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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000456

Date: August 20, 2004


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


Subject: FCN No. 456 - Sodium sulfate salt of ethoxylated (7 moles of ethylene oxide) n- and iso-undecyl alcohol (C11) for use as an emulsifier in the production of polymers


Notifier: Clariant GmbH65926
Frankfurt am Main


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 FCS is intended for use at a level not to exceed 2 percent-by-weight in the production of acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard in contact with all foods. Based on information contained in the EA for FCN 54, which is for a similar substance used in the same manner, the majority of the FCS, 99.5%, is expected to remain with the final food packaging with only minimal losses, 0.5%, to the environment. The claim of categorical exclusion cites the section under which categorical exclusion is claimed, 21 CFR 25.32(i), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.


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




Annette M. McCarthy, Ph.D.