1.China's Taiwan Food Management Authority
The responsibilities for food safety and management in Taiwan are shared by the Council of Agriculture (COA) and The Food and Drug Administration (TFDA).
COA acts as the competent authority at the central level on matters relating to the agricultural, forestry, fishery, animal husbandry, and food industries. It is also responsible for guiding and supervising its provincial and municipal offices working in these areas.
TFDA (under the Ministry of Health and Welfare (MOHW)) was founded on Jan. 1, 2010, and was subjected to extensive restructuring and reform (as part of the reorganization of MOHW) on July 23, 2013, committed to provide professional services to each consumer and safeguard each individual’s food, drugs, medical devices and cosmetics safety.
2.Overarching Regulations
“Act Governing Food Safety and Sanitation” was last amended on Aug. 15, 2022, replacing the “Act Governing Food Safety” that had been in force since 1975. This Act covers the interpretation of food, food additives, food equipment and cleanser, safety and sanitation control, labeling and advertisement, inspection and sanction, and penal provisions on violation of the Act. All major laws, regulations, rules, and ordinances concerning food safety/quality are based on this Act.
The “Enforcement Rules of the Act Governing Food Safety and Sanitation” was firstly introduced on Nov. 20, 1981, and was last amended on Jul. 13, 2017 in accordance with Article 59 of the “Act Governing Food Safety and Sanitation”.
3.Regulations on Major Food Categories
3.1Food additives
According to the “Act Governing Food Safety and Sanitation”, food additives are defined as any single substance or combination of substances that are added to or brought into contact with foods for the purpose of coloring, seasoning, preserving, bleaching, emulsifying, flavoring, stabilizing quality, enhancing fermentation, increasing viscosity, enriching nutritional value, preventing oxidation or other necessary purpose.
In Taiwan, the use of food additives shall comply with the “Standards for Specification, Scope of Application and Limitation of Food Additives”, which introduces several positive lists detailing all the permitted food additives as well as their specifications, scope of application and limits. 800 substances have been included in the Standards till now. In the Standards food additives are classified into 17 categories:
Preservative
Bactericide
Antioxidant
Bleaching agent
Color fasting agent
Leavening agent
Quality improvement, distillery and foodstuff processing agent
Nutritional enriching agent
Coloring agent
Flavoring agent
Seasoning agent
Pasting (Binding) agent
Coagulating agent
Chemicals for food industry
Solvent
Emulsifier
Other
The registration of single food additives with TFDA is required before they are manufactured, processed, repacked, imported or exported into Taiwan. However, food flavorings are exempted from mandatory registration. Contents of the food additive combinations shall be limited to food additives approved by the central competent authority.
3.2 Health Food
Health food is defined in Health Food Control Act as “food with specific nutrient or health maintenance effects which is especially labeled or advertised, and do not aim at treating or remedying human diseases”.
Manufacturers and importers of health food must first submit an application to the Ministry of Health and Welfare or its commissioned body for inspection and registration. Health food manufactured in Taiwan has to comply with Good Manufacturing Practices (GMP). Imported health food has to conform to the GMP of the country of origin.
According to “Health Food Control Act”, products with health food claims must prove that the product has the capacity to contribute to health and/or decrease disease risk. However, no health food may claim to actually prevent/treat disease. Any product with health food claims must be approved by TFDA before being marketed. There have been 13 functional claims approved by TFDA till now.
13 Functional claims:
Protection of the liver
Relieving physical fatigue
Regulation of blood lipid
Regulation of blood sugar level
Regulation of immune system
Alleviation of osteoporosis
Maintenance of dental health
Anti-aging
Promotion of iron absorption
Promotion of gastrointestinal functions
Aiding blood pressure regulation
Attenuation of body fat accumulation
Reducing allergic reactions
3.3 Foods in tablet and capsule forms
Products in tablet and capsule forms are classified as “food”, “health food” or “medicine” according to their functions. For foods in tablet and capsule forms, it should be clearly labeled as “food” with the font size not less than that of the brand name or product name.
For packaged vitamin and mineral tablets and capsules, if the physiological functions are described, the minimum daily intake must be 15% of the daily percentage reference value. Prepackaged vitamin and mineral tablets and capsules shall be labeled with the following warning at a conspicuous place on the outer package or container of the product: “No more than ___tablets (or capsules) each day”, “Excessive intake does not benefit health” or any equivalents.
The limitations on the volume of foods in tablet and capsule form purchased from overseas for personal use (which are exempted from imported food inspection and are released by customs directly) had been adjusted from less than 1,200 pills for each category of product to 12 bottles (packaged by boxes, cans or bags) from Dec.1, 2015. The total volume shall not be more than 36 bottles.
