Document wqzmkOz44nJwV4DvXx6nkkm34

CEMA response to ECHA consultation on PFAS restriction (21/09/2023) SECTION III. Non-confidential comments "0: General Comments" About CEMA CEMA is the association representing the European agricultural machinery industry. With 11 national member associations, the CEMA network represents both large multinational companies and numerous European SMEs active in the sector. The industry comprises about 7,000 manufacturers, producing more than 450 different types of machines with an annual turnover of about 40 billion (EU28 - 2016) and 150,000 direct employees. CEMA companies produce a large range of machines that cover any activity in the field from seeding to harvesting, as well as equipment for livestock management and forestry. Vision: advance Agricultural machinery and solutions for sustainable farming. Mission: bring shared expertise and shape EU legislation for the benefit of sustainable farming and the agriculture machinery and solutions sector. Machineries and their components For Agricultural and Forestry machinery manufactures the environment, health and safety and sustainability are fundamental values that are considered for the design and production/maintenancerepair of agricultural machinery. The "Per-and Polyfluoroalkyl substances" (PFAS) restriction proposal by the European Chemicals Agency (ECHA), has raised concerns among European manufacturers due to the huge impact for the whole Agricultural and Forestry sector. Agricultural and Forestry machineries are designed to work in harsh environments, perform safely and efficiently, to last for decades. Agricultural machineries are essential to produce food and produce it affordably for EU farmers to remain competitive. The addition of automation, intelligence, precision serve to further increase the efficiency of food production but also to deliver on new services, from protection of soil, water, and environment to increase of biodiversity and climate change mitigation. These machineries cover several types of processes: from specialized machineries for orchards and vineyards to open-field machineries for crops and various grains. Machineries that work in forestry can be modified tractors or specialised vehicles essential for proper forest maintenance, harvesting biomass but also (for example) for the mitigation of climate change effects like extreme rainfall by keeping riverbeds and canals cleared. Agriculture and Forestry machineries are key to produce food but also feed for animals. An impact on crop production has therefore a major effect on meat production and the resilience of the European meat sector from external influences/imports.  In agricultural production, is vital to operate at specific moments: indeed, there is a limited harvest period (depending on the cultivar could go from days to a few weeks per year is the temporal window). In the case of any urgent repairs, the lack of spare parts could negatively affect the machinery's operation ability leading to significant crop and income loss. These machineries shall be: fully operational in extremely environmental conditions: from lo continental to desert temperatures; work at low speed (limited natural ventilation), with high continuous forces being applied to pull, push, carry implements, internal processing of crops, that cause internal temperatures to rise up to and over 200 C); work with products with increased fire risk (very dry material) and must be able to environmental conditions, like being resists to dust, mud, etc.; components shall resist to wear and chemicals agents, granting highest reliability for safety functions such as clutches, motion transmission, electric power and implements. Some components used in Agricultural and Forestry machineries contain PFAS being the only technology available on the market to achieve these demanding engineering applications to perform reliably and safely for our industry. Moreover, these machineries are designed to have decades of useful life so it will require much longer time for validation testing and to meet many safety standards required in this industry. The production and usage of PFAS components, if properly treated according to existing European Waste Legislations, do not pose a health or environmental risk as the PFAS in the parts cannot be freely and/or accidentally released. Further information is provided to the specific questions below. Detailed information can be found in the confidential documents Annex in "Section V" of this comment. Same examples of CEMA's machineries (there is up to 450 different machine types) Foreword on data and information of PFAS in Agricultural and Forestry Machineries The research of the presence of PFAS in articles along the supply chain was challenging due to:  very low threshold concentration of 25ppb / 250ppb for the restriction; the lack of a legal obligation for the supplier to declare these substances (except in the case the subset of PFAS is under specific obligation, as per Regulation 1907/2006/EC); short time of the public consultation for 6 months considering the number of the substances involved (about 10.000). Due the above reasons, CEMA has made a survey ("CEMA questionnaire on PFAS" - attached in Section V) in support of its members, to collect as much information and specific data as possible over the supply chain. The data collected helped to identify some of the materials that are made with