Traceability and Raw Material Records: What to Keep, for How Long, and Whether to Upload

Two Layers of Obligation: Everyone Keeps Documents, Designated Businesses Build Systems

Article 9 of the Act Governing Food Safety and Sanitation divides traceability into two layers:

1. Paragraph 1, all food businesses: Must keep documents on the sources of raw materials, semi-finished products, and finished products.
2. Paragraph 2 onward, businesses of designated categories and scale: Must establish a traceability system suited to their industry model, use electronic invoices in stages, and report electronically to the system established by the central competent authority.

Details follow the Regulations Governing Food and Related Products Traceability Systems (食品及其相關產品追溯追蹤系統管理辦法); the current text found at the time of writing was last amended on October 3, 2018. "Food and related products" in Article 2 of the Regulations covers food, food additives, food utensils, food containers or packaging, and food detergents.

Which Documents to Keep

Article 4 of the Regulations lists the minimum items a traceability system must include for manufacturers, processors, and preparers. Compare them with the daily operations of a bun factory:

• Raw material sources: Supplier name, food business registration number, address, contact person and phone; raw material name, quantity, batch number, expiration or manufacturing date, receiving date; for raw materials required by notice to be labeled with origin, keep the origin information. For example, the receiving slips and labels for every batch of flour, pork, and cabbage.
• Product information: Manufacturer, responsible domestic company, product name, main and secondary ingredients, food additives, packaging containers, storage and transport conditions, quantity, expiration date, and manufacturing date.
• Identification marks: Identifiable batch numbers, marks, or text on raw materials, semi-finished products, and finished products.
• Product flow: Logistics provider information; name, address, contact person and phone of direct buyers that are not natural persons (plus registration number for food businesses); product name, quantity, batch number, date, delivery date; quantities, reasons, and handling of recalls, returns, and defective products.
• Inventory and scrapped raw materials and products: names, total weight or volume, handling measures, and reasons.

For direct sales to ordinary consumers, the buyers are natural persons, so product flow doesn't need to be recorded; for sales to restaurants, convenience stores, or distributors, it does.

Importers (Article 5) and retailers and exporters (Article 6) each have corresponding items; packaging operations generally follow the rules for manufacturers (Article 7).

How Long to Keep Them

Article 8 of the Regulations: food businesses must keep traceability vouchers, documents, and other records completely, in paper or electronic form, for at least 5 years. GHP Article 11 also requires records made under GHP to be kept for at least 5 years.

Do You Need to Upload to the Traceability System?

Only designated businesses are required to upload. According to the TFDA's Q&A, businesses designated by notice must not only establish an internal traceability system but also upload the information to the Food Traceability Management Information System, commonly known by its Chinese nickname (非追不可, "must trace") at ftracebook.fda.gov.tw; other businesses may upload voluntarily.

The notice on food businesses required to establish food traceability systems has been expanded many times since 2015 and now covers many sectors, including edible oils and fats, meat, dairy, seafood, meal boxes, and additives. According to the Ministry of Health and Welfare's general explanation of one amendment, it added "manufacturers, processors, and preparers in other food sectors with factory registration and capital of NT$30 million or more," requiring them to implement traceability, upload to FTRACEBOOK, and use electronic invoices. So for ordinary frozen dumpling and bun factories, whether they must upload often hinges on factory registration and capital; notices are amended, so follow the TFDA's latest notice.

How This Relates to Machinery

Traceability depends on "batch numbers" to link raw materials and finished products. Each time a new batch of filling or flour is used on the line, the batch number, time, and equipment used should be written in the production record. If an automated machine has a counting function, the batch output can be recorded directly, making inventory reconciliation easier; equipment cleaning and changeover records are also part of the traceability chain, so when a problem occurs you can tell which time period and which machine produced the product.

Penalties for Violations

• Not keeping documents or keeping them for less than the required period, not establishing a traceability system, or not reporting electronically: if not corrected within the deadline after being ordered to do so, a fine of NT$30,000 to NT$3 million under Article 48 of the Food Safety Act.
• False data in the system or reports: a fine of NT$30,000 to NT$3 million under Article 47.

The registration number appears repeatedly in traceability records; for how to register, see Food Business Registration.

FAQ

Q: What documents does a bun factory need to keep?
A: All food businesses must keep source documents for raw materials, semi-finished products, and finished products (Article 9, Paragraph 1 of the Food Safety Act); designated businesses must also record raw material sources, product information, batch numbers, product flow, inventory, and scrapping under Article 4 of the traceability regulations.

Q: How long must traceability records be kept?
A: Under Article 8 of the Regulations Governing Food and Related Products Traceability Systems, at least 5 years.

Q: Do I have to upload to FTRACEBOOK?
A: Only businesses designated by notice must upload; others may do so voluntarily. The Ministry of Health and Welfare has added other food manufacturers with factory registration and capital of NT$30 million or more; the actual scope follows the latest notice.

Q: Do we need to record product flow for sales to ordinary customers?
A: No. The product flow information in the Regulations refers to direct buyers that are not natural persons, such as restaurants, retail channels, and distributors.