[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR181.1]

[Page 445-446]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 181--PRIOR-SANCTIONED FOOD INGREDIENTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 181.1  General.


    (a) An ingredient whose use in food or food packaging is subject to 
a prior sanction or approval within the meaning of section 201(s)(4) of 
the Act is exempt from classification as a food additive. The 
Commissioner will publish in this part all known prior sanctions. Any 
interested person may submit to the Commissioner a request for 
publication of a prior sanction, supported by evidence to show that it 
falls within section 201(s)(4) of the Act.
    (b) Based upon scientific data or information that shows that use of 
a prior-sanctioned food ingredient may be injurious to health, and thus 
in violation of section 402 of the Act, the Commissioner will establish 
or amend an applicable prior sanction regulation to impose whatever 
limitations or conditions are necessary for the safe use of the 
ingredient, or to prohibit use of the ingredient.
    (c) Where appropriate, an emergency action level may be issued for a 
prior-sanctioned substance, pending the issuance of a final regulation 
in accordance with paragraph (b) of this section. Such an action level 
shall be issued pursuant to section 402(a) of the Act to identify, based 
upon available data, conditions of use of the substance that may be 
injurious to health. Such an action level shall be issued in a notice 
published in the Federal Register and shall be followed as soon as 
practicable by a proposed regulation in accordance with paragraph (b) of 
this

[[Page 446]]

section. Where the available data demonstrate that the substance may be 
injurious at any level, use of the substance may be prohibited. The 
identification of a prohibited substance may be made in part 189 of this 
chapter when appropriate.

[42 FR 14638, Mar. 15, 1977, as amended at 42 FR 52821, Sept. 30, 1977; 
54 FR 39635, Sept. 27, 1989]