Beyond food and beverages, drugs, cosmetics, and any other consumer goods used or applied by humans, the regulation extends to manufacturing processes and the compliance of packaging products.

Food and Drug Administration (FDA).

Coring refers to the tiny fragments of material sheared off by the needle as it penetrates the stopper or septum, which could potentially contaminate the drug inside the container.

OUR CUSTOMER SUPPORT ACTIVITIES INCLUDE: • Food and Drug Administration (FDA) compliance support • Compliance with National Inventories • Biocompatibility compliance • REACH – European Legislation on Registration, Evaluation, Authorization and Restriction of Chemicals • Restriction on Hazardous Substances (RoHS) and Waste Electrical   and Electronic Equipment (WEEE) electronics compliance • Data entry into the International Material Database System (IMDS) • Hazardous communication, including safety data sheets (SDS) and labeling GENERATING REGULATORY COMPLIANCE DOCUMENTATION INCLUDING: • California Proposition 65 • European Food Contact • Individual Customer Restricted Substance lists • Drug Master Files • Medical Application Files • Food and Drug Administration Certification • Potable Water Certification Contact us if you have questions or for specific information on your application’s regulatory compliance requirements.

PHTHALATES FACTS PHTHALATES ARE KNOWN TO BREAK DOWN IN THE HUMAN BODY Research has shown that after entering the body, phthalate are broken down into metabolites within minutes and pass out quickly in urine.2 PHTHALATE EXPOSURE IS CONSIDERED LOW Despite the fact that phthalates are used in a wide range of products, human exposure from all sources is considered to be extremely low.2 PHTHALATES ARE A USEFUL CHOICE FOR HEALTHCARE Flexible vinyl tubing does not react with most medications, allowing for reliable administration of drugs, while flexible vinyl bags prevent blood contamination and extend shelf life of the blood.3 PHTHALATES ARE REGULATED Based on earlier studies, a few specific phthalates have been banned for use in toys or other items for sale to children under twelve to reduce risk of overexposure through hand-to- mouth behaviors. 1 Source: chemicalsafetyfacts.org 2 Source: Centers for Disease Control and Prevention 3 Source: thisisplastics.com www.avient.com Copyright © 2020, Avient Corporation.

KEY CHARACTERISTICS • Available for polyethylene, polypropylene, ABS, polycarbonate and styrenics • Bio-content of resin carrier varies from 70% to 100% depending on polymer—calculated to ASTM D6866 standard • Manufactured at four ISO 13485 certified sites, providing global consistency and security of supply • Documented change control beyond CAS number, reducing risk of change • Drop-in solutions that can be processed like fossil-based grades on common injection molding and extrusion machines • Can be provided as ready-to-use pre-colored or additive formulation REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to US FDA and APPLICATION BULLETIN Sustainability Spotlight Bio-polymers Healthcare use limitations apply—see below.

MEVOPUR COLORANTS • Standard colors in PP and PE to shorten time-to-market • Custom colors matched to Pantone, RAL or other color reference • White colorants for pharmaceutical packaging for LDPE, HDPE and PP with opacity to reach USP chapter MEVOPUR FUNCTIONAL ADDITIVES • Antistatic formulation with good flow/impact for injection molding • Amide- and amine-free antistatic for film in contact with API (Active Pharmaceutical Ingredients) • UV blocking for transparent PP and PE packaging to meet USP chapter • Non-migrating friction reduction/processing aid for PE and PP • Laser marking/welding additive for fast, reliable marking/assembly • MVTR (Moisture Vapor Transmission Rate) reduction for HDPE to improve shelf-life • Thermal protection of the polymer during processing • Gamma/e-beam sterilization protection for PP (up to 50kGy) with color compensation for reduced yellowing 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 Bormed™ is a registered trademark of Borealis 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 level, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Different tones of amber available on request —more or less red or yellow and/or lighter or darker • Also available in liquid form REGULATORY SUPPORT • Pre-tested raw materials: - ISO 10993-1 and USP parts (Class VI) - European Pharmacopeia, monograph 3.1.15, USP and elemental analysis as per ICH Q3D - USP criteria appearance of solution, color • Registered Drug Master File (Type III) by the FDA • Food contact compliance established with FDA/EU* • YBB00102002-2015 (oral liquid pharmaceutical PET bottles) compliance support APPLICATION BULLETIN * FDA/EU compliance information available upon request Healthcare use limitations apply—see below.

KEY CHARACTERISTICS • Formulated specifically for healthcare product applications • Wide portfolio of polymer additive solutions, including: - Antimicrobial technology - Surface energy modification, including low retention - Authentication technology - Lasermarking - Sterilization and content protection - Processing optimization - FDA compliant resin and color changeover solutions • OnCap HC Plus certified for USP Class VI and ISO 10993 bio-compatibility requirements; includes anti-oxidant, lasermarking, antimicrobial, radiopacifier, anti-stat, and polymer and gamma stabilization performance additives OnCap™ HC & OnCap™ HC Plus Additives for Healthcare PRODUCT BULLETIN INDUSTRY SUPPORT • Supported with a broad range of technical support and services: - Restricted medical-grade raw material selection process - Sampling program - World-class FDA cGMP manufacturing facilities - Batch traceability and formulation lockdown systems - FDA Drug Master Files or Medical Device Files maintenance MARKETS AND APPLICATIONS OnCap HC and OnCap HC Plus Additives are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.

Terms Adjustment; Delivery. Seller may change the price and/or terms of delivery and shipment at any time up until delivery, except where a written alternative pricing mechanism exists that is signed by Seller. Unless Seller and Buyer have expressly agreed to a firm delivery date term in a single writing signed by both parties, delay in delivery of any Products shall not relieve Buyer of its obligation to accept delivery thereof.