The Committee urges continued efforts to create a transparent, principle-based regulatory environment for the cosmetics industry to enhance consumer protection, product safety, and economic value.
In 2019, a new Cosmetic Hygiene and Safety Act was enacted, accompanied by more than 30 implementation regulations. A noteworthy milestone for Taiwan’s cosmetic industry, it ushered in a new era by shifting the regulatory control model for cosmetics from pre-market registration to post-market surveillance for enforcing product safety, quality, and advertising claims. We appreciate all the authorities’ efforts over the past year to communicate with industry – taking industry’s difficulties into account, exchanging ideas, and seeking compromise solutions to allow both parties to meet in the middle.
In view of all the new regulatory monitoring and control systems that Taiwan cosmetic companies will need to build in 2020 to meet the high standards and requirements of the new Cosmetic Hygiene and Safety Act, the Committee has identified four top issues and prepared recommendations for the authorities’ consideration. We look forward to continued open-minded and transparent interaction between government and industry to drive win-win solutions that bring Taiwanese the highest level of safety and quality of life.
Suggestion 1: Fund colleges to establish online Safety Assessor (SA) training courses in English and communicate periodically with industry to harmonize product safety assessment rules and standards.
1.1 Foreign Safety Assessors (SAs) play a critical role in the import process by assuring product safety before the product is produced and imported into Taiwan. According to the Cosmetic Hygiene and Safety Act, the qualification criteria for an SA are 1) Possession of a diploma in Pharmacy, Toxicology, Medicine, or Cosmetics; 2) Completion of 54 hours of SA training either in the sourcing countries or Taiwan; and 3) A minimum eight hours of annual refreshing training to maintain the qualification. Since the course requirements include Taiwan cosmetics regulations and guidelines, it presents a technical barrier to trade for foreign SAs as the Taiwan regulations cannot be expected to be included in the SA training in other countries. The only solution is online instruction, but the majority of colleges lack interest in offering it due to the marginal profitability. We suggest that the Taiwan government to provide initial funding to colleges, perhaps for three to five years, to help get such online English-language SA training programs established.
1.2 The most important part of the PIF (Product Information File) system is the safety assessment dossiers. The comprehensiveness of the safety dossier is subject to a variety of factors, such as the complexity of the formula, applicable area, target users, frequency of use, exposure area, storage condition, etc. There is no one rule that is applicable in all different situations.
In addition, from July 2024 local health officials will start to audit both the readiness and the quality of the PIFs. The variety of audit standards employed, as well as the arbitrary and non-transparent nature of the rules and judgments, will present industry with conditions of great uncertainty. The Committee urges TFDA to start engaging with cosmetics industry associations, researching how post-market surveillance is conducted in the U.S., EU, and ASEAN, and most importantly, become familiar with the product safety assessments and measurements that are applicable internationally. The product safety assessment rules should be harmonized with global practice instead of creating Taiwan-unique standards that could amount to technical barriers to trade.
Suggestion 2: Exclude cosmetics importers’ Chinese-language label attachment sites from the “cosmetics manufacturing facilities or sites” that should meet GMP requirements.
Last year, AmCham Taipei reminded the TFDA that since the Chinese-language label-attaching operation for imported cosmetics neither damages existing packaging nor opens existing bottle caps, the quality of the cosmetics is not affected by the Chinese labeling operation. There is therefore no need to impose GMP requirements.
From the perspective of a literal interpretation of the law, Paragraphs 1 and 2 of Article 8 of the Cosmetic Hygiene and Safety Act both refer to “cosmetics manufacturing sites,” but whether they cover “Chinese label attachment sites for imported cosmetics” would certainly depend on the interpretation of Paragraph 1.
In line with the definition of “factories” under the Factory Management Act, the “cosmetics manufacturing sites” set forth in Paragraph 1 would refer to “cosmetics factories that engage in ‘manufacture/processing’ and meet ‘certain area/electrothermal’ criteria.” The Industrial Development Bureau’s explanation of this law points out that “attaching Chinese labels” does not meet the definition of “manufacture/processing,” which involves “the transformation of organic or inorganic substances into new products by mechanical, physical or chemical means.” Therefore, a Chinese label attachment site is not a “cosmetics factory” and should not be subject to the requirements imposed on “cosmetics manufacturing sites.”
