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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000408

Date: May 28, 2004


From: Environmental Scientist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)


Subject: FCN No. 408 - C16-18 fatty acid esters of a branched C20 alcohol as a lubricant/release agent in the manufacture of repeat-use polycarbonate.


Notifier: COGNIS Deutschland
GmbH & Co KG
D-40551 Duesseldorf, GERMANY


To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
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. The claim of categorical exclusion cites the section under which categorical exclusion is claimed, 21 CFR 25.32(j), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.


The use of this food-contact substance (FCS) meets the categorical exclusion criteria because essentially all of the market volume of the FCS is incorporated into repeat-use food-contact articles, and the FCS will remain with the repeat-use food-contact articles through their use and disposal. To support this claim, the notifier stated in a letter dated March 26, 2004, "It is understood that Cetiol is incorporated throughout the polymer and that the long "fatty acid" tails of the molecule that extend to the surface of the polymer facilitate the release of the polymer from the article mold cavity. As such, this material does not "bloom" to the surface in the same fashion as other mold releases are known to function. Therefore, little, if any, of the Cetiol is expected to be removed by washing."


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




Jonathan L. Chappell