A regulatory update on protection of workers from work-related Cancer in the EU

According to the International Labour Organization (ILO), cancers that can be attributed to work-related exposure to carcinogens are by far the largest cause of workplace deaths. Worldwide, nearly 742,000 persons lose their life every year due to occupational exposure to carcinogens.

In the European Union (EU), more than 100,000 people are diagnosed with work-related cancer and 80,000 deaths are recorded every year which is equal to one death every six minutes.

In addition, direct costs to carcinogen exposure include hospitalization, primary, emergency and outpatient care. These costs are estimated at EUR 2.4 billion per year.

Many losses in productivity and negative impacts on the society (reduction in the quality of life) are also observed. And so the list of negative effects goes on and on.

To limit these, many initiatives have been launched, by various interested parties, for example:

• The “Roadmap on carcinogens” is an initiative that was developed by six European Organisations. In this initiative, the European Commission and EU-OSHA took part as community actors whereas the Ministries of Social Affairs of both the Netherlands and Austria represented the Member States. The aim of this initiative is to raise awareness of the risks arising from exposure to carcinogens in the workplace and to exchange good practices. Under this initiative many events were organised and many stakeholders got implicated too.
• The “No-Time-To-Lose” campaign is another great initiative launched in the United Kingdom by the institution of Occupational Safety and Health (IOSH). This campaign is active in providing helpful tools and insights for helping businesses in the protection of their employees from hazards at work.

Engaging campaigns and initiatives are a great tool as they can play an immensely important role in engaging employers to share their best practices and commit to better protect workers.

Nevertheless, regulatory initiatives remain without contest the most effective tool to ensure worker protection and employer commitment in providing this protection. By regulatory initiatives we mean of the adoption of binding pieces of laws or the amendment of those that are already in force.

In this context, let’s examine some regulatory initiatives proposed by the European Commission (EC) and how such initiatives evolved over the course of time to where we are today, at the EU level, with regards to worker protection from work-related cancer.

The European Commission’s regulatory initiatives

In its ongoing effort to better protect workers against work-related cancer, the European Commission have so far proposed limit values for 26 cancer-causing chemicals since the Juncker Commission took office back in 2014.

Of those 26 chemicals, stricter Occupational Exposure Limits (OELs) have been adopted for two of these: hardwood dust and vinyl chloride monomer. In addition, 12 chemicals have new OELs such as ethylene oxide (1.8 mg/m3), acrylamide (0.1 mg/m3) and respirable crystalline silica dust generated by a work process (0.1mg/m3).

OELs for the remaining 12 are still currently under discussion.

Definition of OELs

“OELs” are an upper exposure limit developed for airborne exposure to gases, vapors and particulates. OELs as we will refer to them in this article are time-weighted average (TWA) exposure limits. This is measured as the maximum average concentration of a chemical in air for a normal eight-hour working day and 40-hour week.

The CMD Directive

At the EU level, the Carcinogens and Mutagens Directive 2004/37/EC (CMD Directive) adopted in 2004 introduced many steps for the elimination or the limitation of exposure to carcinogenic and mutagenic chemical agents. It has therefore played an important role in helping to prevent occupational cancers and related diseases.

However, according to studies, deaths attributed to cancer in the EU still amounted to 53 % of occupational deaths, compared with 28% for circulatory diseases and 6% for respiratory diseases.

On this basis, the European Commission has proposed a number of amendments to the CMD directive.

First amendment to the CMD Directive

The first amendment to the CMD Directive resulted from a Commission proposal published on 13 May 2016, which aimed to revise annexes 1 and 3 of the CMD Directive by:

(1) Adding work involving exposure to respirable crystalline silica dust generated by a work process to Annex I of the Directive;

(2) Amending existing limit values; and

(3) Establishing in Annex III limit values for a further 11 additional carcinogens.

The amendments were adopted by Directive (EU) 2017/2398 on 27 December 2017 and entered into force on 16 January 2018, leaving EU Member States with 2 years to transpose it into their national laws and regulations.

The final text of the Directive resulted from countless discussions between trade unions, employers, etc. and compromises agreed upon by the European Parliament and the Council of Ministers.

In addition, a lot controversy during these discussions revolved around certain points and particularly around the OELs for substances that are carcinogenic, mutagenic and reprotoxic (CMRs) of most concern (in particular, those to which large numbers of workers are exposed). Such substances include crystalline silica and chromium VI.

Respirable crystalline silica was the most controversial topic.

Respirable Crystalline Silica

Respirable Crystalline Silica is a “process generated” substance, which is mostly present in the construction sector (81% of the workers exposed to respirable crystalline silica” work in construction) or in the fabrication of products used in construction.

According to the European Commission, even though some companies have good control of airborne concentrations of it, Respirable Crystalline Silica generated by a work process such as cutting, mining, crushing or grinding of silica-containing materials remains a leading cause of both the lung disease ‘silicosis’ and occupational lung cancer. Therefore, it proposed a new OEL for this chemical with a limit of 0.1 milligram per cubic Meter (mg/m3) which was later adopted in Directive (EU) 2017/2398.

However, the 0.1 limit is considered to be not enough to ensure proper protection for example in British Columbia the limit is set at 0.025 mg/m3. In Ireland, Italy, Finland, Portugal and the United States the limit is set at 0.05 mg/m3.

