REACH Regulation and Formaldehyde
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) entered into force on June 1st, 2007 and is the EU’s main framework for chemicals regulation. REACH applies to substances manufactured or imported into the EU and replaced approximately 40 European Directives and Regulations with one comprehensive system.
The goal of REACH is to:
- Provide information on chemical substances
- Assess and manage the risks (or lack thereof) of chemical substances
- Ensure a high level of protection to human health or the environment.
The REACH framework includes several steps before final risk-based decisions are made.
Registration, the “R” in REACH, is the first step whereby producers of chemical substances are required to gather data on the manufacture and use of their products into a “Registration dossier”. This extensive dossier includes all relevant available information on the substance such as substance identity, physico-chemical properties, toxicity, ecotoxicity, environmental fate, exposure and instructions for appropriate risk management.
These dossiers are then submitted to ECHA according to a deadline, depending on the tonnage produced in Europe. As formaldehyde production is over 1 million tonnes per year, formaldehyde was subject to the first Registration deadline on 30 November 2010. As the sector group for formaldehyde manufacturers in Europe, formacare established a REACH taskforce to facilitate the creation of a REACH consortium. Consortia are used by chemical manufacturers to work together as a unified group for their REACH compliance activities.
Non-confidential parts of the Registration dossier for formaldehyde have been published on the European Chemical Agency website.
Evaluation, the “E” in REACH, is the second major step in REACH. REACH Evaluation directly follows REACH Registration and consists in 3 main tasks:
- Check that the Registration dossier submitted by the registrants has all the required information
- Examine any testing proposals made by the REACH registrants (in case of missing information) to ensure that reliable and adequate data will be produced while preventing unnecessary animal testing
- Substance evaluation
Substance evaluation is the most extensive of the three “tasks” under REACH Evaluation. It is a procedure by which Member States clarify potential human health or environmental concerns related to particular substances. European Members States submit individual substances to the Community Rolling Action Plan (CoRAP), a list of substances updated each year, which establishes deadlines for evaluation of substances.
Formaldehyde was included in the CoRAP for February 2012, for the following reasons:
- human health /CMR properties
- exposure/wide dispersive use
- worker exposure
- high aggregate tonnage
The full justification is detailed here.
The substance evaluation of formaldehyde began in February, 2013 and was performed jointly by co-rapporteurs France and the Netherlands. The timing of the evaluation relied on the information requested from the lead rapporteurs. In 2019, co-rapporteurs concluded on the substance evaluation. The results of this procedure are available here.
Co-rapporteurs concluded that with reference to workers health, a Risk Management Option Analysis (RMOA) should be performed to further assess possible risks for occupational safety from exposure to formaldehyde. This RMOA had been launched by French authorities and is not officially concluded. More information is available here. It should be stressed that in parallel, concerns with worker safety were addressed in the Third Amendment to the Carcinogen and Mutagens at Work directive (CMD) which implemented a binding occupational exposure limit (BOEL) at 0.3ppm in a harmonised way across the EU 27 (plus Norway and the UK).
With regards to consumer health, co-rapporteurs concluded that a restriction under REACH on formaldehyde in consumer articles should be launched. This restriction procedure started as of 2017 and found conclusions in 2023 with the adoption of a restriction under REACH Annex XVII protecting consumers in indoor environments, including in vehicles, and preserving the Single Market for formaldehyde-based products.
The restriction sets limits for formaldehyde emissions: 0.062 mg/m3 for wood-based panels, 0.08 mg/m3 for other types of products, and 0.062 mg/m3 for vehicles. Article producers have three years to comply with the restriction while vehicles manufacturers have four years.
The formaldehyde industry is committed to the safe and sustainable use of the substance and as such has cooperated with all involved authorities to ensure that this important chemical can continue to be used safely in the EU. Formacare supported the above-mentioned limit values (more information in the News section).
Risk Assessment and Risk Management Options Study
In March 2012, Formacare contracted TNO Triskelion BV together with RPA (Risk & Policy Analysts Ltd) to undertake a study of Risk Assessment and Risk Management Options for formaldehyde. Although the study was commissioned by Formacare, with support from the European Panel Federation (EPF), TNO and RPA are independent consultants and produced their reports in line with ECHA guidelines for the production of Risk Assessments and Risk Management Option Studies.
