Listing of Color Additives Subject to Certification; D&C Black No. 4
fda-food · Food and Drug Administration · Rule · Published 2018-06-07 · Effective 2018-07-10 · 83 FR 26356
Document
Document number
2018-12218
Federal Register citation
83 FR 26356
CFR reference
21 CFR 74
Type
Rule
Action
Final rule.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
2018-06-07
Effective date
2018-07-10
HHS docket
Docket No. FDA-2017-C-0935
Abstract
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non- absorbable sutures for use in general surgery. This action is in response to a color additive petition (CAP) submitted by DSM Biomedical.