FDA Reader
Simplifying Food Regulation

Blog

FDA Reader: Simplifying Food Regulation

Posts tagged specially regulated foods
Supplemental Registrations and Notifications

Products Requiring Supplemental Registrations & Notifications

Specific product types require additional registration beyond a Food Facility Registration. They include:

  • Acidified Foods & Low-Acid-Canned-Foods

  • Infant Formula

  • New Dietary Ingredient

  • Shell Egg Producer

Acidified Foods & Low-Acid-Canned-Food Registration

This category of foods includes many fermented foods, sauces, salsa, and other food that are kept shelf-stable in a sealed container.

A commercial processor created Acidified Foods (AF) or Low-Acid-Canned-Foods must file with the FDA. Their filing will include the following information:

  • Establishment details

  • List of food processed

  • Processing method

If you are unsure whether this definition applies to your product, check out the glossary below or this guidance document from the FDA:


Infant Formula Registration

adult-affection-baby-1667578.jpg

If you produce or distribute infant formula, then you must register prior to introducing your product to interstate commerce.

**Note that some of these filings must be made 90 days prior to the product entering interstate commerce so that the FDA may have the chance to respond**

This registration will require the following information:

  • Establishment details

  • Product Details

    • name and description

    • An explanation of why it is a new infant formula

    • The quantitative details of the product

    • A description of any reformulation of the product or change in process.

    • Assurance that the infant formula will not be marketed unless in meets FDA criteria.

For specific details about infant formula registrations, click here

New Dietary Ingredients

Dietary supplements that contain a "new dietary ingredient" (anything not marketed before 1994) must notify the FDA about those ingredients. This notification includes information that the new ingredient will be safe to consume as prescribed by the product label.

**Note that this filing must be submitted 75 days prior to the product entering interstate commerce so that the FDA may have the chance to respond**

This notification will contain the following information:

  • Your personal details

  • The name of the new dietary ingredient

  • A description of the supplement that contains the new product

    • Levels of the new ingredient in the product

    • Ordinary conditions of use

    • History or evidence of safe use (i.e. scientific literature, historical evidence, etc.)

Consider consulting this FDA resource about New Dietary Ingredients in Dietary Supplements

Shell Egg Producers

Producers of shell eggs (i.e. an egg hatchery or poultry house) must register the details of their facility. This is due to the high frequency of food borne illnesses associated with shell eggs, largely due to temperature abuse and the transportation of this product. This registration will require the following details:

  • Establishment details

  • Dates/Size of operations

  • Owner information

For more information about requirements for shell egg producers, click here


 
Low Acid Foods Packaged in Hermetically Sealed Containers
06_low_acid.png

What You Need to Know:

  • They are commonly referred to as low-acid-canned-foods (or "LACF") even though they may not be packaged in a can.

  • Low Acid Foods in Hermetically Sealed Containers are by definition (1) shelf stable, (2) heat-treated (3) have a pH of >4.6 and (4) a water activity of 0.85

  • Examples of Low Acid Foods in Hermetically Sealed Containers include: shelf-stable milk in pouches, canned beans, vegetable broth in a pouch.

  • There are 2 primary methods for processing LACF: Using a Retort (pressuring cooker) and Aseptic Processing (a sterile packaging process)

  • They are regulated in 21 CFR Part 113: Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

Key Terms

Low Acid Foods have a pH of >4.6 and a water activity of >0.85

Hermetically Sealed Container is packaging which prevents the entry of microorganisms and maintains the commercial sterility of the contents.

Commercial Sterility means there is zero microbiological activity (including bacteria, spores or anything that could reproduce under shelf-stable conditions

LACF ("Low-Acid-Canned-Food"): This term is used interchangeably with "Low Acid Foods Packaged in Hermetically Sealed Containers". It may apply to foods packaged in containers other than cans (i.e. flexible pouches or jars) which is why the term "hermetically sealed container" is used.

Examples of Low Acid Canned Foods:

This list only includes food products that would be governed under the FDA. Foods that fit the definition of LACF and contain >2% meat content are governed under the USDA.

  • shelf-stable milk (commonly packaged in pouches)

  • Canned tuna

  • Canned black beans

  • Canned corn

  • Canned mushrooms

  • Canned Cauliflower

  • Shelf-stable vegetable broth

Does Part 113 Apply to your food product?

Is my product a Low-Acid-Canned-Food (LACF)?

