The Committee sincerely appreciates the transparent communication, willingness to listen and understand, and close collaboration demonstrated by the authorities in 2024. These efforts enabled the achievement of win-win outcomes that balanced consumer safety, evolving regulatory trends, and business development in Taiwan.

Looking ahead, we anticipate that 2025 will be a year of heightened volatility, with rising expectations around environmental, social, and corporate governance (ESG) practices, consumer protection, and product safety and quality. We recognize these as shared social responsibilities and remain committed to advancing them by raising industry standards.

To navigate growing international trade demands, shifting consumer needs, and global regulatory developments, the Committee will continue to pursue a collaborative working model with the authorities, particularly the Taiwan Food and Drug Administration (TFDA), grounded in regulatory transparency, open dialogue, and mutual cooperation. This approach is essential to maintaining consumer trust and avoiding unfounded public concern stemming from misinterpretation in the media.

The Committee appreciates the TFDA’s continued efforts and improvement initiatives and looks forward to the development of a more refined system that enhances the efficiency and user-friendliness of the cosmetic product notification process.

Suggestion 1: Implement e-labeling for cosmetics and establish supporting regulations to promote sustainability, meet consumer needs, and align with digital trends.

Cosmetic labeling serves a critical function in providing consumers with accurate and comprehensive product information, enabling proper use and ensuring both efficacy and safety. As such, the accessibility, timeliness, and delivery format of labeling content are key considerations.

We acknowledge the TFDA’s efforts align Taiwan’s regulatory framework with international standards through the establishment of the labeling requirements for cosmetic packaging, containers, labels, or directions. However, in light of the United Nations Sustainable Development Goals, the rapid advancement of digital technologies, and evolving international regulatory trends, there is a growing need to promote e-labeling solutions that are space-efficient, timely, and better suited to the demands of today’s consumers and the cosmetics industry.

We recommend that the TFDA accelerate the evaluation of cosmetic e-labeling and engage in ongoing dialogue with industry stakeholders to support its development. A collaborative approach will enable the formulation of innovative strategies and the establishment of practical implementation mechanisms, supported by regulatory frameworks tailored to Taiwan’s market needs.

Given the continued impact of the pandemic on the domestic supply chain and the growing reliance on e-commerce and digital channels, more flexible and efficient labeling tools are urgently needed. As international standards such as the EU’s fragrance labeling requirements evolve, Taiwan must keep pace by adopting modernized solutions. E-labeling will not only improve consumer access to product information but also reduce reliance on printed materials, supporting environmental protection and advancing Taiwan’s sustainable development goals. Moreover, e-labeling enhances access to accurate safety and usage instructions, particularly for products sold online.

E-labeling also allows for the real-time updating of product information, offering an efficient solution for complying with frequent and evolving labeling requirements, particularly for fragrance labeling. This flexibility ensures timely alignment with regulatory changes while supporting transparency and reducing administrative burden for both regulators and industry.

The Committee remains committed to supporting the continued advancement of the cosmetics industry. The implementation of digital e-labeling represents a critical step in addressing emerging regulatory, environmental, and consumer demands. We believe that a selective and phased approach to e-labeling is both practical and feasible, offering mutual benefits for regulators and industry. This transition would enhance regulatory flexibility, improve consumer access to information, and contribute to sustainability objectives, while maintaining alignment with global trends.

Suggestion 2: Enhance the communication process for regulatory changes.

Enhancing communication between regulatory authorities and industry stakeholders is essential to ensure that businesses are well-informed and adequately prepared to comply with new regulations. It also ensures that industry input is meaningfully considered during policy development and public consultations.

The draft regulation on fragrance allergens issued on January 21, 2025, underscores the need for process improvements in regulatory communication, particularly regarding the timing and clarity of information shared with stakeholders. Lack of early and structured engagement led to confusion and inefficiencies in industry preparations for compliance.

