1. General food products

In Taiwan, food is defined by the Act Governing Food Safety and Sanitation ("Act"), last amended on 24 January 2018, as "goods provided to people for eating, drinking or chewing, and the raw materials of such goods." Food products, including food materials, food additives and processing aids, which are used during food manufacturing, as well as vitamins, minerals and nutritive substances without claiming healthcare or therapeutic effects, are primarily regulated in accordance with the Act as well as any supplementary regulations and notices periodically promulgated by the Taiwan Food and Drug Administration ("TFDA"). Novel foods are not allowed to be manufactured, processed, prepared, packaged, transported, stored, sold, imported, exported, presented as a gift or publicly displayed before they pass a regulatory safety evaluation.

2. Health foods

Food products that claim, advertise or are labeled with specific healthcare effects are classed as "health foods" and are governed by the Health Food Control Act (last amended on 24 January 2018).

Under the Health Food Control Act, food products that manufacturers intend to claim, advertise or label as having specific healthcare effects must be registered as a "health food" with the TFDA. Food products without such registration are banned from claiming any healthcare effects or from describing themselves as a "health food." They should be treated as general food products as provided under the Act.

The term "healthcare effect" means an effect that has been scientifically proven to be capable of improving peoples' health, and decreasing the harm and risk of disease. However, it is not a medical treatment aimed at treating or remedying human diseases. These "healthcare effects" are prescribed by the TFDA. As of 26 March 2018, the TFDA has designated 13 healthcare effects which can be claimed for a food product with health food registration if the healthcare effect to be claimed can be substantiated by test results, among others. These 13 healthcare effects include: regulation of blood lipids and blood glucose, modulation of allergic constitution, immune-modulatory effects, regulation of body fat formation, anti-fatigue effects, bone health, anti-aging, improvement of gastrointestinal functions, liver care (for chemical damage to the liver), tooth care, regulation of blood pressure, and improvement of ferrous iron absorption. In addition, the TFDA has also allowed fish oil and monascus with health food registration to claim "to lower blood triglyceride" and "to lower the total blood cholesterol," respectively, if the ingredients of fish oil or monascus meet the specifications prescribed by the TFDA. Testing results to support either healthcare effect are not required for fish oil
and monascus to be registered.

3. Medicines or therapeutic goods are not food

A clear line is drawn between food products and medicines or therapeutic goods. Food products (including general foods and health foods) are strictly banned from claiming any therapeutic effect. Medicines or therapeutic goods are primarily governed by the Pharmaceutical Affairs Act (last amended on 31 January 2018).

4. Alcoholic beverages

Alcoholic beverages are separately regulated by the Tobacco and Alcohol Administration Act (last amended on 27 December 2017) along with tobacco-related products. "Alcoholic beverages" referred to in the Tobacco and Alcoho Administration Act include beverages having an alcohol content by volume of more than 0.5%, as well as undenatured ethyl alcohol and other ethyl products that can be used for the production or preparation of the above-mentioned beverages. However, if an alcoholic beverage has been classified as a medicine by the TFDA, it is exempt from the Tobacco and Alcohol Administration Act.

According to the Act, the container or external packaging of food has to conspicuously indicate the following matters in Chinese and common symbols:

1. product name;
2. list of ingredients. Products containing two or more ingredients need to indicate the respective ingredients in descending order of proportion;
3. net weight, volume or quantity;
4. name of food additives. In the case of a mixture of two or more food additives which are named according to a function, the name of each additive should be indicated separately;
5. name, telephone number and address of the manufacturer or of the responsible domestic company;
6. country of origin (see "Country of origin labeling" for further detail);
7. expiry date;
8. nutrition label;
9. genetically modified raw materials for food; and
10. any other matters designated by the central competent authority in a public announcement.

Containers or external packaging of food must conspicuously indicate the country of origin in Chinese and common symbols. The country of origin is to be determined in accordance with the Regulations Governing the Determination of Country of Origin of Import Goods.

Primarily, a food product's country of origin is determined by:

1. the location where such food product is wholly produced; or
2. the location where such food product underwent the last substantial transformation, when the processing or manufacturing processes involved two or more countries or regions. A substantial transformation would be where: (a) the first six digits of the Customs Import Tariff code of such food product is different from those of the food product's raw materials; or (b) if the Customs Import Tariff code remains unchanged, the major process has been completed or the value-added rate is more than 35%.

