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CFSAN/Office of Food Additive Safety
November 17, 2003
Date: November 17, 2003
From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 372 - 1, 4-Benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-butanediol and adipic acid for use as a single use film and as a coating.
Notifier: BASF Aktiengesellschaft
KS/KF-E 100
67056 Ludwigshafen Germany
To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG
The above referenced notification contains two proposed uses for the food contact substance (FCS), one as a coating and one as a film. The notifier submitted a claim of categorical exclusion under 21 CFR 25.32(i) for the proposed use of the FCS as a coating and an environmental assessment for its proposed use as a film.
We have reviewed the claim of categorical exclusion and have concluded that categorical exclusion is warranted for the proposed use as a coating. The claim of categorical exclusion cites the section under which categorical exclusion is warranted, 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.
We have prepared a Finding of No Significant Impact (FONSI) for the proposed use of the FCS as a film (attached). When this notification becomes effective, this FONSI and the notifier's Environmental Assessment, dated October 10, 2003, may be made available to the public.
Please let us know if there is any change in the identity or use of the FCS.
Annette M. McCarthy, Ph.D.
A food contact notification (FCN No. 372), submitted by BASF Aktiengesellschaft, to provide for the safe use of 1,4-benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-butanediol and adipic acid for use as a single use polyester film.
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 October 10, 2003.
Prepared by__________________________________________ Date: November 17, 2003
Annette McCarthy, Ph.D., Environmental Toxicologist
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
Approved by _________________________________________ Date: November 17, 2003
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
