What is an FDA Food Canning Establishment (FCE) registration?

An FCE registration identifies a facility that manufactures, processes, or packs certain shelf-stable foods such as low-acid canned foods (LACF) and acidified foods for distribution in the United States.

What are SID scheduled process filings?

SID process filings (scheduled process filings) describe the processing methods used for certain acidified and low-acid canned foods. These filings are submitted to FDA for each applicable product and process to help demonstrate food safety controls.

Which products commonly require FCE and SID filings?

Products that may require FCE and SID filings can include shelf-stable low-acid canned foods and acidified foods such as certain sauces, salsas, pickled products, canned vegetables, and similar items depending on formulation and processing.

Do foreign facilities need FCE registration and SID filings?

Yes. If a foreign facility manufactures applicable low-acid canned foods or acidified foods for the U.S. market, the facility may be required to obtain FCE registration and submit SID scheduled process filings, depending on the product and process.

Is FCE/SID the same as FDA food facility registration?

No. FDA Food Facility Registration is a general requirement for many food facilities, while FCE registration and SID filings apply to certain categories such as low-acid canned foods and acidified foods. Some facilities may need both depending on their operations.

Can FDA Registration Assistance help with both FCE registration and SID filings?

Yes. FDA Registration Assistance supports companies with FCE registration and SID scheduled process filings, along with related compliance steps to help reduce delays and regulatory issues when entering the U.S. market.

Food Canning Establishment l FDA Experts

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Low-Acid Canned Food (LACF) & Food Canning Establishment (FCE) Registration Services

Federal regulations require commercial processors of shelf-stable acidified foods and low-acid canned foods packaged in hermetically sealed containers and sold in the United States to comply with specific U.S. Food and Drug Administration (FDA) requirements.

Under 21 CFR Part 108, applicable facilities must:

Register each establishment with the FDA, and
File scheduled processes for each product, product style, container size and type, and processing method.

These requirements are designed to prevent food safety hazards such as Clostridium botulinum and ensure the safety of shelf-stable canned foods.

What Is a Low-Acid Canned Food (LACF)?

A Low-Acid Canned Food (LACF) is defined as any food (excluding alcoholic beverages) that:

Has a finished equilibrium pH greater than 4.6
Has a water activity (aw) greater than 0.85
Is packaged in a hermetically sealed container
Excludes tomatoes and tomato products with a finished equilibrium pH of 4.7 or lower

What Is an Acidified Food (AF)?

An Acidified Food (AF) is a low-acid food to which acid(s) or acid foods are added to achieve:

A finished equilibrium pH of 4.6 or below
A water activity (aw) greater than 0.85

Acidified foods are also subject to FDA registration and process filing requirements when packaged in hermetically sealed containers.

FDA Registration Requirements for LACF & Acidified Foods

Facilities that manufacture, process, or package foods intended for consumption in the United States must register in the FDA Food Facility Registration (FFR) system.

In addition:

Facilities producing certain acidified foods or low-acid canned foods must obtain a Food Canning Establishment (FCE) registration
The FCE registration must be linked to the facility’s FFR
All registration data must match exactly between FFR and FCE records

Process Filings (SID Numbers)

LACF and acidified food facilities are required to submit separate process filings for each scheduled process used during production.

Each process filing must be submitted for:

Each product
Each product formulation or style
Each container size and type
Each processing method

Every filed process is assigned a unique Submission Identifier (SID) number, which the FDA uses to track compliance.

LACF & FCE Registration Assistance Services

FDA Registration Assistance provides professional support to help companies comply with LACF and FCE registration and process filing requirements.

Our services include:

FDA Food Facility Registration (FFR)
Food Canning Establishment (FCE) registration
Scheduled process filing submissions
SID number tracking and compliance support
Regulatory guidance to reduce FDA enforcement risk

To have FDA Registration Assistance assist you with Low-Acid Canned Food (LACF) or Food Canning Establishment (FCE) registration, please contact us today.

Frequently Asked Questions (FAQ)

What is an FCE registration?

A Food Canning Establishment (FCE) registration is an FDA requirement for facilities that manufacture low-acid canned foods or acidified foods packaged in hermetically sealed containers.

Is FCE registration different from FDA Food Facility Registration?

Yes. FFR registration is required for all food facilities, while FCE registration is required in addition for facilities producing certain LACF or acidified foods.