規制対応 • • • 評価試験： - ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF（Type III）および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。 a) 米国食品医薬品局（FDA）または国際標準化機構（ISO）により「インプラント」機器として分類される医療機器、または米国薬局方（USP）または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。

P R O F I L E / S H E E T E X T R U D E R R A I L S A N D K I C K P L A T E S • Convert existing PVC profile and sheet rails and kick plates to polyolefin resin to meet Class A fire safety (ASTM E84) • Provide a system that meets healthy building certifications and approvals • Utilize a more sustainable flame retardant technology, removing brominated or halogenated flame retardants from the environment • Achieve non-compromising performance in aesthetics, impact, dimensional stability, CLTE, and E84 testing • Provided broad flame retardant platform, backed by extensive application and industry expertise, to meet global flammability standards • Has largest UL94 recognized Prospector membership with HB, V-0, V-1, V-2 and 5VA/5VB ratings, and broad glow wire performance products • Included in-house UL certified labs and manufacturing locations to perform UL94 material sampling and testing • Supported application development to meet fire safety standards, address current or emerging healthy building codes, smart home requirements, and LEED credits • Offered custom formulations in small lot quantities Cesa™ Flam Non-Halogen Flame Retardants KEY REQUIREMENTS WHY AVIENT? AVIENT SOLUTION CERTIFICATIONS + QUALITY LEARN MORECopyright © 2022, Avient Corporation.

MAIA+ N° rapport :223-2023-000066-FR 10898066 0.5 jour Date Début / Fin :04/11/2022 /04/11/2022 PolyOne France - site de Saint Ouen l'Aumône 1 /11 ATTESTATION DE RECONNAISSANCE Attribué à PolyOne France - site de Saint Ouen l'Aumône 14 avenue de l'Eguillette / ZA du Vert Galant 95310 - SAINT OUEN L'AUMONE - FRANCE Bureau Veritas Certification certifie que les prestations de l’entreprise susmentionnée ont été évaluées et jugées conformes aux caractéristiques énoncées dans le décret en vigueur à la date d’édition du présent certificat : Décret n°2021-461 du 16 avril 2021 relatif à la prévention des pertes de granulés de plastiques industriels dans l’environnement Sous réserve du respect des caractéristiques vérifiées, cette attestation est valable jusqu’au : 16/02/2026 Date originale : 17/02/2023 Attestation n°: 223-2023-000066-FR Date : 17/02/2023 Affaire n°: 10898066 Laurent CROGUENNEC - Président Adresse de l’organisme certificateur : Bureau Veritas Certification France Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense Des informations supplémentaires concernant le périmètre de cette attestation ainsi que l'applicabilité des exigences du décret peuvent être obtenues en consultant l'organisme.

Based on polysulfone resins and tested to ISO 10993, this line of opaque and transparent colorants is specifically formulated to achieve high heat resistance in healthcare applications.  Formulated with raw materials tested to ISO, USP, EP, and ICH Q3D protocols, the portfolio includes standard color ranges to speed up time to market and custom color solutions tailored to customer requirements. 

KEY CHARACTERISTICS • Customized density offering a wide range of specific gravities (1.2–11 gm/cm3) • Based on recycled resin from PIR and PCR sources • Broad modulus range, from very flexible to very rigid grades • Corrosion resistance that withstands oxidization for long-term use and benefit • Chemical resistance can be adapted depending on base resin as required • Provides visual surface effects, aesthetics, and cool touch • Design flexibility and processing ease MARKETS AND APPLICATIONS Applications in packaging and consumer goods in which a more sustainable solution is preferred: • Cosmetic caps and closures • Perfume caps • Spirit bottle caps • Luxury boxes • Handles and knobs SUSTAINABILITY BENEFITS • Formulated with recycled resin from post-industrial recycled (PIR) and/or post-consumer recycled (PCR) sources including ocean bound plastic waste • Reduces waste and supports the circular economy • Reduces carbon footprint compared to fossil feedstock alternatives • Simplifies manufacturing and lowers costs versus metal PRODUCT BULLETIN CHARACTERISTICS UNITS Gravi-Tech REC-CI GT5200-5089 PT Natural Gravi-Tech REC GT5200-5075 Black X2 Gravi-Tech REC GT5200-5078 Black Gravi-Tech REC GT5200-5079 Black Gravi-Tech REC GT5200-5060 Black Gravi-Tech REC GT5200-5057 Black Base Resin Ocean Bound rPP rPP rPP rPP rPP rPP Recycled Content/Filler g/cm >98% PIR+PCR 60% PIR/Mineral >95% PIR/Mineral >95% PIR+PCR/Mineral 30% PIR/Mineral 30% PIR/Mineral Density (ISO 1183) g/ccm 1.2 1.2 1.2 1.2 1.9 2.0 CHARACTERISTICS UNITS Gravi-Tech REC GT7300-5034 X2 FD Natural Gravi-Tech REC GT7300-5036 Black Gravi-Tech REC GT7300-5025 Black Gravi-Tech REC GT6000-5032 Black Gravi-Tech REC GT6000-5031 Black Base Resin ABS rABS/ABS rABS rPA6 rPA6 Recycled Content/Filler g/cm 50% PIR/Mineral 65% PIR/Mineral 10% PIR/Mineral 20% PIR/Mineral 20% PIR/Mineral Density (ISO 1183) g/ccm 1.5 1.5 2.2 2.7 2.8 AVAILABLE GRADES Copyright © 2024, Avient Corporation.

