Document 5kyj9Jkeonj70GbV07VX20Zzz

Chemours Thermal & Specialized Solutions (TSS) contribution to the universal PFAS restriction ECHA Public Consultation 21 September 2023 Attachment 1 1 Table of Contents Abbreviations and Acronyms List........................................................................................................3 Executive Summary............................................................................................................................6 Introduction ....................................................................................................................................23 CHAPTER 1 - There is no risk to be addressed at EU-level: F-gases and trifluoroacetic acid (TFA) are substances that have been proven safe for their intended use ..........................................................29 Section 1.1 - Substance classification, persistence assessment and risk assessment approach ........... 31 Section 1.2 - Human Health and Environmental Hazard Assessment ................................................... 37 Section 1.3 - Environmental fate............................................................................................................ 50 Section 1.4 - Environmental risk assessment......................................................................................... 54 Section 1.5 - Current (and future) regulatory framework to minimize F-gas emissions ....................... 61 Section 1.5.1 - Description of the current (and future) regulatory framework ................................. 62 Section 1.5.2 - Assessment of appropriateness of the existing regulatory framework for F-gases .. 70 Section 1.5.3 - Conclusions................................................................................................................. 81 CHAPTER 2 - Risks can be more appropriately addressed by means of an alternative Restriction Option (additional risk management measures) ...........................................................................................83 Section 2.1 - Description of alternative risk management measures and assessment of appropriateness ...................................................................................................................................... 83 Section 2.2 - Socio Economic Impact of the alternative risk management measures ........................... 89 CHAPTER 3 - The proposed restriction (RO2) is disproportionate ......................................................91 Section 3.1 - Impurity level and effect on value chain........................................................................... 91 Section 3.2 - Hazard assessment of non-fluorinated alternatives ......................................................... 96 Section 3.3 - Use and limitations of alternatives ................................................................................. 105 Section 3.4 - The setting and updating of codes and standards limiting the charge size of flammable refrigerants ........................................................................................................................................... 108 Section 3.5 - Socio Economic Impact of the proposed restriction option on the F-gas sector ............ 114 Section 3.6: Request for derogations based on disproportionate Cost................................................ 118 Conclusions ................................................................................................................................... 121 Reference List ................................................................................................................................ 127 Chapter 1............................................................................................................................................... 127 Chapter 2............................................................................................................................................... 131 Chapter 3............................................................................................................................................... 132 2 Abbreviations and Acronyms List Abbreviation/Acronym (Alphabetical) AC ADI AHRI AR4 AR6 ASHRAE ATEL APM ATSDR BAF BCF BRL BTU CDEA CDR CFC CLP CMR CO2 CRO CSR CTD CXL DMEL DNEL EC EC50 EEA EEAP EFCTC EFSA EFSA ELV EN EPA EPEE EPR EV F-gas GC-MS GLP GWP Full Term Air Conditioning Acceptable Daily Intake Air-Conditioning, Heating And Refrigeration Institute Intergovernamental Panel on Climate Change Fourth Assessment Report Intergovernamental Panel on Climate Change Sixth Assessment Report American Society of Heating, Refrigerating and Air-Conditioning Engineers Acutely Toxic Exposure Limit Advanced Performance Materials Agency for Toxic Substances and Disease Registry Bioaccumulation Factor Bioconcentration Factor KOMO Assessment Guideline (Netherlands) British Thermal Unit Central Database of Emissions to Air Central Database of Reports Chlorofluorocarbon Classification, Labelling and Packaging Regulation Carcinogenic, Mutagenic, Reprotoxic Carbon Dioxide Central Register of Operators Chemical Safety Report Characteristic Travel Distance Codex Maximum Residue Limit Derived Minimal Effect Level Derived No-Effect Level European Commission Half Maximal Effective Concentration European Environmental Agency Environmental Effects Assessment Panel European FluoroCarbon Technical Committee European Food Safety Agency European Food Safety Authority End of Life Vehicles European Norm Environmental Protection Agency European Partnership for Energy and the Environment Extended Producer Responsibility Electric Vehicle Fluorinated Gas Gas Chromatography coupled with Mass Spectroscopy Good Laboratory Practice Global Warming Potential 3 HAZOP HC HCFC HCFO HCI HF HFC HFO HTHP HVACR IEC IPCC IR ISO KMO Kow Lact LC50 LFL LOQ LRTP LVD MAC MDI MRL MS NBOD NMVOC NOAEC NOAEL NOEC NOx ODL ODS OECD OEM OFS OLPCU ORC OSH PBT, vPvB PAN PED PFAS PFCA PFDA Hazard and Operability analysis Hydrocarbon Hydrochlorofluorocarbons Hydrochlorofluoro-olefin Hydrochloric Acid Hydrofluoric Acid Hydrofluorocarbon Hydrofluoroolefin High Temperature Heat Pumps Heating, Ventilation, Air Conditioning and Refrigeration International Electrotechnical Commission Intergovernmental Panel on Climate Change Infrared International Organization for Standardization Klebranchens Miljordning (National Danish register of F-gas companies) Octanol-Water Partition Coefficient Effects on or via lactation Lethal Concentration (50% population) Lower Flammability Limit Level of Quantification Long-Range Transport Potential Low Voltage Directive Mobile Air Conditioning Metered Dose Inhaler Maximum Residue Limit Member State Nitrogenous Biological Oxygen Demand Non-Methane Volatile Organic Compound No-Observed-Adverse-Effect Concentration No-Observed-Adverse-Effect Level No Observed Effect Concentration Nitrogen Oxides Oxygen Depravation Limits Ozone-Depleting Substances Organization for Economic Cooperation and Development Original Equipment Manufacturer Other Fluorinated Substances Ozone Layer and Climate Protection Organic Rankine Cycle Occupational Safety and Health Persistent, Bioaccumulative, Toxic / very Persistent, very Bioaccumulative Peroxyacetyl nitrate Pressure Equipment Directive Per- and polyfluoroalkyl substances Perfluoroalkylcarboxylic acid Perfluoro-decanoic Acid 4 PFECA PFHxA PFHxS PFNA PFOA PFOS PFPrA PFSA pKa PM PNEC POP POCP ppb ppm PPN PTFE RACHP RCR REACH RMM RMOA RO SAP SDS SOx SSA STOT-RE STOT-SE SVHC SWV Tc TFA TLV TSS UBA UNEP UN-GHS UTC VDKF WEEE WEEL WFD WMO Perfluoroalkyl Ether Carboxylic Acids Perfluorohexanoic acid Perfluorohexane sulfonate Perfluoro-nonanoic acid Perfluorooctanoic acid Perfluorooctane sulfonate Perfluoropropionic Acid Perfluorosulfonic acid Negative Log of the acid dissociation constant (Ka) Particulate Matter Predicted No-Effect Concentration Persistent Organic Pollutant Photochemical Ozone Creation Potential Parts Per Billion Parts Per Million Peroxypropionyl nitrate Polytetrafluoroethylene Refrigeration, Air Conditioning and Heat Pump Risk Characterization Ratio Registration, Evaluation, Authorisation and Restriction of Chemicals Risk Management Measure Risk Management Option Analysis Restriction Option Scientific Advisory Panel Safety Data Sheet Sulfur Oxides Sea Spray Aerosols Specific Target Organ Toxicity - Repeated Exposure Specific Target Organ Toxicity - Single Exposure Substance of Very High Concern Stratospheric Water Vapor Critical Temperature Trifluoroacetic Acid Threshold Limit Value Thermal & Specialized Solutions Umweltbundesamt (Germany Environment Agency) United Nations Environmental Programme United Nations Globally Harmonized System Unintended Trace Contaminant Verband Deutscher Klte-Klima-Fachbetriebe Waste Electrical and Electronic Equipment Workplace Environmental Exposure Limit Waste Framework Directive World Meteorological Organization 5 Executive Summary Introduction The Chemours Company welcomes the opportunity to provide feedback to the ECHA public consultation on the restriction of per and polyfluoroalkyl substances (PFASs) submitted by Germany, Denmark, The Netherlands, Sweden and Norway (hereafter referred to as the Dossier Submitters). PFAS are a large class of substances that have diverse and unique chemical properties. Given the wide range of relevant applications, it is not possible for Chemours to respond meaningfully to the consultation on a generic level. Rather, each of Chemours' business units that specialize in PFASs, Advanced Performance Materials (APM - specializing in fluoropolymers) and Thermal & Specialized Solutions (TSS - specializing in F-gases), has made separate submissions to the public consultation. Whilst TSS and APM have submitted separate comments, the business units share a common objective to demonstrate that a more tailored (differentiated) approach to the scope and conditions of a restriction, recognizing the different properties and conditions of use of different PFASs, could ensure the safe use of PFASs without imposing disproportionate costs or compromising the EU's policy and strategic objectives. This submission is made on behalf of the Thermal and Specialized Solutions (TSS) segment of The Chemours Company FC, LLC. Therefore, the submission and information here provided focuses on this portion of Chemours' portfolio within the scope of the PFAS Restriction Dossier. F-gases are critical to society's daily life, providing solutions that enable both the green and digital transition as outlined in the EU Green New Deal and UN Sustainable Development Goals by enabling technologies such as mobile air conditioning for electric vehicles, high-performance building insulation, immersion cooling and more climate friendly refrigerants in HVACR (Heating, Ventilation, Air Conditioning and Refrigeration) applications such as heat pumps, thanks to their ability to be specifically designed to meet the performance requirements of their applications. Alternatives to PFASs cannot currently be implemented safely or achieve minimum levels of required performance in some of the applications in which it is proposed that F-gases should be banned. Equally, where alternatives can be implemented, they can result in regrettable substitution because of, for instance, safety concerns (e.g., flammability or toxicity) or global warming potential (e.g., as elaborated for propane in section 3.2 of this document). In addition, the technical performance of alternatives will lead to very large societal costs associated with their greater energy demands and associated CO2 emissions. The currently proposed concentration limit will also result in the disruption of global supply chains for F-gases not fulfilling the PFAS definition in use in this restriction proposal. As a result, Chemours believes that the proposed restriction of PFASs, as currently formulated, will have a disproportionate negative impact on EU society. In this submission, TSS presents evidence and analysis which demonstrate that F-gases can continue to be used safely and that an alternative restriction that focuses on risk management of F-gases via emission reduction and mandatory circularity would be more proportionate than the proposed ban (despite the proposed derogations). This would ensure that the EU remains able to realize its policy ambitions whilst maintaining its competitiveness and strategic autonomy. 6 F-gases and their degradation products are safe and are already appropriately regulated in the EU The definition of PFASs used for the proposed restriction covers a wide variety of substances that have very different physico-chemical properties, environmental fate, hazard and risk profile, including hydrofluorocarbon (HFC) and hydrofluorolefin (HFO) used by TSS (termed TSS substances and reported in Table I) and trifluoracetic acid (TFA), which is an atmospheric degradation product of some F-gases. Fgases are characterized by their low molecular weight, relatively high vapor pressure and limited water solubility. They are typically gaseous at ambient temperature. Table I - Description of TSS substances. Common substance name EC number CAS number Structure PFAS* degradation product** Applications*** HFO-1234yf 468-710-7 754-12-1 CF3CF=CH2 TFA 100% estimated HVACR, MAC HFO-1336mzzE 811-213-0 66711-86-2 E - CF3CH=CHCF3 TFA 4% estimated FOAM, HTHP, ORC HFO-1336mzzZ 700-651-7 692-49-9 Z - CF3CH=CHCF3 TFA 4% estimated FOAM, SOLVENT, HTHP HFC-134a 212-377-0 811-97-2 CF3CH2F TFA 7-20% estimated HVACR, MAC, PROPELLANT, MDI HFC-125 206-557-8 354-33-6 CF3CF2H TFA 1-10% estimated HVACR HFC-143a 206-996-5 420-46-2 CF3CH3 TFA 2% estimated HVACR HFC-152a 200-866-1 75-37-6 CH3CF2H The substance is not a PFAS and it does not degrade to a PFAS HVACR, FOAM, PROPELLANT HFC-227ea 207-079-2 431-89-0 CF3CHFCF3 TFA 100% estimated FIRE SUPPRESSANT, MDI TFA, CF3CF2COOH, HFC-4310mee 420-640-8 138495-42-8 CF3CHFCHFCF2CF3 CF3CHFCOOH, SOLVENT CF3CF2CHFCOOH Notes: HFC refers to "Hydrofluorocarbon" and HFO refers to "Hydrofluoroolefin"; *Degradation products that do not meet the PFAS definition in use in this restriction proposal are not reported; **Degradation refers to degradation in the troposphere. Percentages are expressed in terms of molar yield; ***HVACR: Heating, Ventilation, Air Conditioning and Refrigeration; MAC: Mobile Air Conditioning; HTHP: High Temperature Heat Pumps; ORC: Organic Rankine Cycle; MDI: Metered Dose Inhaler. According to the REACH regulation (Article 68), restrictions can only be implemented if there is an EU wide unacceptable risk from the manufacture or use of a substance. The `case-by-case' risk assessment reported by the Dossier Submitters (according to REACH Annex I section 0.10), upon which the justification for the restriction relies, is not a conventional risk assessment approach but rather `reads-across' the hazard properties of the entire PFAS class from the hazard and environmental fate properties of a small number of long-chain PFASs (hereafter termed `model PFASs') that have been demonstrated to be of concern but are structurally and toxicologically unrelated to F-gases and TFA. The Dossier Submitters conclude based on this case-by-case assessment that quantitative risk assessment (i.e. based on safe thresholds and exposure assessment) is not appropriate for any PFAS and that all PFASs should (i) be considered as non-threshold substances for the purposes of risk assessment and (ii) that any PFAS release to the environment should be minimized (to minimize the likelihood of adverse effects). The Dossier Submitters then conclude that the only appropriate regulatory approach to minimize emissions is to propose a ban on the manufacture, placing on the market and use of all PFASs, although some specific uses of PFASs are proposed to be allowed to continue for a limited period until substitution with alternatives is implemented (referred to as `time-limited derogations'). Some of the time-limited derogations proposed are relevant to TSS substances, although these derogations are neither 7 comprehensive nor sufficient to avoid disproportionate socio-economic impacts (derogations are discussed further below). In terms of risk assessment, the Dossier Submitters justify the use of a case-by-case approach, rather than quantitative risk assessment, by referring to a list of `PFAS properties of concern' and `property-related concerns resulting from combinations of these properties'. Persistence is identified as a common property of all PFASs. However, the Dossier Submitters' rationale is that it is the combination of persistence with these listed `supporting concerns' that justifies a conclusion that conventional quantitative risk characterization is not practicable or reliable. However, the properties of F-gases and TFA are demonstrably not consistent with the model PFASs used to develop the case-by-case approach, as well as the identified properties of concern (Table II) or the identified property-related concerns resulting from combinations of properties (Table III), as summarized below. These observations invalidate the conclusions of the Dossier Submitters case-by-case risk assessment with respect to F-gases and TFA; these substances have been demonstrated to be outside of the `applicability domain' of the Dossier Submitters' case-by-case risk assessment. Therefore, despite the persistence of TFA, there is no reliable scientific rationale for why classical quantitative risk assessment cannot be used reliably to demonstrate the safe use of F-gases and TFA, as has been done in relevant REACH registration dossiers and other international assessments (UNEP Environmental Effects Assessment Panel, 2022). Chemours considers that TSS substances should be treated as threshold substances for risk assessment as DNELs and PNECs can be reliably derived and used as the basis for robust, protective, quantitative risk assessment. Table II - PFAS properties of concern are demonstrably not applicable to F-gases and TFA. Annex XIII of the REACH regulation does not establish persistence for the atmospheric compartment. F-gases, which partition exclusively to this compartment until they degrade, cannot, as such, be considered to meet the definition of a persistent substance under REACH. On the contrary, some F- gases, particularly HFOs, have relatively short atmospheric lifetimes e.g., HFO- 1234yf has an atmospheric lifetime of 0.033 years (approximately 12 days). Regarding the atmospheric degradation products of F-gases, it is known that TFA, the atmospheric degradation product of some F-gases, is very persistent Very high in water. However, TFA does not meet the Annex XIII criteria for persistence bioaccumulation and has low ecotoxicity; thus, is not a PBT or vPvB substance and is unlikely to cause adverse effects in the environment. The TFA `yield' of some F-gases can be considered to be a `minor degradation product' (i.e. <10% by molar mass) and it cannot be assumed that all F-gases would degrade to a persistent degradation product, such as TFA. In addition, according to international scientific consensus, whilst TFA has been detected in the environment, accumulation of TFA in the environment over time is not considered to pose a risk to either human health or the environment (UNEP Environmental Effects Assessment Panel Report, 2022).1 1 UNEP EEAP (2023) Environmental effects of stratospheric ozone depletion, UV radiation, and interactions with climate change: 2022 assessment report, | Ozone Secretariat. Available at: https://ozone.unep.org/environmentaleffects-stratospheric-ozone-depletion-uv-radiation-and-interactions-climate-change. 8  This (non-REACH) property describes the tendency of a substance to be transported through one or several environmental compartments over long Long-range transport potential (LRTP) distances and is typically associated with the identification of persistent organic pollutants (POPs) under the Stockholm Convention. It is expressed in terms of a characteristic travel distance (CTD). This property does not constitute a relevant concern for F-gases or TFA, even if fulfilled, because these substances are not associated with other relevant hazard properties, such as PBT/vPvB or classified for any human health endpoint. Mobility (in water) describes the tendency of a substance, based on its physicochemical properties, to remain in the water compartment rather than partitioning to soil or sediment. It is only relevant to TFA (the atmospheric Mobility degradation product of some F-gases). Similarly, to LRTP (above), mobility does not constitute a relevant concern for TFA, even if fulfilled, because TFA is not associated with any other relevant hazard properties, such as PBT/vPvB or classified for any human health endpoint. Accumulation in F-gases do not accumulate in plants. Regarding TFA, EFSA have concluded that plants TFA exposure via the diet will not result in human health risks (see below). Bioaccumulation F-gases and TFA do not fulfil the REACH Annex XIII criteria for bioaccumulation. There is no evidence from available ecotoxicity testing that F-gases pose a risk to the environment, despite some substances having a self-classification for Effects on the aquatic chronic toxicity. F-gases and TFA are not PBT/vPvB substances. The environment available ecotoxicological data for TFA, which is a naturally occurring (ecotoxicity) substance, do not support an environmental classification for acute or chronic aquatic toxicity. In addition, estimated concentrations of TFA in rainfall in 2050 are significantly below NOEC and PNEC values. Endocrine activity There is no evidence that TSS substances and their potential degradation products would be classified as endocrine disrupting substances. TSS substances and TFA have not been associated with any adverse effects on human health. Robust dataset support `no classification' for any human health endpoint. This document summarizes the extensive and robust toxicity datasets that are available for TSS substances and TFA and demonstrates that these substances have a very low hazard potential. Equally, the European Food Safety Authority (EFSA) recently undertook a quantitative risk Effects on human health assessment of TFA exposure in diet resulting from the use of a plant protection product that degraded to form TFA. The exposure assessment also considered combined exposure to TFA in food and drinking water from other sources, including the degradation of HFCs and HFOs as well as industrial uses. The study concluded that exposure to TFA would not result in consumer exposure exceeding toxicological reference values and would be unlikely to pose a human health concern.2 In addition, estimated concentrations of TFA in rainfall in 2050 are significantly below relevant toxicological reference values such as the UBA target and health guideline values for drinking water. 2 EFSA (2014). "Reasoned opinion on the setting of MRLS for Saflufenacil in various crops, considering the risk related to the metabolite trifluoroacetic acid (TFA)" EFSA Journal, 12(2). https://doi.org/10.2903/j.efsa.2014.3585. 9 Table III - PFAS property-related concerns resulting from combinations of properties are not applicable to F-gases and TFA. These concerns do not apply to F-gases and TFA because of (i) the existing High potential for regulatory framework for F-gases that is aimed at minimizing emissions of ubiquitous, increasing HFCs through both a quota phasedown and emission minimization measures, and irreversible (ii) the short atmospheric lifetime of HFOs (and the future extension of the exposure of the emission minimization measures to HFOs) and (iii) the de minimis risk posed environment and by TFA to human health and the environment currently and in the future, as humans demonstrated by the UNEP Environmental Effects Assessment Panel, 2022 Report.1 F-gases and TFA also do not bioaccumulate. Difficulty to decontaminate intake water for drinking These concerns are not applicable to F-gases as they reside in the atmospheric water production, low compartment until they degrade. TFA does not pose a risk to the environment effectiveness of end- or human health, as demonstrated by EFSA and UNEP Environmental Effects of-pipe RMMs and Assessment Panel, 2022 Report.1 difficulty to treat contaminated sites Uncertainty about Exposure models for F-gases and TFA are sufficiently well developed and estimation of future reliable as a result of their use under existing EU and International regulation. exposure levels and As demonstrated by the UNEP Environmental Effects Assessment Panel, 2022 safe concentration Report1, the risks posed by TFA to human health and the environment limits currently and in the future are de minimis. Global warming potential (GWP) is a property that belongs to all substances entering the troposphere. HFCs are characterized by longer atmospheric lifetimes, thus they have a higher GWP when compared to HFOs, for which Global warming the GWP is very low (ultra-low GWP). However, the existing regulatory potential framework for F-gases aims at reducing emissions of HFCs through both a quota phasedown and emission minimization measures, thus we believe that this concern is properly addressed by the existing legislation, without the need of a restriction. The Dossier Submitters conclude that the existing legislative framework for F-gases (e.g., the F-gas regulation and the MAC Directive) is not appropriate to minimize releases of F-gases. The conclusion appears to be based on two arguments: that the F-gas Regulation "does not per se restrict the use of the substances but rather aims for a reduction of their use" and that the current F-gas Regulation does not regulate all fluorinated gases fulfilling the PFAS definition referred to by the Dossier Submitters. Rather, they argue that a REACH restriction is required because that would limit as many uses as practically possible and thereby minimize F-gas emissions (and hence exposures), cover current and future F-gases, and prevent regrettable substitution. Chemours considers that the conclusion that existing legislation is insufficient is unfounded. According to the rationale followed by the Dossier Submitters, the aim of the proposed restriction is emission minimization. Whilst not explicitly acknowledged by the Dossier Submitters, it is important to note that this is also the objective of the existing regulatory framework for F-gases in the EU, as stated in 10 Article 1 of Regulation 517/2014 ("F-gas Regulation").3 Consequently, we demonstrate that the current (and the revised) legislation on F-gases already represents an appropriate and effective means to minimize emissions of F-gases to the environment (based on the REACH Annex XV criteria of effectiveness, practicality and monitorability). More specifically, we highlight that releases of F-gases are already minimized by the existing operational conditions and risk management measures (RMMs) that are required under the existing regulatory framework that comprises both REACH (in terms of data requirements for registration, substance evaluation and safe use) and the F-gas Regulation (and its upcoming reviewed version) as the main pillars, which are complemented by the provisions of the Mobile Air Conditioning (MAC) Directive, the End of Life Vehicles (ELV) Directive (and the upcoming ELV Regulation), the Waste Electrical and Electronic Equipment (WEEE) Directive and the Waste Framework Directive (WFD). As a consequence, we conclude that the proposed restriction of F-gases is disproportionate considering that existing legislation regulating F-gases (that will be further strengthened in the near future) already effectively minimizes releases across all substance lifecycle stages. The F-gas regulation already establishes a phasedown schedule for HFCs, as well as stringent provisions to minimize leakages throughout the lifecycle of the F-gases. It should be noted that the F-gas Regulation currently in force sets requirements for leak minimization, training and certification of technicians, and phasedown only for HFCs, whilst the Commission Proposal to revise the F-gas Regulation ("Commission Proposal") extends the containment, training and certification, and recovery requirements to HFOs and HCFOs. Thus, the substance scope of the F-gas regulation in the future will address all relevant F-gases, negating a key concern of the Dossier Submitters in relation to existing legislation. Uniquely, as mentioned in the Annex XV report, F-gases are the only substances within the scope of the proposed restriction that already have a legal obligation/incentive to be recovered at the end of their service life and then either recycled, reclaimed, or destroyed4 (as per Article 8 of the F-gas Regulation). Chemours considers that because the Annex XV report does not objectively identify and assess a complete range of potential restriction or regulatory management options (it only assesses the appropriateness of a ban), it has not been clearly demonstrated that the proposed restriction is the most appropriate means to regulate the potential risks of PFASs.Specifically, the Annex XV report should include a comprehensive comparative regulatory management option analysis based on the criteria given in Annex XV of REACH of effectiveness, practicality and monitorability. 3 The objective of this Regulation (Regulation 517/2014 on fluorinated gases) is to protect the environment by reducing emissions of fluorinated greenhouse gases. Accordingly, this Regulation: (a) establishes rules on containment, use, recovery and destruction of fluorinated greenhouse gases, and on related ancillary measures; (b) imposes conditions on the placing on the market of specific products and equipment that contain, or whose functioning relies upon, fluorinated greenhouse gases; (c) imposes conditions on specific uses of fluorinated greenhouse gases; and (d) establishes quantitative limits for the placing on the market of hydrofluorocarbons. 4 See Annex XV Report page 42 11 F-gases are used in a wide range of applications for their unique characteristics, and all alternatives have fundamental problems which limit their applicability and cannot simply be engineered away F-gases are used in a great many products and systems used in a wide range of sectors, because they are highly effective, energy-efficient and safe in use. They are preferred over often-cheaper, non-fluorinated alternatives, which all have their own problematic properties which limit their application: hydrocarbons pose a risk of flammability, particularly when used in large quantities and in confined spaces; CO2 is hazardous to human health, operates at high pressures and is less efficient at high ambient temperatures; and ammonia is highly toxic. A summary of some of the key sectors where F-gases are used is given below. F-gases are used in Mobile Air Conditioning (MAC) and heat pumps (HP) to provide driver cabin comfort (air conditioning (AC) & HP AC mode) and operator safety (air ventilation) in all types of vehicles or motorized equipment, including systems using both internal combustion engine and/or electric compressors. In electric vehicles and equipment F-gases have a critical dual purpose of 1) maintaining battery temperature preventing potential thermal runaway and 2) providing cabin thermal comfort. MAC systems using F-gases are extremely high-performing, versatile, durable and reliable, whereas alternatives all have critical problems that despite significant research have not been overcome. Propane and HFC-152a's flammability level, which would require a secondary loop MAC system resulting in poor performance and potential safety implications would make HFC-152a and propane unsuitable for use in mobile systems. CO2-based systems operate at extremely high-pressure (up to 10 times higher than F-gases) and do not perform well at higher ambient temperatures. CO2 systems are also less robust and vulnerable to leaks from road vibrations/shocks which can result in CO2 cabin-leakage above health-based limits. Due to their limited reliability, poor performance during idling, impact on electric battery lifetime, CO2 systems are also particularly unsuitable for electric vehicles. These are problems related to the fundamental properties of the alternative substances which cannot be overcome through engineering design, especially within the limited confines of a vehicle. Meanwhile, Fgases can be used safely in all transport modes and all conditions, while also maintaining high rates of recovery and hence low environmental emissions. Further emission reductions could still be achieved cost-effectively through the mandating of simple best practice measures into MAC system management such as reclaim at end of life, refrigerant leak tests during road worthiness test and added technician certification. These conditions could be included in the proposed REACH restriction or form part of an extension to some other relevant legislation such as the MAC Directive or End-of-Life Vehicles (ELV) Directive. The use of F-gases in stationary Heating, Ventilation, Air Condition and Refrigeration (HVACR) covers a wide range of applications such as commercial and industrial refrigeration, air conditioning and heat pumps, (both for residential and industrial applications), and includes thermal management and heat transfer applications such as high temperature heat pumps. These applications involve a multitude of equipment designs, components and technical requirements. Non-fluorinated alternatives have started to be introduced where their performance limitations (namely flammability, toxicity and thermodynamic constraints) allow. In many applications, non-fluorinated gases cannot be used for safety reasons (e.g., risk of explosion or toxic leaks) or because their operational envelop does not match the requirements (e.g. ambient temperature range, size of equipment or maintenance). It is possible that, unlike MAC, engineering design could address some of these issues, but industry needs adequate time to develop alternatives that can meet the same performance criteria over the broad range of applications and climatic conditions that exist in the European Union. In the meantime - or, indeed, instead of this - stationary HVACR emissions could be reduced cost-effectively (and much more cost-effectively than a 12 ban) through the mandating of best practices such as strengthened leak testing requirements, as well as targets for leak reduction over time. F-gases serve as highly effective blowing agents in foam production for insulation material in buildings, appliances and elsewhere. Currently, there are no alternative blowing agents or alternative insulation materials that can match or even approximate the overall performance and universal applicability of HFOblown spray foam. The exceptional thermal resistance and density of HFO-blown foam means it provides far more insulating capacity than the alternatives in the same amount of space. Additionally, the relative emissions of TFA from F-gas blowing agents are extremely low compared to other sources of PFAS in the environment. However, emissions could still be reduced to a fraction of what they are today, through the implementation of additional measures such as enhanced F-gas recovery at end-of-life, to ensure the foam is recycled or incinerated instead of disposal to landfills, at minimal additional cost. F-gases are used in two-phase immersion cooling (2-PIC) systems and is the only technology enabling the development of the next generation of computing technology while also significantly reducing energy, water, and space consumption for data centers worldwide. F-gases are a vital building block for meeting European policy objectives to support the digital transformation. This is an emerging technology but will be critical for the development and optimization of the European data center market long term. Data centers are forecasted to grow from 15.7 billion (bn) in 2023 to 29.1bn in 2028 (at the USD-EUR exchange rate of 31/08/23). 2-PIC solutions based on F-gases are seen by the industry as key to its development, and a ban on F-gases in this application will risk investment in the EU and drive data center providers to other locations where the best available technology is accessible, such as the US and China. This will not only impact the European economy but also European sovereignty, as storage and processing of European data is shifted to countries outside of the EU. Alternatives such as ammonia, oil and waterglycol based solutions pose serious safety and capability limitations and could lead to massively increased energy use and carbon emissions. Despite having low leak rates (<1%), strict maintenance regimes, training and certification could reduce projected emissions rates by 90% in 2055 at no additional cost. Another decarbonization technology where F-gases are used is in industrial scale high-temperature heat pumps (HTHPs) and Organic Rankine Cycle (ORC) equipment used to recover wasted heat from a lowtemperature heat source and raise it to higher temperature level, where it can be re-used for valuable processes or electricity production. HTHPs provide much more than the direct conversion of electric power to heat by traditional heat pumps, by allowing to re-use heat which would otherwise be lost. HTHPs do this at a fraction of the operating costs of using fossil fuel to accomplish the same function. Applications range from drying and thermal separation and preservation in the food, paper production, chemical process, metal and plastic manufacturing. All these sectors currently rely on fossil fuel burners. HFOs already offer energy efficient solutions for a broad range of HTHP technology across the different temperature lift and application requirements, without the problems exhibited by alternatives, such as narrow range of application and high flammability. We assume that 50% of the market can only be addressed by F-gases. HTHP and ORC equipment operate as closed systems and can achieve very low leak rates (lower than 1% per year). Mandating simple best practice measures similar to those mentioned for MAC and HVACR applications can further reduce these emissions. F-gas extinguishing agents are an additive elective technology which when used as fire suppressants provide performance above and beyond standard code requirements. They are used in a broad range of applications such as data centers, control rooms, aviation, museums and other facilities with historic or 13 high value assets. They protect hazards where the risk of loss or downtime outweighs the significant added cost of F-gases and the performance limitations of non-fluorinated alternatives. End-of-life emissions are also well managed through recovery, recycling and reuse of the agent to support new or existing fire suppression systems, thus limiting emission and release of agent for decades in a circular product life. In propellants, F-gas aerosol technologies are used where non-flammability and high technical performance of sprays are required. They provide several benefits to the final product performance, safety and customer experience that cannot easily be matched using only non-fluorinated propellants or other dispersion technologies. F-gases are also used in Metered Dose Aerosol Inhalers (MDIs) where they provide consistent use for patients through easy-handling design and active agent dispensing. The MDI delivered dose is independent of inspiratory effort at a time when patients are struggling to breathe and is a commonly prescribed pulmonary treatment for many patients. Non-fluorinated alternatives require a stronger lung pull by the patients, do not immediately deliver medication to the respiratory tract, and are thus ineffective and not viable in rescue inhalers or with elderly and young children. F-gases are solvents in cleaning applications, carrier fluids in lubricants and heat transfer fluids in semiconductor and electronics manufacturing because they show favorable toxicity profile, they are nonflammable, safe, and exhibit excellent thermal, environmental, and dielectric properties. These properties make them essential in critical cleaning applications in sensitive manufacturing processes. Only F-gases can be used as a carrier fluid for fluorinated oils. they are the only known heat transfer fluid that can be used in the semiconductor manufacturing process. The non-fluorinated alternatives have significant limitations and risks hindering their adoption. Additional maintenance and management measures would be a far more cost-effective way of reducing emissions than the proposed restriction (ban) Using its knowledge of the sectors and technologies which use F-gases, Chemours has undertaken modelling of the emission reduction benefits and implementation costs of a range of potential additional F-gas management measures, summarized above, described in detail in our submission and also available in Table IV below for a full detail of the package of measures. Chemours has made further estimates of impacts of switching to alternatives (if a ban were introduced) in each of the sectors considered, based on factors such as relative equipment costs, performance efficiency and energy use. Combined with baseline and projected emission estimates, this analysis produces estimates of the cost-effectiveness ( million (M) per tonne) of reducing PFAS emissions via Chemours' suggested management measures and the Dossier Submitters' proposed ban. Figure I presents estimates of baseline emissions made by the Dossier Submitters for stationary HVACR and MAC, and by Chemours for these two sectors plus foam-blowing, immersion-cooling and HTHPs. Chemours' estimates of emissions for HVACR and MAC are based on actual reported leak rates, rather than rates assumed in the modelling which produced the Dossier Submitters' figures, resulting in significantly lower emissions estimates. It can be seen that stationary HVACR is by far the biggest source 14 of emissions (whichever estimate is used), with MAC a clear second; the other sectors are negligible in comparison. Figure I also includes estimates of the impacts on emissions of the package of additional measures proposed by Chemours, based on analysis of factors such as expected changes in leak rates and maintenance frequency. Emissions could be reduced by over 30% in the foam-blowing segment, by 60% in HTHP and ORC and by around 90% in stationary HVACR, MAC and immersion cooling. The overall impact would be to reduced emissions by 88%. Figure I - 2055 baseline emissions and impacts of the proposed package of measures. Figure II combines Chemours' emission and emission reduction estimates with Chemours' calculations of the costs of a switch to alternatives following a ban, on the one hand, and of introducing the proposed package of measures on the other. This produces estimates of the cost of securing emission reductions measured per tonne of emission prevented, which is a measure of the cost-effectiveness of each policy. It can be seen that the Dossier Submitters' proposed ban would generate costs of 3.2M per tonne of emission prevented in the stationary HVACR sector, up to over 300M per tonne in the HTHP segment. In comparison, the proposed package of measures would result in costs per tonne of emission prevented no higher than 0.6M/tonne (in stationary HVACR), and effectively at zero cost in the immersion cooling and HTHP sectors (0.1M/tonne in MAC and 0.04M/tonne in spray foam). These are all maintenance and management measures which have been demonstrated to be feasible and practicable and most of which are in fact in place already in several EU Member States. 15 Figure II - Estimated costs in 2055 of preventing the emission of 1 tonne of PFAS. These calculations suggest that dramatic F-gas emission reductions could be achieved through basic management and maintenance measures, and far more cheaply than through a ban, primarily because Fgas based technologies are far more efficient than the alternatives. This leads to significantly lower energy use and hence lower carbon emissions, that in combination with the industry's commitment to developing ultra-low GWP alternatives further reduces potential emissions. It should be recognized that the ban on F-gases currently proposed by the Dossier Submitters would imply a significant increase in energy demand, representing 727TWh in 2055, a 30% increase over the 2022 energy production of the EU (2 461TWh)5 and a requirement for large investment in additional energy generation capacity, at a time when EU policy is pushing towards greater energy efficiency and lower energy use, not higher. However, it could be argued that these measures do not achieve the objectives of the Dossier Submitters, which is the complete elimination of future PFAS emissions. This is true, but the additional (marginal) costs of using a ban, to eliminate (relatively few) emissions remaining after these measures have been introduced, need to be considered. Figure II also presents estimates of these `marginal abatement costs', based on the previous estimates of the costs of a ban and the new, lower level of emissions reductions 5 Consilium (no date) How is EU electricity produced and sold? , Consilium. Available at: https://www.consilium.europa.eu/en/infographics/how-is-eu-electricity-produced-and-sold/. 16 they would secure if Chemours' additional measures were implemented. It can be seen that, because new baseline emissions are so much lower following the additional measures, the marginal costs of a ban, to secure the final reduction in emissions to zero, is much higher, at between 28 million and 816 million per tonne of emissions prevented, or 81 million per tonne overall. These costs are evidence of an extreme `kink' in the marginal abatement cost curve and emphasize just how much more costly a ban would be compared with simple good housekeeping. Figure III - Marginal abatement cost curve for F-Gas emission reductions in 2055 This can be seen most clearly from Figure III, which plots the emission reductions obtained from each option (additional measures and bans) for each application in order of marginal cost, from lowest to highest, to generate a `marginal abatement cost' curve. It can be seen that emission reductions of almost 90% can be achieved at a cost no more than 622/kg (510/kg on average) by implementing the simple housekeeping measures Chemours suggests. Implementing a ban on the use of F-gases in stationary applications would achieve a further 9% reduction in emissions, but at a cost over 50 times higher (28,500/kg). The last remaining 3% of emissions could be achieved by implementing bans in MAC, immersion cooling, foam and HTHPs, but at even higher cost - banning HTHPs would reduce emissions only by another 20 tonnes, but at a cost of 16bn per year, or over 800,000/kg. We argue that these costs are disproportionate when compared with, e.g. benchmark costs of reducing PBT and vPvB substances, as reviewed by Oosterhuis et al (2017). 17 Chemours' analysis suggests a `hierarchy' of approaches to the management of F-gas emissions On the basis of the detailed assessment prepared for this consultation, Chemours' TSS has identified the following proposals which it would like to recommend for consideration by the Dossier Submitters and ECHA. Please note that these recommendations are presented in order of priority, in terms of the strength of their justification, and that, for instance, requests for derogations only apply in the event that F-gases remain within the scope of the proposed restriction and where a phase-out continues to be preferred by regulators over alternative, more proportionate, approaches to F-gas regulation. Therefore, we ask ECHA to consider the following hierarchy of arguments/asks: 1. F-gases do not pose an unacceptable risk at the EU level and hence should not be included in a REACH restriction: For a restriction to be justified, it needs to be demonstrated that the use of F-gases generates unacceptable risks which need to be addressed at the EU level. However, Chemours' analysis demonstrates that F-gases do not possess the properties which the Dossier Submitters have identified as sources of concern justifying regulatory action towards PFASs generally. Accordingly, the analysis demonstrates that all F-gases (current and future) fulfilling the PFAS definition used by the Dossier Submitters should be exempt from the scope of this restriction because there is no risk to be addressed at the EU level. Similarly, F-gas degradation products, such as TFA, should be exempt, given that the risks to human health and the environment are de minimis. 2. F-gas emissions should be managed under the existing legislative framework: Instead, all F-gases should be regulated under the existing (and future) regulatory framework for F-gases, which includes the F-gas Regulation (current and future), the MAC Directive, the End-of-Life of Vehicles Directive, the WEEE Directive and the Waste Framework Directive, and which already has the objective of minimizing F-gas emissions to the environment, progressively and in a cost-effective manner. As a result, a restriction under REACH, with the same objective is not necessary or helpful. 