FDA Food Canning Establishment (FCE) and Scheduled Process (SID) Registration Support

Registration Compliance for your Canned Product Manufacturing

This service assists food manufacturers in registering their Food Canning Establishment (FCE) and filing Scheduled Process (SID) submissions with the U.S. Food and Drug Administration (FDA) for low-acid and acidified canned foods intended for U.S. distribution. It ensures that thermal processing controls, container sealing, and handling practices meet FDA safety standards, helping prevent foodborne risks such as Clostridium botulinum contamination.

Regulatory Basis

Under Title 21, Code of Federal Regulations (CFR), Parts 108, 113, and 114, the FDA requires all domestic and foreign facilities engaged in manufacturing, processing, or packing of low-acid or acidified canned foods (LACF/AF) for export to the U.S. to:

• Register their establishment through the Food Canning Establishment (FCE) system, and
• Submit Scheduled Process (SID) filings for each product, container size, and processing method.

These filings enable the FDA to verify that each process has been established by a qualified processing authority and that it ensures product safety under commercial conditions.

Ideal For

• Food manufacturers exporting shelf-stable products such as fruit preserves, sauces, pickled goods, or canned vegetables to the United States
• Companies that have received FDA notifications requesting FCE and SID numbers for import clearance
• Facilities that have not yet undergone LACF or AF registration with FDA

Scope of Work

Phase 1: Information Assessment

• Collect product information from client, including:

∘ Product name and description
∘ pH value and water activity (if available)
∘ Container type, size, and closure system (e.g., glass jar, metal can, plastic bottle)
∘ Heat treatment or preservation process used (e.g., pasteurization, hot-fill, retort)

• Assess whether each product qualifies as Low-Acid Canned Food (LACF) or Acidified Food (AF) under FDA definitions. • Identify whether a Process Authority validation exists or needs to be obtained.

Phase 2: FDA Establishment Registration (FCE)

• Prepare establishment information based on client input:

∘ Facility legal name and address
∘ U.S. agent details (for foreign manufacturers)
∘ Contact person for FDA correspondence
∘ Type of product categories handled (e.g., fruit, vegetables, sauces, condiments)
∘ FDA Facility Registration Number and PIN

• Submit FCE registration via FDA’s online system and obtain FCE number. • Provide updates to the client regarding confirmation of successful registration.

Phase 3: Scheduled Process Filing (SID)

• Prepare SID submission for each product and container configuration, including:

∘ Product formulation summary (ingredients, pH, process type)
∘ Container type, size, and code (if applicable)
∘ Thermal processing parameters validated by the processing authority
∘ FDA Form 2541a (Food Process Filing for Low-Acid Canned Foods) or 2541e (for Acidified Foods)

• Submit SID filings through FDA’s electronic system under the registered FCE number. • Coordinate with FDA if clarification or resubmission is required.

Phase 4: Documentation and Completion

• Provide the following to client:

∘ FCE registration confirmation and number
∘ SID confirmation numbers for each product
∘ Record summary of all submitted information for the client’s compliance file

• Advise the client on future update requirements if new products, container sizes, or processing changes are introduced.

Deliverables

• FDA-issued FCE Registration Number
• FDA-confirmed SID filings for each applicable product

Pricing and Timeline

Service Fee

Starting at $650 per establishment (includes up to one product SID filing)

Purchase

• Additional SID Filings: $350 per product variant or container size
• Timeline: Estimated completion within 2 to 3 weeks upon receipt of required product and process information.

Ensure your products meet FDA import clearance requirements.

Start your FCE/SID registration with FSVP Services today.