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as pre-colored formulation or concentrate and for use in different polymers REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU** APPLICATION BULLETIN * Design note: Effect colors require careful consideration of part design and polymer flow paths to minimize visible flow lines.

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number reducing risk of change • Non-phthalate and formulated without animal- derived substances • Available for use in a wide range of polymers including polyolefins, styrenics, polycarbonate and alloys, polyester, POM • Functionality can be combined with colorants into convenient combination concentrates and ready-to-use formulations REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request FUNCTIONALITY TARGET APPLICATIONS DRUG DELIVERY DEVICES SYRINGES & NEEDLES DIAGNOSTICS CATHETERS Clarifying PP Sorbitol-free for transparent applications with reduced migration and improved thermal stability     Lubricant— permanent/ non-migrating Fast acting reduction in friction for wide variety of polymers such as PP, ABS, POM, PC    Protection from UV in transparent applications for PP, PE, PETG, COP UV blocking in 290-450nm with no impact on clarity; can be combined with colors (e.g., amber)   Antistatic ready-to- use solution for PP, ABS, PC/ABS Permanent/non-migrating; fast decay time independent of % relative humidity  Gamma/e-beam sterilization protection of the polymer Preserving the properties of PP and COC/COP; reduction in yellowing using Color Compensation Technology (CCT)    Reduced material consumption/cycle time—nucleation Fast acting new generation nucleant for PE and PP; improved thermal and mechanical properties allows wall thinning; reduction of tolerance/dimensional problems between different colors    Laser marking replacing ink printing/labels Solvent-free, high-speed identification for Nd/YAG laser for PE,PP, ABS, PC, POM     Antioxidants for PE, PP, TPE Thermal protection during converting/downstream sterilization    Brand protection/ anticounterfeit Covert and non-covert systems   Healthcare use limitations apply—see below.

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal- derived substances • Available for use in a wide range of polymers including polyolefins, styrenics, polycarbonate and alloys, polyester, POM • Functionality can be combined with colorants into convenient combination concentrates or formulations REGULATORY SUPPORT • Pre-tested raw materials: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request FUNCTIONALITY TARGET APPLICATIONS EBM/IBM CONTAINERS CLOSURES FILM COMBINATION DEVICES Clarifying PP Sorbitol-free—possibilities in packaging ocular solutions    Slip/torque reduction Slip for PE, PP films, processing aid, torque reduction for closures   Protection from UV in transparent packaging for PP, PE, PETG, COP UV blocking in 290–450nm with no impact on clarity    Antistatic ready-to-use solution for PE films e.g.

KEY CHARACTERISTICS • Designed for Nd:YAG lasers operating between 1060-1070 nm • Available for different polymers including PP, PE, PC, PBT, POM, ABS, MABS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Can be designed for dark marking on natural or white/light colored background or light marking on black/dark background REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request.

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal- derived substances • Standard concentrates in a PE carrier and on request in PP • Pre-colored formulations can be supplied in specific resins selected for the application REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) • Food contact established with FDA/EU* APPLICATION BULLETIN DRUG TYPE COLOR DESCRIPTION PANTONE REFERENCE AVIENT PRODUCT CODE PE BASED Adrenergic agonist combinations Light Green 373 C PE6M176349 Adrenergic agonists Purple 2583 C PE4M176057 Anti-infectives Tan 467 C PE8M176130 Anti-inflammatory, nonsteroidal Grey Cool Grey 4 C PE7M176184 Anti-inflammatory, steroids Pink 197 C PE3M176237 Anti-inflammatory, immunomodulators Olive Green 5763 C On request Beta-blockers Yellow Yellow C PE1M176160 Beta-blocker combinations Dark Blue 281 C PE5M176272 Carbonic anhydrase inhibitors Orange 1585 C PE2M176089 Cytotoxic Black 6 C PL9M176008 Miotics Dark Green 348 C PE6M176267 Mydriatics and cycloplegics Red 1797 C PE3M176236 Prostaglandin analogues Turquoise 326 C PE5M176273 Healthcare use limitations apply—see below.