Translated by Baker & McKenzie Attorneys-at-Law, Taipei.
Edited by Department of Health.
ENFORCEMENT RULES OF THE ACT GOVERNING FOOD SANITATION
Promulgated on November 20, 1981.
Amended and Promulgated on December 20, 1985.
Amended and Promulgated on September 7, 1994.
Amended and Promulgated on May 15, 2000.
Amended and Promulgated on May 3, 2001.
Amended and Promulgated on June 12, 2002.
These Enforcement Rules are prescribed in accordance with the provisions of Article 39 of the Act Governing Food Sanitation (hereinafter referred to as “this Act”).
The term “toxic” referred to in subparagraph 3 of Article 11 of this Act shall mean foods or food additives which contain natural toxins or chemicals and the ingredients or contents of which are harmful to the human health or may possibly harm the human health.
The items that are toxic or contain substances or foreign materials which are harmful to human health as referred to in subparagraph 3 of Article 11 of this Act shall be determined by the central competent authority.
The items that are contaminated by pathogens referred to in subparagraph 4 of Article 11 of this Act shall mean foods or food additives contaminated by pathogenic microorganism or toxins derived from said pathogenic microorganism, which are harmful to the human health or may possibly harm the human health.
The pathogenic microorganisms of the preceding paragraph shall be determined by the central competent authority.
With regard to the product names referred to in subparagraph 1, paragraph 1 of Article 17 of this Act, those that are foods shall use the names set by national standards; those whose names are not set by national standards may set their own names. The names of those that are food additives shall be based on the names stipulated by the central competent authority.
Those product names set by their own in accordance with the preceding paragraph shall be relevant to the nature thereof to avoid confusion.
The labeling for the contents prescribed in subparagraph 2, paragraph 1 of Article 17 of this Act, with the exemption of those products aimed exclusively for export, shall be handled in accordance with the following provisions:
1. weight and capacity shall be labeled using the metric system;
2. those that are a mixture of liquid and solid material shall indicate the respective contents;
3. pursuant to the nature of the foods, the contents may be indicated as minimum quantity, maximum quantity, or both the minimum and maximum quantity; and
4. those that contain two or more ingredients shall indicate the respective contents in descending order of weight.
The labeling for the food additives prescribed in subparagraph 3, paragraph 1 of Article 17 of this Act shall be handled in accordance with the following provisions:
1. the names of food additives shall use those product names announced pursuant to the provisions of Article 12 of this Act or the names commonly known;
2. seasonings (exclusive of artificial sweeteners, sugar alcohols, caffeine), emulsifiers, leavening agents, enzymes, coagulants for soybean curds, and polishing agents may be labeled by name indicating their usages; flavoring agents may be labeled as flavoring agent; natural flavoring agents may be labeled as natural flavoring agent; and
3. preservatives, anti-oxidants, and artificial sweeteners shall indicate both the names of usages and product names or names commonly known to the public.
The date as referred to in subparagraph 5, paragraph 1 of Article 17 of this Act shall be printed on the container or package. And the year, month and day shall be marked in a way that is customarily decipherable. However, for products of which the shelf life is 3 months or longer, with the presumption of being expired at the end of the month, the expiry date may be marked with the year and month only.
The labeling of prepackaged foods or food additives shall be handled in accordance with the following provisions:
1. The length and width of the characters marked on the labels shall not be less than two millimeters. However, where the area of the largest surface of a package is less than 10 square centimeters, the length and width of characters for all items other than the name of the product, the company name, and expiry date, may be less than two millimeters.
2. Where the products are domestically manufactured and their labels are also in foreign languages, the labeling text in Chinese shall be primary and the labeling text in foreign languages is only supplementary. Those that are exclusively for export, however, are not subject to this restriction; and
3. Where the products are imported from overseas, the importer is allowed to import such products when a Chinese label is added in accordance with the provisions of Article 17 of this Act. However, where products need change of packages, repackaging or processing otherwise domestically, the Chinese labeling may be completed prior to the sale of the products.
For food businesses other than food or food additive factories, the construction competent authority shall transmit their business registration documents to the health competent authority for inspection and management.
When performing the duties as provided in paragraph 1 and paragraph 3 of Article 24 of this Act, the personnel of the competent authority shall carry the food sanitation inspection identification issued to them by their agency. Those who find suspicious food or food that should be sealed for a set period of time shall make records and have such records signed by the performing personnel and the owner of the goods or someone present. Receipts shall be issued for food sampled and record seized.
The format of the inspection identifications, records, receipts and inspection items as well as required quantity for sampling as referred to in the preceding paragraph shall be prescribed by the central competent authority.
The record referred to in paragraph 1 of Article 24 means the information about the source of materials, quantity of materials, processing, quality assurance, sales counterpart, sales amount in connection with spot check, or information required for the enforcement of this Act.
Where foods, food additives, food utensils, food containers, food packages, or food cleansers are confiscated, destroyed or are notified to be disinfected, reconditioned, or remedied with safety measures within a set period in accordance with the provisions of Article 29 of this Act, the scope of such confiscation, destruction, disinfection, reconditioning or remedies shall be extended to finished products of the same expiry date, and shall be extended to all finished products on which no expiry date is marked or the expiry date is unintelligible. Products that are of unknown origin and cannot be notified to be disinfected, reconditioned, or remedied with safety measures within a set time period shall be confiscated and destroyed.
Those export foods for which the application has been made to the central competent authority for an inspection and examination at the buyers request shall be handled in accordance with the regulations regarding inspection and examination, and those that comply with the regulations shall be approved with the issuance of a sanitation certification.
These Enforcement Rules shall be implemented from the date of promulgation.