Manufacturing of seals, tubes, and profiles in food-grade silicone with formulations tested under FDA 21 CFR 177.2600, EC 1935/2004, and BfR XV. Controlled production in a certified ISO 8 Cleanroom environment compliant with ISO 9001 / ISO 13485.
The food sector demands materials that guarantee safety, durability, and traceability in direct contact with food and beverages. At ProSilicones64, we develop food-grade silicones produced under an ISO 9001 / ISO 13485 system and manufactured in an ISO 8 cleanroom. Formulations are tested compliant with FDA 21 CFR 177.2600, EC 1935/2004, and BfR XV, ensuring chemical compatibility and compliance with Regulation (EU) 10/2011.
Food-grade silicone components are manufactured and verified under a European and US regulatory framework that guarantees safety, purity, and traceability in direct contact with food.
| Normativa | Ámbito de aplicación |
|---|---|
| FDA 21 CFR 177.2600 | Testing of materials in contact with food (USA) |
| CE 1935/2004 | European regulation on materials in contact with food (EU) |
| BfR XV | German health recommendations for food elastomers |
| Reglamento (UE) 10/2011 | Plastics and polymers intended for food contact (EU Regulation 10/2011) |
| ISO 9001 / ISO 13485 | System management certification and process traceability |
| ISO 8 Cleanroom | Certified environment compliant with ISO 14644 for hygienic production |
| REACH / RoHS | Chemical compatibility and absence of restricted substances |
Food-grade silicones from ProSilicones64 are integrated into processing, packaging, and fluid transfer systems where cleanliness, thermal resistance, and durability are essential:
