Form FDA 3479 FDA 3479 Notification for a Food Contact Substance Formulation

Form Approved: OMB No. 0190-0495, Approval Expires: May 31, 2012
Department of Health and Human Services
Food and Drug Administration

NOTIFICATION FOR A FOOD CONTACT
SUBSTANCE FORMULATION

DATE OF RECEIPT

AGENCY USE ONLY

NOT FOR NEW USES OF FOOD CONTACT SUBSTANCES

When completed
send the form and
notification to:

NOTIFICATION CONTROL ASSISTANT
OFFICE OF FOOD ADDITIVE SAFETY
HFS-275
5100 PAINT BRANCH PARKWAY
COLLEGE PARK, MD 20740-3835

Enter the total number of pages
in the Formulation Notification:

.
.
.

GENERAL INSTRUCTIONS

FCF -

This form is intended for use only to ascertain that all components of a food contact substance formulation may be legally
marketed for their intended use.
This form may not be used to request authorization for a new use of a food contact substance under section 409(h) of the
Federal Food, Drug, and Cosmetic Act. New uses of food contact substances must be the subject of a notification under
section 409(h) including an FDA Form 3480.
You should include all information necessary to ascertain that each component of the formulation may be legally marketed
for its intended use (technical effect). For example, if the basis for compliance is an effective notification, you should provide
information establishing that you may rely on that notification.

Part I - GENERAL INFORMATION
A notification may not be submitted for a formulation unless all of the
components of the formulation may be legally marketed for their
intended use in contact with food. A notification for a food contact
substance formulation should include all information necessary to
establish that each compound in the formulation may be legally
marketed. For example, additional information necessary to establish
that each component of the formulation may be legally marketed for
the intended use in contact with food should be attached. Any
information referenced in a notification must be submitted to FDA
prior to your notification. If you reference information from a third
party that is located in other FDA files, provide a letter of
authorization for such use, if necessary. For example, authorization is
not necessary to reference publicly available information in FDA’s
files. If third party authorization is required, provide the name of the
authorizing official for the third party and a mailing address.

substance formulation will contact in its intended use. If possible, use
the time and temperature conditions of use listed in Table 2 of 21 CFR
176.170(c) to describe the time and temperature conditions of use for
the food contact substance formulation that is the subject of this
notification.
Part Vl - LIST OF ATTACHMENTS
Attach additional sheets if there is not enough space to answer a
question fully. Label each continuation sheet with the corresponding
section heading. List these attachments, any test data or other data and
any optional information included in the notification.
OPTIONAL INFORMATION

Two copies of your complete notification must be submitted, each
with a completed and signed original copy.

You may include any information that you want FDA to consider in
evaluating this notification.

Part II - IDENTITY

CONFIDENTIALITY OF INFORMATION

Provide complete identity information for all components used to
produce the food contact substance formulation. If a component (e.g. a
reagent or solvent) is completely removed from the formulation as
marketed, indicate so. Provide any relevant specifications in order to
establish that all components of the formulation may be lawfully
marketed.

If you are claiming any information in this notification confidential
you should submit a redacted copy of the notification. FDA may
disagree regarding the disclosability of information claimed
confidential.
SAMPLES

Part III - INTENDED USE
If possible, use the food types listed in Table 1 of 21 CFR 176.170(c)
to describe the types of food the food contact

Provide a sample of the food contact substance formulation as
intended for market.

PUBLIC BURDEN STATEMENT
Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing 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 Chief Information Officer (HFA-710), 5600 Fishers Lane, Rockville, MD 20875. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

FORM FDA 3479 (9/09)

Page 1 of 7 Pages

PSC Graphics (301) 443-1090

EF

PART I - GENERAL INFORMATION
POSITION

NAME OF AUTHORIZED OFFICIAL

COMPANY

MAILING ADDRESS (number and street)
1a. PERSON
SUBMITTING
NOTICE
CITY

TELEPHONE NUMBER

STATE

ZIP CODE/POSTAL CODE

FAX NUMBER

COUNTRY

E-MAIL ADDRESS

Please check here if E-Mail is your preferred method of communication.
POSITION

NAME OF AUTHORIZED OFFICIAL

COMPANY

MAILING ADDRESS (number and street)
1b. AGENT
(if applicable)
CITY

TELEPHONE NUMBER

STATE

ZIP CODE/POSTAL CODE

FAX NUMBER

Please check here if E-Mail is your preferred method of communication.

