Form 2541f Food Process Filing for Water Activity/Formulation Contr

Form Approved: OMB NO. 0910-0037; Expiration Date 10/31/2023 (See PRA Statement on last page)

Food Process Filing for Water Activity/Formulation
Control Method (Form FDA 2541f)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Note: There are separate process filing forms for each of the following: Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d); Food Process Filing for Acidified Method
(Form FDA 2541e); Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f); and Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g).
USE FDA INSTRUCTIONS ENTITLED “Instructions for Paper Submission of Form FDA 2541f (Food Process Filing for Water Activity/Formulation Control Method)”
FDA USE ONLY

Date Received by FDA:

/

/

(MM/DD/YYYY)

Food Canning Establishment (FCE) Number (Enter number assigned by FDA)

Submission Identifier (SID) (YYYY-MM-DD/SSS)

20
A. Product Information

Gelatin, Pudding Filling for Pies, Pie Filling (liquid form ready-to-eat such as apple pie
filling, etc.)
Gravies/Sauces (spaghetti sauce, mushroom gravy)

Aquaculture Seafood (e.g., farming of aquatic organisms including fish, mollusks,
crustaceans, etc.)

Imitation Dairy (includes soy-based products)

Baby Food (infant/junior foods including infant formula)

Imitation/Pit/Mixed/Subtropical Fruit

Bakery Products (canned brown bread, bakery glazes)

Imitation/Pit/Mixed/Subtropical Fruit

Beans, Corn, or Peas

Imitation/Pit/Mixed/Subtropical Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping

Beans, Corn, Peas - Fresh Succulent

Leafy/Stem Vegetables

Berry/Citrus/Core Fruit

Leafy/Stem Vegetable
Leafy/Stem Vegetable as a Juice or Drink (e.g., spinach juice, etc.)

Berry/Citrus/Core Fruit
Berry/Citrus/Core Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping

Meal Replacement/Medical Foods (e.g., supplemental liquid nutrition, etc.)

Breakfast Foods (liquid form – ready-to-eat, such as porridge, gruel)

Cheese (does not include soy cheese or imitation dairy)
Cocoa

/

Fungi (e.g., mushrooms, pleurotus, truffles, etc.)

1. (Optional) Select one Food Product Group. If there is no single best Food Product
Group that applies, select Other.

Beverage Base

-

A.1 (Food Product Group) (Continued)

Note: Section A.1 (Food Product Group) requests optional information.

Beans or Peas - Dry or Mature Soaked

-

Mixed Vegetables (e.g., carrots and peas, etc.)

Dairy (milk-based)

Mixed Vegetables as a Juice or Drink (e.g., carrot and green bean juice, etc.)

Dietary Supplement and/or herbal and botanical teas
Dressings/Condiments (e.g., salad dressing, chutney, salsa, pepper sauce, etc.)
Engineered Seafood (e.g., shelf-stable imitation crab, surimi, etc.)

Mixed Fishery (e.g., seafood salad, etc.)

Mixed Vegetables

Coffee/Teas (excluding herbal and botanical teas)

Crustacean (e.g., crab, shrimp, lobster, etc.)

Meat Products (Exotic Meat (emu, elk, etc.))

Fishery (finfish)

Fishery (other aquatic (e.g., alligator, cuttlefish, frog legs, squid, etc.)

Multiple Food (one container with a separate compartment for each product item (e.g.,
lasagna dinner, chop suey dinner, etc.)
Noodle/Pasta
Other Vegetables
Nut Spread and Nut Topping
Pet Food (e.g., dog/cat food, etc.)

Fruit as a Vegetable

Rice, Wheat, Oat or Grain (liquid form – ready-to-eat such as grits)

Fruit as a Vegetable (e.g., eggplant, pumpkin, etc.)
Fruit as a Vegetable Juice or Drink (e.g., eggplant juice, pumpkin juice, etc.)

FORM FDA 2541f (12/20)

Page 1 of 9

PSC Publishing Services (301) 443-6740

EF

Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f)

C. Container Type (Select one)

A.1 (Food Product Group) (Continued)
Root and Tuber Vegetables

Note: If the product is not packaged in one of the container types identified below,
select Other.

