Welcome to Assurentry! New FDA compliance features available.
Skip to main content
21 CFR 108 • 113 • 114

FCE & LACF Registration.

Complete compliance for Acidified and Low-Acid Canned Foods. We handle your Food Canning Establishment (FCE) registration and Scheduled Process Identifiers (SID).

FDA Accepted
256-Bit Encrypted
24/7 Monitoring
RETORT #01
ID: 2026-FCE
BATCH 1
250°F
BATCH 2
250°F
BATCH 3
250°F
BATCH 4
250°F
Sterilization Value
F0 3.0
Cycle Time
00:35:00
SID Validated
Process Filed: 2026-05-12
FCE Registration
Status:ACTIVE
ENFORCEMENT ALERT: ACIDIFIED FOODS DETENTION SURGE - PH < 4.6
FDA WARNING: MISSING SCHEDULED PROCESS FILINGS (SID) HALTING IMPORTS
COMPLIANCE REMINDER: ANNUAL FCE REGISTRATION REQUIRED
ALERT: LOW-ACID CANNED FOODS (LACF) SUBJECT TO MANDATORY RECALL
ENFORCEMENT ALERT: ACIDIFIED FOODS DETENTION SURGE - PH < 4.6
FDA WARNING: MISSING SCHEDULED PROCESS FILINGS (SID) HALTING IMPORTS
COMPLIANCE REMINDER: ANNUAL FCE REGISTRATION REQUIRED
ALERT: LOW-ACID CANNED FOODS (LACF) SUBJECT TO MANDATORY RECALL
ENFORCEMENT ALERT: ACIDIFIED FOODS DETENTION SURGE - PH < 4.6
FDA WARNING: MISSING SCHEDULED PROCESS FILINGS (SID) HALTING IMPORTS
COMPLIANCE REMINDER: ANNUAL FCE REGISTRATION REQUIRED
ALERT: LOW-ACID CANNED FOODS (LACF) SUBJECT TO MANDATORY RECALL
Classification

The pH Threshold.

Is your product Acidified (21 CFR 114) or Low-Acid (21 CFR 113)? The dividing line is pH 4.6. Getting this wrong leads to immediate detention. We help you classify correctly.

Water Activity > 0.85
Hermetically Sealed
0.0
7.0 (Neutral)
14.0
4.6 LIMIT

Acidified Food

pH ≤ 4.6

Form 2541e Required

Low-Acid Canned

pH > 4.6

Form 2541d Required
pH 4.6

Drag slider to see classification

SID

Scheduled Process Filing

Form FDA 2541d (Low-Acid)

Submission ID: 2026-SID-8842
Process Temp
250°F
Process Time
35m
Pressure
15 PSI
Process Authority Validated
FILE WITH FDA
Process Filing

Scheduled Process (SID).

You must file a detailed scheduled process for *every* product size and container type. Temperature, time, pressure, and critical factors must be validated by a Process Authority.

Expert Validation

Process Authority Network.

You cannot validate your own process. FDA requires a “Process Authority” to establish safety parameters. We connect you with vetted thermal processing experts for your specific product type.

Dr. Sarah Chen
USA
VETTED
PhD, Food Science
Specialty: Thermal Processing
Validation Speed
48 HRS
Expert Network
Live Access
Overlap
1.12mm
PASS
Tightness
85%
OPTIMAL
Juncture
50%
CHECK
Vision System
Auto-Seam Analysis Active
21 CFR 113.60

Container Integrity.

Metal cans? Glass jars? Flexible pouches? FDA has specific visual examination and teardown requirements for every closure type. We provide the inspection logs you need.

Crisis Management

Process Deviation.

Temperature drop? Power failure? If you miss your scheduled process, you must segregate the lot and have a Process Authority evaluate it. Our system guides you through the deviation protocol.

Process Monitor
Retort #04 • Cycle 22-A
DEVIATION DETECTED
Trigger
Temp Drop
< 240°F for 120s
AI Protocol
Evaluating...
Reprocess
Restart cycle immediately
Destroy
Document disposal
Action Required: PA Review (Process Authority)
Contact PA
Emergency Recall Plan
STATUS: ACTIVE DRILL
24/7
Recall Team
Coordinator (Ready)
Public Relations (Ready)
Notification
FDA District Office
Consignee List
Mock Recall Effectiveness100% Traceability
21 CFR 108.35(f)

Mandatory Recall Plan.

All LACF manufacturers must have a written recall plan on file. We provide a compliant template and digital emergency response tools to notify FDA districts instantly.

Import Controls

ACE Integration.

Customs brokers must file your FCE and SID numbers in ACE for every entry. If the numbers don't match FDA records exactly, the shipment is flagged. We ensure your broker has the right data.

CBP ACE Portal
Entry Summary
FDA Line DetailsEntry #233-9982
Product Code
21-G-E-03
AF/LACF Status
SID REQUIRED
SID Number
2026-05-0012
REC-2026-01
REC-2026-02
REC-2026-03
REC-2026-04
REC-2026-05
REC-2026-06
REC-2026-07
REC-2026-08
Secure Storage
Policy:21 CFR 113.100
Retention:3 YEARS
Recordkeeping

The 3-Year Archive.

Processing and production records must be retained for 3 years (Acidified) or 3 years (LACF). Our digital vault creates an immutable audit trail accessible instantly during inspection.

Target Pathogen

The 12D Kill Step.

Your process must achieve a 12-log reduction of Clostridium botulinum. We help verify your scheduled process meets this critical food safety standard.

High Risk Zone
LOAD: 10^12
250°F / 121°C
F0 Value: 3.0
Target Reached
Commercial Sterility
PROBABILITY: <10^-9
D-Value (250°F) = 0.21 min
Target = 12 x D
Min Process = 2.52 min
Source
EPA Standard Compliance
Filtration
EPA Standard Compliance
Testing
EPA Standard Compliance
Ingredient Safety

Source Water.

Water used in processing and cooling must be potable and EPA compliant. We track your annual water testing results to ensure no re-contamination occurs after the kill step.

Traceability

Lot Tracking.

Every can must be traceable to its production lot and retort cycle. Our system links production codes to shipping manifests for total supply chain visibility.

Production
Transit
Distribution
LOT: 9942-X
Traceability Requirement

One-step-forward, one-step-back traceability is mandatory. Records must be retrievable within 24 hours.

The Canning Track Record

Trusted by 500+ commercial processors worldwide.

1,200+
SIDs Filed
100% Acceptance
14 Days
Avg. Approval
vs 60 Days Industry
100%
Detentions Resolved
Audit Defense

Full FCE Lifecycle Support

From facility registration to process filing, we cover the entire canning regulation.

Process Authority

Access our network of vetted PAs to validate your thermal process.

Recall Plan

Mandatory recall plan preparation for LACF products.

Detention Response

Expert support if your goods are held for 2541 violations.

Platform vs. Consultants.

Don't rely on PDF forms and email. Use our digital platform to manage your FCE profile.

Comparison
DIY / Consultant
Manual Process
Best Value
Assurentry
Platform
Process Authority
Vetted experts.
You Find One
Network Access
Form Preparation
SID forms 2541d/e.
Manual PDF
Digital Wizard
Submission Speed
Direct filing.
Weeks
Days
FCE Registration
Establishment setup.
Extra Fee
Included
Detention Support
Resolution guidance.
Hourly
Included

Don't risk a recall.

Incorrect thermal processing is a life-safety issue. Get your SID filings done right.

Frequently Asked Questions

Common questions about this regulatory requirement.

100% FDA Acceptance Guarantee

Secure Your Supply Chain.

Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.

256-bit Encrypted
Instant PDF
4.9/5 Rating
Official US Agent