During the global pandemic, the retail sector has become increasingly important to the public and the economy. The Committee is pleased to help the Taiwan government with enhancing Taiwan’s business environment and furthering public interests, while minimizing regulatory restrictions.
The Committee urges the authorities to improve regulatory efficiency and effectiveness and to protect consumer rights on a variety of fronts including dietary supplements, special dietary foods, GMO-free products, traditional Chinese medicinal herbs, and alcoholic beverages.
International best practices and public-private partnerships have become a beacon of hope for addressing a diverse range of issues. The Committee thus looks forward to productive dialogue with our public sector partners as we seek further mutual understanding and more reasonable regulatory control. Taiwan’s consumers and retailers will surely benefit from this positive collaborative environment.
In addition, as we note in the suggestions below, harmonizing Taiwan’s system with that of most trade partner markets can help Taiwan both obtain international business advantages and protect domestic consumers.
Suggestion 1: Promote government-academia-industry cooperation to increase the acceptance rate for product claims.
The duties of the Taiwan Food and Drug Administration’s (TFDA) Advisory Committee of Food Advertisement and Labeling (ACFAL), which meets several times a year, include ruling on the admissibility of product claims regarding foods and food products. The committee members are “scholars and experts specializing in food safety, nutrition, medicine, law, the humanities, and social science.” Under Article 8 of the regulations governing the committee’s establishment, additional experts and scholars, as well as representatives of government agencies – including TFDA departments – may be invited to attend ACFAL meetings “if the need arises.”
With their background in various relevant disciplines, the experts and scholars who are members or invited participants of ACFAL are able to help determine whether product claims are false, misleading, or imply medical efficacy (in which case they should be treated as a drug). But one important source of information is missing from this process: representatives of the companies that are the claim applicants.
The extremely low rate of ACFAL’s acceptance of product claims suggests that the current process is not working adequately. Although numerous requests for new product claims have been submitted to the TFDA since the relevant procedures were implemented in 2018, the total acceptance rate has been under 5%. In addition, when ACFAL rejects a claim, details are rarely provided to explain the reason for the decision.
The Committee urges the TFDA to arrange opportunities for academic organizations, private industry, and government officials to exchange views regarding the types of product claims that should be permitted. We also recommend that product claim applicants be invited to attend the ACFAL review meetings as a matter of regular procedure. Their participation would enable them to answer questions, give further explanation as to the nature of the claim, and perhaps alleviate any concerns on the part of the ACFAL members. In the case of rejections, in would allow the industry representatives to come away with a better understanding of the position of the reviewers and perhaps reduce the number of rejected claims in the future.
On the other hand, if ACFAL were to broaden its interpretation of acceptable claims, it could allow consumers to receive more helpful product information, such as the physiological effects of general nutrients and certain food ingredients.
In any case, this broader communication would benefit the public, government regulators, and industry stakeholders.
Suggestion 2: Remove the requirement to provide evidence of overseas sales and product samples or trial reports to register infant/follow-on formula products and allow the online sale of such products.
The Committee appreciates the TFDA’s consideration of the suggestion it raised in the 2020 and 2021 White Papers to remove the requirement to prove the ethnic compatibility of foods for special medical purposes (FSMP). In December 2021, the TFDA released a proposal to amend the “Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products” (the Review and Registration Regulations), which includes removal of the ethnic compatibility requirement for FSMPs. The Committee hopes that the amendments will be finalized this year.
This year, the Committee suggests removing the Taiwan- specific requirement to provide evidence of overseas sales and product samples or trial reports for registration of infant and follow-on formula products.
According to April 2019 amendments to the Review and Registration Regulations, nutritionally complete and balanced FSMPs that meet the specifications for nutrient composition are exempt from providing the above-mentioned information.
Infant and follow-on formula are food products meant to fulfill the nutritional needs of infants less than one year of age. The composition of these products must comply with the CNS06849, 13235, and 15224 composition rules, which have been incorporated into the December 2021 proposal to amend the Review and Registration Regulations shared with industry. Therefore, infant and follow-on formula should also be exempt from the requirement to provide overseas sales evidence and product samples or trial reports during registration.
In addition, the online sale of infant and follow-on formula is legal in the U.S., Canada, EU, UK, Japan, Singapore, China, and Australia. In Taiwan, certain over-the-counter medicines can be sold online, and as long as only the product name, price, company address, telephone number, and other non-promotional information is listed, their sale is not considered drug advertising. However, sale of infant and follow-on formula online is deemed to be advertising and is banned in Taiwan. The Committee calls on the TFDA to review this regulation, which is not consistent with accepted international practice.
Suggestion 3: Ensure that trade-related regulations reflect the latest market conditions.
3.1 Advancements in food technology have made it possible for healthful nutrients such as vitamins, minerals, protein, and others to be incorporated into snack-style food products that can help increase the nutrient intake of children and those with low appetite due to diseases or other physical conditions. Yet based on the outward appearance of such products, the regulators are currently restricting manufacturers from making claims about the nutritional content.
To avoid limiting consumer choice and stifling the development of the food industry, regulations restricting nutritional claims on food products should be based solely on the volume and ratio of nutrients in those products that may be harmful to human health. The outward appearance of the products should be irrelevant. The Committee urges the authorities to revise relevant regulations such as the “Regulations Governing Nutrition Claims on Packaged Food” to reflect recent technological developments.
