Prior sanctioned substances

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

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. 

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). 

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

Prior sanctioned substances (prior to 1958, issued by either the FDA or the USDA. 

Prior-Sanctioned Substances The prior-sanctioned substances exclusion is found directly in the FDCA. Prior to the passage of the Act in 1958 a number of approvals had been issued by FDA and USDA. These pre 1958 prior-sanctions are still valid. 

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. 

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. 

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... 

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."... 

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

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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