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CFSAN/Office of Food Additive Safety
November 22, 2005
Date: November 22, 2005
From: Environmental Review Group (ERG)/Supervisor
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 546 - 1,3-Benzenedicarboxylic acid, 5-sulfo-,monolithium salt as a modifier of poly(ethylene phthalate)polymers
Notifier: M&G Polymers USA
c/o Keller & Heckman, LLP
Washington, DC 20001
To: Division of Food Contact Notifications (HFS-275)
Attention: Kelly M. Randolph, D.V.M., M.P.H
Attached is the Finding of No Significant Impact (FONSI) for FCN 546. After this notification becomes effective, this FONSI, the EA supplement, and the notifier's environmental assessment, dated September 30, 2005, may be made available to the public and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.
Please let us know if there is any change in the identity or use of the food contact substance.
Attachment
A food contact notification (FCN No. 546), submitted by M&G Polymers USA , to provide for the safe use of 1,3-Benzenedicarboxylic acid, 5-sulfo-, monolithium salt as a modifier of poly(ethylene phthalate) polymers
The Environmental Review Group 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 dated September 30, 2005, on an amendment to the EA dated October 14, 2005, and on the Agency's supplement to the EA.
Prepared by __________________________________________Date: November 22, 2005
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
This document incorporates by reference the notifier's environmental assessment (EA) dated September 30, 2005, and its amendments dated October 14, 2005.
The food contact substance (FCS) is 5 sulfo 1,3 benzenedicarboxylic acid, monolithium salt (food contact substance; FCS); it will be used as a modifying monomer in food contact polyethylene terephthalate polymers (PET) and copolymers (co PET) at a maximum level of 0.6% by weight of the PET and co PET. The finished bottles may contact food types I, II, VI A, and VI C (up to 15% alcohol content) under conditions of use C through G.
The notification states that the FCS is incorporated into the polymeric backbone, thus, modifying it to become a new polymer (modified polyester), which is used thereafter to form finished food-packaging material. This new food additive, the modified polymer, will compose 100% of the finished food-packaging material and, therefore, is not compliant with the criterion for categorical exclusion (i) that requires the substance to be present in finished-food packaging material at not greater than 5 percent-by-weight.
Although it is acceptable that notifiers chose the modifier as the substance which is the subject of the notification (FCS), the substance itself does not represent the food additive but only a reagent used in the manufacture of the resulting food additive (i.e., the covalently modified polymer). Therefore, this notification must contain information that supports the safety and environmental impact of the resulting food additive. Although the FCS would still remain the subject of the notification, the resulting effective FCN will, in fact, also authorize the food additive (i.e., the modified polyester) for its intended use, thereby meeting the requirement that all food additives must undergo premarket approval. In a similar fashion, the FCN needs to contain information that will allow the Agency to determine the environmental impact resulting from the intended use of the food additive. The new polymer is regarded as a new food additive and its impact on the environment is the appropriate subject of the requested action.
The EA states that, "The subject copolymers are slightly modified versions of PET/PET copolymers currently found in a variety of food-contact application, and that the modified copolymers may be used in the same applications as those currently uses." The modification of PET with a small amount of the FCS facilitates the dispersion of other substances that have strong gas-barrier properties in PET, such as nylons, and results in an improved clarity of bottles made from these modified PET blend.
Therefore, the PET/PET copolymers that are modified with the FCS may be used in the manufacture of soda and beer bottles.
Disposal of the Subject Food Packaging Material through Recycling:
The EA discusses the disposal of the subject packaging through landfilling, incineration, and recycling. The EA states that the bottles manufactured from the subject additive are, "...virtually identical to bottles manufactured from currently available PET copolymers and, therefore, bottles manufactured using the subject copolymers collected in the recycling stream should be compatibly coextruded with bottles manufactured using current PET copolymers." We agree with the notifier that food-packaging material made from the subject copolymers is compatible with current PET recycling stream. This conclusion is based on confidential information submitted by the notifier in the original EA including the thermal properties of PET polymers/coplolymers modified with the FCS.
Prepared by ___________________________________________
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