The Committee has observed the following issues:

• Preliminary press release prior to industry notification. The preliminary press release issued to the media prior to formally notifying industry stakeholders created an imbalance in the flow of information. Without prior notice through official channels (such as direct communication or formal letters), industry participants were left to rely on media reports for critical regulatory updates. This approach undermined effective stakeholder engagement and contributed to confusion regarding the draft regulation’s content and implications.
• Premature determination of regulation and its effective date. The regulation and its effective date were publicly announced through the media before the conclusion of the 60-day public hearing period on March 24, 2025. This premature determination curtailed the opportunity for industry stakeholders to provide meaningful input and undermined the purpose of the consultation process. Effective public engagement requires that regulatory decisions remain open to feedback until the formal consultation period is complete.

The Committee recommends adopting a more structured and transparent communication process that includes early engagement, timely sharing of draft proposals, and opportunities for constructive dialogue. This approach will support smoother transitions, foster mutual understanding, and result in more effective and inclusive regulatory outcomes.

Suggestion 3: Establish an audit plan and guidelines for Product Information Files based on the principles of integrity and consistency.

The Product Information File (PIF) is a mandatory dossier that must be compiled and maintained for general-use cosmetics placed on the Taiwanese market. While it is not submitted proactively to the authorities, it must be readily available upon inspection. The PIF is intended to ensure that cosmetic products are safe, correctly labeled, and traceable.

As of July 1, 2024, the PIF system entered its second phase, extending to baby products, lip products, eye products, non-medicated toothpaste, and mouthwash, with implementation set for July 1, 2025. The Committee sincerely appreciates the TFDA’s efforts in providing supporting resources during the transition, including comprehensive guidelines, reference examples, in-person workshops, and online courses through the Medical Device and Cosmetics Digital Learning Platform. We also commend the TFDA for commissioning the Industrial Technology Research Institute to assist companies with establishing PIFs, offering professional on-site visits and tailored recommendations.

Under current regulations, the PIF framework specifies 16 key dossiers, placing responsibility on companies to self-manage and ensure regulatory compliance. A qualified safety assessor is required to sign off on the product’s safety assessment, reinforcing the company’s accountability for product safety and adherence to regulatory standards.

As the PIF regulations advance into the second phase, the Committee recommends that the authorities uphold the principles of integrity and consistency, drawing on internationally recognized audit practices. It is essential to establish and promptly announce standardized guidelines, audit timelines, and inspection frequencies to ensure alignment with international standards, referencing the European Union’s Cosmetics Regulation as the global benchmark, and to avoid inconsistencies that may result from differing interpretations among inspectors or across regions.

Furthermore, the Committee strongly recommends that authorities hold policy briefings or case-sharing sessions prior to audits to ensure that businesses clearly understand the audit criteria and expectations. Following the audit, providing appropriate guidance and a reasonable transition period will support companies in gradually achieving full compliance. This approach will help foster a healthy and sustainable industry ecosystem while reinforcing the principles of self-management.

Suggestion 4: Optimize the cosmetic notification system.

The Committee greatly appreciates the TFDA’s attention to our previous suggestions and feedback, as well as its continued efforts to improve the cosmetics notification system. To further enhance the system’s user-friendliness and overall user experience, we respectfully offer the following three recommendations:

1. Update the cosmetic notification system in real time. The Committee recommends that the cosmetic notification system be updated in real time to reflect any changes in TFDA regulations. This will help prevent disruptions for users submitting product notifications and avoid unnecessary delays or additional costs. Timely system updates will improve operational efficiency and support smoother compliance with evolving regulatory requirements.
2. Continue to optimize the system. We suggest further enhancing the platform’s usability and functionality to allow users to complete product notifications more efficiently. For example, the current system separates payment pages for the four application types (New Notification, Single Change, Multiple Changes, and Case Extension), preventing combined payment across categories. We recommend refining the system to allow consolidated payment processing for all application types, thereby reducing administrative workload and improving overall operational efficiency.
3. Waive additional notification fees due to regulatory changes. The Committee notes the recent draft regulation issued by the TFDA requiring “Specific fragrance or flavor ingredients to be labeled on cosmetics,” which may necessitate re-notification for certain products. We recommend that the TFDA consider implementing supportive measures during the transition to new requirements. In particular, fees associated with re-notification resulting from regulatory changes should be waived. Waiving re-notification fees would help companies prioritize timely updates without incurring unnecessary administrative burdens, thereby avoiding unintended compliance delays caused by regulatory updates.