Form FDA3480 NOTIFICATION FOR NEW USE OF A FOOD

Food Additives; Food Contact Substances Notification System

0495 FDA3480

Food Additives; Food Contact Substances Notification System

OMB: 0910-0495

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0495 can be found here:

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Form Approved: OMB No. 0190-0495, Approval Expires: December 31, 2008
Department of Health and Human Services
Food and Drug Administration

AGENCY USE ONLY
DATE OF RECEIPT

NOTIFICATION FOR NEW USE OF A FOOD
CONTACT SUBSTANCE
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
DATE EFFECTIVE (if effective)

Enter the total number of pages
in the Premarket Notification:

.
.

FCN NUMBER

GENERAL INSTRUCTIONS
You must provide all information requested in this form to the extent that it is known to or reasonably ascertainable by you.
You should make reasonable estimates if you do not have actual data.
Before you complete this form, you should read the appropriate guidance for completion of a notification for a food contact
substance.

Part I - GENERAL INFORMATION

Part III - TOXICOLOGY INFORMATION

Only one new food contact substance (FCS) may be the subject of a
particular notification. However, new multiple uses maybe combined
in a notification. A "new" use is one not otherwise authorized. If
authorization is sought for use of multiple FCSs that are food
additives, separate notifications should be submitted for each new
use. Any accompanying information for a notification may be
provided to FDA in a Food Additive Master File and referenced in a
notification. 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.
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.

Include a list of toxicology studies considered key to the safety
decision, discuss the potential mutagenicity and carcinogenicity of
the notified substance and its constituents, determine the acceptable
daily intake (ADI), as appropriate, and state the basis for your safety
decision. This information should be consistent with the discussion in
the Safety Narrative, which is described in the "Guidance for
Industry: Preparation of Premarket Notifications for Food Contact
Substances: Toxicology Recommendations."

Completion of this form alone may not constitute a complete
notification for a new use of an FCS. A notifier must also submit all
data and information that forms the basis of the notifier’s safety
determination for the use that is the subject of the notification and
any data and information required by regulation. Five copies of your
complete notification must be submitted, each with a completed and
signed original or copy of this form.
Part II - CHEMISTRY INFORMATION

Part VI - 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. Please do
not attach information that can be included on the form.
OPTIONAL INFORMATION
You may include any information that you want FDA to consider in
evaluating this notification.
CONFIDENTIALITY OF INFORMATION

Summarize all pertinent information concerning the FCS that is the
subject of the notification. This should include: chemical identity,
manufacturing process, physical properties and specifications,
conditions of use, intended technical effect, and stability data. In
addition to the summary information provided, your notification
should include all supporting information or data. Also, include
sufficient data to enable FDA to confirm your estimated daily intake
resulting from the intended use of the substance. For information on
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."

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 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 in this
notification to be confidential you should designate the confidential
material in writing, or otherwise mark the confidential material in the
notification (e.g, by drawing a line around it), and submit a separate
redacted copy of the notification. FDA may disagree regarding the
disclosability of information claimed confidential.

PUBLIC BURDEN STATEMENT
Public reporting burden for this collection of information is estimated to average 25 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: Food and Drug Administration, Center for Food
Safety and Applied Nutrition, Office of Food Additive Safety (0910-0495), 5100 Paint Branch Parkway (HFS-200), College Park, MD 20740-3835. 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 3480 (9/05)

Page 1 of 19 Pages

PSC Graphic Arts (301) 443-1090

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PART I - GENERAL INFORMATION
NAME OF AUTHORIZED OFFICIAL

POSITION

COMPANY

1a. PERSON
SUBMITTING
NOTICE

MAILING ADDRESS (number and street)

CITY

STATE

TELEPHONE NUMBER

ZIP CODE/POSTAL CODE

FAX NUMBER

COUNTRY

E-MAIL ADDRESS

Please check here if E-Mail is your preferred method of communication. (Please note that E-Mails may not be secure)
NAME OF AUTHORIZED OFFICIAL

POSITION

COMPANY

b. AGENT
(if applicable)

MAILING ADDRESS (number and street)

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. (Please note that E-Mails may not be secure)
c.

IDENTIFY THE MANUFACTURER/SUPPLIER FOR WHICH THIS FCN WILL BECOME EFFECTIVE

2. If you had a prenotification consultation (PNC) or a corre-

spondence letter (CTS) concerning this notification and FDA
assigned a PNC or CTS number to the consultation, enter
the number.

