Fluororesin products for various pharmaceutical and pharmaceutical intermediate manufacturing processes Lining tank (PTFE), lining piping (PTFE, PFA), lining valve (PTFE, PFA), insertion tube (PTFE, PFA), gasket (PTFE), bellows (PTFE, PFA) Flexible hose (PTFE, PFA), pliable hose (PTFE, PFA) PFAS used in the products is PTFE and PFA, which are polymer materials, and there is no concern about exposure, leakage, or environmental release of eluates.

General Comments: Corden BioChem GmbH Corden Biochem International GmbH Industriepark Hchst Brningstrae 50 65929 Frankfurt Germany Select the relevant boxes that cover the content of your comments and provide your non-confidential comments below, (maximum 63 999 characters) Scope or restriction option analysis o Hazard or exposure o Environmental emissions o Baseline o Description of analytical methods Information on alternatives Information on benefits Other socio economic analysis (SEA) issues Transitional period Request for exemption Corden BioChem GmbH and Corden BioChem International GmbH are an industrial production partner for biotechnologically manufactured products in the sector of food, feed additives, enzymes and for technical applications.

Droog opgwerkte AEC-bodemas Omschrijving Algemene monstervoorbehandeling Aantal Metingen Samenstelling Laboratorium Samenstelling Perfluorobutanoate (PFBA) Perfluoropentanoate (PFPeA) Perfluorohexanoate (PFHxA) Perfluoroheptanoate (PFHpA) Perfluorononanoate (PFNA) Perfluorodecanoate (PFDA) Perfluoroundecanoate (PFUnDA) Perfluorododecanoate (PFDoDA) Perfluorotridecanoate (PFTrDA) Perfluorotetradecanoate (PFTeDA) Perfluorohexadecanoate (PFHxDA) Perfluorooctadecanoate (PFOcDA) Perfluorobutane sulfonate (PFBS) Perfluoropentane sulfonate (PFPeS) Perfluorohexane sulfonate (PFHxS) Perfluoroheptane sulfonate (PFHpS) Perfluorodecane sulfonate (PFDS) 4:2 Fluorotelomer alcohol (4:2 FTOH) (H4PFOS) 6:2 Fluorotelomer alcohol (6:2 FTOH) 8:2 Fluorotelomer alcohol (8:2 FTOH) 10:2 Fluorotelomer alcohol (10:2 FTOH) 2,3,4-tetrafluor-2-(heptafluorpropoxypropanoic acid (HPFO-DA) Perfluorooctanesulfonamide (PFOSA) 2-(N-methylperfluorooctanesulfonamido) (N-MeFOSA) 2-(N-methylperfluorooctanesulfonamido) acetic acid (N-MeFOSAA) N-ethylperfluorooctanesulfonamidoacetic acid (N-EtFOSAA) Sodium bis (1H, 1H, 2H, 2H-perfluorodecyl)phosphate (8;2 diPAP) PFOA (linear) Perfluorooctanoate(PFOA) (branched) PFOA (som) Perfluorooctane sulfonate (PFOS) (branched) Perfluorooctane sulfonate (PFOS) (linear) PFOS som PFBA PFPeA PFHxA PFHpA PFNA PFDA PFUnDA PFDoDA PFTrDA PFTeDA PFHxDA PFOcDA PFBS PFPeS PFHxS PFHpS PFDS 4:2 FTOH 6:2 FTOH 8:2 FTOH 10:2 FTOH HPFO-DA (GenX) PFOSA N-MeFOSA N-MeFOSAA g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds N-EtFOSAA 8:2 diPAP PFOA(l) PFOA(b) PFOA(s) PFOS(b) PFOS(l) PFOS(s) g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds g/kg Ds Gemiddelde stdev Min 48 Meeste in duplo Aantal metingen 62 Nu opgenomen grenzen (grond op landbodem, Aantal kleiner dan Max 95Percentiel wonen of industrie) bepalingsgrens 0,56 0,75 0,07 5,40 1,10 0,14 0,13 0,07 0,60 0,40 0,42 0,53 0,07 2,00 1,70 0,14 0,13 0,07 0,60 0,40 0,14 0,26 0,07 2,00 0,35 0,16 0,19 0,07 1,30 0,35 0,10 0,08 0,07 0,35 0,35 0,09 0,06 0,07 0,35 0,22 0,10 0,08 0,07 0,35 0,35 0,10 0,08 0,07 0,35 0,35 0,10 0,08 0,07 0,35 0,35 0,29 0,47 0,07 1,40 1,40 2,27 2,33 0,07 7,50 6,70 0,11 0,09 0,07 0,35 0,35 0,19 0,24 0,07 0,90 0,70 0,10 0,09 0,07 0,35 0,35 0,10 0,08 0,07 0,35 0,35 0,20 0,56 0,07 3,60 0,35 2,04 3,04 0,07 15,00 7,91 0,23 0,32 0,07 2,10 0,50 0,12 0,10 0,07 0,40 0,35 0,34 1,01 0,07 6,60 0,67 0,10 0,08 0,07 0,35 0,35 0,10 0,08 0,07 0,35 0,35 0,12 0,17 0,07 1,30 0,35 0,11 0,09 0,07 0,35 0,35 0,10 0,08 0,07 0,35 0,35 0,37 0,31 0,07 1,32 1,04 0,10 0,07 0,07 0,36 0,31 0,46 0,33 0,00 1,42 1,16 0,52 0,79 0,07 3,07 2,41 0,23 0,29 0,07 1,27 1,03 0,71 1,05 0,00 4,34 3,31 3,00 17 3,00 48 3,00 31 3,00 45 3,00 54 3,00 45 3,00 59 3,00 47 3,00 61 3,00 61 3,00 61 3,00 61 3,00 3 3,00 55 3,00 51 3,00 57 3,00 61 3,00 58 3,00 10 3,00 39 3,00 49 3,00 51 3,00 60 3,00 61 3,00 55 3,00 51 3,00 60 13 50 7,00 27 39 3,00 31/10/22

