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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 22, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)
 
PART 170FOOD ADDITIVES
 

Subpart A - General Provisions
   § 170.3 - Definitions.
   § 170.6 - Opinion letters on food additive status.
   § 170.10 - Food additives in standardized foods.
   § 170.15 - Adoption of regulation on initiative of Commissioner.
   § 170.17 - Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.
   § 170.18 - Tolerances for related food additives.
   § 170.19 - Pesticide chemicals in processed foods.

Subpart B - Food Additive Safety
   § 170.20 - General principles for evaluating the safety of food additives.
   § 170.22 - Safety factors to be considered.
   § 170.30 - Eligibility for classification as generally recognized as safe (GRAS).
   § 170.35 - Affirmation of generally recognized as safe (GRAS) status.
   § 170.38 - Determination of food additive status.
   § 170.39 - Threshold of regulation for substances used in food-contact articles.

Subpart C - Specific Administrative Rulings and Decisions
   § 170.45 - Fluorine-containing compounds.
   § 170.50 - Glycine (aminoacetic acid) in food for human consumption.
   § 170.60 - Nitrites and/or nitrates in curing premixes.

Subpart D - Premarket Notifications
   § 170.100 - Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA).
   § 170.101 - Information in a premarket notification for a food contact substance (FCN).
   § 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).
   § 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).
   § 170.104 - Action on a premarket notification for a food contact substance (FCN).
   § 170.105 - The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective.
   § 170.106 - Notification for a food contact substance formulation (NFCSF).

Subpart E - Generally Recognized as Safe (GRAS) Notice
   § 170.203 - Definitions.
   § 170.205 - Opportunity to submit a GRAS notice.
   § 170.210 - How to send your GRAS notice to FDA.
   § 170.215 - Incorporation into a GRAS notice.
   § 170.220 - General requirements applicable to a GRAS notice.
   § 170.225 - Part 1 of a GRAS notice: Signed statements and certification.
   § 170.230 - Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect.
   § 170.235 - Part 3 of a GRAS notice: Dietary exposure.
   § 170.240 - Part 4 of a GRAS notice: Self-limiting levels of use.
   § 170.245 - Part 5 of a GRAS notice: Experience based on common use in food before 1958.
   § 170.250 - Part 6 of a GRAS notice: Narrative.
   § 170.255 - Part 7 of a GRAS notice: List of supporting data and information in your GRAS notice.
   § 170.260 - Steps you may take before FDA responds to your GRAS notice.
   § 170.265 - What FDA will do with a GRAS notice.
   § 170.270 - Procedures that apply when the intended conditions of use of a notified substance include use in a product or products subject to regulation by the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture.
   § 170.275 - Public disclosure of a GRAS notice.
   § 170.280 - Submission of a supplement.
   § 170.285 - Disposition of pending GRAS affirmation petitions.

Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.
Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.

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