Even if your product is not "canned", it may fall under the regulation of Part 113. Use the flow (above) to the right to determine whether your product is considered a LACF (aka "low acid food in a hermetically sealed container")

Requirements for Producers of LACF

Personnel

The operators of a processing system that produces LACF must have attended an FDA approved course that instructs on how to safely process these foods. An example of an approved course is "The Better Process Control School" which is offered online or in person.

Source: Part 113.40

Equipment and Procedures

The bulk of regulation under Part 113 relates to the requirements for thermal processing and aseptic processing.

Methods for Processing LACF

The two primary methods for processing low-acid-canned-foods are retort and aseptic processing.

Retort

A retort is a large pressure cooker. Sealed containers of food (typically cans, jars, or pouches) are loaded into the retort and heated using steam and pressure. This thermal treatment kills all of the microbiological activity in the containers.

In a retort process, products are treated after they are packaged and sealed.

The use of high pressure allows the retort to achieve temperatures above boiling, which allows for products to rapidly achieve sterility.

Examples of Foods Processed by Retort: Canned beans, canned vegetables, canned soup, canned tuna

Aseptic Processes

In an aseptic process, the food products are heat processed prior to packaging. Since there is a risk that the packaging or food may become contaminated in the packaging step, the entire process takes place under sterile conditions (hence the term aseptic).

Aseptic manufacturing requires tremendous control to maintain a sterile environment during processing. The machinery to perform this type of process is typically very expensive.

Examples of Foods Processed by Aseptic Process: Shelf-Stable Milk, juice boxes

Exemptions for Producers of Low Acid Canned Foods (LACF)

Processors who operate under Part 113 are exempt from the following requirements:

  • Subpart C (Hazard Analysis and Risk Based Preventive Controls)

  • Subpart G Supply Chain Controls

However, this exemption only applies in regards to microbiological hazards regulated under Part 113. Simply -- if the food processor identifies chemical or physical hazards in their production process, they must address those hazards as they are outlined in Subpart C.

Additionally, if the processor identifies a hazard that requires a supplier-applied preventive control, then the processor would have to conduct supplier verification activities as described in Subpart G.

Source: Part 117.5 (d) (1) & (2)

FAQ

Are fermented foods regulated under Part 113?

If the fermented food has a pH of >4.6 and a water activity > 0.85, then it is considered a "low-acid-canned food" (LACF) and is regulated under Part 113.

If the fermented food has a pH of <4.6 then it is not regulated as a Low-Acid-Canned-Food (Part 113) OR an acidified food (Part 114).

Are Alcoholic Beverages Regulated Under Part 113?

No. Alcoholic beverages are not regulated under Part 113 (Low Acid Foods in Hermetically Sealed Containers) or Part 114 (Acidified Foods).

Sources

21 CFR Part 113 -- Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

 
Acidified Food Regulation (Subpart 114)

What you Need to Know:

If you are unsure of whether your product is an acidified food, see Introduction to Acid Foods

  • If you produce an acidified food, you must conduct additional filings with the FDA (free)

  • Producers of acidified foods must complete the "Better Process Control School" or an equivalent training course (available online)

Required Registrations/Filings for Acidified Food Producers

If you produce an acidified food, you must register your facility and file each acidified foods you process with the FDA.


Food Canning Establishment Registration

Paper Form: Food Canning Establishment Registration

Paper Form: Food Canning Establishment Registration

If you produce an acidified food, you must register the location where you produce that food. This filing is in addition to the normal food-facility-registration.

This filing simply notifies the FDA that acidified foods (which can be higher-risk food products) are being produced at this location. Completing this registration will not trigger an inspection.

File Electronically:Food Canning Establishment Registration (Form 2541).

File in Paper: Food Canning Establishment Registration (Form 2541)

If you have addition questions about completing Form 2541 see Instructions on Registering a Food Canning Establishment


Food Process Filing for an Acidified Food

Paper Form: Food Process Filing for an Acidified Food (Form 2541e)

Producers of acidified foods must file a scheduled process for each acidified product that they produce. If a salsa company produces 5 SKUs that are all acidified foods, then they must submit 5 process filings, one for each SKU.

There is no requirement to file for products that do not fit the definition of an "acidified food".

File Electronically:Food Process Filing for an Acidified Food (Form 2541e)

File in Paper:Food Process Filing for an Acidified Food (Form 2541e)

If you have questions about the filing process, see Instructions on filing Form 2541e


Requirements for Processing Acidified Foods

Always follow your scheduled process and contact your process authority if something goes wrong.

