The Committee highly appreciates recent efforts by the Taiwan Food and Drug Administration (TFDA) and the Ministry of Environment (MOENV) to engage with industry and promote product safety and sustainability. We look forward to engaging in more mutually beneficial collaboration to secure product safety, sustainability, and consumer protection, as well as to accelerate international trade by driving global regulatory harmonization and regulatory transparency.

This year will see the final stretch of a substantial reform of Taiwan’s cosmetics regulatory environment through the adjustment of cosmetics ingredient lists. Starting July 1, the regulations for the cosmetic category will undergo significant changes. The designation of “specific purpose cosmetics” will be merged into “general cosmetics.” Additionally, this reform introduces Taiwan’s first-ever Cosmetic Product Information File (PIF) in accordance with the Good Manufacturing Practice (GMP) regulations for cosmetics. We request that these changes be implemented with transparency and consistent standards to safeguard the rights and safety of both consumers and manufacturers.

The Committee is also dedicated to supporting realization of the government’s ambitions to achieve net-zero carbon emissions by 2050. To facilitate these efforts, we ask for effective communication with industry and a transparent, cohesive, and complete regulatory framework that embraces innovation. In view of those goals, the Committee offers the following recommendations:

Suggestion 1: Avoid non-transparent or arbitrary review standards for proof of claims for cosmetics products and specify rules regarding user-generated content.

1.1   Establish regular communication to clarify review guidelines and the criteria for claim supportability. The “Regulations Governing Criteria for the Label, Promotion, Advertisement with Deception, Exaggeration, or Medical Efficacy of Cosmetic Products” has provided exceptional guidance to industry. However, gray areas remain regarding innovative claims and technologies, particularly following implementation of the PIF. Regular communication through meetings or workshops, taking the industry’s perspectives into consideration, is crucial for enhancing regulatory clarity and ensuring consumers’ rights to accurate product information.

1.2   Distinguish advertising from spontaneous public comments on social media platforms. Article 23 of the Enforcement Rules of the Consumer Protection Act states that advertisement “shall mean to conduct disseminating messages or content of promotion by means of television and radio broadcasting, films, slides, newspapers, magazines, flyers, posters, signboards, arches, computers, facsimiles, electronic video, electronic voice mail or others, to the general public.” Meanwhile, the purpose of user-generated content (UGC) is to provide consumers with a platform to freely share their experiences of using products on social media, a vital component of market research and brand development.

If an advertiser explicitly engages an individual to comment on a product online for the purpose of commercial benefit, this should be classified as advertising and regulated accordingly. However, when posts are spontaneous and unpaid, with no prior coordination with the industry to promote a product, social media users should receive the fullest protection under the principles of free speech and the UGC framework. Yet Taiwan’s health authorities currently treat such user comments as advertisements by nature, subjecting even non-commercial public expressions to rigorous scrutiny.

As a fundamental element of a democratic and pluralistic society, freedom of speech must be protected by the state. Online social platforms have become the center of the communication landscape, with government bodies, individuals, and businesses all establishing websites and using social platforms to facilitate public expression and interaction. This space represents a critical arena for protected speech, where individuals should feel free to express their opinions without fear of retribution.

Taiwan’s commitment to democracy and freedom is internationally acclaimed. To preserve these values, it is imperative for the government to differentiate between spontaneous comments and product advertisements. This approach will help establish clear distinctions between public commentary and advertising, ensuring a balanced protection of legal speech rights and public health.

If a post does not incite violence, engage in libel, slander, or promote harmful actions, the public’s contributions should remain unaltered and uncensored to foster online engagement. Consumer comments, unless they violate specific legal standards, should be preserved to ensure active public participation.

The Committee urges the government to strive for a balance that upholds democratic values, legal interests, and health regulations, both domestically and internationally, with an emphasis on enhancing the consumer experience.

Suggestion 2: Implement an English interface and optimize systems on the medical device and cosmetics digital learning websites, as well as the cosmetic products notification platform system.

2.1   Simplify the sign-up process for foreign nationals. The Committee commends the TFDA for consistently communicating with industry stakeholders, holding explanatory meetings, and establishing English online training courses for cosmetics safety assessors (SAs). These efforts enable foreign professional cosmetics technicians to take and pass the course and submit documents verifying their identity and qualifications to conduct product assessments and sign safety assessment files.

A complete PIF must include a safety assessment file signed by qualified professional technicians. Foreign cosmetics technicians are eligible to sign cosmetics safety assessment files as long as they meet the TFDA’s qualification requirements and provide supporting evidence. Currently, foreign nationals who do not reside in Taiwan must register by submitting a photocopy of their passport and other information through a domestic importer before they become qualified for login with the help of the TFDA. But passport numbers change often, and technicians who do not need to travel abroad may not even hold a passport. It is very likely, however, that they have a driver’s license or social security number.

This lengthy process requires the separate submission of privacy-sensitive identification, missing the opportunity of taking advantage of digital convenience. The Committee recommends that foreign cosmetics technicians be able to register and complete training courses directly in the system, using either their passport or another acceptable identification document.

