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COMPOUNDS
FOR HEALTHCARE AND
RISK AVERSE MARKETS

Product Safety

The Product Stewardship Bulletins (PSB) contain background information about the regulatory status of Cawiton thermoplastic elastomer (TPE) compounds, and is meant to be a standard response to many regulatory questions in a timely manner. Since regulations tend to change very regularly, the content of this PSB is reviewed several times per year, to ensure our response documents provide most recent and relevant information.

Please note that compliance with the regulations cited should not be interpreted to guarantee that the product, will, in fact, perform in a particular application. We certify that during manufacturing of our Cawiton TPE products we do not use or intentionally add any of the chemicals restricted by the regulations and standards listed (and their subsequent amendments) in amounts which exceed the applicable limits. However, neither the raw materials used in our manufacturing processes , nor the final products are analyzed for the potential presence of traces of such substances.

The statements hold for the Cawiton TPE product as it leaves our facilities, but do not include any masterbatches, additives, process aids etc, subsequently added by the converter. Should you have any further questions concerning a Wittenburg (Cawiton) product, or if we can assist in any other way, please do not hesitate to contact us.

Food Contact Grades:
This document covers the raw materials used and the raw material (change) policy adhered to, NIAS (Not Intentionally Added Substances), and it provides also the relevant statements associated with compliance in the EU and in the US.

Medical & Pharma Grades:
This document covers raw materials and requirements, biocompatibility of Cawiton materials , manufacturing processes and quality systems, and outlines the Wittenburg medical policy regarding medical and pharmaceutical applications.

REACH & RoHS:
This document covers Wittenburg’s compliance with REACH-SVHC and RoHS2 regulations.

Chemicals, Regulations & Standards:
This document deals with hazardous substances in general; phthalates, heavy metals, environmental pollutants, polycyclic aromatic hydrocarbons (PAH), CMR substances (California Proposition 65), allergenic substances, Halal & Kosher certification (absence) and the presence of animal origin species  (BSE/TSE risk).

Absence of Substances:
The document lists various hazardous substances which are not intentionally used during manufacturing of Wittenburg Cawiton materials.