What is formaldehyde?
- Formaldehyde is a naturally occurring organic compound with the formula CH₂O
- Formaldehyde is composed of hydrogen, carbon and oxygen. Although it cannot be seen being a colourless gas, it has a distinct odour thus making it easily identifiable.
- Naturally occurring formaldehyde is found in low levels in humans, animals, plants, fruits, vegetables, meats and beverages.
- It is estimated that a normal adult human organism produces between 61 and 92 grams every day as part of a normal metabolic process. In the human body, formaldehyde acts as a critical molecule for the formation many cell constituents.
- Formaldehyde is known to be readily biodegradable and does not accumulate in the environment or within plants and animals. In the air, it is quickly broken down by sunlight. In water and soils compartment, it is digested by bacteria until full degradation.
- Formaldehyde is also a by-product of the oxidation and combustion of certain products, and is released for instance from forest fires, car exhausts, lit candles, tobacco smoke and cooking gas and smokes. It is estimated that the majority of the global formaldehyde emissions in the atmosphere result from natural emissions, i.e. from vegetation, animal beings, forest fires, etc.
Why do we manufacture formaldehyde?
- As a building block to produce more complex chemicals, formaldehyde provides exceptionally high chemical reactivity in the most resource efficient way.
- It is the smallest and simplest molecule delivering carbonyl functionality for the manufacturing of polymers & resins. It does not waste material and energy during its production and use. It also has powerful antibacterial properties.
- Formaldehyde manufactured for industrial purposes is identical to the formaldehyde naturally occurring in the environment: same molecular structure, same properties.
How is formaldehyde produced ?
- Industrial formaldehyde is produced by the reaction of methanol with oxygen. The energy that is released from this process can be captured and reused for different purposes.
- In addition, process gases from formaldehyde production are routinely burned to produce steam and electricity.
- Emissions to air and water remain extremely low and are of relative concern since formaldehyde rapidly biodegrade through sunlight or bacterial exposure. Existing legislation for industrial emissions also ensures minimum exposure to the environment.
- It is worth to note that despite formaldehyde is a colourless gas, it is mostly commercialized and distributed in a liquid form named formalin (which contains in general between 37% and 55% of formaldehyde).
What is formaldehyde used for?
- Formaldehyde is a critical chemical building block in the production of many applications which play an important role in everyday life; yet little or no formaldehyde remains in the final product.
- Formaldehyde is mainly used as an intermediate in the production of resins and glues, polymers and polyols. This represents today around 98% of the total manufactured formaldehyde in Europe, the remaining 2% being for biocidal uses as approved disinfecting and veterinarian agent, in embalming activities or in the medical sector.
- Construction & Decorative products: Formaldehyde-based resins (industrial-type adhesives) are used as the binder system to glue wood chips and other materials together to make plywood, particleboard and fibreboard, sheathing and cladding, asphalt shingles, furniture and paneling, kitchen cabinets, moulding and trim work, insulation and flooring systems, as well as paints and varnishes.
In addition, formaldehyde-based resins are used to make household and kitchen appliances, such as washers and dryers – and for plumbing applications, such as: plumbing pipes, fittings and pump impellers and housings; as well as showerheads, valve mechanisms for blending hot and cold water and in faucets’ on/off operations.
- Automotive and Aerospace: In the automotive industry, formaldehyde-based technologies are used to make interior moulded and under-the-hood components that allow for higher fuel efficiency by reducing vehicle weight, as lighter alternative to metals. It is also used in the production of highly durable exterior primers, clear coat paints, tire-cord adhesives, brake pads and fuel system components.
- Healthcare: Formaldehyde is used in vaccines to inactivate viruses and detoxify bacterial toxins (for example in some influenza, polio and hepatitis vaccines).
Formaldehyde is also used early in the up-stream supply chain to make compounds used in the creation of life-saving medical devices (for example, pacemakers, artificial heart valves, and prosthesis). Finally, formaldehyde is used in histopathology which is the study of tissue diagnoses: formaldehyde preserves tissue samples for medical analysis, without known substitution.
- Clothing and textiles: Formaldehyde is used as an ingredient in textiles, to help bind dyes and make clothes wrinkle-resistant.
Are there alternatives to formaldehyde?
In many instances, because of formaldehyde’s unique physical and chemical properties (i.e. fixative, thermo-resistant, higher compatibility with other chemicals, disinfectant, and preservative functions), few compounds can replace it as a raw material without reducing performance and/or making the final products more expensive. Some identified alternatives to formaldehyde come with their own toxicological profile and associated concerns. Finally, safer alternatives have been identified but production capacities are not yet meeting the high demand from customers.