Root/Tuber Vegetables (e.g., carrots, leeks, potatoes, etc.)
Root/Tuber Vegetables as a Juice or Drink (e.g., carrot juice, etc.)
Shelled Egg

1.
Soup

Shellfish (e.g., clams, mussels, oysters, etc.)

Aluminum/Tinplate/Steel Can
a) What is the shape of the container? (Select one)
Cylindrical

Sweet Goods/Dessert (liquid form – ready-to-eat, such as pudding)

Oval

Rectangular

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Vegetable Protein Products (e.g., imitation meat analog)
Vine/Other Fruit
Vine/Other Fruit

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Vine/Other Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping
Wine Cooler

b) How many pieces are used to construct the container? (Select one or more choices,
as applicable)
i.
2-pieces – Do you use perforated divider plates?
Yes
No

Other (Specify below)
2. Enter Product Name (e.g., soy sauce (low sodium), fish sauce, caramel sauce, cheese
sauce (with or without Jalapeno Peppers), etc.).

ii.

3-pieces – Do you use perforated divider plates?

2.

3. What is the form of the product? (Select all that are applicable)
Liquid (i.e., all liquid no solids)
Round/Spheres
Spears/Stalks

Cut

Diced

On the Cob

Shredded/Julienne

Filet

Paste/Puree

No

How is the side seam sealed? (Select one)
Cemented

Chunks (e.g., chunks, nuggets, etc.)

Yes

French cut

Welded

Ceramic/Glass
a) What is the shape of the container? (Select one)
Cylindrical

Pieces

Rectangular

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Sliced (e.g., slices, quarters, strips, etc.)

Whole

Other (Enter product form)

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

4. What is the packing medium? (Select all that are applicable)
Brine

Cream/Sauce/Gravy

Syrup

Water

Oil

b) Do you use perforated divider plates?

Solid (no packing medium)

None

Yes

No

c) Is overpressure used during the processing of the product to maintain container integrity?

Other (Enter packing medium)

Yes (Continue to c.i)

Continue to Section B.

i.

No (If using a Process Mode of: Batch Agitating,
Hydrostatic Retort, or Still Retort; continue to c.ii-c.iv;
otherwise, continue to Section D).

What is the total overpressure used during processing? _ _._
(enter in pounds per square inch gauge (psig)) (Continue to Section D)

B. Governing Regulation (Refer to the precursor questions in the
instructions)

ii. What is the percent (%) headspace? _ _._

x Low-acid (21 CFR 108.35 and 21 CFR Part 113)

iii. What is the minimum initial temperature? _ _ _._ (enter in Fahrenheit)
iv. What is the vacuum? _ _._ (enter in inches of mercury (Hg))

Continue to Section C.
FORM FDA 2541f (12/20)

Page 2 of 9

Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f)
C. Container Type: 4. Retortable Paperboard Carton (Continued)

C. Container Type (Continued)
3.

Flexible Pouch

c) Is overpressure used during the processing of the product to control container thickness?

a) What is the shape of the container? (Select one)
Flat pouch

Gable top

Yes (Continue to c.i)

Gable top/side gusseted

Gusseted

i.

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

No (Continue to d)

What is the total overpressure used during processing? _ _._ (enter in pounds
per square inch gauge (psig))

d) What is the maximum thickness during retort processing?
_ _ ._ _ (enter in inches)

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

e) What is the maximum residual air? _ _ _ (enter in cubic centimeters)
5.

b) Is the container physically restricted during the processing of the product to control
container thickness?
Yes (Continue to b.i)
No (Continue to c)
i.

c) Is overpressure used during the processing of the product to control container thickness?
No (Continue to d)

b) What kind of rigid container is used? (Select the description that best applies to the
container (i.e., drum, pail, or tote) and select the material that makes up that container)
Drum (Large industrial cylinder container) (Select one)
Aluminum/Steel

Fiberboard

Plastic

Fiberboard

Plastic

Pail (Select one)

d) What is the maximum thickness during retort processing?
_ _ ._ _ (enter in inches)
Not Applicable

4.

Rectangular

Other (Enter material)

What is the total overpressure used during processing? _ _._ (enter in pounds
per square inch gauge (psig))

e) What is the maximum residual air? _ _ _ (enter in cubic centimeters)

Cylindrical

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Other (Attach a picture. Provide name or a brief description of attachment
below.)

i.

