GRAS

FEMA #

FEMA GRAS Database

IOFI Database

2976

CAS# 130-89-2-Quinine Hydrochloride-Quinine Chloride

Not Listed

2977

CAS# 6119-70-6-Quinine Sulphate

Cas# 130-95-06’-methyoxycinchonidineOnly approved for Mexico

The FEMA Expert Panel has not evaluated quinine free base (free amine quinine) so it itself is not considered GRAS.  FEXPAN evaluated the sulfate and chloride salts and since they do impart differing flavors, they were assigned two different FEMA numbers 2976 and 2977, respectively.  The quinine salts are part of GRAS 3 so they had been in common flavor use well before passage of the 1958 Food Additive Amendment.  Quinine free base is not readily soluble in aqueous systems and therefore represents a different specification profile than the sulfate or hydrogen chloride forms.  The attached report from the Merck Index as a reference regarding the solubility of quinine and its various salts.  From a chemical perspective one would have to titrate the free base down to a pH where the quinine would actually go into solution thus creating the salt.   

Quinine sulfate and quinine hydrochloride both have monographs prepared in the Food Chemicals Codex (FCC), which is recognized in the US Code of Federal Regulations .  No such monograph was prepared for quinine free base.  

In the United States, the first edition was given quasi-legal recognition in July 1966 by means of a letter of endorsement from FDA Commissioner James L. Goddard, which was reprinted in the book. The letter stated that “the FDA will regard the specifications in the Food Chemicals Codex as defining an ‘appropriate food grade’ within the meaning of Sec. 121.101(b)(3) and Sec. 121.1000(a)(2) of the food additive regulations, subject to the following qualification: this endorsement is not construed to exempt any food chemical appearing in the Food Chemicals Codex from compliance with requirements of Acts of Congress or with regulations and rulings issued by the Food and Drug Administration under authority of such Acts.”  

Subsequently, various additional specifications from previous FCC editions were also incorporated by reference, in the U.S. Code of Federal Regulations to define specific safe ingredients under Title 21, in various parts of Sections 172, 173, and 184. It is anticipated that FDA will from time to time continue to update its regulatory references to the FCC.  (FCC 7th ed., 2010)

Quinine chloride and quinine sulfate are part of the EU register.  They are included in the “Flavouring Substances Database” operated by the EU.  There is no entry for quinine free base.