3. Further F-gas emission reductions are best achieved through additional management measures: If the current (and future) regulatory framework for F-gases is considered to be insufficient to ensure the safe use of F-gases, and further (and faster) emissions reductions are warranted, additional risk management measures are a much more cost-effective way of securing them, rather than a ban. Such measures include mandatory recovery at end-of-life, minimum inspection (leak-testing) intervals, improved technician training and improvements to system design standards to further reduce leaks. The package of measures which Chemours proposes for this purpose is summarized in Table IV. All of these measures have been demonstrated to be feasible and practicable and most of which already exist in some EU Member States. MAC and Heat Pumps Table IV - Package of measures proposed by Chemours. System architecture enhancements to reduce Mandatory Reclaim at end of life Required leak Certification of test at road technicians (existing worthiness test standards recertification) leak rates over time to: 0.7% at EIF +18 months 0.5% at EIF + 5 years 0.1% at EIF + 7 years 0.05% at EIF + 9 years 18 Stationary HVACR Upfront fee for Reclaim at end of life Increased frequency of leak testing compared to FGR revision council proposal Foam Blowing Agents Immersion Cooling Incineration obligation and landfill prohibition of PU foam Mandatory leak checks Certification of installers Mandatory technician training and certification Strengthened Certification of technicians HTHP and ORC Upfront fee for Reclaim at end of life Strengthened Certification of technicians Enhanced Leaktesting - Leak rate certification of components and equipment - System architecture enhancements Driving system leak rate reduction to : 40% leak rate reduction at EIF + 4.5 years 60% leak rate reduction at EIF + 6.5 years 80% leak rate reduction at EIF + 8.5 years - Leak rate certification of components and equipment - System architecture enhancements: Driving system leak rate reduction to 0.4% per year, 9 years after EiF 4. Exemption based on minimal yield of persistent degradation products: If the arguments presented in points 1, 2 and 3 above are not considered sufficient to exclude F-gases from the scope of a ban: F-gases degrading to a persistent substance (such as TFA) with a molar yield below 10% should be exempt because these make a negligible contribution to the global TFA budget; F-gases degrading to a persistent substance (such as TFA) with a molar yield above 10% (not covered by this exemption) should be subject to the derogation conditions presented under point 5. 5. If a REACH restriction (ban) covering F-gases is to be implemented, sector-specific derogations should be included to avoid disproportionate impacts to society: If F-gases remain in scope and a phase-out is preferred to minimization via additional risk management measures, the following derogations will be required to avoid disproportionate socio-economic impacts on society. Existing equipment using F-gas technologies Existing equipment which uses F-gases cannot be retrofitted to use alternative refrigerants. Therefore, a ban on F-gases would prevent this equipment being serviced and maintained, and lead to premature retirement. A permanent derogation is therefore justified to avoid the unnecessary costs of replacing this equipment. (This justification was used by the Dossier Submitters for their proposed derogation 5i, although this derogation was time-limited and restricted to existing HVACR equipment only). Stationary HVACR and transport refrigeration applications There are significant specific performance limitations associated with the alternatives to Fgases across the different applications in stationary HVACR and in transport refrigeration. It 19 might be possible to overcome these problems through engineering developments, but this will take time and resources. A minimum 12-year derogation is suggested to allow this to happen. A review should be undertaken before the end of the derogation period, to ensure that the necessary substitution activity has been successful. If not, a further extension of the derogation would be justified to avoid disproportionate costs in future; Mobile air conditioning and heat pumps (EV/hybrid mobile air conditioning/heat pumps) (M16 and N17)/, and ICE mobile air conditioning vehicles (M1 and N1) There are fundamental problems with using F-gas alternatives in electric vehicles AC and heat pumps, due to safety concerns and poor performance, especially at higher ambient temperatures. A derogation for F-gases in these applications is therefore justified. ICE vehicles are subject to phase out over a period of time which means investment in new MAC systems which do not use F-gases will never be commercially viable (even if it were possible). A derogation for F-gases in ICE MAC applications is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Foam-blowing agents (Foam-blowing agents in expanded foam sprayed on site for building insulation; Foam-blowing agents in expanded foam for all applications where the foam is not sprayed on site for building insulation) HFO-blown spray foam exhibits exceptional thermal resistance and low density compared with alternative blowing agents and materials, and hence provides much better insulation in a given amount of space. The fundamental disadvantages of alternatives will never be overcome. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Two-phase immersion cooling applications Two-phase immersion cooling based on F-gases is the technology which will support the next generation of data centers and electric vehicle powertrain thermal management. Alternatives are far less effective and would result in significant increases in energy use and cost. A ban on F-gases in these applications would also encourage investment in these key strategic technologies to divert to countries where they can still be used. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. 6 Passenger cars, taxi cabs, motor caravans 7 Pick-up trucks and vans with a weight below 3.5 tonnes 20  Industrial high temperature heat pumps and Organic Rankine Cycle applications HFOs already offer energy efficient solutions for a broad range of HTHP technology across the different temperature and application requirements, without the problems exhibited by alternatives, such as narrow range of application or high flammability. We assume that 50% of waste heat cannot be recovered without the use of F-gases; this would result in significant increases in energy use and cost. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Chemours has developed policy proposals for a set of F-Gas applications for which it possesses expert knowledge and directly applicable evidence. There are other applications of F-Gases - such as MDI; fire protection; propellants; cold plate technology; and the use of solvents in critical cleaning, semiconductor process cooling, and carrier fluids - in which Chemours does not consider itself expert, and hence elected not to develop proposals. However, it is entirely possible that, for these applications too, a similar case could be made for additional measures as a more costeffective risk management approach, and derogation on the grounds of disproportionate cost, if an appropriate analysis was undertaken. Hence, we would encourage the Dossier Submitter and the ECHA Committees to use evidence available from stakeholders and apply the same logic in these and other applications. To assist with this, Chemours is providing the evidence it possesses on these applications, in Attachment 2. The arguments supporting this hierarchy of asks are provided in detail in Attachment 1 (this document) and Attachment 2. Chemours notes that, currently, there is no generic regulatory definition of an "F-gas" i.e., a definition based on molecular structure or substance properties. Rather, F-gases are identified on a substance-bysubstance basis by means of their inclusion in Annex I and Annex II of the F-gas Regulation. However, the proposed REACH restriction relies on a generic PFAS definition based on molecular structure. This generic definition includes most of the substances listed on Annex I and II of the F-gas regulation but also (future) more sustainable substances that could be used as alternatives to existing F-gases that are not currently listed in Annex I or II of the F-gas regulation. In the event that F-gases were excluded from the scope of the proposed restriction (based on the justifications provided in this submission), this incongruity in substance definition between the different regulations would have the effect of inadvertently including future F-gases within the scope of the restriction, preventing innovation to more sustainable F-gases. We consider that future F-gases should be allowed to be used subject to the same conditions of use and emission minimization measures as required for the substances listed in Annex I and II of the F-gas Regulation. Therefore, in the event of derogation for F-gases, we urge the Dossier Submitters, ECHA and the European Commission to address this potential incongruity in order to ensure that the REACH restriction does not prevent the development of future generations of F-gases (i.e., that have even lower global warming potential than the current generation and which do not degrade to persistent degradation products). For example, a generic definition of F-gas could be developed or the Annexes of the F-gas regulation could be periodically (e.g., annually) updated 21 to include novel F-gases on the basis of scientific and technological progress. This would solve such a regulatory incongruence and enable innovation to even more sustainable F-gases. As manufacturer, seller and downstream user of F-gases, Chemours' TSS business unit recognizes the concerns raised by the Dossier Submitters with the safety profiles of some PFASs. TSS is aware of the increased scrutiny on PFASs as outlined in the EU's Chemical Strategy for Sustainability. With expertise in the manufacture, properties and application of F-gases, TSS is committed to take an active, responsible and constructive role in the public consultation on the proposed restriction to facilitate the development of a coherent approach to the regulation of PFASs. 22 Introduction The Chemours Company welcomes the opportunity to provide feedback to the ECHA public consultation on the universal PFAS restriction proposal submitted by Germany, Denmark, The Netherlands, Sweden and Norway (hereafter referred to as the Dossier Submitters). PFAS are a large class of substances that have diverse and unique chemical properties. Given the range of relevant applications, it is not possible for Chemours to respond meaningfully to the consultation on a generic level. Rather, Chemours' two business units specializing in fluoropolymers and fluorinated gases (F-gases): Advanced Performance Materials (APM) and Thermal & Specialized Solutions (TSS) have made separate submissions to the public consultation. Whilst TSS and APM have submitted separate comments, both business units share a common objective: to demonstrate, that a more tailored (differentiated) approach to the scope and conditions of a restriction, recognizing the different properties and conditions of use of different PFASs, would ensure the safe use of PFASs without imposing disproportionate costs or compromising the EU's policy and strategic objectives. As manufacturer, seller and downstream user of F-gases, Chemours' TSS business unit recognizes the concerns raised by the Dossier Submitters with the safety profiles of some PFASs. TSS is aware of the increased scrutiny on PFASs as outlined in the EU's Chemical Strategy for Sustainability. With expertise in the manufacture, properties and application of F-gases, TSS is committed to taking an active, responsible and constructive role in the public consultation on the proposed restriction to facilitate the development of a coherent approach to the regulation of PFASs. The proposed restriction, as currently formulated, will have a disproportionate negative impact on EU society. This is because alternatives to F-gases cannot currently be implemented in applications for which there is no derogation currently proposed or may result in regrettable substitution. Equally, where alternatives can be implemented their technical performance will lead to very large societal costs associated with their greater energy demands and associated CO2 emissions. TSS intends to demonstrate that F-gases can continue to be used safely and that an alternative restriction proposal that focuses on risk management via emission reduction and circularity would be more proportionate than the proposed restriction and would ensure that the EU is able to realize its policy ambitions whilst maintaining its competitiveness and strategic autonomy. The key elements of the submission are, as follows: The grouping approach used by the dossier submitters would lead to the restriction of some substances, specifically F-gases, which can be reliably demonstrated to be safe for human health and the environment. Regulation which adequately deals with the differences in substance properties within the PFAS class, is critical for achieving EU ambitions and competitiveness; reading across the hazardous properties of some PFASs to all PFASs has not been justified based on sufficiently rigorous science. Further emission reduction of F-gases is possible without a ban through the use of an alternative risk management approach that is focused on emission minimization via improved mandatory risk management measures, refined technical standards for equipment (i.e., setting maximum leak rates) and establishing regulatory frameworks that ensure circularity. 23  A ban of all PFAS would heavily impact a range of critical European industries, which are key to achieving the EU's sustainability goals and which rely on the use of F-gases, as there are no suitable alternatives for several technical and/or economic reasons. A more proportionate phaseout, if ultimately preferred by the decision maker over alternative risk management approaches, would be to allow for transitional periods of appropriate duration per industry that recognize the applicable innovation cycle, the high effectiveness of risk management measures in certain uses and the enormous costs to society associated with the use of alternatives with lower technical performance (leading directly to increased energy consumption). Overview of the documents submitted by Chemours' TSS Chemours' TSS submission includes the following 3 attachments: Attachment 1 - This document, which is divided into different chapters: o Executive summary; o Introduction; o Chapter 1, focused on the comparative hazard assessment of F-gases, trifluoroacetic acid (TFA) and the model PFASs referred to by the Dossier Submitters to develop the `case-bycase' approach that underpins the risk assessment for the PFAS class. This chapter also includes an environmental risk assessment of F-gases and TFA as well as a detailed description and assessment of the appropriateness of the current and future regulatory framework for F-gases in the EU; o Chapter 2, which focuses on a series of risk management measures and demonstrates that these could be implemented instead of a ban in a more cost effective manner to provide significant reductions in emissions and we propose that they would be best implemented through the existing F-gas-specific legislation to further reduce emissions to the environment; o Chapter 3, focused on the proportionality of the restriction proposal and including considerations on the concentration limit of 25 ppb proposed for PFAS impurities, the analysis of alternatives and the assessment of socio-economic impacts of both the proposed derogations presented in the restriction dossier and the alternatives; o Conclusions; Attachment 2 - An application-specific document, which includes sections on: o Mobile air conditioning and heat pumps; o Stationary Heating, Ventilation, Air Conditioning and Refrigeration (HVACR); o Foam blowing agents o Immersion cooling o High Temperature Heat Pumps and Organic Rankine Cycle o Fire suppressants o Propellants o Meter dose inhalers o Solvent applications Attachment 3 - A supporting information document, including: o Annex I, which complements the information presented in Chapter 1; o Annex II, specific comments and observations on Annex A of the PFAS restriction dossier; o Annex III, which is focused on the analytical methods described by the Dossier Submitters in Annex E of the PFAS restriction dossier; 24 o Annex IV, which is the Socio-Economic Analysis and Impact Assessment of a potential REACH Restriction on F-gases as PFAS, report for Chemours Thermal Specialized Solutions (TSS) [attached in confidential version] o Annex V, which is the Evaluation of Costs based on Restriction Derogations for Mobile Air Conditioning Maintenance. Chemours' analysis suggests a `hierarchy' of approaches to the management of F-gas emissions On the basis of the detailed assessment prepared for this consultation, Chemours' TSS has identified the following proposals which it would like to recommend for consideration by the Dossier Submitters and ECHA. Please note that these recommendations are presented in order of priority, in terms of the strength of their justification, and that, for instance, requests for derogations only apply in the event that F-gases remain within the scope of the proposed restriction and where a phase-out continues to be preferred by regulators over alternative, more proportionate, approaches to F-gas regulation. Therefore, we ask ECHA to consider the following hierarchy of arguments/asks: 1. F-gases do not pose an unacceptable risk at the EU level and hence should not be included in a REACH restriction: For a restriction to be justified, it needs to be demonstrated that the use of F-gases generates unacceptable risks which need to be addressed at the EU level. However, Chemours' analysis demonstrates that F-gases do not possess the properties which the Dossier Submitters have identified as sources of concern justifying regulatory action towards PFASs generally. Accordingly, the analysis demonstrates that all F-gases (current and future) fulfilling the PFAS definition used by the Dossier Submitters should be exempt from the scope of this restriction because there is no risk to be addressed at the EU level. Similarly, F-gas degradation products, such as TFA, should be exempt, given that the risks to human health and the environment are de minimis. The arguments supporting this recommendation are provided in Chapter 1, sections 1.1 to 1.4. 2. F-gas emissions should be managed under the existing legislative framework: Instead, all F-gases should be regulated under the existing (and future) regulatory framework for F-gases, which includes the F-gas Regulation (current and future), the MAC Directive, the End-of-Life of Vehicles Directive, the WEEE Directive and the Waste Framework Directive, and which already has the objective of minimizing F-gas emissions to the environment, progressively and in a cost-effective manner. As a result, a restriction under REACH, with the same objective is not necessary or helpful. This is discussed in detail in Chapter 1, section 1.5. 3. Further F-gas emission reductions are best achieved through additional management measures: If the current (and future) regulatory framework for F-gases is considered to be insufficient to ensure the safe use of F-gases, and further (and faster) emissions reductions are warranted, additional risk management measures are a much more cost-effective way of securing them, rather than a ban. Such measures include mandatory recovery at end-of-life, minimum inspection (leak-testing) intervals, improved technician training and improvements to system design standards to further reduce leaks. All of these measures have been demonstrated to be feasible and practicable and most of which already exist in some EU Member States. This is covered in Chapter 2 and Attachment 2. 4. Exemption based on minimal yield of persistent degradation products: If the arguments presented in points 1, 2 and 3 above are not considered sufficient to exclude F-gases from the scope of a ban: 25  F-gases degrading to a persistent substance (such as TFA) with a molar yield below 10% should be exempt because these make a negligible contribution to the global TFA budget; F-gases degrading to a persistent substance (such as TFA) with a molar yield above 10% (not covered by this exemption) should be subject to the derogation conditions presented under point 5. These aspects are further elaborated in Chapter 1, sections 1.1 to 1.4. 5. If a REACH restriction (ban) covering F-gases is to be implemented, sector-specific derogations should be included to avoid disproportionate impacts to society: If F-gases remain in scope and a phase-out is preferred to minimization via additional risk management measures, the following derogations will be required to avoid disproportionate socio-economic impacts on society. Existing equipment using F-gas technologies Existing equipment which uses F-gases cannot be retrofitted to use alternative refrigerants. Therefore, a ban on F-gases would prevent this equipment being serviced and maintained, and lead to premature retirement. A permanent derogation is therefore justified to avoid the unnecessary costs of replacing this equipment. (This justification was used by the Dossier Submitters for their proposed derogation 5i, although this derogation was time-limited and restricted to existing HVACR equipment only). Stationary HVACR and transport refrigeration applications There are significant specific performance limitations associated with the alternatives to Fgases across the different applications in stationary HVACR and in transport refrigeration. It might be possible to overcome these problems through engineering developments, but this will take time and resources. A minimum 12-year derogation is suggested to allow this to happen. A review should be undertaken before the end of the derogation period, to ensure that the necessary substitution activity has been successful. If not, a further extension of the derogation would be justified to avoid disproportionate costs in future; Mobile air conditioning and heat pumps (EV/hybrid mobile air conditioning/heat pumps) (M18 and N19), and ICE mobile air conditioning vehicles (M1 and N1) There are fundamental problems with using F-gas alternatives in electric vehicles AC and heat pumps, due to safety concerns and poor performance, especially at higher ambient temperatures. A derogation for F-gases in these applications is therefore justified. ICE vehicles are subject to phase out over a period of time which means investment in new MAC systems which do not use F-gases will never be commercially viable (even if it were possible). A derogation for F-gases in ICE MAC applications is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. 8 Passenger cars, taxi cabs, motor caravans 9 Pick-up trucks and vans with a weight below 3.5 tonnes 26  Foam-blowing agents (Foam-blowing agents in expanded foam sprayed on site for building insulation; Foam-blowing agents in expanded foam for all applications where the foam is not sprayed on site for building insulation) HFO-blown spray foam exhibits exceptional thermal resistance and low density compared with alternative blowing agents and materials, and hence provides much better insulation in a given amount of space. The fundamental disadvantages of alternatives will never be overcome. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Two-phase immersion cooling applications Two-phase immersion cooling based on F-gases is the technology which will support the next generation of data centers and electric vehicle powertrain thermal management. Alternatives are far less effective and would result in significant increases in energy use and cost. A ban on F-gases in these applications would also encourage investment in these key strategic technologies to divert to countries where they can still be used. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Industrial high temperature heat pumps (HTHP) and organic Rankine cycle (ORC) applications; HFOs already offer energy efficient solutions for a broad range of HTHP technology across the different temperature and application requirements, without the problems exhibited by alternatives, such as narrow range of application or high flammability. We assume that 50% of waste heat cannot be recovered without the use of F-gases; this would result in significant increases in energy use and cost. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Chemours has developed policy proposals for a set of F-Gas applications for which it possesses expert knowledge and directly applicable evidence. There are other applications of F-Gases - such as MDI; fire protection; propellants; cold plate technology; and the use of solvents in critical cleaning, semiconductor process cooling, and carrier fluids - in which Chemours does not consider itself expert, and hence elected not to develop proposals. However, it is entirely possible that, for these applications too, a similar case could be made for additional measures as a more costeffective risk management approach, and derogation on the grounds of disproportionate cost, if an appropriate analysis was undertaken. Hence, we would encourage the Dossier Submitter and the ECHA Committees to use evidence available from stakeholders and apply the same logic in these and other applications. To assist with this, Chemours is providing the evidence it possesses on these applications, in Attachment 2. 27 These elements are covered in Chapter 3 and Attachment 2. Chemours notes that, currently, there is no generic regulatory definition of an "F-gas" i.e., a definition based on molecular structure or substance properties. Rather, F-gases are identified on a substance-bysubstance basis by means of their inclusion in Annex I and Annex II of the F-gas Regulation. However, the proposed REACH restriction relies on a generic PFAS definition based on molecular structure. This generic definition includes most of the substances listed on Annex I and II of the F-gas regulation but also (future) more sustainable substances that could be used as alternatives to existing F-gases that are not currently listed in Annex I or II of the F-gas regulation. In the event that F-gases were excluded from the scope of the proposed restriction (based on the justifications provided in this submission), this incongruity in substance definition between the different regulations would have the effect of inadvertently including future F-gases within the scope of the restriction, preventing innovation to more sustainable F-gases. We consider that future F-gases should be allowed to be used subject to the same conditions of use and emission minimization measures as required for the substances listed in Annex I and II of the F-gas Regulation. Therefore, in the event of derogation for F-gases, we urge the Dossier Submitters, ECHA and the European Commission to address this potential incongruity in order to ensure that the REACH restriction does not prevent the development of future generations of F-gases (i.e., that have even lower global warming potential than the current generation and which do not degrade to persistent degradation products). For example, a generic definition of F-gas could be developed or the Annexes of the F-gas regulation could be periodically (e.g., annually) updated to include novel F-gases on the basis of scientific and technological progress. This would solve such a regulatory incongruence and enable innovation to even more sustainable F-gases. 28 CHAPTER 1 - There is no risk to be addressed at EU-level: F-gases and trifluoroacetic acid (TFA) are substances that have been proven safe for their intended use Content covered in Chapter 1 This chapter is primarily focused on the hazard and risk assessment of F-gases and TFA (TFA is the atmospheric degradation product of some F-gases, also included in the scope of the restriction proposal). We report the available information on classification, hazards, environmental fate and risk assessment and we apply a classical risk assessment methodology to robustly demonstrate the safe use of F-gases and TFA and that the case-by-case risk assessment approach followed by the Dossier Submitters and applied to the entire class of PFASs is not appropriate, or necessary, for F-gases and TFA. It is acknowledged that for some of the PFASs falling into the definition in use for this restriction there might be either significant data gaps triggering a potential concern because of their unknown effects for both human health and the environment or clear similarities with other PFASs that are known to have adverse properties and that would justify a read-across approach. However, the definition of PFAS in use for this restriction proposal (which is different from those in use for other PFAS-related policies) covers a variety of substances characterized by very different physicochemical properties, environmental fate, hazard and risk profile, including F-gases and TFA, which have been proved safe for their intended uses. The robust datasets available for F-gases and TFA demonstrate that the properties of F-gases and TFA are different from the `model PFASs' used by the Dossier Submitters to support their case-by-case approach and clearly show that the risk profile of this specific PFAS subclass does not require a restriction under REACH as their risks are already adequately controlled. This is because F-gases and TFA have been demonstrated to be safe for their intended uses and their current and projected emissions to the environment do not pose a risk to human health or the environment. This aspect will also be reflected in a dedicated section of this document, which is focused on environmental risk assessment and which uses estimates of future emissions, from reliable and globally accepted assessments, to show that the risks posed by F-gases and TFA for both human health and the environment, both today and in the future, are de minimis. According to the rationale followed by the Dossier Submitters, the aim of the proposed restriction is emission reduction and emissions are considered as a proxy for risk. This would be justified in case PBT/vPvB criteria are met or there were other justifications for adopting a non-threshold approach to risk assessment. However, this is not the case for F-gases and TFA. Additionally, emission reduction is also the objective of the existing regulatory framework for F-gases in the EU, which includes the F-gas Regulation (EU Regulation 517/2014), the MAC Directive (EU Directive 2006/40/EC) and other pieces of legislation that regulate the end-of-life of equipment containing F-gases, e.g., the End-of-Life Vehicles Directive (EU Directive 2000/53/EC). Consequently, in the last part of this chapter, we demonstrate that the existing legislation on F-gases (taking into account pending revisions) 29 is already an appropriate and effective means to minimize emissions of F-gases to the environment and, therefore, that the inclusion of F-gases into the scope of the proposed restriction is not necessary to achieve the risk management objectives of the Dossier Submitters. Therefore, considering the low risk of F-gases and TFA as well as the existence of a tailored, effective legislation that regulates emissions of F-gases during both their use and end-of-life, we demonstrate that F-gases should be excluded from the scope of the current restriction proposal. Additional notes on the substances listed in Chapter 1 Whereas general considerations on risk and emission reduction can be applied to the whole F-gas subclass of PFAS, as also highlighted later in this document, in some cases Chemours does not own complete data on all F-gases. Therefore, throughout Chapter 1, when our comments apply to a specific subset of substances for which Chemours has available and detailed information, we will refer to them as "TSS substances". TSS substances are listed below in Table 1.1. All substances in the table are gases at 20oC, with the exceptions of HFO-1336mzzZ and HFC-4310mee, which are liquids at 20oC. Table 1.1 - Description of TSS substances for which Chapter 1 comments/arguments apply. HFC refers to "Hydrofluorocarbon" and HFO refers to "Hydrofluoroolefin". Common substance name EC number CAS number Structure PFAS* degradation product** Applications*** HFO-1234yf 468-710-7 754-12-1 CF3CF=CH2 TFA 100% estimated HVACR, MAC HFO-1336mzzE 811-213-0 66711-86-2 E - CF3CH=CHCF3 TFA 4% estimated FOAM, HTHP, ORC HFO-1336mzzZ HFC-134a 700-651-7 692-49-9 212-377-0 811-97-2 Z - CF3CH=CHCF3 CF3CH2F TFA 4% estimated TFA 7-20% estimated FOAM, SOLVENT, HTHP HVACR, MAC, PROPELLANT, MDI HFC-125 206-557-8 354-33-6 CF3CF2H TFA 1-10% estimated HVACR HFC-143a 206-996-5 420-46-2 CF3CH3 TFA 2% estimated HVACR The substance is not HFC-152a 200-866-1 75-37-6 CH3CF2H a PFAS and it does not degrade to a HVACR, FOAM, PROPELLANT PFAS HFC-227ea 207-079-2 431-89-0 CF3CHFCF3 TFA 100% estimated FIRE SUPPRESSANT, MDI TFA, CF3CF2COOH, HFC-4310mee 420-640-8 138495-42-8 CF3CHFCHFCF2CF3 CF3CHFCOOH, CF3CF2CHFCOOH SOLVENT *Degradation products that do not meet the PFAS definition in use in this restriction proposal are not reported; **Degradation refers to degradation in the troposphere. Percentages are expressed in terms of molar yield; ***HVACR: Heating, Ventilation, Air Conditioning and Refrigeration; MAC: Mobile Air Conditioning; HTHP: High Temperature Heat Pumps; ORC: Organic Rankine Cycle; MDI: Metered Dose Inhaler. 30 Section 1.1 - Substance classification, persistence assessment and risk assessment approach In this section of the document, we report the classification for TSS substances and describe the related underpinning studies, as well as the conclusions of existing risk assessments where these are required under REACH. Moreover, we highlight that F-gases, differently from most of the PFASs in scope of the proposed restriction, partition exclusively to air if released, hence the criteria for persistence set in REACH Annex XIII are not applicable. Additionally, from a substance scope perspective, we propose that in the event that F-gases are retained within the scope of the restriction, those that degrade to a negligible amount of TFA should be excluded as these substances pose a de minimis risk to human health or the environment, both currently and in the future. Finally, we counterargue the Dossier Submitters' case-by-case risk assessment approach that considers HFCs/HFOs and TFA as non-threshold substances, and we provide evidence to support that TSS substances and TFA are threshold-substances and that their safe use has been demonstrated using the conventional risk assessment approaches required under the REACH regulation and that further risk management is not necessary. All risks, including those associated with persistence, are well understood and already adequately controlled. Therefore, there is no basis for further restriction under REACH. TSS substances are not classified as CMR, STOT-RE or Lact. and those classified for environmental hazards have complete risk assessments that demonstrate that they are safe for their intended use. The Annex XV report includes information on hazard classification of PFASs in tables B.3 and B.4 of Annex B. However, the information reported is not CAS/EC number-specific and it is presented only at subgroup level. We highlight that without a detailed breakdown of the information at individual substance level, it is not possible to validate that the information presented is representative of the sub-groups to which it is assigned. None of the TSS substances are classified for human health endpoints (i.e., carcinogenicity, mutagenicity, reproductive toxicity, effects on or via lactation and/or specific target organ toxicity following repeated exposure). Equally, none of TSS substances meet the criteria for PBT/vPvB classification. The same considerations apply to TFA, which is the degradation product of some F-gases, as reported in Table 1.1. Two TSS substances (HFO-1336mzzE and HFC-4310mee) are classified for environmental endpoints, as shown in Table 1.2, together with the relevant environmental compartments for unintended release of the substances. Except for HFC-4310mee, none of TSS substances have a harmonized classification under Annex VI of CLP10. Further, except for HFO-1336mzz-E, none of TSS substances are self-classified for any environmental or human health hazard category. 10 Lex - 32022R0720 - en - EUR-Lex (2022) EUR. Available at: https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=CELEX%3A32022R0720 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R1272 31 Table 1.2 - Classification, PBT status and relevant environmental compartment of TSS substances and TFA. Harmonized Harmonized Fulfilling Relevant Common Classification Classification PBT/vPvB environmental Substance EC number CAS number for CMR, Lact for criteria? compartment name and/or Environment STOT RE F-GASES HFO-1234yf 468-710-7 754-12-1 None None No Air HFO-1336mzzE 811-213-0 66711-86-2 None Aq. Chr. 2 (self) No Air HFO-1336mzzZ 700-651-7 692-49-9 None None No Air HFC-134a 212-377-0 811-97-2 None None No Air HFC-125 206-557-8 354-33-6 None None No Air HFC-143a 206-996-5 420-46-2 None None No Air HFC-152a 200-866-1 75-37-6 None None No Air HFC-227ea 207-079-2 431-89-0 None None No Air SOLVENTS HFC-4310mee 420-640-8 138495-42-8 None Aq. Chr. 3 No Air ATMOSPHERIC DEGRADATION PRODUCT TFA 200-929-3 76-05-1 None Aq. Chr. 3 No Water Justifications for substance classification for each hazard category shown in Table 1.2 are based on extensive studies conducted for each substance's respective REACH registration and they are reported in Table 1.3 below. Justifications for non-classification of the substances listed in Table 1.2 will be provided in Section 1.2, that is focused on a comparative hazard assessment between the `model PFASs' used by the Dossier Submitters, F-gases and TFA. HFO-1336mzzE. Aquatic Chronic Category 2 self-classification is justified. The LC/EC50 values for all acute aquatic studies are above 1 mg/L. Therefore, HFO-1336mzzE does not require classification for acute aquatic toxicity. For chronic aquatic toxicity two scenarios can be envisaged, both of which result in a classification of Chronic Aquatic Category 2. HFC-4310mee. Aquatic Chronic Category 3 is justified. The LC/EC50 values for all acute aquatic studies are above 1 mg/L. Therefore, HFC-4310mee does not require classification for acute aquatic toxicity. TFA classification.11 TFA has a harmonized classification as Aquatic Chronic Category 3 under Annex VI of the CLP regulation. A summary of the available aquatic toxicity study endpoints is presented in Table 1.3. In aqueous solution, the pH of the substance is naturally low and for testing on organisms either the sodium or potassium salt (TFANa or TFAK) or pH adjustment was required. The LC/EC50 values for all acute aquatic studies are above 1 mg/L and therefore TFA does not require any classification for acute aquatic toxicity. The aquatic toxicity data for TFA, which are also supported by the full weight of evidence, do not meet the criteria for acute or chronic toxicity to aquatic organisms according to the CLP and the UN-GHS. Consistent with the interpretation of the TFA lead registrant, we believe that TFA should not be classified for aquatic toxicity. This is supported by the recent chronic data available for three trophic levels: algae, invertebrates, and fish and discussed in the TFA section of Table 1.3: it might be possible that the 11 (ECHA, Registration dossier), See Reference List for complete reference 32 3 studies (conducted in 2017, 2010 and 2019) were not considered at the time TFA classification was introduced in CLP (in 2008). Table 1.3 - Justifications for substance classification for each hazard category shown in Table 1.2. HFO-1336mzzE. In the first scenario HFO-1336mzzE is classified according to Table 4.1.0(b)(i) of Annex 1 to Regulation (EC) No. 1272/2008 as it is a non-rapidly degradable substance. The lowest chronic endpoint is 0.131 mg/L from the fish early life stage study (OECD 210). This result is above 0.1 mg/L and below 1 mg/L, indicating that classification as Chronic Aquatic 2 is appropriate . In the second scenario, HFO-1336mzzE is classified according to Table 4.1.0(b)(i) and Table 4.1.0(b)(iii) of Annex 1 to CLP Regulation and the most stringent classification is applied. As presented in the first scenario, classification based on Table 4.1.0(b)(i) results in the Chronic Aquatic 2 classification. For Table 4.1.0(b)(iii) the acute endpoints are compared to classification trigger values. The lowest acute endpoint from the three standard test species was 1.78 mg/L. This figure is above 1 mg/L and below 10 mg/L and hence based on Table 4.1.0(b)(iii) a classification of Chronic Aquatic 2 is appropriate for the substance HFC-4310mee. For chronic aquatic toxicity, HFC-4310mee is classified according to Table 4.1.0(b)(iii) of Annex 1 to CLP Regulation as it is a non-rapidly degradable substance. The lowest acute endpoint from the three standard test species was 10.6 mg/L. This result is above 10 mg/L and below 100 mg/L and hence based on Table 4.1.0(b)(iii) a classification of Chronic Aquatic 3 is appropriate. TFA. Among all the algae species tested, an adverse effect on growth inhibition was found only for Pseudokirchneriella subcapitata (an algae) in the key study, resulting in a 72h-ErC50 and 72h-ErC10 of 237 and 5.6 mg/L, respectively (Chabot, 2017). These effects have been demonstrated in several studies with this algae species with ErC50 results in the range of 6.4 - 237 mg/L. Due to the high variability of the toxicity results, the available data were closely assessed by the TFA lead registrant in line with the validity criteria of the OECD TG 20112 (OECD Testing Guideline 201, last version adopted on 23 March 2006) and using the CRED (Criteria for Reporting and Evaluating Ecotoxicity Data) evaluation method13. Due to various issues identified in these studies, the lead registrant determined that uncertainties on the reliabilities of the data from them was evident. The key study (Chabot, 2017) was GLP-compliant, conducted according to the most recent OECD test guideline 201, and all validity criteria were met. Therefore, the test was considered reliable without restrictions and was considered as the key study for toxicity to aquatic algae. Six other freshwater algae, three marine algae and three freshwater aquatic plants were also tested, and no toxicity was found in any of the species at the highest concentrations tested (up to 2 g/L). For the assessment of shortterm toxicity in invertebrates, three acute studies (one key and two supportive) are available on Daphnia magna. No acute toxicity was observed for Daphnia magna as all studies had an EC50 (48h) greater than or equal to the highest concentration tested of 999 mg/L TFA. For the assessment of short-term toxicity in fish, two acute fish studies (one key and one supporting) are available for Danio rerio. No acute effects were observed at the highest concentration tested of 999 mg/L. Therefore, an LC50 (96h) > 999 mg/L TFA was derived for fish. Reliable chronic data are available for three trophic levels: algae, invertebrates, and fish. In the study of growth inhibition of the algae species Pseudokirchneriella subcapitata performed by Ineris (Chabot, 2017), a 72h-ErC10 of 5.6 mg/L and a 72h NOEC of 2.5 mg/L were determined (measured concentration). A GLP-compliant OECD test guideline 211 study is available for the long-term toxicity in aquatic invertebrates (Kuhl, 2010). The 21-day NOEC for Daphnia magna was determined to be 25 mg TFA/L for the reproduction rate and for the survival of the adult test animals. A chronic fish study conducted according to OECD test guideline 210 (Liu Min, 2019) was performed with the reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate on Gobiocypris rarus. The NOEC was set to 10 mg/L for the test substance, corresponding to a recalculated NOEC (nominal) for TFA of 3.8 mg/L Additionally, the risk assessments of TSS substances having a classification for the environment, as well as HFO-1234yf and HFC-152a (for which risk assessments are not mandatory but were equally done, going beyond the REACH registration requirements) were performed using worst-case-scenario parameters, and are available in the respective REACH dossiers and demonstrate that TSS substances are safe for their intended uses. Based on the outcome of the risk assessments reported in the individual substance CSRs, all risk characterization ratios (RCR) are far below 1 and all risk characterization related to combined exposure to the environment are below 0.01. Later in this chapter, we show that the available data on TSS substances allow a complete assessment of risk and the case-by-case risk assessment approach of the Dossier Submitters is appropriate or necessary 12 (OECD, 2006), See Reference List for complete reference 13 (Moermond et al., 2016), See Reference List for complete reference 33 for either TSS substances or TFA, considering that the supporting concerns or combinations of supporting concerns listed by the Dossier Submitters in the restriction proposal are demonstrated not to be associated with TSS substances and their related degradation products. Regarding the "persistence" property, currently there are no established persistence criteria for the air compartment, the most important compartment to which F-gases would partition after emission under normal foreseeable conditions of use. Therefore, F-gases do not fulfill the P or vP criterion as specified in Annex XIII of REACH. More detailed information is provided below. F-gases should not be assumed to be persistent substances as, if released, they partition only to air prior to their degradation, for which REACH Annex XIII does not define persistence. Moreover, if all F-gases are kept in scope of the restriction, those with a low TFA yield should not be included in the scope as they only contribute negligibly to the overall TFA budget and, as such, pose a de minimis risk to human health and the environment. In Annex B, section B.1.3, the Dossier Submitters refer to a publication by Scheringer et al.14, who argue that there is no need to consider chemical partitioning for persistent substances as the substances anyway cover virtually the entire partitioning space. The property of environmental persistence under REACH, as referenced in Boethling et al. is defined as the degradation half-life of a chemical in soil, water or sediment15. Therefore, F-gases, irrespective of the persistence of degradation products) may be considered to be persistent substances, as such, only if they are determined be persistent in a compartment with associated Annex XIII criteria (i.e., water, soil or sediment). This should mean that F-gases are not considered to be persistent substances as such. Nevertheless, biodegradability screening using aquatic ready biodegradation testing (required for all substances registered under REACH above 1 tonne/y regardless of physical state) generally identifies Fgases as potentially persistent despite this test having limited relevance for F-gases (as they are gases at ambient temperature with a high vapor pressure that rapidly partition to the atmosphere). According to Section R.11.4.1.1.2 of REACH Guidance Chapter R.11,16 there are several references reporting that ready biodegradation tests underestimate the potential for degradation in real environmental conditions.17 A failed ready biodegradability test may indicate the need for further testing under less stringent test conditions (e.g., enhanced biodegradation tests, simulation tests...). In addition, all relevant degradation pathways (biotic, abiotic, aerobic, anaerobic conditions) need to be considered with regard to the relevant route of exposure before concluding on persistence. Therefore, it should not be assumed that F-gases are persistent substances based on the conclusions of ready biodegradation testing. Currently there are no established persistence criteria for the air compartment, the only relevant compartment to which F-gases would partition after emission under reasonably foreseeable conditions of use. Therefore, F-gases themselves do not fulfill the P or vP criterion as specified in Annex XIII of REACH. 