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184.1065 Linoleic acid.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1065 Linoleic acid.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1065]

[Page 489]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  184.1065  Linoleic acid.

    (a) Linoleic acid ((Z, Z)-9, 12-octadecadienoic acid 
(C17H31COOH) (CAS Reg. No. 60-33-3)), a straight 
chain unsaturated fatty acid with a molecular weight of 280.5, is a 
colorless oil at room temperature. Linoleic acid may be prepared from 
edible fats and oils by various methods including hydrolysis and 
saponification, the Twitchell method, low pressure splitting with 
catalyst, continuous high pressure counter current splitting, and medium 
pressure autoclave splitting with catalyst.
    (b) FDA is developing food-grade specifications for linoleic acid in 
cooperation with the National Academy of Sciences. In the interim, this 
ingredient must be of a purity suitable for its intended use. The 
ingredient must also meet the specifications in Sec.  172.860(b) of this 
chapter.
    (c) In accordance with Sec.  184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec.  170.3(o)(12) of this chapter and as a nutrient 
supplement as defined in Sec.  170.3(o)(20) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. The ingredient may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 48534, Dec. 13, 1984]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1065


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