Mark (X)
if None

3. Please site all food master files (FMFs) relevant to this FCN.

Mark (X)
if None

4. If you previously submitted an FCN or FAP for this

substance that is not effective, enter the FCN or FAP
number assigned by FDA.

Mark (X)
if None

5. List all effective notifications for the substance.

FDA maintains a list of effective notifications accessible
through its internet site at:
http://www.cfsan.fda.gov/~dms/opa-fcn.html
FORM FDA 3480 (9/05)

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Mark (X)
if None

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Part II - CHEMISTRY INFORMATION
SECTION A - IDENTIFICATION OF THE FOOD CONTACT SUBSTANCE
See Chemistry Recommendations, Sections II.A.1 through 4.
1. Chemical Abstracts Service (CAS) name

2. CAS Registry Number

3. Trade or Common Name

4. Other Chemical Names (IUPAC, etc.)

5. Description
Provide a description of the FCS, including chemical formula(e), structure(s) and molecular weight(s). For FCSs that cannot be represented by a
discrete chemical structure, such as new polymers, provide a representative chemical structure(s) and the M w and M n . For new copolymers,
also provide the ratio of monomer units in the copolymer.

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Section VI of this form.
6. Characterization
Attach data, such as infrared (IR), ultraviolet (UV), nuclear magnetic resonance (NMR), mass spectra, or other similar data for identification of
the FCS.

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

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Part II - CHEMISTRY INFORMATION (continued)
SECTION B - MANUFACTURE
See Chemistry Recommendations, Sections II.A.4.a through d.
1. List all reagents monomers, solvents, catalyst systems, purification aids, etc. used to manufacture the FCS. Include chemical name, CAS Reg.
No., and function in the manufacture of the FCS.

CHEMICAL NAME

CAS REG.
NO.

FUNCTION

Is residual expected
to remain in the
final food contact material?

Yes

If yes, include in Table II.B.3. If no support this conclusion in the manufacturing process description (#2).
2. Describe the manufacturing process, including reaction conditions (e.g., times and temperatures), and include chemical equations and
stoichiometry 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 Section VI of this form.

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Part II - CHEMISTRY INFORMATION (continued)
SECTION B - MANUFACTURE (continued)
See Chemistry Recommendations, Sections II.A.4.a through d.
3. List impurities in the FCS including: the chemical names, CAS Reg. Nos., and typical and maximum residual levels (percent weight) in the FCS as
it will be marketed. For FCSs that are polymers, include typical and maximum residual monomer concentrations. Provide supporting data
including analytical methods and validation information.
CHEMICAL NAME

CAS REG.
NO.

TYPICAL RESIDUAL
(%)

residual expected
MAXIMUM RESIDUAL to Is
migrate from the final
(%)
food contact material?

If yes, ensure that exposures to these substances are addressed in Section II.G of this form. If no, provide an explanation below.

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

FORM FDA 3480 (9/05)

Page 5 of 19 Pages

Yes

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Part II - CHEMISTRY INFORMATION (continued)
SECTION C - PHYSICAL/CHEMICAL SPECIFICATIONS
See Chemistry Recommendations, Section II.A.5 and 6
Provide physical and chemical specifications for the FCS such as density, melting point, maximum impurity levels, and solubility in food simulants.
Provide specification test results for at least three production batches of the FCS and attach methods for establishing compliance with specifications.
For Values, provide minimum or maximum specification limits or a range, as appropriate.
1. For the FCS:
SPECIFICATION

VALUE

2. For polymeric FCSs provide the following additional information:
a. Polymer Properties and Test Results of Production Batches
Provide relevant physical data, such as molecular weight distribution, glass transition points, intrinsic or relative viscosities, melt flow indices,
morphology, and crystallinity. Analytical methods should be included. Where appropriate, provide test results for at least three production batches
of the FCS.
PROPERTY

FORM FDA 3480 (9/05)

MAX. VALUE

Page 6 of 19 Pages

MIN. VALUE

INDIVIDUAL BATCH VALUES

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Part II - CHEMISTRY INFORMATION (continued)
SECTION C - PHYSICAL/CHEMICAL SPECIFICATIONS (continued)
b. Molecular Weight Profile of the FCS
Provide a value for the maximum percentage of oligomeric species (not including residual monomers, reactants, or solvents) below 1000
Daltons and include supporting data and analytical methods.

