subchapter_subject: "FOOD FOR HUMAN CONSUMPTION (CONTINUED)"
part_code: "184"
part_subject: "DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE"
subpart_code: "B"
subpart_subject: "Listing of Specific Substances Affirmed as GRAS"
section_number: "184.1984"
section_subject: "Zein."
cfr_reference: "21 CFR 184.1984"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 170 to 199"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Zein (CAS Reg. No. 9010-66-6) is one of the components of corn gluten. It is produced commercially by extraction from corn gluten with alkaline aqueous isopropyl alcohol containing sodium hydroxide. The extract is then cooled, which causes the zein to precipitate.
(b)The ingredient must be of a purity suitable for its intended use.
(c)In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1)The ingredient is used as a surface-finishing agent as defined in § 170.3(o)(30) of this chapter.
(2)The ingredient is used in food at levels not to exceed current good manufacturing practice.
(d)Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.