[Federal Register Volume 59, Number 177 (Wednesday, September 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22648]
[[Page Unknown]]
[Federal Register: September 14, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 175
[Docket No. 91F-0359]
Indirect Food Additives: Adhesives and Components of Coatings
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of (5-
cyclopentadienyl)(6-isopropylbenzene)iron(II)
hexafluorophosphate as a photoinitiator in adhesives for use in food-
contact articles. This action is in response to a petition filed by
Ciba-Geigy Corp.
DATES: Effective September 14, 1994; written objections and requests
for a hearing by October 14, 1994.
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: Daniel N. Harrison, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-254-9500.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of October 8, 1991 (56 FR 50726), FDA announced that a food
additive petition (FAP 1B4285) had been filed by Ciba-Geigy Corp.,
Seven Skyline Dr., Hawthorne, NY 10532-2188. The petition proposed that
the food additive regulations in Sec. 175.105 Adhesives (21 CFR
175.105) be amended to provide for the safe use of iron(+),
(5-2,4-cyclopentadien-1-yl)[(1,2,3,4,5,6,-)-
(1-methylethyl) benzene]-, hexafluorophosphate(1-) as a photoinitiator
in adhesives for use in food-contact articles.
In the filing notice, FDA utilized the Chemical Abstract Service
nomenclature to identify the additive. However, in the final rule, the
common name (5-cyclopentadienyl) (6-
isopropylbenzene)iron(II) hexafluorophosphate, is used because the
structure of the food additive is more readily comprehended from this
name.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed use of the food additive is
safe, and that Sec. 175.105 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 October 14, 1994, file with the Dockets
Management Branch (address above) written objections 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 175
Adhesives, 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 175 is amended as follows:
PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF
COATINGS
1. The authority citation for 21 CFR part 175 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 175.105 is amended in the table in paragraph (c)(5) by
alphabetically adding a new entry to the table to read as follows:
Sec. 175.105 Adhesives.
* * * * *
(c) * * *
(5) * * *
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
*******
(5-Cyclopentadienyl)- For use only as a photoinitiator.
(6-
isopropylbenzene)iron(II)
hexafluorophosphate (CAS Reg.
No. 32760-80-8).
*******
------------------------------------------------------------------------
Dated: August 31, 1994.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and
Applied Nutrition.
[FR Doc. 94-22648 Filed 9-13-94; 8:45 am]
BILLING CODE 4160-01-F
