UK REACH - RMOA for formaldehyde and formaldehyde releasers

Overview

The UK REACH work programme for 2022/23 states that the Agency for UK REACH will initiate a Regulatory Management Options Analysis (RMOA) that examines exposure of the general public to formaldehyde from formaldehyde releasers in articles. RMOA is a process through which the Agency assess the potential risks posed by a substance (or group of substances), identifies areas where further information is needed to fill information gaps and recommends regulatory measures to address any identified risks.

This call for evidence aims to gather information and evidence that will support the Health and Safety Executive (HSE) and the UK Health and Security Agency (UKHSA) with the preparation of this RMOA. We are 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. We are 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, we are interested to understand the levels of formaldehyde that can be generated in indoor settings from processes which can release formaldehyde such as cooking, use of candles and indoor domestic combustion such as woodburning stoves and ethanol fires.

UK REACH came into force at the end of the EU exit transition period (31^st  December 2020) and regulates the access of chemicals to the market in Great Britain (GB). Under the Northern Ireland Protocol, EU REACH continues to regulate the access of chemicals to the Northern Ireland market.

Please support your contribution with references and reliable data (facts and figures) where possible.

Background note

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. It is present in indoor air, including in domestic settings because it can be off-gassed from articles which 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. Reviews by Salthammer (2019) and Halios et al. (2022) have identified that the following articles, products and processes can release formaldehyde in indoor settings:

• building, construction, and insulation materials, such as:
  • wood based plate materials for ceiling and flooring
  • laminate
  • mineral wool
  • Urea Formaldehyde (UF) or Phenol Formaldehyde (PF) foam insulation
  • UF pressed wood products, like hardwood plywood panelling and fibreboard, including medium density fibreboard (MDF)
• adhesives and sealants
• coating products: paints, lacquers, surface coatings
• polishes and waxes
• wallpapers
• furniture and mattresses
• textiles, such as curtains, 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
• photocopiers (inks and toners)

The World Health Organisation has established an indoor air quality guideline for formaldehyde of 0.1 mg/m³, for 30-min exposure, which is a level of exposure that aims to be protective for the general population. In March 2019, the EU opened a public consultation on a restriction proposal that aims to limit release of formaldehyde into indoor air from products that may contain formaldehyde residues because of the manufacturing process for that product. 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. The opinion of ECHA’s Risk Assessment and Socioeconomic Assessment Committees on this proposal was adopted in September 2020. So far, this restriction proposal has not been formalised into legislation in the EU.

To help us decide if a similar restriction is needed in GB, we want to find out what levels of formaldehyde are occurring indoors in GB homes and in vehicles (including aircraft cabins) which may be used by the general public. We also want to identify which sources of formaldehyde are making the greatest contribution to levels of formaldehyde in indoor air.

If you are unsure if the article you are providing information for falls within scope of this call for evidence, please submit your information anyway.

HSE’s Confidentiality and GDPR statements

HSE tries to make its call for evidence procedure as thorough and open as possible.

Information provided in response to this call for evidence may be subject to publication or disclosure in accordance with the access to information regimes (these are primarily the Freedom of Information Act 2000 (FOIA), the General Data Protection Regulations (GDPR) and the Environmental Information Regulations 2004 (EIR)). Statutory Codes of Practice under the FOIA and EIR also deal with confidentiality obligations, among other things.

If you would like us to treat any of the information you provide as confidential, please make this clear in your response. If we receive a request under FOIA or EIR for the information you have provided, we will take full account of your explanation, but we cannot give an assurance that confidentiality can be maintained in all circumstances.

An automatic confidentiality disclaimer generated by your IT system will be disregarded for these purposes. Requests for confidentiality should be made explicit within the body of the response.

HSE will process all personal data in accordance with the GDPR. This means that personal data will not normally be disclosed to third parties and any such disclosures will only be made in accordance with the Regulations.

How to submit comments

Basic information can be provided in the call for evidence survey below. More detailed information should be provided in document(s) which can be submitted as attachments at the end of each section. We will not automatically publish information submitted in response to a call for evidence. However, it will be helpful if a “public version” of your information can be provided. We ask for this because we will share a draft version of the RMOA with interested stakeholders to allow them to comment on our proposed regulatory approach. By providing us with a non-confidential version of any information you submit, this will help us understand which information we can include in this draft RMOA. If you also want to provide confidential information in your submission, please additionally complete a “confidential version” and submit both versions as attachments. We will take account of both non-confidential and confidential information when deciding which regulatory approach to propose.

When responding to this questionnaire, please answer all question sets that are relevant to you. For example, if you manufacture the substance and also import the substance, please answer questions for both manufacture and import. You do not need to duplicate information if you have provided this under a previous question set. In this case, please indicate where in the questionnaire the information has been given. If you do not have time to complete this questionnaire (or do not find any questions relevant) but are willing to contribute information for the RMOA, please use the comment box under the question “Do you have any other information that you think might help HSE and/or UKHSA with this RMOA?” to indicate what information you are willing to share and tick that you are willing to be contacted by HSE and UKHSA. This can be found in the section headed “Other information” at the end of this call for evidence.

By submitting information as part of this call for evidence, you agree that any data provided (excluding your personal details) can be shared with UKHSA.

The call for evidence lasts for 60 days and closes at 23:59 London time (BST).