Three reports have been produced, notably:
- Analysis of worker exposure in manufacture and use of formaldehyde in Europe, including downstream applications (TNO Triskelion bv/26 April 2013)
- Analysis of consumer exposure associated with the use of products and articles containing formaldehyde -based resins (TNO Triskelion bv/26 April 2013)
- Analysis of the most appropriate risk management option for formaldehyde and its associated Cost-Benefit Analysis of Proposed RMOs (RPA Risk & Policy analysis and TNO Triskelion BV/15 November 2013)
The reports have been provided to the evaluation rapporteurs, as well as to other interested regulators (European Commission and the appropriate Member State Competent Authorities).
The risk assessment reports for both workers and consumers address the questions raised by the substance evaluators.
The analysis of worker exposure was mainly based on actual workplace exposure measurements made in the European Union during the manufacture of formaldehyde and its use throughout the value chain. For consumers, the analysis was focused on their exposure to formaldehyde present in indoor air. In this case, the analysis relied on data from published literature on indoor air quality, measured in real houses mainly in the European Union.
For worker and consumer exposure, the assessments of risk and determination of safe use were made according to existing legislation, and against the current derived no effect levels (DNELs) for formaldehyde. The DNEL represents the level of exposure above which humans should not be exposed, and values for formaldehyde are well established and defined in the REACH Registration dossier. For workers, the DNEL was at that time of 0.4 ppm, while for consumers the DNEL was 0.1 mg/m3 which is the WHO recommended value from 2010.
Exposure assessment for workers
The risk assessment established that there is safe use, based on measured data, in:
- the manufacture of formaldehyde
- the manufacture of formaldehyde-based resins and other chemicals
- the production of wood based panels
- use in the tyre and rubber industries
In some cases the demonstration of safe use requires the use of appropriate Risk Management Measures (RMMs), such as the wearing of half masks, and the application of suitable Operating Conditions (OCs), for example the use of ventilation systems.
For other downstream uses, insufficient measured data were available. The risk assessment described how safe use is possible for these uses with generally feasible OCs and RMMs on the basis of literature data or exposure modelling.
Exposure assessment for consumers
Studies of domestic situations over the past 20 years have shown that in almost every case the concentrations of formaldehyde in indoor air are below the DNEL, indicating that consumers are safe from exposure to formaldehyde.
Most appropriate risk management options for formaldehyde
The purpose of the risk management options (RMO) study performed by TNO and RPA was to address possible future concerns of the regulators, noting for example the pending reclassification of formaldehyde as CMR 1B. This new situation was taken into consideration during the Third Amendment to CMD for which the binding occupational exposure limits (BOELs) for formaldehyde were reviewed by the EU SCOEL Committee.
The primary use of formaldehyde is in the manufacture of glues and resins for use in the production of wood-based panels. This also constitutes the highest volume application of formaldehyde. For this reason, the RMO study focused on the use of formaldehyde in wood-based panels. With this in mind, the consultants were asked to provide a comprehensive and analytical assessment of the appropriate measures, if any, which may be necessary.
The RMO study came to the following conclusions.
Most Appropriate RMO 1
The most appropriate RMO for worker protection is that a harmonised OEL of 0.4 ppm should be implemented at the EU level as soon as possible.
This was to help ensure an appropriate level of protection for EU workers, avoid confusion for employees and employers in ensuring such protection, minimise the potential for unfair competition between economic operators on the EU market, and enhance the harmonisation of the internal market. In practice, workers in 13 Member States with OELs higher than 0.4 ppm were to be impacted by the introduction of such a harmonised OEL. This provided more clarity regarding risk communication and ensured adequate control of the risks in the workplace.
> It should be stressed that on the basis of the scientific opinion of the SCOEL, the Third Amendment to CMD concluded on a harmonised BOEL at 0.3 ppm, thus ensuring worker safety across the EU 27 (plus Norway and the UK). Formacare and value chains partners supported the proposed BOEL at 0.3 ppm, and a Voluntary Agreement was launched in 2019 to implement the BOEL before the deadline for the transposition in national legislation. More information can be found here.
