2020 was a very challenging year. The COVID-19 pandemic severely impacted the global economy and took millions of lives. The Committee would like to express its appreciation for the superior leadership shown by the Taiwan Food and Drug Administration (TFDA) and other government agencies during this time. We are also very grateful for the TFDA’s continued attention to the cosmetic industry’s issues, as well as its communication and engagement with the industry to work toward resolving those issues.
Cosmetics is one of the few industries that has continued to grow and give consumers a better life over the past several years. According to an October 2020 report from the Ministry of Economic Affairs (MOEA), the average annual growth rate of the cosmetics business in Taiwan is 3.2%, higher than that of the retail sector as a whole. Although it was unavoidable that cosmetics would be impacted by the pandemic, the industry has been back on a growth track since last July, indicating that cosmetics has strong business potential and contributes greatly to Taiwan’s economy and consumers. Yet the industry has never compromised on maintaining product quality and safety; it continues to maintain high standards for consumer protection.
The Committee recognizes the good progress the government has made on our 2020 White Paper issues. One big milestone was the TFDA’s establishment of an online English-language training program for Safety Assessors (SA). The Committee appreciates the TFDA’s adoption of our recommendation to provide assistance to foreign SAs, and believe that this move will help foreign SAs become qualified in Taiwan. Lastly, we urge the TFDA to take a more transparent, open-minded, and scienced-based approach to regulating cosmetics and to adopting emerging trade models. Doing so would make Taiwan the best market to invest in, free of any technical barriers to trade.
Suggestion 1: Align the size of English fonts in cosmetics labels with those of major cosmetics-importing countries and improve the readability of the Chinese and English fonts.
New cosmetics labeling regulations mainly targeted at supplying better information to consumers take effect on July 1 this year. As these will be the first regulations to include font size requirements for the English text of a product’s ingredient list, Committee members have raised concerns regarding the proposed implementation. Initially, the TFDA said that both the height and width of the Chinese and English fonts on a label would be required to be at least 1.2 mm, with a capital “O” and small “o” used to gauge compliance. In a January 2020 clarification responding to industry comments, TFDA stated that it would refer to the height of the English font as the critical factor when determining whether the 1.2-mm font size requirement has been satisfied.
In either case, however, such requirements and the announced basis for determining compliance overlook the legislative examples in many major importing countries and make it difficult for Taiwan to harmonize with the laws and regulations of leading trading partners. They also ignore the fact that Chinese and English fonts have different structures, which impact readability.
U.S. regulations regarding the font size on ingredients for cosmetics labels focus on “font height.” But in the EU, Canada, and ASEAN, regulators have abandoned the rigid designation of font sizes and instead require only that the fonts be “clear, readable and not easy to erase.” In Hong Kong, regulations on mixed Chinese-English labeling on packaged food provide separate standards for the English and Chinese texts, so as to make the label more legible.
The Committee believes that the font size on cosmetics labels should not be regulated or restricted by height and/or width. Instead, the key point should be the overall clarity and readability of the labels at the time of purchase or use by the consumers. If font size is to be regulated, the different structures of Chinese and English fonts should be taken into consideration and their requirements should be different, especially with regard to smaller product packages.
Suggestion 2: Avoid non-transparent or arbitrary review standards for proof of claims for cosmetics products.
Under Article 3 of the “Regulations Governing Criteria for the Labeling, Promotion, and Advertisement of Cosmetic Products with Deception, Exaggeration, or Reference to Medical Efficacy” (the Criteria), one of the situations defined as constituting a “false or exaggerated claim” is when “the content description has no evidence, or the evidence is insufficient to support such description.” In addition, according to Appendix II of the Criteria, the data supporting the claim must be “objective and fair.”
In the Criteria, a claim that a product is anti-bacterial is one for which objective and fair supporting data is required. In 2017 the TFDA published the “Limits and Regulations on Anti-bacterial Agents Used in Cosmetics” (the Regulations), listing ingredients with anti-bacterial properties and the percentage of such ingredients allowed in cosmetics products regulated by the TFDA. We urge the TFDA to permit the claim that certain cosmetics products are anti-bacterial as long as one or more of the ingredients listed in the Regulations is included in the products’ formulas and the concentration of such ingredients meets the standards set out in the Regulations.
The Criteria also require such data for claims that a product is anti-acne. However, when industry has provided in-vitro acne bacillus test results to substantiate such claims, they were rejected by health authorities on the grounds that the results could not prove the efficacy of the products in question on the human body. If in-vitro acne bacillus test results do not constitute “objective and fair” data, the Committee is unclear as to what would.
We urge the TFDA to follow international best practices in evaluating product claims for cosmetics and accept widely adopted tests as supporting data. Doing so would allow cosmetics companies to provide accurate information about their products without being subjected to the vague requirement to provide “objective and fair” data to back up such information.
Suggestion 3: Relax regulations on the production and sale of customized cosmetics.
Providing consumers with the ability to customize their cosmetics products by choosing ingredients according to their skin conditions or preferences is a widely established trend in the cosmetics industry. It allows companies to create unique products that may be more effective than off-the-shelf products. A popular method of doing this is to have trained and certified staff blend and repackage the product on-site at retail stores.
The U.S. Food and Drug Administration provides industry guidelines and a GMP checklist for inspection of customized products, which has allowed many brands to offer such products to U.S. consumers. In the EU, Cosmetics Europe (CE), France’s FEBEA, and the German Cosmetic, Toiletry, Perfumery and Detergent Association (IKW) have provided voluntary guidelines for their members to follow regarding customized cosmetics. In addition, South Korea’s new cosmetics laws allow companies to sell personalized cosmetics after obtaining a specific license. The customization is conducted by certified personnel. In Japan, personalized cosmetics can be made and sold in stores, as long as the premises passes a government audit and the company has obtained a manufacturing license.
Ensuring product safety and quality is the responsibility of the manufacturer. Therefore, first and foremost, customized products should pass a safety assessment and comply with the same local regulatory requirements as with traditional finished and packaged cosmetic products, including labeling, product notification, and registration. In addition, the products should have certain physical-chemical characteristics – for example regarding water activity, alcohol percentage, and the pH of the formula – that prevent the proliferation of microorganisms. The facilities and layout of the customization counter should be designed to allow a reasonable workflow and necessary measures to avoid contamination. In the meantime, an SOP including hygiene protocol should be developed and strictly followed by the qualified staff at each step.
We urge the TFDA to relax relevant regulations and remove barriers to this new business model, so that Taiwanese consumers can enjoy access to this popular trend and to encourage further growth of the cosmetics industry in Taiwan. The Committee would be pleased to engage in dialogue with and provide more detailed information to the TFDA on this topic.
Suggestion 4: Clarify rules regarding the refilling of cosmetics product containers.
Reusing containers is an important means of reducing waste and protecting the environment. Refilling cosmetics bottles is one way in which containers can be reused. Consumers bring their empty cosmetics products to the store, which refills them from a bulk-sized container. Allowing such services would save the Taiwan government some money in waste disposal costs.
As with customized cosmetics, refilling is allowed in many major markets, including the U.S., EU, and South Korea. In addition, the ASEAN Cosmetic Association is in the process of drafting guidelines for refilling products in-store.
Under Taiwan’s GMP requirements, “packaging operations” are defined as “the process in which a semi-finished product becomes a finished one through all packaging steps such as filling, sub-packing and labeling.” The TFDA has also stated that “those cosmetic manufacturing sites where only cosmetic packaging operations are performed are exempt from factory registration.” We therefore ask that the TFDA clarify whether refilling is acceptable under relevant regulations if the stores engaging in such activity comply with GMP standards.