How big is the formaldehyde industry?
- Over 3.6 million tonnes of formaldehyde are produced each year in Europe, creating over 30,000 direct jobs in the chemical processing sector. Downstream industries which rely on formaldehyde, such as the wood-based panels and furniture industries, and the suppliers of the automotive industry, employ more than 1.7 million people across Europe.
Does formaldehyde have negative effects on the environment?
- Despite its presence in all organic life forms, formaldehyde does not accumulate in the environment.
- In the air environment, it is in gaseous form and is very quickly broken down by sunlight. It is demonstrated to have a half-life of an hour, which means that over the course of one hour, the amount of formaldehyde present in the environment decreases by 50%.
- In soil and water until the natural background level, it is digested very quickly by bacteria until complete disappearance.
Is formaldehyde safe for humans?
- Like many chemicals, exposure to a substance at very high concentration can be harmful. In this sense, formaldehyde is classified as a presumed carcinogen (category 1B).
- People produce and exhale formaldehyde themselves, naturally. If a person is exposed to limited external sources of formaldehyde and until a certain level, the nasal and the gastric mucosa breaks it down very quickly, resulting in no formaldehyde entering the body.
- In the case of formaldehyde, exposure in the outdoor is known to remain minimal; in the indoor environment, levels of formaldehyde in the air are usually well below the safe exposure level of 0.1mg/m3 set by the World Health Organization (WHO) in 2010. This been reviewed and confirmed twice so far by expert public health agencies, incl. the French Health Agency, ANSES.
- An independent risk assessment, carried out by two independent consultants TNO Triskelion and RPA (Risk & Policy Analysts Ltd) has reviewed large amounts of published exposure data and concluded that formaldehyde levels in dwellings are well below the safe concentration established by the WHO in 2010. Furthermore, formaldehyde benefits from decades of science concerning its chemical properties and safety. This has allowed effective guidance towards decision-makers for science-based legislation to ensure that formaldehyde can be continued to be produced and used while no risk is permitted for consumers.
- Concerning workers, occupational exposure can occur in industries that use formaldehyde, including during the manufacture of formaldehyde or formaldehyde-based resins. Like many other chemicals, formaldehyde should be handled with care and the appropriate precautions should be taken when working with the substance in an industrial setting.
- Since July 2019, the new EU Binding Occupational Exposure Limit (BOEL) for formaldehyde is set at 0.3 parts per million (ppm) under the Third amendment to the EU Carcinogens and Mutagens Directive (CMD3). Deadline for the transposition of the BOEL in national legislation was set in July 2021.
- In 2021, Formacare released the latest results of its Voluntary Agreement to keep occupational exposure limits below 0.3 parts per million (ppm) for the 8-hour Time-Weighted Average (TWA) and 0.6 ppm for the short-term exposure limit (STEL) which is normally set for 15 minutes exposure. The results showed that 99.9% of the workers were not exposed to formaldehyde levels beyond target occupational exposure limits of 0.3 ppm, prior to the deadline for transposition of the directive. Measures have been put in place for full compliance of the formaldehyde industry with the new legislation, ensuring that no compromises are made when it comes to worker safety.
- Independent risk assessors at TNO Triskelion and RPA had assessed exposure levels at the workplace and concluded that industry operates safely in all current uses. In some cases, safe use requires appropriate Risk Management Measures (RMM), such as suitable operating conditions, for example adequate ventilation systems and individual operators personal protective equipment (PPE) as appropriate.
What does Formacare do to ensure the safe use of formaldehyde?
- It is not just up to regulators to make sure products are safe. It is important that all operators prioritise safety from start to finish. Industry has strongly supported and commissioned scientific studies that improved the general scientific knowledge and understanding of formaldehyde, its properties both in terms of human health and environmental safety.
- In May 2019, Formacare’s General Assembly approved a Voluntary Agreement to implement an occupational exposure limit (OEL) for formaldehyde. Together with industry and trade unions, and before legislation was adopted at EU level, Formacare advocated for binding OEL values of 0.3 ppm to enhance worker safety in a harmonised manner and across Europe. The Voluntary agreement was put in place to speed up the application of these measures more than two years ahead of the deadline for the legal transposition of the Third amendment to the EU Carcinogens and Mutagens Directive (CMD3).
How is formaldehyde classified in Europe?
