The latest version of this guidance issued on April 10, 2002. Below is an earlier version.

Recommendations for Chemistry Data
for Indirect Food Additive Petitions

Footnotes

1. Separate recommendations pertaining to petitions for enzyme preparations, sanitizer formulations, direct food additives, and Generally Recognized as Safe (GRAS) ingredients are available upon request from the Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, FDA, 200 C Street, SW, Washington, DC 20201. (See updated contact information)
2. For example, the recent desire of the packaging industry to use post-consumer recycled plastics and paper in the manufacture of food-contact articles has raised a number of issues concerning the suitability of such materials for food contact. Manufacturers of food-contact articles made from recycled plastic or paper will meet all existing specifications for the virgin material. The Office of Premarket Approval has available on request a document entitled Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations that address many of the important recycling issues and describes the current thinking on approaches to evaluating the capability of a recycling process to produce material suitable for food-contact applications.
3. Phrases in quotations are taken from section 409(b)(c) af the Act.
4. CAS Registry Numbers for new compounds and assistance with nomenclature can be obtained by writing CAS Client Services, Chemical Abstracts Service, Box 3343, 2540 Olentangy River Road, Columbus, Ohio 43210-0334, U.S.A.
5. Migration into food is dependent on the nature of the matrix in which the food additive is used, the chemical structure of the additive, the type of food in contact with the additive and the temperature and duration of food contact. It is important that specific use information be provided so that appropriate testing protocols can be devised (Section D).
6. The Recommendations of 1988 suggested 8% ethanol based on migration studies conducted by Arthur D. Little, Inc. (ADL), under contract to FDA (ADL Final Summary Report: A Study of Indirect Food Additive Migration, FDA Contract 223-77-2360, July 1983), and at FDA (Snyder, R.C. and Breder, C.V., 1985, J. Assoc. Off. Anal. Chem., 68 (4), 770-77).
7. Miglyol 812^TM, a product of Dynamit Nobel Chemicals, is available from HULS America, Inc., 80 Centennial Ave., P.O. Box 456, Piscataway, NJ 08855-0456.
8. HB307 is available from NATEC, Behringstrabe 154, Postfach 501568, 2000 Hamburg 50, Germany.
9. This change also serves to harmonize more closely FDA's migration protocols with those of other nations under GATT without compromising the safety of food-contact articles for the consumer.
10. The LOD is the lowest concentration of analyte that the analytical method can reliably detect. It is preferable that the LOD be determined from analyses of five blank samples. The blank signal (i.e., the analyte response for the blank sample or the width of the baseline close to the actual or expected analyte peak) is measured, and the average signal and standard deviations above the average blank signal. For cases in which it is note feasible to determine the LOD using blank samples, the LOD should be determined from the peak-to-peak noise measured on the baseline close to the actual or expected analyte signal. The region for quantitation of the analyte should clearly be above the LOD. The LOQ is located ten standard deviations above the blank signal. See Keith, L.H., et. Al. "Principles of Environmental Analysis," 1980, Anal. Chem., 55, 2210-18.
11. Federal Register, Vol. 60, No. 136, July 17, 1995, pp. 36582-36596. See also 21 CFR 170.3, 170.39, 171.8 and 174.6.

Return to Recommendations for Chemistry Data for Indirect Food Additive Petitions