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Taiwan: Law on Food Safety Amended

(Feb. 6, 2014) On January 28, 2014, Taiwan’s legislature passed amendments to the Act Governing Food Sanitation. According to a spokesperson for the Ministry of Health and Welfare (MHW), “[t]he latest changes will greatly improve Taiwan’s legal framework for food sanitation management, while promoting consumer protection and protecting public health.” (ROC Legislature OKs Food Act Amendments, TAIWAN TODAY (Jan. 29, 2014).) The spokesperson added that the implementation of improved inspection mechanisms provided for in the Act and imposition of harsher punishments on violators will act as a deterrent to firms’ manufacturing adulterated food products. (Id.)

The amendments were made in the aftermath of several incidents in 2013 of illegal additives being found in food products, giving rise to public concern and threatening food exports. (Id.) The changes include the addition of four new provisions to the Act and revisions to 23 provisions. The name of the Act is also changed, to the Act Governing Food Safety and Sanitation. (Text of Amendments to the Act [in Chinese] [hereinafter Amendments], Parliamentary Library Legislative Yuan website (Jan. 28, 2014); Act Governing Food Sanitation [English translation] (June 19, 2013), LAWS & REGULATIONS DATABASE OF THE REPUBLIC OF CHINA.)

Food Additives

Under the pre-amendment Act Governing Food Sanitation, food additives were defined as “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.” (Act Governing Food Sanitation, art. 3 ¶ 1 item 3.)

In the Amendments, “substances” is replaced by “single or compound substances” and a new sentence is added to the definition. The new sentence states: “the additives used in compound food additives, even if constituted of food additives approved for use by the central competent authorities, and the abovementioned single food additives that have been approved for use, must in every case have a permit number approved by the central competent authorities.” (Amendments, art. 3, item 3). Reportedly, registration of compound additives is not required if that could be interpreted by foreign companies and countries as a trade barrier in violation of WTO regulations. (Wang, supra.)

Food manufacturers will be permitted to use only compound additives made from the 799 additives currently approved by Taiwan’s Food and Drug Administration (FDA) under the MHW. (Chris Wang, Legislature’s Extra Session Concludes, Food Sanitation Act Passes Third Reading, TAIPEI TIMES (Jan. 29, 2014).) The MHW stated that it would “conduct more on-site inspections, strengthen border management procedures and work with relevant agencies to establish an origins management system” of such additives. (ROC Legislature OKs Food Act Amendments, supra.)

Provisions on Genetic Modification

The Amendments to the Act include, among other provisions on genetically modified (GM) foods, a definition of genetic modification as:

technology related to the application of genetic engineering or molecular biotechnology to transfer or transplant inherited matter into living cells or organisms, producing genetic recombination phenomena, causing the appearance of exogenous gene attributes or making the manifestation of its own specific genes impossible. However, it does not include technology of the sort related to traditional fertility, fusion of cells of the same family species, protoplast fusion, cross-breeding, eugenics, in vitro fertilization, body cell variation, or chromosome multiplication. (Amendments, art. 3 ¶ 1 item 11.)

The Amendments also require manufacturers to register GM ingredients with the FDA to enable the MHW to build a database for monitoring and supervising the ingredients and ensure that they are not used in excess. (Id.; Joy Lee, Taiwan to Impose US$2.53m Fine for Unapproved Food Additives, ASIA NEWS NETWORK (Jan. 29, 2014); Amendments, art. 21 ¶ 2.) Importers of registered and licensed GM ingredients are obliged to establish a system for backward and forward tracking of the origin and dissemination of the ingredients. (Amendments, art. 21 ¶ 3.)

Stricter regulations are to be put in place for compound additives and labeling and for GM food labeling, tracing, and risk assessment. However, manufacturers will be given a two-year grace period to make a transition to the new regime. (Wang, supra.)

Punishments for Food Manufacturers

The maximum fine for such acts as failing to correct violations of the rules on good hygiene practice for foods and violations of the rules on food safety control, or manufacturing food products that are rotten or contaminated, has been increased from NT$15 million to NT$50 million. (Amendments, art. 44.)

