Colorcon, Inc.; Filing of Color Additive Petition

---
identifier: "/us/fr/2017-24421"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Colorcon, Inc.; Filing of Color Additive Petition"
title_number: 0
title_name: "Federal Register"
section_number: "2017-24421"
section_name: "Colorcon, Inc.; Filing of Color Additive Petition"
positive_law: false
currency: "2017-11-09"
last_updated: "2017-11-09"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2017-24421"
document_type: "proposed_rule"
publication_date: "2017-11-09"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 73"
fr_citation: "82 FR 52037"
fr_volume: 82
docket_ids:
  - "Docket No. FDA-2017-C-6238"
fr_action: "Notification of petition."
---


#  Colorcon, Inc.; Filing of Color Additive Petition

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notification of petition.

**SUMMARY:**

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules.

**DATES:**

The color additive petition was filed on October 3, 2017.

**ADDRESSES:**

For access to the docket to read background documents or comments received, go to *https://www.regulations.gov* and insert the docket number found in brackets in the heading of this document into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

**FOR FURTHER INFORMATION CONTACT:**

Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1075.

**SUPPLEMENTARY INFORMATION:**

Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 7C0308), submitted by Colorcon, Inc., 275 Ruth Rd., Harleysville, PA 19438. The petition proposes to amend the color additive regulations in § 73.200 (21 CFR 73.200) *Synthetic iron oxide* by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules with a proposed limit of 5 milligrams, calculated as elemental iron, per day for labeled dosages.

We have determined under 21 CFR 25.32(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Dated: November 6, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.