14 (Scheringer et al., 2022), See Reference List for complete reference 15 (Boethling et al., 2009), See Reference List for complete reference 16 (ECHA, 2017), See Reference List for complete reference 17 (Guhl & Steber, 2006), See Reference List for complete reference 34 According to Technical Guidance Document R.7.9.5.118 it may be considered for substances that are gases under ambient conditions that they are removed from the aquatic compartment via volatilization and may be exempted from the general recommendation that volatilization is not a degradation mechanism suitable for use in classification. Therefore, water, soil and sediment are not environmentally relevant compartments for F-gases. The Dossier Submitters state that "all PFASs in the scope of this restriction proposal are either very persistent themselves, or degrade into very persistent PFASs in the environment". We do not consider that this can be assumed for F-gases. In the case of F-gases as such, these substances would not be identified as persistent according to REACH Annex XIII. Therefore, it should not be assumed that all Fgases are persistent. Equally, it should not be assumed that all PFAS F-gases degrade into persistent PFASs, such as TFA. We request that the scope of any proposed restriction acknowledges that F-gases meeting the OECD definition of PFAS may not meet the REACH Annex XIII criteria for persistence (because they do not partition to a compartment with established P criteria) and may not, because of their specific chemistry, degrade to a PFAS that would meet the Annex XIII criteria in a relevant compartment, such as TFA. Such a consideration should apply to both currently existing F-gases and to substances or products that could be developed in the future that would meet the definition of PFAS used to define the scope of any restriction. Therefore, the scope of the restriction should include an explicit mechanism or text that specifically and unambiguously excludes PFAS F-gases that do not degrade to persistent PFASs as these substances do meet the minimum criteria (i.e., persistence) that would bring them within the domain of the conclusions of the case-by-case risk assessment. If non-persistent substances (as such, or via their degradation products) are included within the scope of the restriction this would be a disproportionate regulatory measure and would be a failure of the Annex XV effectiveness criterion that requires restrictions to be `targeted to the identified risk'. F-gases are characterized by relatively high vapor pressures and limited water solubility. Hence, if released, they will partition strongly into the atmospheric gas phase, where reaction with OH radicals results in gas-phase removal of the substances, rendering partitioning into water and soil compartments of these highly volatile compounds negligible. For example, HFO-1234yf is a highly volatile gas (normal boiling point = -29 C, vapor pressure = 607 kPa at 21 C) with limited water solubility (198 mg/L at 24 C) and a dimensionless Henry's Law constant of 1 10-3 M atm-1. As pointed out by Wallington19, it is well established that substances with Henry's Law constants below approximately 103 M atm-1 partition strongly.20 Strong partitioning of HFO-1234yf to the atmospheric gas phase, combined with rapid gas phase removal precludes contamination of aquatic environments and soils by HFO-1234yf. In addition, HFO-1234yf cannot be considered as a persistent substance, as such, because of its rapid degradation in the atmosphere. Nevertheless, as acknowledged above and shown in Table 1.1, some TSS substances degrade to TFA if emitted. However, certain F-gases have an estimated TFA yield that is particularly low and, more specifically, for HFO-1234zeE, HFO-1336mzzZ, HFO-1336mzzE and HCFO-1233zdE the principal degradation products are limited to HF, HCl and CO2, with TFA constituting a "minor degradation product," as acknowledged by the Dossier Submitters in paragraph B.4.1.3.2. 18 (ECHA, 2011), See Reference List for complete reference 19 (Wallington & Anderson, 2015), See Reference List for complete reference 20 (Nielsen et al., 2007), See Reference List for complete reference 35 Furthermore, as indicated by the Dossier Submitters on page 48, Annex XV, "a specific case for excluding a PFAS from the scope of the proposed restriction could be made if sufficient evidence is provided that the specific PFAS is not very persistent itself and does not degrade into a very persistent PFAS". We interpret this statement as justification to request that, if F-gases remain within the scope of the restriction, those that do not degrade to TFA (or another persistent substance) or which degrade with low TFA (or another persistent substance) yield should be excluded from its scope. Specifically, as elaborated subsequently in in Section 1.4 on environmental risk assessment, we recommend that substances with an estimated TFA yield below 10%, which might be considered as "minor degradation product" according to the Dossier Submitters, should be excluded from the scope of the proposed restriction. This is because these substances have a negligible contribution to the global TFA budget and, as for all F-gases, they can be concluded to pose a de minimis risk to human health and the environment both currently and in the future. This recommendation should apply to existing low TFA yield F-gases, such as HFO-1234zeE, HFO-1336mzzZ, HFO-1336mzzE and HCFO-1233zdE as well as to substances that may be developed in the future that might meet any structural definition used to define this scope of a restriction. Such a request should apply if the justifications on the low-risk of all F-gases provided in this Chapter and in Chapter 2 are not considered sufficient to exclude all F-gases from the scope of the restriction. TSS substances should be treated as threshold substances as DNELs and PNECs can be reliably derived and used as the basis for robust, protective, quantitative risk assessment. In section 1.1.6 of the Annex XV report (risk characterization) it is highlighted that "PFASs should be treated as non-threshold substances for the purpose of risk assessment in a similar manner to PBT/vPvB substances." TSS substances are registered under REACH, and in each dossier where a risk assessment is required, safe use of the substance has been reliably and robustly demonstrated based on quantitative risk assessment methodology that demonstrates that risks are adequately controlled. The need for a non-threshold rationale for TSS substances has not been demonstrated by the Dossier Submitters for TSS substances. With respect to TFA (the degradation product of some F-gases), which fulfills the PFAS definition in use in the proposed restriction, similar considerations should apply. Specifically, EFSA considered TFA as a threshold substance by proposing an acceptable daily intake (ADI) of 0.05 mg/kg bw per day.2 By assuming that PFAS should be treated as non-threshold substances, as indicated by the Dossier Submitters, TFA would be assessed differently under different pieces of legislation, breaching the "One Substance One Assessment principle". Moreover, the Dossier Submitters state that "derivation of DNELs/DMELs is not considered relevant for this dossier since PFASs should be treated as non-threshold substances for the purposes of risk assessment." The derivation of DNELs for TSS substances and for TFA is appropriate given their extensive datasets, evidence of threshold-based effects and absence of PBT/vPvB properties. Applying a nonthreshold approach to risk assessment essentially assumes that any exposure signifies risk, which is not appropriate for TSS substances. Therefore, derivation of DNELs and PNECs and quantitative risk characterization is considered to be relevant and reliable for TSS substances and they should be treated as threshold substances , as also supported by the information reported in Section 1.2, discussing the hazard assessment. 36 Section 1.2 - Human Health and Environmental Hazard Assessment This section of the document discusses both human health and environmental hazard assessment, focusing on a comparison between the hazards of TSS substances (and TFA) and the hazards of the `model PFASs' referred to by the Dossier Submitters in the restriction proposal to develop the `case-by-case' approach that underpins the risk assessment for the PFAS class. The aim of this comparative assessment is to show the significant differences between the hazard and risk properties of F-gases (and TFA) compared to specific longer-chain PFASs used as a `model' by the Dossier Submitters to derive conclusions on both hazard and risk assessment for the entire PFAS group, including F-gases and TFA. In line with the considerations on substance classification and safe use reported in Section 1.1, we provide additional evidence and data to demonstrate that the hazards and risks of F-gases and TFA are demonstrably different from the hazard and risks of PFASs used to develop and evidence the 'case-bycase' concern and that these differences are of such an extent that 'safe use' of F-gases can be demonstrated by means of conventional REACH risk assessment and that, therefore, they should be excluded from the scope of the restriction. Environmental fate and environmental risk assessment are discussed in Section 1.3 and Section 1.4, respectively, where additional information supporting the hazard and the risk assessment is provided, with a specific focus on TFA. Hazard assessments for both F-gases and TFA are available and contain sufficient data to derive reliable and robust quantitative health benchmarks. The hazard assessment of both TFA and TSS are based on extensive and robust toxicological and ecotoxicology datasets that are sufficient to derive reliable and robust quantitative health benchmarks, as also highlighted in Section 1.1. Under REACH, uses for substances that are registered above 10 tonnes per year and classified for human health or for the environment are subject to a chemical safety assessment (a risk assessment), which is part of the Chemical Safety Report that accompanies the substance registration dossier. The purpose of the risk assessment is to demonstrate that the risks related to the different registered uses of the substance are adequately controlled (sometimes termed `safe use'). Moreover, F-gases registered in the EU are also substances approved by the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE)21 and ISO 817.22, 23 These two standard-setting organizations have established uniform systems for assigning safety classifications and refrigerant concentration limits to refrigerants based on toxicity and flammability data. One step in that approval is determining a safety class for the substance based on its occupational exposure limit (e.g., WEEL or TLV). The occupational exposure limit is derived by an independent, non-governmental global committee composed of professional experts across a wide range of health-based disciplines. Based on established safety standards, ASHRAE/ISO 817 unambiguously determines the safety class and derives the refrigerant concentration limit for each refrigerant in cooling equipment for safe use of that equipment. Therefore, in addition to the REACH CSR, there is another level of data review by an interindustry panel that also ensures that the predicted exposure to people is well below exposure levels for which adverse health effects may occur. 21 (ANSI/ASHRAE, 2022), See Reference List for complete reference 22 (ISO 817 REFS: ISO 817, 2014), See Reference List for complete reference 23 (ISO 817:2014/Amd 1, 2017), See Reference List for complete reference 37 The qualitative hazard assessment presented in the Annex XV report is not scientifically sound and has significant limitations. The Annex XV report (Annex B, section B.5) states that "the Dossier Submitters applied a qualitative approach for the description of human health concerns of PFASs with focus on endpoints considered most relevant for long-term exposure: repeated-dose toxicity (with targets most consistently affected by PFASs in experimental animals: liver, kidney, thyroid, immune system, and serum lipids), carcinogenicity, and toxicity to reproduction." The Dossier Submitters used this qualitative approach to associate long-term exposure to PFASs with various health concerns. Although the intent is understandable, this grouping / read-across approach to hazard assessment is associated with significant scientific limitations. This is because toxicology studies are designed to ensure that a sufficiently high concentration/dose is used to cause an effect so that hazards may be identified. The observation of an effect in an animal study does not necessarily indicate that a substance is of concern, or poses a risk, for human or environmental health under reasonably foreseeable conditions of use. In addition, expert interpretation of the observations is critical for determining biological plausibility, adversity, human relevance, and substance causality of the effect. In the animal studies referenced in Annex B, section B.5.2, the concentrations where human-relevant, adverse effects were observed are well above expected human exposure levels when the substances are used as intended. Equally, the information reported is not complemented by a comprehensive interpretation of observations, as well as the accompanying risk assessment. The alleged PFAS properties and concerns indicated by the Dossier Submitters are not applicable to Fgases and TFA to the extent that a case-by-case approach to risk assessment would be justified. The Dossier Submitters report a list of "Properties" and "Property-related concerns resulting from combinations of the properties" on page 23 of the Annex XV restriction proposal. It is also acknowledged that "the very high persistence is not sufficient to identify the PFASs as PBT or vPvB substances" (page 47, section 1.1.6) and that "the additional properties described above combined with the very high persistence add substantially to the overall concern which is very similar to those of the PBT/vPvB substances" (page 47, section 1.1.6). Considering both physical-chemical properties and hazard classification of TSS substances and TFA, we highlight the following in relation to the listed properties and property-related concerns: Very high persistence: as outlined above, the relevant environmental compartment for F-gases is air. In the case of F-gases, the definition of persistence cannot rely on the criteria set out in REACH Annex XIII, because the indicator considered for assessing the persistence of a substance (i.e., the degradation half-life) is not defined for the atmospheric compartment, but exclusively for water and soil. Regarding the degradation products, it is known that TFA, the atmospheric degradation product of some F-gases, is very persistent, but non-bioaccumulative and non-toxic (i.e., it does not meet the PBT/vPvB criteria), thus TFA and F-gases should not be grouped together with the `model PFASs' referred to by the Dossier Submitters. Long-range transport potential (LRTP): This non-REACH property describes the tendency of a substance to be transported though one or several environmental compartments over long distances and is typically associated with the identification of persistent organic pollutants (POPs) 38 under the UN Stockholm Convention. It is expressed in terms of a characteristic travel distance (CTD). As F-gases partition exclusively to air, we do not consider that this property, by itself, would constitute a relevant concern as neither TSS substances or TFA have other relevant properties, such as PBT/vPvB properties. Mobility: As elaborated subsequently in this document, it is questionable to consider "mobility as a concern" as stated by the Dossier Submitters because mobility per se does not constitute a toxicological or ecotoxicological hazard, but is rather a fate property. More specifically, factors like long-range transport, high water solubility, low volatility and low adsorption potentially all belong to a substance that is persistent or very persistent in water. Because of its persistence in water, the substance will travel with the water - hence mobility and high water solubility are a prerequisite for persistence in water, otherwise the substance would migrate to soil or sediment. Whereas mobility is not applicable to the air compartment, TFA might be considered as mobile. However, considering the absence of significant TFA toxicity (the substance does not fulfil the "T" criterion) and the de minimis risks posed by TFA emissions to human health end the environment (as shown in Section 1.4), the combination of persistence and mobility for TFA should not be considered to be of sufficient concern to justify a restriction. Accumulation in plants: F-gases do not have the potential to accumulate in plants, as their environmental compartment of relevance is air. Regarding TFA and its possibility to be accumulated in food chain, we refer to the recent EFSA assessment on TFA (reported later in this Chapter) as a relevant metabolite of plant protection products, that concluded that TFA exposure via the diet will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. Bioaccumulation: As earlier explained and further shown below, TSS substances and TFA are not PBT or vPvB substances according to the Annex XIII criteria in REACH. Ecotoxicity: There is no evidence on ecotoxicity for TSS substances. Further, ecotoxicity testing of F-gases requires an aquatic test system to be closed in order to prevent the volatilization of the F-gas. This represents a test condition that is not representative of environmental conditions and so therefore any conclusions that may be drawn from such studies would be very conservative. Regarding TFA, the available toxicological data do not support a "T status" according to the PBT criteria under REACH. Endocrine activity: TSS substances and their potential degradation products are not classified as endocrine disruptors. Justifications for non-classification of TSS substances and TFA are provided in this Chapter. Effects on human health: TSS substances and TFA have not been associated with any adverse effects on human health after human exposure. It will be demonstrated subsequently in this document that the extensive and robust toxicity datasets are available for TSS substances and TFA are consistent with substances with very low hazard potential. Considering the concerns listed by the Dossier Submitters related to the `combination of properties' described above, those would become relevant in case substances have toxicity or bioaccumulation concerns, which are not associated with TSS substances or TFA. Nevertheless, we highlight that: The high potential for ubiquitous, increasing and irreversible exposures of the environment and humans do not apply to F-gases and TFA because of (i) the existing regulatory framework for Fgases that is aimed at minimizing emissions of HFCs through both a quota phasedown and emission minimization measures, (ii) the short atmospheric lifetime of HFOs (and the future extension of the emission minimization measures to HFOs) and (iii) the de minimis risk posed by 39 TFA to human health and the environment currently and in the future. These aspects will be discussed in detail in Section 1.4 and Section 1.5. Regarding the difficulty to decontaminate intake water for drinking water production, low effectiveness of end-of-pipe RMMs and difficulty to treat contaminated sites, as well as the high potential for human exposure via food and drinking water, these concerns are not applicable to either F-gases or TFA for the reasons summarized above and elaborated subsequently in this document (existing EFSA assessment of TFA and information on environmental risk assessment reported in Section 1.4). Concerning the uncertainty about the estimation of future exposure levels and safe concentration limits, we refer again to the existence of emission modelling studies and related assumptions of future emissions of F-gases and TFA, which will be discussed in Section 1.4. The Global Warming Potential (GWP) is a property of some F-gases, specifically HFCs, which are characterized by longer atmospheric lifetimes compared to HFOs. However, the existing regulatory framework for F-gases aims at reducing emissions of HFCs through both a quota phasedown and emission minimization measures, thus we believe that this concern is properly addressed by the existing legislation, without the need of a restriction. This is also reported in Section 1.5. Moreover, regarding the combination of the properties listed above, the Dossier Submitters claim that because many different PFASs are considered to co-occur in the environment, drinking water and food, an assessment of hazards and risks considering such combined exposure would reflect more realistic exposure conditions compared to single compound assessments. Some references that the Dossier Submitters used to substantiate this claim evaluated mixtures containing only four24 or five25 compounds out of 10,000 PFASs that are claimed to exist. Such a small sample size renders unreasonable to make such a broad extrapolation to an entire class of compounds from such a small sample cohort (i.e., 0.05% coverage of the set) - e.g., Hoover et al. tested four different PFAS (perfluorooctane sulfonate (PFOS); perfluorooctanoic acid (PFOA); perfluorohexane sulfonate (PFHxS); and perfluorohexanoic acid (PFHxA)) in an amphibian fibroblast model to demonstrate that that certain mixtures of PFAS may have increased toxicity potential above what the simple sum of PFAS concentrations would suggest. Of note, this assay provided results with unknown relevance to human health. Further, neither mixture reference included any F-gases making the extrapolation to that group even less appropriate. This thinking is inconsistent with EFSA's "Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals"26. According to EFSA, the principles of tiering allow for simple and conservative risk assessment approaches at lower tiers, and more complex and precise approaches at higher tiers when needed. EFSA maintains that the application of dose addition requires a decision on the grouping of chemicals into one or more assessment groups which, according to the underlying theory, have a `similar action' or more pragmatically `substances affecting the same target organ' and `substances having a common adverse outcome'. Given the extremely low potency of TFA and F-gases relative to other PFASs, it would be inappropriate to apply a lower tiered approach to their risk assessments. 24 (Hoover et al., 2019), See Reference List for complete reference 25 (Ojo et al., 2021), See Reference List for complete reference 26 (More et al., 2019), See Reference List for complete reference 40 The available information on classification demonstrates that the hazards of the `model PFASs' used by the Dossier Submitters to develop and evidence the 'case-by-case' concern are significantly different from the hazards of F-gases and TFA and, therefore, it is not appropriate to read-across from them to F-gases. Human and environmental hazard as well as physicochemical properties differ substantially among the PFASs that are within the scope of the restriction proposal. Notably, there is a clear distinction between F-gases and the broader PFAS class. Table 1.4a reveals the vast differences in the chemical and physical properties of long-chain (C8-C10) PFAS substances compared to the short-chain F-gases HFO-1234yf, HFO1336mzzZ and HFC-134a. These differences clearly justify separate toxicological and ecotoxicological considerations for short and long-chain PFASs and that it is not appropriate to read-across hazard properties. For example, the boiling points of the two groups are vastly different, ranging from -29 to 33 oC for the three F-gases, (two of which are gases at room temperature, and one which is a highly volatile liquid) compared to 188 to 260 oC for long-chain perfluorocarboxylic and perfluorosulfonic substances, which are all high boiling point liquids. Vapor pressures at ambient temperatures for the long-chain (C8-C10) PFAS substances are low, ranging from 0.00033 to 4.2 Pa. Similarly, vapor pressures at ambient temperatures for F-gases are extremely high, ranging from 60,435 to 580,000 Pa, differently from the `model PFASs', as shown in Table 1.4a. It is well known that the vapor pressure of a substance plays an important role in its transport, distribution and fate in the atmosphere.27 Given the vast differences in their vapor pressures, the long-chain PFAS substances and the F-gases will differ significantly in their transport, distribution and fate. The high boiling point long-chain PFAS substances partition strongly into aqueous and soil phases, with little partitioning into the atmosphere, whereas the F-gases partition almost entirely into the atmosphere. Log Kow values can be measured for the F-gases, but not for the long-chain PFAS substances due to their forming multiple layers in an octanol-water mixture.28 In addition, the three F-gases reported as an example in Table 1.4a are nonionic compounds which do not dissociate into cationic/anionic pairs, as observed in the long-chain perfluorocarboxylic and perfluorosulphonic substances, as evidenced by pKa values. The long-chain perfluorocarboxylic and perfluorosulphonic substances have low pKa values and are strong acids. This compares to the three Fgases, which cannot dissociate due to a lack of relevant functional groups. The long-chain perfluorocarboxylic and perfluorosulphonic substances are characterized by a hydrophilic head consisting of carboxylates or sulfonates and a hydrophilic tail of fluorinated carbon chain, and this dual property makes them surfactants. The three F-gases lack such properties and hence do not act as surfactants. The Henry's Law constant provides an indication of a substance's volatility/partitioning from water.29 For the F-gases, the Henry's Law constants range from 0.1 to 0.9 atm m-3 mol-1, indicating the materials are very readily volatilized from water, partitioning almost exclusively into the atmosphere. Compare this to PFOA whose Henry's Law constant of 3.57 x 10-6 atm m-3 mol-1 indicates it is very slightly volatile from water and will hence partition almost exclusively into the water compartment. 27 (Bhhatarai, B. and Gramatica, P., Environ. Sci. Technol, 2011), See Reference List for complete reference 28 (ATSDR, 2021), See Reference List for complete reference 29 (Sustainable Futures / P2 Framework Manual, 2012), See Reference List for complete reference 41 Table 1.4a - Comparison of chemical, physical and biological properties of four of the model PFAS used by the Dossier Submitters to develop and evidence the 'case-by-case' concern with F-gases. References are from: a (ATSDR, 2021)28; b (Sigma-Aldrich SDS)30; c (US EPA Emerging Contaminants-PFOS and PFOA, Nov 2017)31; d (Chemours SDS)32; e (Survey and environmental/health assessment of fluorinated substances in impregnated consumer products and impregnating agents, Survey of Chemical Substances in Consumer Products, No. 99 2008)33; f (Confidential_PBT_Assesments_ChemoursFluorochemicals_F-gas Response.xlsx)34; g (CSR 1234yf)35; h (Im, J.; Walshe-Langford, G. E.; Moon, J.-W.; Lffler, J. E. Environmental fate of the next generation refrigerant 2,3,3,3- tetrafluoropropene (HFO-1234yf). Environ. Sci. Technol. 2014, 48,13181)36; i (CSR cis-1,1,1,4,4,4-hexafluoro-2- butene - 3290)37. Abbreviation PFOA PFNA PFDA PFOS HFO-1234yf HFO-1336mzzZ HFC-134a Name Perfluoro-octanoic Perfluoro-nonanoic Acid Acid Perfluorodecanoic Acid Perfloro-octane 2,3,3,3sulfonic acid tetrafluoro-1propene Z-1,1,1,4,4,4hexafluoro-2- butene 1,1,1,2Tetrafluoroethane CAS# 335-67-1 375-95-1 335-76-2 1763-23-1 754-12-1 692-49-9 811-97-2 Formula CF3(CF2)6COOH CF3(CF2)7COH CF3(CF2)8COOH CF3(CF2)7SO3H CF3CF=CH2 Z - CF3CH=CHCF3 CF3CH2F # of Carbons Molecular weight 8 414.07a 9 464.08a 10 514.084 a 8 500.03 a 3 114.04 d 4 164.05 d 2 102.03 d Boiling Point, oC 188a 218 b 219a 258-260c -29 d 33 d -26 d Solubility in Water, mg/L Vapor Pressure, Pa 20 oC log Kow 9,500 a 2,290 a 3,300 a Not available 260 e 4,340 a 4.2 a (25 C) 2.3 a (20 C) 0.64 a 0.102 a Not measurable as substances form multiple layers in octanol-water mixture a 570 a 0.00033 a Not applicable a 192.8 d 580,000d 2 g 763.3 d , f 60,435d,f 2.3 d, f 1500d 570,000d 1.06 d, f Henry's Law Constant, atm m3 mol-1 3.57 x 10-6 a Not available Not Available Not measurablec 0.954 h 0.127 i 0.101 f pKa log Koc -0.5, 0.5 a 2.06 a -0.21 a 2.39 a -0.17 a 2.79a 0.14 a 2.57 a Since the substance cannot dissociate due to a lack of relevant functional groups, the dissociation constant is irrelevant <1.26 g 2.51 sewage sludge ; 2.48 soil f,i 1.57 f Therefore, these data clearly demonstrate that the physical and chemical properties of the F-gases and the long-chain PFAS substances are not sufficiently comparable to reliably read across any of the hazard properties from long-chain substances to F-gases, as proposed by the Dossier Submitters. This questions 30 (Sigma-Aldrich), See Reference List for complete reference 31 (EPA, 2017), See Reference List for complete reference 32 (Chemours SDS), See Reference List for complete reference 33 (Jensen & Poulsen, 2008), See Reference List for complete reference 34 (Confidential Chemours Information), See Reference List for complete reference 35 (ECHA, Registration dossier-a), See Reference List for complete reference 36 (Im et al., 2014), See Reference List for complete reference 37 (ECHA, Registration dossier-b), See Reference List for complete reference 42 the appropriateness of including short-chain PFASs, such as F-gases and TFA, within the scope of the caseby-case risk assessment. Similarly, the very short chain (C2) perfluoroalkylcarboxylic acid (PFCA), TFA and its conjugate base, trifluoroacetate anion, exhibit different chemical, physical and biological properties compared to longer chain PFCAs and their conjugate bases, as it can be seen in Table 1.4b. Properties such as Log Kow (a measure of partitioning between lipids in organisms and water), Koc (a measure of adsorption to soil and sediment), and half-life in humans (a measure of the duration of internal exposure or dose) all vary with changes in the length of the carbon chain which are well recognized as determinants of adversity.1 Table 1.4b - Comparison between chemical, physical and biological properties of PFCAs with different chain lengths. Unless otherwise stated, references are from (PubChem, 2022 National Center for Biotechnology Information, U.S. National Library of Medicine.)38, a (RSC, 2022)39; b (NICNAS, 2016)40; c (EFSA 2020)41 ; d (Chabot, 2017)42; e (Boudreau, 2002)43; f (Wang et al., 2014)44; g (ATSDR, 2021)28; h (Boutonnet et al., 1999)45; i (SigmaAldrich SDS)30; j (Chemical Book)46 Abbreviation TFA PFPrA PFBA PFPeA PFHxA PFHpA PFOA CAS# Formula 76-05-1 CF3COOH 422-64-0 CF3CF2C OOH 375-22-4 CF3(CF2)2C OOH 2706-90-3 CF3(CF2)3C OOH 307-24-4 CF3(CF2)4C OOH 375-85-9 CF3(CF2)5C OOH 335-67-1 CF3(CF2)6COOH # of Carbons 2 3 4 5 6 7 8 Molecular weight 114.02 164.03 214.04 264.05 314.05 414 414.07 g Boiling Point, oC 73 96.5 121 140 a 157 188-192 188 g Solubility in Water, mg/L Miscible Miscible Miscible 122,600 21,700 3400-9500 3300 g Vapor Pressure, Pa log Kow Henry's Law Constant, atm m3 mol-1 15,800 i 0.5 1.11 x 10-7 5322 j 1.5 a 4.43 x 10-6 a 1307 a 2.43 a 0.0051 a 1057 3.262 a 0.029 a 263 3.48 0.174 a 1.77 a 5.024 a 1.521 a 4.2 g Not measurable g 3.57 x 10-6 g pKa 0.3 0.38 a -0.9 -0.06 -0.13 -0.15 -0.5 and 0.5 g Koc , L/kg 0.17-20 12.7 a 58 a 270 a 1247 a 5761 115 g Half-life in rats Half-life in humans 30 h h 16 h h NA 1-9 h NA 72-81 h NA 2-5 h 1.4-2.4 h NA 14-49e days 1.2-1.5 yr 44-322 h 2.1-10 yr Classification information for four of the "model PFASs" (PFOA, PFNA, PFDA, and PFOS), used as a reference by the Dossier Submitters in the restriction proposal to develop and evidence the 'case-by-case' approach, is shown in Table 1.5, along with the relevant environmental compartments for environmental 38 (PubChem, 2022), See Reference List for complete reference 39 (RSC, 2022), See Reference List for complete reference 40 (NICNAS, 2016), See Reference List for complete reference 41 (Schrenk et al., 2020), See Reference List for complete reference 42 (Chabot, 2017), See Reference List for complete reference 43 (Boudreau, 2002), See Reference List for complete reference 44 (Wang et al., 2014), See Reference List for complete reference 45 (Boutonnet et al., 1999), See Reference List for complete reference 46 (Chemical Book, 2017), See Reference List for complete reference 43 receptors upon unintended release of the substances. The relevant environmental compartment information is based on each substance's physicochemical and environmental distribution properties. All model PFASs are associated with the prioritized hazard classes listed in Table B3 and B4 of Annex B of the Annex XV report. Most of them also meet the criteria for a PBT or vPvB substance. On the contrary, TSS substances and TFA are not classified for any of these listed properties, which questions the reliability of the read-across of hazard properties and the conclusions of the case-by-case risk assessment in relation to short-chain PFASs, such as F-gases, and consequently, the scientific justification for including F-gases within the scope of the proposed restriction. Therefore, we consider that it has not be proven with sufficient scientific rigor that short-chain PFASs pose a risk to human health or the environment that is not adequately controlled. In the absence of a robust conclusion, F-gases should not be included within the scope of the proposed restriction. Table 1.5 - Classification, PBT status and relevant environmental compartment of the four model PFASs used in the restriction proposal to develop and evidence the `case by case' approach. Common Substance name EC number CAS number Harmonized Classification for CMR, Lact and/or STOT RE Harmonized Classification for Environment Fulfilling PBT/vPvB criteria? Relevant environmental compartment Carc. 2; H351 / Repr. PFOA 206-397-9 335-67-1 1B; H360D / Lact.; H362 / STOT RE 1; None Yes Water H372 [liver] Carc. 2; H351 / Repr. 1B; H360Df / Lact.; PFNA 206-801-3 375-95-1 H362 / STOT RE 1; None Yes Water H372 [liver; thymus; spleen] Carc. 2; H351 / Repr. PFDA 206-400-3 335-76-2 1B; H360Df / Lact.; None Yes Water H362 Carc. 2; H351 / Repr. PFOS 217-179-8 1763-23-1 1B; H360D / Lact.; H362 / STOT RE 1; None Yes Water H372 F-gases and TFA do not have bioaccumulation properties, which is different to most of the model PFASs referred to in the Annex XV report. In Annex B, section B.4.2.9, the Dossier Submitters report data from modelling, laboratory, and field studies as well as from monitoring campaigns to discuss PFAS bioaccumulation. As also stated previously, TSS substances as well as TFA are not classified as PBT/vPvB, thus they do not meet the Annex XIII REACH criteria for bioaccumulation. Due to their physicochemical properties (high Henry's Law Constant) and low Log Kow, F-gases do not have the potential for bioaccumulation in aquatic organisms (see respective REACH dossiers). The most likely route of air-breathing organism exposure to F-gases is via inhalation. Based on the weight of evidence 44 from several toxicokinetic studies, F-gases are rapidly absorbed during inhalation exposures47, 48, 49, 50, 51 (see respective REACH dossiers). F-gases are only slightly soluble in blood and tissue as evidenced by their blood/air and tissue/air partition coefficients. Consequently, they are poorly taken up into the blood following inhalation and do not accumulate in organs or tissues. Any F-gas that is absorbed will be eliminated primarily by exhalation, without biotransformation or degradation. No quantitative conclusions can be drawn with respect to absorption, distribution, metabolism, and/or excretion, as no mass balance is feasibly (and safely) determined in any of the in vivo studies (i.e., it is neither practical or safe to conduct inhalation exposure studies with radiolabeled test substance). However, since very little (e.g., for HFO-1234yf less than 0.1%) of the administered dose is recovered from urine in the form of metabolites, biotransformation appears to be low and most of the absorbed test substance will have most likely been exhaled as parent compound. In a study52 where male rats were exposed via inhalation for 6 hours to 1000, 5000 or 50,000 ppm HFC-125, the compound was poorly absorbed during the exposure and rapidly eliminated from the body. The authors concluded that no bioaccumulation would be expected following inhalation exposures and that HFC-125 is relatively inert and undergoes little metabolism in rats. TFA is not classified as PBT or vPvB. It is an acidic liquid, with a pH of approximately 0.45 and is fully miscible in water, where it will exist under its ionized form. Because of this and its estimated Log Kow of 0.5, TFA has a low potential for bioaccumulation in aquatic organisms. Considering both the results of the studies and the TFA physicochemical properties, the following toxicokinetics can be assumed: TFA is rapidly absorbed by the oral route of exposure and after skin contact at non-corrosive/irritant concentrations, considering both the moderate partition coefficient Log Kow (and its high solubility in water, together with its molecular mass (114 g/mol). Inhalation of TFA vapor may occur at room temperature followed by absorption considering the physicochemical properties described above. After oral exposure, TFA is submitted to enterohepatic circulation, distributed in the body via the blood in its ionized form considering its distribution coefficient log D (-0.58), and excreted mainly in the urine and in the bile (to a lesser extent) as parent compound (ECHA dossier). Together, these data support the conclusion that bioaccumulation of TFA in air-breathing organisms is unlikely. As opposed to F-gases and TFA, C11-C14 PFCAs and C6-PFSA have been shown to fulfil the vB-criterion and C8-C10-PFCA the B criterion (vB not assessed) under REACH. According to the data and as stated in the Annex XV restriction report (section 1.1.4.6), "studies with mammalian species show that PFASs are readily absorbed and distributed across various tissues and that some PFASs (particularly long-chain PFASs) have a long half-life in organisms. Data for PFCAs and PFSAs and some PFECAs indicate that PFASs partition to proteins. Binding to albumin and transporter proteins, which are classes of proteins that are ubiquitously expressed, efficiently distributes PFASs into different tissues, and enhance passage across brain, placental barriers, and transfer via milk. Accordingly, PFASs do not follow typical accumulation patterns, i.e., partitioning into adipose tissue, but rather bind and accumulate in protein-rich organs like the liver." And, "among the 43 PFASs for which mean BCF and BAF studies are available in different aquatic species 62% (27 compounds) have a BCF and/or BAF values above the threshold for fulfilment of the Bcriterion in REACH Annex XIII". These quotes from the Annex XV report show that data for specific PFAS subgroups are inappropriately extrapolated to characterize the whole PFAS class. The bioaccumulation 47 (Rusch, 2018), See Reference List for complete reference 48 (Morgan, 1972), See Reference List for complete reference 49 (Emmen et al., 2000), See Reference List for complete reference 50 (Ernstgrd et al., 2012), See Reference List for complete reference 51 (Gunnare et al., 2006), See Reference List for complete reference 52 (HFC-125 Registration dossier), See Reference List for complete reference 45 properties of F-gases, particularly, are demonstrably different from the bioaccumulation properties of the modal PFASs used by the Dossier Submitters to develop the case-by-case risk assessment approach. Therefore, the conclusions of the case-by-case risk assessment should not apply to F-gases. In addition to their overall lack of chronic toxicity, based on toxicokinetic studies in animals and humans, F-gases do not demonstrate biopersistent properties in air-breathing organisms. Once inhaled, F-gases are poorly absorbed into the body, and rapidly exhaled unchanged. Biotransformation is very low and the majority of the absorbed test substance will have most likely been exhaled as parent compound. Clearance rates are rapid with half-lives on the order of minutes. Blood to air partition coefficients are generally below two. F-gases and TFA are not classified for human health endpoints, differently from most of the model PFASs referred to in the restriction proposal. In a 2022 paper by Anderson et al., focused on PFAS grouping for human health risk assessment purposes, most of the experts consulted agreed that "it is inappropriate to assume equal toxicity/potency across the diverse class of PFAS."53 Such a statement is supported by the fact that there are still significant challenges to develop a practicable and technically sound grouping approach that considers the chemical variety of PFASs, including, among others, the current lack of agreement on a common mode of action and the likelihood that mode of actions are species- and/or tissue-specific. Similarly, in a report by the United Nations Environmental Effects Assessment Panel (which consists of a collection of international scientists working in photobiology and photochemistry, mainly in universities and research institutes), the authors state that "this same argument applies to the inclusion of TFA, with a two-carbon chain and a single CF3 group, into a class with longer chain PFAS"1. The Dossier Submitters applied a qualitative approach for the description of human health concerns with focus on endpoints considered most relevant for long-term exposure: repeated-dose toxicity (with targets most consistently affected by model PFASs in experimental animals: liver, kidney, thyroid, immune system, and serum lipids), carcinogenicity, and toxicity to reproduction. The endpoints acute toxicity, irritation, corrosiveness, and sensitization were not considered relevant by the dossier submitters for the human health risk assessment of the restriction proposal for PFASs. Mutagenic effects were also not considered further for the PFAS hazard assessment. The associations between PFASs and human health outcomes reviewed in the restriction dossier were mostly based only long chain PFASs, such as PFOS and PFOA. The long chain PFASs are very different in physical properties compared to F-gases (HFCs, HFOs and HCFOs), as also shown previously in Table 1.4a. Only three studies regarding ultrashort-chain PFASs such as trifluoroacetic acid (TFA) were reviewed in the restriction dossier. Although TFA has been detected in serum, no association between TFA exposure and health outcomes have been reported. The first study was conducted among a Chinese population with an unknown source of TFA exposure (Duan et al., 2020). The dossier submitters incorrectly interpreted the findings of this study in the Annex XV report and stated the sum of ultrashort-chain perfluoroalkyl carboxylic acids (PFCAs C2-C3: TFA & PFPrA) was positively associated with glycemic biomarkers linked to increased risk of diabetes. In fact, it was an inverse association between PFCAs C2- 53 (Anderson et al., 2022), See Reference List for complete reference 46 C3 and HbA1c level in adjusted model with an estimate of -0.014 (95%CI: -0.027-0.001) and p value = 0.037, which is an indication of a protection effect, rather than the implied adverse effect. The same inverse association for individual substance of TFA and PFPrA was not statistically significant at p value=0.05. This was a cross-sectional study conducted among volunteer staff and support workers at Nankai University (China). Therefore, the study results are not generalizable, and causality could not be inferred. The source of TFA exposure among this specific study population could come from many sources such as laboratory reagents, by-products in the chemical synthesis process, and degradation of pharmaceuticals and plant protecting agents with tri-fluoromethyl moieties. Two other studies were conducted among the Sweden population. Although TFA was detected among blood samples in Swedish studies (Aro et al. 2020b, 2021c - as referenced in Annex B of the restriction proposal), the concentrations were below the limit of quantification (LOQ) with poor recovery in the blood samples. For the first study (Aro et al., 2021c), 148 blood samples (92 samples were detected for TFA) were obtained from people who donated blood with unknown source of TFA exposure. In the second study (Aro et al., 2020b), 20 blood samples (1 sample was detected for TFA) were obtained from individuals living in a single municipality of Ronneby who are known to have been exposed to PFASs from firefighting foams used at a nearby military airport via consumption of PFAS contaminated drinking water. Unlike the properties of the model PFASs reported the restriction dossier, neither F-gases nor TFA are classified for human health endpoints, as also reported previously in this document. Justifications for classification and non-classification are based on extensive studies conducted for each substance's respective REACH registration. The data consist of robust toxicological testing primarily conducted under Good Laboratory Practice (GLP) conditions and according to internationally accepted and validated testing guidelines. A summary of data that are currently available for these endpoints is shown in Attachment 3, Annex I. As an example, a summary of the data available for HFO-1234yf, HFO-1336mzzZ and TFA is reported in Table 1.6 below. A complete description of the data shown in Table 1.6 is provided in Attachment 3, Annex I. Table 1.6 - Summary of available toxicity data for HFO-1234yf, HFO-1336mzzZ and TFA, reported as an example. Full information is available in in Attachment 3, Annex I. HFO-1234yf HFO-1336mzzZ TFA Name 2,3,3,3-tetrafluoropropene (2Z)-1,1,1,4,4,4-Hexafluorobut2-ene Trifluoroacetic Acid EC Number 468-710-7 700-651-7 200-929-3 CAS Number 754-12-1 692-49-2 76-05-1 ACUTE TOXICITY Acute Inhalation Lethality 4-hr LC50 > 405,000 ppm (> 1887 mg/L), rat 1-hr NOAEC > 100,000 ppm (> 466 mg/L), rabbit 4-hr LC50 > 102,900 ppm (> 690 mg/L), rat 4-hr LC50 > 64 ppm (> 0.3 mg/L), rat Acute Cardiac Sensitization NOAEL = 120,000 ppm LOAEL > 120,000 ppm NOAEL = 12,500 ppm LOAEL = 25,000 ppm no data Dermal Irritation Eye Irritation Skin Sensitization In vitro None None None Negative (mutagenicity & clastogenicity) None None None GENOTOXICITY Negative (mutagenicity & clastogenicity) Corrosive Corrosive None (read-across) Negative (mutagenicity & clastogenicity) In vivo Negative (clastogenicity) Negative (clastogenicity) no data 47 Inhalation Oral Developmental Toxicity Reproductive Toxicity Acute Aquatic Toxicity Chronic Aquatic Toxicity REPEAT DOSE TOXICITY 13-week NOAEC = 50,000 ppm, rat* 4-week NOAEC = 10,000 13-week NOAEC = 5000 ppm, ppm, minipig* rat 4-week NOAEC = 500 ppm, rabbit Not a relevant route of exposure. Not a relevant route of exposure. DEVELOPMENTAL & REPRODUCTIVE TOXICITY Not a developmental toxicity hazard, rat & rabbit Fetal NOAEC = 50,000 ppm (rat developmental)* Fetal NOAEC = 4000 ppm (rabbit developmental) Not a developmental toxicity hazard, rat & rabbit Fetal NOAEC = 1500 ppm (rat developmental) Fetal NOAEC = 7500 ppm (rabbit developmental) Not a reproductive toxicity hazard, rat NOAEC = 50,000 ppm (twogeneration repro)* Not a reproductive toxicity hazard, rat NOAEC = 2500 ppm (twogeneration repro)* ECOTOXICITY 96-hr LC50 > 197 mg/L, fish 48-hr EC50 > 100 mg/L, daphnia 72-hr EC50 > 100 mg/L, algae 96-hr LC50 76.1 - > 95.7 mg/L, fish 48-hr EC50 = 22.5 mg/L, daphnia 72-hr EC50 > 23.7 mg/L, algae No data NOAEC = 9.59 mg/L, fish NOAEC = 10.2 mg/L, daphnia NOAEC = 6.92 mg/L, algae Not a relevant route of exposure. 13-week NOAEL = 8.4 mg/kg, rat 52-week NOAEL = 37.8 mg/kg, rat* Not a developmental toxicity hazard, rat Fetal NOAEL = 150 mg/kg (rat developmental)* Developmental toxicity hazard, rabbit Fetal NOAEL not established, LOAEL = 180 mg/kg (rabbit developmental)*** Not a reproductive toxicity hazard, rat NOAEL = 242-265 mg/kg (extended one-generation repro)* 96-hr LC50 = 999 mg/L, fish 48-hr EC50 = 999 mg/L, daphnia 72-hr EC50 = 237 mg/L, algae (read-across) NOAEC = 3.8 mg/L, fish NOAEC = 25 mg/L, daphnia NOAEC = 5.6 mg/L, algae ENVIRONMENTAL FATE Biotic Degradation Not readily biodegradable Not readily biodegradable Not readily biodegradable Soil Adsorption no data 2.51 0.8 Coefficient (LogKoc) *highest exposure/dose tested; *** According to the dossier submitters, the findings seem to be rabbit specific since comparable findings were not observed in a developmental toxicity study in rats at comparable dose levels (TFA registration dossier).11 Further investigations are underway to elucidate the reason for the species differences and potential essential mechanism of action to fully understand the relevance of the findings for human health. Chemours participates in a partnership with other companies ("TFA Task Force") which operate under the EU Plant Protection Product Framework to collectively contribute to the reprotoxicological assessment of TFA. A conclusion on the classification and labelling of TFA will be postponed until the final results of the studies investigating the effects on development are available. 