[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: 21CFR178.3480]
[Page 411]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS--Table of Contents
Subpart D_Certain Adjuvants and Production Aids
Sec. 178.3480 Fatty alcohols, synthetic.
Synthetic fatty alcohols may be safely used as components of
articles intended for use in contact with food, and in synthesizing food
additives and other substances permitted for use as components of
articles intended for use in contact with food in accordance with the
following prescribed conditions:
(a) The food additive consists of fatty alcohols meeting the
specifications and definition prescribed in Sec. 172.864 of this
chapter, except as provided in paragraph (c) of this section.
(b) It is used or intended for use as follows:
(1) As substitutes for the corresponding naturally derived fatty
alcohols permitted for use as components of articles intended for use in
contact with food by existing regulations in parts 174, 175, 176, 177,
178 and Sec. 179.45 of this chapter: Provided, That the use is in
compliance with any prescribed limitations.
(2) As substitutes for the corresponding naturally derived fatty
alcohols used as intermediates in the synthesis of food additives and
other substances permitted for use as components of food-contact
articles.
(c) Synthetic fatty alcohols identified in paragraph (c)(1) of this
section may contain not more than 0.8 weight percent of total diols as
determined by a method titled ``Diols in Monohydroxy Alcohol by
Miniature Thin Layer Chromatography (MTLC),'' which is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
(1) Synthetic fatty alcohols. (i) Hexyl, octyl, decyl, lauryl,
myristyl, cetyl, and stearyl alcohols meeting the specifications and
definition prescribed in Sec. 172.864 of this chapter, except that they
may contain not more than 0.8 weight percent total diols.
(ii) Lauryl, myristyl, cetyl, and stearyl alcohols manufactured by
the process described in Sec. 172.864(a)(2) of this chapter such that
lauryl and myristyl alcohols meet the specifications in Sec.
172.864(a)(1)(i) of this chapter, and cetyl and stearyl alcohols meet
the specifications in Sec. 172.864(a)(1)(ii) of this chapter.
(2) Conditions of use. (i) Synthetic fatty alcohols as substitutes
for the corresponding naturally derived fatty alcohols permitted for use
in compliance with Sec. 178.3910.
(ii) Synthetic lauryl alcohol as a substitute for the naturally
derived lauryl alcohol permitted as an intermediate in the synthesis of
sodium lauryl sulfate used in compliance with Sec. 178.3400.
[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982;
54 FR 24898, June 12, 1989]
Additives that reference this regulation: |