PFAS, their application, characteristics, and alternatives. Up to 10.000 companies have potentially participated in the survey, but in the majority of feedback received, only partial information was collected due to the difficulties mentioned above. CEMA derogation proposals The main points of our proposal for derogations could be summarized as follows: the application of the restriction proposal should be applied at least after 48 months (instead 18 months) as lead time to the European industry to be ready for the transition in relation to the restriction and its effect on our supply chain. Our machines are designed to have decades of useful life so it will require much longer time for validation testing and to meet many safety standards required in our industry; general derogation for unlimited time must be granted for fluoropolymers plastic and elastomeric used (see "Specific Information Requests 6"); expand the derogations for "Automotive sector" to include the "Agricultural and Forestry sector" due to the high amount of shared supply chain and the off-road sectors adopting many of the automotive design changes (see "Specific Information Requests 6", "Specific Information Requests 7"); specific exemptions to aftermarket parts and components to protect against the premature obsolescence of machineries, so they could be repaired as produced and to be in line with the European Green Deal maintaining the long-life expectancy of our products on the market (see "Specific Information Requests 6"); extension of the derogation period for some "uses" as identified in the "Specific Information Requests 7" and foreseen after, a re-evaluation of the impacts on the industry. Use Sector Sub-uses Proposed derogation by Report pf restriction TULAC (Annex E.2.2.) Other: Textiles for use in engine bays in automotives (for noise and vibration insulation) 12 years (for Automotive sector) Transport (Annex E.2.10.) Use of PFASs in applications affecting the proper functioning related to the safety of vehicles, and affecting the safety of operators, passengers or goods, to the extent not addressed under other parts of this proposed restriction (e.g. under lubricants, electronic equipment and TULAC) Hydraulic fluids 12 years (for Automotive sector) 12 years (for Aircraft and Aerospace CEMA requests of derogation Expand derogation for Automotive to include Agriculture and Forestry Machineries Industry (see Specific Information Requests 7) 12 years (see Specific Information Requests 7) Expand the derogation for Aircraft and Aerospace industry) industry to include Agriculture and Forestry Machineries Industry (see Specific Information Requests 7) Mobile Air Conditioning (MAC) 5 years 12 years (see Specific Information Requests 7) Lubricants (Annex E.2.14.) Sector as a whole 12 years 12 years to apply for Agricultural and Forestry Machineries (see Specific Information Requests 7) Other "uses" according to Table A.1 of Annex A of the Annex XV restriction report (see details in Specific Information Requests 6) Plastics (other than packaging) and rubber/elastomer production (including flame retardants) Fluoropolymers plastics -PTFE (Teflon TM, Polyflon resins, Fluon TM, etc); -PVDF (Kynar , Hylar , Solef , etc..); -PFA (Everflon TM, Neoflon TM GP, etc..) Fluoropolymers elastomeric (i.e. rubbers) -FPM, FVMQ, FKM, FFKM, Viton , Aflas , etc... Not defined Unlimited time for general derogation of fluoropolymers plastic and elastomeric (see Specific Information Requests 6) Other niche applications a. Agricultural and Forestry Machineries b. Spare parts Not defined Include Agriculture and Forestry Machineries Industry in the derogation for Automotive (see Specific Information Requests 6) time-unlimited derogation (see Specific Information Requests 6) Specific Information Requests 1: "Sectors and (sub-)uses" According to the Table 9 of the Annex XV (Proposal Restriction Report), in the following Table are summarized the "uses" of interest for Agricultural and Forestry Machineries (considering only the Table 9. For other "uses" not listed, see other Specific Information Requests of the ECHA questionnaire). Use Sector TULAC (Annex E.2.2.) Sub-uses Other: Textiles for use in engine bays in automotives (for noise and vibration insulation) Some examples of components which could be made with PFAS (not exhaustive list) Engines (Similarity with Automotive industry) Metal plating and manufacture of metal products (Annex E.2.4.) Other uses with relevance to transport covered elsewhere in the dossier, according to E.2.10 Transport (Annex E.2.10.) Decorative plating with chrome, plating on plastics and plating with metals other than chrome Manufacture of metal products not addressed elsewhere Use of PFASs in applications affecting the proper functioning related to the safety of vehicles, and affecting the safety of operators, passengers or goods, to the extent not addressed under other parts of this proposed restriction (e.g. under lubricants, electronic equipment and TULAC) Hydraulic fluids Electrical engineering and information technology Metal parts components Engines Filters Parts exposed to external agents (extreme temperature, UV rays) Seals Pipes Lubricants Spare parts Hydraulic systems Steering systems Lifting and load carrying applications Computer based control systems Data transmission Batteries Fuel cells Mobile Air Conditioning (MAC) Airco systems HVACR to cool down/heat traction