UK Calls for Evidence to Support RMOA for Formaldehyde and Formaldehyde Releasers

The United Kingdom’s (UK) Health and Safety Executive (HSE) issued a call for evidence on April 26, 2023, to gather information and evidence that will support HSE and the UK Health and Security Agency (UKHSA) with the preparation of a regulatory management options analysis (RMOA) that examines exposure of the general public to formaldehyde from formaldehyde releasers in articles. HSE states that it is “interested in all aspects of the manufacture, import and use of articles that have the potential to release formaldehyde to indoor air during their service life, the rate of emissions of formaldehyde from these articles and actions that may be taken to reduce exposure to formaldehyde from these sources.” HSE is also interested in any product-specific legislation and standards that apply to these articles, as well as industry initiatives to reduce the potential for formaldehyde to be released from these articles. In addition to articles that have the potential to release formaldehyde, HSE notes that it is interested to understand the levels of formaldehyde that can be generated in indoor settings from processes that can release formaldehyde, including cooking, use of candles, and indoor domestic combustion, such as woodburning stoves and ethanol fires. The call for evidence will close June 25, 2023.

The RMOA is a preliminary step used within the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) framework. The RMOA collates, combines, and analyzes information on the nature and extent of exposure to chemical substances, and it considers existing laws and also how chemical substances are managed around the world, including Europe, Asia, and the United States. HSE will use the RMOA to characterize risks and identify the most appropriate tools to manage any identified risk, including:

• Substance evaluation prioritization for the rolling action plan (RAP);
   
• The placing of substances of very high concern (SVHC) on the Candidate List;
   
• Future recommendations to the Authorisation List (Annex 14) — substances subject to authorization; and
   
• Restriction on the use or placing on the market of substances.

HSE publishes the conclusions of the RMOAs and builds the pipeline of activities that will be taken forward in UK REACH.

According to HSE, formaldehyde “is hazardous to health because it is carcinogenic, it is suspected of causing genetic defects, it is toxic if swallowed, in contact with skin or if inhaled, and it is also a skin sensitiser.” HSE states that formaldehyde is present in indoor air, including in domestic settings, because it can be off-gassed from articles that are produced using formaldehyde-based substances, and because it can be generated in situ from combustion sources such as cooking, lighted candles, and wood-burning stoves. HSE notes that reviews have identified that the following articles, products, and processes can release formaldehyde in indoor settings:

• Building, construction, and insulation materials, including:
  
  • Wood-based plate materials for ceiling and flooring;
     
  • Laminate;
     
  • Mineral wool;
     
  • Urea formaldehyde (UF) or phenol formaldehyde (PF) foam insulation; and
     
  • UF pressed wood products, like hardwood plywood paneling and fiberboard, including medium-density fiberboard (MDF);
     
• Adhesives and sealants;
   
• Coating products: Paints, lacquers, and surface coatings;
   
• Polishes and waxes;
   
• Wallpapers;
   
• Furniture and mattresses;
   
• Textiles, such as curtains and carpets;
   
• Washing and cleaning agents;
   
• Personal care products and cosmetics;
   
• Air cleaning devices;
   
• Candles, air fresheners/fragrance products and incense burning;
   
• Wood-burning and ethanol fireplaces;
   
• Cooking activity;
   
• Tobacco smoking and electronic cigarettes; and
   
• Photocopiers (inks and toners).

HSE notes that the World Health Organization (WHO) has established an indoor air quality guideline for formaldehyde of 0.1 milligrams per cubic meter (mg/m³) for 30 minutes of exposure, which is a level of exposure that aims to be protective for the general population. In March 2019, the European Union (EU) held a public consultation on a restriction proposal to limit release of formaldehyde into indoor air from products that may contain formaldehyde residues because of the manufacturing process for those products. According to HSE, the proposal is intended to apply to articles where formaldehyde or formaldehyde releasers are used in their production and where formaldehyde releases occur during use. HSE states that the opinion of the European Chemicals Agency’s (ECHA) Risk Assessment and Socioeconomic Assessment Committees on the proposal was adopted in September 2020. The restriction proposal has not yet been adopted into legislation in the EU but is expected to enter into force in 2023.

HSE states that to help it determine if a similar restriction is needed in Great Britain (GB), it wishes to know what levels of formaldehyde are occurring indoors in GB homes and in vehicles (including aircraft cabins) that may be used by the general public. HSE also wishes to identify which sources of formaldehyde are making the greatest contribution to levels of formaldehyde in indoor air.

HSE states that if stakeholders are unsure if the article for which they are providing information falls within scope of the call for evidence, “please submit your information anyway.” Basic information can be provided in the call for evidence survey. More detailed information should be provided in document(s) that can be submitted as attachments at the end of each section. HSE states that it will not automatically publish information submitted in response to a call for evidence, but that it would be helpful if a “public version” of the information can be provided. Stakeholders that also want to provide confidential information in their submissions should additionally complete a “confidential version” and submit both versions as attachments. HSE will take account of both non-confidential and confidential information when deciding which regulatory approach to propose.

Commentary

The UK’s call for evidence follows approval of the European Commission’s (EC) draft amendment to Annex XVII Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH) regarding formaldehyde and formaldehyde releasers by the REACH Committee in February 2023. Twenty-six member states representing 84.84 percent of the EU population approved the EC’s draft restriction, which aligns well in scope with the UK’s call for evidence, but places lower limits on permissible exposures than the WHO. The EU’s draft amendment received “no opposition” from the European Parliament and Council on May 13, 2023. The EU restrictions are likely to enter into force in 2023, with an implementation period of 36 months for all sectors except road vehicles, which will have an implementation period of 48 months.

Whether the UK’s RMOA results in risk management options that align with the EU’s Article XVII restrictions or considers restrictions that align more closely with the WHO guideline value remains to be seen. As noted, comments are due by June 15, 2023.