Prenotification Consultation or Master File (concerning a food contact substance)

Contains Nonbinding Recommendations

Instructions for Completing Form FDA 3480: OMB No. 0910-0495
Department of Health and Human Services
Food and Drug Administration
Food Contact Notification (FCN)
Pre-Notification Consultation (PNC)
Food Master File (concerning a Food Contact Substance) (FMF)

I.

Using Form FDA 3480 with FCNs, PNCs and FMFs

II.

Steps in Preparing Your Submission

III.

Entering Information on the Form

III.

Transmitting Your Submission

IV.

General Regulatory Instructions for FCNs

V.

Specific Instructions for Certain Items on the Form (FCNs, PNCs, FMFs)
A.
B.

Part I: General Information
Part II: Chemistry Information
1. General Instructions for Part II
2. Entering Chemical Information and Quantities on the Form
3. Entering Information Into Table 4 in Section F.1.b – Summary of the Migration
Testing
C. Part III: Safety Information
D. Part IV: Environmental Information
E. Part V: Certification
F. Part VI: List of Attachments.
VI.
Folder Location Quick Reference (based on Internet Resource #1, Part V.B.)
VII.

FDA Internet Resources

I.

Using Form FDA 3480 with FCNs, PNCs and FMFs


Form FDA 3480 is intended to help you assemble a FCN, PNC, or FMF
concerning a food contact substance (FCS) to FDA.



Before you complete the form, you should read the appropriate guidance
(administrative, chemistry, toxicology, and environmental) for completion of a
notification for a food contact substance (the guidances are Internet Resources #36 listed at the end of these instructions.)



For FCNs, a completed Form FDA 3480 is required as part of your submission.
You must provide all applicable information requested in the Form to the extent
that it is known or reasonably ascertainable by you. You should make reasonable
estimates if you do not have actual data.

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

II.

For PNCs and FMFs concerning a FCS, a completed Form FDA 3480 is
recommended but not required. Using Form FDA 3480 when you submit PNCs
and FMFs for FCSs will assure uniformity with the arrangement of information
submitted in FCNs. You should provide responses and data on the form only for
those items relevant to the purposes of your submission.
Steps in Preparing Your Submission



For submissions in electronic format, download a FCN folder structure (see
Appendix 15: Links to Downloadable Foldering Structures of Internet Resources
#1, listed at the end of these instructions.)



Prepare attachment documents (documents responsive to items on Form 3480) in
accordance with FDA guidances for food contact substance submissions, Internet
Resources #3-6 below.



For submissions in electronic format, place your attachment documents in the
appropriate folders in the folder structure (see Internet Resource #1, Part V.B.:
Food Contact Notification Submissions in Electronic Format for descriptions of
the attachment documents to be placed in each folder in the FCN folder structure
and the basic file-naming format.) For paper submissions, arrange the documents
according to the order of items on the form.



List your attachment documents and their folder locations (volume and page
numbers for paper submissions) in the List of Attachments (Part VI of the form)
as described in Section V.F. of these instructions, then proceed to filling out all
relevant items on Form 3480, referencing your attachment documents or other
FDA files as appropriate for each item on the form.

III.

Entering Information on the Form

(Note: you should frequently save Form 3480 as you enter information because certain
actions, e.g., executing a digital signature, choosing a write-in choice from a pull-down
menu may be irreversible.)


Entering information on the Form. The form is a PDF document with fillable text
fields. It can be filled in using Adobe Acrobat or Acrobat Reader and possibly
other PDF reading software. We recommend you enter complete information in
all applicable fields that are provided on Form 3480, rather than only attaching the
information. Our systems will “capture” information you enter in the fields (both
for electronic and paper submissions). This enables us to use this information as
searchable index information for your FCN in our database.
o To enter information on the form, you can type the information or paste it
from other sources. In Acrobat or Acrobat Reader you can change the font
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Contains Nonbinding Recommendations
to underline, superscript, subscript, bold, etc., by selecting the text, rightclicking and selecting “text style”, or typing (Cntrl+”E”), or selecting the
button View → Tool Bars →Properties Bar.
o Placing stamps, sticky notes, drawings or other mark-ups on the form is
disabled in order to allow extended functions in Acrobat Reader. As for
the form you actually submit, we request it not be saved as a version
allowing these operations, nor printed as a new PDF, as this will remove
needed functionality and our ability to capture the form data.