- The current harmonised classification of formaldehyde is as follows:
- Acute Toxicity 3, for oral exposure, for skin exposure and for inhalation exposure
- Skin Corrosion 1B
- Skin Sensitiser 1
- Mutagenic (suspected) 2
- Carcinogen (presumed) 1B
- In 2014, formaldehyde was reclassified as a carcinogen category 1B. According to the EU Classification, Labelling and Packaging (CLP) Regulation, category 1B substances are presumed to have carcinogenic potential for humans, based on animal evidence. The rationale for this classification was not based on new scientific evidence but was triggered by a change of the classification criteria and their interpretation under REACH.
- The new classification entered into force on 24 June 2014, with a transition period for full compliance to 1 January 2016.
- A compliance check of the dossier performed by ECHA in 2018 confirmed that the REACH dossier of formaldehyde is fully up to date. New scientific data is taking into consideration in the necessary reviews of the REACH dossier and updates may be done when appropriate.
What does the classification cover?
- The classification for carcinogenicity of formaldehyde refers to one of the rarest forms of cancer in the EU: the nasopharyngeal cancer. When concluding on their assessment for the carcinogenicity of formaldehyde, experts from the EU’s Committee for Risk Assessment (RAC) rejected all possible links to leukemia: it is scientifically demonstrated that when inhaled, formaldehyde does not penetrate further in the organism and cannot be associated with any toxic effects in the body.. Since the epidemiology evidence does not support a link for humans, the classification is based entirely on evidence from animal studies. For this reason, the EU reclassified formaldehyde as carcinogen 1B (presumed human carcinogen) instead of 1A (known human carcinogen) as initially proposed in the classification dossier.
What does the classification mean?
- As a key principle under the European CLP regulation, classifications of chemicals are based on intrinsic hazardous properties. This means that classification does not consider risk characterization elements such as exposure or potency and are thus considered to be hazard-based in Europe. In practice, this means that a classified hazardous chemical still can be produced and used as long as the risk to humans and to the environment is properly managed.
- The classification of formaldehyde was established based on animal tests performed under high exposure conditions, which are not expected to occur in real-life situations.
- Finally, formaldehyde differs from many other carcinogens in the sense that it was scientifically demonstrated as being a “threshold carcinogen”, notably by the former Scientific Committee on Occupational Exposure Limits (SCOEL) in 2016; this means that a risk of cancer in humans may only occur if only a certain threshold of exposure to formaldehyde is reached. So, in practical terms, only repeated exposure at very high levels of formaldehyde may cause cancer.
- Since formaldehyde has, depending on the concentration, corrosive or irritating properties, inhalation of formaldehyde causes substantial eyes irritation and breathing distress that cannot be sustained for a long period of time. When exposed to formaldehyde, the expected human reaction would be to leave or ventilate the area to stop the exposure and thus reducing potential effects.
What is the regulatory status of formaldehyde under REACH?
- Formaldehyde was registered under REACH in 2010.
- In 2012, formaldehyde was included on the second CoRAP List for REACH substance evaluation, to clarify if the substance was used safely and was adequately regulated. This process began formally in February 2013, performed jointly by the competent authorities from France and the Netherlands.
- This procedure reached conclusion in 2019:
- Concerning worker safety, authorities recommended for specific occupational exposure limits to be set for the protection of workers. These concerns were addressed by the adoption of the EU harmonised BOEL at 0.3 ppm in 2019. Such a BOEL was considered by authorities as the most relevant and efficient regulatory tool to ensure worker safety.
- Concerning consumer safety, authorities recommended for the launch of a restriction in consumer articles, to address possible concerns with consumer exposure to formaldehyde in indoor environment. Formacare welcomes the restriction launched by ECHA in 2017 in that it will clarify the identified concerns. This procedure is still ongoing and may find conclusion in 2022.
- It is worth to note that Formaldehyde has not been identified as a SVHC as a result of the launched Risk Management Analysis Options (RMOA) by the French authorities. Formaldehyde is thus not being considered for authorization under REACH.
What is the current status of the ongoing REACH restriction for formaldehyde and formaldehyde releasers in articles?
- In 2017, ECHA prepared a dossier for a restriction of formaldehyde and formaldehyde releasers in article. This is to address possible concerns with consumer exposure to formaldehyde in indoor environment.
- Formacare has been involved in this procedure since its beginning and has submitted evidence and inputs during the appropriate consultation opportunities.
- The risk assessment was concluded by ECHA in 2020 and the file has been sent to the European Commission responsible for the risk management measures. A draft legislative proposal has to be prepared and adopted by the REACH Committee meeting. This may happen in 2022.
- In the meantime, it is premature to anticipate the final conclusions of this ongoing procedure.