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Section VI of this form.
SECTION D - INTENDED USE
See Chemistry Recommendations, Sections II.B and II.C
1. Describe the intended use of the FCS. Include maximum use level(s) in food-contact materials, types of food-contact articles with or in which the
FCS is expected to be used (e.g., films, coatings, molded articles) and maximum thickness, as applicable. Indicate whether single or repeat use
(or both) is intended:
Single Use
Repeat Use

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Section VI of this form.
2. a. For single-use articles, list the food types expected to contact the FCS, with examples if known. Refer to the food type classifications in
the chemistry recommondations, when possible. Also provide maximum temperatures and times of food contact, referring to the conditions of use
in the chemistry recommondations, when possible. (click here for example)
USE

FORM FDA 3480 (9/05)

FOOD TYPE

Page 7 of 19 Pages

CONDITION OF USE

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Part II - CHEMISTRY INFORMATION (continued)
SECTION D - INTENDED USE (continued)
2. a. CONTINUED

USE

FOOD TYPE

CONDITION OF USE

b. For repeat-use articles, provide a typical use scenario. Include the highest intended use temperature, maximum food-contact time for the article,
and typical amount of food contacted over the service lifetime of the article.

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

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Part II - CHEMISTRY INFORMATION (continued)
3. State the intended technical effect of the FCS. Summarize data demonstrating that the FCS will achieve the intended technical effect.
Specifically address the minimum amount required to achieve the intended technical effect. Include data as an attachment.

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Section VI of this form.
SECTION E - STABILITY DATA
See Chemistry Recommendations, Section II.D.2
1. Describe any degradation, decomposition or other chemical breakdown process (oxidation, photolysis, hydrolysis, etc.) that the FCS may
undergo during either its intended use in the manufacture of a food-contact article or during migration testing (if performed) of a test plaque
containing the FCS. If no degradation is expected, so state.

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

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Part II - CHEMISTRY INFORMATION
2. List the breakdown products for the FCS and provide CAS names, CAS Reg. Nos., and structures, as appropriate. Address the amount of any
breakdown products that migrate to food and ensure that exposures to these substances are addressed in Section II.G of this form.
SUBSTANCE NAME

CAS REG. NO.

SUBSTANCE NAME

STRUCTURE

SUBSTANCE NAME

STRUCTURE

CAS REG. NO.

SUBSTANCE NAME

STRUCTURE

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

FORM FDA 3480 (9/05)

CAS REG. NO.

Page 10 of 19 Pages

CAS REG. NO.

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Part II - CHEMISTRY INFORMATION (continued)
SECTION F - MIGRATION LEVELS IN FOOD
See Chemistry Recommendations, Sections II.D and Appendix II
Summarize information on migration testing and/or calculations in the appropriate sections below for both the FCS and any migrants. A full report of
all analytical testing, including detailed descriptions of methodology, raw data, and sample instrumental output (spectra, chromatograms, etc.) must
be attached.
If exposure estimates are determined by assuming 100% migration to food, or through the use of other methods (see Chemistry Recommendations
II.D.5), skip to Section II.F.2 and provide full details of all calculations.
For repeat-use articles, estimate migrant levels in food using migration testing and/or calculations which take into account the amount of food
contacting the article over its service lifetime (see Chemistry Recommendations, Appendix II, Part 4).
1. MIGRATION TESTING OPTION
See Chemistry Recommendations, Sections II.D.1 through II.D. 3
a. Describe test specimen(s), including full composition (e.g., comonomer composition of base polymer, identities and concentrations of adjuvants,
levels of residual monomer(s)), dimensions (thickness and surface area), and relevant base polymer properties (e.g., density, Tg , Tm , %
crystallinity). Indicate whether specimens were extracted by total immersion or exposed to solvent on a single side.

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Section VI of this form.
b. Identify food or food simulants employed, times and temperatures of extraction, volume of simulant used per extraction, and food simulant
volume-to-specimen surface area ratio (e.g, 10% ethanol, conditions of use A [121°C/2 h, then 40°C/238 h], 200 mL of 10% ethanol solution per
extraction, 10 mL/in²). If the food simulant volume-to-specimen surface area ratio is less than 10 mL/in², provide evidence (e.g., turbidity or
precipitation data) showing that saturation of the food simulant has not occurred.

