Health and Safety
Like most chemicals, either naturally occurring or man-made, very high concentrations of formaldehyde can be hazardous to our health. However, its natural presence in our bodies at low levels means that human beings have the right metabolic processes to ensure that it is broken down quickly and does not build up in the body. It is estimated that the average adult produces between 61 and 92 grams every day as part of a normal metabolic process.
In March 2012, Formacare and the European Panel Federation (EPF) commissioned an independent study to TNO Triskelion and Risk & Policy Analysts Limited (RPA) to assess the safety of formaldehyde at the workplace and in homes. The risk assessment, based on workplace exposure measurements in the EU, confirmed that formaldehyde can be used safely at the workplace. For workers in some industries however, specific tasks require the use of risk management measures and personal protection equipment, such as half masks, to meet safe levels.
Protocols are in place to minimise as much as possible worker exposure, and everywhere necessary.
Likewise, indoor levels of formaldehyde in houses are shown to be safe, based on studies with large numbers of measurements in real homes in the EU over the past 20 years. Formaldehyde concentrations in homes are well below the safe level of 0.1 mg/m3 recommended by the WHO. More information can be found here.
Like many substances, formaldehyde should be handled with care and the appropriate precautions should be taken when working with the substance in an industrial setting. Occupational exposure can occur in industries that use formaldehyde, including the manufacture of formaldehyde or formaldehyde-based resins. A wide array of safety measures are implemented to limit exposure to formaldehyde process emissions and formacare recommends the highest level of protection in occupational settings, including the use of closed systems and high standard ventilation units.
In 2018, the European Commission included formaldehyde in its proposal for a third amendment to the Carcinogens and Mutagens Directive (Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work). As part of this procedure and in 2019, the European Commission’s Scientific Committee on Occupational Exposure Limits (SCOEL) recommended an Occupational Exposure Limit of 0.3ppm for 8H Time Weighted Average (TWA). A recommendation for an OEL could be derived since the substance is known to have a threshold mode of action. It was also aligned with the DNEL (Derived No Effect Level) developed by the lead registrant for the Chemical Safety Report and the Extended Safety Data Sheets.
Following the ordinary legislative procedure, the European Parliament and the Council of the EU voted the CMD3 in March 2019. The CMD3 brought a Binding Occupational Exposure Limit through a harmonised regulation that is protective for the European workers and enables industry to strive in Europe. Following its transposition into national law until July 2021, CMD3 also facilitated the creation of a level playing field at European level for formaldehyde production.
CMD3 brought the following values as a maximum level for workers exposure in the EU (incl. the UK):
· 0.3 ppm Time Weighted Average (TWA)
· 0.6 ppm Short-Term Exposure Limits (STEL)
Users of formalin for embalming and medical purposes (such as anatomopathology) were granted an extra 3 years of transition period, versus 2 years for all other uses.
Formacare committed itself to very tight standards for workers safety: in 2019, a voluntary agreement was launched to cut the transition period and make the 0.3ppm BOEL applicable immediately within the membership. More information is accessible here.
Because industrially produced formaldehyde is used mainly as an intermediate, consumers rarely come into direct contact with formaldehyde. Formaldehyde is used in many applications in full compliance with specific European regulations to ensure consumers benefit from the properties of formaldehyde in a safe and comfortable way.
Indoor air Consumers may be exposed to trace amounts of formaldehyde in indoor air. A study by Salthammer et al estimates that 10 to 50% of the formaldehyde found in indoor air comes from organic uses such as candles, incense, cooking, gas heaters, cigarette smoke or from natural wood itself. Meaning no formaldehyde was added for industrial purposes, yet the formaldehyde is naturally present. The rest stems from emissions from materials produced from formaldehyde like resins or glues. Because formaldehyde-based resins are used in many construction and decorative products, these can indeed emit very low levels of formaldehyde into the indoor air. Industry innovation has led to a steady decrease in formaldehyde indoor air levels over the last 40 years, to levels that are often so low they are difficult to detect. A study by the World Health Organisation established an indoor air quality guideline of 0.1 mg/m³ for consumer safety. The average levels of formaldehyde in homes are already well below the recommended guidelines. Indeed, instances where formaldehyde levels exceed the WHO recommended indoor guidelines are extremely rare. The WHO 2010 guidelines for formaldehyde also concluded that formaldehyde does not present a greater risk to vulnerable populations such as children and the elderly.
Prof. Tunga Salthammer – A critical review of indoor formaldehyde concentrations and guideline values
Prof. Gunnar Nielsen – WHO (2010) Guideline value on formaldehyde and recent scientific studies
Safety of Construction & Decoration products
Wood naturally emits formaldehyde. It is simply not possible to achieve zero formaldehyde emissions from wood and wood-based products. Through technical progress and innovation, the wood panel industry has, however, developed a voluntary European standard (E1) based on the WHO recommendation for indoor air levels of formaldehyde. Although wood products still emit formaldehyde, the E1 label ensures that these products remain significantly below the WHO guideline, and thus allows consumers to safely benefit from all the properties of formaldehyde-based wood products. The voluntary efforts of the wood panel industry have helped lower the concentration of formaldehyde in resins from around 100 mg/100g of panels in 1975, to less than 8mg/100g nowadays; that is from 0.1% to 0.008%.
The REACH restriction on formaldehyde for consumer articles launched in 2017 will harmonise the maximum emissions possible in Europe in EU legislation. This procedure is expected to lead to even lower emission values of formaldehyde from wood-based products. This procedure is ongoing.
Safety in other applications
Formaldehyde as an aqueous solution is a very effective disinfectant that can terminate bacteria and fungi. Also, because of this beneficial property, formaldehyde is used in certain vaccines and other healthcare applications such as in anti-infective drugs and in gel capsules to promote maximum absorption. In vaccines, where the product is injected into the body, the amounts of formaldehyde are too low to affect levels that naturally occur in the body. The development and use of vaccines are governed in the EU by the European Medicines Agency (EMA).
Formaldehyde is no longer authorised for use in cosmetic and personal care products, under the European Cosmetic Products Regulation (CPR). Some formaldehyde releasers (i.e. chemicals that release formaldehyde) are still authorised for preservation purposes. Their uses are strictly regulated and also subject to labelling requirements, under the Annex V of the Cosmetic Products Regulation No 1223/2009.