Title 21, Part 170 — Food Additives

Definitions.

Opinion letters on food additive status.

Food additives in standardized foods.

Adoption of regulation on initiative of Commissioner.

Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.

Tolerances for related food additives.

Pesticide chemicals in processed foods.

General principles for evaluating the safety of food additives.

Safety factors to be considered.

Eligibility for classification as generally recognized as safe (GRAS).

Affirmation of generally recognized as safe (GRAS) status.

Determination of food additive status.

Threshold of regulation for substances used in food-contact articles.

Fluorine-containing compounds.

Glycine (aminoacetic acid) in food for human consumption.

Nitrites and/or nitrates in curing premixes.

Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA).

Information in a premarket notification for a food contact substance (FCN).

Confidentiality of information related to premarket notification for a food contact substance (FCN).

Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

Action on a premarket notification for a food contact substance (FCN).

The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective.

Notification for a food contact substance formulation (NFCSF).

Definitions.

Opportunity to submit a GRAS notice.

How to send your GRAS notice to FDA.

Incorporation into a GRAS notice.

General requirements applicable to a GRAS notice.

Part 1 of a GRAS notice: Signed statements and certification.

Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect.

Part 3 of a GRAS notice: Dietary exposure.

Part 4 of a GRAS notice: Self-limiting levels of use.

Part 5 of a GRAS notice: Experience based on common use in food before 1958.

Part 6 of a GRAS notice: Narrative.

Part 7 of a GRAS notice: List of supporting data and information in your GRAS notice.

Steps you may take before FDA responds to your GRAS notice.

What FDA will do with a GRAS notice.

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.

Public disclosure of a GRAS notice.

Submission of a supplement.

Disposition of pending GRAS affirmation petitions.