FORM FDA 3479 (9/09)

Page 2 of 7 Pages

COUNTRY

E-MAIL ADDRESS

PART II - IDENTITY
SECTION A - IDENTIFICATION OF THE FOOD CONTACT SUBSTANCE
1. CHEMICAL IDENTITY

TRADE OR COMMON NAMES

2. FORMULATION COMPOSITION

CHEMICAL NAME AND MANUFACTURER
CHEMICAL NAME (1)

FORM FDA 3479 (9/09)

MANUFACTURER (2)

TYPICAL
COMPOSITION
(3)

MAXIMUM
RESIDUAL
(4)

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Page 3 of 7 Pages

CAS
REG. NO.
(5)

BASIS FOR
COMPLIANCE
(6)

TECHNICAL EFFECT
(7)

PART II - INFORMATION ON IDENTITY, USE AND EXPOSURE (continued)
SECTION A - IDENTIFICATION (continued)
b. CHARACTERIZATION
List those characteristics of the formulation necessary to verify that the formulation may be lawfully marketed.
POLYMER PROPERTIES

VALUES

c. Describe the manufacturing process, including times and temperatures, and include chemical equations for all synthetic steps and side
reactions. Describe any purification steps.

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Part IV of this form.

FORM FDA 3479 (9/09)

Page 4 of 7 Pages

PART III - INTENDED USE
1. Describe the intended use of the food contact substance formulation, including maximum use levels (or thickness) in food contact materials, and
types of food contact articles in which it is expected to be used (e.g., films, coatings, molded articles). State whether single or repeated use is
intended. Provide maximum temperatures and times of food contact, refer to classifications in 21 CFR 176.170(c) Table 2 when possible.

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Part IV of this form.
2. List types of food expected to contact the formulation, with examples if known. Refer to classifications in 21 CFR 176.170(c) Table 1 when
possible.

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Part IV of this form.

FORM FDA 3479 (9/09)

Page 5 of 7 Pages

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET
To assist FDA’s review of physical and chemical properties data, please complete the following worksheet for data you provide and
include it in the notification. Identify the property measured, the page of the notification on which the property appears, the value of
the property, and the units in which the property is measured (as necessary). The measured properties should be for the food
contact substance formulation. You are not required to submit this worksheet.
PROPERTY

MARK (X)
IF
PROVIDED

(a)

PAGE
NUMBER
(b)

VALUE

MEASURED OR
ESTIMATE
(M or E)

(c)
(s)

M

E

Torr

M

E

g/cm 3

M

E

g/L

M

E

g/L

M

E

°C

M

E

°C

M

E

M

E

M

E

Particle size distribution

M

E

Octanol/water partition coefficient

M

E

M

E

M

E

M

E

M

E

M

E

M

E

M

E

M

E

M

E

Physical state of the substance
Vapor pressure
@ Temperature

°C

Density/relative density (specify temperature)
Solubility
@ Temperature

°C

Solubility in water @ Temperature

Solvent

°C

Melting Temperature
Boiling/sublimation temperature @

torr pressure

Spectra
Dissociation constant

Henry’s Law constant
pH

@ concentration

Adsorption/coefficient
Other - Specify
Polymer specific
(If a range is applicable, indicate so)
% crystallinity of polymer
Degree of orientation
Thermal transitions of polymer (i.e., Tg, Tm)
Density of polymer (specify temperature)

FORM FDA 3479 (9/09)

Page 6 of 7 Pages

(g)

(l)

PART IV - LIST OF ATTACHMENTS
Attach continuation sheets for sections of the form and test data and other data (including physical/chemical properties and
structure/activity information), and optional information after this page. Clearly identify the attachment and the section of the form to
which it relates, if appropriate. Number consecutively the pages of the attachments. In the column below, enter the inclusive page
numbers of each attachment. Notifiers need not list other components of their notification not specifically referenced to this form.

ATTACHMENT NAME

FORM FDA 3479 (9/09)

Page 7 of 7 Pages

ATTACHMENT
PAGE NUMBER(S)