All you need to know about EFCTC’s Regulatory Management Option Analysis (RMOA)
on eight F-gases falling under the scope of PFAS
EFCTC is conducting a Regulatory Management Options Analysis (RMOA) on a number of F-gases to collect information in the context of the upcoming proposal for a REACH restriction of PFAS.
The aim of this project
The intention is to submit to the outcome of the study to the European Chemicals Agency during the public consultation planned for 2023.
Background
5 countries (Denmark, Germany, Norway, Sweden, and the Netherlands) are preparing a proposal for a broad REACH restriction of a group of substances known as PFAS. According to the latest communication from the authorities of these countries, some F-gases fall under the definition of PFAS that will be used in the context of this REACH restriction proposal. The aim of the RMOA launched by EFCTC is to provide important data to the Socio-Economic Analysis Committee (SEAC) and to the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) in the context of their opinion forming process for this proposed restriction.
EFCTC has already submitted detailed scientific information on known environmental effects of F-gases to the national competent authorities of the five states in the frame of two public consultations (“calls for evidence”) for this file.
However, at this stage of the process, F-gases have not been excluded from the scope of the restriction proposal and more needs to be done in order to demonstrate that F-gases are already successfully managed under the F-gas Regulation Reg (EU) No517/2014) or conclude on the best alternative Regulatory Management Options.
What is an RMOA?
A Regulatory Management Options Analysis (RMOA) is an assessment (case-by-case analysis) of regulatory needs concerning one or more substances. The purpose of an RMOA is to help authorities decide whether further regulatory risk management activities are required for a substance and to identify the most appropriate instrument to address a concern. An RMOA can conclude that regulatory risk management at EU level is required for a substance (e.g. harmonized classification and labelling, restriction, other EU legislation) or that no regulatory action is required at EU level.
EFCTC’s RMOA
EFCTC has decided to work with Ricardo Energy & Environment to conduct an RMOA on a selection of eight F-gases in scope of the PFAS restriction proposal. The RMOA shall ensure that the ECHA receives a full set of information on these substances covering:
- Hazard profiles, performance, risk considerations to human health and the environment
- Analysis of alternatives for each F-gas/blend in scope and for each of their uses
- A socio-economic analysis (SEA) for each F-gas in scope and for each of their uses
Scope & Goal
The focus of the RMOA will be on a selection of eight F-gases, whose specific uses/ applications shall be looked at:
The goal is to conclude on the most appropriate regulatory risk management measure for each of the F-gases in scope and to submit the assessment to the ECHA public consultation on the PFAS file expected to be launched on 22 March 2023 and to run for 6 months.
EFCTC webinar on F-gas RMOA for PFAS
A webinar explaining the project and how to fill in the questionnaire was held on 3 November 2022. You can find the recording below.
FAQs
Frequently Asked Questions on the EFCTC Regulatory Management Options Analysis project on a number of F-gases in the context of the upcoming proposal for a REACH restriction of PFAS
Why is EFCTC doing this study?
5 countries (Denmark, Germany, Norway, Sweden, and the Netherlands) are preparing the proposal for a broad REACH restriction on the group of substances known as PFAS. According to the latest communication from the authorities of these countries, some F-gases fall under the definition of PFAS that will be used in the context of the REACH restriction proposal. The aim of the EFCTC RMOA study is to provide important data to the Socio-Economic Analysis Committee (SEAC) and to the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) in the context of their opinion forming process for this proposed restriction.
EFCTC has already submitted detailed scientific information on known environmental effects of F-gases to the national competent authorities of the five states in the frame of two public consultations (“calls for evidence”) for this file.
However, at this stage of the process, F-gases have not been excluded from the scope of the restriction proposal and more needs to be done in order to demonstrate that F-gases are already successfully managed under the F-gas Regulation Reg (EU) No517/2014) or conclude on the best alternative Regulatory Management Options.
Are you trying to stop/prevent the restriction?
Not at all. The REACH restriction process requires a number of datasets to be generated and considered. EFCTC is conducting this study in order to provide to the authorities as much information as possible to demonstrate that F-gases are already successfully managed under the F-gas Regulation.
What are you intending to do with the study? How does the study fit into the REACH restriction process?
EFCTC will submit the full study to the ECHA public consultation on this restriction dossier that will be launched in early 2023, approximately one month after the publication of the proposal expected for 13 January 2023. The aim is to provide important data to the Socio-Economic Analysis Committee (SEAC) and to the Risk Assessment Committee (RAC) in the context of their opinion forming process for this proposed restriction to demonstrate that F-gases are already successfully managed under the F-gas Regulation or share the best alternative Risk Management Option.
What are the focus and scope of the study?
The study aims at giving a complete picture of each of the F-gases in scope with detailed information of:
– Hazard profiles, performance, risk considerations to human health and the environment, and socioeconomic assessment of each F-gas and their blends and for each of their uses2
– Analysis of alternatives for each F-gas/blend in scope in each of their uses, in existing equipment as well as for new installations, especially in RACHP applications.
– A socioeconomic assessment for each F-gas in scope in each of their uses
– The goal is to conclude on the most appropriate risk management measure for each of the F-gases in scope.
The geographical scope of the assessment will focus solely on the European Economic Area (EEA).
The substances assessed in the study are the following:
• HFC-134a, -125, -143a, -227ea
• HFO-1234yf, -1234ze, -1336mzz(Z)
• HCFO-1233zd
• And their blends
What are the downside of not participating to the study?
According to the intelligence collected so far, it would appear that the dossier submitters have not conducted a Risk Management Options Analysis at single F-gas level; therefore, this EFCTC study will probably be the only possibility to collect and provide this detailed information into the restriction process. Your participation to the stakeholder survey expected to be launched on 14 November will allow the collection of sufficient data to ensure a complete and statistically sound outcome. Not submitting a study, for example, the EFCTC study, during the ECHA consultation process due to lack of data could result in a complete ban of F-gases, without the possibility of derogations. The EFCTC study will enable ECHA to build a comprehensive database of information to determine the actions that should be taken.
Unlike the EFCTC socioeconomic assessment, this study will provide detailed application-specific information that could be used by other associations to strengthen their advocacy efforts.
What would be the expected demand on downstream users/associations?
Our consultant has prepared tailored questionnaires to collect important data from associations/companies. Overall, you will be asked to answer between 20 and 70 questions (depending on whether you have already responded to the SEA survey launched on 4 April), and more information has been given during a webinar on 3 November (recording available on EFCTC website). The survey will be launched on 14 November and will run for 8 weeks until 9 January 2023.
Information provided in the context of the survey are covered by Non-Disclosure Agreements (NDAs) signed between the respondent and our consultant; EFCTC and Cefic will have no access to confidential information.
If you are not able to provide a response to all the questions, we appreciate partial submissions as well.
You can contact directly the consultant team and/or the EFCTC Secretariat, should you have any questions.
What is the timeline of this project and how does it fit into the REACH restriction timeline?
The proposal for the restriction was submitted on 13th of January 2023 to the European Chemicals Agency (ECHA) and pre-published on 7th of February 2023. On the 22nd of March 2023, ECHA launched a 6-month public consultation to collect input from any interested parties, may they be authorities, NGOs, industry representatives or private individuals. In this context, we encourage anybody who might have relevant information on PFAS to share them within the consultation.
The RMOA project has been launched in September 2022 and the final outcome is expected by the end of July 2023, perfectly on time to be submitted to the ECHA public consultation. To collect more information, a stakeholder survey will be held between 14 November and 9 January 2023; any interested parties are welcome to participate by requesting the questionnaire using this link.