Environmental Decision Memo for Food Contact Notification No. 1417

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.

Date: March 21, 2014

From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: FCN No. 1417 – Fatty acids, soya, epoxidized, 2-ethylhexyl esters; Epoxidized 2-ethylhexyl soyate (CAS Reg. No. 68082-34-8) intended for use as a plasticizer in polyvinyl chloride.

Notifier: Galata Chemicals

To: Hui Chen Chang, Division of Food Contact Notifications (HFS-275)
Through: Leah Proffitt, Environmental Reviewer, Office of Food Additive Safety, HFS-255____

Attached is the Finding of No Significant Impact (FONSI) for FCN 1417. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 3, 2014, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.

Please let us know if there is any change in the identity or use of the food-contact substance.

Mariellen Pfeil

Attachment: Finding of No Significant Impact


A food-contact notification (FCN No. 1417), submitted by Galata Chemicals, to provide for the safe use of Fatty acids, soya, epoxidized, 2-ethylhexyl esters intended for use as a plasticizer in polyvinyl chloride.

The Office of Food Additive Safety has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and, therefore, will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated January 3, 2014, and confidential business data provided by the notifier, as summarized below.

The FCS is intended for use in polyvinyl chloride (PVC) at levels up to 15 percent by weight of the finished article in contact with Food Types I, II, IV-B, VI-A, VI-B, VI-C (up to 15% alcohol), VII-B, and VIII under Conditions of Use C though G.

The FCS is expected to be wholly incorporated into finished food packaging materials and remain in them through use and disposal by the consumer. Thus, no significant environmental release is expected.

Introduction of the FCS into the environment is expected to occur via land disposal and waste combustion, with approximately 82% being landfilled and 18% incinerated, according to 2011 EPA figures referenced in the EA1,2. Due to EPA's regulations governing landfills at 40 CFR Part 258, only very small amounts of the FCS or its components are expected to enter the environment. Furthermore, no violations of federal, state or local emissions laws are expected as a result of disposal by permitted solid waste incineration facilities, due to regulations at 40 CFR Part 60. There are no extraordinary circumstances surrounding manufacture, use, or disposal of the FCS.

Similarly, the replacement of other polymers by the FCS is not expected to adversely affect the use of energy and resources, as the manufacture and use of the FCS will consume comparable resources as those substances it is intended to replace. The copolymers that are the subject of this FCN are substitutional for other plasticizers currently authorized for use in plasticized PVC polymers and will therefore, not impact current or future recycling programs for these materials.

Therefore, no significant environmental impacts are anticipated from the proposed use and disposal of the FCS.

Prepared by ______________________________________ Date: see electronic signature
Mariellen Pfeil
Office of Food Additive Safety 
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by ______________________________________ Date: see electronic signature
Robert I. Merker
Supervisory Consumer Safety Officer
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

1 Municipal Solid Waste in the United States: 2011 Facts and Figures, EPA530-R-13-001, U.S. Environmental Protection Agency,, May 2013
2 The distribution of disposal patterns is re-calculated from the EPA report based on only the percent land disposed and combusted: % Combusted = 11.7% combusted ÷ (11.7% combusted + 54.3% land disposed) = 17.7% combusted. % Land-disposed = 54.3% land-disposed ÷ (11.7% combusted + 54.3% land disposed) = 82.3% land-disposed.

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