Not Applicable

Rigid Container (industrial size)
a) What is the shape of the container? (Select one)

Racks

Yes (Continue to c.i)

Not Applicable

Aluminum/Steel
Not Applicable

Other (Enter material)
Tote (Large industrial rectangular container) (Select one)

Retortable Paperboard Carton
a) What is the shape of the container? (Select one)

Aluminum/Steel

Rectangular

Fiberboard

Plastic

Other (Enter material)

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Other (Enter rigid container)
b) Is the container physically restricted during the processing of the product to control
container thickness?
Yes (Continue to b.i)
i.

(Attach a picture or schematic. Provide name or a brief description of
attachment below.)

No (Continue to c)

Racks
Other (Attach a picture. Provide name or brief description of attachment below.)

FORM FDA 2541f (12/20)

Page 3 of 9

Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f)
C. Container Type: 6. Semi-Rigid (Continued)

C. Container Type (Continued)
6.

Semi-Rigid

f) Is the container physically restricted during the processing of the product to control
container thickness?

a) What is the shape of the container? (Select one)
Bowl

Cylindrical

Oval

Rectangular

Yes (Continue to f.i)

Tray

i.

Irregular (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

Other (Attach a picture. Provide name or a brief description of attachment
below.)

Other (Attach a picture or schematic. Provide name or a brief description of
attachment below.)

g) Is overpressure used during the processing of the product to control container thickness?
Yes (Continue to g.i)
i.

b) Is this a compartmentalized container?
Yes

How many compartments? _ _

No

Paperboard

Aluminum/Steel

i) What is the maximum residual air? _ _ _ (enter in cubic centimeters)
7.

Not Applicable

Nylon

b) Specify the material that, based on weight, is the predominant material used to make the
container stock. This is the material that constitutes the highest weight value of the
container stock.

PET (polyethylene teraphthalate)
Not Applicable
Other (Enter material)

c) Specify the material that, based on weight, is the predominant material used to make the
lid stock. This is the material that constitutes the highest weight value of the lid stock. If
the container does not have a lid, specify Not Applicable.

e) How is the lid sealed to the body of the container? (Select one)
Heat Seal
Threaded Closure

Induction Weld

Other (Enter container type)
a) Attach schematic or picture of container. (Provide name or a brief description of
attachment below.)

HDPE (high-density polyethylene)

HDPP (high-density polypropylene)

Press Twist

d) Specify the method used to seal the lid to the body of the container. If the container does
not have a lid, specify Not Applicable.

Ultrasonic Seal

Not Applicable
Other (Enter seal type)

FORM FDA 2541f (12/20)

Not Applicable

PET (polyethylene teraphthalate)

d) What is the predominant material used to make the lid of the container? (Select one)

Snap On

What is the total overpressure used during processing? _ _._ (enter in pounds
per square inch gauge (psig))
_ _ ._ _ (enter in inches)

HDPP (high-density polypropylene)

Other (Enter material)

Double Seam

No (Continue to h)

h) What is the maximum thickness during retort processing?

c) What is the predominant material used to make the body of the container? (Select one)
HDPE (high-density polyethylene)

No (Continue to g)

Racks

Continue to Section D.

Page 4 of 9

Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f)
E. Processing Method: 1.c. Water Activity Control (Continued)

D. Container Size

Syrup Strength (degrees brix) _ _._ (Select one)

Note: You are required to complete either D.1 (Dimensions) or D.2 (Volume). You may
complete D.2 if you intend to select the thermal process mode in Section G as: 1) High
Temperature Short Time (HTST); 2) Hot Fill and Hold; or 3) Steam Jacketed Kettle.

minimum
minimum

If you are completing D.2 because you intend to select HTST, Hot Fill and Hold, or
Steam Jacketed Kettle, and if 1) your product is a cheese product under Section A.1,
and 2) you have identified “Other” under Section C, you may indicate “Not Applicable”
in your response to D.2. In all other circumstances, if you are completing D.2 in
accordance with the directions in paragraph 1, you may not select “Not Applicable.”

minimum

% Other (Enter Name)
minimum

b) _ _ _ _ Length _ _ _ _ Width _ _ _ _ Height/Thickness (Use for container shapes
other than cylindrical) (see accompanying instructions for proper coding)

2.

