Importation of gelatin derived from bovines.

CFR · 2024-01-01 · US · Title 9

(a) The importation of gelatin derived from bovines is prohibited because of BSE, unless: (1) The gelatin meets the requirements of either paragraph (b), (c), or (d), as well as the requirements of paragraph (e) of this section and all other applicable requirements of this part; or (2) The gelatin is authorized importation under paragraph (f) of this section and meets all other applicable requirements of this part. (b) The gelatin is derived from hides and skins, provided the gelatin has not been commingled with materials ineligible for entry into the United States. (c) The gelatin is derived from the bones of bovines and originates in a region of negligible risk for BSE. (d) The gelatin is derived from the bones of bovines, originates in a region of controlled risk or undetermined risk for BSE, and meets the requirements of paragraphs (d)(1) through (d)(4) of this section: (1) The bones from which the gelatin was derived were derived from bovines that passed ante-mortem and post-mortem inspection. (2) The bones from which the gelatin was derived did not include the skulls of bovines or the vertebral column of bovines 30 months of age or older. (3) The bones were subjected to a process that includes all of the following steps, or to a process at least as effective in reducing BSE infectivity: (i) Degreasing; (ii) Acid demineralization; (iii) Acid or alkaline treatment; (iv) Filtration; and (v) Sterilization at 138 °C (280.4 °F) or greater for a minimum of 4 seconds; and (4) T

official document · source cfr-2024 · id 9:§ 94.23