US Codex
C.F.R.
Browse by date

View an earlier version

Latest
Current
Browse all versions by date
Notes

21 C.F.R. §§ 170.225–170.255

7 sections in range

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

21 C.F.R. § 170.225

(a)
Part 1 of your GRAS notice must be dated and signed by a responsible official of your organization, or by your attorney or agent.
(b)
Except as required by paragraph (c)(8) of this section, you must not include any information that is trade secret or confidential commercial information in Part 1 of your GRAS notice.
(c)
In Part 1 of your GRAS notice, you must—
(1)
Inform us that you are submitting a GRAS notice in accordance with this subpart;
(2)
Provide the name and address of your organization;
(3)
Provide the name of the notified substance, using an appropriately descriptive term;
(4)
Describe the intended conditions of use of the notified substance, including the foods in which the substance will be used, the levels of use in such foods, and the purposes for which the substance will be used, including, when appropriate, a description of a subpopulation expected to consume the notified substance;
(5)
Inform us of the statutory basis for your conclusion of GRAS status (i.e., through scientific procedures in accordance with § 170.30(a) and (b) or through experience based on common use in food in accordance with § 170.30(a) and (c));
(6)
State your view that the notified substance is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on your conclusion that the notified substance is GRAS under the conditions of its intended use;
(7)
State that, if we ask to see the data and information that are the basis for your conclusion of GRAS status, either during or after our evaluation of your notice, you will:
(i)
Agree to make the data and information available to us; and
(ii)
Agree to both of the following procedures for making the data and information available to us—
(A)
Upon our request, you will allow us to review and copy the data and information during customary business hours at the address you specify for where these data and information will be available to us; and
(B)
Upon our request, you will provide us with a complete copy of the data and information either in an electronic format that is accessible for our evaluation or on paper;
(8)
State your view as to whether any of the data and information in Parts 2 through 7 of your GRAS notice are exempt from disclosure under the Freedom of Information Act, 5 U.S.C. 552 (e.g., as trade secret or as commercial or financial information that is privileged or confidential).
(9)
Certify that, to the best of your knowledge, your GRAS notice is a complete, representative, and balanced submission that includes unfavorable information, as well as favorable information, known to you and pertinent to the evaluation of the safety and GRAS status of the use of the substance;
(10)
State both the name and position or title of the person who signs the GRAS notice; and
(11)
When applicable, state as required by § 170.270 whether you:
(i)
Authorize us to send any trade secrets to the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture; or
(ii)
Ask us to exclude any trade secrets from the copy of the GRAS notice that we will send to FSIS.
Notes, amendments, and revision history

Source

Source: 81 FR 55048, Aug. 17, 2016, unless otherwise noted.

Authority

Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

Source

Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.

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

21 C.F.R. § 170.230

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.
Notes, amendments, and revision history

Source

Source: 81 FR 55048, Aug. 17, 2016, unless otherwise noted.

Authority

Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

Source

Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.

§170.235. Part 3 of a GRAS notice: Dietary exposure.

21 C.F.R. § 170.235

In part 3 of your GRAS notice, you must provide data and information about dietary exposure (i.e., the amount of relevant substances that consumers are likely to eat or drink as part of a total diet), regardless of whether your conclusion of GRAS status is through scientific procedures or through experience based on common use in food, as follows:
(a)
You must provide an estimate of dietary exposure to the notified substance that includes exposure from its intended use and all sources in the diet; and
(b)
When applicable, you must provide an estimate of dietary exposure to any other substance that is expected to be formed in or on food because of the use of the notified substance (e.g., hydrolytic products or reaction products);
(c)
When applicable, you must provide an estimate of dietary exposure to any other substance that is present with the notified substance either naturally or due to its manufacture (e.g., contaminants or by-products);
(d)
You must describe the source of any food consumption data that you use to estimate dietary exposure in accordance with paragraphs (a) through (c) of this section; and
(e)
You must explain any assumptions you made to estimate dietary exposure in accordance with paragraphs (a) through (c) of this section.
Notes, amendments, and revision history

Source

Source: 81 FR 55048, Aug. 17, 2016, unless otherwise noted.

Authority

Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

Source

Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.

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

21 C.F.R. § 170.240

In circumstances where the amount of the notified substance that can be added to food is limited because food containing levels of the notified substance above a particular level would become unpalatable or technologically impractical, in Part 4 of your GRAS notice you must include data and information on such self-limiting levels of use.
Notes, amendments, and revision history

Source

Source: 81 FR 55048, Aug. 17, 2016, unless otherwise noted.

Authority

Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

Source

Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.

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

21 C.F.R. § 170.245

If the statutory basis for your conclusion of GRAS status is through experience based on common use in food, in Part 5 of your GRAS notice you must include evidence of a substantial history of consumption of the notified substance for food use by a significant number of consumers prior to January 1, 1958.
Notes, amendments, and revision history

Source

Source: 81 FR 55048, Aug. 17, 2016, unless otherwise noted.

Authority

Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

Source

Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.

§170.250. Part 6 of a GRAS notice: Narrative.

21 C.F.R. § 170.250

In Part 6 of your GRAS notice, you must include a narrative that provides the basis for your conclusion of GRAS status, in which:
(a)
(1)
You must explain why the data and information in your notice provide a basis for your view that the notified substance is safe under the conditions of its intended use. In your explanation, you must address the safety of the notified substance, considering all dietary sources and taking into account any chemically or pharmacologically related substances in such diet;
(2)
In your explanation, you must identify what specific data and information that you discuss in accordance with paragraph (a)(1) of this section are generally available, and what specific data and information that you discuss in accordance with paragraph (a)(1) of this section are not generally available, by providing citations to the list of data and information that you include in Part 7 of your GRAS notice in accordance with § 170.255;
(b)
You must explain how the generally available data and information that you rely on to establish safety in accordance with paragraph (a) of this section provide a basis for your conclusion that the notified substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use;
(c)
You must either:
(1)
Identify, discuss, and place in context, data and information that are, or may appear to be, inconsistent with your conclusion of GRAS status, regardless of whether those data and information are generally available; or
(2)
State that you have reviewed the available data and information and are not aware of any data and information that are, or may appear to be, inconsistent with your conclusion of GRAS status;
(d)
If you view any of the data and information in your notice as exempt from disclosure under the Freedom of Information Act, you must identify the specific data and information; and
(e)
For non-public, safety-related data and information considered in reaching a conclusion of GRAS status, you must explain how there could be a basis for a conclusion of GRAS status if qualified experts do not have access to such data and information.
Notes, amendments, and revision history

Source

Source: 81 FR 55048, Aug. 17, 2016, unless otherwise noted.

Authority

Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

Source

Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.

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

21 C.F.R. § 170.255

(a)
In part 7 of your GRAS notice, you must include a list of all of the data and information that you discuss in Part 6 of your GRAS notice to provide a basis for your view that the notified substance is safe under the conditions of its intended use as described in accordance with § 170.250(a)(1).
(b)
You must specify which data and information that you list in accordance with paragraph (a) of this section are generally available, and which data and information are not generally available.
Notes, amendments, and revision history

Source

Source: 81 FR 55048, Aug. 17, 2016, unless otherwise noted.

Authority

Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

Source

Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.