48 The EEAP (Environmental Effects Assessment Panel) 2022 UNEP Report highlights that "Trifluoroacetic acid (TFA) has biological properties that differ significantly from the longer chain polyfluoroalkyl substances (PFAS) and inclusion of TFA in this larger group of chemicals for regulation would be inconsistent with the risk assessment of TFA". The latest 2022 EEAP Report1 concluded that PFAS should not all be grouped together because of their different properties and characteristics, and TFA specifically should be excluded for that reason. Because the term PFAS includes thousands of substances, judging them as a group based on their persistence does not account for differing toxicities, potencies, or other characteristics. With additional regard to persistence as the regulatory criterion, the EEAP Report indicates that TFA does not bioaccumulate nor is it toxic at the low to moderate exposures currently measured in the environment, and indicates (page 290) that their "opinion is that persistence should only be considered as a regulatory criterion for substances that are moderately or highly toxic and/or are bioaccumulative in organisms and/or undergo trophic magnification" (i.e., undergo increasing concentration as they move across the nutritional levels in a food chain). The 2022 EEAP Report also indicates that TFA's chemical structure also separates it from the PFAS group, pointing out (page 278) that it is well known that perfluorocarboxylic acids (PFCAs) have "key chemical, physical, and biological properties that become quite different with increasing length of the carbon chain". It is therefore inappropriate to compare short-chain (C2) TFA with longer chain PFCAs which have vastly different physicochemical and biological properties, as also stated earlier when commenting Table 1.4b. Therefore, the need for risk management of TFA should be based on its own unique properties and not on the properties of longer chain substances. Additional evidence from the 2022 EEAP Report to support this statement is provided below: "Trifluoroacetic acid has biological properties that differ significantly from the longer chain polyfluoroalkyl substances (PFAS) and inclusion of TFA in this larger group of chemicals for regulation would be inconsistent with the risk assessment of TFA" (page 25). "TFA is a perfluorinated acid that has been included in the class of per- and polyfluoroalkyl substances (PFAS). This class of chemicals contains 4730 substances, of which about 256 are in commercial use. Even in the subclass of perfluorinated alkanoic acids, the physical, chemical, and biological properties of these substances differ widely, mostly in relation to length of the alkyl chain. To regulate these substances as a class (as has been suggested) is not scientifically defensible and TFA should be treated as a unique chemical for the purposes of regulation" (page 292). "The stability of TFA and its salts indicates a half-life >> 6 months, but our opinion is that persistence should only be considered as a regulatory criterion for substances that are moderately or highly toxic and/or are bioaccumulative in organisms and/or undergo trophic magnification. TFA does not bioaccumulate nor is it toxic at the low to moderate exposures currently measured in the environment or those predicted in the distant future" (page 290). 49 According to the European Food Safety Agency (EFSA), TFA exposure via the diet will not result in a consumer exposure exceeding the toxicological reference values derived for this metabolite and therefore is unlikely to pose a public health concern. The Dossier Submitters highlight that TFA "has been identified as a significant degradation product in numerous studies conducted as part of the EU evaluation of plant protecting active substances" (Annex B, section B.4.1.3.1). The European Commission had requested EFSA to perform a risk assessment2 of saflucenacil and its major metabolite, TFA and a comprehensive dietary consumer exposure assessment was performed as requested by the EC taking into account all sources. Sources included: 1) TFA residues in primary crops resulting from the use of saflufenacil; 2) TFA residues in rotational crops grown on fields previously treated with saflufenacil; 3) TFA residues resulting from other pesticides that are metabolized to TFA and where measurable TFA concentrations are expected in primary or rotational crops; and 4) TFA residues in food resulting from environmental contaminations (e.g., degradation of organic compounds containing a trifluoromethyl-group such as HFCs and HCFCs and industrial manufacturing sources). Food of animal origin derived from animals exposed to saflufenacil was also considered. However, EFSA concluded that this was not a significant source of exposure to TFA as metabolism studies performed to investigate the absorption, distribution, metabolism, and excretion of saflufenacil in rodent and livestock studies did not give any indications that TFA is formed as a metabolite. EFSA acknowledges that their estimations of TFA concentrations in the various crops were "very conservative." EFSA used TFA toxicological data submitted by the applicant (BASF) and a position paper submitted by Bayer Crop Science in its risk assessment. No acute consumer risk was identified in relation to the estimated TFA concentrations in food. EFSA concluded that for the intended use of saflufenacil on the crops for which Maximum Residue Limits (MRLs) were requested in the framework of the MRL application (EFSA-Q-2011-00208), including the Codex Maximum Residue Limits (CXLs) established by Codex Alimentarius Commission, TFA exposure via the diet will not result in a consumer exposure exceeding the toxicological reference values derived for this metabolite and therefore is unlikely to pose a public health concern. Additional assessments have been conducted and it has been determined that based on recent levels of TFA in water and diet, there is no indication of health risks to humans.54 Section 1.3 - Environmental fate This section describes the environmental fate of both F-gases and TFA. It also reflects on both natural and anthropogenic sources of TFA and the related potential transport mechanisms that might contribute to its partition into the environment. Whereas it is acknowledged that certain F-gases constitute one of the several anthropogenic sources of TFA, it is also highlighted that TFA is mainly a naturally occurring substance. 54 (Dekant & Dekant, 2023), See Reference List for complete reference 50 TFA is the predicted degradation product of the F-gases in the scope of the proposal. Environmental Fate of F-Gases. The environmental fate of those F-gases in the scope of the proposal is reaction with hydroxyl radicals (OH) in the troposphere, leading to H-abstraction in the case of the HFCs (HFC-125, HFC-134a, HFC-143a and HFC-227ea), and addition of OH to the double bond in the case of the HFOs and HCFOs (HFO-1234yf, HFO-1234zeE, HFO-1336mzzZ and HCFO-1233zdE). Following their initial reaction with OH, the resultant radicals undergo various atmospheric reactions to ultimately form final degradation products which include HF, CO2, and TFA (and HCl in the case of HCFO-1233zdE). The F-gases in scope of the proposal are all predicted to form TFA as a final tropospheric degradation product in yields ranging from minor (~2%) to quantitative following their release into the atmosphere1 . Atmospheric Lifetimes and Distribution of F-Gases and TFA. Table 1.7 shows the atmospheric lifetimes and other properties of the F-gases in scope of the proposal. The HFCs in the Table are long-lived, with atmospheric lifetimes ranging from 14 to 51 years. As discussed in the UNEP EEAP 2022 Assessment Report1 on page 292, long-lived HFCs will distribute globally and TFA from the HFC substances is more evenly deposited on a global basis. The HFOs and HCFOs in Table 1.7 have much shorter lifetimes in the atmosphere, ranging from 0.033 to 0.116 years, and deposition of the HFOs, HCFOs and TFA is likely to be more localized. This will result in greater concentrations of TFA near the locations of release. However, as noted in the 2022 EEAP Report1 this is unlikely to present a risk to humans or the environment in these locations but changes in concentration in surface water (or soil) would respond rapidly to releases. Monitoring of the environment for residues of TFA would provide an early warning if trends in concentration indicate rapid increases." Table 1.7 -Atmospheric lifetime, GWP and TFA yield of some F-gases in the scope of the restriction proposal. AR6 (IPCC Sixth Assessment Report) values are also included.55 F-Gas Structure Atmospheric lifetime, years (AR6) GWP, 100 year (AR6) TFA Estimated Yield, % TFA yield, upper Limit, % HFC-125 CF3CF2H 30 3740 1-10 - HFC-134a CF3CH2F 14 1530 7-20 - HFC-143a CF3CH3 51 5810 2 30 HFC-227ea CF3CHFCF3 36 3600 100 - HFO-1234yf CF3CF=CH2 0.033 0.501 100 - HFO-1234zeE E CF3CH=CHF 0.052 1.37 2 30 HFO-1336mzzZ Z CF3CH=CHCF3 0.074 2.08 4 60 HCFO-1233zdE E CF3CH=CHCl 0.116 3.88 2 30 Formation of TFA from F-Gases in Scope of the Proposal. The Table shows the estimated yields of TFA from the EEAP 2022 Report1 for the F-gases in scope of the proposal. The upper theoretical TFA yield limits shown are highly uncertain. For those F-gases where an upper limit is shown, tropospheric degradation involves the possible formation of CF3CHO hydrate (CF3CH(OH)2) from the hydrolysis of the intermediate degradation product CF3CHO. As also pointed out in the UNEP Report on page 315 "The contribution to TFA from CF3CHO hydrate formation and processing remains highly uncertain." 55 (IPCC, 2023), See Reference List for complete reference 51  Fate of TFA. As discussed in the World Meteorological Organization (WMO) SAP 2022 Report56 on page 137, "TFA is highly soluble and is scavenged from the atmosphere via rain, fog, and snow, as well as dry deposition. Some fraction of the TFA dissolved in cloud water can partition back into the gas phase when the cloud water evaporates. More than 90% of TFA is physically removed from the atmosphere via wet and dry deposition (about 80% via wet deposition and 10% via dry deposition), with an estimated global mean deposition lifetime of about 5-10 days. TFA is also chemically destroyed in the atmosphere by OH. This is estimated to be a minor loss channel (about 6%), with a global mean partial lifetime against OH of ~4 months. Criegee intermediate chemistry, under which ozone reacts with biogenic emissions of alkenes is a minor contribution to overall global TFA loss (<1%) but is important near the surface in the forested regions where biogenic emissions are high." Additional information on TFA degradation is provided in Attachment 3, Annex I. Anthropogenic TFA is the degradation product of different PFAS precursors, including plant protection products, medicinal products in addition to F-gases. The Dossier Submitters highlight that "TFA in precipitation was measured by Freeling et al.57 in samples collected in Germany over one year. The article points to anthropogenic sources, and in particular formation of TFA in the atmosphere by photodegradation of certain hydrofluorocarbons (HFCs), hydrochlorofluorocarbons (HCFCs), and unsaturated hydrofluorocarbons (hydrofluoroolefins, HFOs) as sources of atmospheric TFA." Such a statement is reported in Annex B, section B.1.3.1. However, this statement is misleading as there are numerous other anthropogenic sources of TFA besides HFCs, HCFCs, HFOs and HCFOs, such as TFA itself (which is used to produce other chemicals), certain fluoropolymers as well as certain pharmaceuticals, pesticides and reagents which contain a trifluoromethyl (-CF3) group.58 TFA is a naturally occurring substance. In Annex B, section B.1.3.1, the Dossier Submitters state that "natural sources for TFA in the oceans have been questioned." However, this statement is based on a single publication59 that differs in its conclusion from a number of other published studies.1Error! Bookmark not defined., 5858, 60, 61, 62, 63, 64, 65 The Joudan's paper concluded that "the presence of TFA in the deep ocean and lack of closed TFA budget is not sufficient 56 (WMO, 2022), See Reference List for complete reference 57 (Freeling et al., 2020), See Reference List for complete reference 58 (Solomon et al., 2016), See Reference List for complete reference 59 (Joudan et al., 2021), See Reference List for complete reference 60 (Lindley, 2023), See Reference List for complete reference 61 (UNEP, 2014), See Reference List for complete reference 62 (Frank et al., 2001), See Reference List for complete reference 63 (Scott et al., 2005), See Reference List for complete reference 64 (Norwegian Environment Agency, 2017), See Reference List for complete reference 65 (IPCC/TEAP Special Report, 2005), See Reference List for complete reference 52 evidence that TFA occurs naturally, especially without a reasonable mechanism of formation." However, a recent publication has provided an inventory accounting for most of the fluorspar employed in the production of fluorochemicals and the resultant TFA emissions, providing clear evidence that the quantity of TFA in the oceans must include a large natural burden. The 2022 EEAP Report1Error! Bookmark not defined. also supports the occurrence of natural TFA. In its comments on the publication59 questioning natural sources, the EEAP indicates that "the authors focused on atmospheric sources of TFA in surface waters and ice, which originates in precipitation and did not consider measurements in other bodies of water such as endorheic lakes and playas located in areas of low precipitation and little fluorochemical industry. One of these locations, the Dead Sea, had a reported concentration of 6400 ng L-1. 1 The Dead Sea is in a rift valley with a history of geological faulting and with a volume of 114 km, so that this concentration is equivalent to 730 tonnes of TFA. That this amount of TFA (measured in the 1990s) is all from anthropogenic sources is very unlikely, and geogenic sources are more plausible." The 2022 EEAP Report also states that "the background value of 200 ng TFA L-1 in the oceans as suggested by Frank et al.62 would be equivalent to 268 x 106 tonnes of TFA in the global oceans if well mixed globally. However, based on analyses in several oceanic basins, lesser amounts (a range of 61-205 x 106 tonnes equivalent to 45-152 ng L-1) were suggested by Scott et al.63 From the total known use and release of HFC134a, HFC-143a, and HFC-227ea between 1990 and 2015, the total amount of TFA that could theoretically have been produced is 4.5 x 106 tonnes. This is very much less than the total based on the range of concentrations measured in the oceans, which, using an estimated ten-fold range, would be equivalent to 27-270 x 106 tonnes. Even with this assumption, this is equivalent to a discrepancy of 6 to 60-fold that is much larger than would be explainable by anthropogenic activity in relation to use of the HFCs. This gap is most likely from natural sources." Therefore, the statement of the Dossier Submitters runs contrary to numerous earlier conclusions and is disputed by a recent detailed study60 and by the 2022 EEAP Report. Sea spray aerosol transport constitutes a relevant mechanism by which TFA in the ocean is transferred to terrestrial compartments. The Dossier Submitters claim that "TFA in fresh water and in the terrestrial environment originates from anthropogenic sources" (Annex B, section B.4.2.7.3). There is no scientific justification for this statement. First, there are no studies which have reported methods that can differentiate TFA from natural vs anthropogenic sources. Second, this statement is not aligned with what is reported on page 105 of the Annex XV report, indicating that "sea spray aerosols could be an important source of PFASs to the atmosphere and, over certain areas where sea spray deposition is important, a significant source to terrestrial environments too" and also that "SSA [sea spray aerosols] may currently be an important source PFASs to the atmosphere and, over certain areas, to terrestrial environments triggering also long-range transport." In other words, sea spray aerosols can transport PFASs from the ocean to the terrestrial environment. Hence, if natural TFA is found in ocean water, sea salt aerosols represent a mechanism by which natural and anthropogenic TFA in the ocean are transferred to the terrestrial compartments. 53 The Dossier Submitters mention that "sea spray aerosols (SSA) could be an important source of PFASs to the atmosphere and, over certain areas where sea spray deposition is important, a significant source to terrestrial environments, too" (Annex B, section B.4.2.8.1). In general, the transport pathways of TFA are the same as those described for other PFASs in this section. As discussed in Solomon et. al, "whatever the source of TFA in the atmosphere or other compartments in the environment, the ultimate sink is in surface waters. TFA is soluble in water and dissolves or partitions into water (droplets in the atmosphere in the case of the atmospheric degradation of HFCs and HFOs). Upon contact with soil or surface waters, TFA forms salts with ions such as sodium, potassium, magnesium, and calcium, which are present in soils and most surface waters. TFA salts released from other sources, such as industrial wastes and sewage treatment, also remain in the aqueous phase and eventually move to terminal sinks in the ocean, salt, or playas (endorheic lakes) from which there is no outflow and the only loss of water is via evaporation." In conclusion, this section reported relevant information on the environmental fate of both F-gases and TFA, which is particularly relevant in the context of the environmental risk assessment, presented in Section 1.4. TFA is both an anthropogenic and a naturally occurring substance that can be transported in the environment through different pathways. Section 1.4 - Environmental risk assessment In this section of the document, we report estimates of F-gas and TFA emissions from the World Meteorological Organization (WMO) and the UNEP EEAP 2022 reports, as well as the outcome of the EPEE HFC Outlook model. Furthermore, the conclusions from the UNEP EEAP 2022 report regarding both the human health and the environmental effects of current and projected emissions of TFA are reported, together with the TFA emission levels derived from the EPEE model, which are converted in average rainwater concentrations and compared to the currently existing advisory values for TFA in drinking water and NOEC values. The aim is to demonstrate that projected F-gas emissions in the future would result in a negligible TFA risk. The HFC emission forecasts presented by the WMO in the Scientific Assessment of Ozone Depletion (SAP) 2022 report show that the EU+UK contribution to the global emissions is already very low (4%, in terms of CO2 equivalents), without considering the further minimization measures that will be introduced under a revised EU F-gas Regulation. The WMO SAP 2022 Report566 discusses forecast emissions of HFCs and Figure 1.1 below shows projected emissions to 2050. The updated emissions projections ("The Kigali Amendment 2022 update scenario") in the WMO SAP 2022 Report takes into account updated trends in consumption and emissions, the provisions of the Kigali Amendment and national regulations including the EU F-gas regulation and MAC directive, the HFC phasedown in the USA, and regulations in Japan. 54 Figure 1.1 - Estimated HFC Emissions (Figure 2-15 of WMO SAP Report)566 Emissions from the Kigali Amendment (2022 update) scenario, are projected to be 0.9-1.0 Pg CO2-eq/yr in 2050, and the corresponding radiative forcing is predicted to decrease from a 2018 "without control measures" scenario value of 0.22- 0.25 W/m2 to a value of 0.09- 0.10 W/m2 in 2050. As seen in Figure 1.1, the EU+UK share of global HFC emissions is rapidly decreasing and even without additional minimization measures foreseen under a revised F-gas Regulation, EU (EU+UK) is forecast to contribute only 4% to global HFC emissions as CO2 equivalents in 2050. This global overview clearly shows that the existing regulatory framework for F-gases is an effective tool to reduce emissions, both at EU and global level, particularly with very low emissions starting from 2035. On the basis of the projected emissions reported in the WMO SAP 2022 Report, the increase of concentration of TFA sodium salts in the oceans at global level would be between 27 and 45 ng/L in 2100, compared to the current levels (239 ng/L), as shown in the UNEP EEAP 2022 Report. Emission projections of HFO-1234yf and HFC-134a from the EEAP 2022 Report.1 (based on discussion in the WMO SAP 2022 Report) are shown in Figure 1.2. As discussed in the WMO SAP 2022 Report, the model employed "is restricted to the formation of TFA from the degradation of HFC-134a and HFO-1234yf, which, according to current knowledge, are expected to have the most significant influence on future TFA concentrations among those gases controlled by the Montreal Protocol or used as substitutes." For HFO1234yf, projected emissions were taken from the low and high scenarios of low-GWP alternatives shown in Figure 1.3 (i.e., Figure 7-5 from the WMO SAP 2022 Report), and thereby, it is assumed that 50% of the 55 future emissions of the low-GWP alternatives (Figure 7-5 of WMO SAP 2022) are related to HFOs, of which 50% is HFO-1234yf. Figure 1.2 - Projected Emissions of HFO-1234yf, HFC-134a and TFA, from EEAP Report,1 Table 3. Figure 1.3 - Projected Emissions and Impacts on Climate Change from Figure 7-5 of WMO SAP Report. 566 56 Figure 1.2 shows the annual TFA formation rates related to projected HFC-134a and HFO-1234yf emissions, and the mass of deposited TFA from each (and the resultant sum) for the periods 2020 - 2050 and 2020 - 2100. The EEAP Report notes that these amounts of TFA are estimated to increase concentrations in the global oceans from the nominal value of 200 ng/L (equivalent to 239 ng/L TFA sodium salt) estimated by Frank et al62 to 266-284 ng/L sodium salt in 2100 if evenly distributed across all oceans. TFA is characterized by minimal impacts on human health and the environment. TFA does not pose a risk to humans or to the environment because its concentrations in the environment are well below the safe threshold levels and it does not bioaccumulate. Based on the emission projections shown above, the EEAP 2022 Report indicates that while TFA has been found in the environment, the levels are sufficiently low that they are not likely to pose a significant threat to humans or the environment. Moreover, the EEAP Report highlights several properties of TFA that demonstrate the absence of a threat to humans or the environment. Since TFA does not react with biomolecules its persistence is not a concern. Salts of TFA also do not bioaccumulate in food chains and exemplify low toxicity to animals and plants, demonstrating that they do not present a risk. Current loads of TFA being released will contribute to environmental concentrations, but as pointed out in the EEAP Report, the amounts will still be well below the threshold of concern for human and environmental health. Additionally, the report concludes that with regard to risks to aquatic life, TFA represents a de minimis risk. We report below some relevant quotes from the EEAP 2022 report to support what stated above:" The increases in trifluoroacetic acid concentrations due to replacements of the ozone-depleting substances are not expected to pose significant risk to humans or the environment at the present time" (page 25). "Because of its lack of reactivity, TFA salts are persistent in the environment and estimates of halflife are uncertain but could be in the range of centuries or millennia. This persistence is not a major concern because it does not react with biomolecules. TFA and its salts are easily excreted by animals and do not bioaccumulate in food chains. Salts of TFA have low toxicity to animals and plants and there are very wide margins between current/projected exposures and toxicity values" (page 292). Replacement of HCFCs and HFCs with HFOs releases "will add to the existing load of TFA in the environment but predicted amounts are well below the threshold for concern with respect to human and environmental health" (page 292). "The HFOs and HCFOs have shorter lifetimes in the atmosphere and deposition of TFA from these substances is likely to be more localized. This will result in greater concentrations near the locations of release. This is unlikely to present a risk to humans or the environment in these locations but changes in concentration in surface water (or soil) would respond rapidly to releases. Monitoring of the environment for residues of TFA would provide an early warning if trends in concentration indicate rapid increases" (page 293). "These releases will add to the existing load of TFA in the environment but predicted amounts are well below the threshold for concern with respect to human and environmental health" (page 292). 57  "TFA has a long environmental lifetime, accumulates in surface and ground waters, and has been found in blood, drinking water, beverages, dust, plants, and agricultural soils. However, it does not interact with biological molecules and, due to its high solubility in water, it does not bioaccumulate. It is unlikely to cause adverse effects in terrestrial and aquatic organisms. Continued monitoring and assessment are nevertheless advised due to uncertainties in the deposition of TFA and its potential effects on marine organisms" (page 5). "The physical and chemical properties of TFA are well known but key to assessing environmental risk is that it is a strong acid and is completely miscible with water. In the environment, it forms salts with alkali metals, which are also very soluble in water. These properties indicate that TFA and its salts will not bioaccumulate in organisms other than terrestrial plants and will not biomagnify in food chain" (page 279). "The margin of exposure between the distribution of No Observed Effect Concentrations (NOECs) and the observed and expected concentrations in the oceans and endorheic basins is several orders of magnitude and is indicative of de minimis risk" (page 290). Based on an extrapolation of the TFA emission values reported in the EPEE HFC Outlook EU model, the projected TFA emissions in 2050 are considerably lower than UBA estimates. The extrapolated TFA emission values in 2050 would result in a very low risk, considering both the recommended TFA level in drinking water by UBA and the NOEC/PNECs. The EPEE HFC Outlook EU model66 developed by Gluckman Consulting, carries out detailed modelling of the future markets for refrigerants in the EU+UK and takes into account the latest political discussions on the F-gas Regulation revision and technical developments. The HFC Outlook EU model is highly regarded, and parallel models are used beyond the EU's borders. The UN has worked with EPEE and Gluckman Consulting to create country specific models to help Montreal Protocol Article 5 countries prepare their F-Gas reductions plans. The HFC Outlook EU projections are built bottom-up, providing an analysis of the stock of equipment in more than 50 HFC market sub-sectors. This includes the RACHP (Refrigeration, Air Conditioning and Heat Pump) sectors and also non-RACHP HFC applications such as MDIs, technical aerosols and foams. The HFC Outlook EU model has been used to provide forecasts of consumption for individual HFCs and HFOs, and emissions from their use until 2050. Whereas the assumptions used to support the emission projections until 2035 have a high level of reliability, the emission values presented for 2035 - 2050 are more uncertain, due to variables such as the market penetration of non-fluorinated alternatives. In addition, the contribution related to innovation, including both the development of new F-gas blends and new F-gas molecules (which could have a different degradation profile compared to the F-gases currently in use), as well as the increased tightness of equipment, which would lead to further leak reduction, cannot be definitively captured for the timeframe 2035 - 2050. This might result in an overestimation of the TFA emissions in 2050, which were estimated to be about 14,000 tonnes/year. As a consequence, the TFA emissions calculated in 2050 should be considered as an approximate value. However, in the section below, we show how even considering this approximate TFA emission value, the resulting environmental concentrations of TFA are well below the NOEC value. For a complete comparison with the UBA estimates on HFC and HFO emissions, as well as other emission estimates derived from literature, we refer to the EFCTC submission to the Public Consultation. 66 (Gluckman Consulting), See Reference List for complete reference 58 The EPEE model also allows an understanding of the relative contribution of the different F-gas precursors that degrade to TFA. As mentioned earlier in this document, F-gases have different degradation patterns, leading to different degradation products and, in the case of TFA, the degradation yield ranges from 0 to 100%. In the case of substances such as HFO-1234ze(E), HFO-1336mzz isomers and HCFO-1233zd(E), the EPEE model shows that their contribution to the overall TFA emissions from F-gas precursors is less than 1% (which means that less than 140 tonnes/year of TFA are emitted) in 2050, considering that this figure also takes into account the contribution to TFA from HFC degradation. The estimated TFA yields for these F-gases are within the range 0-4%, hence from an environmental risk perspective the relative contribution to the overall TFA budget from these substances is negligible. Such a conclusion is also supported by the fact that even considering the contribution of all HFCs and HFOs to TFA emissions, the risks associated would still be de minimis, as also reported below in this section, where both the UNEP 2022 EEAP Report and the EPEE model figures are used to compare emission values with safe environmental concentrations of TFA. As a consequence, as also mentioned earlier in this document, the TFA produced by the degradation of low TFA yield precursors might be considered as "minor degradation product". Therefore, these substances should not be included within the scope of the proposed restriction. This recommendation should apply for both currently existing F-gases, such as HFO-1234zeE, HFO-1336mzzZ, HFO-1336mzzE and HCFO-1233zdE, and future substances or products that might meet the definition of a PFAS but which would not degrade to a persistent arrowhead. Such a request should apply in case the justifications on the low-risk of all F-gases provided in this chapter are not considered sufficient to exclude all F-gases from the scope of the restriction. Based on an extrapolation of TFA emissions, the HFC Outlook EU model, using the UNEP EEAP 2022 Assessment Report yields of TFA for each HFC and HFO, forecasts 0.37 Tg (Teragrams) of TFA generation from HFCs and HFOs between 2000 and 2050. Subsequent transfer to the oceans would result in an increase of 0.3 ng/L in average oceanic concentration of TFA by 2050. This additional quantity is minor compared to the measured oceanic concentrations and estimated oceanic quantities around the year 2000. This estimate ignores the approximately 6% of TFA that is destroyed in the atmosphere. The model forecasts about 14,000 tonnes of TFA emissions for Europe in 2050. This is considerably lower than the UBA forecast of 49,717 tonnes. The UNEP EEAP 2022 report discusses the yield of TFA from individual HFC and HFO substances. For some substances such as HFC-134a, a range is quoted, with the yield of TFA depending on conditions and for these the central estimate was used. However, there is uncertainty about the TFA yield. For the HFCs, HFOs and HCFOs that degrade via CF3CHO (i.e., HFC-143a, HFC-245fa, HFC-365mfc, HFO-1234ze(E), HFO1336mzz isomers, and HCFO-1233zd(E)), the TFA yield from processing of CF3CHO is estimated at 2% with an upper theoretical limit of ~ 30%." However, it should be highlighted that this upper theoretical limit is highly uncertain, as also discussed in the UNEP EEAP 2022 Report. Nevertheless, for these substances, applying the upper limit TFA yield has little effect on the HFC Outlook EU model forecast for TFA emissions in 2050, which would be about 14,000 tonnes. Subsequent transfer to the oceans would result in an increase of 0.3 ng/L (i.e. the same as above to one decimal place) in average oceanic concentration of TFA by 2050. The HFC Outlook Model forecasts emissions of TFA for all HFCs and HFOs of about 14,000 tonnes/year for Europe in 2050. The European emissions of HFC and HFOs that can degrade to form TFA are mainly constituted by the ultra-low GWP HFOs and HCFOs in 2050. For each substance that degrades to generate 59 TFA, the TFA deposition profile is linked to the TFA yield and atmospheric lifetime of the substance. However, the HFOs and HCFOs that degrade to form low yields of TFA have short atmospheric lifetimes, with two having similar lifetimes to HFO-1234yf. While a complete atmospheric model for Europe would be required to provide a more accurate assessment, TFA rainfall concentrations due to emissions of HFCs and HFOs from Europe in 2050 can be tentatively estimated by using the Henne et al. study67 rainfall concentrations. Emissions of 14,000 tonnes of TFA (HFC Outlook Model) could result in estimated concentrations of TFA in precipitation averaging 420 ng/L to 600 ng/L. The UBA report68 and the HFC Outlook Model forecasts show that the combined contribution to TFA emissions in Europe of the HFOs 1234ze(E), HFO-1336mzz isomers and HCFO-1233zd(E) are minor in the period until 2050, due to their low yield of TFA formation and their forecast low emissions. The estimated concentrations of TFA in precipitation averaging 420 ng/L to 600 ng/L (0.42 g/L to 0.6 g/L) can be compared to the UBA target value for TFA in drinking water of 10,000 ng/L (10 g/L) and the UBA health guidance value for TFA in drinking water of 60,000 ng/L (60 g/L).69 Reliable chronic data are available for three trophic levels: algae, invertebrates and fish. In aqueous solution, the pH of the substance is naturally low and for testing on organisms either the sodium or potassium salt (TFANa or TFAK) or pH adjustment were required. The EEAP 2022 Assessment Report summarizes a new toxicity test11 for an aquatic organism. This was a retest of the most sensitive alga (Raphidocelis subcapitata, previously known as Pseudokirchneriella subcapitata and Selenastrum capricornutum). The study protocol followed the most currently available OECD test guideline 201 and demonstrated that all validity criteria for guideline compliance were met. The endpoint for the study was inhibition of growth, expressed as logarithmic increase of biomass (average specific growth rate) during the 72-hour exposure period and effect values were reported. A no observed effect concentration (NOEC) of 2.5 mg/L (2,500,000 ng/L or 2500 g/L) and a 72h-ErC10 value of 5.6 mg/L TFA were obtained from this study. A GLP-compliant guideline (OECD test guideline 211) study based on reproduction and survival is also available for the long-term toxicity in aquatic invertebrates whereby the 21-day NOEC for Daphnia magna was determined to be 25 mg/L TFA. Finally, a GLP-compliant guideline (OECD test guideline 210) chronic fish is available whereby the 35-day NOEC for Gobiocypris rarus was determined to be 3.8 mg/L TFA. The dossier registrants used these key studies for classification and hazard assessment purposes. Derivation of Predicted No-Effect Concentrations (PNECs) for TFA in freshwater and marine water was based on the guidance provided in REACH Guidance Document Chapter R.1070 "Characterisation of dose [concentration]-response for environment". The derived freshwater and marine PNECs for TFA are 0.56 mg/L (560,000 ng/L) and 0.056 mg/L (56,000 ng/L)11 respectively. Therefore, based on the TFA emissions estimated in the EU in 2050, the resulting concentration in rainwater and the comparison with the current UBA health guidance value for TFA in drinking water, as well as the NOEC and PNECs reported above, the current and projected emissions of TFA until 2050 do not pose a risk that would require a preventive restriction of F-gases and TFA under REACH. Such comparisons, together with the UNEP assessments summarized earlier in this section, clearly demonstrate the low risk arising from F-gas use over time, for both human health and the environment. 67 (Henne et al., 2012), See Reference List for complete reference 68 (Behringer et al., 2021), See Reference List for complete reference 69 (Trifluoressigsure (TFA) 2020), See Reference List for complete reference 70 (ECHA, R.10), See Reference List for complete reference 60 Section 1.5 - Current (and future) regulatory framework to minimize F-gas emissions A REACH restriction is any measure on the manufacture, placing on the market and/or use of a substance (on its own, in a mixture or in an article) to address an `unacceptable' risk. REACH restrictions, therefore, are not limited to bans but can comprise, for example, requirements for use of risk management measures, training or certification. Before a restriction can be implemented, the European Commission and the EU Member States must have concluded that it is the most appropriate means to address the identified risk. To inform this decision, restriction proposals (also called Annex XV restriction reports) should include a comprehensive restriction and regulatory management option analysis (RMOA). We consider that, because the Annex XV report does not objectively identify and assess a complete range of potential restriction or regulatory management options (it only assesses the appropriateness of a ban), it has not been clearly demonstrated that the proposed restriction is the most appropriate means to regulate the potential risks of PFASs. Specifically, the Annex XV report should include a comprehensive comparative regulatory management option analysis based on the criteria given in Annex XV of REACH of effectiveness, practicality and monitorability. In this section of the document, we describe the currently existing (and future) regulatory framework to minimize F-gas emissions. We start considering the information reported by the Dossier Submitters on Fgas-specific legislation and we expand it by providing additional information on the provisions under both the sectorial legislation for F-gases and other pieces of legislation that regulate F-gas emissions at the end of life. The purpose is to demonstrate that the current (and future) regulatory framework for F-gases already aims at minimizing F-gas emissions to the environment and a restriction under REACH, aiming at the same objective, would not be justified. Finally, we provide information to support the assessment of appropriateness of such a combined regulatory framework by reporting examples of data showing the effectiveness of the RMMs across the substance lifecycle, but also reporting elements on practicability and monitorability present in the national legislation in different EU Member States. In such an overview, a particular focus on the enforcement of the F-gas Regulation and the End of Life Vehicles (ELV) Directive will be given. The Dossier Submitters report that the F-gas Regulation aims to reduce the GWP of emissions from industry by 70% in 2030 compared with 1990 levels, through a gradual phase-down of the use of HFCs, bans on the use of some F-gases if alternatives are available, and expansion of regulations governing activities such as leak testing, recovery and disposal. They also mention (although only implicitly) that the F-gas Regulation imposes legal obligations and/or incentives to recover and recycle waste F-gases. They also report that the MAC Directive prohibits the use of F-gases with a GWP of more than 150 in new cars and vans produced from 2017, but that it does not cover vehicles such as commercial vehicles, buses or trains. Based on this, the Dossier Submitters conclude that the F-gas regulation and MAC Directive are insufficient to manage the risks that they associate with F-gases. The conclusion appears to be based on two arguments: that the F-gas Regulation "does not per se restrict the use of the substances but rather aims for a reduction of their use" and that the current F-gas Regulation does not regulate all fluorinated gases fulfilling the PFAS definition referred to by the Dossier Submitters. Rather, they argue that a REACH restriction is required because that would limit as many uses as practically possible and thereby minimize F-gas emissions (and hence exposures), cover current and future F-gases, and prevent regrettable substitution. Derogations (generally time-limited) are proposed for "some key applications of fluorinated 61 gases [where] alternatives are not yet available." We believe that the conclusion that existing legislation is insufficient is unfounded, for the reasons elaborated below. According to the rationale followed by the Dossier Submitters, the aim of the proposed restriction is emission minimization. Whilst not explicitly acknowledged by the Dossier Submitters, it is important to note that this is also the objective of the existing regulatory framework for F-gases in the EU, as stated for example in Article 1 of Regulation 517/2014 ("F-gas Regulation").71 Consequently, we show how the current (and the revised) legislation on F-gases already represents a strong tool that effectively minimizes emissions to the environment. We recommend that the existing legislation for F-gases is more appropriate to address the risk and it should be used to achieve the emission minimization objective of the proposed restriction. More specifically, we highlight that the potential risks of F-gases are already addressed (i.e. minimized) by existing operation conditions and risk management measures (RMMs) required under the existing regulatory framework that comprises both REACH (in terms of data requirements for registration, substance evaluation and safe use) and the F-gas Regulation (and its upcoming reviewed version) as the main pillars, which are complemented by the MAC Directive, the ELV Directive (and the upcoming ELV Regulation), the WEEE Directive and the WFD (Waste Framework Directive). As a consequence, we conclude that the proposed restriction of F-gases is a disproportionate considering that existing legislation (further strengthened in the future) regulating F-gases already effectively minimizes releases across all substance lifecycle stages. Section 1.5.1 - Description of the current (and future) regulatory framework Introduction F-gases are already strictly regulated under the current Regulation 517/2014 ("F-gas Regulation")72. It establishes a phasedown schedule for HFCs, as well as stringent provisions to minimize leakages throughout the lifecycle of the F-gases. It should be noted that the F-gas Regulation currently in force foresees provisions on leakage minimization, training and certification of technicians, and phasedown only for HFCs, while the Commission Proposal to review the F-gas Regulation ("Commission Proposal")73 currently under discussion extends the containment, training and certification, and recovery measures to Annex II - Section I F-gases (HFOs and HCFOs). As mentioned in the Annex XV report, F-gases are the only substances within scope that already have a legal obligation/incentive to be recovered and then either recycled, reclaimed, or destroyed74 (as per 71 Article 1 F-gas Regulation: The objective of this Regulation is to protect the environment by reducing emissions of fluorinated greenhouse gases. 72 Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006; 73 Proposal for a Regulation of the European Parliament and of the Council on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014; 74 Annex XV Restriction Report Proposal for a restriction for per- and polyfluoroalkyl substances (PFASs), p. 42; 62 Article 8 of the F-gas Regulation). Recycling is a basic cleaning process for reuse mainly done by installers,75 whereas reclamation - a more sophisticated reprocessing with a quality guarantee76 - is done by professional reclamation companies. The quantities of F-gases being recycled and reclaimed has increased substantially since the current F-gas Regulation entered into force (i.e. the quantities reported as reclaimed HFCs increased from 377 tonnes in 2014 to 1,026 tonnes in 2021).77 Recycled and reclaimed Fgases also have specific labelling requirements. In this section, we analyze the specific provisions of the current F-Gas Regulation aimed at preventing Fgas emissions both during the use phase and at the end of life. Since the F-gas Regulation is under revision (currently at trialogue stage), we will also summarize the additional requirements/provisions foreseen in the Commission Proposal, the Council General Approach, and the Parliament position. The F-gas Regulation is currently following the ordinary legislative procedure. The ongoing trialogue negotiations are expected to be concluded in the autumn of 2023 and the revised Regulation is expected to enter into force on 1 January 2024. It is important to note in that respect that the provisions of the final version of the F-gas Regulation, once agreed and published in the Official Journal of the European Union, might differ from those specified in this document. Additionally, there is other EU legislation, which in a greater or lesser degree, relate to the management of F-gases. In this regard, as it will be seen below, the rules in those pieces of legislation are complementary to the F-gas Regulation, and contribute to the objective to manage and minimize emissions of F-gases, which is, in essence, the objective of the PFAS restriction proposal. This occurs by regulating the products and equipment placed on the market containing F-gases or by establishing requirements for the end-of-life of products and equipment. F-gas Regulation: Provisions in the current regulation Prevention of emissions during the use phase. The containment measures to prevent emissions of fluorinated gases (e.g. prevention of emissions, leak checks) constitute the corner stone of the EU F-gas Regulation 517/2014. As the Commission's impact assessment specifies78, the leakage rates of F-gases have been reduced following the introduction of improved containment measures with the current F-gas Regulation in force since 2015. Prevention of emissions at the end-of-life. Besides the emissions occurring during the use phase of F-gascontaining equipment, the end-of-life of this equipment present another potential source of F-gas emissions. Therefore, the current F-gas Regulation sets out legal requirements for the recovery, recycling, reclamation and destruction of F-gases for operators of equipment. Importantly, a key benefit of F-gases is their circularity, i.e., their ability to be reclaimed, recovered, recycled and reused in new applications. Under the current regime, operators of stationary equipment or of refrigeration units of refrigerated trucks and trailers containing F-gases must ensure that the recovery of those gases is carried out by the 75 Article 2(15) F-gas Regulation; 76 Article 2(16) F-gas Regulation, 77 ETC CM report 2022/3 Fluorinated greenhouse gases 2022, available at https://www.eionet.europa.eu/etcs/etccm/products/etc-cm-report-2022-03; 78 Commission Staff working Document - Impact Assessment Report accompanying the Proposal for a regulation of the European Parliament and of the Council on fluorinated gases, "Impact Assessment F-gas Regulation" (p. 68); 63 natural persons that hold the relevant certificates, so that these gases are recycled79. Therefore, the operators of such equipment must recover the F-gases in all cases, which additionally need to be carried out by a certified person. For other products and equipment containing F-gases (such as mobile air conditioning equipment -"MAC equipment"- in cars and light vans), operators must arrange for the recovery of the gases, to the extent that it is technically feasible and does not entail disproportionate costs.80 After the recovery, F-gases are recycled, reclaimed or destroyed. Only personnel with a training certification are considered appropriately qualified for the recovery of these gases from air-conditioning equipment in motor vehicles (i.e. those under the scope of the MAC Directive).81 F-gas Regulation: Provisions in the Commission Proposal Prevention of emissions during the use phase. The Commission Proposal would expand several existing requirements from HFCs to HFOs/HCFOs. This is a fundamental evolution of the F-gas Regulation, which has direct relevance for minimizing emissions targeted by the current restriction proposal. The Commission Proposal would set the following measures to prevent emissions during use: Operators and manufacturers would be obliged to take all necessary precautions to prevent emissions/leakage82 during the production, storage, transport, and transfer of F-gases. The inclusion of the F-gas supply chain in the leakage prevention obligation would lead to a further reduction in emissions of F-gases as leaks can also occur during transport or transfer. Furthermore, operators of equipment would be obliged to check their applications for leaks83 and keep detailed records on relevant information,84 such as the results of those checks, the quantity of gas added or recycled and the measures taken to recover or dispose of the gas. Member States would also be required to adapt the certification programmes85 for persons installing, servicing and recovering equipment containing F-gases to cover HFOs/HCFOs. These amendments would close a remaining gap when it comes to the monitoring of F-gas emissions during the use life of applications. Prevention of emissions at the end-of-life. The evaluation of the 2014 F-gas Regulation highlights that the Regulation has increased the recovery and reclamation rates of refrigerants.86 The Commission proposal for the revised F-gas regulation would set further additional requirements for the end-of-life products and equipment: Similar to the containment measures, the end-of-life obligations would be extended to cover HFOs/HCFOs, closing a remaining gap in emission prevention.87 Under the Commission proposal, the recovery obligation would be mandatory for operators of stationary products and equipment listed in paragraphs 1, 6[sic] and 7[sic] of the Commission 79 Article 8(1) F-Gas Regulation; 80 Article 8(3) F-Gas Regulation; 81 Ibid; 82 Article 4 Commission Proposal; 83 Article 5 Commission Proposal; 84 Article 7 Commission Proposal; 85 Article 10 Commission Proposal; 86 Impact Assessment F-gas Regulation (p.97); 87 Article 8 Commission Proposal; 64 Proposal.88 For operators of other equipment (such as MAC equipment for passenger cars), the Commission Proposal establishes that the recovery of the F-gases must be performed "unless it can be established that it is not technically feasible or entails disproportionate costs"89.Therefore, unlike the case of stationary equipment and refrigeration units of refrigerated trucks and trailers, the recovery obligation for MAC equipment is not absolute but subject to conditions. However, the Commission proposal strengthens such conditions compared to the 2014 F-gas Regulation, by stating that recovery must be performed, unless either technical infeasibility or disproportionate costs are proven (unless it can be established). As in the current F-gas Regulation, only personnel with a training attestation is considered appropriately qualified for the recovery of these gases from air-conditioning equipment in passenger cars. To further enable refrigerant reclamation and contribute to the circular economy, the Commission Proposal empowers the Commission to adopt delegated acts to establish a list of products and equipment where the recovery or destruction should be considered "technically and economically feasible, specifying, if appropriate, the technologies to be applied"90. F-gas Regulation: Provisions in the Council general approach Prevention of emissions during the use phase. The Council proposes to further specify the obligation to prevent emissions by stating that where the release is technically necessary, operators shall take all measures that are technically and economically feasible to prevent, to the extent possible, the release of F-gases into the atmosphere, including by recapturing the gases emitted.91 Furthermore, the Council extends the leak checks obligation to a variety of operators with mobile equipment (e.g. air-conditioning equipment and heat pumps in trucks, vans, buses, non-road mobile machinery).92 Prevention of emissions at the end-of-life. The Council proposes to expand the scope of the mandatory recovery obligation of stationary equipment to also include certain types of mobile equipment: "(a) the cooling circuits of refrigeration units of refrigerated trucks and trailers; (b) the cooling circuits of refrigeration units of refrigerated light-duty vehicles, vans, intermodal containers including reefers and train wagons; and (c) the cooling circuits of air-conditioning and heat pumps in trucks, vans, buses, nonroad mobile machinery used in agriculture, farming, mining and construction operations, trains, metros, trams and aircraft."93 As regards the recovery obligation for MAC equipment, the Council has (in a strange fashion) proposed to move this it to Article 8(1) but has not included it in the list of other mobile equipment subject to the mandatory obligation. Therefore, despite that amendment of the text, it should still be considered as subject to Article 8(6), i.e. operators must recover the F-Gases unless it can be established that it is not technically feasible or entails additional costs.94 88 Article 8(1) Commission Proposal; 89 Article 8(6) Commission Proposal; 90 Article 8(8) Commission Proposal; 91 Article 4(1) Council General Approach; 92 Article 5(2)(a) Council General Approach; 93 Article 8(1) Council General Approach; 94 The upcoming F-Gas Regulation is under the ordinary legislative procedure, therefore this reading should be confirmed upon publication of the official text of the new revised F-Gas Regulation. In the event the final wording is not clear enough, we suggest requesting access to documents to the discussions within the trilogues on Article 8. However, this information can only be granted by the time the legislative procedure is finalised. 