[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR82.2051]
[Page 445]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 82 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS--
Subpart D Externally Applied Drugs and Cosmetics
Sec. 82.2051 Lakes (Ext. D&C).
(a)(1) General. Any lake made by extending on a substratum of
alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide,
talc, rosin, aluminum benzoate, calcium carbonate, or on any combination
of two or more of these (i) one of the straight colors hereinbefore
listed in this subpart, which color is a salt in which is combined the
basic radical sodium, potassium, barium, or calcium; or (ii) a salt
prepared from one of the straight colors hereinbefore listed in this
subpart by combining such color with the basic radical sodium,
potassium, aluminum, barium, calcium, strontium, or zirconium.
(2) Specifications.
Ether extracts, not more than 0.5 percent.
Soluble chlorides and sulfates (as sodium salts), not more than 3.0
percent.
Intermediates, not more than 0.2 percent.
(b) Each lake made as prescribed in paragraph (a) of this section
shall be considered to be a straight color and to be listed therein
under the name which is formed as follows:
(1) The listed name of the color from which the lake is prepared;
(2) The name of the basic radical combined in such color; and
(3) The word ``Lake.'' (For example, the name of a lake prepared by
extending the color Ext. D&C Yellow No. 2 upon a substratum is ``Ext.
D&C Yellow No. 2--Calcium Lake,'' and a lake prepared by extending the
barium salt prepared from Ext. D&C Red No. 2 upon the substratum is
``Ext. D&C Red No. 2--Barium Lake.'')
Back to Top
© 2007 Betterchem Corp.
|
