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

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f)
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 LowAcid 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)”
Date Received by FDA _ _ /_ _/_ _ _ _ (MM/DD/YYYY) (FDA USE ONLY)
Food Canning Establishment (FCE) Number: _ _ _ _ _ _
Submission Identifier (SID) 20_ _-_ _-_ _/_ _ _ (YYYY-MM-DD/SSS)
A. Product Information:
Note: Section A.1 (Food Product Group) requests optional information.
1. (Optional) Select one Food Product Group. If there is no single best Food Product Group that applies, select Other.
Aquaculture Seafood (e.g., farming of aquatic organisms including fish, mollusks, crustaceans, etc.);
Bakery Products (canned brown bread, bakery glazes); Beans, Corn, or Peas (Select one):
Berry/Citrus/Core Fruit (Select one):
Beverage Base;
botanical teas);

Berry/Citrus/Core Fruit;

Dairy (milk-based);

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

Cocoa;

Coffee/Teas (excluding herbal and

Engineered Seafood (e.g., shelf-stable imitation crab, surimi, etc.);

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

Fruit as a Vegetable (Select one):

Fruit as a Vegetable (e.g., eggplant, pumpkin, etc.)

Fungi (e.g., mushrooms, pleurotus, truffles, etc.);
Gravies/Sauces (spaghetti sauce, mushroom gravy);
Imitation/Pit/Mixed /Subtropical Fruit (Select one):

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Beans, Corn, Peas - Fresh Succulent;

Dietary Supplement and/or herbal and botanical teas;

Dressings/Condiments (e.g., salad dressing, chutney, salsa, pepper sauce, etc.);
Fishery (finfish)

Beans or Peas - Dry or Mature Soaked;

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

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

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

Baby Food (infant/junior foods including infant formula);

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

Gelatin, Pudding Filling for Pies, Pie Filling (liquid form ready-to-eat such as apple pie filling, etc.);
Imitation Dairy (includes soy-based products);
Imitation/Pit/Mixed /Subtropical Fruit;

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

Form FDA 2541f

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
Leafy/Stem Vegetables (Select one):

Leafy/Stem Vegetable;

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

Meal Replacement/Medical Foods (e.g., supplemental liquid nutrition, etc.);
Mixed Vegetables (Select one):

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

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

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

Multiple Food (one container with a separate compartment for each product item. e.g., lasagna dinner, chop suey dinner, etc.);
Pet Food (e.g., dog/cat food, etc.);

Noodle/Pasta;

Nut Spread and Nut Topping;

Other Vegetables;

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

Root and Tuber Vegetables (Select one):
Shelled Egg;

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

Root/Tuber Vegetables (e.g., carrots, leeks, potatoes, etc.);

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

Soup ;

Root/Tuber Vegetables as a Juice or Drink (e.g., carrot juice, etc.);

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

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

Vine/Other Fruit;

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

Wine Cooler;

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

3. What is the form of the product?

Chunks (e.g., chunks, nuggets, etc.)
Cut
Diced
Fillet
French Cut
Liquid (i.e., all liquid no solids)
On the Cob
Paste/Puree
Pieces
Round/Spheres
Shredded/Julienne
Sliced (e.g., slices, quarters, strips, etc.)
Spears/Stalks
Whole
Other (Enter product form) __________________________________________________

4. What is the packing medium?

Brine
Cream/Sauce/Gravy
Oil
Solid (no packing medium)
Syrup
Water
Other (Enter packing medium) _______________________________________________

None (i.e., the product is all liquid)

Continue to Section B.

______________________________________________________________________________________________________________________
B. Governing Regulation: (Refer to the precursor questions in the instructions)
Low-acid (21 CFR 108.35 and 21 CFR Part 113)
Continue to Section C.

______________________________________________________________________________________________________________________
C. Container Type: (Select one)
Note: If the product is not packaged in one of the container types identified below, select Other.
1.

