Source: https://www.fdareader.com/blog/tag/acidified+foods
Timestamp: 2019-05-21 14:42:11
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Matched Legal Cases: ['art 114', '§114', '§114', 'art 114', 'art 114', 'art 117', 'art 114', 'art 114', 'art 114', 'art 114']

Posts tagged acidified foods
Acidified Food Regulation (Subpart 114)
If you are unsure of whether your product is an acidified food, see Introduction to Acid Foods
Food Process Filing
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.
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.
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.
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)
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.
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
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
Specially Regulated Foods
Guidance DocumentNed Klein December 21, 2018 title acidified foods regulation (part 114), acidified foods, specially regulated foods, fermented foods, canned foods, pickled foods
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
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:
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:
Use this key to determine if your food is an acidified food.
Consider this flow chart to determine if your product is regulated by the FDA as an Acidified Food:
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.
More on Specially-Regulated Foods
Guidance DocumentNed Klein December 20, 2018 acid foods, acidified foods, specially regulated foods, fermented foods, pickled foods, canned foods, title introduction to acid foods, front page