View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 70 01 _1 /A pr il 20 22 /V er si on 2 .0 Certificate Avient Colorants Spain S.A. Martorell no.124 08740 Sant Andreu de la Barca Spain Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46388 Page 1 of 1 Validity 25. 02. 2024 – 24. 02. 2027 Issue 25. 02. 2024 A.Grisard, President SQS F.

C er ti fi ed M anagement System s by Switzerland Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. Avient Colorants Germany GmbH Kornkamp 50 22926 Ahrensburg Germany Scope Production of Color- and Additives Concentrates, Compounds and Foaming Agents Normative base ISO 50001:2018 Energy Management System Reg. no. 46090 Validity 20. 01. 2021 – 19. 01. 2024 Issue 12. 04. 2021 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

C er ti fi ed M anagement System s by Switzerland Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. Martorell no.124 08740 Sant Andreu de la Barca Spain Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems Requirements for any organization in the food chain Reg. no. 46388 Validity 25. 02. 2021 – 24. 02. 2024 Issue 25. 02. 2021 Swiss Madesqs.ch F.

MEDICAL DEVICE MANUFACTURER G U I D I N G C A T H E T E R • Ultra-soft hardness of about Shore 50A • Excellent extrusion performance, achieving a thickness of about 0.1 mm • Smooth surface • Certification for biocompatibility • Delivered an ultra-soft TPU that has good elasticity, abrasion, and tear resistance • Complied with ISO 10993 biocompatible properties • Offered onsite service to support rapid extrusion performance for the customer NEUSoft Thermoplastic Polyurethanes KEY REQUIREMENTS WHY AVIENT?

Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards. Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards.

PHARMACEUTICAL PACKAGING OEM V I A L S , B O T T L E S & C O N T A I N E R S • Raw materials pre-tested to USP 661.1 and ICHQ3D guidelines • Stabilization during molding and sterilization processes for both opaque and transparent polymer materials • Certified formulations available globally • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the pharmaceutical value chain • Delivered specialized formulated solutions to meet stringent pharmaceutical packaging requirements • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Concentrates KEY REQUIREMENTS WHY AVIENT? AVIENT SOLUTION CERTIFICATION + AVAILABILITY LEARN MORE © 2021, Avient Corporation, All Rights Reserved https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/mevopur-custom-colors-and-formulations

In the event of a conflict between this Quality Commitment and any mutually agreed specifications or quality agreement that is executed by NEU, the mutually agreed specifications or signed quality document shall control. 1.0 PRODUCT DESCRIPTION Thermoplastic material in pellet form. 2.0 TEST METHODS NEU test methods are modeled after ASTM testing standards, where applicable. 3.0 OPERATIONAL DEFINTIONS 3.1 Lot (Batch): Material manufactured at one time. 3.2 Blend: No more than three lots of a specific raw material, combined together to form a homogeneous mixture. 3.2.1 Full lot tractability of non-proprietary formulations will be reflected on the COC 3.3 Certification: “Certificate of Conformance” or “Certificate of Analysis” based material requirements 3.4 Certificate of Analysis: Document containing information that the product conforms to the established Product Specifications. 3.5 Certificate of Conformance: Document containing confirmation that the product conforms to the defined formulation. 3.6 Finished Product Form: Finished product shape (Cylindrical, Spherical) 3.7 Product Specification: the product specifications that are contained in a written document signed by NEU, or if such document does not exist, the Certificate of Analysis or Certificate of Conformance issued by NEU. 4.0 PACKAGING 4.1 Standard product packaging options include: 4.1.1 Drum 4.1.2 Gaylord 4.1.3 Pail 4.1.4 Individual bag in box Approved Plant/Local : Reference Document Document #: DOC-10815 Revision: 3 Document Owners: Dean Clark Effective Date: Oct 29, 2020 Title: NEU Quality Commitment Page 2 of 4 Only the electronic version of this document in ETQ is the controlled version of the document. as applicable) 4.2.2 Customer Description 4.2.3 Manufacturer’s Product Code 4.2.4 Manufacturer's Lot Number 4.2.5 Quantity and Units (Example 25 lbs.) 4.2.6 Company Name 4.2.7 Date of Manufacture 4.2.8 Expiration Date (as applicable) 5.0 SUPPORTING DOCUMENTATION 5.1 Certification: Each shipment of product will be accompanied by a Certification that, at the time of shipment, the material conforms to the Product Specifications. 5.1.1 Certification document will include: 5.1.1.1 Customer Part Number 5.1.1.2 Customer Purchase Order Number 5.1.1.3 Customer Material Description 5.1.1.4 Manufacturer's Lot Number 5.1.1.5 Total quantity shipped (with units) 5.1.1.6 Test values (as applicable) 5.1.2 Certification will be sent with each product shipment, addressed to the Customer’s shipping location and/or electronically sent to appropriate Customer contact. 5.1.3 The Certification document may contain test values conducted by NEU on the product for those characteristics listed under certification. 5.2 Safety Data Sheets: A Safety Data Sheet will be made available upon request or may be available on NEU’s website. In the event that the NEU determines that it is the root cause of the Customer complaint, a corrective action will be issued, and preventive actions will be developed to address the root cause. 10.0 MANAGEMENT OF SUPPLIERS 10.1 NEU will maintain and ensure oversight and monitoring of applicable suppliers in accordance with the requirements of ISO 13485 Quality Management System. 11.0 TRACABILITY, RECORDS & RETENTION 11.1 NEU is responsible for establishing and maintaining controlled documentation of product and raw material component traceability during all stages of production and shipment. 11.2 An electronic record of the manufacturing conditions and raw materials (vendor ID and lot number) used to manufacture each batch is retained and preserved for a period of at least 7 years from the manufacture date or as specified by applicable Regulatory Requirements. 11.3 An electronic record of the Customer purchase order and NEU sales order confirmation will be retained and for a period of at least 7 years from order acceptance date. 11.4 A representative sample of the product manufactured will be retained for a period of at least 1 year from manufacture date. 12.0 EXPIRATION 12.1 NEU’s obligations contained in this Quality Commitment will automatically expire if the Customer does not purchase product from NEU for a period of one year.

C er ti fi ed M anagement System s by Switzerland Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. Cibodas Kecamatan Cibodas, Tangerang 15138 Indonesia Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems Requirements for any organization in the food chain Reg. no. 46391 Validity 25. 02. 2021 – 24. 02. 2024 Issue 30. 06. 2021 Swiss Madesqs.ch F.

C er ti fi ed M anagement System s by Switzerland Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. Avient Colorants Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate Singapore 618684 Singapore Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems Requirements for any organization in the food chain Reg. no. 46390 Validity 25. 02. 2021 – 24. 02. 2024 Issue 30. 06. 2021 Swiss Madesqs.ch F.

View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 70 01 _1 /A pr il 20 22 /V er si on 2 .0 Certificate Avient Colorants MX S.A. de C.V. Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46389 Page 1 of 1 Validity 25. 02. 2024 – 24. 02. 2027 Issue 20. 12. 2023 A.Grisard, President SQS F.