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178.3480 Fatty alcohols, synthetic.

Home > Regulations > Indirect food additives: Adjuvants, production aids, and sanitizers > 178.3480 Fatty alcohols, synthetic.



[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3480


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