Last reviewed 26 August 2020

In this feature, Caroline Raine looks at the chemical formaldehyde and discusses recent and future changes regarding its control in the workplace.

Introduction/Background

Formaldehyde is a naturally occurring organic compound. It has the chemical formula CH2O (H−CHO) and the systematic name methanol, not to be confused with methanol! It is an aldehyde and is an important precursor to many other materials and chemical compounds. Formaldehyde is often stored as an aqueous solution of formalin due to the fact that it polymerises.

Classification and properties

Formaldehyde has perhaps one of the easiest to remember CAS numbers (50-00-0) and the EC number 200-001-8. It has the harmonised classification;

Carc. 1B

H350

Muta. 2

H341

Acute Tox. 3 *

H331

Acute Tox. 3 *

H311

Acute Tox. 3 *

H301

Skin Corr. 1B

H314

Skin Sens. 1

H317

The entry in full in as follows;

Formaldehyde is required to be labelled as Danger! Corrosive, Serious Health Hazard and Acute Toxicity

According to the harmonised classification and labelling (ATP06) approved by the European Union, this substance is toxic if swallowed, is toxic in contact with skin, causes severe skin burns and eye damage, is toxic if inhaled, may cause cancer, is suspected of causing genetic defects and may cause an allergic skin reaction.

Formaldehyde is manufactured or imported into Europe in excess of 1 000 000 tonnes per annum and those that have registered formaldehyde under the REACH regulation have also declared that this substance is fatal if inhaled and causes serious eye damage.

Formaldehyde is also being reviewed for use as a biocide in the EEA and/or Switzerland, for: disinfection, veterinary hygiene, embalming or taxidermy.

Finally, formaldehyde is included in the Community Rolling Action Plan (CoRAP). The Community rolling action plan (CoRAP) prioritises substances for evaluation over a period of three years.

ECHA Investigation report

ECHA was asked by the European Commission to prepare an investigation report on formaldehyde and formaldehyde releasers. The intention of the report was to help with the decision process on whether or not to request ECHA to prepare an Annex XV restriction dossier. The investigation was done in 2016 and 2017 with the report being published in 2017. The report shows that ECHA identified several formaldehyde releasers and potential ones that would be subject to REACH and clarified their uses. It also concluded that;

“there appears to be a risk to workers from one or more uses of formaldehyde. In relation to consumer, there are many more uncertainties related to the exposure and the health-based limit value to be used. Information on exposure may become available from the Substance Evaluation in late 2017. However, there seem to be divergent views what can be regarded as a protective limit value of formaldehyde in indoor air, even though the one proposed by WHO is supported by other scientific studies. However, peak concentrations may need to be taken into account if a limit value is developed.”

The report can be found on the ECHA website;

Directive 2019/983

In June 2019 DIRECTIVE (EU) 2019/983 was published which amends Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. The regulations states that;

“Formaldehyde meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. Formaldehyde is a local acting genotoxic carcinogen and there is sufficient scientific evidence of its carcinogenicity in humans. Formaldehyde is also a contact allergen for the skin (skin sensitiser). It is therefore appropriate, on the basis of the available information, including scientific and technical data, to establish a long- and short-term limit value for formaldehyde in that Directive and to assign a notation for skin sensitisation. In addition, at the request of the Commission, ECHA is also gathering existing information to assess the potential exposure to formaldehyde and formaldehyde releasers at the workplace, including industrial and professional uses.”

The regulation introduces new exposure limits for five chemicals;

  • Cadmium and its inorganic compounds.

  • Beryllium and inorganic beryllium compounds.

  • Arsenic acid and its salts, as well as inorganic arsenic compounds.

  • Formaldehyde.

  • 4,4’-Methylene-bis(2-chloroaniline).

The new limits for formaldehyde are;

8 hours 0.37 mgm-3 / 0.3 ppm

Short term 0.74 mgm-3/ 0.6 ppm

With a limit value of 0.62 mgm-3 /0.5 ppm for the health care, funeral and embalming sectors until 11 July 2024. In some Member States, it is foreseeable that the healthcare and funeral and embalming sector will have difficulties in complying, in the short term, with a limit value of 0.37 mgm-3 or 0.3 ppm. For those sectors a transitional period of five years has been introduced where the limit value of 0.62 mgm-3 or 0.5 ppm should apply. The healthcare sector should, however, minimise exposure to formaldehyde and is encouraged to respect the limit value of 0.37 mgm-3 or 0.3 ppm during the transitional period where possible.

The Directive and so the new limits must be adhered to by 11 July 2021.

Voluntary occupational exposure limit for formaldehyde

Members of Formacare, the European association of formaldehyde producers have signed a voluntary agreement to limit exposure of workers to formaldehyde. The intention was to implement the occupational exposure limit (OEL) for workers in the formaldehyde sector, ahead of the legislation, which has a deadline of mid-2021.

Formacare members intend to use the OEL values as proposed by European Scientific Committee on Occupational Exposure Limit (SCOEL). The Occupational Exposure Limit (OEL), will be 0.3ppm (parts per million) for the 8-hour average and 0.6ppm for the short-term exposure limit. Formacare state that this will help to protect 30, 000 European workers of formaldehyde.

Lars-Eric Johansson, Chairman of Formacare, commented: “The agreement is a result of the work that Formacare and the European Chemical Employers Group (ECEG), as well as trade unions representatives from the European Trade Union Confederation (ETUC) and industriALL, have done over the past few years in the context of the revision of the EU Carcinogens and Mutagens Directive (CMD) to promote workplace safety. It is a clear demonstration of what can be achieved via open and constructive collaboration with our trade union partners”.

The agreement can be read in full on the Formacare website.

Conclusions

For those working with formaldehyde, it is important to review processes and procedures to reduce the exposure to workers.

The new limits of 8 hours 0.37 mgm-3 / 0.3 ppm and Short term 0.74 mgm-3/ 0.6 ppm must be adhered to by the 11th July 2021.

There is a transition period of five years for those in the healthcare, funeral and embalming sectors during which the limit value of 0.62 mgm-3 or 0.5 ppm should apply.