Designating non-disclosable (confidential) information on the form. You should
designate information you enter on the form that you consider trade secret,
confidential commercial, or otherwise non-disclosable to the public under the
Freedom of Information Act. In the text field where the confidential information
is entered, we recommend you place the confidential information in brackets and
precede it with “confidential:”, as:
confidential:[your confidential information]



Notes. There is space for “notes” under many of the items on the form that
request responsive information be attached. We recommend that you place any
clarifying information here, such as: “We are incorporating by reference the
manufacturing information in FMF 099999.” or “not applicable.”



Mandatory fields. These “mandatory” fields may have a visible border
highlighting them, indicating an entry of text (or a check in a box) is required (the
form will not permit a signature until they are filled in); this is to help assure that
FCN 3480 is completed (most fields will not be mandatory for PNCs and FMFs).
Entering text in one field may cause others to become mandatory or become nonmandatory, depending on the logical interrelationships of the fields on the form.
If you attempt a signature in Part V of Form 3480 with one or more mandatory
fields unfilled, the form will indicate this, not allow the signature, and change the
view (move the cursor) to the location on the form where entry of text is required.
Note: the fact that some fields are designated as mandatory does not imply other
fields are not important; for FCNs, all portions of Form 3480 relevant to your
submission must be completed.

III.


Transmitting Your Submission
To transmit your submission (submission by one of the electronic means is
recommended; first two choices below):
o You may upload the completed FCN folder structure with included
documents to the Electronic Submission Gateway (ESG). For information
on using the ESG, see Internet Resource #2 in Section VII of these
instructions.
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o You may send a single copy of the completed FCN folder structure with
included documents on physical media (e.g., CD-ROM, DVD) to:
Notification Control Assistant, Office of Food Additive Safety, HFS-275,
5100 Paint Branch Parkway, College Park, MD 20740-3835.
o You may send the submission in paper format to the above address. You
should submit five copies of a completed FCN if submitted only in paper
format (each with all attachments and a signed original or copy of Form
FDA 3480). For PNCs or FMFs, we recommend that you either send 5
paper copies (each with all attachments and a signed original or copy of
Form FDA 3480), or consult with FDA regarding the number of paper
copies to send. NOTE: Printing the form generates approximately 12 full
pages of (large) bar coded information added at the end of the form; these
represent the data you entered on Form 3480 that we will electronically
capture as index data for your FCN. If you are sending your submission in
paper format only, please include all printed barcode pages with your
completed form.
IV.

General Regulatory Instructions for FCNs
(These instructions appeared on page 1 of previous versions of Form 3480)


Subject of a FCN. Only new uses of a FCS may be the subject of a notification.
A “new” use is one not otherwise authorized. Only one FCS may be the subject
of a particular notification, but multiple new uses of the same FCS may be
combined in one notification. If you seek authorization for new uses of multiple
FCSs that are food additives, you should submit a separate notification for each
FCS.



Referencing Information. Additional information regarding your FCN may be
provided to FDA, by you or by a third party, in a Food Master File. You may
reference this additional information in your FCN if it is submitted to FDA prior
to the submission of your FCN. If information you refer to is from a third party
and is not publicly available, provide a letter of authorization for such use,
including the name of the authorizing official for the third party and a mailing
address. Authorization is not necessary to reference publicly available
information in FDA’s files.



Complete Notification. Completion of Form FDA 3480 alone may not constitute
a complete notification for a new use of an FCS. You must also submit all data
and information that forms the basis of your safety determination for the use that
is the subject of the notification and any data and information required by
regulation.



Confidential Information. By submitting a notification under section 409(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(h)), a notifier waives any
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Contains Nonbinding Recommendations
claim to confidentiality for information necessary to describe the food contact
substance and the intended conditions of use that are the subject of the
notification. If you are claiming any information to be confidential, you should
designate the confidential information in writing, or otherwise mark the
confidential information in the notification (e.g., by drawing a line around it or by
following the recommendations in Section II of Internet Resource #1). You also
may submit a separate redacted copy of the notification. However, FDA may
disagree regarding the disclosability of information claimed confidential.


For additional regulatory information, see “Guidance for Industry: Preparation of
Food Contact Notifications: Administrative” (see Internet Resource #3 in Section
VII of these instructions).

V.

Specific Instructions for Certain Items on the Form (FCNs, PNCs, FMFs)

A.

Part I: General Information




B.

