engine exhaust emissions.

After intense discussions, workplace diesel engine exhaust emissions were included in the directive's scope. The binding occupational exposure limit values for these emissions was set at 0.05 mg/m³, to be implemented in all EU Member States by 21 February 2023.

The directive’s scope also included work involving the absorption through the skin of mineral oils previously used in internal combustion engines. The limit on diesel engine exhaust emissions will affect 3.6 million workers in the EU and is expected to lead to 6,000 fewer deaths a year from lung cancer.

The directive must be transposed into the national legislations of the Member States by 5 February 2021.

Third batch

On 5 April 2018, the Commission presented a proposal that includes new exposure limit values for five chemical agents. The Council amended the original proposal by introducing a transitional period for cadmium and formaldehyde. The directive, adopted on 5 June 2019, must be transposed into the national legislations by 11 July 2021.

The most recent directive requires that the Commission assess the further extension of the directive no later than 30 June 2020, ‘taking into account the latest developments in scientific knowledge, and after appropriate consultation with relevant stakeholders’. Specifically, it should:

assess the option of amending this Directive in order to include hazardous drugs, including cytotoxic drugs, or to propose a more appropriate instrument for the purpose of ensuring the occupational safety of workers exposed to such drugs.

(Article 1(1))

Related dictionary terms

Dangerous substances Framework Directive on health and safety occupational accidents and diseases risk assessment

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