UK REACH – Terphenyl, hydrogenated RMOA – Call for evidence

Overview

The UK REACH work programme for 2022/23 states that the Agency for UK REACH will carry out an assessment to decide if it should recommend that terphenyl, hydrogenated is added to Annex 14 (the Authorisation List ) of UK REACH. This assessment will take the form of a Regulatory Management Options Analysis (RMOA). This call for evidence aims to gather information and evidence that will support the preparation of this RMOA.

We are keen to obtain GB specific information about manufacture, import (including importation of mixtures and articles possibly containing the substance) and use of the substance and articles possibly containing the substance; and, also about possible alternatives.

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

Terphenyl, hydrogenated (TH) (CAS No. 61788-32-7, EC No. 262-967-7) was included  in ECHA’s 10^th recommendation of substances to be added to Annex XIV of EU REACH which was submitted to the European Commission in April 2021. In June 2022, ECHA opened a consultation on a proposal to restrict the use of TH as a substance, in mixtures and in articles. The proposed restriction will prohibit placing on the market of the substance on its own or in mixtures or articles at >0.1 % w/w. There are proposed derogations for: use and placing on the market as a heat transfer fluid, provided use is in strictly controlled closed systems with technical containment measures to prevent environmental emissions; and, for the use and placing on the market in plasticiser applications for the production of aircrafts and their spare parts for 5 years after the restriction coming into force.

Based on information submitted during ECHA’s consultation on its draft 10^th recommendation, the manufacturer stated that 96% of total EU volumes are used as a high-temperature non-pressurised heat transfer fluid under the commercial name Therminol 66. This use takes place in closed systems. However, situations may arise in which releases could be possible (e.g., top-up, sampling, transport, cleaning and maintenance or final disposal). The sectors which rely on this substance may include manufacturers of fine chemicals, bulk/large scale chemicals, plastic, metal, textile and food products, electrical equipment, transport equipment as well as the construction and electricity/steam/gas/water supply sectors. Other uses listed in ECHA’s registration database include use as solvent/process medium, formulation and use of adhesives and sealants, paints, coatings, inks, formulation and use of additives in plastics (plasticiser), formulation of construction products. TH is used as a high viscosity plasticiser in polysulfide sealants in the aerospace and defence industry, and in the catalyst component of general purpose epoxy adhesives. It is also used in the formulation of bitumen-based polyurethane for expansion joints in concrete constructions and filling compound for underground high voltage joints up to 550 kV. We do not know how many of these uses are relevant for GB and we are particularly interested in understanding GB aerospace, defence, and construction applications. We are also keen to hear from recycling/waste disposal installations that process TH.

If you are unsure if the substance you are providing information for falls within scope of the substance definition given in the Candidate List, 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).