The Regulatory Wrinkle

January 1, 2002 - 2 minutes read

All substances affirmed as GRAS by FDA in 21 CFR §184 are not equal. FDA lists substances which it has reviewed and affirmed as GRAS in this section along with the use conditions for each substance. Many substances can be used in food in accordance with §184.1(b)(1), i.e. no limitations other than current good manufacturing practice (cGMP). In some cases, the Agency has affirmed GRAS status for substances with limited conditions of use considered to be consistent with cGMP including use only in certain food categories, specified technical effects, and levels of addition or functionality. In the separate listings for these GRAS affirmed substances, the ingredient is cited for use in food not too exceed cGMP in accordance with §184.1(b)(1) along with the limitations on use.

 

Substances in this category can be extended for different use the intended use is GRAS. For some substances, the FDA has established specific limitations of use for the food categories, functional use and level of addition. In the individual listings, the FDA regulation cites that the ingredient can be used in accordance with §184.1(b)(2) and gives the limitations of use. These ingredients may not be used for other intended uses without a food additive petition. The restrictions posed by §184.1(b)(2) do not allow these ingredients to be approved by the independent expert panel GRAS process for uses other than those listed by the regulations in §184 Subpart B. So, if you want to use a GRAS affirmed substance for a new use through an independent GRAS review, make sure it is classified as an §184.1(b)(1) ingredient.