Prior-sanctioned

Any substance that is not GRAS or sanctioned by use prior to 1958 (prior sanctioned) is considered a food additive. The Act prohibits the marketing of a food additive unless PDA has pubHshed a regulation that approves the intended use of the substance (22). A food additive is deemed unsafe if it is used without an approving regulation a food is deemed adulterated if it is, bears, or contains an unapproved food additive. 

Priority-based Assessment of Food Additives (PAFA) program, 23 667 Priority pollutants, 9 443 Prior sanctioned substances, 12 34 Pristane, 18 592... 

This document deals only with estimating exposure to direct additives and chemical contaminants. The procedures used to estimate exposure to chemical contaminants in food (including naturally occurring toxicants, such as mycotoxins) are essentially the same as those used for direct additives. Thus, contaminants will be considered in the discussion of direct additive exposure estimation. The procedures discussed herein are equally applicable to color additives, GRAS substances, prior-sanctioned ingredients, and pesticide residues. 

Priority-based Assessment of Food Additives (PAFA). It contains administrative, chemical, and toxicological information for over 2000 substances regulated by the FDA as direct, secondary direct, color additives, GRAS substances, and prior-sanctioned substances. In addition, the database contains only administrative and chemical information for less than 1000 such substances. 

FDA 2001 g. Prior-sanctioned food ingredients. Plasticizers. U.S. Food and Drug Administration. Code of Federal Regulations. 21 CFR 181.27. http //ffwebgate.access.gpo.gpv/cgi-bin/. December 10, 2001. 

If a candidate substance is to be used directly in/on food, and is not already covered under prior sanction or GRAS categorization, and is not bioengineered nor a dietary supplement, then it is most likely a bona fide food additive/ingredient and stringent premarket (i.e., FDA approval before marketing) approval is mandated by a petition process. If... 

The FDA has indicated that processed flavors were not recognized prior to September 6, 1958 and therefore are not prior-sanctioned GRAS materials. The statute authorizes die scientific community, and not the FDA, to make judgments of GRAS. Therefore, the FDA assumes diat the manufacturer has scientific evidence of the safety of process flavors. 

We begin with a glossary of the terms by which the regulatory status of food ingredients is defined. To be used in food, a chemical substance must be either a "food additive" or "Generally Recognized As Safe (GRAS)" or "prior sanctioned."... 

A" prior sanctioned" substance is one which is used in accordance with a sanction or approval granted prior to enactment of the 1958 Food Additive Amendments to the Federal Food, Drug and Cosmetic Act (11). 

Sodium metasilicate has food additive regulation status as boiler water additive in the preparation of steam that will contact food (23). In addition it is believed to be "prior sanctioned" under the Meat Inspection Act for hog scalding and tripe denuding. 

Paragraph (c) lists the substances that can be included in adhesives, including GRAS substances, prior-sanctioned substances, flavoring and color permitted for... 

Substances used in the manufacture of paper and paperboard products used in food paclaging (prior sanctioned food ingredients). ... 

Uses Dispersant leveling agent antistat in cosmetics food additive bakery prods. prod, of ice cream in adhesives for beer bottle labeling, foil-paper lamination, wood door adhesives binder in paper coatings protective colloid in emulsion polymerization Regulatory FDA 21 CFR 135.110, 135.140 granted prior sanction via clearance for optional use in food standards for frozen desserts Trade Name Synonyms Atrasein 115 t[Atramax ]... 

Hexane has been used since the 1940 s as an oilseed-extraction solvent on the determination that it is GRAS and it may also be subject to a prior sanction. However, like many other food-processing substances, there is no U.S. FDA regulation specifically listing hexane as GRAS or prior sanctioned. 

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