2. Volume: _ _ _._ (Select one)
Not Applicable

3. Net Weight (Optional): _ _ _._ _ (enter in ounces)

a) What is the % (Sodium Chloride + Di-Sodium Phosphates)? _ _ ._ _ (Select one)
minimum
maximum

c) What is the finished equilibrium pH of the product after processing? _ _ ._ _
d) What is the % Catechins? _ _ ._ _ (Select one)
minimum
maximum

E. Processing Method

e) What is the % Fat? _ _ ._ _ (Select one)
minimum
maximum
f) What is the % Phosphates? _ _ ._ _ (Select one)

What method is used for processing this product? (Select one)
Water Activity Control

minimum
maximum
g) What is the % Polyphenols? _ _ ._ _ (Select one)
minimum
maximum

a) What is the finished equilibrium pH of the product after processing? _ _ ._ _

b) What is the maximum water activity? 0. _ _ _

h) What is the % Microbial Preservatives (e.g. benzoate, sorbate)?

(Attach documentation to support this value.)

i) What is the % Salt (e.g., sodium chloride, potassium chloride) _ _ ._ _ (Select one)
minimum
maximum

c) What is controlling the water activity? (Select all applicable factors)

j) What is the maximum water activity? 0. _ _ _

% Salt (e.g., sodium chloride, potassium chloride) _ _ ._ _ (Select one)
minimum

Formulation Control (Identify all applicable critical factors.)
(Attach supporting challenge study.)

b) What is the % moisture? _ _ ._ _ (Select one)
minimum
maximum

Continue to Section E.

1.

No

i. Enter the preservative(s) and each minimum associated % (e.g., benzoate – 0.1%;
sorbate – 0.2%)

a) _ _ _ _ Diameter _ _ _ _ Height (Use for cylindrical shapes) (see accompanying
instructions for proper coding)

Milliliters

maximum

d) Does the product contain microbial preservatives?
Yes (Continue to d.i)

Liters

maximum

(Value) _ _ ._ _ (Select one)

1. Dimensions:

Gallons

maximum

% Moisture _ _ ._ _ (Select one)

For all other circumstances, complete D.1. Section D.3 (net weight) is optional
information.

Fluid Ounces

maximum

% Solids _ _ ._ _ (Select one)

(Attach documentation to support this value.)

maximum

(Continue next page – Formulation Control)
FORM FDA 2541f (12/20)

Page 5 of 9

Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f)
E. Processing Method: 2. Formulation Control (Continued)

H. Container and Container Closure Treatment: (Complete this section
ONLY for Process Modes: 1) High Temperature Short Time (HTST);
2) Hot Fill and Hold; 3) Steam Jacketed Kettle

k) What is the % Solids? _ _ ._ _ (Select one)
minimum

maximum

Describe how the container, headspace, and interior surface (the surfaces that are in contact
with the food) of the container closure are treated. (Select one)

l) What is the Syrup Strength (degrees brix) _ _._ (Select one)
minimum

maximum

1.

m) Other (Enter Name)
(% Value) _ _ ._ _ (Select one)
minimum

Aseptically Filled:
a) What is the filler name and model?

maximum
2.

Continue to Section F.

Heating Tunnel
a) What is the process time? _ _._ (Select one)

F. Process Source

Seconds

1. What is the Process Source?

Minutes

b) What is the temperature in the heating tunnel? _ _ _._ (enter in Fahrenheit)
3.

(Attach support documentation)

Hot Fill and Hold
a) What is the temperature of the product in the container at the end of the hold time?
_ _ _._ (enter in Fahrenheit)

2. What is the date of the Process Source Document (mm/dd/yyyy)? _ _ / _ _ / _ _ _ _

i. Select one of the container closure treatments.
Inversion/Laydown of Container: How long is the product inverted/laid-down?
_ _._ (Select one)

Continue to Section G.

G. Process Mode (Select one)
1.

High Temperature Short Time (HTST)

2.

Hot Fill and Hold

3.

