[Federal Register Volume 59, Number 123 (Tuesday, June 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15667]
[Federal Register: June 28, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 176
[Docket No. 90F-0202]
Indirect Food Additives: Paper and Paperboard Components
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 siloxanes
(silicones), dimethyl, isopropyl methyl, methyl 1-methyl-C9-
49-alkyl, as a modifier for polyolefin resins to be used as
coatings for paper and paperboard. This action responds to a food
additive petition filed by Chugai Boyeki (America) Corp.
DATES: Effective June 28, 1994; written objections and requests for a
hearing by July 28, 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: Julius Smith, 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 July 17, 1990 (55 FR 29105), FDA announced that a petition
(FAP 9B4171) had been filed by Chugai Boyeki (America) Corp.
(``Chugai'' was inadvertently misspelled in the filing notice as
``Chaugai''), 500 Fifth Ave., suite 1730, New York, NY 10110. The
petition proposed to amend the food additive regulations to provide for
the safe use of the addition product of (C10-C50) alkene and
propylene to polymethyl hydrogensiloxane for use as a modifier and as
an antifoaming agent for polyolefin resin coatings for paper and
paperboard.
FDA has evaluated the data in the petition and other relevant
material and concluded that the proposed use for the additive in paper
and paperboard coatings is safe. However, based upon a complete review
of the petition, the agency has determined that the appropriate
technical effect of the additive is primarily as a polymer modifier,
that effect is reflected in the listing regulation. The agency has
further determined that the Chemical Abstracts Service nomenclature and
registry number more accurately describe the additive than the
description in the notice of filing, and therefore, the agency has used
them in this rule. Under this nomenclature, the additive is denominated
``Siloxanes (silicones), dimethyl, isopropyl methyl, methyl 1-methyl-
C9-49-alkyl.'' Accordingly, FDA concludes that the food
additive regulations should be amended in Sec. 176.170 Components of
paper and paperboard in contact with aqueous and fatty foods (21 CFR
176.170) 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 28, 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 176
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 176 is amended as follows:
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
1. The authority citation for 21 CFR part 176 continues to read as
follows:
Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
2. Section 176.170 is amended in the table in paragraph (a)(5) by
alphabetically adding a new entry under the headings ``List of
Substances'' and ``Limitations'' to read as follows:
Sec. 176.170 Components of paper and paperboard in contact with
aqueous and fatty foods.
* * * * *
(a) * * *
(5) * * *
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List of Substances Limitations
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Siloxanes (silicones), dimethyl, For use only as a component of
isopropyl methyl, methyl 1-methyl- polyolefin coatings with Sec.
C9-49-alkyl (CAS Reg. No. 144635- 177.1520 of this chapter at a
08-5). level not to exceed 3 percent by
weight. The finished coating will
be used only for paper and
paperboard that contact food of
types VI-A and VI-B of Table 1 in
paragraph (c) of this section, and
under conditions of use C, D, and
E, as described in Table 2 in
paragraph (c) of this section,
with a maximum hot fill
temperature of 200 deg.F (94
deg.C).
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Dated: June 21, 1994.
L. Robert Lake,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-15667 Filed 6-27-94; 8:45 am]
BILLING CODE 4160-01-F
