Eastman Chemical Company has announced announce that in addition to the existing Food Contact Notification (FCN) clearance from the U.S. Food and Drug Administration (FDA), its Eastman 168 non-phthalate plasticizer is now listed in EU Commission regulation (EC) No 975/2009 amending Annex III (the list of additives which may be used in the manufacture of plastic materials and articles) of Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs.

As of Jan. 1, the list of additives in Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs has become a positive list to the exclusion of all others.

A non-phthalate plasticizer with a long established history of safety and utility in the manufacture of consumer products, Eastman 168 is now cleared in the U.S. and the EU for a range of food contact applications.

"Eastman 168 has a history of safe use by manufacturers of consumer products since introduced more than 30 years ago," said Dr. Steve Cullen, plasticizers business manager, Eastman.

A versatile plasticizer for PVC, Eastman 168 has a long and growing track record of regulatory approvals. It has been demonstrated to be a ready, drop-in replacement for some of the most widely used ortho-phthalate products that are currently experiencing regulatory pressure in markets around the world. It finds particular utility in sensitive applications where brand owners are looking for compliance and differentiation, while continuing to provide the same high-performance products for their customers.

"The inclusion of Eastman 168 in the EU positive list for additives used in materials and articles intended to come into contact with foodstuffs in addition to the U.S. FDA's regulatory green light opens up a whole new area of sensitive applications where brand owners can realize the benefits of our product. We believe that Eastman 168^TM is clearly proving itself to be the best non-phthalate plasticizer on the market today," Cullen said.
Eastman has completed a debottlenecking project to allow increased production of the non-phthalate plasticizer in response to rapidly growing global customer demand, particularly in toys, childcare articles, medical devices, and other sensitive applications. In addition, Eastman has also recently more than doubled the bulk storage capacity in the EU to maintain the reliability of supply that comes from having large quantities of product available quickly, from a local source.