Environmental Decision Memo for Food Contact Notification No. 000473
Date: December 6, 2004
From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 473 - Novapex U-110 for use as a UV light absorber in polyethylene phthalate polymers used in contact with food at levels not to exceed 3.3 weight percent
Notifier: Mitsubishi Chemical Corp.
Minakato-ku, Tokyo 108-0014
To: Division of Food Contact Notifications (HFS-275)
Attention: Julie Mayer
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG
We have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that categorical exclusion is warranted. Novapex U-1100 is 2,6-napthalenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol and 4,4'-(1,3,6,8-tetrahydro-1,3,6,8-tetraoxobenzo-[lmn][3,8]phenanthroline-2,7-diyl)bis[benzoic acid].
The FCN states that the intended use of the FCS was for single use only. However, a review of the information provided in the FCN supported the use of the FCS in repeat use articles. The chemistry memo dated December 2, 2004, does not limit the use of the FCS but instead states that the intended use of the FCS is "as an ultraviolet light absorber in polyethylene phthalate polymers used in contact with food at levels not to exceed 3.3 wt-% of polyethylene phthalate polymers. The FCS is intended for use in contact with all types of food under Conditions of Use B through H functioning as a UV light absorber in polyethylene phthalate polymers used in contact with food to prevent UV-induced deterioration of beverages, edible oils, and other foods." The expanded use required a claim of categorical exclusion under 21 CFR 25.32(j) in addition to the claim of categorical exclusion 21 CFR 25.32(i) that was required for the requested use of the FCS in single use articles.
The revised claim of categorical exclusion cites the sections under which categorical exclusion is warranted, 21 CFR 25.32(i) and (j), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.
When this notification becomes effective this categorical exclusion memo will be made available to the public 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.
*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.