batteries of electric vehicles Electronics and semiconductor (Annex E.2.11.) Other uses with relevance to transport covered elsewhere in the dossier, according to E.2.10 Energy sector (Annex E.2.12.) Other uses with relevance to transport covered elsewhere in the dossier, according to E.2.10 Energy (Batteries and fuel cells) Lubricants (Annex E.2.14.) Electronics Semiconductors Sector as a whole Proton-exchange membrane (PEM) fuel cells (Lithium-Ion) batteries Sector as a whole Wires and cables Batteries Greases Specific Information Requests 6: "Missing uses - Analysis of alternatives and socio-economic analysis" According to Table A.1 of Annex A of the Annex XV restriction report (see Picture 1), in the red rectangle are indicated the "other" applications of PFAS for "Agricultural and Forestry Machineries". Picture 1. Table A.1 of Annex A of the Annex XV restriction report. Plastics (other than packaging) and rubber/elastomer production (including flame retardants) Elements indicated in the questionnaire: a) Annual tonnage b) Key functionalities Comments from CEMA Data not available Fluoropolymers plastics PTFE (Teflon TM, Polyflon resins, Fluon TM, etc); PVDF (Kynar , Hylar , Solef , etc..); PFA (Everflon TM, Neoflon TM GP, etc..): Characteristics (some examples): Chemical resistance High electrical resistance and dielectric strength Low coefficient of friction Excellent qualities of resistance to external agents High degree of non-adhesiveness High degree of resistance to low and high temperatures (from -200C to +260C) stable from a thermal point of view Water repellent Friction control Wear resistance creep resistance PVDF exhibits excellent mechanical strength and toughness, stiffness, high dielectric strength, abrasion resistance, creep resistance, high purity, chemical inertness, low flammability, low moisture absorption, corrosion resistance Perfluoro(propylvinyl ether) is characterized by very high resistance to chemicals and solvents and good biocompatibility PTFE is characterized by high electrical resistance and dielectric strength, low coefficient of friction, excellent qualities of resistance to external agents, a high degree of non-adhesiveness, a high degree of resistance to low and high temperatures (from -200C to +260C) stable from a thermal point of view Water repellent, chemical and thermal resistance, non-stick properties anti-extrusion, reduce friction, increase smoothness Fluoropolymers elastomeric (i.e. rubbers) FPM, FVMQ, FKM, FFKM, Viton , Aflas , etc... c) Number of companies in the sector affected d) Available alternatives e) No alternative yet f) More time required g) Substitution technically or feasible is not economically Characteristics (some examples): Wear resistance High resistance to fuels, oils and aggressive substances as well as high resistance to the effects of weathering and aging and high temperatures; Chemical resistance, High temperature resistance in applications > 200 C, up to 250 C FKM is characterized by high resistance to fuels, oils and aggressive substances as well as high resistance to the effects of weathering and aging and high temperatures resistance Viton is characterized by high resistance to fuels, oils and aggressive substances as well as high resistance to the effects of weathering and aging and high temperatures, resistance to hot oils and wear, chemical inertness, temperature resistance (sealing of the valves/components) 100% Availability of substance o No information yet Technical and economic feasibility o No information yet Hazard and risks o No information yet R&D process status o No information yet Time investment o No information yet Financial investment o No information yet Likelihood of successful completion o No information yet Time expected for substitution o No information yet Major challenges o No information yet Cost magnitude o No information yet Time to complete the substitution o No information yet Differences in functionality o No information yet Consequence for downstream users o No information yet Benefits for alternative providers o No information yet Socio-economic impacts The ban could cause a temporary or complete production stop of machines and spare parts. It would be impossible to purchase a new machine or have one repaired. The Agricultural sector would be at risk not to be able to deliver on the market food demands and farmers would be facing serious loss of income. As a result, it would trigger a food shortage which would inevitably lead to a rise in food prices, economic and world instability. o Fluoropolymers like PTFE, FEP, PFA, ETFE, PVDF and VDF co-HFP are mainly used not only in industrial applications but also in the agricultural machinery. Henry et al. (2018) pointed out, that all fluoropolymers are "polymers of low concern" [1]. These polymers are non-toxic, chemically stable, non-bioavailable and non-water soluble. [1] Henry, B. J; Carlin, J. P; Hammerschmidt, J. A; Buck, R. C; Buxton, L W.; Fiedler, H.; Seed, J.; Hernandez, O. A Critical Review of the Application of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers. Integr. Environ. Assess. Manage. 