Further, the “cosmetics manufacturing sites” referred to in Paragraph 2 as governed by the mandatory GMP requirements should also be limited to “cosmetics factories that both engage in ‘manufacture/processing’ and meet the ‘certain area/electrothermal criteria.’” Since a Chinese label attachment site does not meet the definition of “manufacture/processing,” it is excluded from the scope of “cosmetics manufacturing sites” mentioned in this paragraph.
The question has also been raised as to whether the so-called simplified version of GMP meets the needs of importers. If Chinese label attachment sites are not considered to be “cosmetics manufacturing sites” in line with the above legal interpretation, there is no justification for the so-called simplified version of GMP to be applied in this context.
Suggestion 3: Align the requirements for the size of English fonts under the labeling regulations with those of major cosmetics importing countries.
U.S. regulations regarding the font size on cosmetics labels focus on “font height.” If the total area of a label is greater than 77 sq.cm., the font height should reach 1.58 mm. If the area is less than 77 sq.cm., the required height is only 0.79 mm. In the EU, the 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 Taiwan, the literal meaning of the cosmetics labeling laws and regulations is that the height and width of a font are both required to be at least 1.2 mm, with a capital “O” and small “o” used to gauge compliance with the 1.2 mm requirement. (In an official response to trade associations and on other occasions, however, the authorities indicated that the height is used as the critical factor when determining whether the 1.2 mm requirement has been satisfied). Such requirements and basis for determining compliance overlook the legislative examples in major importing countries for Taiwan’s cosmetics products and make it difficult to harmonize with the laws and regulations of our major trading partners. They also ignore the reality that computer fonts come in sets, with letters displayed proportionally.
The Committee believes that the font size in 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, it should be noted that English letters do not all share the same proportion of height to width, and it is therefore sufficient to regulate font sizes based on height only, as is done in the U.S.
In addition, TFDA’s clarification is needed as to whether the method of calculating a cylinder’s “maximum surface area” for purposes of cosmetics labeling regulation is also applicable to “irregular cylinders.”
Suggestion 4: 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, 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 Regulations, the data supporting the claim shall be “objective and fair.”
Both cases of attempted guidance to industry are too vague to be helpful. How to determine what is “sufficient” and what is “insufficient,” or what is “objective and fair” rather than “nonobjective and unfair?” The judgment of local health officials may be quite different from that of the central FDA. Some officials set high standards and requested clinical/in-vivo data. In the absence of a standard that both government and industry can agree upon, local FDA regulators may take a highly arbitrary stance that leaves industry vulnerable. In reality, numerous published journals and academic works are available for reference, in addition to well-established in-vivo/in-vitro testing methods that are acceptable and used by the cosmetics industry globally.
TFDA should follow global practice by routinely communicating with industry to reach agreement on the proper means for evaluating claims, avoiding setting a super-high bar or adopting unique requirements that would impact consumers’ rights to enjoy safe, high-quality products or impede the growth of the cosmetics business.
Suggestion 5: Extend the notification deadline under the two-year grace period to March 8, 2022.
According to Article 4 of the Cosmetic Hygiene and Safety Act and the Regulations Governing Notification of Cosmetic Products, responsibility for competing notification rests with the cosmetics manufacturer or importer. Based on the TFDA’s implementation plan, product notifications for general cosmetics should be completed by July 1, 2021, which includes a two-year grace period. The consequences for failing to comply by that date could be very serious, including fines and recalls.
Over the past two years, many of the companies that started to upload their product notifications to TFDA encountered bugs in the system. TFDA made improvements based on that feedback, and the most recent revised portal, which became effective on March 9, 2020, added some new requirements such as GMP-related information regarding manufacturing and labeling sites.
Surprisingly, for general cosmetics that were already successfully notified, companies cannot simply revise the previous file but have to create an entirely new one. Some companies even found that their uploaded data was missing. With so many companies forced to start the process over from scratch, industry is concerned that the two-year grace period is almost half over.
Given these circumstances, the Committee urges TFDA to extend the notification grace period for general cosmetics to March 8, 2022. In addition, TFDA should do its best to make the notification system more stable and user-friendly to reduce industry’s burden and ensure a good quality of data in the system.