Document N2bxw32OKLagv7N3xJv2JmGk8

ba ELaS What is a Regulatory Management Option Analysis (RMOA)? KES The purpose of an RMOA is to evaluate all the possible Regulatory Management Options (RMOs) that could be selected to address concerns related to a chemical substance or group of substances, and to identify the most appropriate RMO in terms of effectiveness and proportionality. The methodology used to develop this RMOA is based on a variety of sources such as a tailored RMOA questionnaire delivered to manufacturers, importers, and downstream users (DUs) within the European supply chain, one-on-one calls with FPG Members, scientific literature review related to PFAS and FPs, and a Socio-Economic Analysis (SEA) on fluoropolymers (FPs), amongst others. Consideration of the Possible Regulatory Management Options ii Relevant it could help in addressing concerns a E ET l P: ceva Fos themselves have alow fnrrme) | toxicroelloegviacnatl,pnrootfialepplicable to polymers EETeE TEETI Nt relevant, not applicable to polymers EReaEchE Relevant, due to the potential inclusion of FPs in the NRoEtArCelHevPanFt,ASSrVeHstCricitdieonntification would not address. E Listing ETpotenrteilaelvacnotn,cpearrntsicularly when restriction is already Nunodterreldeivsanctu,sspiaornticularly if other RMOS on PR es Rmealneuvfaanctt,utrheisarceouilmdphleelmpetnoteadddress concerns out of DETERRIATS scope of other RMOS efuvratlhueartion? YES Yes Yes KR Regulatory Management Opti" ons Consi"dered by ChemServi"ce Ke sce tRhMe OEU.1:fu restriction leaditnoag practical banor elimination of FP manufacture and se across RuMseOof2P:FpAarStipaollryemsetrriicztaitoinoinnacildusdifnogr tahdeemraonguaftaicotnuorfeFoPfmFaFsn.ufacture and uses buat ban on the. RinMthOe 3E:U,relsitnrkicetditono ianVcolluudnitnagray bInrdouasdtrdyeIrnoigtaiattiiovenwthoiaclhlgowuacroannttieneusedthmaatniunfdaucsttruyrewialnadddurseesosftFhPe.s situationsofconcern related to manufacture and use of FPs. oRfMFOP p4r:oudpudcattseaonfdeaxritsitcliensg.EU regulations on waste that would impactthe end-of-life treatment Outcome of the RMOA KEE I'd 4 + A derogation of FPs and relevant monomers from the PFAS REACH restriction should be granted. The result of the RMOA concluded that the best regulatory option to deal with concerns from Fs would be a combinationof RMOs 3 and 4 + The use of PFAS-based polymerization aids for the manufacture of FPs should be allowed by the regulators. Industry, however, would need to commit to efficiently address the concerns related to the manufacture and purity of FPs placed on the EU market + EU legislation dealing with industrial emissions and waste should be reviewed and updated to J) aFdPdsraensds farnoym arrilsikcldeesrciovnetdaifnrinogmFtPhse. disposal of Key Takeaways of the RMOA 12 KEE ao + Afull restriction would put at risk key applications that are necessary to ensure competitiveness and achieving ambitious EU Green Deal goals. Chemservice's RMOA concludes | + Regulatory actions that could lead to limiting the that a full restriction ofFPs is not market access for a selected numobf teypres of the most effective tool to meet fluoropolymers could result in the manufacture of theseCoombpjeectteinvtesaustehtobrytttehse five baneycotmyipnegofecthoensoemifcluaolrloypoilnyfmeeasripbrloed.ucts + Afull restriction could have unpredictable consequences for the critical sectors that rely )) rea on tuoropobmers. Key Takeaways of the RMOA 22 KES ad + There are no alternatives that can replace the combined performance provided by fluoropolymers in "virtually every critical application in which they are used". Fluoropolymers are irreplaceable in `many uses without reliable alternatives + Fluoropolymers are indispensable for applications in the chemical, electronics, semiconductors, healthcare and transport sectors and the deployment of 5G networks. + The RMOA study confirms that fluoropolymers are critical materials for innovation and are deemed necessary to achieve the EU goals on )) areas like decarbonization, renewable energies or competitiveness in the digital transition. Safety of Fluoropolymers During the Use-phase KES af 96%ofthe global commercially available fluoropolymers meet or exceed the OECD polymers of low concern (PLC) criteria. + Fluoropolymers that meet the OECD PLC criteria are non-toxic, bio-compatible, non-soluble and non mobile molecules and they are deemed as such to have insignificant environmental and human health impacts. + Fluoropolymers possess distinct physical, chemical and biological properties and should not be grouped vith other PFAS for hazard assessment or regulatory purposes. Landfill Fluoropolymers are chemically, thermally and biologically stable and are not expected to transform to dispersive non-polymeric PFAS when disposed of in a landfil Incineration Fluoropolymers are mineralized under commercial waste-to-energy incineration operating conditions. Recycling In primary and secondary recyciing, solid fluoropolymer waste is ground and later fed back into the manufacturing cycle of some fluoropolymer products. In secondary recycling, waste is ground, followed by degradation to approximately 1 % of the original degree of polymerization by using electron beams, gamma rays or thermo-mechanical degradation In tertiary recycling, solid fluoropolymer is ground, then decomposed into the starting monomers at temperatures above 600 C to obtain the same chemical components from which the fluoropolymer was manufactured. 10 Chemservice r RMAOh Lkeey ) Pa DEAL m SE SREm SN DEAL Pers -- Jy [re A EG E FEt @ REA RESTRICTION Plc INDUSTRY Eel [ Sp es EoNpEr ENE Lhlann rapa EU LEGISLATION a fond -- ol M-- we