3.2 Article 22, Paragraph 1, Subparagraph 9 of the Act on Food Safety and Sanitation (the Act) states that “the container or outer packaging of food and food raw materials shall be clearly marked in Chinese or with common symbols to show the use of genetically modified food raw materials.” In order to protect consumers’ right to know and choose, products that possess evidentiary support that they contain no genetically modified ingredients should be allowed to be promoted as “Non-GMO,” “GMO-free,” or similar wording on their packaging. While no restriction on these labels currently exists, the TFDA does not allow for their use on relevant products. As in the U.S. and EU countries such as Germany, Taiwan should permit manufacturers to voluntarily use such labels provided they are not false or misleading.
3.3 Under current regulations, certain goods made in China are subject to import restrictions imposed by the Ministry of Economic Affairs to address security concerns, protect Taiwan’s vulnerable industries, or maintain the market share of domestic products. However, if Taiwan’s manufacturers are unable or unwilling to produce the restricted goods for a long enough period of time and thereby demonstrate that the import of such products would have no substantial impact on Taiwanese industry or domestic market share, the restrictions should be abolished as no longer justified.
Suggestion 4: Re-classify traditional Chinese medicinal herbs as food raw materials and regulate them under the Act Governing Food Safety and Sanitation.
Traditional Chinese medicinal herbs are different in nature from Western pharmaceuticals in that they can be used as either food or in the manufacture of Traditional Chinese Medicine (TCM).
However, such herbs are concurrently managed and regulated by different administrative agencies, which has caused confusion regarding the regulation of these materials. The TFDA’s “Consolidated List of Raw Materials That May Be Used for Food,” issued pursuant to Article 15-1 of the Act Governing Food Safety and Sanitation, authorizes the TFDA to uniformly regulate all raw materials that may be used for food, including certain traditional Chinese medicinal herbs.
However, the MOHW’s Department of Chinese Medicine and Pharmacy, without proper legal authorization, has also issued a “List of Traditional Chinese Medicinal Materials That Can Be Concurrently Used for Food.” This list allows use of only 37 traditional Chinese medicinal herbs in food and employs a narrow definition of medicine to cover the overall concept of traditional Chinese medicinal herbs. It further overlooks the fact that such herbs include items that are not required for registration under the Pharmaceutical Affairs Act and ignores their dual use as food and medicine.
The Committee is concerned that this administrative approach may also limit the development of the industry, violate traditional habits, and run counter to the concepts of food nutrition and preventive medicine.
Although the Committee raised this issue with the authorities last year, we have yet to receive a response to our concerns. We therefore once again recommend that the authorities confirm the legal position that “traditional Chinese medicinal herbs” are in essence food products and regulate such materials under the Act Governing Food Safety and Sanitation. To promote the health and wellbeing of the public, we also call on the authorities to specify the scope of use, dosage, safety assessments, and other restrictions on traditional Chinese medicinal herbs used as raw materials of TCM.
Suggestion 5: Prohibit the sale of imported alcoholic beverages for which the original manufacturing lot code has been changed or removed.
The Committee continues to seek possible solutions to this longstanding issue impacting food hygiene and safety. The crux of the issue is that Article 32 of the Tobacco and Alcohol Administration Act (TAAA) explicitly stipulates that packaged alcoholic products for sale must bear a lot code – a number indicating the quantity of a certain product manufactured at a specified time on a specific production line. Article 3 of the Consumer Protection Act underscores the government’s responsibility to enforce such labeling legislation.
On February 8, the Executive Yuan announced a decision to lift the long-term ban on the import of Japanese food from areas affected by the Fukushima disaster. The FDA has mandated that such food products contain labeling clearly indicating their origin, and the MOHW releases a daily report on its random checks on the presence of such labeling, as well as radiation test results. This approach is a positive demonstration of the government’s attention to food safety among consumers. However, such protection does not extend to imported alcohol, which we believe is equally important.
Lot codes are vital for protecting consumer interests and safety by ensuring that alcoholic products in the market can be traced and recalled in case issues arise. Some parallel importers remove the original lot codes and replace them with their own serial numbers, which do not contain the information needed for tracing. Yet the Ministry of Finance (MOF), the competent authority for regulating alcohol sales, has never adequately enforced the law requiring lot codes by conducting inspections and imposing administrative fines on violators.
Requiring lot codes on alcohol products is a matter of international practice. According to information collected by the MOF from foreign trade offices in Taipei, countries in the European Union (including France and Italy), as well as the UK and Canada, all require that alcoholic products bear lot codes. Specifically, the EU’s Directive 2011/91/EU expressly requires that all European alcohol businesses display the lot code from the original manufacturer on their products.
Some officials harbor the misconception that the Certificate of Age and Origin for Scotch Whisky (C&E 94J) issued by UK Customs can serve as a substitute for the lot code. The C&E 94J, however, is merely a form of certification and is not an integral part of the packaging of alcoholic products. It therefore cannot replace lot codes as a tool to protect consumer health and safety by ensuring traceability. Further, cases have occurred of a forged C&E 94J for imported name-brand alcoholic products.
We consider the lot code issue to be so important because of the need to be certain that alcoholic products are traceable and recallable when food or alcohol safety is in doubt. In order to safeguard consumers’ interests, we once again ask the MOF to:
• Conduct systematic inspections and enforce the law (prohibit the non-code-bearing products from being imported or sold) quickly and effectively when violations are found.
• Establish a robust and effective reporting mechanism to replace the current voluntary reporting procedure.