DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Washington, DC 20204
Thomas J. Muldoon
Bell, Boyd & Lloyd
Three First National Plaza
70 West Madison Street
Suite 3300
Chicago, IL 60602-4207
Dear Mr. Muldoon:
This responds to your submissions of December 6, 1999, and February 15 and 28, June 21, and July 1, 2000, concerning the use of your product CompCoteTM, a composite carbon-based polymeric aluminum oxide coating produced by anodizing aluminum in the presence of sulfuric acid electrolyte modified by a polyaniline additive on food-processing equipment.
We indicated in subsequent correspondences (January 28, and June 29, 2000) and in a telephone conversation (July 7, 2000) the need for additional information regarding the composition, identity, migration, and manufacturing process for the subject coating.
Subsequently, we have reviewed all the additional information and have completed our review of your request. We conclude that your coating, a composite carbon-based polymeric aluminum oxide coating, is expected to be highly resistant to corrosion and abrasion. Therefore, there is little, if any likelihood that components of this coating would migrate into food in other than insignificant amounts. In addition, because the coating will be used in the manufacture of food-processing equipment for repeated use, the concentration of any migrant would be extremely low due to the large volume of food processed. Therefore, the use of your composite carbon-based polymeric aluminum oxide coating, as described in your submission, to create an anodized metal finish on food-processing equipment, does not require an amendment of the food additive regulations.
We trust that this letter is responsive to your inquiry. Please do not hesitate to contact us if we can be of further assistance.
Sincerely,
Sandra Varner
Acting Director
Division of Petition Control
Center for Food Safety and Applied Nutrition
