FDA Regulatory Status: Some Estane® thermoplastic polyurethane (TPU) compounds are composed of ingredients which are either listed in FDA regulation 21CFR 175.105, 177.1680, 177.1210 and 177.2600 or other applicable regulations, are ""Generally Recognized as Safe"" (GRAS), or are prior sanctioned for use.
Approval for use in US, 4 classifications:
- 175.105 Adhesives
- 177.1210 Closure with sealing gaskets for food containers
- 177.1680 Polyurethane Resins
- 177.2600 Rubber articles intended for repeated use
EU-regulation 10/2011 (including amendments):
Food contact approval according to European legislation ("PIM- Plastics Implementations measure") but works as a positive list.
- Approval is based on recipe check
- Various Estane® TPU products have been evaluated (self-evaluation) based on supplier information