65 F-gas Regulation: Provisions in the Parliament position Prevention of emissions during the use phase. Among the amendments to the Commission Proposal, the European Parliament proposes to extend the obligation to manufacturers to ensure that the equipment is checked for leaks "during manufacturing"95. It also covers new equipment such as refrigeration units of vans and ships96 and air-conditioning equipment in metros, trains, ships, planes and in road transport vehicles outside the scope of Directive 2006/40/EC ("MAC Directive")97. Prevention of emissions at the end-of-life. In its position, the European Parliament seeks to establish mandatory Extended Producer Responsibility schemes for the recovery of F-gases by the end of 2027 and requests the Commission to set minimum requirements for such schemes by 2025.98 The recovery provisions also cover refrigeration units of vans and ships.99 Other legislation related to F-Gases The following legislation does not address F-gases directly. However, they contain provisions that create synergies with the F-Gas Regulation as regards the management of F-gases emissions. This occurs by establishing a global warming potential (GWP) limit for the refrigerants filled in cars (section 3.1); or by establishing requirements at the end-of-life of products and equipment that usually contain F-gases (sections 3.2-3.3), as well as establishing general rules on waste management (section 3.4). On a general basis, since all these EU pieces of legislation correspond to EU Directives, it should be noted that under EU law, Member States can choose the form and methods for transposing them into national law (Article 288 of the Treaty of the Functioning of the European Union). However, they are bound by the terms of the directives as to the result to be achieved and the deadline by which the transposition should take place. In other words, they can set stricter requirements under national law but could not apply more lenient requirements. National authorities must notify the Commission of the measures they have adopted, which will in turn verify the completeness and correctness of transposition. Within this context, we understand that the national transposition of these Directives may provide more stringent obligations. MAC Directive The Directive 2006/40/EC relating to emissions from air-conditioning systems in motor vehicles ("MAC Directive") required all new passenger cars (and light goods vehicles) from 1 January 2017 to be filled with a refrigerant with a global warming potential (GWP) no higher than 150.100 95 European Parliament (30 March 2023), Amendments adopted by the European Parliament on 30 March 2023 on the proposal for a regulation of the European Parliament and of the Council on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014 ("EP position"), Amendment 45; 96 Amendment 48 EP position; 97 Amendment 49 the EP position 98 Amendments 60-62 EP position; 99 Amendments 52-53 EP position; 100 Article 5(1) MAC Directive; 66 End of Life Vehicles Directive Directive 2000/53/EC on end-of-life vehicles ("ELV Directive") lays down measures on how vehicles should be treated at the end-of-life, with a focus on the reduction of disposal of waste and the increase of reuse, recycle and other forms of recovery of end-of-life vehicles. In this regard, we consider that the provisions under the ELV Directive are complementary to the F-gas Regulation and provide additional information on how to manage and treat end-of-life vehicles. Especially: Recovery under the F-gas Regulation means "the collection and storage of F-gases from products, including containers, and equipment during maintenance or servicing or prior to the disposal of the products or equipment".101 Treatment under the ELV Directive means any activity after the end-of life vehicle has been handed over to a facility for depollution, dismantling, shearing, shredding, recovery or preparation for disposal of the shredder wastes, and any other operation carried out for the recovery and/or disposal of the end-of life vehicle and its components.102 Annex I to the ELV Directive provides the minimal technical requirements for treatment of ELV. In particular, as regards operations for depollution, operators must remove, separate collect and store the airconditioning system fluids and any other fluid contained in the end-of-life vehicle.103 For the depollution of the ELV, the fluids must be removed using specialist equipment and transferred to a collection cylinder. We also note that the depollution activities involve air-conditioning system fluids, which tend to be Fgases. Therefore, it can be concluded that most AC fluids (as referred to Annex I(3) to the ELV Directive) are also subject to the F-gas Regulation. The definitions of depollution of ELV (i.e. removal, separate collection and removal of the AC fluids) and recovery of F-gases are technically similar and entail comparable actions to carry out by the operator. The F-gas Regulation provides additional obligations as regards the recovery of F-gases from passenger vehicles (for example, as regards the training requirement for the operator when recovering the F-gas). In any event, the measures provided in the ELV Directive, applied in combination with the F-gas Regulation, provide an effective and appropriate framework to manage the emissions of refrigerants at the end-of-life. This is confirmed by the approach taken by Member State authorities (e.g. Ireland for which national guidance for recovery of air conditioning system fluids from ELVs104 addresses both pieces of legislation together). The ELV Directive requires transposition into national laws. In this regard, the Commission noted that the removal of fluids is an obligatory treatment operation across almost all Member States.105 Additionally, Member States must ensure that these technical requirements are respected as a minimum, "without 101 Article 3(14) F-Gas Regulation, Article 3(11) Commission Proposal; 102 Article 2(5) ELV Directive. Please note that the meaning of recovery in the ELV Directive differs from the F-Gas Regulation; 103 Annex I(3) ELV Directive; 104 Environmental Protection Agency, Recovery of Air Conditioning System Fluids from ELVs at Authorised Treatment Facilities and Metal Shredder Sites, available at: https://www.epa.ie/publications/compliance-enforcement/air/ods--f-gas/Removal-of-Air-Conditioning-Gases-at-Authorised-Treatment-Facilities-and-WasteShredder-Sites-(EPA,-v1-Jan-2022).pdf; 105 Draft evaluation report ELV Directive, page 84; 67 prejudice to national regulations on health and environment"106 in line with the principle of implementation of EU Directives into national law (see above). End of Live Vehicles Regulation Proposal The ELV Directive is currently under revision. On 13 July 2023, the Commission published a proposal for a Regulation on circularity requirements for vehicle design and on management of end-of-life vehicles ("ELV Regulation Proposal")107, which would replace the current ELV Directive and become directly applicable in all Member States. The ELV Regulation aims to prevent and reduce the adverse impacts from management of end-of-life vehicles and to ensure a high level of protection of human health and the environment. Given the change of legal instrument (from a directive to a regulation), the proposal will harmonize the national legal requirements on the management of end-of-life vehicles. In particular, the minimum treatment requirements for depollution operations are further specified that in the ELV Directive (which are currently implemented by national laws), thus clarifying the steps for the recovery of the F-gases contained in vehicles. In this regard, the operators must carry out the depollution operations as soon as possible after its delivery to the authorized treatment facility.108 Annex VII specifies that (1) fluids and liquids contained in ELV such as air-conditioning system fluids must be removed from the ELV unless they are necessary for the re-use of the parts concerned;109 and (2) parts, components and materials such as air conditioning systems and refrigerants must be treated in accordance with the F-Gas Regulation.110 Additionally, it states that all parts, components and materials collected during the depollution shall be stored in designated containers.111 It also further specifies that the collection containers in which the AC systems fluids/AC systems/refrigerants are collected must be accordingly labelled and stored in a secure location, in order to prevent accidental spillage, leakage or unauthorized access to it.112 The proposal also provides information obligations for car manufacturers, which must provide waste management operators and repair and maintenance operators access to information enabling a safe removal of parts, components and materials which contains fluids and liquids and are contained in vehicles.113 Therefore, the ELV Regulation explicitly reinforces the complementarity (and coherence) between this piece of legislation and the F-gas Regulation, being the measures providing a correct and sufficient framework to manage the emissions of refrigerants at the end-of-life. It should be noted that the ELV Regulation proposal will follow the ordinary legislative procedure, which is expected to last, at least, several months. 106 Article 6(1) ELV Directive; 107 Proposal for a Regulation of the European Parliament and of the Council on circularity requirements for vehicle design and on management of end-of-life vehicles, amending Regulations (EU) 2018/858 and 2019/1020 and repealing Directives 2000/53/EC and 2005/64/EC. 108 Article 29 ELV Regulation Proposal; 109 Annex VII(B)(1) ELV Regulation Proposal; 110 Annex VII(B)(2) ELV Regulation Proposal; 111 Ibid.; 112 Ibid.; 113 Article 11 ELV Regulation Proposal; 68 Waste Electrical and Electronic Equipment Directive Directive 2012/19/EU on waste electrical and electronic equipment ("WEEE Directive") lays down measures to protect the environment and human health by prevention or reducing the adverse impacts of the generation and management of WEEE. The scope of the Directive includes products and equipment such as (air conditioning equipment, heat pumps, clothes dryers). This Directive complements the F-gas Regulation, since it makes multiple links as regards the waste management of cooling equipment or any other equipment that contain F-gases. As regards the particular operations to be carried out by operators dealing with WEEE, it should be noted that proper treatment under the WEEE Directive must include, other than preparing for re-use, and recovery or recycling operations, as a minimum, the removal of all fluids and a selective treatment in accordance with Annex VII114, in particular: Removal of chlorofluorocarbons (CFCs), hydrochlorofluorocarbons (HCFCs) or hydrofluorocarbons (HFCs), hydrocarbons (HCs) have to be removed from any separately collected WEEE115; Gases with a GWP above 15 must be properly extracted and properly treated116. Interestingly, the WEEE Directive further states that ozone-depleting gases must be treated in accordance with the Ozone Regulation, but no mention is made of the F-gas Regulation. As provided in the Impact Assessment of the F-gas Regulation, Annex VII of the WEEE Directive "misses an opportunity to reinforce the link to the [F-Gas] Regulation and the objectives around recovery"117. The definition of proper treatment of WEEE and recovery of F-Gases are not exactly the same, but technically similar. As provided in the Impact Assessment for the F-Gas Regulation, in some cases "the WEEE Directive goes beyond the provisions of the [F-Gas] Regulation through requiring the extraction and treatment gases with a GWP > 15 from foams and refrigeration circuits, such as those used as insulation in domestic and small commercial refrigeration appliances (although foams do not require recovery under Article 8 of the Regulation)".118 Therefore, we conclude that, for the particular waste stream "waste electrical and electronic equipment", the provisions of the WEEE Directive are complementary to the F-Gas Regulation and provide additional rules on how to manage and treat the waste, thereby allowing to better control F-gas emissions at the end of life. The WEEE Directive is currently under revision. The Commission adoption for a revised WEEE Directive is planned during the second quarter 2024. The consultation period is open from 16 June 2023 to 22 September 2023. This revision is a good opportunity to make clearer the links between the WEEE Directive and the F-Gas Regulation. Through the revision of the WEEE Directive, which would follow the ordinary legislative procedure, it would be possible to amend Annex VII and add an explicit reference to HFOs in the removal obligation, if not covered by the HFC definition currently in use in this Directive. 114 Article 8(1) WEEE Directive; 115 Annex VII(1) the WEEE Directive; 116 Annex VII(2) WEEE Directive; 117 Impact Assessment F-Gas Regulation, p. 163; 118 Impact Assessment F-Gas Regulation, p. 163; 69 Waste Framework Directive Directive 2008/98/EC on waste ("Waste Framework Directive" or "WFD") lays down measures to protect the environment and human health by preventing or reducing the adverse impacts of the generation and management of waste and by reducing overall impacts of resource use and improving the efficiency of such use. As regards the scope of this Directive, "gaseous effluents emitted into the atmosphere" (such as F-gases) are excluded.119 The F-gas Regulation (both the currently applicable and the Commission proposal) establishes that Member States must encourage the development of extended producer responsibility (EPR) schemes for the recovery of F-gases.120 As mentioned in the Commission Proposal, "Reinforced producer responsibility schemes as promoted by the F-gas Regulation could make a significant contribution to improve current practices and reduce end-of-life emissions. This is an opportunity in light of the on-going revision of the Waste Framework Directive"121. The evaluation study commissioned by the EU Commission demonstrates that Member States as well as industry have established Producer Responsibility Schemes which are effective to support the reduction of F-gas emissions.122 Further monitoring of such schemes was recognized as a key avenue to boost recovery and reclamation.123 As stated above, the Parliament seeks in its position to make those EPR schemes mandatory. For that purpose, it links the EPR provisions of the WFD (i.e. Article 8 and 8a) with the proposed EPR scheme for Fgases (Amendments 60-62). According to the Parliament position, the EPR fees would cover at least the following costs: "(a) costs of collection, including the provision of accessible collection points, storage and transport; and (b) costs of the recycling units for natural persons certified in accordance with Article 10 for the purposes of on-site recycling." Therefore, the provisions of the WFD are relevant and complementary to the ones of the F-gas Regulation as regards the management of emissions at the end-of-life if a clear link between the EPR schemes (encouraged/mandatory) in the F-gas Regulation and the EPR provisions in the WFD is established. This would be the case if the content of the amendments 60-62 of the Parliament position are integrated in the final and agreed F-gas Regulation. Section 1.5.2 - Assessment of appropriateness of the existing regulatory framework for F-gases Effectiveness The Fluorinated greenhouse gases 2022 report is prepared by the European Environmental Agency (EEA). This annual report of the EEA provides a summary of the information reported on the production, import, 119 Article 2(1)(a) WFD; 120 Article 9 f-Gas Regulation; 121 Commission Proposal, p. 5; 122 Impact Assessment F-gas Regulation (p.97, 111-114); 123 Impact Assessment F-gas Regulation (p.97); 70 export and destruction of fluorinated greenhouse gases (F-gases) in the European Union since 2007 as required by the EU F-gas Regulation and previously under Regulation 842/2006. It monitors the implementation of the EU F-gas Regulation (EU, 2014) and the results of the EU-wide phase-down of HFCs, which started in 2015. The EU F-gas Regulation mandates companies to report their annual production, imports, exports and other activities involving HFCs and other F-gases and includes all the F-gases covered by the Kyoto Protocol. The successful implementation of the F-gas regulation can be demonstrated by the implementation of an EU-wide phase-down of HFCs, the implementation of training and certification schemes, the monitoring programs across the EU, but also by the trend in emissions and the increase in quantities of F-gases being recycled and reclaimed and particularly the statements and data to that effect in the report: "Total emissions [in CO2Eq T] have started to decline since peaking in 2014 and were about 20% lower in 2020 in the EU-27 compared with 2014."124 The quantities of F-gases being recycled and reclaimed has increased substantially since the entering into force of the current F-gas Regulation (i.e. the quantities reported as reclaimed HFCs increased from 377 tonnes in 2014 to 1,026 tonnes in 2021).125 The results achieved with HFCs can be extended to HFOs with the inclusion of HFOs in the revised F-gas regulation. The implementation of leak check requirements in the F-Gas regulation has also been an effective measure to reduce the leak rates across the industry as demonstrated by publicly available statistic on leak rates reported in various forums or publications. At the 2021 ECA meeting in February 2021, Poland presented the leak rate trend of the data captured in their electronic database and equipment logbooks,126 which shows an improvement in leak rates from 2016 to 2020 demonstrating an effective monitoring of leak checks and the subsequent leak rate reduction throughout the period. This is reported in Figure 1.4 below. Figure 1.4 - Leakages of F-gases from refrigeration, air conditioning and heat pump equipment containing 5 t of CO2 equivalent or more (% per year) in the period 2016-2020. 124 (EEA Greenhouse Gases, 2023), See Reference List for complete reference 125 (ETC CM report, 2022/3), See Reference List for complete reference 126 (Lukasiewicz Research Network, 2023), See Reference List for complete reference 71 In Germany VDKF, the leading German trade association in the refrigeration, air conditioning and heat pump industry since 1962 published127 collected leak rate statistics, which also shows a reduced leak rate over time across all applications in a similar manner as the Polish statistics. This is shown in Figure 1.5. Figure 1.5 - Leakage rate trend over the period 2017-2021 according to the statistics reported by the German VDKF association. The data from the EEA report show how the F-gas regulation phase down is effectively being implemented throughout the Member States. The examples on leak rate reduction shown above demonstrate how the measures implemented through the regulation, such as operator training, leak checks and reporting are contributing to the effective reduction of emissions through leakage and the increase amounts recycled and reclaimed. Practicality and monitorability Summary At EU level, the rules concerning control of emissions during use and at the end-of-life of fluorinated greenhouse gases ("F-gases") are mainly contained in the F-gas Regulation 517/2014 (in its current and upcoming revision). Additionally, the Directive 2000/53/EC on end-of-life vehicles ("ELV Directive"), as well as its upcoming revision, provides specific requirements on the depollution treatment of vehicles, such as the collection and removal of air conditioning system fluids. In order to understand the practical tools that ensure effective implementation (practicality) and monitorability of these two pieces of legislation, we have provided an overview of implementation in some Member States. 127 (VDKF, 2022), See Reference List for complete reference 72 For that purpose, we have selected elements on practicality and monitorability present in the national legislation in three EU Member States: the Netherlands, Germany and Denmark. These countries are also Dossier Submitters of the "Annex XV Restriction Report Proposal for a restriction for per- and polyfluoroalkyl substances (PFASs)" (the "PFAS restriction Proposal"). In essence, practicality of the F-gas Regulation is ensured through effective national implementation of articles 3 to 5, which concern rules on the control of F-gas emissions during use, and article 8, which concerns rules on the control of F-gases during end-of-life. Another tool showing practicality is the prompt notification of article 10(10), by which Member States notified the Commission of their certification and training programs for natural or legal persons carrying out activities on F-gases. Given the presence of these programs across Member States, the objectives of the F-gas Regulation have been achieved by ensuring proper management of F-gases. Additionally, the following peculiarities set under national law ensure effective practicability. In the Netherlands, there are assessment guidelines ("BRLs") needed prior to a certification for the handling of F-gases being issued. In Germany, there is a "take-back" obligation for the recovery of F-gases for manufacturers and distributors. In Denmark, a national register ("KMO") handles the types of authorizations of companies and persons who work with refrigerants. Similarly, practicality of the ELV Directive is ensured through the effective national implementation of the minimum requirements set out in Annex I(3), which concerns the removal, separate collection and storage of the air-conditioning system fluids ("AC fluids"). Furthermore, the following peculiarities of national law ensure effective practicality. In the Netherlands, there are rules ensuring that AC fluids must be drained or dismantled and stored as soon as possible, but no later than ten working days after receipt of the vehicle and must be stored separately to the extent necessary for recycling as a product or recovery. In Germany, AC fluids must be removed and recycled "as far as technically possible and economically reasonable". In Denmark, there are further rules applying to waste handlers: for refrigerants from AC and refrigeration systems, the draining of refrigerant must be carried out using a suitable system; in case refrigerants cannot be recycled, they are delivered in an independent fraction to municipal hazardous waste schemes or to waste companies, thereby minimizing the risks of emissions at the end-of-life. The monitorability of the F-gas Regulation is ensured through the prompt and effective notification of article 25(1), by which Member States notified the Commission of the penalties applicable to infringements of the provisions of the F-gas Regulation and through the effective functioning of national registers of persons and companies handling F-gases. Another example of monitorability can be found in Germany, where the German Federal Environmental Agency regularly publishes reports and statistics, such as the Inventory of F-Gases 2019/2020. The effective monitorability of the ELV Directive is ensured through effective national enforcement. In the Netherlands, the Minister of Infrastructure has delegated enforcement powers to the Human Environment and Transport Inspectorate, who can impose administrative conditional fines or administrative orders subject to administrative coercion. In Germany, there are comprehensive obligations regarding documentation as well as obligations to provide information intending inter alia to facilitate inspections by the competent administrative authorities. In Denmark, a fine must be imposed for not handling and delivering liquids, materials, components, tires, vehicles and residual waste fraction. 73 Practicality: The F-gas Regulation Case study #1: The Netherlands: National Legislation transposing the F-gas Regulation The F-gas Regulation itself has direct effect in the Netherlands. However, its provisions are further implemented and specified in national law with the Decree on Fluorinated Greenhouse Gases and Ozone Depleting Substances (Besluit gefluoreerde broeikasgassen en ozonlaagafbrekende stiffen), i.e. the `NL Decree',128 and the Ministerial Regulation on Fluorinated Greenhouse Gases and Ozone Depleting Substances (Regeling gefluoreerde broeikasgassen en ozonlaagafbrekende stiffen), i.e. the `NL Regulation'.129 Both the Decree and the Ministerial Regulation are based on the Environmental Management Act (Wet milieubeheer). The Decree regulates, among other things, who is the competent authority as referred to in the F-gas Regulation, the prohibitions for the directly applicable obligations from the F-gas regulation and the principles for certification of persons and companies. As a preliminary remark, it should be noted that the rules set out in the F-gas Regulation are directly applicable in the Netherlands. Therefore, the further requirements listed below are thus limited to the specifics of national law, which overall strengthen the application of the F-gas Regulation. Implementation of the rules on control during use - such as prevention of emissions, leak checks and training and certification of operators (e.g. Articles 3, 4, 5 and 10 F-gas Regulation) Articles 3 to 5 of the F-gas Regulation are directly applicable in the Netherlands and have been transposed at national level. These provisions mostly mirror the content of the F-gas Regulation. Additionally, as regards the prevention of emissions of F-gases, the national law specifies that if an anomaly is found during the check, the operator must have this repaired immediately by a natural person that has the above-mentioned certificate (article 6 (3) of the NL Regulation);130 As regards instead article 10 of the F-gas Regulation, national law further specifies the training and certification programs required for natural or legal persons carrying out activities such as recovery of F-gases131, installation, servicing, maintenance, repair or decommissioning of certain equipment containing F-gases132. Additionally, the NL Decree contains more administrative rules on how accreditations are granted by the Ministry. In this sense, the NL Regulation establishes the assessment guidelines ("BRLs") needed for a certification to be issued133 and provides formal rules on the information to be included in the certificate134. As regards the notification referred to in article 10(10) of the F-gas Regulation (i.e. certification and training programs issued nationally), the Netherlands notified the Commission on 6 March 2017. Implementation of the rules on control during end-of-life Article 8 of the F-gas Regulation has a direct effect in the Netherlands and the Dutch legislation did not introduce any separate national rules. 128 wetten.nl - Regeling - Besluit gefluoreerde broeikasgassen en ozonlaagafbrekende stoffen - BWBR0037088 (overheid.nl) 129 wetten.nl - Regeling - Regeling gefluoreerde broeikasgassen en ozonlaagafbrekende stoffen - BWBR0037094 (overheid.nl). 130 Article 6(3) NL Regulation 131 Article 6(1) NL Decree 132 Article 6(2) NL Decree 133 Article 4 NL Regulation 134 Article 3 NL Regulation 74 Case study #2: Germany: National Legislation transposing the F-gas Regulation The F-gas Regulation itself has direct effect in Germany. However, its provision are further implemented and specified in national law with the Chemicals Climate Protection Regulation (Chemikalien-Klimaschutzverordnung - ChemKlimaschutzV)135 and Chemicals Act (Chemikaliengesetz - ChemG).136 As a preliminary remark, it should be noted that the rules set out in the F-gas Regulation are directly applicable in Germany. Therefore, the further requirements listed below are thus limited to the specifics of national law, which overall strengthen the application of the F-gas Regulation. Implementation of the rules on control during use - such as prevention of emissions, leak checks and training and certification of operators (e.g. Articles 3, 4, 5 and 10 F-gas Regulation) Articles 3 to 5 of the F-gas Regulation are directly applicable in Germany and have been transposed at national level. Additionally, in relation to Article 3 of the F-Gas Regulation, Section 3(1) of the Chemicals Climate Protection Regulation requires operators of stationary equipment (in the sense of Art. 4 (2) a-d) of the F-Gas Regulation) to ensure that the "specific refrigerant loss" of the equipment during normal operation does not exceed certain thresholds set out in Section 3(1) of the Chemicals Climate Protection Regulation. Section 3(2) of the Chemicals Climate Protection Regulation requires operators of mobile equipment used for the refrigeration of goods during transport containing at least three kilogram of F-gases as refrigerant to run leakage checks at least once every twelve month and to document that leakage checks and keep records for at least five years. As regards certificates, Section 5 of the Chemicals Climate Protection Regulation transposes the certification requirements for individuals into national law and provides for the administrative procedure for obtaining certification (inter alia needed for recovery from air-conditioning systems in motor vehicles, cf. Sec. 5(1), sentence 1). Furthermore, Section 6 of the Chemicals Climate Protection Regulation sets out requirements and procedures of national German law for obtaining a certificate for companies. As regards the notification referred to in article 10(10) of the F-gas Regulation (i.e. certification and training programs issued nationally), Germany notified the Commission on 20 February 2017. Implementation of the rules on control during end-of-life While article 8 of the F-gas Regulation is directly applicable in Germany, it should be noted that national rules allow operators responsible for the recovery from equipment or from the recovery of residual gases from containers to delegate their responsibilities regarding recovery to a third party.137 Additionally, it is worth noting that manufacturers and distributors are required to take back Fgases after use or to ensure they are taken back by third parties (i.e. providing contractors a responsible third party to drop off (products containing) F-gases in their possession138. Those manufacturers and distributors, as well as operators of disposal facilities who dispose of F-gases must keep records of the type and quantity of substances and preparations taken back or disposed of and of their whereabouts. Finally, producers and distributors are under a general obligation to ensure environmental sound disposal.139 135 Accessible via ChemKlimaschutzV.pdf (gesetze-im-internet.de) 136 Accessible via ChemG.pdf (gesetze-im-internet.de) 137 Section 4(1) of the Chemicals Climate Protection Regulation 138 Section 4(2) of the Chemicals Climate Protection Regulation 139 Section 23 of the German Lifecycle Management Act (Kreislaufwirtschaftsgesetz - KrWG), accessible via KrWG.pdf (gesetze-im-internet.de) 75 In particular, as regards the recovery from passenger cars, the Chemicals Climate Protection Regulation clarifies that for the recovery from air-conditioning systems in motor vehicles not listed in Art. 8(1) of the F-Gas Regulation "a person in charge with such recovery needs to hold a certificate".140 Also, the operator of air-conditioning systems in motor vehicles or other mobile refrigeration and air-conditioning systems not covered by Section 8(2) of the Chemicals Climate Protection Regulation shall ensure that the recovery of F-gases from such systems is carried out only by natural persons who can present a certificate of competence in accordance with section 5 Chemicals Climate Protection Regulation, qualifying them for the activity in question.141 Case study #3: Denmark: National Legislation transposing the F-gas Regulation The F-gas Regulation is implemented in Denmark with different legal acts, most importantly Executive Order no. 1326 of 19 November 2018, Executive Order 1901 of 30 September 2021, Statutory Order no. 552 of 2 July 2002 Regulating Certain Industrial Greenhouse Gases and the Chemicals Act, cf. Executive Order No. 849 of 24 June 2014. Implementation of the rules on control during use - such as prevention of emissions, leak checks and training and certification of operators (e.g. Articles 3, 4, 5 and 10 F-gas Regulation) Articles 3 to 5 of the F-gas Regulation are directly applicable in Denmark and have been transposed at national level. As regards the notification referred to in article 10(10) of the F-gas Regulation (i.e. certification and training programs issued nationally), Denmark notified the Commission on 7 December 2016. Implementation of the rules on control during end-of-life As a preliminary remark, it should be noted that the rules set out in the F-gas Regulation are directly applicable in Denmark. Therefore, the further requirements listed below are thus limited to the specifics of national law, which overall strengthen the application of the F-gas Regulation. The KMO is the competent authority handling the authorization of companies and persons who must work with refrigerants. Among authorizations, it should be distinguished between "Category 1 approval", which requires working with fillings over 2.5 kg (4 years of professional training as a cooling technician) and "Category 2 approval" which is required for fillings under 2.5 kg (14 days course), i.e. authorization for decommissioning and emptying. Overall, it should be noted that Denmark has a similar approach to other Nordic countries in waste management and handling. In fact, organized collection and access to incineration, special treatment, and recycling facilities are a common part of the infrastructure, except for Iceland where parts of the waste are disposed at landfills.142 In particular, as regards EPR schemes, a voluntary deposit-refund scheme (the so-called "KMO scheme") has been running by the contractor's association since 1992 and initially focused on ozone depleting substances but was expanded to HFCs later. Furthermore, a voluntary commitment is in place to incentivize proper recovery, reclamation and destruction: an upfront fee is charged together with the price for the virgin refrigerant by the operator and is used to cover for expenses related to recovery, reclamation and destruction.143 140 Section 5(1) of the Chemicals Climate Protection Regulation 141 Section 8(3) of the Chemicals Climate Protection Regulation 142 Nordic Working Paper p. 26 143 Support contract for an Evaluation and Impact assessment for amending Regulation (EU) No 517/2014 on fluorinated greenhouse gases, Evaluation Final Report, p. 57. 76 Practicability: The ELV Directive Case study #1: The Netherlands: National Legislation transposing the ELV Directive The ELV Directive is implemented in the Netherlands with the following Dutch laws and regulations: the Decree on the Management of Car Wracks (Besluit beheer autowrakken),144 the Decree on the Management of Car Tyers (Besluit beheer autobanden),145 the Decree on the Extended Producers' Responsibility (Besluit uitgebreide producentenverantwoordelijkheid),146 the Environmental Management Activities Decree (Activiteitenbesluit milieubeheer)147 and the Environmental Management Activities Regulation (Activiteitenregeling milieubeheer).148 Implementing measures on depollution activities, e.g. removal, separate collection and store of the air-conditioning system fluids ("AC fluids") (Annex I (3) of the ELV Directive) The minimum requirements set out in Annex I(3) of the ELV Directive are implemented through national legislation. Therefore, the following assessment will analyze the specificities of national law, which reinforce the general rules established in the ELV Directive. In this regard, national legislation149 includes further rules, particularly: o certain substances, including air conditioning fluids, must be drained or dismantled and stored as soon as possible, but no later than ten working days after receipt of the wreck;150 o drained substances, such as air conditioning fluids, must be stored separately to the extent necessary for recycling as a product or recovery;151 o Please note that next to the general obligations that follow from the above-mentioned legislation, usually an environmental permit for the depollution of an end-of-life vehicle is required (most likely under a waste management permit). That permit include o specific permit requirements that the establishment that dismantling end-of-life vehicles must comply with. Case study #2: Germany: National Legislation transposing the ELV Directive The ELV Directive is implemented into German law through the Verordnung ber die berlassung, Rcknahme und umweltvertrgliche Entsorgung von Altfahrzeugen, or abbreviated as Altfahrzeug-Verordnung (AltfahrzeugV).152 Furthermore, annually, the Federal Environmental Agency (Umweltbundesamt - UBA) reports on end-of-life vehicle recycling rates in Germany.153 Implementing measures on depollution activities, e.g. removal, separate collection and store of the air-conditioning system fluids ("AC fluids") (Annex I (3) of the ELV Directive) 144 Accessible via: wetten.nl - Regeling - Besluit beheer autowrakken - BWBR0013707 (overheid.nl); 145 Accessible via: wetten.nl - Regeling - Besluit beheer autobanden - BWBR0016038 (overheid.nl) 146 Accessible via: wetten.nl - Regeling - Besluit regeling voor uitgebreide producentenverantwoordelijkheid BWBR0044197 (overheid.nl); 147 Accessible via: wetten.nl - Regeling - Activiteitenbesluit milieubeheer - BWBR0022762 (overheid.nl); 148 Accessible via: wetten.nl - Regeling - Activiteitenregeling milieubeheer - BWBR0022830 (overheid.nl) 149 Paragraph 3.3.3 of the Environmental Management Activities Decree and paragraph 3.3.3 of the Environmental Management Activities Regulation 150 Article 3.27d (2)(i) of the Environmental Activities Regulation 151 Article 3.27e (2) of the Environmental Activities Regulation 152 Accessible via AltfahrzeugV.pdf (gesetze-im-internet.de) 153 Accessible via https://www.bmuv.de/download/jahresberichte-ueber-die-altfahrzeug-verwertungsquoten-indeutschland 77 The minimum requirements set out in Annex I(3) of the ELV Directive are implemented through national legislation. Therefore, the following assessment will analyse the specificities of national law, which reinforce the general rules established in the ELV Directive. According to Section 3(1) of the AltfahrzeugV, "vehicle manufacturers are obliged to take back all end-of-life vehicles of their brand from the last car owner". Further, according to Section 4 of the AltfahrzeugV, anyone who wishes to discard a vehicle is obliged to hand it over to "a 78pprox.78ed collection point, a 78pprox.78ed take-back point or a 78pprox.78ed dismantling facility." According to Section 5(2) of the AltfahrzeugV, such facilities shall comply with the requirements of the Annex of the AltfahrzeugV applicable to them in each case. With regard to air-conditioning fluids, this Annex sets out the following requirements: Pre-treatment by operators of dismantling facilities (cf. Section 3.2.1. of the Annex) requires inter alia: "Operators of dismantling facilities must remove and separately collect the following operating fluids and materials before further treatment of the vehicle:- [...]- Refrigerants from air conditioning systems (CFCs, etc.), - [...]"Section 3.2.2.4 of the Annex to the AltfahrzeugV requires the use of "closed systems" for removal of air-conditioning fluids:"[...] For the removal of refrigerants closed systems complying with the state-of-the art shall be used." With regard to the reuse, recycling and disposal, Section 3.2.4.1 of the Annex to the AltfahrzeugV sets out the following: "Brake fluid, hydraulic fluid, refrigerant from air-conditioning systems and radiator fluid shall be recycled as far as technically possible and economically reasonable." Section 3.3.3. of the Annex to the AltfahrzeugV requires dismantling facilities to document, inter alia "Inventory and whereabouts of removed substances, materials and parts by type and quantity". Overall, it should be noted that while removal/separation (and consequent storage) is mandatory and should be deemed as "recovery", "recycling" is instead limited to the extent that is technically possible and economically reasonable. Case study #3: Denmark: National Legislation transposing the ELV Directive The ELV has been implemented into Danish Law by various statutory orders, which have been consolidated in the Statutory Order no. 1654 of 29 December 2022 on the management of waste in the form of motor vehicles, the collection of environmental contributions and the payment of scrapping compensation ("ELV Order")154. Enforcement of the ELV Directive Without prejudice of the decisions taken by the Danish Environmental Protection Agency, the municipal council have supervision competences in assuring the compliance of the rules laid down in the ELV Order155. Implementing measures on depollution activities, e.g. removal, separate collection and store of the air-conditioning fluids ("AC fluids") (Annex I (3) of the ELV Directive) The minimum requirements set out in Annex I(3) of the ELV Directive are implemented through national legislation. Therefore, the following assessment will analyze the specificities of national law. The ELV Order further specifies the treatment requirements that are provided in the ELV Directive. In this regard, it obliges to any registered waste handler who receives end-of-life vehicles to ensure that the liquids, materials and components (such as refrigerants from air conditioning and 154 Available via https://www.retsinformation.dk/eli/lta/2022/1654 155 Article 62 ELV Order 78 refrigeration systems) are removed from all vehicles accepted for waste treatment and handled in accordance with the requirements provided in that Order156. In particular, the following obligations apply to the waste handlers: o As regards refrigerants from air conditioning and refrigeration systems, the draining of refrigerant must be carried out using a suitable system whereby the refrigerant is transferred in a closed system to approved pressure vessels. Refrigerants are then stored in pressure vessels approved for their storage.157 o In case refrigerants cannot be recycled, they are delivered in an independent fraction to municipal hazardous waste schemes or to companies to which the waste producer can legally deliver the waste in accordance with the Waste Ordinance.158 Monitorability: The F-gas Regulation Case study #1: The Netherlands: National Register In the Netherlands, the Ministry of environment has set up an online national register for companies certified to work with F-gases159 and for persons.160 This register, which is not mandatory, allows easy traceability of companies and personnel handling F-gases. Case study #2: Germany: National Legislation transposing the F-gas Regulation The German Federal Environmental Agency (Umweltbundesamt - UBA) regularly publishes reports and statistics, such as the Inventory of F-Gases 2019/2020,161 usually published on the Umwelt Bundesamt page related to F-gases, which appears an effective tool to constantly monitor F-gases.162 Implementation of article 25 of the F-gas Regulation and enforcement Germany's notification of implementation of article 25 to the Commission is publicly available.163 More specifically, Section 10 of the Chemicals Climate Protection Regulation sanctions noncompliance with certain provisions through fines by way of administrative offences. It should be noted that comprehensive documentation duties to facilitate inspections by administrative authorities. By way of example, documentation of performance of leakage checks is required,164 while manufacturers and importers supplying F-gases and all other suppliers along the supply chain must submit a declaration of compliance with the quota obligation of the F-GasRegulation, allowing the traceability of origin of F-gases and enabling competent authorities to review compliance/adherence to quotas.165 156 Article 14(1) ELV Order 157 Annex 3 ELV Order 158 Annex 4 ELV Order 159 NL National register for companies 160 NL national register for persons 161 Accessible via Inventarermittlung der F-Gase 2019/2020 (umweltbundesamt.de) 162 Accessible via Emissions of fluorinated greenhouse gases ("F-gases") | Federal Environment (umweltbundesamt.de) 163 DE Notification of article 25 of the F-gas Regulation 164 Section 4(3) of the Chemicals Climate Protection Regulation 165 Sections 12i and 12j of the Chemicals Act Agency 79 Case study #3: Denmark: National Legislation transposing the F-gas Regulation Beside national legislation implementing the ELV Directive, additional reports, such as the Danish consumption and emission of F-gases report166 published by the Danish Environmental Protection Agency and the Nordic Working Paper167 issued by the Nordic Council of Ministers provide additional guidance on the rules concerning F-gases in Denmark which help understand the national developments and provide an overview of some monitored data (e.g. F-gases imports). National Register In Denmark, the Klebranchens Miljordning ("KMO")168 registers all companies, installers and mechanics dealing with F-gases. This register allows easy traceability of companies and personnel handling F-gases. The KMO is managed by a private company which answers to the Danish EPA. The list includes every RACHP company and those which deal with F-gases and fall under the MAC directive. It is publicly accessible so every customer can find out if a company is certified and to what extent. KMO gathers information from wholesalers about the use of different F-gases. Wholesalers are not authorized to deliver F-gas to a customer unless the latter can supply a certificate. Finally, the KMO is financed by wholesalers who charge a fee for each liter of refrigerant they sell.169 Implementation of article 25 of the F-gas Regulation and enforcement Denmark's notification of implementation of article 25 to the Commission is publicly available.170 This clarifies that the provisions on sanctions for breaching the F-gas Regulation are contained in the Chemicals Act, cf. Executive Order No. 849 of 24 June 2014. Monitorability: The ELV Directive Case study #1: The Netherlands: Enforcement of the ELV Directive The Dutch implementation of the ELV Directive is enforceable by the competent authority, which is the Minister of Infrastructure. The Minister has delegated this authority to the Human Environment and Transport Inspectorate. The obligations can be enforced in several ways. For example, the Inspectorate can impose an administrative conditional fine or, which is less common, an administrative order subject to administrative coercion. Case study #2: Germany: Enforcement of the ELV Directive There are comprehensive obligations regarding documentation as well as obligations to provide information (cf. e.g. with regard to Section 10(1) no. 2 of the AltfahrzeugV on "environmentally sound treatment of end-of-life vehicles, in particular the removal of all fluids; and dismantling") intending inter alia to facilitate inspections by the competent administrative authorities. Section 11 of the AltfahrzeugV (which refers to Section 69 of the German Lifecycle Management Act) 166 Danish consumption and emission of F-gases report 167 Nordic Working Paper 168 Accessible via http://www.kmo.dk/default.aspx 169 Competent Authorities in Member States and Northern Ireland, Contact points for issues related to F-Gases in Member States and Northern Ireland1 Version July 2023 170 DK Notification of the article 25 of the F-gas Regulation 80 sanctions non-compliance in the case of violation of certain provisions of the AltfahrzeugV through fines by way of administrative offences (up to 1,000, depending on the type and severity of the violation). Case study #3: Denmark: Enforcement of the ELV Directive Among the different penalties, in particular regarding the management of F-gases in ELVs, the ELV Order provides a fine must be imposed for not handling and delivering liquids, materials, components, tyres, vehicles and residual waste fractions as prescribed in accordance with the correspondent provisions of the ELV Order171. Section 1.5.3 - Conclusions F-gases are already strictly regulated under the F-gas Regulation. In this regard, the upcoming revised Fgas Regulation will in all likelihood expand its scope to HFOs and HCFOs, and establish further obligations for operators both during the use phase and at the end-of-life. Chemours fully supports the extension of the risk minimization measures to HIFOs in the revised F-gas regulation. Moreover, the legal obligation/incentive to recover F-gases has been already acknowledged in the PFAS restriction proposal. Additionally, with respect to emissions of F-gases during the end-of-life treatment of an application, clear instructions by the Commission on their recovery as well as constructive minimum requirements for the responsibility of producers will further reduce emissions occurring during the recovery or destruction of F-gases, including HFOs/HCFOs. As national authorities and industry alike consider reclamation of F-gases to be an effective measure to reduce emissions, the expansion of Producer Responsibility Scheme offers a key avenue to ensure a comprehensive approach to the end-of-life treatment of F-gases. Furthermore, the EU legislative framework to manage F-gas emissions does not end with the F-gas Regulation. In this regard, as recognized in the Impact Assessment for the F-gas Regulation, the provisions in the MAC Directive, WEEE Directive and (especially) ELV Directive (and upcoming ELV Regulation) create synergies with the F-Gas Regulation, therefore contributing to the objective to manage and reduce emissions of F-gases which is, in essence, the objective of the PFAS restriction proposal. Finally, as demonstrated above, the existing sectorial legislation already provides an appropriate legislative framework to minimize F-gas emissions to the environment (the risk management objective of the Dossier Submitters for F-gases) when assessed against the REACH Annex XV criteria of effectiveness, practicality and monitorability. As such, the proposed restriction cannot be considered as an appropriate, proportionate, legislative approach to address F-gas emissions. A more appropriate restriction proposal would exclude PFASs that are already subject to the F-gas regulation (avoiding double regulation), similar to the approach adopted by the Dossier Submitters for plant protection products, biocides and human and veterinary medical products. Nevertheless, Chapter 2 of this document will explore additional risk management measures that could be implemented (ideally through the existing - and future - F-gas-specific legislation) in order to further minimize F-gas emissions across their life-cycle. Implementation of such additional measures would be 171 Article 64(10) ELV Order 81 more proportionate, and thus preferable, to the proposed restriction (ban). Again, such an approach is consistent with the Dossier Submitters' approach to plant protection products, biocides and medicinal products that identifies that improvements to sectorial legislation may be required to address potential risks from PFASs, despite them being derogated from the scope of the proposed restriction. 