2018, 14 (3), 316-334.) Therefore, CEMA requests a general derogation of unlimited time for fluoropolymers plastic and elastomers Other niche applications: a. Agricultural and Forestry Machineries Elements indicated in the questionnaire: a) Annual tonnage b) Key functionalities Comments from CEMA Data not available Agricultural and Forestry machineries are designed to work in harsh environments, perform reliably, safely and efficiently, to last for decades. Agricultural machineries are essential to produce food and produce it affordably for EU farmers to remain competitive. The addition of automation, intelligence, precision serve to further increase the efficiency of food production but also to deliver on new services, from protection of soil, water and environment to increase of biodiversity and climate change mitigation. Machineries that work in forestry can be modified tractors or specialised vehicles essential for proper forest maintenance, harvesting biomass but also e.g. for the mitigation of climate change effects like extreme rainfall by keeping riverbeds and canals cleared. Agriculture and forestry machines are key to produce food for human but also for farm animals. An impact on crop production would also have a major effect on meat production and the resilience of the European meat sector from external influences/imports. In agricultural production, often there is a critical and limited time for operations especially during harvest season. Any urgent repairs that could not be performed due to a lack of spare parts could lead to significant crop and income loss. Being a niche sector, Agricultural machinery share a common supply chain to the "onroad" sector, such as the "Automotive sector". c) Number of companies in the sector affected d) Available alternatives e) No alternative yet f) More time required 100% Availability of substance o No information yet Technical and economic feasibility o No information yet Hazard and risks o No information yet R&D process status o No information yet Time investment o No information yet Financial investment o No information yet Likelihood of successful completion o No information yet Time expected for substitution o No information yet Major challenges o No information yet Cost magnitude o No information yet Time to complete the substitution o No information yet Differences in functionality o It is not possible to determine differences, seen that alternatives have not yet been identified Consequence for downstream users The ban would cause a premature End of Life of machines. It will be impossible to repair them, leading to an unnecessary waste of what normally would be operatable equipment and large additional cost for farmers to purchase new machinery. The Agricultural sector would be at risk not to be able to deliver on the market food demands and farmers would be facing serious income loss. g) Substitution technically or feasible is not economically Agricultural and Forestry machineries are designed to have decades of useful life so it will require much longer time for validation testing and to meet many safety standards required in this industry Replacement substances and new materials would need a complete redesign of systems. It would be unlikely to replace a part with a PFAS-free one with the same shape and dimensions and maintain the same performance and reliability, thus leading to a premature End of Life of vehicles that could not be repaired. Therefore, CEMA requests to expand the derogations for "Automotive sector" to include "Agricultural and Forestry sector" due to the shared supply chain. Other niche applications: b. Spare Parts Elements indicated in the questionnaire: a) Annual tonnage b) Key functionalities c) Number of companies in the sector affected d) Available alternatives e) No alternative yet f) More time required Comments from CEMA Data not available The repair of products is key for a long working life and to avoid premature obsolescence of Agricultural and Forestry machineries. Long product life is a key element of the European Green Deal; A reliable, continued availability of spare parts is crucial for the agricultural primary production sector. In agricultural production, is vital to operate at specific moments: indeed, there is a limited harvesting period (depending on the crop, it could go from days to a few weeks per year is a finite window). In the case of any urgent repairs, the lack of spare parts could negatively affect the machine's operation availability leading to significant crop and income loss. 100% Availability of substance o No information yet Technical and economic feasibility o No information yet Hazard and risks o No information yet R&D process status o No information yet Time investment o No information yet Financial investment o No information yet Likelihood of successful completion o No information yet Time expected for substitution o No information yet Major challenges o No information yet Cost magnitude o No information yet Time to complete the substitution o No information yet Differences in functionality o It is not possible to determine differences, because that alternatives have not yet been identified g) Substitution technically or feasible is not economically Consequence for downstream users The ban would cause a premature End of Life for machines. It will be impossible to repair them, leading to a premature end to machine life. Agriculture market sector would be greatly disrupted. Prices of food would likely rise. Many activities in agriculture sector such as farming, breeding, and gardening manufacturers would be directly affected. Socio-economic impacts o Substituting new materials would most likely require a complete redesign of systems. Therefore, it