Page 1 / 1 has been assessed and certified as meeting the requirements of ISO 9001:2015 For the following activities The Design and Manufacturing of Plastic Color Concentrated, Plastic Additive Concentrated and Pigment Powder for Thermoplastic & Rubber Industries. Certified since 03 November 2000 Jonathan Hall Global Head - Certification Services Authorised by SGS United Kingdom Ltd Rossmore Business Park, Ellesmere Port, Cheshire, CH65 3EN, UK t +44 (0)151 350-6666 - www.sgs.com https://www.sgs.com/en/terms-and-conditions/

Domestic: 1-844-835-7433 http://edge.media-server.com/m/p/v48otc68/lan/en Domestic: 1-855-859-2056

Get Help Now +1-866-737-2066 ASTM ISO Shore A/D ASTM/ISO %

Sources: 1)    https://verpackungsgesetz-info.de/wp-content/uploads/2021/06/twopager-packaging-amendment-1.pdf 2)    https://ec.europa.eu/commission/presscorner/detail/en/IP_18_3846 3)    https://verpackungsgesetz-info.de/en/#verpackungsgesetz

Sources: 1)    https://verpackungsgesetz-info.de/wp-content/uploads/2021/06/twopager-packaging-amendment-1.pdf 2)    https://ec.europa.eu/commission/presscorner/detail/en/IP_18_3846 3)    https://verpackungsgesetz-info.de/en/#verpackungsgesetz

Additionally, Avient’s ISO 13485 manufacturing site in Singapore for its Mevopur™ formulations recently achieved ISO/IEC 17025 accreditation for Biological Evaluation of Medical Devices–Part 5: Tests for In-Vitro Cytotoxicity.  Mevopur™ Healthcare Colorants and Functional Additives: formulations pre-tested to support compliance with regulatory requirements, such as USP Class VI, ISO 10993, EP3.1, USP661.1, and ICH Q3D and manufactured across a global network of ISO 13485-certified facilities or under GMP certifications. PCF values are available for these products and are based upon a TUV-certified ISO-14067: 2018 process.

Get Help Now +1-866-737-2066 ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D evaluations reduce risk of non-compliance during regulatory submission ISO 6009 color range

Like other Mevopur products, they are formulated with raw materials tested to ISO 10993-1 and USP , European Pharmacopeia 3.1.3 and 3.1.5, USP and ICH Q3D.   Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is commercially available globally. Versaflex™ HC Thermoplastic Elastomers series HC3810: translucent TPE formulations offering excellent colorability for injection molded parts and over-molding, developed to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS

_2 /Ju n- 20 19 /V er si on 1 .0 Certificate Avient Colorants Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate 618684 Singapore Singapore Scope Administration, Site management, Manufacture, Laboratory, Procurement, Maintenance, infrastructure, Warehouse and Transport Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45483 Validity 01. 03. 2022 – 28. 02. 2025 Issue 01. 03. 2022 A.Grisard, President SQS F.