82 CHAPTER 2 - Risks can be more appropriately addressed by means of an alternative Restriction Option (additional risk management measures) Section 2.1 - Description of alternative risk management measures and assessment of appropriateness Technologies using F-gases achieve very high levels of performance, versatility and durability, and are a key facilitating technology for the European Union's decarbonization strategy (such as Heat pumps for RePower EU, Mobile AC and EV Thermal management systems for Smart and Sustainable Mobility, spray foam for the Renovation Wave or immersion cooling for the Digital Transformation). F-gases can be used safely, in a circular manner, with high rates of recovery and hence low emissions to the environment in non-emissive applications. Robust environmental and human health risk assessment of F-gases (see Chapter 1) has demonstrated that all environmental and human health risks are adequately controlled and that F-gases (and their degradation products) do not have the properties of concern associated with other types of (long-chain) PFASs, such as PFOS or PFOA. Nevertheless, as certain F-gases are greenhouse gases, or are associated with the formation of TFA (a persistent, but benign, atmospheric degradation product), it is necessary to minimize their emissions during their use, reclamation, recycling and at the end of their life. The Dossier Submitters concluded that the F-gas regulation and MAC Directive are insufficient to manage the risks associated with F-gases and that a REACH restriction is required because that would limit as many uses as possible and, thereby, further minimize F-gas emissions (and hence exposures), cover current and future F-gases, and prevent regrettable substitution. As elaborated earlier in this document, we consider that the current (and future) regulatory framework is a more appropriate means to address the risks of Fgases (including those associated with global warming potential). Nevertheless, we have identified and assessed various means, on an application-by-application basis, by which the existing legislative framework could be further strengthened, and which are outlined below. Based on an assessment of their effectiveness, practicality and monitorability (REACH Annex XV criteria) application of these additional measures should be considered to be more appropriate (i.e., proportionate) than the restriction option proposed by the Dossier Submitters. As such, they should be considered as alternative restriction options and considered alongside (i.e., complementary to) the existing legislation as the Dossier Submitter, RAC and SEAC evaluate the proposed restriction. The analysis of individual applications (in Attachment 2) demonstrates that a ban of F-gases on entry into force of any restriction or after a transitional period (duration depending on the application) would result in disproportionate impacts (i.e., costs) to society. Chemours believes that further emission reduction can be achieved more proportionately (i.e., more cost-effectively) through the mandating of further simple good-housekeeping measures in F-gas-containing systems and their associated maintenance and recovery regimes. These conditions could be included in the proposed REACH restriction or be incorporated in other relevant legislation, such as the F-gas regulation or the MAC directive. Below is a general qualitative overview of RMMs which we propose to be implemented in the various applications of F-gases. The existing legislation (much of which is via EU Directives) can be further strengthened by using the REACH restriction to harmonize a requirement to implement certain measures 83 that have, up till now, only been implemented by some individual Member States (but which proved to be particularly effective). These measures, some of which are described in the German, Dutch and Danish legislation case studies reported earlier in Section 1.5, are detailed under each RMM. The tools to further improve the monitorability of these RMMs beyond the existing framework described in Section 1.5 are summarized at the end of this section, since they apply to all RMMs. The proposed RMMs are briefly assessed below in terms of their effectiveness, practicability and monitorability. In each individual application section, the detailed implementation recommendations for each relevant RMM are explained, and their quantitative socio-economic impact is calculated. The socioeconomic impact described in Section 2.2 will detail the cost of these measures. Please refer to each individual application-specific document in attachment 2 for the detailed information by application. 1. End of life management Stricter provisions need to be implemented on the obligation to recover F-gases after use, consistent with the proposal of the EU Council during the revision of the F-gas regulation to make the recovery of F-gases in passenger cars mandatory "unless it can be established that it is not technically feasible or entails disproportionate costs".172 Chemours considers that the minimum requirements for F-gases should go further and make all recovery mandatory at end of life, in all applications therefore reducing emissions to a minimum. Practicability The following examples of how regulations on end-of-life recovery of F-gases in have been implemented in individual MSs demonstrate that it would be practicable to extend mandatory recovery at end-of-life. Implemented in France: Decree No. 92-1271 of December 7, 1992 made the recovery of CFCs, HCFCs and HFCs mandatory by law in France (Decree No. 92-1271 of December 7, 1992 relating to certain refrigerants used in refrigeration and air conditioning equipment, 1992). The establishment of an upfront fee payment system will also support the recovery of F-gases, such as those implemented in France or Denmark: France: In 1993, the industry agreement on F-gases was revised to introduce an eco-contribution system that would support the recovery of F-gases. A study carried out by Armines, a branch of the Ecole des Mines de Paris, calculated that the amount of greenhouse gases emissions avoided between 1993 and 2015 because of this measure amounted to 45 million tonnes of CO2 equivalent (Association of distributors, fillers, recoverers & reclaimers of refrigerants, n.d.).173 Denmark: An instrument of voluntary commitment is in place to incentivize proper recovery reclamation and destruction: an upfront fee is charged together with the price for the virgin refrigerant by the operator and is used to cover for expenses related to recovery, reclamation and destruction.174 172 Article 8(6) Commission Proposal; 173 adc3r (2021) valuation conomique: missions de Fluides Frigorignes vites Grce la convention de 1993, adc3r. Available at: https://adc3r.com/en/evaluation-economique-emissions-de-fluides-frigorigenes-evitees-gracea-la-convention-de-1993/. 174 Support contract for an Evaluation and Impact assessment for amending Regulation (EU) No 517/2014 on fluorinated greenhouse gases, Evaluation Final Report, p. 57. 84  There are also obligations to remove and separate F-gases in motor vehicles at end of life in Germany: According to Section 4 of the AltfahrzeugV, anyone who wishes to discard a vehicle is obliged to hand it over "o "a recognised collection point, a recognised take-back point or a recognised dismantling facility." According to Section 5(2) of the AltfahrzeugV, such facilities shall comply with the requirements of the Annex of the AltfahrzeugV applicable to them in each case. With regard to air-conditioning fluids, this Annex sets out the following requirements: Pre-treatment by operators of dismantling facilities (cf. Section 3.2.1. of the Annex) requires inter ali": "Operators of dismantling facilities must remove and separately collect the following operating fluids and materials before further treatment of the vehicle:- [...]- Refrigerants from air conditioning systems (CFCs, etc.), - "...]" Section 3.2.2.4 of the Annex to the AltfahrzeugV requires the use "f "closed systems" for removal of air-conditioning fluids:"[...] For the removal of refrigerants, closed systems complying with the state-of-the art shall be used." In the Netherlands, there are obligations to remove AC fluid from a vehicle within 10 working days after receipt of the wreck. National legislation175 includes further rules related to ELV, particularly: certain substances, including air conditioning fluids, must be drained or dismantled and stored as soon as possible, but no later than ten working days after receipt of the wreck;176 Drained substances, such as air conditioning fluids, must be stored separately to the extent necessary for recycling as a product or recovery;177 2. Required inspection intervals The current F-gas regulation already contains provisions for leak testing depending on the size of the equipment, and the F-gas regulation review is further strengthening these requirements by including Annex II gases. Strengthening these requirements by shortening leak testing intervals and expanding leak testing to a broader equipment base (requirement for smaller equipment or for applications where no leak testing is required today), is a cost effective measure for reducing emissions by improving system tightness and faster leak detection, where specific examples are given in the application-specific sections. These requirements can be in certain cases included in other servicing requirements such as regular inspection in automobiles. Technician training and certification (beyond the existing provisions) and monitoring will be necessary to ensure best practices are followed. Practicability Extending these measures would be a practicable policy, since they are already handled through the Fgas regulation and the provisions in place in the regulation. 175 Paragraph 3.3.3 of the Environmental Management Activities Decree and paragraph 3.3.3 of the Environmental Management Activities Regulation 176 Article 3.27d (2)(i) of the Environmental Activities Regulation 177 Article 3.27e (2) of the Environmental Activities Regulation 85 3. Technician training Technician training and certification is already an integral part of the F-gas regulation, as described in article 10 of the current Regulation and of the Commission proposal stating that: "Member States shall, on the basis of the minimum requirements referred to in paragraph 5 (of article 10), establish or adapt certification programs, including evaluation processes, and ensure that training on practical skills and theoretical knowledge is available." The EU Council proposal for the F-gas revision recognizes this need and defines a certification requirement for technicians. Chemours supports this proposal and considers that the requirements of training and certification should be made explicit to ensure that the training is harmonized and effective. Additional training can be provided at minimal cost by combining with other existing maintenance certificates (for opening the refrigeration circuit and changing components for example) by existing certification companies178, allowing technicians to receive training and certification to improve circularity of F-gases with skills that will ensure the minimization of leaks and improving recovery rates. Technicians should not be allowed to work without being trained and certificates delivered demonstrating the assimilation of best practices in important fields, at least including: Jointing (soldering and braising), Leak detection, Leak reduction optimization, Certification on end-of-life management best practice before being able to perform these critical leak minimization activities. An annual certification refresher course would ensure that the skill level is maintained and the risk of unintended emissions during system maintenance is reduced as much as possible. Practicability The practicability of extending these certification provisions is evidenced by the fact that they are already handled within the F-gas regulation, and additional measures are implemented in Germany for the Certification for individuals recovering F-gases in motor vehicles at end of life: Regarding the recovery from passenger cars, the Chemicals Climate Protection Regulation clarifies that for the recovery from airconditioning systems in motor vehicles not listed in Art. 8(1) of the F-Gas Regulation "a person in charge with such recovery needs to hold a certificate".179 4. System design improvements While the F-gas regulation has been successful in reducing leak rates through compulsory leak checks and contractor training for example, setting maximum leak rate targets would further support emissions reduction Improving the design of systems to reduce the leak rate of individual components as well as the introduction of a mandatory certification/declaration requirement that ensures that a system meets the maximum required leak rate limit at equipment handover are viable options that would reduce the leak rates of equipment once placed in the field. Implementing best in class technologies in terms of system design and pipe joining and defining and certifying maximum leak rate at the component level to meet 178 (Erweitern sie ihr wissen), See Reference List for complete reference 179 Section 5(1) of the Chemicals Climate Protection Regulation ChemKlimaschutzV.pdf (gesetze-im-internet.de) 86 the leak rate certification requirements has the potential to further improve system leak rates further reducing emissions and further improving circularity. Practicability It would be practicable to implement these measures through the establishment of maximum leak rate targets. Maximum leak rate targets have already be implemented in national legislation such as is in Germany: In relation to Article 3 of the F-Gas Regulation, Section 3(1) of the Chemicals Climate Protection Regulation requires operators of stationary equipment (in the sense of Art. 4 (2) a-d) of the F-Gas Regulation) to ensure that the "specific refrigerant loss"" of the equipment during normal operation does not exceed certain thresholds set out in Section 3(1) of the Chemicals Climate Protection Regulation. The regulation stipulates, for example, that the threshold is 1 percent with a refrigerant charge above 100 kilograms for applications installed at the installation site after June 30, 2008. Monitorability The effectiveness of the implementation of the proposed RMMs can be further monitored through the measures implemented by certain Member States detailed below and that we propose being implemented across the EU: Implementation of electronic registration of companies dealing with F-gases, such as in Denmark: The Klebranchens Miljordning "KM")180 registers all companies, installers and mechanics dealing with F-gases. This register allows easy traceability of companies and personnel handling F-gases. The KMO is managed by a private company which answers to the Danish EPA. The list includes every Refrigeration Air conditioning and heat pump (RACHP) company and those which deal with F-gases and fall under the MAC directive. It is publicly accessible so every customer can find out if a company is certified and to what extent. KMO gathers information from wholesalers about the use of different F-gases. Wholesalers are not authorized to deliver F-gas to a customer unless the latter can supply a certificate. Finally, the KMO is financed by wholesalers who charge a fee for each liter of refrigerant they sell.181 Implementation of databases which enable comprehensive Ozone-Depleting Substances and Fgas controls such as in Poland, Italy or France: Poland182: Poland has central electronic databases which enable comprehensive ODS (OzoneDepleting Substances) and F-gas controls. This comprises of: o A Central Register of Operators (CRO) operated by the Ozone Layer and Climate Protection Unit (OLCPU); o An electronically operated centralized system for "Equipment Logbooks" kept by F-gas (and controlled ODS) equipment operators, data from which has demonstrated that the leakage of F-gases from different categories of HVACR equipment dropped dramatically from 2016 to 2020, evidence for effective monitoring of leakage checks Central Database of Reports (CDR) operated by OLCPU; 180 Accessible via http://www.kmo.dk/default.aspx 181 Competent Authorities in Member States and Northern Ireland, Contact points for issues related to F-Gases in Member States and Northern Ireland1 Version July 2023 182 (Kozakiewicz, 2021), See Reference List for complete reference 87 o Electronically operated centralized system for reports on F-gases, other fluorinated substances (OFS) and ODS submitted annually by the entities, which among other things provide data on quantities recovered, recycled, reclaimed, destroyed and also on quantities emitted or lost for other reasons; o Central Database of Emissions to Air (CDEA) operated by another institution. The electronic logbook is available here: www.bds.ichp.pl Italy: Italy has established an electronic register, the National Telematic Registry of fluorinated greenhouse gases and equipment containing fluorinated gases, which provides traceability on all pieces of equipment. Based on obligations laid out in the F-gas regulation itself, Presidential Decree n. 43 of 2012 introduced the earliest version of the F-gas register, requiring operators, of stationary appliances for air conditioning, heat pump, refrigeration and for stationary fire extinguishing systems with a charge of greenhouse F-gas exceeding 3 kg, to report data on emissions. Presidential Decree No. 146/2018 (Gazzetta Ufficiale della Repubblica Italiana, 2019), implementing relevant provisions in the revised F-gas EU regulation No. 517/2014, further revised the F-gas register to create the electronic database mentioned above where the sales of fluorinated greenhouse gases and equipment containing such gases, as well as the servicing, maintenance, repair and decommissioning of such equipment, are reported. France: In France, recovery obligations are complemented by record-keeping requirements. Distributors must keep a register showing, for each transfer of fluid, the name of the purchaser, the purchase's certificate number if applicable, the nature of the fluid and the quantities transferred. Likewise, operators are required to declare the fluids they have handled to the approved body that issued their certificate of competence, before 31 January every year. Publication of national statistics on inventory and emissions of F-gases such as in Germany and Denmark: Germany: The German Federal Environmental Agency (Umweltbundesamt - UBA) regularly publishes reports and statistics, such as the Inventory of F-Gases 2019/2020,183 usually published on the Umwelt Bundesamt page related to F-gases, which appears an effective tool to constantly monitor F-gases.184 Denmark: Beside national legislation implementing the ELV Directive, additional reports, such as the Danish consumption and emission of F-gases report185 published by the Danish Environmental Protection Agency are available. Detailed record keeping of performance of leak checks such as in Germany: Comprehensive documentation duties to facilitate inspections by administrative authorities. By way of example, documentation of performance of leakage checks is required.186 Detailed record keeping, including of destruction such as in Germany: Manufacturers and distributors are required to take back F-gases after use or to ensure they are taken back by third parties (i.e. providing contractors a responsible third party to drop off (products containing) Fgases in their possession.187 Those manufacturers and distributors, as well as operators of disposal facilities who dispose of F-gases must keep records of the type and quantity of substances and 183 Accessible via Inventarermittlung der F-Gase 2019/2020 (umweltbundesamt.de) 184 Accessible via Emissions of fluorinated greenhouse gases ("F-gases") | Federal Environment Agency (umweltbundesamt.de) 185 (Ministry of Environment of Denmark, 2022), See Reference List for full reference 186 Section 4(3) of the Chemicals Climate Protection Regulation 187 Section 4(2) of the Chemicals Climate Protection Regulation 88 preparations taken back or disposed of and of their whereabouts. Finally, producers and distributors are under a general obligation to ensure environmental sound disposal.188 In Germany, the recovery of fluorinated gases, is mostly done by regional HVACR contractors, who are responsible for maintaining or servicing the equipment. This is monitored by the Federal States (Bund/Lnder-Arbeitsgemeinschaft Abfall, 2023)189. Between 2019 and 2021, between 160,000- 180,000 tonnes of refrigerant equipment was treated. Over this collection period, a total of approx. 152,400 kg refrigerant was collected in 2019, approx. 155,800 kg refrigerant in 2020 and approx. 147,400 kg refrigerant in 2021.189 According to Germany's 2021 National Inventory Report,190 the recovery of F-gases is increasingly efficient with losses decreasing compared to the initial refrigerant charge for commercial, household and industrial emissions (p.374). The 2023 report by the Federal/State Working Group on Waste confirms this, finding the recovery rates for equipment containing fluorinated gases to be between 99.8 % and 90,9 %.184 In Germany there are also comprehensive obligations regarding documentation as well as obligations to provide information (cf. e.g. with regard to Section 10(1) no. 2 of the AltfahrzeugV on "environmentally sound treatment of end-of-life vehicles, in particular the removal of all fluids; and dismantling") intending inter alia to facilitate inspections by the competent administrative authorities. Section 11 of the AltfahrzeugV (which refers to Section 69 of the German Lifecycle Management Act) sanctions non-compliance in the case of violation of certain provisions of the AltfahrzeugV through fines by way of administrative offences (up to 1,000, depending on the type and severity of the violation). Section 3.3.3. of the Annex to the AltfahrzeugV requires dismantling facilities to document, inter alia "Inventory and whereabouts of removed substances, materials and parts by type and quantity". Section 2.2 - Socio Economic Impact of the alternative risk management measures Chemours believes that further emission reduction can be achieved more cost-effectively by mandating alternate, additional, RMMs for F-gas-containing systems, which are described in this Chapter and in more detail in Attachment 2. These conditions could be included in the proposed REACH restriction or form part of an extension to some other relevant legislation, such as the F-gas regulation or the MAC directive. Applying these measures can further minimize the emissions from systems containing F-gases, at a fraction of the social cost of the proposed restriction. The total socio-economic cost to EU society of the proposed alternative RMMs, for mobile air conditioning, stationary HVACR, foam blowing agents, immersion cooling and high temperature heat pumps alone represents less than EUR 12bn in 2055, and the cost to reduce one tonne of PFAS emissions can range from zero to 0.6M per tonne (based on Chemours estimates of the impact of these measures on the future emissions of the different applications). These results are summarized in Table 2.1, which also shows an estimate of the emission reduction in 2055 for each application that can be achieved by applying the alternative RMMs proposed by Chemours. For certain applications, large emission reductions 188 Section 23 of the German Lifecycle Management Act (Kreislaufwirtschaftsgesetz - KrWG), accessible via KrWG.pdf (gesetze-im-internet.de) 189 (Bund/Lnder-Arbeitsgemeinschaft Abfall, 2023), See Reference List for complete reference 190 (Klimawirksame Stoffe 2019), See Reference List for complete reference 89 can be achieved, and for others, the actual emission level is already estimated to be very low, and the additional RMMs can further improve the emission level. Table 2.1 - Emissions estimate, estimated total cost, and cost per tonne of PFAS removed for each application considering the risk management measures proposed in this chapter. Stationary HVACR MAC and Heat pumps Foam blowing agents Immersion Cooling High Temp Heat Pumps and Organic Rankine Cycle Baseline emissions Chemours 20,975 3,147 415 1,111 50 estimate 2055 Emissions (tonnes) Emissions estimate Alt. Restriction 2,328 260 282 131 20 Option based on RMM 2055 Effectiveness 89% 92% 32% 88% 60% Estimated cost of Alt. Restriction 11,594 231 Option based on RMM 2055 Cost to prevent the release of 1 tonne of PFAS (Chemours emissions Socio Economic Cost (EUR million) estimate 2055) based on an alternative restriction option requiring mandatory additional RMMs rather than a ban. 0.6 0.1 Cost to prevent the release of 1 tonne of PFAS (Chemours emissions 3.2 14.0 estimate 2055) based on the Dossier Submitter's proposed restriction 5 0 0.04 Zero 200.4 31.2 0 Zero 326.3 Conclusions Emissions of F-gases can be effectively minimized by application of alternative RMMs at significantly lower cost to European society than the proposed ban. These measures are able to reduce overall emissions by nearly 90% across the above-mentioned segments for a fraction of the cost (all the details are available in Chapter 3, but for example in HVACR, the cost of a ban proposed by the dossier submitters reduces the emissions by 100% as opposed to 89% in the case of the alternative RMMs, but at a cost more than 5 times higher than the alternative RMMs, representing in 2055 EUR 3.2M per tonne of emission prevented). An alternative approach to risk management is demonstrably more proportionate than the proposed restriction as it maintains the societal benefits of F-gases, whilst ensuring that residual releases are minimized. The implementation of the additional risk management measures mentioned in this Chapter could be facilitated by a voluntary commitment which involves all actors of the F-gas supply chain, including manufacturers/importers, distributors, downstream users, research institutes and trade associations. Chemours supports the initiative to establish a stakeholder platform involving such actors to develop the measures described above (such as the set up of certification systems) in a collaborative and constructive manner together with authorities and regulators. 90 CHAPTER 3 - The proposed restriction (RO2) is disproportionate In this Chapter we provide evidence and arguments to demonstrate that the proposed restriction is a disproportionate regulatory option. We consider a range of issues, including the concentration limit of 25 ppb proposed for PFAS impurities, the conclusions of the analysis of alternatives and the assessment of socio-economic impacts. We consider that the regulatory option proposed by the Dossier Submitters is disproportionate because: - The concentration limit of 25 ppb set for PFAS impurities would prevent the placing on the market and circularity of F-gas products that do not fulfil the PFAS definition in use in the current restriction proposal. (Section 3.1) - There is a risk of regrettable substitution, considering the toxicological and ecotoxicological profile of alternatives, as well as the thermodynamic and safety limitations of the non-fluorinated alternatives to F-gases identified by the Dossier Submitters. (Section 3.2 and Section 3.3) - Codes and standards limit the use of alternatives and must be updated/amended before alternatives can be used, and this process can take a long time. (Section 3.4) - A restriction immediately following the transition period or after a time-limited derogation period would have a disproportionate socio-economic burden considering the restriction option proposed by the Dossier Submitters. (Section 3.5) Section 3.1 - Impurity level and effect on value chain In this section, we discuss the 25 ppb threshold (applicable also to impurities) proposed in the Annex XV restriction report, highlighting its implications and impacts considering the availability of analytical methods, the presence of residual F-gases from manufacturing process, supply chain, as well as its impact to the effective recovery and recycling of F-gases (as required by the F-gas regulation). More specifically, the proposed concentration limits do not consider the procedures and processes for the manufacturing, supply chain, recovery, recycling and reclamation of HFCs, HFOs and HCFOs. The analytical methods included in the restriction proposal are not relevant to the practical analysis of these F-gases and their impurity levels. A number of F-gases are not, due to their chemical structure, within the scope of the proposed restriction (referred to below as "excluded F-gases"). While the concentration limits in the proposal do not apply to these excluded F-gases, these excluded F-gases may contain very low concentrations of short chain PFAS (that is, other HFCs and HFOs which fall under the restriction proposal) that may be formed during the manufacture of the excluded F-gases. As such, the excluded F-gases would be similarly restricted from being placed on the market. Furthermore, it cannot be ruled out that the excluded F-gases could become contaminated with low quantities of short chain HFCs/HFOs/HCFOs that are in scope of the restriction, due to factors within the supply chain used to distribute and then return recovered F-gases (as required under the F-gas regulation). 91 This section explains why the proposed concentration limits are not appropriate to the F-gases sector, and could hinder the manufacture, placing on the market, and use of refrigerants that are not intended to fall into the scope of the proposed restriction. The section also provides further information on the F-gas supply chain and how it can affect impurity levels of virgin and reclaimed F-gases. We recommend that a specific concentration limit is established for fluorinated impurities as a threshold for the virgin and reclaimed F-gases which, for reasons of effectiveness, practicability and proportionality, should be equivalent to the existing AHRI 700 2019 Standard for Specifications for Refrigerants191, which details allowable fluorinated impurities in F-gases of up to a maximum of 0.5% w/w, without any individual limits. The AHRI 700 2019 is a globally accepted standard used in the global F-gas supply chain. Maintaining this limit under the conditions of any restriction would still allow the F-gas supply chain, which is a global supply chain, with most of the F-gases produced outside of the EU, to use a global fleet of cylinders/containers regardless of their destination or origin. Use of a concentration limit of 0.5% w/w would ensure that a previously used cylinder/containers can be used for non-PFAS F-gases, even if the same cylinder/container was used previously for F-gases fulfilling the PFAS definition. Implementing a lower concentration limit would result in global supply chain disruption and incur disproportionate costs associated with the need for a dedicated cylinder/container fleet for the sole supply of non-PFAS F-gases to the EU. Analysis Methods and Limitations The Annex XV report proposes a generic concentration limit for PFAS impurities in substances and mixtures at 25 ppb for individual compounds and respectively 250 ppb for their sum. For F-gases, such a low threshold is impracticable from analytical and technical points of view. In order to ensure the correct measurement of the 25 ppb concentration limit, the detection limit of an analytical method must be less or equal to 1 ppb, and this is not applicable/feasible for all types of matrices (air, water, individuals/blended F-gases), but only applicable/feasible for an air matrix. Such measurements can be achieved only using Gas Chromatography coupled with Mass Spectroscopy (GC-MS). GC-MS is, however, not a technology for routine analysis in industrial settings, but only used in research laboratories as it requires highly technical equipment and personnel skilled in the interpretation of the results. Appendix E.4 of the Annex XV Report mentions a few possible analytical methods for F-gases. It should be noted, however, that all these methods are used to identify specific F-gases in the air matrix, and cannot be considered relevant for qualitative and quantitative analysis of impurities in an F-gas matrix. Manufacturing Processes The impurities present in raw materials are inherent to the manufacturing process and are found in trace concentrations in the finished product. Their complete removal at the end of the process is often technically not possible due to, for example, similar boiling points or to the formation of azeotropes. The quantitative identification of impurities is necessary to ensure performance and safety of products. AHRI 700 2019 Standard is a globally accepted standard applicable to F-gases, where the allowed overall impurities of other F-gases is set at a maximum of 0.5%. While there is no EU-wide official standard 191 (AHRI), See Reference List for complete reference 92 relating to impurities in F-gases, EU industry has over time adapted their manufacturing processes to fit with the AHRI 700 standard. The values included in this standard are not a PFAS specific threshold, but in principle the standard covers all impurities (PFAS and non-PFAS) contained in the refrigerant. Typically, virgin HFCs/HFOs/HCFOs have a level of purity higher than 99.5% (e.g. up to 99.9% purity with 1000 ppm of volatile impurities) at the manufacturing phase. No PFASs are deliberately added or used, but short chain PFAS at low concentrations may be formed in low quantities during the manufacturing process. Supply Chain Refrigerants go through an extensive supply chain, which often includes repacking from large containers, usually ISO tank containers of 15 - 20 metric tonnes, to smaller ones such as ton tanks of 650 - 900 kg or cylinders of 2 - 60 kg, until they reach the end customer. The end customer is typically an installer who will fill the refrigerant into a refrigeration/air-conditioning or heat pump system. It should also be noted that since July 4th 2007, all containers used in the EU must be refillable in accordance with Annex III of the 2015 F-gas Regulation and with Annex II of the 2006 F-gas Regulation. Due to the limited availability of containers for transport or storage of refrigerants, it is possible that the same container is used for the transport and storage of multiple gases alternatingly, including both F-gases included and excluded in the PFAS proposal. As a consequence, traces of contaminants of F-gases contained within the proposed PFAS restriction could remain in the container. However, a gas chromatography analysis performed by the manufacturers and distributors before shipping/delivery guarantees the minimum purity of 0.5% as established by the AHRI 700 standard. Recovery and Recycling Articles 8 and 9 of the EU F-gas Regulation lay down provisions for the recovery of used F-gases and for their subsequent recycling, reclamation and re-use, or destruction. In order to contribute to EU circularity goals, the efficiency of resources should be maximized. Systems and practices to ensure the circularity of F-gases are already in place, with F-gases being extensively recovered and either recycled and reused directly by installers, or reclaimed by distributors and specialized companies to be re-placed on the market. For the re-use of excluded F-gases, it is possible that small quantities of the products within the proposed restriction may occur due to the recovery, recycling and reclamation processes. Dedicated containers (Rcylinders), typically suitable for liquified compressed gases, are used to collect and transport recovered refrigerants. Smaller quantities of different refrigerants may also be `bulked up' into larger containers, which, as mentioned above, must be refillable according to the F-gas Regulation. The re-use of these containers might result in the presence of trace contamination from previous use, possibly including refrigerants within the scope of the proposed restriction. In addition, equipment used to recover refrigerant from air-conditioning / refrigeration equipment may have also been used to recover refrigerants within the scope of the proposed restriction. While the reclamation process includes a final analysis which is based on the requirements of the AHRI 700 2019 Standard, recycling - which is a basic cleaning process that can be performed on site by installers of air-conditioning / refrigeration equipment - does not foresee or require any final quality check. Hence, enforcement of the proposed concentration limit would not be practical and would prevent the recycling 93 of F-gases, which would be in contradiction with the EU F-gas Regulation, which does not ask for a quality analysis for recycled material. Impurity thresholds set under other REACH restrictions or EU sectoral legislation It is important to ensure that impurity concentration limits proposed in the PFAS restriction consider the technical, legal, and practical limitations of each sector. There is currently significant variation of impurities concentration limits, set under other REACH restrictions or EU sectoral legislation. A limit of 25 ppb as Unintended Trace Contaminant (UTC) was set up in Annex I to Regulation (EU) 2019/1021 specifically for PFOA and its salts in polytetrafluoroethylene (PTFE) micropowders, only after it had been assessed that the respective manufacturers where able to comply with this limit. The same regulation established a generic concentration limit in substances and mixtures at 1 mg/kg for PFOA and 10 mg/kg for PFOS. It is worth noting that both PFOS and PFOA are substances with a very high bioaccumulation potential, which is not the case for the F-gases in scope, nor the F-gases degradation product TFA. Another relevant example is the restriction of siloxanes D4 and D5, which were identified as PBT and vPvB respectively, and for which the concentration limits in widespread uses (rinse off cosmetics) were set at 0.1 % by weight. In comparison, the F-gases have a benign hazard profile, and their emissions are already strictly controlled at EU and global level. Testing and safety assessment are carried out on the substance including impurities. However, for substances with a particular hazard profile (e.g. CMR), REACH imposes specific thresholds above which restriction or reporting requirements apply. For example, under REACH, SVHCs in articles require reporting in concentrations above 0.1%, whereas the presence of CMR in certain consumer products (clothing, textiles, footwear) is restricted to maximum concentrations varying from 1 to 3000 ppm. Horizontal chemicals legislation (REACH, CLP, OSH) and sectoral specific legislation use different tools to regulate the presence and concentrations of impurities, depending on the use of the product. Thus, for industrial chemicals the most relevant regulations are those governing exposure at workplaces, and the emissions and presence in certain consumer products (which do not have sectoral specific regulation), whereas for products such as cosmetics or medicinal products, specific concentration limits apply at substance and product type levels. The table below provides an overview of the different impurity levels across various legislations. Legislation Commission Regulation (EU) 2018/1513 amending REACH Annex XVII, concerning certain CMR cat 1A and 1B in clothing, textiles & footwear (with specific derogations for Personal Protective Equipment and Medical Devices) Commission Regulation (EU) No 1272/2013, amending REACH Annex XVII concerning the presence of certain Polycyclic Aromatic Compounds classified as carcinogen cat 1B in certain plastic and rubber parts of consumer articles Directive 2004/37/EC, last amended by Directive (EU) 2022/431, concerning the binding occupational exposure limits to carcinogens at workplace Concentration limits From 1 to 3000 ppm From 1 to 5 ppm From 0.001 mg/m3 to 54.7 mg/m3 (in air) 94 Commission Regulation (EU) No 366/2011, amending REACH Annex XVII, concerning the acrylamide concentration limits for grouting applications (building foundations consolidation) Commission Regulation (EU) No 494/2011 amending REACH Annex XVII, concerning the presence of Cadmium in jewelry Commission Regulation (EU) 2018/35 amending REACH Annex XVII, concerning the siloxanes D4 and D5 concentration limits in wash of cosmetics Regulation (EC) No 1223/2009, Annex III (restricted substances in cosmetics products) Commission Regulation (EU) No 231/2012 concerning the purity of food additives (non-exhaustive list of examples) Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food 0.1 % by weight in grouting mixtures 0,01 % by weight 0,1 % by weight From 0,0001 % to 12% by weight Heavy metals: from 1 to 10 ppm Aromatic amines: up to 100 ppm Dichloromethane: 10 ppm perfluorooctanoic acid, ammonium salt can be used as additive or polymer production aid in repeated use articles, sintered at high temperatures without any Specific migration limit The establishment of impurity concentration limits should be justified from a toxicological/ ecotoxicological perspective, and thresholds limits should be based on both product safety assessment (for humans or the environment) as well as on the practical possibility of routine measurement and enforcement. The proposed 25 ppb level threshold it is not justified from the hazard point of view, and it cannot be implemented in practice for HFCs/HFOs/HCFOs that do not fall under the scope of the proposed PFAS restriction. Conclusions Based on the information presented above, it is recommended that a specific concentration limit is established for fluorinated impurities as a threshold for virgin and reclaimed excluded F-gases. For effectiveness, practicability and proportionality reasons, this should be based on the AHRI 700 2019 Standard for Specifications for Refrigerants. The AHRI 700 2019 is a globally accepted standard used in the F-gas supply chain. It allows fluorinated impurities in F-gases of up to a maximum of 0.5%, without any individual limits. Maintaining this limit would allow the F-gas supply chain, which is a global supply chain, with most of the F-gases produced outside of the EU, to use the existing global fleet of cylinders/containers, regardless of their destination or origin, and even if the same cylinder/container was used previously for F-gases fulfilling the PFAS definition. Setting a lower concentration limit for impurities in F-gas cylinders/containers would generate a supply chain disruption at a global level and potentially require investment, with associated costs, into a dedicated cylinder/container fleet for the sole supply of F-gases that do not fulfil the PFAS definition currently used in this restriction proposal to the EU. In the limit, this requirement might prevent the international trade of F-gases between the EU and the rest of the world. In practice, the purity level of virgin F-gases is usually higher. A specific concentration limit consistent with AHRI 700 standard will ensure that possible minor contaminations occurring during logistics (e.g. 95 repacking from larger containers to smaller containers) will not hinder the compliance of the refrigerants. Setting a common concentration limit such as 0.5% of impurities for both, virgin and reclaimed F-gases, also reflects the EU F-gas Regulation, which establishes that reclaimed F-gases should "match the equivalent performance of a virgin substance, taking into account its intended use" (Recital 16). In addition, the HFCs/HFOs/HCFOs impurities that could potentially be present are short chain substances (typically C4) which will degrade in the atmosphere and highly unlikely to be long chain PFAS ( C6) which have very different properties to the short chain impurities. Section 3.2 - Hazard assessment of non-fluorinated alternatives In this section, we provide information on the hazard assessment of the main three alternatives to F-gases (propane, ammonia and CO2), mentioned by the Dossier Submitters in the restriction proposal. The aim is to highlight and summarize the main elements on both toxicity and ecotoxicity profiles of these nonfluorinated alternatives which were missing and not discussed in the restriction proposal by the Dossier Submitters. Environmental fate of propane The atmospheric oxidation pathways of propane and its by-products has been detailed by Rosado-Reyes, et. al.192 Oxidation of propane by OH radicals can proceed via the abstraction of the primary or secondary H atoms in propane. Singh, et.al.193 and Finlayson-Pitts, et. al.194 report the reaction proceeds with a branching ratio of secondary H abstraction to primary H abstraction of 80:20. In a later study, Jenkin, et. al.,195 reported a branching ratio of secondary H abstraction to primary H abstraction of 82:18. Figure 3.1, adapted from Rosado-Reyes, et. al192 is a schematic diagram of the atmospheric degradation of propane. The reaction of propane with OH produces acetone (CH3C(O)CH3) and propionaldehyde (CH3CH2C(O)H) as the major products in a ratio of approximately 80:20. Minor degradation products include formaldehyde (HC(O)H) and acetaldehyde (CH3C(O)H). 