Processed product for chemical plant applications Applicationr: Chemical Plant Materials used in the field are PTFE (CAS NO: 9002-84-0), PCTFE (CAS NO: 9002-839), PFA (CAS NO: 26655-00-5), PVDF (CAS NO: 24937-79-9), and ETFE (CAS NO: 94228-79-2).

Table 4.15 Fluororesin characteristics list (representative values) Characteristic Melting point Density Tensile strength Elongation Compressive strength Izod impact strength Rockwell hardness Shore hardness Flexural modulus Tensile modulus Dynamic friction Thermal conductivity Specific heat Coefficient of linear expansion Ball pressure temperature Deflection temperature under load Maximum operating temperature (continuous) Volume resistivity Dielectric strength (short term) Dielectric constant Loss tangent Arc resistance Water absorption rate Flame retardance Limiting Oxygen Index (LOI) Effects of direct sunlight Chemical resistance acid alkali Organic solvent Unit g/cm3 MPa MPa [10Deformation] J/m [R scale] [D scale] GPa GPa [0.69MPa, 3m/min] W/mK 103J/kgK 10-5/ K (-30+30) [1.81MPa] [0.45MPa] JIS K 6935 K 7112 K 7162 K 7181 Test method ISO 12086 1183 527 Same above 604 ASTM D 4591 D 792 D 638 D 695 K 7110 180 D 256 K 7202 2039 D 785 K 7215 868 D 2240 K 7171 K 7161 K 6935 A 1412 K 7123 178 527 8302 D 790 D 638 D 1894 C 177 D 696 Compliance with the Report on Registration System for Thermoplastic Ball Pressure Used in Electrical Appliances K 7191 75 D 648 PTFE 327 2.13-2.20 20-35 200-400 10-15 150-160 R20 D50-55 0.53-0.58 0.40-0.60 0.1 0.23 1.0 10 180 55 120 cm[50%RH,23] MV/m [3.2mm Thickness] [ 60Hz] [103Hz] [106Hz] [ 60Hz] [103Hz] [106Hz] sec [24hr] [3.2 Thickness] K 7226 K 6911 K 6935 K 6935 K 6935 K 7209 K 7140 K 6935 2578 IEC 60093 IEC 60243 IEC 60250 IEC 60250 62 1210 4589 D 257 D 149 D 150 D 150 D 495 D 570 UL-94 D 2863 D 543 260 >1018 19 2.1 2.1 2.1 0.0002 0.0002 0.0002 >300 0.01 V-0 >95 Non S.E S.E S.E PFA 310 2.12-2.17 25-35 300-350 15-20 non breaking R50 D62-66 0.54-0.64 0.31-0.35 0.2 0.19 1.0 12 230 47 74 260 >1018 20 2.1 2.1 2.1 0.0002 0.0002 0.0003 >300 0.01 V-0 >95 Non S.E S.E S.E FEP 260 2.15-2.17 20-30 250-330 14-19 non breaking R50 D60-65 0.55-0.67 0.32-0.36 0.3 0.2 1.2 9 170 50 72 200 >1018 22 2.1 2.1 2.1 0.0002 0.0002 0.0005 >300 0.01 V-0 >95 Non S.E S.E S.E PCTFE 220 2.10-2.20 31-41 80-250 31-51 135-145 R80 D75-80 1.25-1.79 1.03-2.10 0.4 0.22 0.9 6 170 90 126 120 >1018 22 2.6 2.6 2.6 0.0012 0.025 0.020 >300 0.01 V-0 >95 Non E E V.G ETFE 270 1.73-1.74 38-42 300-400 40-50 non breaking R50 D67-78 0.90-1.20 0.70-0.85 0.4 0.24 2.0 6 185 74 104 150 >1017 16 2.6 2.6 2.6 0.0006 0.0008 0.005 75 0.03 V-0 32 Non V.G V.G V.G ECTFE 245 1.68-1.69 41-48 200-300 35-40 non breaking R50 D53-57 0.66-0.69 1.55-1.70 0.4 0.16 2.0 8 180 77 116 150 >1015 20 2.6 2.6 2.6 0.0005 0.0015 0.015 18 0.01 V-0 60 Non E E E PVDF 151-178 1.75-1.78 30-70 20-370 32-74 160-375 R93-116 D64-79 0.60-1.99 0.37-2.58 0.4 0.17 1.2 16 150 100 156 150 >1015 11 8.4 7.7 6.4 0.049 0.018 0.017 60 0.03 V-0 43 Non E V.G G PVF 203 1.38-1.57 (82) 115-250 (1.9) 0.14-0.17 1.0 7.1-7.8 100 >1014 8.2-8.5 6.2-6.7 6.2-7.0 0.3 <0.5 HB 23 Non G V.G G Super Excellent(S.E): Not attacked by most chemicals and solvents even under harsh conditions.