Most Appropriate RMO 2
For consumer protection, harmonised restrictions should be introduced at the EU level under the REACH Regulation on wood-based panels (WBPs) with formaldehyde emissions higher than the E1 standard (0.1 ppm concentration in the relevant emission test).
This measure was to help ensure an adequate level of protection for EU citizens, avoid unfair competition on the EU market and enhance the harmonisation of the internal market. It was also recommended that adequate monitoring programmes are put in place to ensure compliance of imported WBPs with this restriction. This RMO took into account the findings of the risk assessment which showed that adequate control of the risks to EU citizens was possible when using E1 WBP.
- In 2017, ECHA proposed a dossier for a restriction on formaldehyde in consumer articles, covering wood-based panels and other products that can be a source of formaldehyde exposure for consumers (for instance, in automotive and airplanes environments). Formacare and value chain partners supported the draft restriction at the proposed values.
Most Appropriate RMO 3
The E1plus standard should be introduced as soon as possible via an industry self-regulatory initiative or voluntary agreement.
Under this initiative, companies would manufacture wood-based panels with formaldehyde emissions lower than E1plus emission levels (0.065 ppm in the relevant emission test), in cases where this is technically suitable, economically feasible and does not result in higher risks to workers’ health. Appropriate monitoring and (annual) reporting mechanisms would also be documented and established to report on the extent to which the E1plus standard is being taken up.
Authorisation – Harming Workers, Consumers and the Environment
The RMO study also considered the option of authorisation of formaldehyde under REACH. The study made it clear that such a measure was unnecessary for the protection of workers and consumers, and would be unwarranted based on the European Commission’s existing guidance at the time:
“In concluding, EC (2013) states that “before considering the inclusion of a substance in the candidate list, an assessment of the best risk management option under REACH is performed … and no automatic link is assumed between the classification of a substance as a CMR and its inclusion in the candidate list”. This study considered the RMOs available for dealing with concerns relating to formaldehyde and concludes inter alia that restrictions are the most appropriate RMOs for wood-based panels on the basis that proper implementation and enforcement of risk management measures will not be possible under Authorisation, in particular, due to issue of imports.”
The RMO study provided an extensive review of the substitutes that could be used as an adhesive/binder in wood-based panels. This involved a thorough consideration of the availability of alternatives for the applications of concern, where this includes alternative substances, and the technologies and/or processes involved.
The study examined:
- Formaldehyde-based Adhesives
- Non-Formaldehyde-based Adhesives
- Bio-based Adhesives
The study found that in 2013 there was no alternative which is generally suitable for use across all grades of WBP. Further, the alternatives available also result in a different set of risks, leading to potential trade-offs of risk. There would also be cost and availability issues with many of the alternatives considered.
The RMO study concluded that the best alternative to the most commonly used urea-formaldehyde (UF) resin would be to use other lower-emission formaldehyde resins. This conclusion is based on a thorough consideration of the technical and economic feasibility of the alternative substances, and also consideration of environmental and health concerns – the study noted that several of the alternatives were also listed under the CoRAP list, in 2013.
The study concluded: “Overall, taking into account the information on alternatives, it is clear that the most appropriate RMO must focus on the key concern which is releases of formaldehyde from wood-based panels, rather than on focusing solely on switching away from formaldehyde-based resins as a family. The analysis of alternatives indicates that there are other formaldehyde-based resins (PF, MF, MUF, RF, and PRF) which release little to no formaldehyde from the cured product and, as such, can be considered as substitutes for higher-emitting UF resins. The use of these resins effectively reduce, if not eliminate (to background levels), releases of formaldehyde from wood-based panels and avoid adverse effects on the health of consumers.”
Cost Benefit Analysis
An analysis of the costs to industry associated with introduction of Most Appropriate RMO 1 (above) suggests that reducing occupational exposure limits below 0.4 ppm would incur significant costs, particularly for the wood panel industry, without significant improvement in the health and safety of workers.
The report also notes that authorisation under REACH would incur far greater costs to industry. Unfortunately, workers health is unlikely to benefit, and the public health could be harmed as authorisation would do nothing to address the import of cheap and high emitting wood based panel boards coming from outside the EU.