Goto Main Content
:::

Chapter Law Content

Title: Act Governing Food Safety and Sanitation CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter III Sanitary Control of Food Businesses
Article 7
Food businesses shall implement self-management and enact food safety monitoring plan to ensure food sanitation and safety.
Food businesses shall test their raw materials, semi-products or end products on their own, or deliver them to other testing agency (institution), corporation, or organization for testing.
Food businesses that are Exchange-Listed, OTC-Listed or belonging to a category and scale designated by the central competent authority in a public announcement shall be equipped with laboratories to perform said self-testing.
The central competent authority shall prescribe in a public announcement on the category and scale of the food businesses that shall enact the food safety monitoring plan in Paragraph 1 and conduct testing in Paragraph 2, the minimum testing cycle, and other relevant matters in paragraph 2.
Upon discovery that food products may be harmful to sanitation and safety, the food businesses shall immediately cease manufacturing, processing, sale and recall such products voluntarily and report to the municipal or county/city competent authority.
Article 8
The personnel, operation sites, sanitation management of facilities and quality assurance system of food businesses shall meet the regulations on good hygiene practice for foods.
Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall meet the regulations on food safety control system.
Food businesses belonging to a category and scale designated by the central competent authority in a public announcement may commence its business operation only after applying for registration with the central competent authority, the municipal or county/city competent authority.
The regulations on good hygiene practice for foods referred to in Paragraph 1, the regulations on food safety control system referred to in Paragraph 2 and the regulations governing the condition, procedure, and the matters to be registered for the application for registration and application for amendment, revocation or termination of registration and other matters to be complied with mentioned in the preceding paragraph shall be prescribed by the central competent authority.
Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall obtain the certification of sanitation and safety management systems.
The certification in the preceding paragraph shall be performed by the institution accredited by the central competent authority. The regulations governing the condition or reason of the application, termination and revocation for accredition; the charge, procedure, method for performing such certification; and other relevant matters shall be prescribed by the central competent authority.
Article 9
Food businesses shall retain the related source documents of the raw materials, semi-products and end products.
Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall establish their own traceability system for tracing the source and tracking the flow of the raw materials, semi-products and end products according to their respective industry modes.
To govern the food safety, sanitation and quality, and ensure the information accuracy of food traceability system, the central competent authority shall require the businesses in the preceding paragraph to use electronic uniform invoices in a phased public announcement, according to the necessity of tracing the source.
The central competent authority shall establish the traceability system in Paragraph 2. Food businesses shall use electronic methods to declare the information of the traceability system. The electronic declaration method and specification shall be prescribed by the central competent authority.
The types of documents to be retained and the period of retention mentioned in Paragraph 1 and the regulations governing the establishment, matters to be recorded, examination and other matters to be complied with for the traceability system mentioned in Paragraph 2 shall be prescribed by the central competent authority.
Article 10
Factory registration of food businesses shall be handled by the competent industrial authority in conjunction with the competent authority.
The construction and equipment of a food factory shall conform to the establishment standard, which shall be prescribed by the central competent authority in conjunction with the central competent industrial authority.
The food or food additive factory shall be independently established and shall not engage in non-food manufacturing, processing, or preparation at the same address and the same factory. However, this regulation shall not apply to those factories manufacturing both drug and food products, were examined and confirmed to conform to the Pharmaceutical Good Manufacturing Practice Regulations by the central competent authority.
For the factories mentioned in the preceding paragraph that were not independently established prior to the amendment of this Act on 18th November 2014, the central competent authority shall announce within six months after promulgation of this Act, and those factories shall complete independent establishment within one year after the announcement.
Article 11
Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall have sanitation control personnel.
The regulations governing the qualification, training, duty and other matters to be complied with for the sanitation control personnel of the preceding paragraph shall be prescribed by the central competent authority.
Article 12
Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall have a certain percentage of professionals with vocational or technical certification in food, nutrition, catering etc. responsible for food sanitation and safety control.
The regulations governing the placement, duty, execution of business, and management of professionals with vocational or technical certification mentioned in the preceding paragraph shall be prescribed by the central competent authority.
Article 13
Food businesses belonging to a category and scale designated by the central competent authority in a public announcement shall take out product liability insurance.
The insured amount and contents of the insurance contract of the preceding paragraph shall be prescribed by the central competent authority.
Article 14
The regulations governing the sanitation of public food and beverage sites shall be prescribed by the municipal or county/city competent authority based on the various sanitation standards or laws promulgated by the central competent authority.