Non-phthalate PVC plasticizer obtains FDA compliance for key food contact applications

19-Apr-17

Perstorp has obtained independent expert opinion advising that its Pevalen™ non-phthalate PVC plasticizer can be used in important food contact applications in the USA. The advice, from an international law firm that has expert knowledge in food contact legislation, says that Pevalen is suitable for use at levels up to 32% in PVC intended to produce conveyor belts and gloves used in meat and poultry processing facilities, as well as in tablecloths.

In a letter to Perstorp, the law firm wrote: “Based on the information you have provided, as well as other publicly available information and data, it is our opinion that sufficient scientific evidence supports the conclusion that the intended uses of the Pevalen are GRAS [Generally Regarded As Safe] and that Pevalen may be lawfully used as intended without obtaining prior approval from, or notifying, FDA.”
“This is an important development, especially as true non-phthalate plasticizers are increasingly in demand for food contact applications,” says Dr. David Bray, Vice President – BU Plasticizers at Perstorp. “We shall soon be applying for FDA approval for the use of Pevalen in a wider range of uses. This GRAS notification will enable us to enter the US market for food contact applications in PVC ahead of FDA approval.”
Pevalen (chemical name pentaerythritol tetravalerate, PETV) is already used in numerous close-to-consumer applications that do not involve food contact.