U.S. Food & Drug Administration
Center for
Food
Safety &
Applied
Nutrition
Office of Premarket Approval
June 1995
(Effective June 18, 2001, Office of Premarket Approval is now
Office of Food Additive Safety. See
updated contact information)
|
The latest version of
this guidance issued on April 10, 2002.
Below is an earlier version.
Footnotes
- 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)
- 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.
- Phrases in quotations are taken from section
409(b)(c) af the Act.
- 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.
- 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).
- 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).
- Miglyol 812TM, a product of Dynamit Nobel
Chemicals, is available from HULS America, Inc., 80
Centennial Ave., P.O. Box 456, Piscataway, NJ 08855-0456.
- HB307 is available from NATEC, Behringstrabe 154,
Postfach 501568, 2000 Hamburg 50, Germany.
- 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.
- 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.
- 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
This document was issued in June 1995.
For more recent information on Guidance and Reference Documents for
Petitions and Notifications
see
http://www.cfsan.fda.gov/~dms/opa-guid.html
The latest version of
this guidance issued on April 10, 2002.
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