KINGSPORT, TENN., (March 29, 2010) - Eastman Chemical Company is pleased to announce that in addition to the existing Food Contact Notification (FCN)¹ 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, 2010 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 others2.
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 United States and the European Union 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,” says 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 Eastman168™ is clearly proving itself to be the best non-phthalate plasticizer on the market today,” says Cullen.
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 European Union (EU) to maintain the reliability of supply that comes from having large quantities of product available quickly, from a local source.
For more information about Eastman 168™ non-phthalate plasticizer including other Eastman™ non-phthalate products, visit our Web site at www.EastmanPlasticizers.com.
1. Eastman 168 may be lawfully used in accordance with FCN 770; 21 CFR 176.180 Components of paper and paperboard in contact with dry food; 21 CFR 175.105 Adhesive and 21 CFR 175.125 Pressure-sensitive adhesives. It is also permitted as a component of closure-sealing gaskets for food containers under 21 CFR 177.1210 subject to certain limitations on food type and conditions of use as described in tables 1 and 2 of 21 CFR 176.170.
2. Substances on the provisional list may continue to be used according to national legislation after this date until a decision on their inclusion or non-inclusion into the positive list is taken.