Aluminum/Tinplate/Steel Can
a) What is the shape of the container? (Select one)
Cylindrical
Irregular (Attach a picture or schematic) __________________________________________________________________
Rectangular
Other (Attach a picture or schematic) _____________________________________________________________________________

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Form FDA 2541f

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Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
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
ii.
3-pieces – Do you use perforated divider plates?
Yes
No How is the side seam sealed? (Select one)
2.

3.

Cemented

Welded

Ceramic/Glass
a) What is the shape of the container? (Select one)
Cylindrical
Irregular (Attach a picture or schematic) _____________________________________________________________
Other (Attach a picture or schematic) ______________________________________________________________________
b) Do you use perforated divider plates?
Yes
No
c) Is overpressure used during the processing of the product to maintain container integrity?
Yes (Continue to c.i)
No (Continue to c.ii-c.iv)
i. What is the total overpressure used during processing? _ _._ (enter in pounds per square inch gauge (psig)) (Continue to Section D)
ii. What is the percent (%) headspace? _ _._
iii. What is the minimum initial temperature? _ _ _._ (enter in Fahrenheit)
iv. What is the vacuum? _ _._ (enter in inches of mercury (Hg))
Flexible Pouch
a) What is the shape of the container? (Select one)
Flat pouch
Gable top
Gable top/side gusseted
Gusseted
Irregular (Attach a picture or schematic)_____________________________________________________________
Other (Attach a picture or schematic) _______________________________________________________________
b) Is the container physically restricted during the processing of the product to control container thickness? Yes (Continue to b.i)
i.
Racks
Other (Attach a picture) ____________________________________________________________________
c) Is overpressure used during the processing of the product to control container thickness?
Yes (Continue to c.i)
i. What is the total overpressure used during processing? _ _._ (enter in pounds per square inch gauge (psig))

Rectangular

No (Continue to c)

No (Continue to d)

d) What is the maximum thickness during retort processing? _ _._ _ (enter in inches)
e) What is the maximum residual air? _ _ _ (enter in cubic centimeters)
Not Applicable
4.

Retortable Paperboard Carton
a) What is the shape of the container? (Select one)
Rectangular
Other (Attach a picture or schematic) _______________________________________________________
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.
Racks
Other (Attach a picture) ____________________________________________________
c) Is overpressure used during the processing of the product to control container thickness?
Yes (Continue to c.i)
i. What is the total overpressure used during processing? _ _._ (enter in pounds per square inch gauge (psig))

No (Continue to d)

d) What is the maximum thickness during retort processing? _ _._ _ (enter in inches)
e) What is the maximum residual air? _ _ _ (enter in cubic centimeters)
Not Applicable
5.

Rigid Container (10 pounds or more of product)
a) What is the shape of the container? (Select one)
Cylindrical
Rectangular
Other (Attach a picture or schematic) ____________________________________________________
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
Other (Enter material) _____________________________________________________
Pail (Select one)
Aluminum/Steel
Fiberboard
Plastic
Other (Enter material) ____________________________________________________
Tote (Large industrial rectangular container) (Select one)
Aluminum/Steel
Fiberboard
Plastic
Other (Enter material) ____________________________________________________
Other (Enter rigid container) ________________________________________ (Attach a picture or schematic) __________________________________________________________________

6.

Semi-Rigid
a) What is the shape of the container? (Select one)

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Bowl

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Cylindrical

Irregular (Attach a picture or schematic) ________________________________________________________