Steam Jacketed Kettle

Seconds
Steam Flow Closure

Other (Enter container closure treatment)
What is the exposure time? _ _._ (Select one)

When process mode 1, 2, or 3 is selected, continue to Section H.

Seconds

4.

Batch Agitating Retort

5.

Crateless Retort

6.

Heating Tunnel - Hot Air, Steam or Water (water cascade, water immersion, water spray)

7.

Hydrostatic Retort

8.

Sterilmatic

9.

Still Retort (Steam or Water)

10.

Bath (Steam or Water)

11.

Other (Attach support documentation)

When process mode 4-11 is selected, continue to Section I.

FORM FDA 2541f (12/20)

Minutes

4.

Minutes

Water spray
a) What is the process time? _ _._ (Select one)
Seconds
Minutes
b) What is the temperature of the water spray? _ _ _._ (enter in Fahrenheit)

5.

Other (Specify below)

Continue to Section I.
Page 6 of 9

Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f)

I. Scheduled Process: (Do not write in shaded areas -- Check appropriate box under column heading, when applicable, and enter numerical values on
dashed lines.)
In the section below, please do NOT enter decimal points. They are already on the form. No blank spaces are allowed, therefore, enter leading zeros, where necessary.
Col. 1

Col. 2

Col. 3

Col. 4

Col. 5

Col. 6

Col. 7

Process
No

Step

Temperature

Process
Time

Process
Temperature

F value
(only one)

Thruput
Headspace
(Containers
per Minute)

Min. Initial

Seconds

Lowest
Hold
Temp.

Minutes

Fo
(F18/250)
Other F
Ref T _____
z: _ _._
(◦F only)

Col. 8

Col. 9
a. Reel
Speed

b. Reel
Diameter

c. Steps per
Turn
of Reel

d. Chain/
Conveyer
Speed

e. Cooker
Capacity

f. Frequency
Strokes per
Minute

Col. 10

Col. 11

Maximum
Fill Weight

Other

Net

Feet

Fill

Gross

Carriers

NA

NA

Flights
(per minute)

Number

Number

◦Fahrenheit

See above

◦Fahrenheit

Minutes

Number

Inches

RPM

Inches

Number

Number

Number

Number

Ounces

__

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FORM FDA 2541f (12/20)

Page 7 of 9

Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f)

J. Additional Information (Optional)
Heat Penetration Study (Attach document. Provide name or a brief description of attachment below.)

Temperature Distribution Study (Attach document. Provide name or a brief description of attachment below.)

Other (Attach document. Provide name or a brief description of attachment below.)

Comments:

Note: Under the terms and provisions of Title 18, Section 1001, United States
Code, in any matter within the jurisdiction of the executive branch of the
Government of the United States it is a criminal offense to falsify, conceal, or
cover up a material fact; make any materially false, fictitious, or fraudulent
statement or representation; or make or use any false writing or document
knowing the same to contain any materially false, fictitious, or fraudulent
statement or entry.

when it contains parameters that cannot be reconciled with one another, such
that the filing does not describe a process that could actually be carried out. If
we determine that your process filing appears fabricated, we will delete the
filing from our system and notify you. We will not consider you to have
complied with 21 CFR 108.35(c)(2) until you submit a completed process filing
that does not appear to be fabricated.

If your process filing appears to be fabricated, the product on this form will not
be in compliance with 21 CFR 108.35(c)(2). A process filing appears fabricated
Full Name (Please Type or Print)
Establishment Name

FORM FDA 2541f (12/20)

Signature
State or Province

Country (other than U.S.)

Page 8 of 9

Date

Telephone No.

Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f)

LACF Contact Information
For more information, contact the LACF Registration Coordinator by e-mail at [email protected] or phone: 240-402-2411.
For paper submissions, send completed forms to:
Food and Drug Administration
LACF Registration Coordinator (HFS-303)
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park, MD 20740-3835

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
PAPERWORK REDUCTION ACT NOTICE
The time required to complete this collection of information is estimated to average 20 minutes per response,
including the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any other
aspect of this information collection, including suggestions for reducing this burden, to:
FDA PRA Staff
Office of Operations
Food and Drug Administration
email to [email protected]
“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 number.”

FORM FDA 2541f (12/20)

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