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 chemical regulation. REACH applies to substances manufactured or imported into the EU and replaces 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 assessment 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 accomplishes 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 and to prevent 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 given in detail here.
Read the formacare press release on the inclusion of formaldehyde in the CoRAP.
The substance evaluation of formaldehyde began in February 2013, and is being performed jointly by co-rapporteurs France and the Netherlands. The timing of the evaluation depends largely on the information requested to the lead rapporteurs. Once the Evaluation is completed, the co-rapporteurs may conclude that the risks are sufficiently under control and necessary measures are already in place. Otherwise, they can propose EU-wide risk management measures such as proposals for restriction, authorisation and occupational exposure limits. More information can be found here.
The formaldehyde industry is committed to the safe and sustainable use of formaldehyde and as such will continue to cooperate with the rapporteurs to ensure that this important chemical can continue to be used safely in the EU.
Formaldehyde and CLP
Formaldehyde is one of the most thoroughly evaluated substances.
In 2014 Formaldehyde was reclassified as a Carcinogen Category 1B. According to the CLP Regulation, Category 1B substances are presumed to have carcinogenic potential for humans and classification is largely based on animal evidence as opposed to substances falling under Category 1A.
The new classification entered into force in June 2014 when published in the Official Journal of the European Union. However, authorities have foreseen a transition period allowing suppliers to adapt to the new classification. The European Commission has recently proposed to expand the transition period until 1 January 2016.
Background and rationale
When evaluating the carcinogenicity of substances, European regulators take into account evidence from studies on both animals and humans. Since 1980 there have been over 100 studies investigating the potential link between formaldehyde and cancer.
On 28 September 2011, France submitted a dossier to ECHA for the reclassification and labelling of formaldehyde as Category 1A ‘substances known to have carcinogenic potential’. There was then a 45 day public consultation that began in October 2011. On behalf of the formaldehyde industry, formacare submitted a contribution to the public consultation on the scientific merits of France’s proposal for harmonised C&L.
After the public consultation, the rapporteur appointed on behalf of the Risk Assessment Committee (RAC) of ECHA, Germany, began the review of the formaldehyde dossier. On 7 December 2012 ECHA announced the adoption of a scientific opinion of the RAC to reclassify formaldehyde as carcinogen 1B “presumed human carcinogen” and germ cell mutagen category 2. In reaching their opinion the RAC found that the science relating to human exposure could not support France’s proposal to classify formaldehyde as carcinogen category 1A, and they instead agreed that category 1B was warranted. The proposed classification is based on nasopharyngeal cancer, an extremely rare form of cancer in Europe.
On 20 December 2013 the EU REACH Committee adopted a decision to reclassify formaldehyde as a category 1B carcinogen. This decision was implemented through the 6th Adaptation to Technical Progress (ATP) to the CLP Regulation published in the Official Journal of the European Union on 6 June 2014.
On November 25 2014, the EU REACH Committee agreed via written procedure to postpone the deadline for the transition period until 1 January 2016. On March 23 2015, the decision was formally confirmed with the publication of the Commission Regulation 2015/491. Industry has therefore until 1 January 2016 to comply with the new classification.
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 funded 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.
We would expect the results derived from the TNO/RPA study should be the same as those found by the Dutch and French substance evaluators.
Three reports have been produced:
- 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 for Workers and Consumers (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 reports can be made available to other interested parties on request to formacare.
The risk assessment reports for both workers and consumers address the questions raised by the substance evaluators. This is the most comprehensive and up-to-date assessment of safety for workers and consumers exposed to formaldehyde.
The analysis of worker exposure was mainly based on real, recent 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 recent 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 current 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 is 0.4 ppm, while for consumers the DNEL is 0.1 mg/m3, the WHO recommended value.
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 in a large number of real homes over the past 20 years show that in almost every case the concentrations of formaldehyde in indoor air are below the DNEL, indicating that consumers are safe.
Most appropriate risk management options for formaldehyde
The risk assessments reported above have found that today, under existing legislation in the European Union, formaldehyde is used safely in the workplace, and does not present a risk to consumers. However 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, and that the occupational exposure limits (OELs) for formaldehyde are presently under review 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 focuses 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 harmonized OEL of 0.4 ppm should be implemented at the EU level as soon as possible.
This will help ensure an appropriate level of protection for EU workers, avoid confusion for employees and employers in ensuring such protection, minimize the potential for unfair competition between economic operators on the EU market, and enhance the harmonization of the internal market. In practice, workers in 13 Member States with OELs higher than 0.4 ppm might be impacted by the introduction of such a harmonised OEL. This provides more clarity regarding risk communication and ensures adequate control of the risks in the workplace
Most Appropriate RMO 2
For consumer protection, harmonised restrictions should be introduced at the EU level under the REACH Regulation on wood based panels with formaldehyde emissions higher than the E1 standard (0.1 ppm concentration in the relevant emission test).
This measure will help to ensure an adequate level of protection for EU citizens, avoid unfair competition on the EU market and enhance the harmonization of the internal market. It is also recommended that adequate monitoring programmes are put in place to ensure compliance of imported WBPs with this restriction. This RMO takes into account the findings of the risk assessment which shows that adequate control of the risks to EU citizens is possible when using E1 WBP.
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 should manufacture WBP 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 must 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 makes it clear that such a measure is unnecessary for the protection of workers and consumers, and would be unwarranted based on the European Commission’s existing guidance:
“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 has considered the RMOs available for dealing with concerns relating to formaldehyde and concludes inter alia that restrictions are the most appropriate RMOs for WBP on the basis that proper implementation and enforcement of RMMs 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 there is no alternative which is generally suitable for use across all grades of WBP. Further, the alternatives currently available also result in a different set of risks, leading to potential trade-offs of risk. There are also 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 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 notes that several of the alternatives are also listed under the CoRAP list.
The study concludes: “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 WBP, 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 high-emitting UF resins. The use of these resins effectively reduce, if not eliminate (to background levels), releases of formaldehyde from WBP 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.