Evonik Industries has announced that it has received FDA approval for a food contact substance notification (FCN) for its family of PA1010 polyamides. Its VESTAMID Terra DS16 natural may be used as a basic polymer in the production of articles intended for food contact. Further details on the approved applications can be found in the FCN#001439, however, in main, the material may be come in contact with all types of food at chilled to elevated room temperatures for single use, as well as all types of food in repeated use application up to 100°C.
Food contact substances (FCS) are materials intended to come into contact with food, such as processing equipment, packaging and containers, and containers used in transport. Due to the migration of molecules from the food contact material to the food, these substances are regulated in many countries. In the U.S., this is regulated via the Food Contact Notification Program established by the FDA within the Center for Food Safety and Applied Nutrition's (CFSAN) Office of Food Additive Safety. All FCS must be approved by the U.S. FDA through the process of FCN.
Approval of the Vestamid Terra DS polyamides is based on the simulation and actual tested migration behavior of the monomers, oligomers and other trace substances. Similar to the previous approvals obtained for the monomer DMDA under EU food contact materials Framework Regulation-1935/2004, compliance with very low specific migration levels (SML)was required. In the case of Vestamid Terra se, the SML's were found to be well within the limits for food contact applications, Benjamin Brehmer, business manager for biopolymers, commented that: "receiving the FDA approval is a validation that our efforts to strive for the best quality bio-based polyamides on the market has paid off." He added: "This milestone also allows us to confidently enter new markets with clarity of the regulatory situation."
Vestamid Terra polymers are partially or entirely based on renewable feedstocks. The starting material is the castor bean and its oil derivates, a raw material that is not animal feed, and which does not compete with that of food crops. These are synthesized into monomers that form the basis of the Vestamid Terra product range. Vestamid Terra DS is based on polyamide 1010, which is the polycondensation product of 1,10-decamethylene diamine (D) and 1,10-decanedoic diacid (sebacic acid - S). Both decamethylene diamine and sebacic acid are derived from castor oil, which means that Terra DS has a bio-content of 100%. Vestamid Terra HS, which has a bio-content of 63%, is based on polyamide 610, which is the polycondensation product of 1,6-hexamethylene diamine (H) and 1,10-decanedoic diacid (sebacic acid - S) and was previously approved in the EU and USA for food contact with non-alcoholic foods. Having food contact approvals for both products will considerably broaden the range of commercial applications open to Evonik's portfolio of bio-based polyamide on the market.