RMOA for bisphenols including the use of bisphenols in thermal paper and other uses

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 the use of bisphenols in thermal papers.

Since 2 January 2020, a restriction has been in place which prevents the supply of thermal papers containing bisphenol A (BPA) in a concentration equal to or greater than 0.02 % by weight. Evidence gathered by the EU suggests that BPA may have been substituted by other bisphenols with similar hazard profiles. The Agency wishes to understand which substances are being used as replacements for BPA. This call for evidence aims to gather information and evidence that will support HSE and the Environment Agency with the preparation of this RMOA.

The Agency is also interested to gather information on other uses for bisphenols and bisphenol derivatives in GB. In December 2021, ECHA published its Assessment of Regulatory Needs (ARN) for a group of 148 bisphenols and bisphenol derivatives. Germany has submitted a restriction proposal which will target uses of BPA and other bisphenols with endocrine-disrupting properties for the environment. The Agency needs to understand how the substances which are covered in ECHA’s ARN are used and disposed of in GB to help it assess the need for wider restrictions (or other regulatory actions) on the use of bisphenols in GB.

We are interested in all aspects of the manufacture, import, hazard profile, use and exposure throughout the life cycle including use in articles and occurrence in polymers, environmental fate, waste and its disposal requirements, recycling opportunities for these substances and products that contain these substances, and any legislation and standards that apply, including product specific legislation and standards.

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 GB market. 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

Bisphenols and bisphenol derivatives is a large family of substances with similar chemical structures based on two linked phenol rings. This group of substances has been under the regulatory spotlight for many years owing to concerns about their hazardous properties for human health and the environment. The main human health hazards are their potential endocrine disrupting properties, reproductive toxicity and skin sensitisation. Many bisphenols are also of concern due to possible endocrine disrupting properties for the environment and PBT/vPvB properties (based on REACH Annex XIII screening criteria).

Bisphenols have a variety of uses. They are used to manufacture polycarbonate plastics and epoxy resins both of which are used in a wide range of consumer goods including food contact materials. Bisphenols are also used in thermal papers, inks and textiles.

In GB, bisphenol A is identified as a SVHC due to its endocrine disrupting properties for humans and the environment and 2,2-bis(4’-hydroxypehnyl)-4-methylpentane is identified as a SVHC due to its reproductive toxicity.

Within the EU, three bisphenols (BPA, bisphenol B (BPB) and 2,2-bis(4'-hydroxyphenyl)-4-methylpentane) have been identified as SVHCs.

In December 2021, ECHA published its Assessment of Regulatory Needs (ARN) for a group of 148 bisphenols and bisphenol derivatives. In this document the substances were grouped according to specific bisphenol types, defined by the nature of the bridge between the two phenol rings. These groups are:

• BPA and BPA derivatives
• BPS and BPS derivatives
• BPF and BPF derivatives
• BPAF and BPAF derivatives
• Miscellaneous bisphenols: Heterogeneous subgroup with bisphenols and bisphenol derivatives addressed as one subgroup for practical reasons
• Other aliphatic or aryl bridged bisphenol derivatives: Heterogeneous subgroup addressed as one subgroup for practical reasons

In addition to the REACH restriction on the use of BPA in thermal paper, Germany has submitted a proposal to restrict uses of BPA and other bisphenols with endocrine-disrupting properties for the environment. The restriction aims to limit release to the environment. Bisphenols in scope of this restriction will not be permitted to be present in articles or mixtures at a concentration of 0.02% by weight or more and there will also be limits on the rate of release for BPA from articles during their service life.

Classification and labelling work is also in progress in the EU for BPA, bisphenol S (BPS) and bisphenol AF (BPAF).

Given the range of activities being pursued in the EU, the Agency is interested to understand which of the substances covered by ECHA’s ARN document are manufactured and/or used in GB to help it consider how these substances should be regulated in GB.

If you are unsure if the substance or 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 the Environment Agency with this RMOA?” to indicate what information you are willing to share and tick that you are willing to be contacted by HSE and EA. 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 the Environment Agency.

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