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.
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.
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.
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.
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.”