3.4 Infant formula
In Taiwan, infant and follow-up formulas are classified as special nutritional foods which are subject to examination and registration by TFDA.
Infant and follow-up formulas in Taiwan are classified into 3 types:
Infant Formula: It refers to the specially-made food substitute for breast milk, and can be used for feeding alone before infants begin eating supplementary food as it satisfies the nutritional needs of infants of 0-6 months.
Follow-up Infant Formula: It refers to the food for infants of 6-12 months, and serves as the weaning formula for feeding in conjunction with complementary foods; however, it is not fit for feeding alone for infants who are under six months of age.
Infant Formula for Special Medical Purposes: It refers to the food substitute for breast milk or infant formula and satisfies the special nutritional needs of infants suffering from nutritional disorder or diseases or having health conditions. After growing older, infants may begin eating proper supplementary food.
No advertisement shall be made for infant and follow-up formula unless it is printed on academic medical journals or provided for the use by medical personnel only.
3.5 Alcoholic products
There are 9 categories of alcohol products outlined as below:
Beer
Wine (including grape wine and other fruit wine)
Beverages brewed from grains
Other brewed alcoholic beverages
Distilled spirits
Reprocessed alcoholic beverages
Cooking alcohols
Ethyl alcohol
Other alcoholic beverages
Imported alcohol products may be permitted only after having been inspected for their conformity to the hygiene requirements.
Hygiene items | Category of alcohol products | Limitation |
Methyl alcohol | Alcoholic beverages | 1,000-4,000mg/L (100% ethyl alcohol) |
Lead | Alcoholic beverages | 0.3mg/L |
Sulphur dioxide | Alcoholic beverages brewed from fermented fruits | 0-0.4g/L |
Sorbic acid | Alcoholic beverages brewed from fermented fruits | 0.2g/L |
Benzoic acid | Alcoholic beverages with an alcohol content of 15% or less | 0.4g/L |
Lutein | Alcoholic beverages | 10mg/L |
Other additives | Alcoholic beverages | Shall not have the following: 1. Toxic or any other substances/matter harmful to human health. 2. Never been used on food/beverages and have not yet been proven to be harmless to human health. |
The conformity assessment procedure includes: lot-to-lot inspection, lot-sampling inspection, documentary examination, and spot check.
3.6 Drinking water and soft drinks
Packaged drinking water: the quality of the source water used in the production of packaged drinking water shall meet the requirements of “Quality Standard of Source Water for Drinking Water”. Its maximum tolerance of heavy metals and microbiological criteria are:
Heavy metal | Max. tolerance (ppm) |
As | 0.01 |
Pb | 0.05 |
Zn | 5.0 |
Cu | 1.0 |
Hg | 0.01 |
Cd | 0.05 |
Microorganism | Limit |
Coliform bacteria | Negative |
Fecal streptococci | Negative |
Pseudomonas aeruginosa | Negative |
Fruit and vegetable juices: All packaged fruit and vegetable juices that contain less than 100% natural juice should indicate on the outer package the percent natural juice. If the percentage of natural juice is less than 10%, the products are required to display "less than 10% of natural juice" conspicuously in the front of the outer package.
Packaged drinks containing caffeine: All packaged drinks containing caffeine should indicate the caffeine content on the outer packages:
Coffee: Those products labeled as “low caffeine” shall not have more than 2 mg/100 mL (20ppm) caffeine.
Tea and cocoa: The caffeine contents shall not exceed 50 mg/100 mL (500ppm).Those products labeled as “low caffeine” shall not have more than 2 mg/100 mL (20ppm) caffeine.
If beverages, other than tea, coffee and cocoa, contain caffeine, the caffeine contents shall not exceed 32 mg/100 mL (320 ppm).
3.7 GMO foods
All genetically engineered products are required to obtain pre-market registration and approval in Taiwan. The foods that have been traded by obtaining GMO ingredient registration license are:
Soybean, corn, cotton, canola and beet
All prepackaged foods, food additives and unpacked foods with a GMO content of more than 3% should be clearly labeled using a font height and width not less than 5mm. If the final products do not contain GMO ingredients but are processed using GMO ingredients, it should be labeled as “this product contains GMO ingredients in its raw materials but not in its final products”. In case of processing facilities where there is a possibility of cross contamination, labels should contain information on the rate of unintentional addition of GMO raw materials.
For unpacked foods, processed products using GMO raw materials such as soybean milk, bean curd, Tofu pudding, dried bean curd, and meat substitutes made by soy protein all require mandatory GMO labeling.