Genetically modified raw materials for food may not be used in foods until they have passed a regulatory health risk assessment and are registered with the TFDA. In practice, the assessment and registration will take at least one year and should not exceed 540 days. Registration is valid for one to five years, subject to the discretion of the TFDA, and can be renewed before expiration. The registration holder is required to establish a traceability system for tracing the source and tracking the flow of the genetically modified food raw materials.

Claims about the presence or absence of nutritional properties are governed by the Regulations on Nutrition Claims for Packaged Foods, which set out the specific form and wording to be followed for such claims. For example, where food is listed as sugar-free, the amount of sugar in such food may not be more than 0.5 g per 100 g of solid (semi-solid) food or per 100 ml of liquid food.

Foods claiming specific healthcare effects are regulated under the Health Food Control Act. Pursuant to the Health Food Control Act, no foods may be labeled or advertised as a health food or claim any of the approved 13 healthcare effects before passing a health food evaluation and being registered with the TFDA as a health food.

As a general rule, no food product (including general foods and health foods) may claim any therapeutic effect.

The Rule Governing Labeling of Allergens in Food Products, which was announced by the TFDA on 7 March 2014 and came into force on 1 July 2015, requires food products containing shrimp, crab, mango, peanut, milk, egg and products made thereof to add a statement to warn consumers that such products contain an allergen.

In addition to warnings pertaining to allergens, the TFDA has also published advisory statements for the use of novel foods or materials. For example, food products containing Aloe must state that such product is not suitable for women during pregnancy.

There are no specific laws or regulations governing trade measurement markings on foods in Taiwan. Any measurement markings related to trade are generally governed by the Weights and Measures Act. Taiwan adopts the International System of Units and the acceptable measurements include ml, kg, etc.

Food businesses may recall food products voluntarily. If a food business finds that its food product may have a safety or sanitation concern, it should cease manufacturing, processing and selling such product, and should recall such products circulated on the market.

Food products must be recalled in accordance with a mandatory request of the competent authorities in any of the following circumstances: 

(1) when a significant or an unexpected food safety incident occurs, the TFDA may require a food business to recall specified products or products from specified areas on the basis of a risk assessment made by the TFDA or any epidemiological survey results; and

(2) the Department of Health of each municipal government ("Local DOH") may order, at its discretion, a food business to recall food products if there is found to be a violation of the Act, for example:

A. the food product contains an additive that has not been approved by the TFDA;

B. the food products are adulterated or counterfeited;

C. the food products are determined as causes of food poisoning; or

D. the food business fails to comply with labeling requirements set forth in the Act, to the extent that the violation is serious.

Since a series of food safety scandals in Taiwan from 2009, the TFDA has intensified its control on food safety. In general, food safety control in Taiwan partly relies on the control of the TFDA and Local DOHs as well as partly on selfmanagement by food businesses.

To ensure food sanitation and safety, the TFDA and Local DOHs are obligated to establish a reporting system to collect and handle the reporting of suspicious food poisoning incidents according to Art. 6 of the Act. In addition, if a serious violation of the Act is found, the TFDA or the Local DOH may order the violator to recall its product as part of its sanctions.

Food businesses in Taiwan are also expected to actively pursue self-management to ensure food sanitation and safety. Food businesses designated by the TFDA are required to formulate a food safety monitoring plan (including the implementation of compulsory self-inspection) to ensure food safety. If a food business finds that its food products may be harmful to sanitation and safety, it is obligated to cease the manufacturing, processing and sale and to recall the food products concerned. The food business must also report such an incident to the Local DOH.

The TFDA's and Local DOHs' processes for determining the causes of food safety scandals, food poisoning incidents, etc. are usually difficult and time-consuming. In order to trace the cause of a food safety scandal or food poisoning incident more efficiently and to ensure a prompt reaction by the TFDA or Local DOH to such event, certain food businesses (e.g., food additives businesses) designated by the TFDA are required to establish their own traceability system for tracing the source and the flow of the raw materials, semi-products and end products according to their respective industry practice.

