[Federal Register Volume 59, Number 92 (Friday, May 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11745]


[[Page Unknown]]

[Federal Register: May 13, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 172

 [Docket No. 93F-0404]

 

Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Glyceryl Tristearate

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 broaden certain specifications for the safe use 
of glyceryl tristearate. This action is in response to a petition filed 
by Huls America, Inc.

DATES: Effective May 13, 1994.; written objections and requests for a 
hearing by June 13, 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:  Martha D. Peiperl, Center for Food 
Safety and Applied Nutrition (HFS-217), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-254-9515.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of December 3, 1993 (58 FR 63995), FDA announced that a food 
additive petition (FAP 3A4403) had been filed by Huls America, Inc., 
Turner Pl., P.O. Box 365, Piscataway, NJ 08855-0365. The petition 
proposed that the food additive regulations in Sec. 172.811 Glyceryl 
tristearate (21 CFR 172.811) be amended to broaden the specifications 
for the acid number, saponification number, and melting point for 
glyceryl tristearate.
     FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that glyceryl tristearate conforming to 
the specifications requested by the petitioner is safe, and that the 
food additive regulations 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 Sec. 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 determined under 21 CFR 25.24(a)(9) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
     Any person who will be adversely affected by this regulation may 
at any time on or before June 13, 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 172

     Food additives, Reporting and recordkeeping requirements.
     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 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

     1. The authority citation for 21 CFR part 172 continues to read as 
follows:

     Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 
379e).

     2. Section 172.811 is amended by revising paragraph (b) to read as 
follows:


Sec. 172.811  Glyceryl tristearate

 * * * * *
     (b) The food additive meets the following specifications:

                                                                        
                                                                        
                                                                        
 Acid number.......................   Not to exceed 1.0.                
 Iodine number.....................   Not to exceed 1.0.                
 Saponification number.............   186-192.                          
 Hydroxyl number...................   Not to exceed 5.0.                
 Free glycerol content.............   Not to exceed 0.5 percent.        
 Unsaponifiable matter.............   Not to exceed 0.5 percent.        
 Melting point (Class II)..........  69  deg.C-73  deg.C.               
                                                                        

 * * * * *

    Dated: May 6, 1994.
L. Robert Lake,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-11745 Filed 5-12-94; 8:45 am]
BILLING CODE 4160-01-F