Act Governing Food Safety and Sanitation: Basic Rules for Food Factories and Shops

The First Law to Know if You Sell Dumplings

Whether you make dumplings at a market stall, open a bun shop, or build a frozen food factory, as long as what you make is sold for others to eat, the most fundamental law is the Act Governing Food Safety and Sanitation (食品安全衛生管理法, commonly called the Food Safety Act). The current text found at the time of writing was last amended on June 12, 2019; the accompanying Enforcement Rules of the Act Governing Food Safety and Sanitation (食品安全衛生管理法施行細則) were last amended on July 13, 2017.

The Act itself is a framework; the details are spread across the regulations, rules, and public notices it authorizes, such as the Regulations on Good Hygiene Practice for Food (GHP), the Regulations on Food Safety Control System (HACCP), and the Regulations Governing Registration of Food Businesses. So when reading the Act, remember: "the Act says what must be done; how far it must be done is in the subsidiary regulations."

Who Is a "Food Business"?

Article 3, Subparagraph 7 of the Act defines food businesses very broadly: anyone engaged in the manufacturing, processing, preparation, packaging, transportation, storage, sale, import, or export of food or food additives; even businesses that manufacture, process, import, export, or sell food utensils, food containers or packaging, or food-use detergents are included.

Subparagraph 4 of the same article says "food utensils" are machinery, tools, or utensils that come into direct contact with food or food additives. In other words, a snack shop making dumplings and a factory making frozen buns are food businesses; going by the text of the article, businesses that manufacture or sell machinery in direct contact with food also fall within this definition. Which obligations each type of business actually bears depends on the competent authority's notices on categories and scale.

Basic Obligations of Food Businesses

In article order, the ones you'll encounter most often:

• Article 7, self-management: Establish a food safety monitoring plan and test raw materials and products in-house or through a lab; if a product is found to pose a possible hazard to health and safety, voluntarily stop manufacturing and selling it, recall it, and report to the local competent authority. Which businesses must have a plan and what must be tested are set by notices of the central competent authority.
• Article 8, hygiene practice and registration: The personnel, work areas, facility hygiene, and quality assurance systems of all food businesses must comply with GHP; businesses of categories and scale designated by public notice must also comply with HACCP, register before operating, and obtain food safety management system certification.
• Article 9, documents and traceability: Keep source documents for raw materials, semi-finished products, and finished products; businesses designated by public notice must establish a traceability system.
• Article 10, factories: The buildings and equipment of food factories must meet the factory establishment standards, and the factory must be set up separately; non-food manufacturing or processing may not take place in the same factory building at the same site.
• Articles 11 and 12, personnel: Businesses designated by public notice must appoint hygiene management personnel or employ a certain proportion of professionals or certified technicians.
• Article 13, insurance: Businesses designated by public notice must carry product liability insurance.
• Article 15, prohibitions: Food that is spoiled or rotten, contains harmful substances or foreign matter, is past its expiration date, or uses unapproved additives may not be manufactured or sold.
• Article 22, labeling: Packaged food must be labeled in Chinese with the product name, contents, net weight, additives, manufacturer information, country of origin, expiration date, nutrition labeling, and so on.

Roughly What Range Are the Penalties?

Penalties vary widely depending on the article violated. The article numbers are as follows:

• Article 44: For example, violating GHP or HACCP rules and failing to correct within the deadline after being ordered to do so, or violating the prohibitions in Article 15, is punishable by a fine of NT$60,000 to NT$200 million; in serious cases, the business may be ordered to close or suspend operations, or its registration may be revoked.
• Article 47: For example, labeling that violates Article 22, false registration or traceability data, failing to appoint hygiene management personnel as required, or evading or refusing inspection, is punishable by a fine of NT$30,000 to NT$3 million.
• Article 48: For example, failing to register, failing to keep documents or keeping them for less than the required period, or failing to establish a traceability system, and not correcting within the deadline after being ordered to do so, is punishable by a fine of NT$30,000 to NT$3 million.
• Article 49: Adulteration or counterfeiting, adding unapproved additives, containing harmful substances, and similar acts carry criminal liability, with up to 7 years' imprisonment and an optional fine of up to NT$80 million; if death or serious injury results, the penalty is higher still.

Actual fine amounts are set by the competent authority's separate penalty standards, calculated according to the number of violations, scale, and circumstances.

Homework You Can Do Before Starting

The generally recommended order is: first confirm your business type (factory, shop, stall, online sales) and scale, then compare against the general requirements of GHP, and then check whether you fall within the scope of the notices on registration, HACCP, traceability, and hygiene management personnel. When in doubt, your local health bureau is the most direct point of contact.

To learn GHP's specific requirements for premises and equipment, continue with Key Points of the Regulations on Good Hygiene Practice for Food; to register, see Food Business Registration.

FAQ

Q: I just run a small shop making dumplings to sell. Do I have to follow the Food Safety Act?
A: Yes. Food businesses under Article 3 include those engaged in manufacturing, processing, and selling food, with no exemption for small scale. GHP is the general rule for all food businesses, while obligations such as registration and HACCP depend on the categories and scale designated by public notice.

Q: When was the Food Safety Act last amended?
A: At the time of writing (October 2026), the current text shown in Taiwan's Laws & Regulations Database was last amended on June 12, 2019.

Q: If we're caught with noncompliant labeling, what's the fine?
A: Violating the labeling rules in Article 22 is punishable under Article 47 by a fine of NT$30,000 to NT$3 million, with a notice under Article 52 to recall and correct within a deadline.

Q: Is a company that sells food machinery a food business?
A: According to the text of Article 3, businesses that manufacture or sell "food utensils" (including machinery in direct contact with food) fall within the definition of a food business; the specific obligations depend on the competent authority's notices on categories and scale.