To further Taiwan’s efforts in internationalization, digitalization, efficiency, and bilingualism, the Committee urges that the medical device and cosmetics digital learning website should be available in English, that foreign cosmetics technicians be allowed to register directly in the system, and that a flexible mechanism be provided to verify identification.

2.2   Optimize systems to enhance user-friendliness. The current cosmetic products notification platform has significant shortcomings regarding data importation and management. Specifically, it fails to automatically transfer complete data sets into the notification system, particularly concerning formulation ingredients. The system imports only the functional ingredients and omits the full ingredient list. As a result, users must enter all ingredients manually to maintain the correct sequence, as the system does not allow for manual reordering of the automatically imported ingredients. Despite industry participants registering tens of thousands of cases on this platform, generating millions of Taiwan dollars in notification fees, there is a clear need for the optimization of this system. We recommend allocating resources specifically to enhance the platform’s functionality and user experience.

Furthermore, critical information such as the names of manufacturers, packaging facilities, and product categories is not seamlessly integrated into the system. This inefficiency forces users to manually input comprehensive details, which is time-consuming and increases the risk of errors.

Another problem involves the management of factory GMP certificates, which currently requires manual input of expiration dates. The Committee recommends enhancing the system with an automated notification feature that alerts users to renew their GMP certificates one to three months before they expire, similar to the functionality in the TFDA food notification system.

The system also makes it difficult to process multiple amendments simultaneously, particularly concerning fee payments and document submissions. For instance, if a name change is needed for two products, the system requires separate payment receipts for each, with no provision for combined submissions. Furthermore, the search functionality for manufacturers or packaging factories is cumbersome, requiring the input of complete names.

To streamline these processes, the Committee recommends revising the system to allow for consolidated fee payments and document submissions. Improving the search function to support keywords or dropdown menus would significantly improve the user experience and operational efficiency.

Suggestion 3: Establish transparent PIF audit mechanisms, guidelines, and priorities.

The implementation of PIFs for specific-purpose cosmetics products is scheduled to begin its first phase on July 1. The Committee thanks the TFDA for its ongoing dialogue with industry stakeholders and acknowledges the efforts of the Industrial Technology Research Institute in offering guidance and assistance to cosmetics companies in the creation of PIFs.

Although new compliance measures will soon take effect, the authorities have yet to announce clear audit plans or guidelines, leaving industry uncertain as to how to proceed and on what schedule. The Committee urges the adoption and swift announcement of guidelines based on internationally recognized audit practices. These should clearly define the focus, criteria, schedules, and frequency of inspections in alignment with global standards.

To better prepare industry stakeholders for these audits, we recommend that the authorities organize explanatory meetings or share practical case studies in advance of their commencement. This proactive approach will help demystify the process and set clear expectations.

Additionally, it is essential that companies be given a reasonable grace period to provide any required documentation post-audit. This will ensure that businesses can comply without facing undue pressure or operational disruptions.

Suggestion 4: Create a transparent packaging regulatory environment with a sufficient grace period to fully implement new requirements and manage product lifecycles.

Policies supporting a shift toward sustainable practices are crucial to accelerating the UN’s 17 Sustainable Development Goals. Collaboration among the MOENV, cosmetic companies, and other stakeholders supporting packaging initiatives will be a critical part of shaping a new circular economy that tackles climate change and helps preserve our planet. While the MOENV’s determination to reform the regulatory environment through the Resource Circulation Promotion Act is laudable, the Committee believes that the Act’s success will depend on actual and excellent execution.

Since 2023, the MOENV has been conducting discussions on the legislative direction of the draft Resource Circulation Promotion Act, which incorporates the spirit of the Waste Disposal Act and Resource Recycling Act. Although industry is somewhat familiar with the overarching law, there remains a gap in understanding the specifics of future corresponding subsidiary legislation, which is expected to be enacted in 2025.

The Committee urges the MOENV to make public a complete outline of the planned subsidiary legislation and a defined regulatory framework. This clarity would enhance communication, enabling industry to fully understand the nuances and consequences of these regulations and foster collaboration across various ministries to establish a unified and comprehensive regulatory system. Furthermore, innovations such as the TFDA’s proposals for e-labeling should be incorporated into this framework.

Given the interconnected nature of these regulations and the uncertain timeline for their announcement, the Committee asks for a well-defined schedule to allow industry opportunities to strategize effectively and engage constructively in the policymaking process. Adequate preparation time for adapting to each sub-law and its announcements is critical as companies strive to ensure continuous supply and consumer access to daily necessities.

The Committee suggests organizing explanatory sessions and sharing practical examples to aid industry stakeholders in navigating these changes. If post-audit document supplementation is necessary, a reasonable grace period should be afforded. Committed to sustainable objectives, we believe that with a clear and phased implementation plan for both the primary law and its subsidiary legislation, businesses can transition smoothly to sustainable practices, thereby achieving mutual benefits for both the government and the industry.