Lining resin material Chemical resistance comparison data Hydrochloric acid () Sulfuric acid () 20 40 60 80 100 120 150 20 40 60 80 100 120 150 20 PFA ETFE polyethylene resin hard vinyl chloride resin judgement: Excellent Good Poor Sodium hydroxide () 40 60 80 100 120 150

POSITION PAPER Date: 18/09/23 JBCE'S POSITION ON REACH ANNEX XV REPORT CONSULTATION OF PER- AND POLYFLUOROALKYL SUBSTANCES (PFAS) INTRODUCTION Being a cross-sector association with member companies operating in different industries and stages in the supply chain (electronics, chemicals, polymer, automotive, HVACR, machinery, semiconductor, wholesale trade, precision instruments, pharmaceutical, steel, nonferrous metal, textiles, ceramics, and glass products), JBCE welcomes the opportunity to contribute to the discussion regarding REACH Annex XV report in the context of the consultation on the restriction on the manufacture, placing on the market and use of PFAS.

VDMA e.V.

Impact of the PFAS Restriction on Badger Meter- Technical and Socioeconomic assessment Overview of Badger Meter Badger Meter is an innovator in flow measurement, water quality and control products, serving water utilities, municipalities, and commercial and industrial customers worldwide.

I.V.STAR Filter Infusion filters and filter systems I.V.STAR Filter Safe and reliable: I.V.STAR Infusion filters from CODAN With the infusion filters and complete filter systems from the I.V.STAR series, CODAN sets standards in infusion therapy.

Impact of the current draft of the PFAS proposal on connections and seals for food, beverage, chemical and pharmaceutical applications DIN NAA Dear ECHA Committee Members: DIN NAA is a committee within the German standards organization, which is publishing consensus standards related to tubes, flanges and connections used for food, beverage, chemical and pharmaceutical applications.

Figure 1.

Annex to comment in PFAS consultation - test results of alternative material in synchronous belts (Resorcinol Formaldehyde Latex (RFL) treated jacket material) vs PTFE 4885-8107-2514, v. 1

please find attached to this E-Mail the draft agenda including the WebEx details for the next monthly meeting 18 May.