Process and Controls

Scheduled Process

  • The manufacturer must follow a scheduled process.

  • The schedule process must be established by a person who as expert knowledge about the acidification and processing of acidified foods.

Processing Operations

  • The food must be thermally-processed (i.e. a heat-based kill step) to eliminate bacteria capable of reproducing in the finished product. Preservatives may be used in lieu of thermal processing for controlling the growth of microorganisms that are not harmful (i.e. spoilage bacteria that would ruin the food but not cause illness in humans).

  • Keep your production records onsite (digital is fine) for at least 3 years.

Source: §114.80 (a) (1)

Acidification Procedures

Some acceptable methods used to acidify foods include:

  • Blanching ingredients in acidified solutions

  • Immersing blanched ingredients in acidified solutions

  • Directly adding a measured amount of acid solution into a batch of food.

  • Directly adding a measured amount of acid into individual containers during product.

Source 114.80 (a) (3)

Measuring pH

  • The equilibrium pH of the final product must be below 4.6 and it must reach this within the timeframe set in the scheduled process.

  • The pH of the product must be measured and recorded to maintain control throughout the process. If the final pH of the product is ≥4.0, then a potentiometric pH meter must be used (these are more accurate). If the final pH is <4.0, any type of pH meter may be used.

  • pH readings should be taken at a temperature of 20ºC-30ºC (68º-86ºF). Optimal temperature for pH test accuracy is 25ºC (77ºF).

Source 114.80 (a) (1) & (2)

For a full explanation of pH and testing methodology, see §114.90

Containers and Coding:

  • You must test and examine your containers to confirm that they protect your final product from leakage or contamination

  • Each container must be labeled with a code that specifies the following:

    • Where the product was packed

    • The contents of the container

    • The date of packing

    • The code must be changed for each personnel shift, at minimum.

Deviations from Scheduled Process

If the equilibrium pH is measured at >4.6 the processor must take one of the following steps:

  • Fully reprocess the food using a process approved by a process authority (this can be simply re-processing according to your usual method)

  • Thermally process the food as a low-acid-canned food

  • Set aside the food for evaluation by a process authority

  • Destroy the food.

Make a record of this incident, regardless of the outcome.


FAQ

Do I need to register my facility and products if I operate outside the US?

If you produce a product that meets the definition of an "acidified food" for consumption inside the US, then you must register your facility (Form 2541) and each of your acidified food products (2541e).

Processors located outside the US must also complete these registrations if their food will be exported for consumption inside the US.

Wholesalers, importers, distributors and brokers are not required to register and file processes

Source

Does compliance with Subpart 114 exempt me from other requirements?

A business operating under Acidified Food Regulations ( Subpart 114 ) is still subject to the requirements in Subpart 117 B: Current Good Manufacturing Processes as it relates to determining whether a product is adulterated.

 
Introduction to Acid Foods
Foods with a pH of &lt;4.6 are called "Acid Foods" Some types of acid foods, such as  acidified foods , are subject to specific regulation.

Foods with a pH of <4.6 are called "Acid Foods" Some types of acid foods, such as acidified foods, are subject to specific regulation.

What are Acid Foods?

Acid Foods: A food with a natural pH of ≤4.6. There are many naturally acidic foods, including apples, yogurt, peaches, onions, tomatoes, strawberries and lemons.

"Acid Foods" as a general group are not regulated, although certain sub-groups of acid foods are.

Types of Acid Foods

There are two main types of acid foods

Acid-Food-Types-1-1.jpg

Acidified Food: These are low-acid foods that has been acidified by adding something acidic so that the end product is ultimately acidic has an equilibrium pH of ≤4.6) . This includes foods such as: dill pickles, hot sauce, and pickled fish.

The FDA does not include the following to be Acidified Foods:

  • Carbonated Beverages

  • Jams, jellies & preserves

  • Naturally acid foods like peaches and most fruit juices

  • Foods with a water activity of ≤0.85

  • Foods which are stored under refrigeration

  • Fermented foods (i.e. kimchi, sauerkraut, natto)

The FDA regulates acidified foods in 21 CFR Part 114.

Formulated Acid Foods: These are composed mostly of acid foods to which a small amount of low-acid ingredients are added (generally less than 10% by weight). The low proportion of low-acid ingredients means that the pH doesn't change significantly from the pH of the dominant ingredients. Examples include:

  • Barbecue Sauce

  • Salad Dressings

  • Marinades

Use this key to determine if your food is an acidified food.