would be impossible to replace a PFAS-free part having the same shape and dimensions, thus leading to a premature End of Life of vehicles that could not be repaired. o Lack of spare parts could lead to shortage of operational farming equipment which would result in significant crop and income loss. Therefore, CEMA requests a derogation to replacement parts for an unlimited time to protect against the premature obsolescence of machinery. Specific Information Requests 7: "Potential derogations marked for reconsideration - Analysis of alternatives and socio-economic analysis" According to the Paragraphs 5 and 6 of the proposed restriction entry text (see table starting on page 4 of the summary of the Annex XV restriction report), (Picture 2), in the following are summarized the CEMA's proposal of modifications. Picture 2. Shots of the Table to be considered 5.o. [additives to hydraulic fluids for anti-erosion/anti-corrosion in hydraulic systems (incl. control valves) in aircraft and aerospace industry until 13.5 years after EiF] As reported in Annex A.3.1.11.5 Hydraulic fluids "... This information specifically focused on hydraulic fluids in aerospace, but this might also be valid for other sectors of transportation. Hydraulic fluids are used in the transportation sector in steering systems, brake systems or other special applications such as systems for lifting and lowering of vehicle parts or cargo..." These lifting and lowering applications are used in Agriculture and Forestry machineries too. Therefore, CEMA asks to have the same derogations granted to aircraft and aerospace industry Proposed text: 5.o. [additives to hydraulic fluids for anti-erosion/anti-corrosion in hydraulic systems (incl. control valves) in aircraft, aerospace, Agricultural and Forestry Industry until 13.5 years after EiF] 5.p. [refrigerants in mobile air conditioning systems in vehicles and machineries until 13.5 years after EiF] Refrigerants used in the Mobile Air Conditioning (MAC) systems are regulated by the Fgas Regulation EU 517/2014 and its upcoming revision. To avoid double regulation on a single application, refrigerants should be dealt with by a unique legislative framework. Given the time needed to develop alternatives, validate and test them the suggested derogation time frame is not sufficient. Therefore, CEMA asks an extended time to develop and test safe applications Proposed text: 5. p. [refrigerants in mobile air conditioning systems in vehicles and machineries (for example Agricultural and Forestry) until 13.5 years after EiF] 5.s. [lubricants where the use takes place under harsh conditions or the use is needed for safe functioning and safety of equipment until 13.5 years after EIF] Lubricants use: according to the Table E.155 (annex of the report of restriction) PFASs in lubricants states that a 12-year derogation will enable room to further research and development to identify alternatives, for relevant uses under harsh conditions and/or for safe functions and safety of equipment. Agricultural and Forestry machinery, as more detailed in the "General Comments" of this questionnaire, are subjected to harsh conditions, ensuring safe functions of the machines and for the operator. Even though these products and applications are common in the Agricultural and Forestry Machinery Industry, there is not an explicit mention. Therefore, CEMA asks to have the same derogations of similar industries and technology Proposed text: 5.s. [lubricants where the use takes place under harsh conditions, or the use is needed for safe functioning and safety of equipment (for example for Agricultural and Forestry Machinery) until 13.5 years after EIF] 5.u. [textiles for the use in engine bays for noise and vibration insulation used in the Automotive Industry until 13.5 years after EiF] The technology and supply chain of engine components is shared between "Automotive" and "Agriculture and Forestry" Machinery Industry. The overall volume of machineries produced each year is low compared to passenger cars, thus suppliers had to face higher costs for new dedicated developments. The technical challenge and difficulty for the new material/design is the same as the automotive sector. Therefore, CEMA asks to have the same derogations granted to the Automotive Industry Proposed text: 5.u. [textiles for the use in engine bays for noise and vibration insulation used in the Automotive, Agriculture and Forestry Machineries Industry until 13.5 years after EiF] 6.o [Applications affecting the proper functioning related to the safety of transport vehicles, and affecting the safety of operators, passengers or goods until 13.5 years after EiF] Agricultural and Forestry machineries are designed to work in harsh environments, perform safely and efficiently, to last for decades. Taking into account that safety components are made and provided in a complex supply chain, it supported the position EUROMOT request, which would include "Internal Combustion Engine Systems and Alternative Powertrain systems" (see 29th June 2023 2023-0368 Rev.1 - Technical Report, chapter 6) Therefore, CEMA asks to review the derogation statement Proposed text: 6.o. [Applications affecting the proper functioning related to the safety and reliability of Internal Combustion Engine systems and Alternative Powertrain systems, and affecting the safety of humans or reliability of equipment until 13.5 years after entry into force]