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Electronic Code of Federal Regulations

e-CFR data is current as of February 19, 2020

Title 21Chapter ISubchapter BPart 170


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 170—FOOD ADDITIVES

rule

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.
rule

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.
rule

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.
rule

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).
rule

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.

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