[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR181.1]

[Page 461-462]
 
                        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.




                      Subpart A_General Provisions

Sec.
181.1 General.
181.5 Prior sanctions.

          Subpart B_Specific Prior-Sanctioned Food Ingredients

181.22 Certain substances employed in the manufacture of food-packaging 
          materials.
181.23 Antimycotics.
181.24 Antioxidants.
181.25 Driers.
181.26 Drying oils as components of finished resins.
181.27 Plasticizers.
181.28 Release agents.
181.29 Stabilizers.
181.30 Substances used in the manufacture of paper and paperboard 
          products used in food packaging.
181.32 Acrylonitrile copolymers and resins.
181.33 Sodium nitrate and potassium nitrate.
181.34 Sodium nitrite and potassium nitrite.

    Authority: 21 U.S.C. 321, 342, 348, 371.

    Source: 42 FR 14638, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 181 appear at 61 FR 
14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001.



    (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

[[Page 462]]

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]