[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR181.1]
[Page 463]
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 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]
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