Item 1: Enter the date that you transmit the submission to FDA in the format
YYYY-MM-DD (e.g., 2007-12-23). If you include a cover letter, the date you
enter should match the date of the cover letter.
Item 2: You should check electronic submissions for viruses (with updated virus
protection software) before transmitting them to FDA; check the box to indicate
you have done this.
Item 3:
o a. Indicate the mode of transmission (ESG Gateway or courier/mail) and
the format of your submission if you submit by courier/mail (electronic
physical media or paper).
o b. If submitted by courier/mail, describe in the space provided the type of
electronic media (e.g., CD-ROM, DVDs) and the number of discs, or the
number of volumes and copies for paper submissions.
Part II: Chemistry Information
1.

General Instructions for Part II

o Summarize all pertinent information concerning the FCS that is the subject of
the notification. This should include:
 Chemical identity (Section A);
 Manufacturing process (Section B);
 Impurities and physical/chemical properties and specifications
(Section C);
 Intended use and intended technical effect (Section D);
 Stability (Section E);
 Migration Levels in food (Section F); and
 Estimated daily intake (Section G).
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Contains Nonbinding Recommendations

o In addition to the summary information provided, your notification should
include all supporting information or data. For recommendations on
migration testing and presentation of the chemistry information see
“Guidance for Industry: Preparation of Premarket Notifications and Food
Additive Petitions for Food Contact Substances: Chemistry
Recommendations” (see Internet Resource #4 in Section VII of these
instructions). On Form FDA 3480, we refer to this guidance as “Chemistry
Recommendations.”
o Include sufficient supporting information and data to enable FDA to confirm
values and results reported on the Form or in attachments or appendices,
including the estimated daily intake(s) resulting from the intended use of the
substance.
2.

Entering Chemical Information and Quantities on the Form

Below, we provide some specific recommendations for entering information in the fields
in Part II of the Form:


For chemical names in the tables, the Chemical Abstracts Service (CAS) name, or
the International Union of Pure and Applied Chemistry (IUPAC) name is
acceptable. Do not use trade or code names/numbers. Many fields in the tables
allow several lines of text for the entry of long chemical names. If a chemical
name will not fit in the space provided in a text field on the form, enter terms that
will identify the substance in the context of your submission and refer to the
location in your submission where the complete chemical name can be found. For
example, you might enter:
“(oxidation product of FCS, see attachment 3)”
You should still enter the CAS registry number, if it exists, and other requested
information in the row for the substance.



To name non-specified total nonvolatile extractives (TNEs) or oligomers for a
given polymeric FCS, enter the FCS chemical name followed, in parentheses, by
(TNEs) or (oligomers), space permitting, and use the FCS CAS number.



For CAS registry numbers, use the standard CAS format that includes hyphens,
e.g., 12367-78-9. Enter “none” if no CAS number exists for the given chemical.



For quantity fields, report values in the units specified in the table column on the
Form, e.g., ppb, mg/in2, and use ordinary base ten, e.g., 0.0000045. Do not use
scientific notation.

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Contains Nonbinding Recommendations


If you exceed the available number of rows in a table, click the check box below
that table; this causes a continuation page of the table to be generated.
3.
Entering Information Into Table 4 in Section F.1.b – Summary of the
Migration Testing

Below is an example of information entered in Table 4 in Part II, Section F.1.b:
Example: A notifier conducted a migration study to support the use of a polymer
adjuvant, Adjuvant X, intended for use at a maximum level of 0.01 wt.% in LDPE. The
example table below shows how the notifier might tabulate migration data obtained from
sample plaques tested in 10% ethanol under conditions of use B.
Table 4: Summary of Migration Testing
TEST SAMPLE
FORMULATION
LDPE containing
0.01 wt.% of
Adjuvant X

C.

MIGRANT

FOOD OR
FOOD
SIMULANT

Adjuvant
X

10%
ethanol

TEMPERATURE
AND TIME OF
ANALYSIS

MIGRATION
(each replicate)

AVERAGE
MIGRATION
(average of
replicates)

100°C
analysis after
2 hours

0.012 mg/in²
0.011 mg/in²
0.021 mg/in²

0.015 mg/in²

40°C
analysis after
24 hours

0.015 mg/in²
0.014 mg/in²
0.022 mg/in²

0.017 mg/in²

40°C
analysis after
96 hours

0.017 mg/in²
0.017 mg/in²
0.023 mg/in²

0.019 mg/in²

100°C
analysis after
240 hours

0.020 mg/in²
0.021 mg/in²
0.023 mg/in²

0.021 mg/in²

Part III: Safety Information




Provide a safety narrative, comprehensive toxicology profile(s) (CTPs), and list
pertinent toxicological studies as directed on the Form.
Include full study reports of studies that are used as the basis of the safety
determination and current literature search results.
For more complete recommendations regarding the safety information, see
“Guidance for Industry: Preparation of Premarket Notifications for Food Contact

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Substances: Toxicology Recommendations” (see Internet Resource #5 in Section
VII of these instructions). On Form FDA 3480, we refer to this guidance as
“Toxicology Recommendations.”

