Collagen derived from bovines.

CFR · 2024-01-01 · US · Title 9

(a) The importation of collagen derived from bovines is prohibited because of BSE unless: (1) The collagen 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 collagen is authorized importation under paragraph (f) of this section and meets all other applicable requirements of this part: (b) The collagen is derived from hides and skins, provided the collagen has not been commingled with materials ineligible for entry into the United States. (c) The collagen is derived from the bones of bovines that originated from a region of negligible risk for BSE. (d) The collagen is derived from the bones of bovines that originated from a region of controlled 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 collagen was derived were derived from bovines that passed ante-mortem and post-mortem inspection; (2) The bones from which the collagen was derived did not include the (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) The collagen has not been commingled with materials ineligible for ent

official document · source cfr-2024 · id 9:§ 95.7