Food Contact Specifications & Regulatory Approvals
FDA Regulatory Status: Estane® Engineered Polymers 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-directive 2002/72: Food contact approval according to European legislation ("Monomers directive") but works as a positive list.
- Approval is based on recipe check
- If not approved for EU 2002/72, approval for an individual EU-country is still possible
- Various Estane® Engineered Polymers products have been evaluated (self-evaluation)
- Some Estane® Engineered Polymers products are certified (recipe check by official institution - certificate available for customer reference) LIST of Estane® TPU products officially certified
BGVV (Bundesinstitutes für gesundheitlichen Verbrauchershutz und Veterinärmedizin) (previously BGA): Food contact approval according to German legislation (recommendation)
- Recommendations but not legally binding since the EC directive is highly regarded.
List of Estane® Engineered Polymers products approved for BGVV