Occupational Safety and Health (OSH) – a formaldehyde case study

What is OSH?

In the European Union, worker safety and health are ensured by the Directive 89/391/EEC, commonly known as the Occupational Safety and Health (OSH) “Framework Directive”.

  • It lays down fundamental principles aimed at promoting continuous improvements in the safety and health of workers at work.
  • It also sets minimum safety and health requirements throughout the European Union while Member States are allowed to maintain or establish more stringent measures.

It should be noted that the OSH Framework Directive is complemented by a series of additional directives, which focus on specific aspects of safety and health at work. Together, these directives form the cornerstone of occupational safety and health legislation within the European Union.

What about chemicals?

As far as reducing exposure to hazardous chemicals is concerned, two main directives can be mentioned:

  • The Directive 98/24/EC for the risks related to chemical agents at work (known as the CAD legislation); and
  • The Directive 2004/37/EC for Exposure to carcinogens, mutagens or reprotoxicants at work (the so-called CMRD).

Focusing on groups of substances that pose a risk to workers, these directives are regularly updated to establish (Indicative or Binding) Occupational Exposure Limits ((I/B)OEL). These limits define the maximum allowed levels of exposure to workers over the course of a standard working day, typically eight hours.

What about formaldehyde?

Classified in the EU as a Category 1B carcinogenic substance, formaldehyde was included in the third amendment to the Carcinogens and Mutagens at Work Directive (CM(R)D), adopted by the European Union in June 2019 as Directive (EU) 2019/983.

For several years, Formacare actively promoted the idea of a harmonised BOEL for formaldehyde, with the aim of ensuring a consistent level of worker protection across Europe. Prior to this, exposure limit values were determined at national level, leading to a highly fragmented regulatory landscape. In 2016, this promotion culminated in the creation of the “Formacare Value Chain Alliance”, a collaborative effort bringing together industry representatives, employer organisations and trade unions. More information is available here.

Supported by Formacare and its members, the European Union adopted in 2019 the setting of a BOEL for formaldehyde as follows:

  • 0.3 ppm (parts per million) for the 8-hour Time-Weighted Average (TWA);
  • 0.6 ppm for the short-term exposure limit (STEL).

What is the situation today?

Member States of the European Union were required to transpose the EU directive into their national legislation by July 2021.

It is worth noting that embalmers and the medical sector were granted an additional transitional period of three years for the implementation of the same BOEL at 0.3 ppm. A transitional BOEL of 0.5 ppm remained in effect for these two sectors until July 2024.

Currently, the same BOEL at 0.3 ppm applies across the continent and to all sectors, with the exception of the Netherlands where a historically established national OEL at 0.1 ppm remains in effect.

These legislations apply to all industries involved in the production or use of formaldehyde. They also extend to industries where formaldehyde exposure arises as a by-product of industrial processes that generate the substance, such as rubber vulcanisation.

Formacare remains strongly dedicated to the EU BOEL at 0.3 ppm, which is regarded as a global gold standard for protecting workers from potential exposure to formaldehyde. We offer guidance and support to industries both within and outside Europe for which worker safety in relation to formaldehyde is relevant.