[Federal Register Volume 60, Number 114 (Wednesday, June 14, 1995)]
[Rules and Regulations]
[Pages 31243-31244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14464]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 94F-0451]
Indirect Food Additives: Adjuvants, Production Aids, and
Sanitizers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of copper chromite
black spinel as a colorant for all polymers intended to contact food.
This action is in response to a petition filed by The Shepherd Color
Co.
DATES: Effective June 14, 1995; written objections and request for a
hearing by July 14, 1995.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3081.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of January 12, 1995 (60 FR 2976), FDA announced that a food
additive petition (FAP 5B4446) had been filed by The Shepherd Color
Co., 4539 Dues Dr., Cincinnati, OH 45246. The petition proposed to
amend the food additive regulations in Sec. 178.3297 Colorants for
polymers (21 CFR 178.3297) to provide for the safe use of copper
chromite black spinel (C.I. Pigment Black 28) as a colorant in all
polymers intended to contact food.
FDA has evaluated the data in the petition and other relevant
material. The agency concludes that the proposed use of the additive is
safe and that the regulations in Sec. 178.3297 should be amended as set
forth below.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person listed above. As provided in 21 CFR
171.1(h), the agency will delete from the documents any materials that
are not available for public disclosure before making the documents
available for inspection.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Any person who will be adversely affected by this regulation may at
any time on or before July 14, 1995, file with the Dockets Management
Branch (address above) written objections
[[Page 31244]]
thereto. Each objection shall be separately numbered, and each numbered
objection shall specify with particularity the provisions of the
regulation to which objection is made and the grounds for the
objection. Each numbered objection on which a hearing is requested
shall specifically so state. Failure to request a hearing for any
particular objection shall constitute a waiver of the right to a
hearing on that objection. Each numbered objection for which a hearing
is requested shall include a detailed description and analysis of the
specific factual information intended to be presented in support of the
objection in the event that a hearing is held. Failure to include such
a description and analysis for any particular objection shall
constitute a waiver of the right to a hearing on the objection. Three
copies of all documents shall be submitted and shall be identified with
the docket number found in brackets in the heading of this document.
Any objections received in response to the regulation may be seen in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
List of Subjects in 21 CFR Part 178
Food additives, Food packaging.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 178 is amended as follows:
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
1. The authority citation for 21 CFR part 178 continues to read as
follows:
Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).
2. Section 178.3297 is amended in the table in paragraph (e) by
alphabetically adding a new entry under the headings ``Substances'' and
``Limitations'' to read as follows:
Sec. 178.3297 Colorants for polymers.
* * * * *
(e) * * *
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Substances Limitations
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Copper chromite black spinel (C.I. For use at levels not to exceed 5
Pigment Black 28, CAS Reg. No. percent by weight of polymers. The
68186-91-4). finished articles are to contact
food only under conditions of use
A through H as described in Table
2 of Sec. 176.170(c) of this
chapter.
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Dated: May 26, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-14464 Filed 6-13-95; 8:45 am]
BILLING CODE 4160-01-F