FAQ

Is my product an Acidified Food?

Consider this flow chart to determine if your product is regulated by the FDA as an Acidified Food:

Click to enlarge

What's the difference between an acidified food and a formulated acid food?

The difference between these two types acid foods depends on the proportion of low acid and high-acid ingredients in each product:

Acidified foods are typically low acid foods with an added acid (which acidifies the low acid food.)

Formulated Acid foods are composed mainly of high acid foods with a small amount of low acid foods added.

Formulated Acid Foods

In order to qualify as a "formulated acid food", the low-acid ingredients must not significantly shift the pH of the product from the natural pH of the high-acid ingredients.

For a food product whose equilibrium (final) pH is <4.0, then a shift of up to 0.4 is considered insignificant.

For a food product whose equilibrium (final) pH is >4.0, then a shift of up to 0.1 is considered insignificant.:

Example #1:  Ned's BBQ Sauce.

Ingredients by weight: Tomato paste (93%), Sugar (5%), Spices (2%)

Ned's BBQ Sauce Equilibrium pH: 3.9

pH of only High-Acid Ingredients: 3.6

Change between high-acid ingredients and final product = 0.3

Since the equilibrium pH of Ned's BBQ Sauce is below 4.0, only an increase of 0.4 or more would be considered significant. Since the low-acid ingredients only increase the pH by 0.3, this change is considered insignificant.

Outcome: Ned's BBQ Sauce is a Formulated Acid Food. It is not subject to 21CFR Part 114



Example #2: Ned's Marinade

Ingredients by weight: Tomatoes (60%) Onion (10%) Vinegar (20%) Sugar (7%) Spices (3%)

Ned's Marinade Equilibrium pH: 4.2

pH of only High-Acid Ingredients: 4.0

Change between high-acid ingredients and final product = 0.2

Since the equilibrium pH of Ned's BBQ Sauce is above 4.0, an increase of above 0.1 would be considered significant. Since the low-acid ingredients increase the pH by 0.2, this change is considered significant.

Outcome: Ned's BBQ Sauce is an acidified food. As a result, it is subject to The regulations in 21 CFR Part 114.

 
Specially Regulated Foods

Introduction

If you are producing human food then you are most likely governed under Title 21 -- Chapter 1 -- Subchapter B -- Part 117. 

However, some foods are subject to special requirements. If your business produces one of the food types below, click the link to learn more their special requirements:

If you don't produce any of these specially regulated products, then you are likely regulated under Part 117

Animal Food

If you make animal food (including pet treats), then you will be governed under Title 21 -- Chapter 1 -- Subchapter E.

Unfortunately, this resource doesn't have any detailed information for you, but you can access the regulations at the link above.

Infant Formula

Infant Formula is defined in the FDA regulation as

If your business produces infant formula, you will be required to comply with:

Bottled Water

Bottled water is defined as:

This includes water labeled as "Drinking water", "Mineral water", "Spring water", "Purified water".

To be clear, water is the only ingredient bottled water.

Water with added carbonation (i.e. soda water, tonic water, and seltzer) is generally regulated by the FDA as soft drinks.

If you are still unclear about what is bottled water, read the definition in the FDA Regulation

Bottled Water producers are subject to the following regulations:

Dietary Supplements

This term is legally complicated and only a partial definition is offered below. Click through the image to access the full definition from the FD&C Act

Fish & Fishery Products (Seafood)

Fish / Fishery Products are defined in the FDA Regulation as:

fish-fishery-product-definition.png

The regulation for Fish & Fishery Products can be found in the FDA Regulations at:

Note that the Food Safety and Modernization Act has impacted the regulation of Seafood -- in some ways allowing for exemptions to the above regulations. For more detail, see the following guidance document on Seafood HACCP and the FDA FSMA

Juice

Juice is defined as:

A juice processor is regulated in the FDA Regulations at:

Unlike many other food types, juice processors must comply with Part 120 even if their product is not entering interstate commerce.

If compliant with Part 120, then Juice processors are exempt from 117 Subpart C (Food Safety Plan) and Subpart G (Supply Chain Program)

For more information on juice processing regulations, check out the Section For Juice Processors on the FDA website or this guidance document, below

What's Next:

Do you produce a different type of product?  Requirements for FDA Food Producers

Not sure if the FDA Regulates your business? Learn about FDA Jurisdiction