[Federal Register Volume 60, Number 203 (Friday, October 20, 1995)]
[Rules and Regulations]
[Pages 54188-54190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25973]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 92F-0493]
Indirect Food Additives: Polymers
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 ethylene-maleic
anhydride copolymers containing no more than 2 percent by weight of
polymer units derived from maleic anhydride in contact with food at
temperatures not to exceed 49 deg.C (120 deg.F). This action is in
response to a petition filed by Showa Denko K. K.
DATES: Effective October 20, 1995; written objections and requests for
a hearing by November 20, 1995.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration,
[[Page 54189]]
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Edward J. Machuga, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3085.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of February 12, 1993 (58 FR 8290), FDA announced that a food
additive petition (FAP 3B4351) had been filed by Showa Denko K. K.,
Tokyo, Japan, c/o Center for Regulatory Services, 2347 Paddock Lane,
Reston, VA 22091. The petition proposed to amend the food additive
regulations in 21 CFR part 177 Indirect Food Additives: Polymers by
adding a new section to provide for the safe use of ethylene-maleic
anhydride copolymers containing no more than 2 percent by weight of
polymer units derived from maleic anhydride in contact with food at
temperatures not to exceed 49 deg.C (120 deg.F). However, subsequent
to the publication of the filing notice, the agency decided, with
concurrence of the petitioner, that the subject additive would be more
appropriately regulated in Sec. 177.1520 Olefin polymers (21 CFR
177.1520). Therefore, this final rule is amending Sec. 177.1520 to
provide for the safe use of ethylene-maleic anhydride copolymers
containing no more than 2 percent by weight of polymer units derived
from maleic anhydride in contact with food at temperatures not to
exceed 49 deg.C (120 deg.F).
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 the regulations in Sec. 177.1520 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 November 20, 1995 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 177
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 177 is amended as follows:
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
1. The authority citation for 21 CFR part 177 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 177.1520 is amended by adding a new paragraph (a)(6) and
in the table in paragraph (c) by adding a new item ``6'' to read as
follows:
Sec. 177.1520 Olefin polymers.
* * * * *
(a) * * *
(6) Ethylene-maleic anhydride copolymers (CAS Reg. No. 9006-26-2)
containing no more than 2 percent by weight of copolymer units derived
from maleic anhydride.
* * * * *
(c) * * *
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Maximum
extractable Maximum soluble
fraction fraction
Melting point (MP) (expressed as (expressed as
Olefin polymers Density or softening point percent by weight percent by weight
(SP) (Degrees of polymer) in N- of polymer) in
Centigrade) hexane at xylene at
specified specified
temperatures temperatures
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* * * * * *
*
6. Ethylene-maleic anhydride 0.92-0.94 .................. 1.36 pct at 50 2.28 pct at 25
copolymers described in .......... deg.C.. deg.C.
paragraph (a)(6) of this
section for use as the adhesive
component in multilaminate
structures, or as the sealant
layer in flexible packaging, in
contact with food at
temperatures not exceeding 49
deg.C (120 deg.F).
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[[Page 54190]]
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Dated: October 4, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-25973 Filed 10-19-95; 8:45 am]
BILLING CODE 4160-01-F
