3503 Food and Color Additive Petition and Food and Color Mast

Form Approved: OMB No. 0910-0016; Expiration Date: xx/xx/xxxx
(See last page for OMB Statement)

Department of Health and Human Services
Food and Drug Administration

FDA USE ONLY

FOOD ADDITIVE PETITION (FAP)
COLOR ADDITIVE PETITION (CAP)
FOOD MASTER FILE (FMF)
COLOR MASTER FILE (CMF)

SUBMISSION NUMBER
DATE OF RECEIPT

Transmit completed form and attachments electronically via the Electronic Submission Gateway (see Instructions); OR Transmit
completed form and attachments in paper format or on physical media to: Office of Food Additive Safety (HFS-200), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740-3835.

PART I - INTRODUCTORY INFORMATION ABOUT THE SUBMISSION
1. Type of Submission (Complete a. or b. below)
a. If New Submission, check one of the following.
New Food Additive Petition (21 CFR 171.1)

New Color Additive Petition (21 CFR 71.1)

New Food Master File

New Color Master File

b. If Additional Information/Incoming Correspondence, check one of the following.
Update
Amendment
Enter the appropriate number applicable to this update or amendment.

2.

FAP Number

FMF Number

CAP Number

CMF Number

All electronic files included in this submission have been checked and found to be virus free. (Check box to verify)

3a. For New Submissions Only: Enter the date of most recent presubmission consultation
(if any) with FDA on the subject substance (yyyy/mm/dd):
3b. For Amendments only: Is your amendment
submitted in response to a communication
from FDA? (Check one)

Yes

No

If yes, enter the date of
communication (yyyy/mm/dd):

PART II - INFORMATION ABOUT THE PETITIONER
OR PERSON RESPONSIBLE FOR MASTER FILE
Position

Name of Contact Person
1a. Petitioner
Company (if applicable)
or Person
Responsible
for Master File
Mailing Address (number and street)
City

State or Province

Telephone Number

Zip Code/Postal Code

E-Mail Address

Fax Number

Name of Contact Person
1b. Agent or
Attorney (if
applicable)

Country

Position

Company (if applicable)
Mailing Address (number and street)

City
Telephone Number

FORM FDA 3503 (01/17)

State or Province

Zip Code/Postal Code

Fax Number

Country

E-Mail Address

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PART III - GENERAL ADMINISTRATIVE INFORMATION
1. Title of Submission
2. Submission Format (Check appropriate box(es))
Electronic Submission Gateway

3. For paper submissions only
Electronic files on physical media with
paper signature page

Paper

If applicable, give number and type of physical media

Number of volumes:

Total number of pages:

4. Does this submission incorporate any information in FDA's files by reference? (Check one)
Yes (Proceed to item 5)

No (Proceed to item 6)

5. The submission incorporates by reference information from a previous submission to FDA as indicated below. (Check all that apply)
b) Food Master File No. FMF
a) Food Additive Petition No. FAP
c) Color Additive Petition No. CAP

d) Color Master File No. CMF

e) GRAS Notice No. GRN

f) GRAS Affirmation Petition No. GRP

g) Other or additional information (briefly describe or enter information in a format similar to a) through f))

6. Have you designated information in your submission that you view as trade secret or as confidential commercial or financial
information? (Check one)
Yes, see attached designation of confidential information
Yes, information is designated at the place where it occurs in the submission

No

7. Have you attached a redacted copy of some or all of the submission? (Check one)
Yes, redacted copy of complete submission
No

Yes, redacted copy of part(s) of submission

PART IV.A - FOOD ADDITIVE PETITION ONLY
1. Additive Type (Check one)
Direct

Secondary Direct

Indirect

Source of Radiation

2. Does the intended use of the additive include any use in meat, meat
food product, or poultry product? (Check one)
Yes

No

The undersigned submits the attached petition pursuant to section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with
respect to (state the name of the food additive and its proposed use)

PART IV.B - COLOR ADDITIVE PETITION ONLY
1. Regulated products that would contain additive
(Check applicable)
Food (including meat, meat food product or poultry product)

2. Fee enclosed (Check one)
New listing for color additive for use in food ($3,000)

Food (excluding meat, meat food product or poultry product)

New listing for color additive for use in cosmetics, drugs, or
medical devices ($2,600)

Food-contact material

Amendment for color additive for use in food ($1,800)

Cosmetics

Drugs

Medical devices

Amendment for color additive for use in cosmetics, drugs,
or medical devices ($1,600)

