Document n9kd7MzEVDOmbZZNo1p1Q1nD2

gemm ed., EFCTC EFCTC submission to ECHA consultation on U-PFAS Annex 5 September 2023 Annex 5 - EFCTC technical paper on impurities and concentration limits for the U-PFAS restriction proposal Summary & Recommendations The PFAS impurity limits indicated within the restriction proposal do not consider the procedures and processes for the manufacturing, supply, recovery, recycling and reclamation of HFCs, HFOs and HCFOs (see substances listed in Annex I and Annex II Section 1 of the F-gas Regulation revision proposal). The analytical methods included in the restriction proposal are not relevant to the practical analysis of these F-gases and their impurity levels. This paper explains why the proposed concentration limits are not applicable to the F-gases sector, and provides further information on the F-gas supply chain and how it can affect impurity levels of virgin and reclaimed F-gases. It is recommended that a specific concentration limit is established for fluorinated impurities as a threshold for the virgin and reclaimed F-gases which, for consistency, should be based upon the AHRI 700 2019 Standard for Specifications for Refrigerants, with allowable fluorinated impurities in F-gases of up to a maximum of 5000 ppm, without any individual limits. Analytical methods and limitations Annex XV report for the U-PFAS restriction proposes a generic concentration limit for PFAS impurities in substances and mixtures at 25 ppb for individual compounds and respectively 250 ppb for the sum of these. For F-gases, such a low threshold could be detected only in specialized laboratories, making it impracticable from a technical point of view due to the limited equipment and expertise available in some of the plants. 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. The cost of a GC-MS (several hundreds of thousands of Euros) is very different of the cost of a GC (few tens of thousands of Euros). GC-MS is a technology that requires regular maintenance and calibration by the manufacturer. This is not the case with GC, which can be maintained by the laboratory technician. Sampling and sample injection conditions will be very different depending on whether GC or GC-MS is being used. Finally, the use of a GC-MS requires specific training and a dedicated operator with excellent skills. Rue Belliard 40, Box 15, B-1040 Brussels www.fluorocarbons.org I Wcefic.be EU Transparency Register n 64879142323-90 1 A sector group of Cefic European Chemical Industry Council Cefic aistal ago EFCTC EFCTC submission to ECHA consultation on U-PFAS Annex 5 Appendix E.4 of 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 air matrix, and cannot be considered relevant for qualitative and quantitative analysis of impurities in an F-gas matrix. Manufacturing Process The impurities present in the 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, for example, to 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 5000 ppm. While there is no EU-wide official standard 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 nonPFAS) contained in the refrigerant. Typically, virgin HFCs/HFOs/HCFOs have a level of purity higher than 99.5%2 (e.g. up to 99.9% purity with 1000 ppm of volatile impurities) at the manufacturing phase. Preparation of F-gases uses hydro-fluorination in their manufacture. No PFAS 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, who 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. As a consequence, traces of contaminants of F-gases contained within the proposed U-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 5000 ppm as established by the AHRI 700 standard. Recovery and Recycling Articles 8 and 9 of the 2014 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 the 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. 1 https://www.ahrinet.org/search-standards/ahri-700-700c-and-700d-specifications-refrigerants 2 AHRI 700 2019 Standard, Table 1B CLrTr Rue Belliard 40, Box 15, B-1040 Brussels www.fluorocarbons.org I Mpcefic.be EU Transparency Register n 64879142323-90 2 A sector group of Cefic European Chemical Industry Council - Cele alibi oda i taii EFCTC EFCTC submission to ECHA consultation on U-PFAS Annex 5 Dedicated containers (R-cylinders), 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 the 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 nor require any final quality check. As mentioned above, in order to guarantee a 5000 ppm impurity level, gas chromatography is required. However, installers do not have the laboratory equipment necessary to perform such an analysis, nor the expertise for its operation. Hence, enforcement of the proposed concentration limits would not be practical and would hinder, recycling of F-gases, coming in contradiction with the EU Fgas 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 impurities concentration limits proposed in the U-PFAS restriction considers the technical, legal, and practical limitations of each sector. There are significant variations of impurities concentration limits, set under other REACH restrictions or EU sectoral legislation. The 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 has 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 1,000 ppm (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 the 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, SVHC 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 are the 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 impurities levels laid out across various legislations. Rue Belliard 40, Box 15, B-1040 Brussels www.fluorocarbons.org I Wcefic.be EU Transparency Register n 64879142323-90 3 A sector group of Cefic European Chemical Industry Council - Cele offal gemm ed, EFCTC EFCTC submission to ECHA consultation on U-PFAS Annex 5 Legislation Concentration limits 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) From 1 to 3000 ppm 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 From 1 to 5 ppm Directive 2004/37/EC, last amended by Directive (EU) 2022/431, concerning the binding occupational exposure limits to carcinogens at workplace From 0.001 mg/m3 to 54.7 mg/m3 (in air) Commission Regulation (EU) No 366/2011, amending REACH Annex XVII, concerning the acrylamide concentration limits for grouting applications (building foundations consolidation) 0.1 % by weight in grouting mixtures Commission Regulation (EU) No 494/2011 amending REACH Annex XVII, concerning the presence of Cadmium in jewellery 0,01 % by weight Commission Regulation (EU) 2018/35 amending REACH Annex XVII, concerning the siloxanes D4 and D5 concentration limits in wash of cosmetics 0,1 % by weight Regulation (EC) No 1223/2009, Annex (restricted substances in cosmetics products) III From 0,0001 % to 12% by weight Commission Regulation (EU) No 231/2012 concerning the purity of food additives (non-exhaustive list of examples) Heavy metals: from 1 to 10 ppm Aromatic amines: up to 100 ppm Dichloromethane: 10 ppm Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food 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 impurities 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 4 FFCTC Rue Belliard 40, Box 15, B-1040 Brussels www.fluorocarbons.org I Mc@cefic.be EU Transparency Register n 64879142323-90 A sector group of Cefic European Chemica/ Industry Council - Co& aiskal u'-- EFCTC EFCTC submission to ECHA consultation on U-PFAS Annex 5 point of view, and it cannot be implemented in practice for HFCs/HFOs/HCFOs that do not fall under the scope of the proposed U-PFAS restriction. Conclusions Based on the information provided above, EFCTC recommends that a specific concentration limit is established for the sum of fluorinated impurities in virgin and reclaimed F-gases which, for consistency, should be based upon the AHRI 700 2019 Standard for Specifications for Refrigerants, with allowable fluorinated impurities in F-gases of up to a maximum of 5000 ppm, without any individual limits. In practice, the purity level of virgin manufactured 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. repacking from larger containers to smaller containers) will not hinder the compliance of the refrigerants. Setting a common concentration limit such as 5000 ppm 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 have no potential for bioaccumulation and will degrade in the atmosphere. Those impurities are highly unlikely to be long chain PFAS ( C6) which have very different properties to the short chain impurities. Rue Belliard 40, Box 15, B-1040 Brussels www.fluorocarbons.org I Wcefic.be EU Transparency Register n 64879142323-90 5 A sector group of Cefic Europcul Chimiad Industry Council - Cofic alsbl