VYNOVA™ S6630

Food Contact Applications

Food contact materials in the European Union are subject to the requirements of European Regulation 1935/2004, laying down general requirements that materials should not transfer their constituents to food in quantities that may endanger human health. The principle regulation for plastic materials intended to come into contact with foodstuffs is Commission Regulation 2011/10/EC. Vinyl chloride presence, detectable by a method complying with the criteria set out in Article 11 of Regulation (EC) N° 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, is restricted to a maximum level of 1 mg/kg in materials and articles. Commission Regulation 2011/10/EC introduced an overall migration limit to the final article of 10 mg/dm² or 60 mg/kg (60 ppm). VYNOVA resins are manufactured using only monomers and starting substances listed in Annex 1 of Commission Regulation 2011/10/EC. Compositions based on our resins, when processed in accordance with best known practice, are believed to comply with the mentioned migration limits. It remains however the responsibility of the manufacturer to conduct relevant tests on the final article to assure appropriate migration requirements are satisfied.

Medical Applications

• Materials based on plasticised PVC for containers for human blood and blood components.
• Materials based on plasticised PVC for tubing used in sets for the transfusion of blood and blood components.
• Materials based on non-plasticised PVC for containers for non-injectable, aqueous solutions.
• Materials based on non-plasticised PVC for containers for dry dosage forms for oral administration.
• Materials based on plasticised PVC for containers for aqueous solutions for intravenous infusion.

Vynova resins must be stored at temperatures below 50°C, and protected from sunlight and moisture. Direct contact with the soil has to be avoided. When conditions of storage and packaging are respected, we guarantee a shelf life of three years after production of the material.