Inventory of Effective Premarket Notifications for Food Contact Substances

FDA - US Food and Drug Administration
Center for Food Safety and Applied Nutrition
Department of Health and Human Services
15feb2005

[All links are to the FDA website]

The following is an inventory of effective notifications for food contact substances. Under section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 348 (h)(2)(C)) a notification is only effective for the manufacturer or supplier identified in the notification. Persons who market a food contact substance based on an effective notification must be able to demonstrate that the notification is effective for their food contact substance. All persons who purchase a food contact substance manufactured or supplied by a manufacturer or supplier identified in an effective notification may rely on that notification to legally market or use the food contact substance for the use that is the subject of the notification, consistent with any limitations in that notification.

Section 409(h)(6) of the FFDCA (21 U.S.C. 348(h)(6)) defines a food contact substance as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food." The premarket notification process for food contact substances in section 409(h) of the FFDCA is the primary method by which the Food and Drug Administration (FDA) authorizes the use of food additives that are food contact substances.

A notification for a food contact substance must contain sufficient information to demonstrate that the substance is safe for the intended use that is the subject of the notification (21 U.S.C. 348(h)(1)). To meet FDA's environmental requirements under the National Environmental Policy Act (NEPA), a notification must also contain either an environmental assessment (EA) under 21 CFR 25.20(i) or a claim of categorical exclusion (CAT. EXCL.) under 21 CFR 25.15 for actions specified in 21 CFR 25.32 (i), (j), (k), (q), or (r). For more specific guidance on the data and information recommended for inclusion in a food contact substance notification, potential notifiers should consult FDA's draft guidance on chemistry and toxicology information recommended in notifications and FDA's draft administrative guidance concerning formatting of such information. FDA is developing an environmental guidance document that will be made available through a notice published in the Federal Register. In the meantime, for information on preparing an EA or claim of categorical exclusion for a notification, please contact the Office of Food Additive Safety at the address below. Please note that on May 11, 2000, FDA published a direct final rule that would amend 21 CFR 25 by 1) expanding the existing categorical exclusions in 21 CFR 25.32 to include actions to allow a notification to become effective and 2) amending the list of those actions in 21 CFR 25.20 that require an EA to add actions allowing a notification to become effective in cases where a categorical exclusion doesn't apply. The direct final rule became effective on August 24, 2000. Consequently, the interim environmental guidance, that was included as attachment 3 of the recently issued premarket notification administrative guidance document (citation) is no longer in effect.

The inventory includes the Agency's environmental decision under NEPA. These decisions are coded as either an environmental assessment and finding of no significant impact (EA/ FONSI), a categorical exclusion (regulation cited), or an environmental impact statement (EIS). The agency's finding of no significant impact and the evidence supporting the finding, contained in an environmental assessment, are available from the Office of Food Additive Safety at the address below.

This table will be updated approximately monthly. We recommend for those who will be visiting this page frequently to clear your browser cache. Directions for clearing a browser cache can be found at CFSAN's Web Site Help page.

To access the specific regulations listed below, type in the title number, 21, and then the section and part numbers, e.g. 177 and 1220 at the Government Printing Office web site.

To search this list, use your browser's "find" feature. In most web browsers look under the Edit menu at the top of your browser window and click on Find (or use CTRL-F) to bring up the browser's "find" window. Type in the phrase you wish to search on, and your browser window should move to the next occurrence of that phrase on this web page.

For further information about the premarket notification program for food contact substances, contact:

The Office of Food Additive Safety (HFS-200)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835
(301) 436-1196
(301) 436-1175
or by electronic mail at mailto:OPAPMN@cfsan.fda.gov

Food Contact Substance (FCS)

Notifier

Intended Use

Limitations/ Specifi-
cations

Effective Date

Environ-
mental Review

Manufacturer
of the FCS

Silver sodium hydrogen zirconium phosphate, rhombohedral framework structure, of the general formula Ag_xNa_yH_zZr₂(PO₄)₃
_{x=(0.1-0.5);

y=(0.1-0.8);

z=(0.1-0.8)}

Milliken & Company

Antimicrobial additive for polymeric food-contact materials

Inventory of Effective Premarket Notifications for Food Contact Substances

FDA - US Food and Drug Administration Center for Food Safety and Applied Nutrition Department of Health and Human Services 15feb2005

FDA - US Food and Drug Administration
Center for Food Safety and Applied Nutrition
Department of Health and Human Services
15feb2005