192 (Rosado-Reyes, 2007), See References List for complete reference 193 (Singh et al, 1994), See References List for complete reference 194 (Finlayson-Pitts et al., 1993), See References List for complete reference 195 (Jenkin et al., 2017), See References List for complete reference 96 Figure 3.1 - Schematic diagram of the atmospheric degradation of propane. Atmospheric Fate of Acetone. Acetone, the major (80% molar yield) product of the atmospheric degradation of propane, undergoes atmospheric degradation as shown in Figure 3.2 to produce formaldehyde (HC(O)H and CO2 as major products, and acetic acid (HC(O)OH), and methyl glyoxal (CH3C(O)C(O)H) as minor products. 192 Figure 3.2 - Atmospheric degradation of acetone. 97 Formaldehyde is ubiquitously found in the environment, as it is formed by numerous natural sources and anthropogenic activities, and is readily photo-oxidized in air to form CO2 196, 197, 198 and also reacts with OH to form CO2 and H2O as final products.197 Atmospheric Fate of Propionaldehyde. Propionaldehyde, formed in 20% molar yield from the atmospheric degradation of propane, undergoes atmospheric degradation as shown in Figure 3.3 to produce CO2, acetaldehyde (CH3C(O)H) and peroxypropionyl nitrate (PNN, CH3CH2C(O)OONO2).192 192Acetaldehyde undergoes atmospheric degradation to form CO2, formaldehyde and peroxyacetyl nitrate (PAN, CH3C(O)OONO2) as shown in Figure 3.4. 192192 Figure 3.3 - Atmospheric degradation of propionaldehyde. Figure 3.4 - Atmospheric degradation of acetaldehyde. 196 (WHO, 2010), See Reference List for complete reference 197 (Zhang et al., 2014), See Reference List for complete reference 198 (Tyndall et. al., 2002), See Reference List for complete reference 98 Environmental fate of propane Contribution to Ground Level Ozone (Smog). Propane is classified as a non-methane volatile organic compound (NMVOC) and hence it is in the scope of Directive EU 2016/2284 - Clean Air Package. NMVOCs contribute to the formation of ground level ozone formation, i.e., smog. Propionaldehyde, acetone, acetaldehyde and formaldehyde - formed in the atmospheric degradation of propane - are also classified as an NMVOC. Table 3.1 compares the Photochemical Ozone Creation Potentials (POCPs) of propane and its atmospheric degradation products. For most of the HFOs, the POCP is lower compared to the POCP of propane (e.g., 7 for HFO-1234yf or 3.1 for HFO-1336mzz-Z) and for HFCs the POCP is negligible (equal or, in most cases, lower than 1).199 Table 3.1 - POCPs of propane and its degradation products.200 Substance Photochemical Ozone Creation Potential (POCP) Propane 14 Acetone 6 Propionaldehyde 72 Formaldehyde 46 Acetaldehyde 55 Global Warming. The overall or net global warming potential (GWP) of an individual molecule is the sum of its direct GWP and indirect GWP.201 The direct GWP of an emitted substance relates to the effects on global warming of the emitted substance itself, for example an increase in global warming due to the absorption of IR radiation by an emitted greenhouse gas. Direct contributions to the net GWP of an emitted substance are large for fluorocarbons, but small for hydrocarbons. The indirect GWP of a substance relates to the effects on global warming of (1) the degradation products of the emitted substance, or (2) changes in the atmospheric concentrations caused by the emitted substance or its degradation products. Examples of indirect effects include direct effects of the degradation products of the substance, changes in concentration of atmospheric OH radical or O3 caused by the emitted substance, enhancement of stratospheric water vapor (SWV), and secondary aerosol formation. Indirect contributions to the net GWP of an emitted substance are large for hydrocarbons, but negligible for fluorocarbons. As pointed out by Hodnebrog, et al.,202 the direct effect is considerably smaller than the indirect effects for hydrocarbons such as ethane propane, and n-butane. In the case of propane, the direct 100 year time horizon GWP is 0.018, and the indirect GWPs due to O3 production and impact on methane lifetime are 4.0 and 5.5, respectively, leading to a net 100 year GWP of 9.5. Figure 3.5 compares the 100 year net GWP values for ethane, propane, n-butane and HFO-1234yf. The 100 year net GWP of propane (9.5) is approximately 19 times that of HFO-1234yf, which has a 100 year 199 (Wallington et al., 2015), See Reference List for complete reference 200 (Derwent et al., 2007), See Reference List for complete reference 201 (UNEP, 2007), See Reference List for complete reference 202 (Hodnebrog et al., 2018), See Reference List for complete reference 99 net GWP of 0.501.203 In other words, the emission of 1 kg of propane has 19 times the impact on global warming as a 1 kg emission of HFO-1234yf. Figure 3.5 - Comparison of net GWPs for different hydrocarbons (and HFO-1234yf, added in scale). Degradation Products. Table 3.2 summarizes the properties of the major degradation products of propane, together with their regulatory status under US EPA and the EU Directive 2016/2284 on NMVOC. The atmospheric degradation of propane produces PAN and PNN, both of which are components of photochemical smog, eye irritants, lachrymators, phytotoxins and bacterial mutagens. Table 3.2 - Regulatory status of propane and related degradation products. Substance Hazardous Air NMVOC VOC Pollutant Status EU Dir Status Other Status (US EPA) 2016/2284 US EPA Propane No NMVOC Yes Greenhouse gas, GWP = 9.5 Acetone No NMVOC No Propionaldehyde Yes NMVOC Yes Acetaldehyde Yes NMVOC Yes Formaldehyde Yes NMVOC Yes PAN No No No Component of photochemical smog, PNN No No No eye irritant, lachrymator, phytotoxin, bacterial mutagen Environmental impacts of ammonia The widespread use of ammonia has led to the conduct of numerous studies and reports related to the environmental impacts of ammonia. Ammonia does not contribute directly to ozone depletion, and its 203 (WGI Report), See Reference list for complete reference 100 primary environmental impacts relate to (1) its role in the formation of fine particles in the atmosphere and (2) its deleterious impacts on aquatic ecosystems. Secondary Particle Formation. The role of ammonia in the formation of secondary particulate matter is well established.204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217 Ammonia plays a primary role in the formation of secondary particulate matter by reacting with acidic species such as nitric acid (HNO3), sulfuric acid (H2SO4), to form ammonium (NH4+) containing aerosols, which constitute the major fraction of PM2.5 aerosols (particulate matter with a diameter < 2.5 m) in the atmosphere. HNO3 and H2SO4 are produced in the atmosphere when SOx and NOx emissions react with water and oxygen. SOx and NOx are combustion products formed from sources ranging from powerplants and steel mills to automobiles and trucks. PM2.5 aerosol formation has a deleterious effect on air quality, leading and/or contributing to adverse human health conditions such as cardiovascular disease, diabetes mellitus, and adverse birth outcomes. Underlying mechanisms by which such effects are elicited include intracellular oxidative stress, mutagenicity, genotoxicity and inflammatory responses.218, 219 Impacts on Ecosystems. The deleterious impact of ammonia on ecosystems is well documented.217, 219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229Error! Bookmark not defined., 230, 231 Ammonia (unionized as NH3) is registered in the EU under REACH at an annual tonnage band of greater than 1000 MT. The registrants self-classify the substance as Aquatic acute 1 ("Very toxic to the environment;" H400) due to its acute effects on fish. Also, 204 (Wang, et al., 2015), See Reference List for complete reference. 205 (Behera & Sharma 2010), See Reference List for complete reference. 206 (Updyke, et al., 2012), See Reference List for complete reference. 207 (Ye, et al., 2011), See Reference List for complete reference. 208 (Xu & Penner, 2012), See Reference List for complete reference. 209 (Park et al., 2014), See Reference List for complete reference. 210 (Finlayson-Pitts, et al., 1993), See Reference List for complete reference. 211 (Committee on the Environment and Natural Resources Air quality Research Subcommittee, Reference List for complete reference. 212 (Ma, et al., 2021), See Reference List for complete reference. 213 (Plautz, 2018), See Reference List for complete reference. 214 (Liu, et al., 2019), See Reference List for complete reference. 215 (Van Damme, et al., 2018), See Reference List for complete reference. 216 (Bauer, et al., 2016), See Reference List for complete reference. 217 (EEA, no date), See Reference List for complete reference. 218 (Feng et al., 2016), See Reference List for complete reference. 219 (ICEF, 2022), See Reference List for complete reference. 220 (Sampaio, et al., 2002), See Reference List for complete reference. 221 (Camargo & Alonso, 2006), See Reference List for complete reference. 222 (Anjea, et al., 2008), See Reference List for complete reference. 223 (Breitberg, et al., 2018), See Reference List for complete reference. 224 (EPA, no date), See Reference List for complete reference. 225 (APIS, no date), See Reference List for complete reference. 226 (Bobbink, et al., 2010), See Reference List for complete reference. 227 (Krupa, 2003), See Reference List for complete reference. 228 (Pitcairn, 1998), See Reference List for complete reference. 229 (Sheppard, et al., 2008), See Reference List for complete reference. 230 (van den Berg, et al., 2008), See Reference List for complete reference. 231 (Wiedermann, et al., 2009), See Reference List for complete reference. 2000), See 101 based on the lowest NOEC value for chronic toxicity to fish (0.0135 mg/L), ammonia is also self-classified as Aquatic chronic 2 ("Toxic to aquatic life with long lasting effects;" H411). The toxicity of ammonia to aquatic organisms is highly dependent on physicochemical factors, most notably pH because of its importance in chemical speciation. The acute toxicity of ammonia is also influenced to a lesser degree by temperature, carbon dioxide, dissolved oxygen, and salinity. In aqueous solution, ammonia exists primarily in two forms, un-ionized ammonia (NH3) and ammonium ion (NH4+), which are in equilibrium. As pH increases, the fraction of the total ammonia which is un-ionized increases. It is this un-ionized ammonia which is generally considered to be the primary cause of toxicity in aquatic systems. Ammonia emissions can lead to increased acid depositions and excessive levels of nutrients in soil, rivers or lakes, which can have negative impacts on aquatic ecosystems and cause damage to forests, crops and other vegetation. 217Error! Bookmark not defined. Eutrophication (excess nitrogen present in water bodies) can lead to severe reductions in water quality with subsequent impacts including decreased biodiversity, and toxicity effects. 217, 225, 226, 227, 228, 229, 230, 231 Eutrophication leads to heavy plant growth224 and harmful algae blooms which consume dissolved oxygen and lead to fish kills.219 Error! Bookmark not defined. Ammonia is a common cause of fish kills. However, the most common problems associated with ammonia relate to elevated concentrations affecting fish growth, gill condition, organ weights and hematocrit. Error! Bookmark not defined.219, 222, 223 Ammonia also exerts a biochemical oxygen demand on receiving waters (referred to as nitrogenous biological oxygen demand or NBOD). This occurs because dissolved oxygen is consumed as bacteria and other microbes oxidize ammonia into nitrite and nitrate. The resulting dissolved oxygen reductions can decrease species diversity and even cause fish kills. 224 A summary of effects of ammonia on vegetation are: 225 Eutrophication leading to changes in species assemblages; increase in N-loving species (e.g. grasses) and species that can up-regulate their carbon assimilation at the expense of species that are conservative in their N use. Shift in dominance from mosses, lichens and ericoids (heath species) towards grasses like Deschampsia flexuosa, Molinia caerulea and ruderal species, e.g. Chamerion angustifolium, Rumex acetosella, Rubus idaeus. Increased risk of frost damage in spring. Increased winter desiccation levels in Calluna and summer drought stress. Increase in N-loving epiphytes, e.g. Xanthoria parietina, at the expense of epiphytes that prefer acid bark. Increased incidence of pest and pathogen attack, e.g. heather beetle outbreaks. Direct damage and death of sensitive species, e.g. lichens and mosses, Sphagnum, Pleurozium schreberi. Reduced root growth and mycorrhizal infection leading to reduced nutrient uptake, sensitivity to drought and nutrient imbalance with respect to N that is taken up via the foliage. Increase in soil pH follows acidification. Ammonia excess will lead to increases in nitrification and denitrification, contributing to greenhouse gas emissions. Carbon Dioxide Emissions and Ammonia Production. Almost 2% of global carbon dioxide (CO2) emissions come from the production of ammonia.219 102 Health and Safety Concerns Associated with Ammonia Refrigeration System The primary health concerns associated with ammonia are its flammability and its acute toxicity to humans at high concentrations. Ammonia (unionized as NH3) is registered in the EU under REACH at an annual tonnage band of greater than 1000 tonnes. The substance is gaseous so the relevant route of exposure is by inhalation. Once inhaled, the substance will exist in the body in solution as aqueous ammonia/ammonium hydroxide with an equilibrium between NH4+ and NH3 strongly (>99.9%) in favor of NH4+. Nevertheless, the dossier includes studies performed by other exposure routes with aqueous ammonia and related water-soluble salts of ammonia. Anhydrous ammonia is classified as corrosive and studies using this substance identify local effects at the site of contact. Anhydrous ammonia and its aqueous solutions have a harmonized classification for corrosive effects. The gaseous and aqueous forms of ammonia are classified as: Category 1B ("Causes severe skin burns and eye damage;" H314) according to Annex VI of the CLP Regulation 1272/2008/EC. The REACH registrants self-classify the substance as Acute toxicity 3 ("Toxic if inhaled;" H331) due to its acute effects in acute inhalation studies. Short-term toxicity (Acutely Toxic Exposure Limit (ATEL)) is the basis for establishing the safe refrigerant concentration in an occupied space as defined by the American Society of Heating, Refrigeration and Airconditioning Engineers (ASHRAE) in ASHRAE Standard 34-202221 and the International Standards Organization (ISO) in ISO817. The health effects endpoints considered when deriving the ATEL are lethality, cardiac sensitization, anesthetic effects, and other escape impairing effects. While it would not be meaningful to make decisions on refrigerant safety based on minor ATEL differences, refrigerants with relatively low ATELs should be carefully assessed for health effects before selection. Refrigerants such as R1234yf (HFO-1234yf) and R513A (blend of HFO-1234yf and HFC-134a) have ATEL values of 100,000 and 72,000 ppm, respectively. In contrast, the ATEL value for R717 (ammonia) is 320 ppm. As discussed,219 the most common health effect from ammonia inhalation is chemesthesis (irritation of the skin and mucous membranes). As shown in Figure 3.6 below, 100-200 ppm will cause eye irritation, concentrations of 400 ppm will cause throat irritation, 700 ppm will cause coughing and severe eye irritation with possible loss of sight, 1700 ppm causes serious lung damage, and 2400 ppm results in death after 30 minutes of exposure. Pure anhydrous ammonia has a lower flammability limit of 15% in air219 However, at ammonia concentrations of 16-25% there is a risk of fire or explosion, and the US Environmental Protection Agency (EPA) cautions that this range may be expanded when ammonia is contaminated with lubricating oil.232 Indeed, a prior study indicated that lubricating oil contamination can reduce the lower flammability limit to 8%, depending on the composition and quantity of oil present.233 Ammonia leakage has led to numerous major accidents including fire and vapor cloud explosions. A recent review of safety issues and risk assessment of industrial ammonia refrigeration system reported that from 2007 to 2017, 60 ammonia accidents occurred in different industries across the United Kingdom.234 For ammonia-based industrial refrigeration facilities, 9 accidents were reported worldwide (Austria, Ukraine, Canada, USA, China, India, Malaysia, the Philippines) from 2004 to 2022 with 157 deaths and more than 500 workers and civilians were injured or taken to the hospitals or evacuated. Due to its high hazard, the cost associated with operating an ammonia industrial system is high, in both monetary and human lives. 232 (US EPA, 2001), See Reference List for complete reference 233 (Fenton et al., 1995), See Reference List for complete reference 234 (Khudhur et al., 2022), See Reference List for complete reference 103 Figure 3.6 - Ammonia concentrations and corresponding impacts on air quality and human health. 219 Risk Assessment Associated with Ammonia Refrigeration System The current challenge for stakeholders is to realize and to understand the complexity of developing and conducting a comprehensive risk assessment model for the ammonia refrigeration system due to its high hazard profile.234 The majority of ammonia leakage-related accidents occurred during maintenance and commissioning activities due to corroded pipes and valve failures. Other responsible factors involved in fatal accidents are human and organizational errors, and failures to follow guidelines, proper procedures, and safety measures. The available tools (e.g., HAZOP, fault tree, event tree) for risk analysis of ammonia refrigeration systems are static, and have many gaps and limitations234 A comprehensive and advanced risk assessment tool is needed such as a Bayesian network in which all potential failures of an ammonia refrigeration system could be identified. 234 This is essential to ensure that ammonia as a refrigerant is safely used at industrial facilities which are appropriately designed, constructed, operated, and maintained to avoid future fatal accidents. Health and Safety Concerns Associated with Carbon Dioxide (CO2) Refrigeration System The primary health concern associated with carbon dioxide (CO2) is its acute toxicity caused by displacing oxygen leading to asphyxiation. Adverse health effects could occur at the concentration as low as 2% by volume of CO2 (Table 3.3). Deaths could occur at concentration as low as 6.3% by volume of CO2 (Table 3.4). CO2 gas is classified235 for specific target organ toxicity-single exposure (STOT SE) category 3 (H335 respiratory tract irritation), and/or acute toxicity for inhalation category 4 (H332 - harmful if inhaled) by 235 (ECHA-c, C&L Inventory), See Reference List for complete reference 104 manufacturers or importers who have submitted classification and labeling data to ECHA according to criteria as described in CLP Regulation. Table 3.3 - Adverse health effects at different concentrations of CO2.236 Carbon dioxide concentration (%)* Adverse health effects 2 to 5 Headache, dizziness, sweating, shortness of breath 6 to 10 Hyperventilation, tachycardia, worsening dizziness 11 to 17 Drowsiness, muscle twitching, loss of consciousness >17 Convulsions, coma and death (*) Concentration by volume Table 3.4 - Inhalation exposure time versus CO2 concentration.237 Inhalation exposure time (min) Concentration in air v/v of Concentration in air v/v of specified level of toxicity (1-5% significant likelihood of death fatalities)* (50% fatalities)* 60 6.3 % 8.4 % 30 6.9 % 9.2 % 20 7.2 % 9.6 % 10 7.9 % 10.5 % 5 8.6 % 11.5 % 1 10.5 % 14 % (*) Concentration by volume Section 3.3 - Use and limitations of alternatives The fundamental properties that are described in this section are applicable to all applications that are using alternatives as they are driven by the basic thermodynamic, physical, and chemical properties of the refrigerant gases themselves. These general principles are immutable. For example, due to its low Critical Temperature and high operating pressures the efficiency CO2 will be lower than that of F-gases. Propane (R-290), will always have a highly flammable rating, regardless of the application. From supermarket refrigeration to residential air conditioning, data center cooling, or industrial heat pumps, there will always be real, practical limitations based on the refrigerant fluids' fundamental properties which hold true for all applications. Most chemicals utilized as working fluids (i.e., refrigerants) in vapor compression cycles have been around for close to a century or longer. Choosing the best fluid for a given application is far from simple and continues to be an iteration of optimizations and trade-offs between the many intrinsic properties of the refrigerants and the complexity, cost, and performance of the mechanical systems and components238. While it may seem the industry is in a continual state of transition, the one thing that does not change is the basic thermodynamic, physical, and chemical properties of the refrigerant gases themselves. Physical 236 (Cotter, 2022), See Reference List for complete reference 237 (Harper, 2023), See Reference List for complete reference 238 (Ashrae, 2018), See Reference List for complete reference 105 and chemical properties of non-fluorinated alternatives such as boiling points, liquid density, vapor pressures, and heat capacities do not change over time. The development of fluorinated solutions was triggered by the need to address the inherent weaknesses the available alternatives, as well as the associated industry needs in each application segment. This process led to the development of specific products with very specific chemical properties to address operational, energy efficiency, safety and design requirements. Non-fluorinated alternatives today still present the same limitations which led to the development of fluorinated solutions in the first place. Thus, fluorinated gases can be considered progressive technologies, in the sense that new innovations can be implemented over time in response to weaknesses in alternatives and, indeed, weaknesses in earlier Fgas products. Therefore, banning F-gases does not just mean the loss of functionality provided by existing F-gases, but it also means foregoing the benefits of even better-performing F-gases which are likely to be developed in future. In this section, we will summarize these serious limitations that non-fluorinated alternatives exhibit in terms of performance or safety which mean that non-fluorinated alternatives, while being an important part of the overall refrigerant toolbox, can in no way offer a universal solution to replace decades of F-gas technological development that addressed operational performance, energy efficiency, safety and design requirements. More detailed information of the limitations of non-fluorinated alternatives is presented in the individual application-specific documents in Attachment 2. Ammonia One of the earliest available industrial gases initially used for refrigeration was ammonia (R-717). While ammonia's thermodynamic performance as a refrigerant (cooling capacity (BTU/Hr.) and energy efficiency (BTUHr/KW) were favorable, its extreme acute toxicity, in addition to its non-compatibility with copper and flammability, have been properties that limited its applicability from its earliest days up to the present. For example in the HVACR application submission, it explains how for its industrial process refrigeration (IPR) equipment Chemours would not have been able to use ammonia, which was found to be reactive with some of the chemicals used in the manufacturing facility, and a significant safety concern was raised due to the proximity of the surrounding neighbourhood and the related consequences in a leak event, where the loss of a full charge would cause an unacceptable toxicity and flammability risk. Even if systems and safety mitigation innovations may help lower the risk profile, they cannot change the basic toxicological properties and in the final analysis there will always be a limit to how much, where, and in what types of systems ammonia can be deployed.239 Hydrocarbons Propane, butane, or other hydrocarbons have similar problems to ammonia. They are and will always be considered highly flammable - which will forever limit adoption compared to lower or nonflammable options which are fundamentally safer. A review of numerous studies comparing the performance of hydrocarbons to typical f-gas refrigerants generally reported capacity and efficiencies of non-optimized systems to typically be within +/- 10 % of each other.240 To limit the charge size of hydrocarbons and stay 239 (Bitzer, no date), See Reference List for complete reference 240 (Granryd et al., 2006), See Reference List for complete reference 106 within the maximum charge size prescribed by the codes and standards, one option is to use secondary loop systems. Secondary loop systems have the advantage of requiring a smaller charge, less piping and have lower leak rates, but they also have added pumping costs (1st cost + energy), lower system capacity due to the added pumping heat and lower system efficiency due to the secondary heat exchanger241. Despite their good capacity and efficiency, the limitation on charge size and loss of efficiency when using secondary loop systems prevent hydrocarbons from being widely adopted. Carbon Dioxide (R-744) CO2 (R-744), while not flammable, is similarly limited by different fundamental physical properties, in this case its vapor pressure and critical temperature (Tc). The vapor pressure curve for CO2 (R-744) (pressure of saturated CO2 at a given temperature) is well established and across the board is much higher than a typical F-gas242 as shown Figure 3.7. Figure 3.7 - Vapor pressure curve for CO2 (R-744) compared to R-404A and R-134a For example, an air conditioning chiller operating at 105F (40.6 Deg C) condensing would have a pressure of 313psi (21.6 bar) with R-454B. However, if CO2 (R-744) were used, the pressure would be 1417 psi (97.7 bar). These increased working pressures result in higher compression ratios, increased compressor work, component stress and higher leak probability. Another fundamental physical property of CO2 is its critical temperature (Tc), which at just 31 Deg C is much lower than those of typical F-gases with Tc in the 70-100 Deg C range. The practical implication of this is that condensing conditions will more often exceed a low Tc, at which point the refrigerant vapor cannot be condensed, meaning that a series of mechanical elements and operational design complexities must be introduced to allow the system to operate at what is called trans-critical conditions. All these added components and steps result in lost efficiency, increased energy usage, and complex service practices which in many cases are not practical, or possible, due to space or cost limitations. These 241 (Kapsha & Tim Pacitti, 2015), See Reference List for complete reference 242 (Patenaude, 2023), See Reference List for complete reference 107 inefficiencies result in the poor energy performance commonly associated with CO2 systems at higher ambient conditions and in warm climates.243 Non-PFAS F-gases Additionally, certain non-traditional F-gases have also been proposed as alternatives to legacy refrigerants like R-410A, but these too are not without fundamental limitations. For example, HFC-152a appears to be an attractive fluid because of its low GWP, but its molecular structure, with four hydrogens, results in it being classified as Class 2 flammable, and as such it will require more safety mitigation or the use of secondary loop systems to limit the charge size, reducing the performance and limiting its uptake in many applications. HFC-32 is another F-gas and potential alternative to legacy refrigerants with a lower flammability, A2L safety rating. However, being a small molecule, with only a single carbon atom, HFC-32 will develop more internal heat when compressed compared with larger molecules, like HFO-1234yf, which have more atomic bonds and degrees of freedom to dissipate internal heat of compression energy. The practical results are that HFC-32 systems operate with much higher discharge temperatures and require enhanced heat management schemes to safely maintain the systems' reliability over their lifetime and to avoid lubrication degradation and hardware issues. Furthermore HFC-32 has a relatively high GWP (675, AR4), which means it is an interim solution under the EU F Gas Reg revision's phase down or a blend component for low GWP blends. It is clear that to fully optimize the HVACR industry and support all of its varied and demanding applications, such as commercial refrigeration distributed systems or condensing units, domestic heat pumps or industrial process refrigeration, a variety of refrigerant working fluids will be required. Overly limiting the choices for system designers will result in suboptimal system performance and societal impact. Section 3.4 - The setting and updating of codes and standards limiting the charge size of flammable refrigerants Codes and standards are essential to the successful design and installation of air conditioning and refrigeration systems. Safety standards are developed through a consensus process, with input from a wide variety of stakeholders and technical experts, to help ensure the safe and reliable application of these systems. Changing standards is a lengthy process, especially when considering large scale changes that have industry wide impact, such as expanding the use of flammable refrigerants. To broaden the use of non-fluorinated alternatives from where they are today, significant changes to safety standards and building codes would be required. Unless these codes and standards can be, and are updated to allow the use of alternatives (where suitable), the types of bans proposed by the Dossier Submitters will be infeasible to implemented and will thus have disproportionate costs. and their implementation are unfeasible. Standards must be modified first, before bans can be implemented, not vice versa. 243 (Bitzer, no date a), See Reference List for complete reference 108 Throughout the proposal by the dossier submitters, there are numerous quotes citing the inadequacy of the current codes and standards: "safety standards limits on flammable refrigerants charges are too restrictive", "higher charge size limits are possible", "standards and codes were unnecessarily restrictive", or also "the safe application of higher charge limits is possible". These safety standards are mainly based on calculations of Lower Flammability Limit (LFL), Oxygen Depravation Limits (ODL) or Acute Toxicity Exposure Limits (ATEL) which are the physical properties of a substance. Such properties cannot change, and the resulting constraints will always exist and will always be more restrictive for more dangerous substances. Changing a standard is a lengthy process, as demonstrated below with the description of the evolution of standard IEC 60335-2-40. The revision process requires action first, at the international, then at EU level before being translated into national standards. The current relevant standards in place in Europe limiting the charge size of flammable refrigerants are reviewed below. EN IEC 60335-2-89: Limitations on adopting flammable refrigerants in commercial refrigeration appliances: This standard specifies the safety requirements for electrically operated commercial refrigerating appliances and ice-makers that have an incorporated motor-compressor or that are supplied in two units for assembly as a single appliance in accordance with the instructions (split system). Examples of equipment that fall within the scope of this standard are: - refrigerated display and storage cabinets; - refrigerated carts; - self-service and service counters - blast chillers and blast freezers; - commercial ice makers. Commercial use of these refrigerating appliances is, for example, in restaurants, canteens, hospitals and commercial enterprises such as bakeries, butcheries, supermarkets etc (i.e applications not intended for domestic use). In practice, the standard imposes the following charge sizes limitations: Only hermetically sealed systems shall be used in appliances with flammable refrigerant. For appliances with a remote refrigerant unit or motor-compressor (split system), the refrigerant charge of flammable refrigerant shall not exceed 150 g in any refrigerating circuit. For appliances with an incorporated refrigerant unit or motor-compressor, the refrigerant charge of flammable refrigerant shall not exceed 13 times the LFL of the flammable refrigerant or 1.2 kg in any refrigerating circuit, whichever is smaller. This represents 0.494 kg for R-290. There is no charge size limitation under this standard for refrigerants from the group A1 (nonflammable). This standard does not apply to refrigerants with a group B toxicity classification (such as ammonia). Furthermore, all other requirements of the standard will need to be met, such as maximum pressure allowed, site minimum floor area, site ventilation openings requirements, servicing personnel suitable qualification, etc. 109 IEC 60335-2-40 Ed 6th: Limitations of adopting flammable refrigerants in Household and similar electrical appliances This standard (IEC 60335-2-40, 6th Ed) specifies safety requirements for electric heat pumps, including sanitary hot water heat pumps, air conditioners, and dehumidifiers incorporating motor-compressors and hydronic fan coils units, their maximum rated voltages being not more than 250 V for single phase appliances and 600 V for all other appliances. Appliances not intended for normal household use, but which nevertheless may be a source of danger to the public, such as appliances intended to be used by non-professionals in shops, in light industry and on farms, are within the scope of this standard. In practice, the standard imposes the following charge sizes limitations: A maximum charge size of 0.3 kg for A3 flammable refrigerants (such as propane) for stand-alone systems or non-fixed factory sealed single package units; A3 flammable refrigerants are not allowed in multi-split systems, ducted systems and chillers. Furthermore, all other requirements of the standard will need to be met, such as exposure to hot surfaces, enclosure of electrical components, enhanced tightness, maximum pressure allowed, site minimum floor area, site ventilation openings requirements, servicing personnel suitable qualification etc. EN 378: Limitations on adopting flammable refrigerants in refrigerating systems and heat pumps This European standard specifies the requirements for the safety of persons and property, provides guidance for the protection of the environment and establishes procedures for the operation, maintenance and repair of refrigerating systems and the recovery of refrigerants. The term "refrigerating system" used in this European standard includes: Heat pumps; Refrigerating systems, stationary or mobile, of all sizes, such as commercial refrigeration systems, condensing units connected to evaporators, cold storage, blast freezers, industrial refrigeration systems, process cooling, rooftops, air-handling units, but not vehicle air conditioning systems which are covered by a specific product standard e.g. ISO 13043; secondary cooling or heating systems like chillers, cold/hot water loops or brine loops. In practice, the standard imposes the following charge sizes limitations by category of refrigerating system: Human comfort and ceiling-mounted applications: like mono/multi-split air conditioning systems A maximum charge size of 1.5kg for A3 flammable refrigerants; A maximum charge size of 12kg for A2L mildly flammable refrigerants such as R-454B (OpteonTM LX41) without any additional safety measure (but can reach 59kg if additional safety measures are put in place and the area is great enough). 110 Figure 3.8 - Maximum charge size of R-290 and OpteonTM XL41 in human comfort and ceiling mounted applications Refrigeration systems, with the condensing unit outside and the evaporator inside and in areas only accessible to staff (Class II category b), such as cold storage: A maximum charge size of 2.5kg for A3 flammable refrigerants (if above ground application); A maximum charge size of 25kg for A2L mildly flammable refrigerants such as R-454B (OpteonTM LX41) without any additional safety measures (but can reach 59kg if additional safety measures are put in place and the area is great enough). Figure 3.9: Maximum charge size of R-290 and OpteonTM XL41 in Refrigeration systems, with the condensing unit outside and the evaporator inside and in areas only accessible to staff Refrigeration systems, with the condensing unit outside and the evaporator inside and in areas accessible to the public (Class II category a), such as refrigerated display cases: A maximum charge size of 1.5kg for A3 flammable refrigerants; 111  A maximum charge size of 11.5kg for A2L mildly flammable refrigerants such as R-454C (OpteonTM XL20) without any additional safety measures (but can reach 57kg if additional safety measures are put in place such as mechanical ventilation and gas detection and the area is great enough). Figure 3.10 - Maximum charge size of R-290 and OpteonTM XL20 in refrigeration systems, with exterior condensing unit and interior evaporator and in areas accessible to the public, no additional measure Figure 3.11 - Maximum charge size of R-290 and OpteonTM XL20 in refrigeration systems, with the condensing unit outside and the evaporator inside and in areas accessible to the public with additional safety measures Furthermore, all other requirements of the standard will need to be met, such as additional protection measures required to reduce the risk if excessive refrigerant is emitted in a given space. 112 Codes and Standards update process Charge sizes of flammable refrigerants, for example, can not simply be increased on a whim. First, significant industry research and testing is required to demonstrate that these higher charge sizes are necessary and can be safely applied. Once this vital step has been completed, the standards development process can begin in earnest. Ideally, international standards are developed first. These standards then serve as a template that can be used by different regions or individual countries. Regional and national standards are then updated. Once a country has updated their national standards, changes to building codes can then be proposed. These updates need to be codified before alternative refrigerants can be broadly applied. The entire process is lengthy, often taking many years to complete. An example of this is demonstrated by the evolution of the IEC 60335-2-40 standard described below. Additionally, updates to safety standards to broadly apply the use of alternative refrigerants may not be possible for all applications. Alternative refrigerants often have increased risk associated with their usage, such as higher toxicity and/or flammability or material compatibility concerns. With flammable refrigerants, risk tends to increase with increasing charge size. Charge levels that have been deemed safe and acceptable for fluorinated refrigerants, for example, may not be achievable for alternative refrigerants while maintaining the same level of risk. IEC 60335-2-40 is an international standard related to safety, and covers equipment containing refrigerants such as heat pumps, including heat pumps for domestic hot water, air conditioners and dehumidifiers consisting of hermetic motor-compressors, the maximum rated voltage of which is not more than 300 V for single-phase devices and at 600 V for all multi-phase appliances. Edition 6 of the standard was published in January 2018. The timeline in Figure 3.12244 describes in more detail how the revision of an international standard can take up to 36 months from the preparatory phase to the approval phase. This timeline does not include the proposal phase to start a new project, which also needs to be taken into consideration in the total timeline. In the case of IEC 60335-2-40, Edition 7 was published in May 2022, nearly 4.5 years after the publication of the previous edition. To be applicable in the EU, international standards need to be adopted into EN standards. EN standards usually are not just adopted but harmonized with relevant and applicable European laws like Pressure Equipment Directive (PED), the Low Voltage Directive (LVD) and the Machinery Directive. This enables system manufacturers who follow the harmonized EN standards to be compliant also with EU legal requirements. If IEC standards are applied directly (which can be done), for each deviation between the EN and the IEC standard, the system manufacturer must perform a risk assessment demonstrating that the system is still safe despite these deviations. This requires a high effort and increases the system manufacturer's responsibility for product safety. For this reason, most smaller OEMs will only follow the harmonized EN standards. 244(IEC, no date), See Reference List for complete reference 113 Figure 3.12 - Detailed description of the revision process for an international standard In the case of IEC 60335-2-40, the current version of the EU standard, EN IEC 60335-2-40 is still based on the IEC 60335-2-40 edition 5, published in 2013. The publication of EN IEC 60335-2-40 (based on IEC 60335-2-40 Edition 6) is still delayed and is expected to be published during the second half of 2023, which is five years after the publication of IEC 60335-2-40 Edition 6. As such, it will likely be years before we see the EN 60335-2-40 standard harmonized with the flammable refrigerant requirements found in the 7th edition of the IEC 60335-2-40 standard. EN standards need to be further adopted into national standards, which often consists of a translation to the national language, which will take another period of time and further delay the process. This is an important step, since many small system manufacturers only use national standards for language reasons. When the dossier submitters talk about relaxation of standards, regardless that this might not be possible from a health and safety perspective, the process could easily take 5 to 10 years, considering the process of developing a new IEC standard and subsequent adoption into a related EN standard and then national standards. Section 3.5 - Socio Economic Impact of the proposed restriction option on the F-gas sector The analysis of individual applications available in Attachment 2 demonstrates that a ban on the use of PFASs at entry into force or after the time-limited derogation periods proposed by the dossier submitters (depending on the application) would be extremely costly to society and likely disproportionate because of the lower energy efficiency of alternative technologies and associated additional energy costs. Specifically, the total socio economic cost to EU society of the ban proposed by the Dossier Submitters, for mobile air conditioning, stationary HVACR, foam blowing agents, Immersion cooling and high temperature heat pumps alone, is more than EUR 240 billion only for 2055 (the total costs of implementing the restriction between 2025 and 2055 will be much greater and can be found in the 114 individual application submissions) , while the cost to reduce one tonne of PFAS emissions in 2055 can range from EUR 3.2 million to EUR 326 million per tonne (based on Chemours estimates of the future emissions of the different applications). These estimates are shown in Table 3.5 below, which also shows the potential additional energy consumption resulting from a ban. Table 3.5 - Potential additional energy consumption of a ban and the total cost, as well as the cost per tonne of PFAS removed for each application. Stationary HVACR MAC and Heat pumps Foam blowing agents Immersion Cooling HTHP and ORC Emissions Baseline emissions Dossier submitters 2055 43,074 16,945 (tonnes) Baseline emissions 20,975 3,147 415.3 1,111 50 Chemours estimate 2055 Energy 214 71 271 113 57 (TWh) Energy cost of ban 2055 Socio Economic Cost (EUR million) Estimated cost of a Ban in 2055 Cost to prevent the release of 1 tonne of PFAS (Chemours emissions estimate 2055) based on the Dossier Submitter's proposed restriction Cost to prevent the release of 1 tonne of PFAS (Chemours emissions estimate 2055) based on an alternative restriction option requiring mandatory additional RMMs rather than a ban. 66,394 3.2 0.6 43,953 83,220 34,628 14.0 200.4 31.2 0.1 0.04 Zero 16,242 326.3 Zero 115 Figure 3.13 - Estimated costs in 2055 of preventing the emission of 1 tonne of PFAS. Figure 3.14 - 2055 baseline emissions and impacts of the proposed package of measures. Black diamonds represent the emission reduction percentage achieved by the Alternative restriction option based on mandatory additional risk management measures described in Chapter 2. 