[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
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
(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: