The Food Canning Establishment (FCE) registration is a critical requirement for businesses seeking to export or distribute shelf-stable canned food products in the United States. This registration, issued by the FDA, plays an essential role in ensuring food safety while facilitating market access. Therefore, in this article, UCC will thoroughly guide you through the key aspects of the FCE registration process and highlight its significance for your business.
1. Definition of Food Canning Establishment
FCE (Food Canning Establishment) is the registration number issued by the FDA to identify food processing establishments. As such, it is a mandatory requirement for most companies producing shelf-stable canned food products that intend to export or distribute these products in the U.S. Furthermore, the FCE number enables the FDA to effectively monitor food production facilities and ensure compliance with rigorous food safety standards. Therefore, it represents a critical step in securing access to the U.S. market.
While the FCE focuses on the registration of the establishment, the SID (Scheduled Process Identification) number manages processing procedures to ensure the safety of specific food products. Both of these elements are crucial for controlling food safety and support each other in ensuring compliance with FDA regulations.
2. Applicability of Food Canning Establishment
2.1. Eligible Parties
The Food Canning Establishment is assigned to entire food processing establishments, not to individual products. For example, a factory that produces both canned fruit and canned meat only needs one FCE number for the entire facility. However, the factory will need separate SID numbers for managing the processing procedures of each product type.
2.2. Exempt Products
Certain food products are exempt from Food Canning Establishment registration. These include:
- Food additives
- Beverages containing alcohol or carbonation
- Jams and jellies
- Sauces
- Refrigerated or frozen foods
- Fermented foods
- Meat and poultry products directly supervised by the USDA
- Tomatoes and tomato-based products
Canned or packaged products that fall under the above categories must meet the following conditions:
- Final pH level ≥ 4.6
- Water activity (aw) ≥ 0.85
For tomato products, the final pH level must be ≥ 4.7 in order to remain exempt from FCE and SID registration. Consequently, these parameters ensure that the products are not classified as acidified or low-acid foods.
3. Food Canning Establishment Registration Requirements
3.1. Information Required
To register for an Food Canning Establishment, the following information is necessary:
- Establishment Name: The complete name of the facility responsible for processing, manufacturing, or packaging canned food products.
- Address: The full physical address of the establishment, including city, state (if applicable), and country.
- Contact Information: The establishment’s phone number, email address, and any other relevant contact details.
- Legal Representative: The name and contact details of the individual legally accountable for the establishment.
- Product List: A comprehensive list of the low-acid and acidified food products produced at the facility.
- Additional Details: Any supplementary information required by the FDA to ensure proper registration.
Businesses should prepare this information carefully to avoid delays or additional requests that could impact business timelines. In addition, businesses must ensure that all provided details are accurate to avoid delays in the registration process.
3.2. Timeframe
Food canning establishments are required to complete the Food Canning Establishment (FCE) registration within 10 days of commencing the production, processing, or packaging of food products. Failure to do so may result in non-compliance with FDA regulations.
4. Important Notes
- FFR (Food Facility Registration Number): Often referred to as the FDA registration number, this is a basic requirement for all food canning establishments. Notably, it must be obtained before registering for the FCE & SID. Furthermore, it serves as the initial step in achieving compliance with FDA regulations.
- Exempt Entities: Headquarters are not required to register for an FCE. Instead, only the production facilities that directly manufacture or process food for export to the U.S must complete the registration. Furthermore, if products are processed or packaged at another facility, the responsibility for FCE registration rests with that facility, not with the distributor.
- Registration Timeframe: FCE & SID registration can take several months to complete, often 3-4 months. Therefore, businesses should initiate the registration process at least 3-4 months before the anticipated export date to prevent customs delays or FDA hold-ups at the port.
5. Food Canning Establishment Registration Process at UCC
Step 1: Consultation and Requirement Determination
UCC Vietnam will assist you in determining whether your business and products require FCE registration. Additionally, we will explain the relevant FDA regulations related to your products and guide you through the necessary requirements.
Step 2: Information Submission
Once the need for registration is confirmed, you will need to provide the required information about your facility and products.
Step 3: Document Completion and FDA Submission
After receiving the necessary information, UCC will complete the documentation and submit the FCE registration to the FDA. If the business has already registered for FFR, the process typically takes 3-5 days.
UCC LLC is located in Bellingham, USA. With more than 15 years of experience collaborating with the US FDA, UCC possesses extensive expertise in managing legal matters and liaising with the FDA. Furthermore, we are fully equipped to assist with complex legal issues, including FDA warnings, product holds, and product returns at ports.
For more information: Voluntary Qualified Importer Program: FDA’s Expedited Process
We hope this article has provided you with valuable insights into the food canning establishment registration process. UCC look forward to the opportunity to collaborate with you in the future.