116 Thus, it can be seen that the costs in 2055 of preventing one tonne of PFAS emissions via RO2 are estimated to be 3.2 million in the stationary HVACR sector, 14 million in the MAC and heat pumps sectors, 31.2 million in the immersion cooling sector, 200.4 million in foam-blowing and 326.3 in high temperature heat pumps and organic Rankine cycles. However, regulating emissions of PFASs by means of mandatory additional risk management measures would cut emissions from the stationary HVACR sector by approximately 90% at an estimated cost per tonne of 0.6 million, by a similar amount from MAC and heat pumps at a cost of 0.1 million per tonne, from foam blowing by approximately 30% at an estimated cost per tonne of 0.04 million, 90% immersion cooling and 60% in HTHP and ORC at negligible cost. This is a more economically efficient, proportionate, means of regulating PFASs as emissions are minimized whilst the benefits to society in terms of high energy efficiency are maintained. Figure 3.15 - Marginal abatement cost curve for F-Gas emission reductions in 2055 Figure 3.15 plots the emission reductions obtained from each option (additional measures and bans) for each application in order of marginal cost, from lowest to highest, to generate a `marginal abatement cost' curve. It can be seen that emission reductions of almost 90% can be achieved at a cost no more than 622/kg (510/kg on average) by implementing the simple housekeeping measures Chemours suggests. Implementing a ban on the use of F-gases in stationary applications would achieve a further 9% reduction in emissions, but at a cost over 50 times higher (28,500/kg). The last remaining 3% of emissions could be achieved by implementing bans in MAC, immersion cooling, foam and HTHPs, but at even higher cost - banning HTHPs would reduce emissions only by another 20 tonnes, but at a cost of 16bn per year, or over 800,000/kg. 117 In conclusion, the restriction proposed by the Dossier Submitters immediately after the transition period or after a time-limited derogation period would have a disproportionate socio-economic costs to society. The cost of a ban is also disproportionate when considered relative to the cost of implementing the alternate risk management measures with high abatement effectiveness that are described in chapter 2. The risk management measures proposed are able to reduce overall emissions of PFASs in these applications by nearly 90%, relative to baseline, for a fraction of the cost of a ban. Therefore, it can be clearly concluded that a restriction option that required the implementation of additional risk management measures, rather than a ban, would be a more appropriate restriction option. Chemours requests that the Dossier Submitters, RAC and SEAC specifically consider the appropriateness (i.e., effectiveness, practicality and monitorability) of a restriction option based on additional RMMs, rather than a ban, in the event that existing regulation is not considered appropriate for F-gases. Section 3.6: Request for derogations based on disproportionate Cost If F-gases are kept in scope and the additional risk management measures suggested are not considered sufficient to address the risk of emissions, we argue that the costs of the proposed R02 would be disproportionate in relation to many uses of F-gases. This argument is based on a comparison of the marginal abatement costs of a ban compared with the suggested additional measures, as shown in Table 3.6. Table 3.6 - Marginal abatement cost of a ban vs additional risk management measures. Stationary HVACR MAC and Heat pumps Foam blowing agents Immersion Cooling HTHP and ORC Total Baseline emissions tonnes 20,975 3,147 415 1,111 50 25,699 Ban cost EUR M 66,394 43,953 83,220 34,628 16,242 244,438 Cost/tonne (EUR M) 3.2 14.0 200.4 31.2 326.3 9.5 Measures impact % Measures impact tonnes Measures cost/tonne (EUR M) 89% 92% 32% 18,648 2,973 415 0.6 0.1 0.04 88% 1,111 0.0 60% 88% 50 23,197 0.0 0.7 New baseline tonnes 2,328 260 282 131 20 3,021 Marginal ban cost/tonne (EUR M) 28.5 169.0 294.7 264.9 815.7 80.9 The first three lines of Table 3.6 are based on Chemours' estimates of baseline emissions and repeat the calculations of the estimated cost of a ban, per tonne of PFAS emissions prevented, across the five sectors and overall. The second three lines repeat the calculation of the costs of preventing PFAS emissions through the additional risk management measures suggested by Chemours' analysis. The final two lines of Table 3.6 are as follows. The first calculates what remaining emissions would be if the suggested additional measures were implemented. This is the additional reduction in emissions which would be achieved by a ban over and above the additional measures. The costs of a ban remain as previously estimated, so the final line is an estimate of the marginal costs of a ban, from the new, lower baseline emissions after the additional measures have been implemented. It can be seen that, because new baseline emissions are so much lower following the additional measures, the marginal costs of a ban, to 118 secure the final reduction in emissions to zero, are much higher, at between 28 million and 816 million per tonne of emissions prevented, or 81 million per tonne overall. We argue that these costs are disproportionate when compared with, e.g. benchmark costs of reducing PBT and vPvB substances, as reviewed by Oosterhuis et al (2017).245 If a REACH restriction (ban) covering F-gases is to be implemented, sector-specific derogations should be included to avoid disproportionate impacts to society: If F-gases remain in scope and a phase-out is preferred to minimization via additional risk management measures, the following derogations will be required to avoid disproportionate socio-economic impacts on society. Existing equipment using F-gas technologies Existing equipment which uses F-gases cannot be retrofitted to use alternative refrigerants. Therefore, a ban on F-gases would prevent this equipment being serviced and maintained, and lead to premature retirement. A permanent derogation is therefore justified to avoid the unnecessary costs of replacing this equipment. (This justification was used by the Dossier Submitters for their proposed derogation 5i, although this derogation was time-limited and restricted to existing HVACR equipment only.) Stationary HVACR and transport refrigeration applications There are significant specific performance limitations associated with the alternatives to Fgases across the different applications in stationary HVACR and in transport refrigeration. It might be possible to overcome these problems through engineering developments, but this will take time and resources. A minimum 12-year derogation is suggested to allow this to happen. A review should be undertaken before the end of the derogation period, to ensure that the necessary substitution activity has been successful. If not, a further extension of the derogation would be justified to avoid disproportionate costs in future; Mobile air conditioning and heat pumps (EV/hybrid mobile air conditioning/heat pumps) (M1246 and N1247), and ICE mobile air conditioning vehicles (M1 and N1) There are fundamental problems with using F-gas alternatives in electric vehicles AC and heat pumps, due to safety concerns and poor performance, especially at higher ambient temperatures. A derogation for F-gases in these applications is therefore justified. ICE vehicles are subject to phase out over a period of time which means investment in new MAC systems which do not use F-gases will never be commercially viable (even if it were possible). A derogation for F-gases in ICE MAC applications is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. 245 (Oosterhuis et. al, 2017), See Reference List for complete reference 246 Passenger cars, taxi cabs, motor caravans 247 Pick-up trucks and vans with a weight below 3.5 tonnes 119  Foam-blowing agents (Foam-blowing agents in expanded foam sprayed on site for building insulation; Foam-blowing agents in expanded foam for all applications where the foam is not sprayed on site for building insulation) HFO-blown spray foam exhibits exceptional thermal resistance and low density compared with alternative blowing agents and materials, and hence provides much better insulation in a given amount of space. The fundamental disadvantages of alternatives will never be overcome. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Two-phase immersion cooling applications Two-phase immersion cooling based on F-gases is the technology which will support the next generation of data centers and electric vehicle powertrain thermal management. Alternatives are far less effective and would result in significant increases in energy use and cost. A ban on F-gases in these applications would also encourage investment in these key strategic technologies to divert to countries where they can still be used. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Industrial high temperature heat pumps and organic Rankine cycle applications; HFOs already offer energy efficient solutions for a broad range of HTHP technology across the different temperature and application requirements, without the problems exhibited by alternatives, such as narrow range of application or high flammability. We assume that 50% of waste heat cannot be recovered without the use of F-gases; this would result in significant increases in energy use and cost. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Chemours has developed policy proposals for a set of F-Gas applications for which it possesses expert knowledge and directly applicable evidence. There are other applications of F-Gases - such as MDI; fire protection; propellants; cold plate technology; and the use of solvents in critical cleaning, semiconductor process cooling, and carrier fluids - in which Chemours does not consider itself expert, and hence elected not to develop proposals. However, it is entirely possible that, for these applications too, a similar case could be made for additional measures as a more costeffective risk management approach, and derogation on the grounds of disproportionate cost, if an appropriate analysis was undertaken. Hence, we would encourage the Dossier Submitter and the ECHA Committees to use evidence available from stakeholders and apply the same logic in these and other applications. To assist with this, Chemours is providing the evidence it possesses on these applications, in Attachment 2. 120 Conclusions Through this submission, Chemours TSS has demonstrated that an alternative restriction proposal that focuses on risk management via emission reduction and circularity would be more proportionate than the proposed restriction and ensure that the EU realizes its policy ambitions whilst maintaining its competitiveness and strategic autonomy. In Chapter 1, we highlighted that the definition of PFAS in use for this restriction proposal (which is different from those in use for other PFAS-related policies) covers a variety of substances characterized by very different physicochemical , environmental fate, hazard and risk properties, including F-gases and TFA, which have been proved safe for their intended uses. The robust datasets available for F-gases and TFA demonstrate that the properties of F-gases and TFA are different from the `model PFASs' used by the Dossier Submitters to support their case-by-case approach and clearly show that the risk profile of this specific PFAS subclass does not require a restriction under REACH as their risks are already adequately controlled. F-gases and TFA have been demonstrated to be safe for their intended uses and their current and projected emissions to the environment do not pose a risk to human health or the environment. This conclusion is also reflected in globally accepted assessment reports, such as the UNEP EEAP 2022 report, showing that the risks posed by F-gases and TFA for both human health and the environment, both today and in the future, are de minimis. Additionally, emission reduction is the objective of both the current restriction proposal and the existing regulatory framework for F-gases in the EU, which includes the F-gas Regulation (EU Regulation 517/2014), the MAC Directive (EU Directive 2006/40/EC) and other pieces of legislation that regulate the end-of-life of equipment containing F-gases, e.g., the End-of-Life Vehicles Directive (EU Directive 2000/53/EC). Consequently, we demonstrated that the existing legislation on F-gases (taking into account pending revisions) is already an appropriate and effective means to minimize emissions of F-gases to the environment and, therefore, that the inclusion of F-gases into the scope of the proposed restriction is not necessary to achieve the risk management objectives of the Dossier Submitters. Therefore we ask ECHA to consider the following hierarchy of arguments/asks: 1. F-gases do not pose an unacceptable risk at the EU level and hence should not be included in a REACH restriction: For a restriction to be justified, it needs to be demonstrated that the use of F-gases generates unacceptable risks which need to be addressed at the EU level. However, Chemours' analysis demonstrates that F-gases do not possess the properties which the Dossier Submitters have identified as sources of concern justifying regulatory action towards PFASs generally. Accordingly, the analysis demonstrates that all F-gases (current and future) fulfilling the PFAS definition used by the Dossier Submitters should be exempt from the scope of this restriction because there is no risk to be addressed at the EU level. Similarly, F-gas degradation products, such as TFA, should be exempted, given that the risks to human health and the environment are de minimis. 2. F-gas emissions should be managed under the existing legislative framework: Instead, all F-gases should be regulated under the existing (and future) regulatory framework for F-gases, which includes 121 the F-gas Regulation (current and future), the MAC Directive, the End-of-Life of Vehicles Directive, the WEEE Directive and the Waste Framework Directive, and which already has the objective of minimizing F-gas emissions to the environment, progressively and in a cost-effective manner. As a result, a restriction under REACH, with the same objective is not necessary or helpful. If the current (and future) regulatory framework for F-gases is not deemed sufficient to address the risk, the arguments presented in Chapter 2 should be considered. We showed that emissions of F-gases can be effectively minimized by application of alternative RMMs at significantly lower cost to European society than the proposed ban. These measures are able to reduce overall emissions by nearly 90% across the mobile air conditioning, stationary HVACR, foam blowing agents, immersion cooling and high temperature heat pumps for a fraction of the cost. (For example in stationary HVACR, the cost of a ban proposed by the Dossier Submitters reduces the emissions by 100% as opposed to 89% in the case of the alternative RMMs, but at a cost more than 5 times higher than the alternative RMMs, representing EUR 3.2M per tonne of emission prevented in 2055.) An alternative approach to risk management is demonstrably more proportionate than the proposed restriction as it maintains the societal benefits of F-gases, whilst ensuring that residual releases are minimized. Therefore we ask ECHA to further consider the following hierarchy of arguments/asks: 3. Further F-gas emission reductions are best achieved through additional management measures: If the current (and future) regulatory framework for F-gases is considered to be insufficient to ensure the safe use of F-gases, and further (and faster) emissions reductions are warranted, additional risk management measures are a much more cost-effective way of securing them, rather than a ban. Such measures include mandatory recovery at end-of-life, minimum inspection (leak-testing) intervals, improved technician training and improvements to system design standards to further reduce leaks. The package of measures which Chemours proposes for this purpose is summarized in the table below. All of these measures have been demonstrated to be feasible and practicable and most of which already exist in some EU Member States. MAC and Heat Pumps Stationary HVACR Foam Blowing Agents Mandatory Reclaim at end of life Required leak Certification of test at road technicians (existing worthiness test standards recertification) Upfront fee for Reclaim at end of life Increased frequency of leak testing compared to FGR revision council proposal Incineration obligation and landfill prohibition of PU foam Certification of installers Strengthened Certification of technicians System architecture enhancements to reduce leak rates over time to: 0.7% at EIF +18 months 0.5% at EIF + 5 years 0.1% at EIF + 7 years 0.05% at EIF + 9 years - Leak rate certification of components and equipment - System architecture enhancements Driving system leak rate reduction to : 40% leak rate reduction at EIF + 4.5 years 60% leak rate reduction at EIF + 6.5 years 80% leak rate reduction at EIF + 8.5 years 122 Immersion Mandatory leak Cooling checks Mandatory technician training and certification HTHP and ORC Upfront fee for Reclaim at end of life Strengthened Certification of technicians Enhanced Leaktesting - Leak rate certification of components and equipment - System architecture enhancements: Driving system leak rate reduction to 0.4% per year, 9 years after EiF 4. Exemption based on minimal yield of persistent degradation products: If the arguments presented in points 1, 2 and 3 above are not considered sufficient to exclude F-gases from the scope of a ban: F-gases degrading to a persistent substance (such as TFA) with a molar yield below 10% should be exempt because these make a negligible contribution to the global TFA budget; F-gases degrading to a persistent substance (such as TFA) with a molar yield above 10% (not covered by this exemption) should be subject to the derogation conditions presented under point 5 below. As highlighted in Chapter 3, the inclusion of F-gases in the scope of this restriction proposal would trigger the following consequences: The concentration limit of 25 ppb set for PFAS impurities would hinder the placing on the market and circularity of F-gas products not fulfilling the PFAS definition in use in the current restriction proposal. Therefore, we recommend referring to the 0.5% w/w limit for F-gas impurities set in AHRI 700 standard; There is a risk of regrettable substitution, considering the toxicological and ecotoxicological profile, as well as the thermodynamic and safety limitations of the main non-fluorinated alternatives to F-gases listed by the Dossier Submitters in the restriction proposal; Codes and standards limit the use of alternatives and must be updated/amended before alternatives can be used. This process can take a long period of time and there is no guarantee that standards will be sufficiently relaxed to allow the use of certain alternatives in all instances (e.g., flammable or acutely toxic refrigerants). Moreover, as reported in Chapter 3 and Attachment 2, a restriction immediately following the generic transition period or after a time-limited derogation would have a disproportionate socio-economic burden. The total socio-economic cost to EU society of the ban proposed by the Dossier Submitters, for mobile air conditioning, stationary HVACR, Foam Blowing Agents, Immersion Cooling and High Temperature Heat Pumps alone, is estimated to be more than EUR 240bn only for 2055, while the cost to reduce one tonne of PFAS emissions can range from EUR 3.2M to EUR 326M per tonne (based on Chemours estimates of the future emissions of the different applications). The cost of a ban is also disproportionate compared to the cost of alternate measures that are discussed in Chapter 2. Therefore we ask ECHA to further consider the following arguments/asks: 5. If a REACH restriction (ban) covering F-gases is to be implemented, sector-specific derogations should be included to avoid disproportionate impacts to society: If F-gases remain in scope and a phase-out is preferred to minimization via additional risk management measures, the following derogations will be required to avoid disproportionate socio-economic impacts on society. 123  Existing equipment using F-gas technologies Existing equipment which uses F-gases cannot be retrofitted to use alternative refrigerants. Therefore, a ban on F-gases would prevent this equipment being serviced and maintained, and lead to premature retirement. A permanent derogation is therefore justified to avoid the unnecessary costs of replacing this equipment. (This justification was used by the Dossier Submitters for their proposed derogation 5i, although this derogation was time-limited and restricted to existing HVACR equipment only.) Stationary HVACR and transport refrigeration applications There are significant specific performance limitations associated with the alternatives to Fgases across the different applications in stationary HVACR and in transport refrigeration. It might be possible to overcome these problems through engineering developments, but this will take time and resources. A minimum 12-year derogation is suggested to allow this to happen. A review should be undertaken before the end of the derogation period, to ensure that the necessary substitution activity has been successful. If not, a further extension of the derogation would be justified to avoid disproportionate costs in future; Mobile air conditioning and heat pumps (EV/hybrid mobile air conditioning/heat pumps) (M1248 and N1249), and ICE mobile air conditioning vehicles (M1 and N1) There are fundamental problems with using F-gas alternatives in electric vehicles AC and heat pumps, due to safety concerns and poor performance, especially at higher ambient temperatures. A derogation for F-gases in these applications is therefore justified. ICE vehicles are subject to phase out over a period of time which means investment in new MAC systems which do not use F-gases will never be commercially viable (even if it were possible). A derogation for F-gases in ICE MAC applications is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Foam-blowing agents (Foam-blowing agents in expanded foam sprayed on site for building insulation; Foam-blowing agents in expanded foam for all applications where the foam is not sprayed on site for building insulation) HFO-blown spray foam exhibits exceptional thermal resistance and low density compared with alternative blowing agents and materials, and hence provides much better insulation in a given amount of space. The fundamental disadvantages of alternatives will never be overcome. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Two-phase immersion cooling applications 248 Passenger cars, taxi cabs, motor caravans 249 Pick-up trucks and vans with a weight below 3.5 tonnes 124  Two-phase immersion cooling based on F-gases is the technology which will support the next generation of data centers and electric vehicle powertrain thermal management. Alternatives are far less effective and would result in significant increases in energy use and cost. A ban on F-gases in these applications would also encourage investment in these key strategic technologies to divert to countries where they can still be used. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Industrial high temperature heat pumps and organic Rankine cycle applications; HFOs already offer energy efficient solutions for a broad range of HTHP technology across the different temperature and application requirements, without the problems exhibited by alternatives, such as narrow range of application or high flammability. We assume that 50% of waste heat cannot be recovered without the use of F-gases; this would result in significant increases in energy use and cost. A derogation for F-gases in this application is therefore justified. It is not possible to specify a meaningful (evidence-based) time-limited derogation/transition period because it is not clear that alternatives can ever be economically competitive. Hence the costs of a ban are expected to remain disproportionate for the foreseeable future. Chemours has developed policy proposals for a set of F-Gas applications for which it possesses expert knowledge and directly applicable evidence. There are other applications of F-Gases - such as MDI; fire protection; propellants; cold plate technology; and the use of solvents in critical cleaning, semiconductor process cooling, and carrier fluids - in which Chemours does not consider itself expert, and hence elected not to develop proposals. However, it is entirely possible that, for these applications too, a similar case could be made for additional measures as a more costeffective risk management approach, and derogation on the grounds of disproportionate cost, if an appropriate analysis was undertaken. Hence, we would encourage the Dossier Submitter and the ECHA Committees to use evidence available from stakeholders and apply the same logic in these and other applications. To assist with this, Chemours is providing the evidence it possesses on these applications, in Attachment 2. Chemours notes that, currently, there is no generic regulatory definition of an "F-gas" i.e., a definition based on molecular structure or substance properties. Rather, F-gases are identified on a substance-bysubstance basis by means of their inclusion in Annex I and Annex II of the F-gas Regulation. However, the proposed REACH restriction relies on a generic PFAS definition based on molecular structure. This generic definition includes most of the substances listed on Annex I and II of the F-gas regulation but also (future) more sustainable substances that could be used as alternatives to existing F-gases that are not currently listed in Annex I or II of the F-gas regulation. In the event that F-gases were excluded from the scope of the proposed restriction (based on the justifications provided in this submission), this incongruity in substance definition between the different regulations would have the effect of inadvertently including future F-gases within the scope of the restriction, preventing innovation to more sustainable F-gases. We consider that future F-gases should be 125 allowed to be used subject to the same conditions of use and emission minimization measures as required for the substances listed in Annex I and II of the F-gas Regulation. Therefore, in the event of derogation for F-gases, we urge the Dossier Submitters, ECHA and the European Commission to address this potential incongruity in order to ensure that the REACH restriction does not prevent the development of future generations of F-gases (i.e., that have even lower global warming potential than the current generation and which do not degrade to persistent degradation products). For example, a generic definition of F-gas could be developed or the Annexes of the F-gas regulation could be periodically (e.g., annually) updated to include novel F-gases on the basis of scientific and technological progress. This would solve such a regulatory incongruence and enable innovation to even more sustainable F-gases. As manufacturer, seller and downstream user of F-gases, Chemours' TSS business unit recognizes the concerns raised by the Dossier Submitters with the safety profiles of some PFASs. TSS is aware of the increased scrutiny on PFASs as outlined in the EU's Chemical Strategy for Sustainability. With expertise in the manufacture, properties and application of F-gases, TSS is committed to take an active, responsible and constructive role in the public consultation on the proposed restriction to facilitate the development of a coherent approach to the regulation of PFASs. 126 Reference List Chapter 1 Anderson, J.K. et al. (2022) `Grouping of PFAS for human health risk assessment: Findings from an independent panel of experts', Regulatory Toxicology and Pharmacology, 134, p. 105226. https://doi.org/10.1016/j.yrtph.2022.105226. ANSI/ASHRE (2022) ANSI/ASHRAE Standard 15-2022, Safety Standard for Refrigeration Systems and ANSI/ASHRAE Standard 34-2022, Designation and Safety Classification of Refrigerants, ASHRAE Refrigeration Resources. Available at: https://www.ashrae.org/technical-resources/bookstore/ashrae-refrigerationresources#:~:text=ASHRAE%20Standard%2015%20specifies%20requirements,New%20overpressure%20protection Behringer, D. et al. (2021) Persistent degradation products of halogenated refrigerants and blowing agents in the environment: Type, environmental concentrations, and fate with particular regard to new halogenated substitutes with low global warming potential, Umweltbundesamt. Available at: https://www.umweltbundesamt.de/en/publikationen/persistent-degradation-products-of-halogenated. Bhhatarai, B. and Gramatica, P. (2010) `Prediction of aqueous solubility, vapor pressure and critical micelle concentration for aquatic partitioning of perfluorinated chemicals', Environmental Science & Technology, 45(19), pp. 8120-8128. https://doi.org/10.1021/es101181g. Boethling, R. et al. (2009) `Environmental persistence of organic pollutants: Guidance for development and review of Pop Risk Profiles', Integrated Environmental Assessment and Management, 5(4), p. 539. https://doi.org/10.1897/IEAM_2008-090.1. Boudreau, T. M. (2002). Toxicity of Perfluorinated Organic Acids to Selected Freshwater Organisms under Laboratory and Field Conditions. M.Sc., University of Guelph, Guelph. Available At: https://atrium.lib.uoguelph.ca/items/b2d039c9-f298-4276-8992-6666f10b0ef7 Boutonnet, J. C., et al, (1999). Environmental risk assessment of trifluoroacetic acid. Human and Ecological Risk Assessment, 5, 59-124. https://doi.org/10.1080/10807039991289644 Chabot L. (2017). ALGA, GROWTH INHIBITION TEST Effect of the trifuoroacetic acid on the growth of the unicellular alga Pseudokirchneriella subcapitata, according to OECD guideline 201 (Study conducted for RHODIA OPERATIONS - SOLVAY). Vol. 17-005-167094. Verneuil-En-Halatte, Verneuil-En-Halatte, France. Cited and discussed in TFA Ecotoxicological Information at https://echa.europa.eu/registration-dossier/-/registered-dossier/5203/6/2/6/ Chemical Book (2017) `422-64-0(Perfluoropropionic acid) Product Description.' Available at: https://www.chemicalbook.com/ChemicalProductProperty_US_CB6139447.aspx Chemours SDS (no date) R-1234yf Refrigerant: OpteonTM YF: Official Manufacturer, Opteon. Available at: https://www.opteon.com/en/products/refrigerants/r1234yf. Confidential Chemours Information, Confidential_PBT_Assesments_ChemoursFluorochemicals_F-gas Response.xlsx. 127 Dekant, W. and Dekant, R. (2023) `Mammalian toxicity of trifluoroacetate and assessment of human health risks due to environmental exposures', Archives of Toxicology, 97(4), pp. 1069-1077. https://doi.org/10.1007/s00204023-03454-y. ECHA (2017) Guidance on information requirements and chemical safety ... - ECHA, ECHA. Available at: https://echa.europa.eu/documents/10162/13632/information_requirements_r11_en.pdf/a8cce23f-a65a-46d2ac68-92fee1f9e54f. ECHA (no date) Chapter R.10: Characterisation of dose [concentration ... - homepage - ECHA, ECHA. Available at: https://echa.europa.eu/documents/10162/13632/information_requirements_r10_en.pdf/bb902be7-a503-4ab79036-d866b8ddce69. ECHA (no date) Registration dossier, ECHA. Available at: https://echa.europa.eu/registration-dossier/-/registereddossier/5203/1/1. ECHA (no date a) Registration dossier, ECHA. Available at: https://echa.europa.eu/registration-dossier//registered-dossier/16012. ECHA (no date b) Registration dossier, ECHA. Available at: https://echa.europa.eu/registration-dossier//registered-dossier/10030. EEA Greenhouse Gases - Data viewer (2023) European Environment Agency. Available at: https://www.eea.europa.eu/data-and-maps/data/data-viewers/greenhouse-gases-viewer. Emmen, H.H. et al. (2000) `Human safety and pharmacokinetics of the CFC alternative propellants HFC 134a (1,1,1,2-tetrafluoroethane) and HFC 227 (1,1,1,2,3,3,3-heptafluoropropane) following whole-body exposure', Regulatory Toxicology and Pharmacology, 32(1), pp. 22-35. https://doi.org/10.1006/rtph.2000.1402. EPA (2017) Technical fact sheet - perfluorooctane sulfonate (PFOS) and ... - US EPA. Available at: https://19january2021snapshot.epa.gov/sites/static/files/201712/documents/ffrrofactsheet_contaminants_pfos_pfoa_11-20-17_508_0.pdf. Ernstgrd, L. et al. (2012) `Uptake and disposition of 1,1-difluoroethane (HFC-152A) in humans', Toxicology Letters, 209(1), pp. 21-29. https://doi.org/10.1016/j.toxlet.2011.11.028. ETC CM report 2022/3 Fluorinated greenhouse gases (2022), available at https://www.eionet.europa.eu/etcs/etccm/products/etc-cm-report-2022-03; Frank, H. et al. (2001) `Trifluoroacetate in Ocean Waters', Environmental Science & Technology, 36(1), pp. 12-15. https://doi.org/10.1021/es0101532. Freeling, F. et al. (2020) `Trifluoroacetate in precipitation: Deriving a benchmark data set', Environmental Science & Technology, 54(18), pp. 11210-11219. https://doi.org/10.1021/acs.est.0c02910. Gluckman Consulting (no date) HFC Outlook EU, epeeglobal.org. Available at: https://epeeglobal.org/hfc-outlookeu/. Guhl, W. and Steber, J. (2006) `The value of biodegradation screening test results for predicting the elimination of chemicals' organic carbon in waste water treatment plants', Chemosphere, 63(1), pp. 9-16. https://doi.org/10.1016/j.chemosphere.2005.07.082. Gunnare, S. et al. (2006) `Toxicokinetics of 1,1,1,2-Tetrafluoroethane (hfc-134a) in male volunteers after experimental exposure', Toxicology Letters, 167(1), pp. 54-65. https://doi.org/10.1016/j.toxlet.2006.08.009. 128 Henne, S. et al. (2012) `Future emissions and atmospheric fate of hfc-1234yf from Mobile Air Conditioners in Europe', Environmental Science & Technology, 46(3), pp. 1650-1658. https://doi.org/10.1021/es2034608. HFC-125 Registration dossier (no date) ECHA. Available at: https://echa.europa.eu/registration-dossier//registered-dossier/15415/7/2/2/?documentUUID=186e0557-3e13-456d-9309-3a9456da8aeb. Hoover, G. et al. (2019) `In&nbsp;vitro and in silico modeling of perfluoroalkyl substances mixture toxicity in an amphibian fibroblast cell line', Chemosphere, 233, pp. 25-33. https://doi.org/10.1016/j.chemosphere.2019.05.065. Im, J. et al. (2014) `Environmental fate of the next generation refrigerant 2,3,3,3-tetrafluoropropene (HFO-1234yf)', Environmental Science & Technology, 48(22), pp. 13181-13187. https://doi.org/10.1021/es5032147. IPCC (2023) Ar6 synthesis report: Climate change 2023, IPCC. Available at: https://www.ipcc.ch/report/sixthassessment-report-cycle/. IPCC/TEAP Special Report (2005), Safeguarding the Ozone Layer and the Global Climate System 2005 Chapter 2: Chemical and Radiative Effects of Halocarbons and Their Replacement ISO 817:2014(EN), refrigerants? Designation and Safety Classification (2014) ISO. Available at: https://www.iso.org/obp/ui/#!iso:std:52433:en. ISO 817:2014/AMD 1:2017 (2017) ISO. Available at: https://www.iso.org/standard/73250.html. Jensen, A.A. and Poulsen, P.B. (2008) Survey and Environmental/Health Assessment of fluorinated substances in ..., ResearchGate. Available at: https://www.researchgate.net/publication/299430668_Survey_and_environmentalhealth_assessment_of_fluorin ated_substances_in_impregnated_consumer_products_and_impregnating_agents_Survey_of_Chemical_Substanc es_in_Consumer_Products. Joudan, S., De Silva, A.O. and Young, C.J. (2021) `Insufficient evidence for the existence of natural trifluoroacetic acid', Environmental Science: Processes & Impacts, 23(11), pp. 1641-1649. https://doi.org/10.1039/d1em00306b. Lindley, A.A. (2023) `An inventory of fluorspar production, industrial use, and emissions of trifluoroacetic acid (TFA) in the period 1930 to 1999', Journal of Geoscience and Environment Protection, 11(03), pp. 1-16. https://doi.org/10.4236/gep.2023.113001. Lukasiewicz Research Network (2023) Sie Badawcza Lukasiewicz. Available at: https://lukasiewicz.gov.pl/en/. Moermond, C.T.A. et al. (2016) `CRED: Criteria for reporting and evaluating Ecotoxicity Data', Environmental Toxicology and Chemistry, 35(5), pp. 1297-1309. https://doi.org/10.1002/etc.3259. More, S.J. et al. (2019) `Guidance on harmonised methodologies for human health, Animal Health and ecological risk assessment of combined exposure to multiple chemicals', EFSA Journal, 17(3). https://doi.org/10.2903/j.efsa.2019.5634. Morgan, A. et al. (1972) `The absorption and retention of inhaled fluorinated hydrocarbon vapours', The International Journal of Applied Radiation and Isotopes, 23(6), pp. 285-291. https://doi.org/10.1016/0020708x(72)90076-2. Nielsen, O.J. et al. (2007) `Atmospheric Chemistry of CF3CF CH2: Kinetics and mechanisms of gas-phase reactions with cl atoms, oh radicals, and O3', Chemical Physics Letters, 439(1-3), pp. 18-22. https://doi.org/10.1016/j.cplett.2007.03.053. 129 Norwegian Environment Agency (2017), Study on Environmental and Health Effects of HFO Refrigerants, Norwegian Environment Agency Report No. No. M-917|2017, https://www.miljodirektoratet.no/globalassets/publikasjoner/M917/M917.pdf OECD (2006) `Test no. 201: Alga, growth inhibition test', OECD Guidelines for the Testing of Chemicals, Section 2: Effects on Biotic Systems [Preprint]. https://doi.org/10.1787/9789264069923-en. Ojo, A.F., Peng, C. and Ng, J.C. (2021) `Assessing the human health risks of per- and polyfluoroalkyl substances: A need for greater focus on their interactions as mixtures', Journal of Hazardous Materials, 407, p. 124863. https://doi.org/10.1016/j.jhazmat.2020.124863. PubChem (2022) PubChem, National Center for Biotechnology Information. PubChem Compound Database. Available at: https://pubchem.ncbi.nlm.nih.gov/. EFSA (2014). "Reasoned opinion on the setting of MRLS for Saflufenacil in various crops, considering the risk related to the metabolite trifluoroacetic acid (TFA)" EFSA Journal, 12(2). https://doi.org/10.2903/j.efsa.2014.3585. RSC (2022) RSC, ChemSpider. Available at: http://www.chemspider.com/. Rusch, G.M. (2018) `The development of environmentally acceptable fluorocarbons', Critical Reviews in Toxicology, 48(8), pp. 615-665. https://doi.org/10.1080/10408444.2018.1504276. Scheringer, M. et al. (2022) `Stories of global chemical pollution: Will we ever understand environmental persistence?', Environmental Science & Technology, 56(24), pp. 17498-17501. https://doi.org/10.1021/acs.est.2c06611. Schrenk, D. et al. (2020) `Risk to human health related to the presence of perfluoroalkyl substances in food', EFSA Journal, 18(9). https://doi.org/10.2903/j.efsa.2020.6223. Scott, B.F. et al. (2005) `Trifluoroacetate profiles in the Arctic, Atlantic, and Pacific Oceans', Environmental Science & Technology, 39(17), pp. 6555-6560. https://doi.org/10.1021/es047975u. Short Chain Perfluorocarboxylic Acids and their Direct Precursors: Human Health Tier II Assessment. National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Canberra AU. Available at: https://www.industrialchemicals.gov.au/sites/default/files/Shortchain%20perfluorocarboxylic%20acids%20and%20their%20direct%20precursors_%20Environment%20tier%20II%2 0assessment.pdf Sigma-Aldrich (no date) Safety Data Sheet - sigma-aldrich: Analytical, biology, chemistry ..., Sigma-Aldrich. Available at: https://www.sigmaaldrich.com/US/en/sds/aldrich/339741. Solomon, K.R. et al. (2016) `Sources, fates, toxicity, and risks of trifluoroacetic acid and its salts: Relevance to substances regulated under the Montreal and Kyoto Protocols', Journal of Toxicology and Environmental Health, Part B, 19(7), pp. 289-304. https://doi.org/10.1080/10937404.2016.1175981. Sustainable Futures / P2 Framework Manual (2012) EPA. Available at: https://www.epa.gov/sustainablefutures/sustainable-futures-p2-framework-manual. Toxicological profile for perfluoroalkyls - agency for toxic substances ... (2021) ATSDR. Available at: https://www.atsdr.cdc.gov/ToxProfiles/tp200-p.pdf. 130 Trifluoressigsure (TFA)-Gewsserschutz im Spannungsfeld von toxikologischem Leitwert, Trinkwasserhygiene und Eintragsminimierung. Erluterungen zur Einordnung des neuen Trinkwasserleitwerts von 60 g/L. 20. Oktober 2020. Umweltbundesamt UNEP (2014) United Nations environment programme. Available at: https://ozone.unep.org/sites/default/files/2019-05/eeap_report_2014.pdf. UNEP EEAP (2023) Environmental effects of stratospheric ozone depletion, UV radiation, and interactions with climate change: 2022 assessment report, | Ozone Secretariat. Available at: https://ozone.unep.org/environmentaleffects-stratospheric-ozone-depletion-uv-radiation-and-interactions-climate-change. VDKF Verbandszeitung Juli- August (2022) available at: https://www.vdkf.de/download/vdkf-verbandszeitung-juliaugust-2022/ Wallington, T.J. and Anderson, J.E. (2015) `Comment on "environmental fate of the next generation refrigerant 2,3,3,3-tetrafluoropropene (hfo-1234yf).', Environmental Science & Technology, 49(13), pp. 8263-8264. https://doi.org/10.1021/es505996r. Wang, Y., Niu, J., Zhang, L., & Shi, J. (2014). Toxicity assessment of perfluorinated carboxylic acids (PFCAs) towards the rotifer Brachionus calyciflorus. The Science of the Total Environment, 491-492, 266-270. https://doi.org/10.1016/j.scitotenv.2014.02.028 WMO (2022) Scientific assessment of the Ozone Layer Depletion: 2022, UNEP. Available at: https://www.unep.org/resources/publication/scientific-assessment-ozone-layer-depletion-2022. Chapter 2 Bund/Lnder-Arbeitsgemeinschaft Abfall. (2023). -Bericht ber die Rckgewinnung von Klteund Treibmitteln bei der Behandlung von FCKW-, HFCKW-, HFKW- und KW-haltigen Khlgerten und anderen WrmebertrgerGerten. Umweltbundesamt. Danish consumption and emission of F-gases in 2020 (2022) Miljstyrelsen. Available at: https://mst.dk/service/publikationer/publikationsarkiv/2022/jan/danish-consumption-and-emission-of-f-gases-in2020/. Erweitern sie ihr wissen in der Klte-Klima-Technik mit der Bundesfachschule (no date) BFS. Available at: https://www.bfs-kaelte-klima.de/. Kozakiewicz, J. (2021). Ozone Layer and Climate Protection Unit, Lukasiewicz Research Network, Industrial Chemistry Institute, Warsaw, Poland. Presentation for the on-line ECA meeting. Klimawirksame Stoffe (2019) Statistisches Bundesamt. Available at: https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Umwelt/Klimawirksame-Stoffe/_inhalt.html. 131 Chapter 3 AHRI (no date) Ahri 700, 700C and 700D: Specifications for Refrigerants, AHRI. Available at: https://www.ahrinet.org/search-standards/ahri-700-700c-and-700d-specifications-refrigerants. Air Quality Research Subcommittee (2000) Atmospheric Ammonia: Sources and fate. Available at: https://csl.noaa.gov/aqrs/reports/ammonia.pdf. Aneja, V.P. et al. (2008) `Ammonia assessment from agriculture: U.S. status and needs', Journal of Environmental Quality, 37(2), pp. 515-520. https://doi.org/10.2134/jeq2007.0002in. APIS (no date) | Air Pollution Information System. Available at: https://www.apis.ac.uk/overview/pollutants/overview_nh3.htm. Ashrae (2018) Ashrae Position Document on refrigerants and their responsible use. Available at: https://www.ashrae.org/file%20library/about/position%20documents/pd_refrigerants-and-their-responsible-usepd-6.29.2020.pdf. Bauer, S.E., Tsigaridis, K. and Miller, R. (2016) `Significant atmospheric aerosol pollution caused by world food cultivation', Geophysical Research Letters, 43(10), pp. 5394-5400. https://doi.org/10.1002/2016gl068354. Bobbink, R. et al. (2010) `Global assessment of nitrogen deposition effects on terrestrial plant diversity: A synthesis', Ecological Applications, 20(1), pp. 30-59. https://doi.org/10.1890/08-1140.1. Behera, S.N. and Sharma, M. (2010) `Investigating the potential role of ammonia in Ion Chemistry of Fine Particulate Matter Formation for an urban environment', Science of The Total Environment, 408(17), pp. 3569- 3575. https://doi.org/10.1016/j.scitotenv.2010.04.017. Bitzer (no date) General chemical and physical properties of R717. Available at: https://www.bitzer.de/shared_media/html/at-640/en-GB/103563787103609611.html. Bitzer (no date a) Carbon dioxide R744 (CO2) as an alternative refrigerant and secondary fluid. Available at: https://www.bitzer.de/shared_media/html/a-500-501/en-GB/681560843.html. Breitburg, D. et al. (2018) `Declining oxygen in the global ocean and Coastal Waters', Science, 359(6371). https://doi.org/10.1126/science.aam7240. Camargo, J.A. and Alonso, . (2006) `Ecological and toxicological effects of inorganic nitrogen pollution in Aquatic Ecosystems: A global assessment', Environment International, 32(6), pp. 831-849. https://doi.org/10.1016/j.envint.2006.05.002. Committee on the Environment and Natural Resources Air quality Research Subcommittee (2000). Atmospheric Ammonia: Sources and Fate: A Review of Ongoing Federal Research and Future Needs, Committee on the Environment and Natural Resources Air quality Research Subcommittee. Cotter, D. (2022). Carbon dioxide hazard assessments and safety system requirement assessment-A systematic approach to risk assessment and emergency planning. https://www.star-ref.co.uk/smart-thinking/carbon-dioxidehazard-and-safety-requirement-assessment-a-systematic-approach-to-risk-assessment-and-emergency-planning/. Derwent, R.G. et al. (2007) `Reactivity-based strategies for photochemical ozone control in Europe', Environmental Science & Policy, 10(5), pp. 445-453. https://doi.org/10.1016/j.envsci.2007.01.005. 132 ECHA (no date c) C&L Inventory, C&L inventory. Available at: https://echa.europa.eu/en/information-onchemicals/cl-inventory-database/-/discli/details/131271. EEA (no date). Ammonia (NH3) emissions (2015) European Environment Agency. Available at: https://www.eea.europa.eu/data-and-maps/indicators/eea-32-ammonia-nh3-emissions-1. Feng, S. et al. (2016) `The health effects of ambient PM2.5 and potential mechanisms', Ecotoxicology and Environmental Safety, 128, pp. 67-74. https://doi.org/10.1016/j.ecoenv.2016.01.030. Fenton, D.L. et al. (1995) Operating characteristics of a Flame/oxidizer for the disposal of ammonia from an industrial refrigeration facility, Operating characteristics of a flame/oxidizer for the disposal of ammonia from an industrial refrigeration facility (Book) | OSTI.GOV. Available at: https://www.osti.gov/biblio/215704. Finlayson-Pitts, B.J. and Pitts, J.N. (2000) `Applications of atmospheric chemistry', Chemistry of the Upper and Lower Atmosphere, pp. 871-942. https://doi.org/10.1016/b978-012257060-5/50018-6. Finlayson-Pitts, B.J., Hernandez, S.K. and Berko, H.N. (1993) `A new dark source of the gaseous hydroxyl radical for relative rate measurements', The Journal of Physical Chemistry, 97(6), pp. 1172-1177. https://doi.org/10.1021/j100108a012. Granryd, E. et al. (2006) Comparison of R-290 and two HFC blends for walk-in Refrigeration Systems, International Journal of Refrigeration. Available at: https://www.sciencedirect.com/science/article/pii/S0140700706002271?via%3Dihub. Hodnebrog, ., Dalsren, S.B. and Myhre, G. (2018) `Lifetimes, direct and indirect radiative forcing, and global warming potentials of ethane, propane, and butane', Atmospheric Science Letters, 19(2). https://doi.org/10.1002/asl.804. Harper, P. (2023). Assessment of the major hazard potential of carbon dioxide (CO2). https://www.hse.gov.uk/carboncapture/assets/docs/major-hazard-potential-carbon-dioxide.pdf. ICEF (no date) Roadmap: Innovation for cool earth forum (ICEF), Roadmap | Innovation for Cool Earth Forum (ICEF). Available at: https://www.icef.go.jp/roadmap/. IEC (no date) Target dates, IEC. Available at: https://www.iec.ch/standards-development/work-programme. Kapsha, C. and Tim Pacitti, F.E. (2015) Secondary refrigerants: The benefits and costs, Process Cooling RSS. Available at: https://www.process-cooling.com/articles/88143-secondary-refrigerants-the-benefits-andcosts?v=preview. Khudhur, D.A., Tuan Abdullah, T.A. and Norazahar, N. (2022) `A review of safety issues and risk assessment of industrial ammonia refrigeration system', ACS Chemical Health & Safety, 29(5), pp. 394-404. https://doi.org/10.1021/acs.chas.2c00041. Krupa, S.V. (2003) `Effects of atmospheric ammonia (NH3) on terrestrial vegetation: A Review', Environmental Pollution, 124(2), pp. 179-221. https://doi.org/10.1016/s0269-7491(02)00434-7. Liu, M. et al. (2019) `Ammonia emission control in China would mitigate haze pollution and nitrogen deposition, but worsen acid rain', Proceedings of the National Academy of Sciences, 116(16), pp. 7760-7765. https://doi.org/10.1073/pnas.1814880116. Ma, R. et al. (2021) `Mitigation potential of global ammonia emissions and related health impacts in the trade network', Nature Communications, 12(1). https://doi.org/10.1038/s41467-021-25854-3. 133 Oosterhuis, F., et al. (2017), Towards a proportionality assessment of risk reduction measures aimed at restricting the use of persistent and bioaccumulative substances. Integr Environ Assess Manag, 13: 11001112. https://doi.org/10.1002/ieam.1949 Park, R.S. et al. (2014) `Contribution of ammonium nitrate to aerosol optical depth and direct radiative forcing by aerosols over East Asia', Atmospheric Chemistry and Physics, 14(4), pp. 2185-2201. https://doi.org/10.5194/acp14-2185-2014. Patenaude, A. (2023) CO2 as a refrigerant - properties of R744, Copeland E360 Blog. Available at: https://e360blog.emerson.com/co2-as-a-refrigerant-properties-ofr744/#:~:text=The%20critical%20point%20occurs%20at,year%2C%20depending%20on%20the%20climate. Pitcairn et al., 1998; Environmental Pollution 102 41-48 Plautz, J. (2018) `Piercing the haze', Science, 361(6407), pp. 1060-1063. https://doi.org/10.1126/science.361.6407.1060. Rosado-Reyes, C.M. and Francisco, J.S. (2007) `Atmospheric oxidation pathways of propane and its by-products: Acetone, acetaldehyde, and propionaldehyde', Journal of Geophysical Research, 112(D14). https://doi.org/10.1029/2006jd007566. Sampaio, L.A., Wasielesky, W. and Miranda-Filho, K.C. (2002) `Effect of salinity on acute toxicity of ammonia and nitrite to juvenile mugil platanus', Bulletin of Environmental Contamination and Toxicology, 68(5), pp. 668-674. https://doi.org/10.1007/s001280306. Sheppard, L.J. et al. (2008) `Stress responses of calluna vulgaris to reduced and oxidised n applied under "real world conditions"', Environmental Pollution, 154(3), pp. 404-413. https://doi.org/10.1016/j.envpol.2007.10.040. Singh, H.B. et al. (1994) `Acetone in the atmosphere: Distribution, sources, and sinks', Journal of Geophysical Research, 99(D1), p. 1805. https://doi.org/10.1029/93jd00764. Tyndall, G., et. al., Mechanism of the reaction of OH radicals with acetone and acetaldehyde at 251 and 296 K, Phys. Chem. Chem. Phys., 2002, 4, 2189-2193. https://doi.org/10.1039/B111195G. UNEP (2007) AR4 Climate Change 2007: The Physical Science Basis, IPCC. Available at: https://www.ipcc.ch/report/ar4/wg1/. Updyke, K.M., Nguyen, T.B. and Nizkorodov, S.A. (2012) `Formation of brown carbon via reactions of ammonia with secondary organic aerosols from biogenic and anthropogenic precursors', Atmospheric Environment, 63, pp. 22- 31. https://doi.org/10.1016/j.atmosenv.2012.09.012. US EPA (no date) Ammonia, EPA. Available at: https://www.epa.gov/caddisvol2/ammonia#:~:text=Ammonia%20(NH3)%20is%20a,(ammonia%2C%20NH3). US EPA (2001) Chemical Safety Alert: Hazards of ammonia releases at ammonia ... Available at: https://www.epa.gov/sites/default/files/2013-11/documents/ammonia.pdf. Van Damme, M. et al. (2018) `Industrial and agricultural ammonia point sources exposed', Nature, 564(7734), pp. 99-103. https://doi.org/10.1038/s41586-018-0747-1. van den Berg, L.J.L. et al. (2008) `Reduced nitrogen has a greater effect than oxidised nitrogen on dry heathland vegetation', Environmental Pollution, 154(3), pp. 359-369. https://doi.org/10.1016/j.envpol.2007.11.027. 134 Wallington, T.J., Sulbaek Andersen, M.P. and Nielsen, O.J. (2015) `Atmospheric Chemistry of short-chain haloolefins: Photochemical ozone creation potentials (pocps), global warming potentials (gwps), and ozone depletion potentials (odps)', Chemosphere, 129, pp. 135-141. https://doi.org/10.1016/j.chemosphere.2014.06.092. Wang, S. et al. (2015) `Atmospheric Ammonia and its impacts on regional air quality over the megacity of Shanghai, China', Scientific Reports, 5(1). https://doi.org/10.1038/srep15842. Wiedermann, M.M. et al. (2009) `Can small-scale experiments predict ecosystem responses? an example from peatlands', Oikos, 118(3), pp. 449-456. https://doi.org/10.1111/j.1600-0706.2008.17129.x. WGI Report (no date) Climate change 2021: The Physical Science Basis, IPCC. Available at: https://www.ipcc.ch/report/sixth-assessment-report-working-group-i/. WHO (2010) WHO guidelines for Indoor Air Quality: Selected Pollutants, World Health Organization. Available at: https://www.who.int/publications-detail-redirect/9789289002134. Xu, L. and Penner, J.E. (2012) `Global simulations of nitrate and ammonium aerosols and their radiative effects', Atmospheric Chemistry and Physics, 12(20), pp. 9479-9504. https://doi.org/10.5194/acp-12-9479-2012. Ye, X. et al. (2011) `Important role of ammonia on Haze Formation in Shanghai', Environmental Research Letters, 6(2), p. 024019. https://doi.org/10.1088/1748-9326/6/2/024019. Zhang, W., Du, B. and Qin, Z. (2014) `Catalytic effect of water, formic acid, or sulfuric acid on the reaction of formaldehyde with oh radicals', The Journal of Physical Chemistry A, 118(26), pp. 4797-4807. https://doi.org/10.1021/jp502886p. 135