It is also worth noting that recently, in a groundbreaking decision in the United States, the Court of Appeals upheld the Occupational Safety and Health Administration’s (OSHA) rule on exposure to crystalline silica which concerned the setting of an OEL of 0.05 mg/m3 limit averaged over an 8-hour day which represents an 80% decrease from the previous 0.25 mg/m3 level applicable to the construction industry.

The European Commission also committed itself to evaluate the need to modify this limit by the first quarter of 2019 at the latest. Therefore, a stricter limit for respirable crystalline silica dust in the EU may be proposed.

Hardwood dusts and vinyl chloride monomer

In its initial proposal, the European Commission intended to reduce the OEL for hardwood dust from 5 mg/m3 to 3 mg/m3 with a review period between 3 and 5 years. During the interinstitutional talks some parties opposed this limit whereas others were in favor of an OEL of 2 mg/m3. Finally, a limit was set at 3 mg/m3 up until 17 January 2023 and a 2 mg/m3 limit will be applicable thereafter. The limit for vinyl chloride monomer is also tightened from 7.77 mg/m3 to 2.6 mg/m3.

In France for example, the concentration of hardwood dust and vinyl chloride monomer cannot exceed 1 mg/m3 for hardwood dust which is considerably more stringent than the required limit on the EU level and 2.59 mg/m3 for vinyl chloride monomer.

Chromium VI

Around 900 000 workers in the EU are estimated to be exposed to hexavalent chromium (Chromium VI) at work.

According to Directive (EU) 2017/2398 a new limit of 0.025mg/m3 for Chromium VI used in welding, plasma-cutting or similar processes applies until 17 January 2025. After that date, a limit of 0.005 mg/m3 would apply. This was not included in the Commission’s initial proposal and was also a controversial point. It should be noted that an 0.05 mg/m3 OEL for Chromium VI is the most common and widely spread one around the globe (applicable in Australia, Austria, Belgium, Finland, United Kingdom and many other countries).

Reprotoxins

Reprotoxins were also controversial in whether they should be included in the scope of the CMD Directive. According to Directive (EU) 2017/2398, the European Commission must assess this possibility by the first quarter of 2019 at the latest.

Second and third envisaged amendments to the CMD Directive

Finally, on 5 April 2018, the European Commission proposed to include new exposure limit values for 5 chemicals in a proposed amendment to the CMD Directive, in addition to the 14 substances that were already covered under Directive (EU) 2017/2398 or the 7 substances that were suggested in its second amendment proposal in January 2017. The following 5 chemicals that have been selected are as follows:

• Cadmium and its inorganic compounds;
• Beryllium and inorganic beryllium compounds;
• Arsenic acid and its salts, as well as inorganic arsenic compounds;
• Formaldehyde; and
• 4,4′-Methylene-bis(2-chloroaniline) (MOCA).

These chemicals are mostly used in refining, nickel-cadmium battery manufacture, mechanical plating, zinc and copper smelting sectors.

What is the process for Carcinogenic substances to become regulated in the EU?

As shown above, OELs in the European Union can be closely aligned to OELs adopted elsewhere around the world. Sometime they can be much stricter, other times, more relaxed. But how does the European Commission decide on these limit values? On which information and according to which reasoning do they base their decisions? To answer this question, it’s important to understand that the European Commission is not the only actor involved in the decision-making process. Firstly, the European Commission is assisted by the Scientific Committee on Occupational Exposure Limits (SCOEL). This Committee evaluates the latest available scientific data and recommends the OELs together with the European Commission. The Commission then comes up with a proposal and the proposal is subject to the appropriate Committee’s voting (in this case the Employment Committee); to inter-institutional talks; and after that a plenary vote which ultimately should lead to the adoption of the new limit.

What does all of this mean for employers?

Needless to say, if an employer has workers that are exposed to carcinogenic agents in the European Union, they must ensure those employees are not exposed to carcinogens exceeding the OELs set in Directive (EU) 2017/2398. However, it is also important to stay abreast of proposed changes in OELs in the future, so that employers can take timely and appropriate steps. It should also be noted that EU Member States can maintain or introduce more stringent protective measures if they wish.

There is also nothing to prevent companies to implement stricter internal standards than those prescribed by the legislation in the countries they operate in.

In general, employers must also comply with the requirements of the CMD Directive such as assessing and reducing occupational exposure and providing information, training and health surveillance to workers that are exposed to respirable crystalline silica dust generated by a work process since this kind of work is now classified as carcinogenic.

Employers will also have to bear the associated costs for providing health surveillance of exposed workers since the health surveillance according to Directive (EU) 2017/2398 can continue after the end of exposure, for as long as needed to safeguard health.

Conclusion

The EU Commission is raising the level of protection of workers exposed to carcinogens by introducing OELs for new substances or stricter OELs for existing ones. The regulatory initiatives are accompanied by important campaigns and wide media coverage. As we have seen, very important steps for the better protection of protection were done and many others are on their way. Considerable protective measures are now in place at the EU level. However, it remains for us to observe the implementation and transposition phase to see to which extend these measures will be respected and enhanced.