Form FDA 2541f

Oval

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
Rectangular
Tray
Other (Attach a picture or schematic) __________________________________________________________________________)
b) Is this a compartmentalized container?
Yes How many compartments? _ _
No
c) What is the predominant material used to make the body of the container? (Select one)
HDPE (high-density polyethylene)
HDPP (high-density polypropylene)
Paperboard
PET (polyethylene teraphthalate)
Other (Enter material) _________________________________________________________________
d) What is the predominant material used to make the lid of the container? (Select one)
Aluminum/Steel
HDPE (high-density polyethylene)
HDPP (high-density polypropylene)
Nylon
PET (polyethylene teraphthalate)
Other (Enter material) _________________________________________________________________
Not Applicable
e) How is the lid sealed to the body of the container? (Select one)
Double Seam
Heat Seal
Induction Weld
Press Twist
Snap On
Threaded Closure
Ultrasonic Seal
Other (Enter seal type) ___________________________________________
Not Applicable
f) Is the container physically restricted during the processing of the product to control container thickness?
Yes (Continue to f.i) No (Continue to g)
i.
Racks
Other (Attach a picture) _________________________________________________________________________
g) Is overpressure used during the processing of the product to control container thickness?
Yes (Continue to g.i)
i. What is the total overpressure used during processing? _ _._ (enter in pounds per square inch gauge (psig))

No (Continue to h)

h) What is the maximum thickness during retort processing? _ _._ _ (enter in inches)
i) What is the maximum residual air? _ _ _ (enter in cubic centimeters)
Not Applicable
7.

Other (Enter container type) ______________________________
a) Attach schematic or picture of container. _______________________________________________________________________________________________
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. ___________
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 _________________
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 __________________________
Continue to Section D.

_______________________________________________________________________________________________________________
D. Container Size:
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.
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.”
For all other circumstances, complete D.1. Section D.3 (net weight) is optional information.
1. Dimensions:
a) _ _ _ _ Diameter _ _ _ _ Height (Use for cylindrical shapes) (see accompanying instructions for proper coding)
b) _ _ _ _ Length _ _ _ _ Width _ _ _ _ Height/Thickness (Use for container shapes other than cylindrical) (see accompanying instructions for proper coding)
2. Volume: _ _ _._ (Select one)

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Fluid Ounces

Gallons

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Liters

Milliliters

Not Applicable

Form FDA 2541f

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
3. Net Weight (Optional) _ _ _._ _ (enter in ounces)
Continue to Section E.
___________________________________________________________________________________________________________________________________________________
E. Processing Method: What method is used for processing this product? (Select one)
1.

2.

Water Activity Control
a) What is the finished equilibrium pH of the product after processing? _ _._ _
b) What is the maximum water activity? 0._ _ _ (Attach documentation to support this value) _________________________________________________________________________________
c) What is controlling the water activity? (Select all applicable factors)
% Salt (e.g., sodium chloride, potassium chloride) _ _._ _ (Select one)
minimum
maximum
Syrup Strength (degrees brix) _ _._ (Select one)
minimum
maximum
% Solids _ _._ _ (Select one)
minimum
maximum
% Moisture _ _ _._ _ (Select one)
minimum
maximum
% Other (Enter Name) ___________________________________________________ (Value) _ _._ _
(Select one)
minimum
maximum
d) Does the product contain microbial preservatives?
Yes (Continue to d.i)
No
i. Enter the preservative(s) and each minimum associated % (e.g., benzoate – 0.1%; sorbate – 0.2%): _________________________________________________________________________________
Formulation Control (Identify all applicable critical factors and attach supporting challenge study) ____________________________________________________________________________
a) What is the % (Sodium Chloride + Di-Sodium Phosphates)? _ _._ _ (Select one)
minimum
maximum
b) What is the % moisture? _ _._ _ (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) What is the % Fat? _ _._ _ (Select one)
minimum
maximum
f) What is the % Phosphates? _ _._ _ (Select one) minimum
maximum
g) What is the % Polyphenols? _ _._ _ (Select one)
minimum
maximum
h) What is the % Microbial Preservatives (e.g. benzoate, sorbate)? ___________________________________________________________________________
i) What is the % Salt (e.g., sodium chloride, potassium chloride) _ _._ _ (Select one)
minimum
maximum
j) What is the maximum water activity? 0._ _ _ (Attach documentation to support this value) ___________________________________________________________________________________
k) What is the % Solids? _ _._ _ (Select one)
minimum
maximum
l) What is the Syrup Strength (degrees brix) _ _._ (Select one)
minimum
maximum
m) Other (Enter Name) ______________________________ (% Value) _ _._ _ (Select one)
minimum
maximum
Continue to Section F.

