[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR571.100]

[Page 488]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 571--FOOD ADDITIVE PETITIONS--Table of Contents
 
            Subpart B--Administrative Actions on Applications
 
Sec. 571.100  Regulation based on petition.


    (a) The Commissioner will forward for publication in the Federal 
Register, within 90 days after filing of the petition (or within 180 
days if the time is extended as provided for in section 409(c)(2) of the 
act), a regulation prescribing the conditions under which the food 
additive may be safely used (including, but not limited to, 
specifications as to the particular food or classes of food in or on 
which such additive may be used, the maximum quantity that may be used 
or permitted to remain in or on such food, the manner in which such 
additive may be added to or used in or on such food, and any directions 
or other labeling or packaging requirements for such additive deemed 
necessary by him to assure the safety of such use), and prior to the 
forwarding of the order to the Federal Register for publication shall 
notify the petitioner of such order and the reasons for such action; or 
by order deny the petition, and shall notify the petitioner of such 
order and of the reasons for such action.
    (b) If the Commissioner determines that additional time is needed to 
study and investigate the petition, he shall by written notice to the 
petitioner extend the 90-day period for not more than 180 days after the 
filing of the petition.