FDA/EU compliance information available upon request REMAFIN™ EP White Colorants for Pharmaceutical Packaging REMAFIN™ EP is a range of PE and PP based masterbatches designed for protecting oral, topical, parenteral, ophthalmic and nasal pharmaceuticals by opacifying primary and secondarypharmaceutical packaging. KEY CHARACTERISTICS • Manufactured under change control principles beyond CAS number (similar level as MEVOPUR concentrates), reducing risk of change • Free from animal-derived substances and phthalates • Suitable for blown film, injection molding, blow molding and extrusion REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP chapters , including Class VI, a requirement for ophthalmic and nasal drugs - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities - USP and USP light transmission • Registered Drug Master File (Type III) • Food contact compliance established with FDA/EU* APPLICATION BULLETIN CARRIER MATERIAL PIGMENT CONTENT/TYPE LIGHT FASTNESS THERMAL STABILITY PRODUCT CODE HDPE 50% TiO2 8 300°C PH00075525 LLDPE 60% TiO2 8 300°C PL00075542 LLDPE 70% TiO2 8 300°C PL00075545 PP 50% TiO2 8 300°C PP00075717 Healthcare use limitations apply—see below. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and components used for its manufacture, and with all applicable laws and regulations. 1.844.4AVIENT www.avient.com

animal derivatives, phthalates, BPA, allergens, GMOs) • Will this device be used in a commercial kitchen where NSF (National Sanitation Foundation) compliance (e.g., NSF-51 for food equipment) will be required for the material or the final part? Common regulations • REACH SVHC, RoHS 3 (EU 2015/863), CA Prop 65, Heavy Metals (CONEG, 94/62/EC) and Conflict Minerals • Substances of Concern (could include phthalates, latex, PVC, BPA, halogens, PAH, flame retardants) Other market-specific regulations • Consumer Product Safety Improvement Act of 2008 (CPSIA) - Lead and phthalate limits for products designed for children • Chemicals of High Concern for Children (CHCC) - Several US states (OR, WA, VT, ME, MN) have lists of chemicals of concern for products . designed for children • Global Automotive Declarable Substance List (GADSL) - Specifically for automotive applications • End of Life Vehicles (ELV) Directive, 2000/53/EC - Restrictions on certain heavy metals for .. automotive applications • EC1223/2009 - Covers prohibited, restricted substances in cosmetic products This list is not exhaustive and regulatory requirements change and evolve. Material suppliers can provide documentation of compliance with substance restrictions.

All employees, supervisors, and members of management must accept individual responsibility for ensuring compliance with this policy. You are encouraged to contact your supervisor, your Human Resources representative, or the Corporate Human Resources department if you believe that there has been a violation of this policy, or you can notify the company’s EEO/AA compliance officer at PeopleLink@avient.com.

Precision wound packages yield the greatest length per package, provide solid package stability, and ensure minimum ballooning at speeds reaching 4000 RPM.

However, they recently reached out to Avient, expressing interest in switching to a more sustainable, recycled material for a new product—the cubyko leaf, a waterproof outdoor socket.

These engineered TPEs also have the added benefit of eliminating secondary processing, which reduces energy use and supports manufacturers in reaching their sustainability goals.

During the third quarter we completed the acquisition of the protective materials business of DSM ("Dyneema") and announced that we reached an agreement to divest our Distribution segment. 

They are formulated with  raw materials that are pre-tested to ISO, USP, EP and ICH Q3D protocols to mitigate the risk of product non-compliance of healthcare products. These color and additive solutions are formulated with bio-based polymers and pre-tested raw materials to help reduce the carbon footprint of medical plastics and mitigate the risk of non-compliance.

Because the trays were regularly handled by consumers and filled with food, it was very important that any changes made to the material would not jeopardize the packaging’s FDA compliance. Even more importantly, the additive technology met FDA-compliance, so the improved packaging was delivered without any service interruption to the end customer, saving the converter thousands of dollars in packaging redesign efforts, and solidifying the sheet producer’s relationship with their valuable customer.

APPLICATIONS • Medical devices • Drug delivery devices • Labware KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing risk of change 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* * FDA/EU compliance information available upon request Copyright © 2023, Avient Corporation. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.