_________________________________________________________________________________________________________________________________________
F. Process Source:
1. What is the Process Source? ________________________________________________ (Attach support documentation) _________________________________________________
2. What is the date of the Process Source Document (mm/dd/yyyy)? _ _/_ _/_ _ _ _
Continue to Section G.
________________________________________________________________________________________________________________________________________________________
G. Process Mode: (Select one)

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Form FDA 2541f

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
1.
2.
3.

High Temperature Short Time (HTST)
Hot Fill and Hold
Steam Jacketed Kettle

When process mode 1, 2, or 3 is selected, continue to Section H.
4.
5.
6.
7.
8.
9.
10.
11.

Batch Agitating Retort
Crateless Retort
Heating Tunnel – Hot Air, Steam or Water (water cascade, water immersion, water spray)
Hydrostatic Retort
Sterilmatic
Still Retort (Steam or Water)
Water Bath
Other (Attach support documentation) _________________________________________________________________________________

When process mode 4-11 is selected, continue to Section I.
_____________________________________________________________________________________________________________________________________________________
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
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)
1.

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

2.

Heating Tunnel:
a) What is the process time? _ _._ (Select one)
Seconds
Minutes
b) What is the temperature in the heating tunnel? _ _ _._ (enter in Fahrenheit)

3.

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)
i. Select one of the container closure treatments.
Inversion/Laydown of Container: How long is the product inverted/laid-down? _ _._ (Select one)
Seconds
Minutes
Steam Flow Closure
Other (Enter container closure treatment) ________________________________________________________________ What is the exposure time? _ _._ (Select one)

4.

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) ___________________________________________________________

Seconds

Minutes

Continue to Section I.
___________________________________________________________________________________________________________________________________________________________

I. Scheduled Process: (Do not write in shaded areas -- Check appropriate box under column heading, when applicable, and enter numerical values on dashed lines.)

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Form FDA 2541f

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
Col. 1
Process
No

Col. 2
Step

Col. 3
Temperature

Col. 4
Process Time

Col. 5
Process
Temperature

Col. 6
F value
(only one)

Col. 7
Thruput
(Containers
per Minute)

Sterilmatic
or Heating
Tunnel
ONLY

Min. Initial
Fill

Fo
(F18/250)

Seconds
Minutes

Number

Number

◦Fahrenheit

See above

◦Fahrenheit

Other F
Ref T ____
z: ___._
(◦F only)
Minutes

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Col. 8
Headspace

Batch
Agitating
Retort or
Sterilmatic
ONLY

a. Reel
Speed

b. Reel
Diameter

Sterilmatic
or Batch
Agitating
Retort
ONLY

Sterilmatic
ONLY

c. Steps
per
Turn of
Reel

Col. 9
d. Chain /
Conveyer
Speed

Sterilmatic
ONLY

e. Cooker
Capacity

f. Frequency
Strokes per
Minute

Sterilmatic
ONLY

Oscillation
Agitating
ONLY

Feet
Carriers
Flights

Net
Gross
NA

Col. 10
Maximum
Fill Weight

Col. 11
Other

Fill
NA

(per
minute)
Number

Inches

RPM

Inches

Number

Number

Number

Number

Ounces

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J. Additional Information (Optional):
Heat Penetration Study (Attach document) ________________________________________________________________________________________________
Temperature Distribution Study (Attach document) __________________________________________________________________________________________
Other (Attach document) _____________________________________________________________________________________________________________

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Form FDA 2541f

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Comments:

Full Name (Please Type or Print)
Establishment Name

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Signature
State or Province

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Country (other than U.S.)

Date

Telephone No

Form FDA 2541f

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
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
5100 Paint Branch Parkway
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.*
The burden time for this collection of information is estimated to average .333 hour 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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
1350 Piccard Drive, Room 400
Rockville, MD 20850
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Form FDA 2541f

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
“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.”

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Form FDA 2541f