A new article provides for a penalty of from NT$30,000 to NT$3 million to be applied to entities commissioned by food enterprises to handle health safety that violate regulations on health safety testing, accreditation, and certification procedures. If the circumstances are serious, the authorities may suspend, terminate, or revoke the commission or certification; for those whose commission has been terminated or certification revoked, they cannot receive a commission or reapply for certification within a year. (Id. art. 48-1.)

Another new article penalizes those who, as a result of deliberately violating the law, acquire property or interest on assets. Any property or interest retained by such offenders, aside from what has been returned to the offender’s victims, will be confiscated. If all or part of the property or interest on assets cannot be confiscated, the monetary value will be levied on the offenders or their assets will be used for compensation. To assure compensation by this means, when necessary the authorities can consider garnishing their assets. (Id. art. 49-1.)

A fine of up to NT$4 million (formerly NT$200,000) will be imposed on conviction for the offense of intentional mislabeling of products. (Id. art. 45.) A maximum sentence of five years, instead of the former three years, may be imposed for the addition of food additives not approved by the central regulatory authorities. (Id. art. 49.)

Protections for Whistleblowers Enhanced

A new provision is added to the article on protection of whistleblowers, extending the guarantee of protection of the confidentiality of a whistleblower’s identity data, which is protected in general, to protection in court proceedings specifically, thereby loosening restrictions on whistleblowing’s applicable scope and, in the FDA’s view, increasing the motivation for whistleblowing. (Id. art. 43 ¶ 3; Passage of Amendments of Some Articles of the Act Governing Food Sanitation Strengthens Food Industry Order and Ensures Food Safety [in Chinese], Taiwan FDA website (Jan. 28, 2014).)

An amendment to another provision reduces or exempts from punishment not just employees, as was formerly the case, but “persons aside from the employer,” who had violated provisions of the Act and should bear criminal responsibility for it, but wh
o disclose such acts to the competent authorities or to judicial authorities and thereby help them to uncover the employer’s actions in violation of the Act. (Amendments, art. 50 ¶ 3.)

Some Other New Provisions

Based on the Amendments, in order to be approved for distribution in the market, new food products will have to undergo three stages of inspection: testing by the food company, examination by a third party, and a final round of inspections by the government. (Lauly Li , Cabinet Passes Amendment to Food Safety Law, THE CHINA POST (Nov. 22, 2013).)

The amended Act prescribes that the MHW can establish a food safety protection fund to help consumers pursue their food safety-related rights will be financed from a variety of sources, including the revenue from fines and government budget allocations. (ROC Legislature OKs Food Act Amendments, supra, Amendments, art. 56-1.)

Related Developments

Taiwan’s Executive Yuan (Cabinet) has newly established food safety incident standards “to classify the degree of seriousness of any future food safety scandals.” The classification system is aimed at reducing public concern by “clarifying the gravity of each case as quickly as possible.” (Li, supra.) The four classes in the system are: Class 1, for the most serious incidents, in which food products have ingredients harmful to humans; Class 2, incidents in which the production process for a food violates the Act but the food itself may not be an immediate threat to human health; Class 3, incidents involving adulterated products; and Class 4, incidents involving mislabeling of food products. (Id.)

On November 26, 2013, the Taiwan FDA issued the Draft Amendments to the Enforcement Rules of the Act Governing Food Sanitation for public consultation, to last for a period of 15 days. Among other highlights of the Rules, definitions of infant formula and older infant formula, domestic manufacturers, place or country of origin, and bulk products are added, and provisions on the marking of food additive names, of the manufacturer, of the place of origin are revised. (Rachel Shen, Taiwan to Amend Enforcement Rules of the Act Governing Food Sanitation, CHEM LINKED (Nov. 29, 2013)[the article has a hyperlink to a Taiwan FDA press release on the subject, which links in turn to a comparative text of the draft rules and the current rules].)

The Taiwan FDA has also recently issued a draft proposal on modifying the Labeling Rules of Prepackaged Beverages Containing Fruit and/or Vegetable Juice. It is expected that the modified rules will take effect on July 1, 2014, a year ahead of schedule. (Daisy Suo, Taiwan to Modify the Labeling Rules of Prepackaged Beverages Containing Fruit and/or Vegetable Juice, CHEM LINKED (Jan. 23, 2014).)