The formulations also meet regulatory compliance requirements, including ATEX and ESD. Additional food contact compliance grades are also available.  

The plant, which is already fully operational, becomes the fourth global source for MEVOPUR™ polymer solutions, which are produced under carefully controlled conditions to support more reliable compliance with regulations governing medical devices and pharmaceutical packaging. We aim to limit non-compliance risk and support safety in use by using only raw materials that have been specially tested in accordance with medical standards.

Avient to highlight its range of colorants and additives for medical applications at Pharmapack 2025, including its ever-expanding Mevopur™ Healthcare Colorants and Formulations, to help accelerate the development of healthcare products and mitigate the risk of non-compliance They can be used to accelerate the development of healthcare products and help reduce the risk of non-compliance.

The new materials have been pre-tested for compliance with the United States FDA requirements under 21 CFR 177.2600 for repeated-use applications and the European standard 10/2011 for food contact. However, compliance does not depend solely on the right polymer formulation, but also on the design of the finished article.

Importantly, this solution is manufactured without intentionally added fluoropolymers, fluoroelastomers, or any other pre- and poly- fluoroalkyl substances (PFAS), supporting customer’s sustainability goals and regulatory compliance by offering an alternative to intentionally added PFAS materials. PRODUCT STEWARDSHIP At Avient we are focused on providing our customers with the highest levels of service and are dedicated to meeting their needs for regulatory support and global regulatory compliance. 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.

Our internal policies and practices often go beyond compliance as part of our continuing commitment to corporate responsibility and sustainability. Regulatory Requests and Certificates (FDA certificate, Absence declaration, REACH, SDS) Available upon request, please contact your sales representative. HACCP Avient Colorants Spain S.A., Avient Colorants Toluca Mexico, and PolyOne Spain SLU follow the structure of HACCP (Hazard Analysis and Critical Control Point) as a system for assessing compliance to food safety standards.

Trilliant™ HC Healthcare Thermoplastics are specifically formulated to meet the high-performance material requirements of medical device manufacturers as well as demonstrate compliance with various regulatory bodies. Avient's TPEs and engineered materials for auto-injector pens offer excellent chemical and impact resistance, good self-lubrication functions, durability to extend product life, and compliance with biocompatibility and food-contact safety regulations.  Trilliant HC thermoplastics provide chemical performance and regulatory compliance for microwell application

Regulatory/Compliance: Meets all regulatory and customers' raw material requirements.

PolyOne Delivers Certified OK Compost HOME Colorants to Simplify Bio-Degradable Packaging Compliance

Perfluoroalkoxy  (PFA), for example, is at the high end; it has a typical continuous use temperature of 500°F (260°C) and typically reaches 715°F (380°C) during processing; equipment temperatures can be even higher than the melt temperature3. At the lower end, polyvinylidene fluoride (PVdF) has a typical continuous use temperature of 300°F (150°C) and typically reaches 450°F (232°C) during processing3.