Standard: HHS - 21 CFR PART 189


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General Provisions

Substances prohibited from use in human food.

(a) The food ingredients listed in this section have been prohibited from use in human food by the Food and Drug Administration because of a determination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in human food. Use of any of these substances in violation of this section causes the food involved to be adulterated in violation of the act.

(b) This section includes only a partial list of substances prohibited from use in human food, for easy reference purposes, and is not a complete list of substances that may not lawfully be used in human food. No substance may be used in human food unless it meets all applicable requirements of the act.

(c) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to establish, amend, or repeal a regulation under this section on the basis of new scientific evaluation or information. Any such petition shall include an adequate scientific basis to support the petition, pursuant to part 10 of this chapter, and will be published for comment if it contains reasonable grounds.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 189
Publish Date: 2015-04-01
Page Count: 8
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 189 Change Type: COMPLETE REVISION Update Date: 2017-04-01 Status: ACTV
21 CFR PART 189 Change Type: COMPLETE REVISION Update Date: 2014-04-01 Status: ACTV
21 CFR PART 189 Change Type: COMPLETE REVISION Update Date: 2016-04-01 Status: ACTV

Standards That Reference This Standard

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