(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.50 FR 8999, Mar. 6, 1985, as amended at 73 FR 8608 , Feb. 14, 2008