Industry Boasts Near 100% Compliance with Carcinogens and Mutagens Directive on Formaldehyde Exposure Limit

Current evidence on long-term exposure to formaldehyde chemical in an industrial setting suggests that it may cause nasal tumours (nasopharyngeal cancer) and leukaemia (though read our report on potential discrepancies, here).[1] It has been classified as ‘carcinogenic to humans’ (Group 1) by the International Agency for Research on Cancer (IARC) for well over a decade.[2]

Under the 3rd amendment to the Carcinogens and Mutagens Directive (CMD) 2004/37/EC, a new binding 8-hour time-weighted average (TWA) occupational exposure limit for formaldehyde of 0.3 parts-per-million (ppm) was adopted and was due to enter into force on 11 July 2021 (not planned until July 2024 for the funeral and embalming industry[3]), assuming that transposing UK legislation was passed to amend the existing UK exposure limit of 2 ppm.[4]

The fact that the UK has now left the EU and has not yet acted on this puts OEL reform in a precarious position.

In May 2019, 2-years ahead of the enforcement deadline, a voluntary agreement was signed by members of Formacare to speed up the reduction of workplace exposure to the carcinogen.

Formacare is the formaldehyde sector group of the European Chemical Industry Council (Cefic). It represents large chemical and manufacturing companies across Europe, which produce formaldehyde and derivatives, including aminoplast resins and glues, polyacetals, paraformaldehyde and polyols.

Thanks to the signatures of 23 corporate members, the ‘vast majority’ of formaldehyde production in 16 European countries (including the UK) has been committed to the voluntary agreement.

Lars Eric Johansson, Chairman of Formacare, has praised this initiative for ensuring the ‘highest standards’ of worker protection,[5] as figures show that last year:

  • 2% of workers surveyed (4,500) were not exposed to formaldehyde at all (these workers were all part of sales, purchasing or administrative departments).
  • 5% of workers surveyed (3,206) were exposed to levels of formaldehyde at or below 0.3 ppm.
    • 9% at 0.05 ppm.
    • 1% at 0.10 ppm.
    • 0% at 0.15 ppm.
    • 3% at 0.20 ppm.
    • 9% at 0.25 ppm.
    • 4% at 0.3 ppm.
  • 3% of workers surveyed (22) were exposed to levels of formaldehyde above 0.3 ppm.
    • 1% at 0.4 ppm.
    • 1% at 0.5 ppm.
    • 0% at 0.6 ppm.
    • 1% over 0.6 ppm.[6]

To have achieved 99.7% compliance by 2020 is a positive sign for the health of workers in chemical and manufacturing plants and may result in fewer cases of causative latent disease in years to come. 

Formacare is continuing its dialogue with trade union and industry partners to safeguard the same levels of protection across the entire formaldehyde value chain.

In time, it will be interesting to see whether other sectors, e.g. the healthcare sector, have been taking precautionary measures in preparation for the updated CMD. Medical professionals can encounter significant levels of formaldehyde when fixing tissue biopsies using a standard chemical preservative solution, called Formalin.

Although use of personal protective equipment (PPE), e.g. respirators, goggles, gloves, etc., is recommended when handling Formalin biopsy pots, this is said to rarely happen in practice. Interviews recently carried out by UK Medical demonstrated that clinicians have a generally poor perception of risk and, as such, formaldehyde exposure remains an ‘accepted but unacceptable occupational risk’,[7] with one professional recounting worryingly as follows:

‘We often spill Formalin on the worktops but just wipe it up with paper towels and pop it in the household waste bin’.


[1] Public Health England, ‘Formaldehyde: general information’ (16 November 2017 GOV.UK) <> accessed 2 June 2021.

[2] IARC Classifies Formaldehyde as Carcinogenic. Oncology Times: July 10, 2004 - Volume 26 - Issue 13 - p 72 <> accessed 2 June 2021.

‘Formaldehyde, 2-Butoxyethanol and 1-tert-Butoxypropan-2-ol - IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 88’ (2006 IARC) <> accessed 2 June 2021.

Baan R, A review of human carcinogens--part F: industrial chemicals. The Lancet. 10:1143-1144 <> accessed 2 June 2021.

[3] ‘Formaldehyde: Industrial Health and Safety – Question for Department for Work and Pensions’ UIN HL17390 (23 July 2019 UK Parliament) <> accessed 2 June 2021.

[4] ‘EH40/2005 Workplace exposure limits (4th Edition)’ (2020 HSE) <> accessed 2 June 2021.

[5] ‘Voluntary agreement and workplace safety’ (Formacare) <> accessed 2 June 2021.

[6] ‘Voluntary Agreement: Second campaign – Results’ (12 May 2021 Formacare) <> accessed 2 June 2021.

[7] ‘Formalin and Formaldehyde: Accepted but unacceptable: It's the risk associated with biopsies’ (UK Medical) <> accessed 2 June 2021.