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

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Part II - CHEMISTRY INFORMATION (continued)
SECTION F - MIGRATION LEVELS IN FOOD (continued)
c. Summarize results of migration testing for each test specimen. Give individual and average migration values (mg/in²) for all analytes in each
simulant at all time points (an example of how the data should be presented is given below). In addition, provide sample calculations relating the
instrumental output to reported migration values in mg/in². For new polymers, provide a measure of oligomer migration and, if possible,
characterize the individual low-molecular weight oligomer components. (click here for example)
SUMMARY OF MIGRATION TESTING
TEST SAMPLE
FORMULATION

FORM FDA 3480 (9/05)

MIGRANT

FOOD OR
FOOD
SIMULANT

TEMPERATURE
AND TIME OF
ANALYSIS

Page 12 of 19 Pages

MIGRATION
(each replicate)

AVERAGE
MIGRATION
(average of replicates)

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Part II - CHEMISTRY INFORMATION (continued)
SECTION F - MIGRATION LEVELS IN FOOD (continued)
d. Provide a summary of method validation results. Give average percent recovery for all analytes, food or food simulants, and fortification (spiking)
levels. Full details, including description of spiking procedure and calculations, must be included as an attachment.

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Section VI of this form.
2. MIGRATION CALCULATION OPTION
See Chemistry Recommendations, Sections II.D. for discussions on 100% migration calculations, II.D.4 for information on FDA’s migration database,
and II.D.5 for migration modeling.
Describe the basis of the mathematical approach used in estimating migration levels to food for the FCS or any migrants, such as impurities,
monomers or breakdown products, in the FCS. Fully describe assumptions made in deriving the estimates and show all calculations.

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

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Part II - CHEMISTRY INFORMATION (continued)
SECTION G - ESTIMATED DAILY INTAKE (EDI)
See Chemistry Recommendations, Sections II.E and Appendix IV
The EDI for the notified use must be calculated by the notifier for both the FCS and any migrants. The notifier is also responsible for providing
cumulative EDIs (CEDIs) reflecting any previously regulated, notified, or otherwise authorized uses of the FCS. The notifier may wish to consult FDA
to obtain this information prior to submitting a notification.

1. SINGLE-USE ARTICLES
Show representative calculations for the EDI for all migrants. Clearly describe the food-type distribution factors (fT ) and consumption factors (CF)
used in the calculations (see Chemistry Recommendations Appendix IV). If f T and/or CF values other than those assigned by FDA are used,
information supporting derivation and use of such factors must be attached. The following general equation is used to calculate an EDI:

EDI

= DC x 3 kg food/p/d
= CF x x 3 kg food/p/d
= CF x [(M aq )(f aq )+(M ac )(f ac )+(M al )(f al )+(M fat )(f fat )] x 3 kg/p/d

where: (aq) is aqueous, (ac) is acidic, (al) is alcoholic, and (fat) is fatty

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number in Section VI of this form.
2. REPEAT-USE ARTICLES
Using the migration levels to food determined in Section II.F.2 and the use scenario information described in Section II.D.2.b, show the
calculations used for determining DC and EDI for the FCS and any migrants.

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

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Part II - CHEMISTRY INFORMATION (continued)
SECTION G - ESTIMATED DAILY INTAKE (EDI) (continued)
See Chemistry Recommendations, Sections II.E and Appendix IV
3. SUMMARY OF THE CHEMISTRY INFORMATION
Summarize the values for weight-average migration (), dietary concentration (DC), and EDI for the FCS and any migrants, including oligomeric
species and breakdown products, as appropriate. Provide cumulative EDI (CEDI) to include this use, where appropriate.

CHEMICAL NAME

FORM FDA 3480 (9/05)

CAS REG.
NO.

(ppb)

Page 15 of 19 Pages

DC
(ppb)

EDI
(mg/person/day)

CDC
(ppb)

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Part III - SAFETY NARRATIVE
The safety narrative is an executive summary describing the scientific basis of your determination that the food contact substance (FCS) is safe
under the conditions of use requested in this notification. Your safety narrative should address any negative information regarding the safety of the
FCS and its constituents. Your safety narrative should summarize the chemistry and toxicology information that justify a conclusion that the intended
use of the FCS is safe. Your safety narrative should also address the safety of any mutagenic or carcinogenic constituents of the FCS. Upper bound
lifetime cancer risk levels and acceptable daily intake values should be included as appropriate. Instructions are provided in Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations, Section VI. Do not provide detailed study
summaries in the safety narrative. Such summaries and supporting documentation should be included in the Comprehensive Toxicology Profile(s) as
an attachment to this notification (see Guidance for Industry - Preparation of Premarket Notification for Food Contact Substances: Toxicology
Recommendations, Section VII).