The advertisement of food products is primarily supervised by the TFDA and the Local DOH pursuant to the Act. The Health Food Control Act may apply when claims pertaining to healthcare effects are involved.

As a general rule, a food business is prohibited from making false, exaggerated or misleading statements (Art. 28(1) of the Act) or from claiming any therapeutic effects (Art. 28(2) of the Act) on/in its food labels, advertisements or promotional materials.

If a general food product makes false, exaggerated or misleading statements, the advertiser may incur a fine of up to NTD 4 million (about USD 136,340) and be ordered to recall the products. If the violation continues, the Local DOH may even confiscate and destroy the products concerned.

If a general food product claims any therapeutic effect, the advertiser may incur a fine of up to NTD 5 million (about USD 170,430) and the Local DOH can immediately confiscate and destroy the products in question. In order to implement such provisions for product advertising, the TFDA has published the "Guidelines on Determining False and Exaggerated Wording or Therapeutic Claim Contained in Food Advertisements or Labels" ("Guidelines"), last amended
on 13 March 2017. The Guidelines provide:

1. claims that mention therapeutic effects (such as preventing, remedying, alleviating, diagnosing or treating certain diseases or physiological conditions, etc.) are not allowed;
2. claims that incorporate exaggerated or misleading statements (e.g., about physiological functions) are not allowed;
3. examples of allowable descriptions for foods include "nourish and tone up the body," "build up physical strength," "maintain vigorous vitality," etc.; and
4. certain claims that refer to the physiological functions of dietary fiber, vitamins and minerals are allowed (e.g., it is permissible to claim that Vitamin C promotes the formation of collagens, assists in healing wounds, maintains a tight arrangement of cells, assists in the growth of bones and teeth, promotes the absorption of iron and has an anti-oxidation effect).

Pursuant to Art. 6 of the Health Food Control Act, prior to obtaining approval from the TFDA to be registered as a health food, a food product must not be advertised as, or labeled with the phrase, "health food" or advertised as having any healthcare effects. Breach of this provision is a criminal offense and may incur a criminal fine of up to NTD 1 million (about USD 34,080).

A health food may not make any claim that is false, exaggerated or misleading, or claim a healthcare effect outside the scope approved by the TFDA, or that involves any therapeutic effects. Violation of such restriction is punishable by a fine of up to NTD 2 million (about USD 68,170). If the violation is serious, the violating health food business may be further ordered by the Local DOH to recall the products.

Taiwan does not have regulations specifically for the governance of credence claims. However, organic claims can only be used on a certified organic food. Other credence claims, such as natural, fresh, etc. are allowed to be used as long as they are not false, exaggerated or misleading.

1. Organic claims

In Taiwan, organic claims can only be used on certified organic foods under the Agricultural Production and Certification Act ("Certification Act"), last amended on 29 January 2007. Under the Certification Act, "organic product" means any agricultural product that is cultivated, processed and packaged in accordance with relevant regulations and is certified under the Certification Act. Chemical pesticides, chemical fertilizers, animal drugs or any other chemicals, except for those permitted by the authority, cannot be used in organic products or their processed products. If a food product without any organic certification makes an organic claim, a fine of up to NTD 1 million (about USD 34,080) may be imposed on the manufacturer or importer/seller.

2. Other credence claims

Pursuant to Art. 28 of the Act, except for claims that are false, exaggerated or misleading, or involve any therapeutic effects, other claims are generally allowed to be made for food products. Therefore, credence claims such as natural and fresh are allowed to be used as long as they are genuine. In practice, the Local DOH occasionally inspects products with such credence claims. If such claims are determined to be false, exaggerated or misleading, the food business will face a fine of up to NTD 4 million (about USD 136,340).

There are several food quality marks, which can be labeled on food packaging in Taiwan. Those food quality marks may be granted by governmental organizations (e.g., Health Food Mark granted by the TFDA) or by independent food associations (e.g., Taiwan Quality Food (TQF) Mark granted by the Taiwan Quality Food Association), provided that certain criteria set by those parties are fulfilled. The inclusion of foreign health ratings or logos on the packaging of the food products to be imported to Taiwan is not prohibited, as long as those foreign health ratings or logos are true and non-misleading. Nevertheless, the substantiations to support those foreign health ratings or logos may be required at the request of the health authorities during food inspections.