4. Labeling Requirements
All prepackaged food products must carry a general label and a nutritional label in traditional Chinese.
4.1 General label
Prepackaged foods or food additives shall conspicuously indicate the following material facts on the container or packaging:
Product name
Content name
Net weight, volume or quantity
Name of food additive
Contact information of the manufacturer and domestic principal distributor/agent
Country (district) of origin
Shelf life
Nutrition facts
GMO ingredients
Other items required by the competent authority
4.2 Nutritional label
The nutritional labeling for a packaged food shall provide the following information in a conspicuous place on the outer package or package container:
Title of “Nutrition Labeling”
Energy content
Protein, fat, saturated fat, trans-fat, carbohydrate and sodium content
Contents of other nutrients declared in the nutrition claim
Contents of other nutrients voluntarily labeled by the manufacturer
4.3 Nutrition claims
Nutrition claims are divided into two categories "moderate intake" and "supplementary intake" subject to the impact of the intake of the particular nutrient on national health.
- Moderate intake needed: calories, fat, saturated fatty acids, cholesterol, sodium and sugar
- Supplementary intake needed: dietary fiber, Vitamin A, Vitamin B1, Vitamin B2, Vitamin C, Vitamin E, calcium and iron
4.4 Mandatory food allergen labeling
The labeling of six allergenic raw materials including shrimp, crab, mango, peanut, milk (lactitol excluded) and egg is mandatory, with the sentences of “XX is contained in this product”, or “XX contained in this product is not suitable for …” or any other equivalent sentences.
Labeling of allergens such as goat milk, fish, cephalopoda, spiral shell, nut seed, cereal containing gluten, soybean, kiwifruit and its processed products or when the total volume of sulfite or sulfur dioxide residues in a product reaches 10mg/kg or above is still be a non-mandatory requirement.
5. Pesticides, Veterinary Drugs and Other Contaminants
Imports of fruits, vegetables, meat and other products are subject to inspection and testing for pesticides, veterinary drugs and other agrochemicals or contaminants at the port of entry. Taiwan does not automatically adopt those MRLs established by international standard or rule setting bodies, e.g. Codex Alimentarius, as default standards; Taiwan authorities are required by law to establish domestic MRLs. All established MRLs are implemented across the board for both imports and domestically produced products.
The “Standards for Pesticide Residue Limits in Foods” was last amended on Jul. 14, 2016. Total items formulated have been 5,919 MRLs for 378 pesticides upon the latest amendment.
The “Standards for Veterinary Drug Residue Limits in Foods” was last amended on Oct. 16, 2015, which has been totaled 1,389 MRLs for 135 veterinary drugs.
TFDA drafted “Hygienic Standard for Contaminants and Toxins in Foods” in Jul. 2016, which integrates all the existing stipulations on heavy metals, fungal toxins as well as other contaminants and toxins in foods.
6. Import Inspection of Food and Food-Related Products
Imported foods and related products must apply for food import inspections at TFDA offices at the ports of entry in compliance with the “Act Governing Food Safety and Sanitation” and “Regulations of Inspection of Imported Foods and Related Products”. The foods may only be imported if they pass inspection. Nonconforming products must be either returned or destroyed according to Taiwanese law.
The importer or its agent shall apply for import inspection 15 days before the products arrive at port with the following dossiers submitted:
Import inspection application form
Products information
Import declaration duplicates
Other dossiers designated by TFDA
There are three inspection regimes for imported food and food-related products:
1. Regular randomly-selected batch inspection: The inspection is performed based on a 2-10% inspection rate.
2. Reinforced randomly-selected batch inspection: The inspection is performed based on a 20-50% inspection rate.
3. Batch-by-batch inspection: The inspection is carried out for each submitted batch of product, 100% testing rate.
Import permit notification will be issued if the inspection is passed.
7. Food Traceability System
Administrative Measures for Tracking and Traceability System of Food and Food-related Products
TFDA announced 19 industries required to establish a food tracing and tracking system till now, including:
Edible oil
Processed meat products
Processed dairy products
Aquatic products
Foods contained in lunch boxes
Food additives
GMO food raw materials
Labeled GMO foods
Labeled non-GMO foods
Civil commodities (including soybean, wheat, corn, flour, starch, salt, and sugar)
Tea
Packaged tea beverage
Soybean products
The following information is required for establishing food traceability system:
Raw material information (goods receiving)
Product information
Labels and symbols
Product flow information (goods delivery)
Other internal traceability information or records regarding product source and flow
Food manufacturers and traders are required to keep complete traceability information and records for not less than 5 years. A maximum fine of TWD 3 million will be imposed for any violations.
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