FEDERAL REGISTER · PROPOSED RULESeptember 23, 2024PROPOSED — NOT IN FORCE

DSM Biomedical; Filing of Color Additive Petition

What this record is not

Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSPROPOSED — NOT IN FORCE

PROPOSED EFFECTIVE—

COMMENTS CLOSE—

APPLIES TO · SPEQ TAGNot tagged

Document type

Proposed Rule

Agency

Health and Human Services Department

Published

September 23, 2024

Document number

2024-21684

CFR references

21 CFR 74

Docket

FDA-2024-C-4339

ABSTRACT

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of phthalocyanine green to color surgical sutures made of ultra- high molecular weight polyethylene (UHMWPE) for use in general surgery, at a concentration of no more than 0.5 percent by weight of the suture.

Abstract as published in the Federal Register.

AMENDING THE SAME CFR PART · 21 CFR 74

2026-08-05Final ruleMicro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing
2026-07-23Final ruleRevocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
2026-07-23Proposed ruleProposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges
2025-09-17Proposed ruleProposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
2025-01-16Final ruleColor Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs

21 CFR 74 in the tracker's recent documents →

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