The petitioner submits the attached petition pursuant to section 721(b)(1) of the Federal Food, Drug, and Cosmetic Act
requesting listing by the Commissioner of the color additive
as suitable and safe for use in or on
subject to the conditions that

FORM FDA 3503 (01/17)

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PART IV.C - FOOD MASTER FILE OR COLOR MASTER FILE ONLY
1. Reason for the submission

2. When applicable, other information not addressed or listed on this form

PART V - IDENTITY
(Including all constituents)
Note: When entering information in the table below, abbreviate Primary as P, and Constituents as C. (Include residual monomers,
residual solvents, impurities (including carcinogenic impurities), catalysts, etc.)
Chemical
Type

CAS* Registry
Number

Chemical Name

Trade Name (If
any)

Add Continuation Page

* CAS = Chemical Abstracts Service

FORM FDA 3503 (01/17)

Link To Chemical
Structure

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PART VI - OTHER ELEMENTS IN YOUR SUBMISSION
(check the list below to help ensure your submission is complete. check all that apply.)
1.

2.

3.

4.

4.

Administrative
1.1

Designation of Nondisclosable Information

1.2

Redacted Document

1.3

Incoming Correspondence
1.3.1

Amendment

1.3.2

Update

Safety (Continued)
4.2

Studies (Continued)
4.2.9
4.2.10

Administrative Technical
2.1

Proposed Regulation

2.2

Proposed Tolerance

2.3

Exempt from Certification (Color additive only)

Chemistry

Combined Chronic Toxicity/
Carcinogenicity Studies Rodents
In Utero Exposure Phase for Addition
to Carcinogenicity Studies Rodents

4.2.11

Reproduction Studies

4.2.12

Developmental Toxicity Studies

4.2.13

Immunotoxicity Studies

4.2.14

Metabolism and Pharmacokinetic
Studies

4.2.15

Neurotoxicity Studies

4.2.16

Human Studies

4.2.17

Dermal Studies

4.2.18

Ocular Studies

4.2.19

Other Studies

3.1

Identity

3.2

Use and Technical Effect

3.3

Labeling

3.4

Manufacturing Method

3.5

Residues

3.6

Specifications

4.3.1

Literature Publications

3.7

Exposure Estimates

4.3.2

Other (including unpublished, etc.)

3.8

Studies

4.3

5.

References

Environmental

3.8.1

Stability

5.1

Environmental Assessment

3.8.2

Intended Effect

5.2

Claim of Categorical Exclusion

3.8.3

Migration

5.3

Confidential Environmental Information

3.8.4

Other Studies

5.4

Studies

5.5

References

3.9

Methods

3.10

References
3.10.1

Literature Publications

3.10.2

Other (including unpublished, etc.)

6.

Safety
4.1

Toxicology Narrative

4.2

Studies
4.2.1

Genetic Toxicity Tests

4.2.2

Short Term Toxicity Studies Rodents

4.2.3

Short Term Toxicity Studies Non-Rodents

4.2.4

Subchronic Toxicity Studies Rodents

4.2.5

Subchronic Toxicity Studies Non-Rodents

4.2.6

One-Year Toxicity Studies Non-Rodents

4.2.7

Chronic Toxicity Studies Rodents

4.2.8

Carcinogenicity Studies Rodents

FORM FDA 3503 (01/17)

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Other (Information in original submission that does
not fall under any of the above subfolders)

PART VII - SIGNATURE
Signature of Responsible Official, Agent or Attorney

Printed Name and Title

Date (mm/dd/yyyy)

PART VIII - LIST OF ATTACHMENTS
List your attached files or documents containing your petition or master file, forms, updates, or amendments and other
pertinent information. Clearly identify the attachment with appropriate descriptive file names (or titles for paper documents),
preferably as suggested in the guidance associated with this form. When submitting paper documents, enter the inclusive
page numbers of each portion of the document below.
Element Number/Folder
Location
(see Part VI above)

Name of Attachment

Page Number(s)
for Paper Copy Only

Add Continuation Page

OMB Statement: Public reporting burden for this collection of information is estimated to average 1 hour per response,
including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden to: Department of Health and Human Services,
Food and Drug Administration, Office of Operations, Paperwork Reduction Act (PRA) Staff, [email protected].
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to, a collection of information unless it displays a currently valid OMB control number.
FORM FDA 3503 (01/17)

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