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e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter BPart 170Subpart E → §170.230


Title 21: Food and Drugs
PART 170—FOOD ADDITIVES
Subpart E—Generally Recognized as Safe (GRAS) Notice


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

In Part 2 of your GRAS notice, you must include:

(a) Scientific data and information that identifies the notified substance.

(1) Examples of appropriate data and information include the chemical name, applicable registry numbers (such as a Chemical Abstracts Service (CAS) registry number or an Enzyme Commission (EC) number), empirical formula, structural formula, quantitative composition, and characteristic properties.

(2) When the source of a notified substance is a biological material, you must include data and information sufficient to identify:

(i) The taxonomic source (e.g., genus, species) including, as applicable, data and information at the sub-species level (e.g., variety, strain);

(ii) The part of any plant or animal used as the source; and

(iii) Any known toxicants that could be in the source;

(b) A description of the method of manufacture of the notified substance in sufficient detail to evaluate the safety of the notified substance as manufactured;

(c) Specifications for food-grade material; and

(d) When necessary to demonstrate safety, relevant data and information bearing on the physical or other technical effect the notified substance is intended to produce, including the quantity of the notified substance required to produce such effect.

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