[Federal Register Volume 61, Number 173 (Thursday, September 5, 1996)]
[Notices]
[Page 46814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95F-0255]


GE Silicones; Filing of Food Additive Petition; Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is amending the filing 
notice for a food additive petition filed by GE Silicones to indicate 
that the petitioner also proposed that the food additive regulations be 
amended to provide for the safe use of diallyl maleate as an optional 
polymerization inhibitor and dimethyl(methyl hydrogen) polysiloxane as 
a cross-linking agent for vinyl-containing siloxanes used in coatings 
on paper and paperboard that contact food. The agency is also 
clarifying that the petitioner proposed to expand the safe use of 
vinyl-containing siloxanes in coatings that contact additional food 
types and under additional conditions of use. The previous filing 
notice stated that the petition proposed that the food additive 
regulations be amended to list 1-ethynyl-1-cyclohexanol as an optional 
inhibitor for vinyl-containing siloxanes and to increase to 200 parts 
per million (ppm) the level of platinum used in the manufacture of the 
additive.

FOR FURTHER INFORMATION CONTACT: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of September 25, 1995 (60 FR 49414), FDA announced that a food 
additive petition (FAP 5B4475) had been filed by GE Silicones,
c/o 700 13th St. NW., Washington, DC 20005, proposing to amend the food 
additive regulations in Sec. 176.170 Components of paper and paperboard 
in contact with aqueous and fatty foods (21 CFR 176.170) to provide for 
the safe use of vinyl-containing siloxanes as a component of coatings 
for paper and paperboard in contact with food, to provide for the safe 
use of 1-ethynyl-1-cyclohexanol as an optional inhibitor (more 
accurately termed a polymerization inhibitor) for the additive, and to 
increase the level of platinum catalyst used in the manufacture of the 
additive to 200 ppm.
    Upon further review of the petition, the agency notes that the 
petitioner also requested the use of diallyl maleate as an optional 
polymerization inhibitor and dimethyl(methylhydrogen) polysiloxane as a 
cross-linking agent in the manufacture of vinyl-containing siloxanes. 
In addition, the agency would like to clarify that the petitioner 
proposed to expand the safe use of coatings with vinyl-containing 
siloxanes for contact with additional food types and under additional 
conditions of use. Therefore, FDA is amending the filing notice of 
September 25, 1995, to state that the petitioner requested that the 
food additive regulations be amended: (1) To provide for the safe use 
of diallyl maleate and 1-ethynyl-1-cyclohexanol as optional 
polymerization inhibitors and dimethyl(methyl hydrogen) polysiloxane as 
a cross-linking agent in the manufacture of vinyl-containing siloxanes 
that are used in coatings for paper and paperboard that contact food; 
(2) to increase the level of the platinum catalyst used in the 
manufacture of vinyl-containingsiloxanes to 200 ppm; and (3) to expand 
the safe use of coatings with vinyl-containing siloxanes for contact 
with additional food types and under additional conditions of use.

    Dated: August 5, 1996.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 96-22693 Filed 9-4-96; 8:45 am]
BILLING CODE 4160-01-F