D.

Part IV: Environmental Information


Either:
o provide a complete claim of categorical exclusion by, under item 1,
checking the box(es) for the exclusion(s) you are claiming, completing the
items below the exclusion, and completing items 2 and 3 if the proposed
use qualifies for exclusion from the need to prepare an Environmental
Assessment (EA) as defined under 21 CFR 25.32; or
o Submit an EA.



E.

For more information about the environmental information in a FCN, see
“Guidance for Industry: Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety and
Applied Nutrition” (see Internet Resource #6 in Section VII of these instructions).
On Form FDA 3480, we refer to this guidance as “Environmental
Recommendations.”
Part V: Certification

In Part V, an authorized official or agent signs and dates the form and provides his/her
title. For information on electronic signatures, see Internet Resource #1, Part III.G.
F.

Part VI: List of Attachments.


For electronic submissions:
o Click on “Insert” to insert the name of a file from the directory on your local
hard drive that is the FCN folder structure wherein you have placed the
documents for your submission. Clicking on “Clear” will remove the name
if you need to change it. This assures that the name of the file entered in the
table matches the name of the file included your submission (our system will
automatically check the filenames in the List of Attachments against the
filenames of files actually included in the folder structure of your
submission). Alternatively, type or paste the filename (name files according
to the File Naming Conventions in Appendix 12 of Internet Resource #1,
including the 3 character extension (e.g., .pdf, .mol).
o NOTE: Documents you list are not actually “attached” in any way to Form
3480; you must place the documents in the appropriate folders in the FCN
foldering structure according to Part V.B. of Internet Resource #1 and
Section VI: Folder Location Quick Reference, below.
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Contains Nonbinding Recommendations
o Select the folder location (indicating the folder in the standard FCN foldering
structure in which you placed the document) from the pull down menu. For
example:
Att.1-DesignationOfNondisclosableInformation_HPNHin
Polypropylene_ACME_2007-10-12.pdf
Att.2-MigrationStudy_HPNH_StandardCurves,chromatograms,
calculations_2007-9-24.pdf

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2





VI.

Administrative
Chemistry/Studies

For paper submissions:
o List the title of each document included with Form 3480.
o Type in the volume number and inclusive page numbers of each document,
as applicable.
If a document is responsive to a given item on the Form, the attachment number
adjacent to the document name should match the attachment number entered
under the given item on the Form (note: not all attached documents will
necessarily be responsive to items on Form 3480).
Folder Location Quick Reference (based on Internet Resource #1, Part V.B.)

(Note: Chemistry, Safety, Environmental and Administrative information should not be
combined in a single file)
If the file is or contains:

Place the file in the folder:

Form FDA 3480, administrative, regulatory Administrative
information, designation of nondisclosable
information, redacted copies
FCS identity, specifications, use,
manufacture, impurities, technical effect

Chemistry

Migration, stability or other chemistry
study reports & data

Chemistry/Studies

Published chemistry information

Chemistry/References

Safety narrative

Safety

Comprehensive toxicological profile (CTP)
and/or literature search information for a
given substance (Chemical Name 1)

Safety/Chemical Name 1

Safety study reports, data of a given study
type, for a given substance (Chemical
Name 1)

Safety/Chemical Name 1/Studies/Study
Type

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Published safety studies/information on a
given substance (Chemical Name 1)

Safety/Chemical Name 1/References

EA, categorical exclusion supporting
information

Environmental

Environmental study reports & data

Environmental/Studies

Published environmental
studies/information

Environmental/References

Confidential information referenced in the
EA

Environmental/Conf. Envr. Info

VII.

FDA Internet Resources

The following resources are available on FDA’s Internet site.
1. Guidance for Industry: Providing Regulatory Submissions in Electronic or
Paper format to the Office of Food Additive Safety
2. Electronic Submission Gateway
3. Guidance for Industry: Preparation of Food Contact Notifications:
Administrative
4. Guidance for Industry: Preparation of Premarket Notifications and Food
Additive Petitions for Food Contact Substances: Chemistry Recommendations
5. Guidance for Industry: Preparation of Premarket Notifications for Food Contact
Substances: Toxicology Recommendations
6. Guidance for Industry: Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety and
Applied Nutrition

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