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

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Part IV - ENVIRONMENTAL INFORMATION (21 CFR Part 25)
All FCN submissions must contain either a claim of categorical exclusion under 21 CFR 25.32 or an environmental assessment (EA) under 21 CFR
25.40.
A - CLAIM OF CATEGORICAL EXCLUSION
1. Cite the specific section(s) of the CFR under which the categorical exclusion is claimed:
21 CFR 25.32 (i)
a. Is the FCS a component of a coating?

Yes

b. If no, the % of the FCS in the finished food-contact article is _______________________________________ and
c. The % of the total market volume that remains with the food-contact articles is _______________________________________
21 CFR 25.32 (j)
Is the FCS a component of a:
a. Repeat-use article?

Yes

b. Permanent or semi-permanent food-contact surface?

Yes

21 CFR 25.32 (k)
21 CFR 25.32 (q)
a. Is current FIFRA label attached?

Yes

b. Is the requested use essentially the same as the label?

Yes

If current FIFRA label has limitation on food-contact uses, provide a draft copy of a revised label you intend to submit to EPA to include
food-contact uses.
21 CFR 25.32 (r)
2. Does your proposed food-contact use comply with the categorical exclusion criteria?
If no, go to section B below.

Yes

3. To the best of your knowledge, are there any extraordinary circumstances that would require your submission of an EA? (see 21 CFR 25.21)
If yes, go to section B below.
Yes
No
B - ENVIRONMENTAL ASSESSMENT
See Environmental Recommendations
1. If an EA is required, state that an EA has been prepared under 21 CFR 25.40, and is attached.
2. Environmental assessments are public documents and should not contain confidential information. Such information should be included in a
separate section of the FCN, labeled confidential and summarized to the extent possible in the EA.

Part V - CERTIFICATION
The accuracy of the statements you make in this notice should reflect your best prediction of the anticipated facts regarding the chemical
substance described herein. Any knowing and willful misinterpretation is subject to criminal penalty pursuant to 18 U.S.C. 1001.
The notifying party certifies that the information provided herein is accurate and complete to the best of his/her knowledge.

SIGNATURE OF AUTHORIZED OFFICIAL OR AGENT

DATE

TITLE

FORM FDA 3480 (9/05)

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Part VI - 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, as appropriate.
Number consecutively the pages of the attachments. In the column below, enter the inclusive page numbers of each attachment.

ATTACHMENT
PAGE NUMBER(S)

ATTACHMENT NAME

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

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LIST OF EXAMPLES
Go Back to Form
2. a. For single-use articles, list the food types expected to contact the FCS, with examples if known. Refer to the food type classifications in
chemistry guidance, when possible. Also provide maximum temperatures and times of food contact, referring to the conditions of use in chemistry
guidance, when possible.
Example: A notifier wishes to obtain approval for the use of a polymer adjuvant, Adjuvant Y, in two specific olefin polymers for use with different
food Types (see chemistry guidance) under different Conditions of Use (see chemistry guidance).

USE

FOOD TYPE

Adjuvant Y used in HDPE at levels not
exceeding 0.3 wt.% of the finished
polymer

Aqueous, Acidic and Low- Alcoholic
(Types I, II, IVB, VIA, VIB and VIIB)

A through H

CONDITION OF USE

Adjuvant Y used in PP at levels not
exceeding 0.2 wt.% of the finished
polymer

Fatty Foods (Types III, IVA, V, VIIA, IX)

C through G

c. Summarize results of migration testing for each test specimen. Give individual and average migration values (mg/in²) for all analytes in each
simulant at all time points (an example of how the data should be presented is given below). In addition, provide sample calculations relating the
instrumental output to reported migration values in mg/in². For new polymers, provide a measure of oligomer migration and, if possible,
characterize the individual low-molecular weight oligomer components.
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.

Go Back to Form
TEST SAMPLE
FORMULATION

LDPE containing
0.01 wt.% of
Adjuvant X

FORM FDA 3480 (9/05)

SUMMARY OF MIGRATION TESTING
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

Page 19 of 19 Pages

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File Modified	2006-02-03
File Created	2005-06-17