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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications
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Petition(s): CAP 7C0310

Listing of Color Additives Subject to Certification; D&C Black No. 4

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Petitioner: DSM Biomedical
Docket number (legacy and/or former docket number(s)): FDA-2017-C-0935
Subject additive and intended use: 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.
21 CFR* affected: 74.3054D&C Black No. 4.
Substance(s)*, (CAS Registry® No.): D&C Black No. 4
Federal Register publication history: Mar 6, 201782 FR 12531Notice of petition
Jun 7, 201883 FR 26356Final RuleJul 10, 2018
Sep 18, 201883 FR 47069Final Rule; Confirmation of Effective DateJul 10, 2018


*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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