US FDA食品設施註冊 (FDA FFR: Food Facility Registration)
由美國Agent作為FDA美國代理人,進行FFR及各產品相關註冊,如FCE-SID。
FFR : Food Facility Registration
FCE : Food Canning Establishment
SID : Submission Identifier
註冊費用
1. 美國FDA不收取政府年度費用 (食品設施)。
2. 註冊及美國代理或通訊費用每年600美金 。
3. 如果是罐頭食品，需額外註冊 FCE-SID，一次性1000 美金。
註冊流程（FDA: 1 到 2 天）
1. 確認收到註冊費，如果有DUNS鄧白氏號碼，1~2 天完成註冊。
2. 如果沒有DUNS鄧白氏號碼，需要額外1週申請。
服務內容
1. 國際（美國以外地區）食品設施註冊。
2. 一年美國代理 (US Agent) 通訊服務。
3. 提供免費電子證書。
4. 設施註冊、或更新展延。
需要內容:
FCE SID
- Our process time is 1~2 days to get SID number if the data you provide us is
up to FDA standard. You can use the number to export canned product. - Please note: we can only input your process data for you. We can’t create process
for your factory. - During 1~2 days, FDA hasn’t reviewed the process flow. When they review later, it
may be OK or not. You have 30 days to respond to FDA request. - Please ask the factory to fill out the Two forms. If they don’t know which form
(d, e, f, g) to use, we can ask FDA.
FCE-SID needs two submissions:
- Food Canning Establishment Registration using Form FDA 2541
- Process filings using the following forms (choose one):
- Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method)
- Form FDA 2541e (Food process Filing for Acidified Method)
- Form FDA 2541f (Food Process Filing for Water Activity/Formulation Control Method)
- Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems)
If you are not sure which form touse, we will check with FDA:
Information needed:
For each product, please provide the followinginformation:
- aW
- Overall pH
- The pH and weight % of each ingredient.
- Product Label (in English)
Canned Foods(FCE-SID) requirement:
Alow-acid canned food (LACF) is any food (other than alcoholic beverages) with a
finished equilibrium pH greater than 4.6 and a water activity greater than
0.85, excluding tomatoes and tomato products having a finished equilibrium pH
less than 4.7.
An acidified food (AF) is a low-acid food to which acid(s) or acid food(s) are
added and which has a finished equilibrium pH of 4.6 or below and a water
activity (aw) greater than 0.85.
How to tell if aproduct is LACF/AF:
- Is the product stored at room temperature?
- Is the product packaged in a hermetically sealed (airtight) container – metal cans, glass bottles/jars,
plastic bottles/jars, laminated pouches, plastic bags? - Does the finished product have a water activity of greater than .85?
If you answeredyes to all above questions, your product appears to be LACF or AF.
What Products areexcluded from LACF/AF Regulations?
- Alcoholic Beverages
- Carbonated Beverages
- Jams, jellies, and Preserves IF they meet the definition of 21 CFR 150
- Fermented Foods (low-acid foods subjected to the action of certain microorganisms, which produce acid
during their growth and reduce the pH of the food to 4.6 or below (i.e.
some green olives, pickles, and sauerkraut)
If you do have aLACF/AF – What are the Requirements?
- Every LACF/AF manufacturing site must register their facility. FDA will issue each site a Food Canning
Establishment number (FCE number). Processors must then file a
separate scheduled process (SID) for each product and product style, and
for each container size of all LACF/AF.
Processing FilingForms
- Each process filing form is identified by a Submission Identifier (SID), which is
created by the manufacturer. An SID consists of the following numeric
format to represent the date that the form is submitted to FDA. Process
filing Forms contain technical information about how the product is
processed.
