The Committee commends the Taiwan Food and Drug Administration (TFDA), the Ministry of Environment (MOENV), and other relevant authorities for their continued engagement with industry and for the progress made on key regulatory issues in 2025.

Taiwan remains an important and attractive market for the global cosmetics industry, supported by steady consumer demand, ongoing innovation, and continued international investment. At the same time, rapid advancements in digital technologies, including the use of artificial intelligence in product development, compliance, and supply chain management, are reshaping industry operations and increasing both market competition and regulatory complexity.

The Committee looks forward to continued constructive dialogue with regulators and to further collaboration in advancing regulatory transparency and international alignment. Key priorities include the development of a standardized and shareable product information file (PIF) audit FAQ, improvements to the cosmetic product notification system, the introduction of e-labeling, and the promotion of sustainable product design.

In addition, for any new or revised regulatory requirements that involve relabeling or product reformulation, the Committee encourages early government engagement with industry and the provision of sufficient implementation timelines, including clear public communication and appropriate transition periods. Such measures are essential to support effective compliance and minimize disruption to business operations.

Suggestion 1: Initiate meaningful communication between industry and government on cosmetics e-labeling policies.

Cosmetic labeling is a core regulatory tool for ensuring product safety and enabling informed consumer use. Under the Cosmetic Hygiene and Safety Act and related requirements, manufacturers must provide accurate information on product use, ingredients, and precautions. As product portfolios expand and supply chains become more dynamic, maintaining accurate and up-to-date information through paper-based labeling alone is becoming increasingly complex.

Digital labeling offers a practical solution. E-labeling can improve accessibility by allowing consumers to access more detailed and current product information, while supporting sustainability objectives by reducing the use of packaging materials. It also enables more timely updates in response to regulatory changes, safety considerations, or product modifications.

While the TFDA has permitted the use of two-dimensional barcodes, the continued requirement for full paper labeling has confined e-labeling to a supplementary function. As a result, digital tools cannot be used to streamline labeling, reduce the packaging burden, or provide real-time updates, leading to duplicative compliance requirements without corresponding regulatory benefit.

Without a clear regulatory pathway for partial or phased substitution of paper labeling with digital formats, Taiwan risks falling behind international developments and increasing compliance costs for companies operating across multiple markets. This trend may also constrain the growth of e-commerce and digital supply chain management.

The Committee therefore recommends that the TFDA establish a formal e-labeling framework that allows appropriate elements of labeling information — supported by clear standards on accessibility, data integrity, and consumer protection — to be provided digitally in place of paper labels. In developing such a framework, early and structured engagement with industry stakeholders will be essential to ensure that regulatory requirements are both practical and effective.

Suggestion 2: Establish audit guidelines and a risk-based regulatory framework for cosmetic product information files.

With the full implementation of the Cosmetic Product Information File (PIF) system on July 1, 2026, all cosmetics that fall within its scope are required to establish and maintain a PIF. The Committee appreciates the TFDA’s efforts to support implementation of the system though such means as training programs, digital learning resources, and on-site advisory visits conducted by external experts. These initiatives have played an important role in facilitating industry understanding during the transition period.

However, as implementation progresses, several gaps have become apparent. Existing training materials and guidance focus primarily on how to compile PIF documentation, with limited clarity on audit expectations, evaluation criteria, and documentation standards. As a result, companies may adopt differing approaches to structuring their PIFs, while auditors may apply inconsistent interpretations during inspections. This lack of standardization reduces transparency and predictability in the audit process and may lead to increased compliance costs and potential disputes.

International practice, including in the European Union, generally emphasizes the completeness, accessibility, and scientific validity of PIF documentation rather than prescribing rigid formats or templates. Such approaches allow flexibility in documentation structure while maintaining clear expectations regarding safety assessment, good manufacturing practice (GMP) documentation, and supporting evidence.

As Taiwan transitions from implementation to enforcement, clear and standardized guidance regarding the scope, purpose, and schedule of audits is needed to ensure the effectiveness of the PIF system and create regulatory certainty.

The Committee therefore recommends that the TFDA establish a more structured and risk-based audit framework, supported by clear and publicly available guidance, to ensure consistency, transparency, and efficient allocation of regulatory resources.

2.1   Issue clear audit guidelines and reference materials. The TFDA should develop and publish administrative guidance outlining audit procedures, evaluation criteria, and expectations for PIF documentation. Providing illustrative case examples of common deficiencies would enable industry to engage in self-assessment and promote consistent interpretation among auditors.

2.2   Adopt a risk-based audit approach. Audit frequency, depth, and scope should be aligned with product and company risk profiles, taking into account factors such as ingredient risk, product claims, target consumer groups, and compliance history. This process would improve regulatory efficiency and reduce unnecessary burdens on low-risk products.

2.3   Strengthen pre- and post-audit communication mechanisms. Prior to audits, the TFDA could provide briefings or guidance on audit focus areas and expectations. Following audits, in addition to required corrective actions, regulators should provide clear feedback and reasonable timelines for remediation to support effective compliance.

2.4   Support digitalization and data integration in PIF management. The audit framework should be designed to accommodate digital PIF systems, including standardized indexing or tagging approaches that facilitate efficient document access, review, and traceability.

Establishing clear audit guidelines and a risk-based framework would improve regulatory consistency, enhance transparency, and reduce unnecessary compliance costs, while strengthening the effectiveness of the PIF system as a core tool for ensuring cosmetic product safety.

Suggestion 3: Enhance the efficiency and responsiveness of the cosmetic product notification system through user-centered design and proportionate implementation measures.

The Committee appreciates the TFDA’s continued efforts to improve the cosmetic product notification system — the online platform where companies must submit basic information about their cosmetic products (such as ingredients, product type, manufacturer details, etc., before placing them on the market. This process allows regulators to monitor product safety and ensure compliance with relevant regulations.

We also appreciate the TFDA’s openness to industry feedback as it seeks to make those improvements. As the system has become a central platform for product registration and regulatory oversight, its performance directly affects compliance efficiency, the administrative burden, and the overall operating environment for the cosmetics industry.

As system usage increases, practical challenges related to usability, administrative processes, and the implementation of regulatory updates have become more apparent. Addressing these issues will be important to ensure that the system remains efficient, user-friendly, and aligned with the needs of both regulators and industry.

The Committee therefore recommends the following measures:

3.1   Strengthen structured industry engagement and improve system usability. Regular and structured engagement with industry representatives would allow the TFDA to identify operational challenges and prioritize system improvements based on real-world usage. Establishing periodic technical consultations or feedback mechanisms would also support continuous system optimization.

In addition, targeted improvements to system design would enhance efficiency. For example, the current separation of payment processes across various application types (such as new notifications, changes, and extensions) prevents consolidated payment and increases the administrative workload for authorities. Allowing integrated payment functionality would streamline operations and reduce processing time.

3.2   Adopt proportionate implementation measures for regulatory updates. When regulatory changes require companies to revise previously submitted notifications, such revisions are typically driven by compliance obligations rather than voluntary product changes. In such cases, applying standard amendment or re-notification fees may create unnecessary administrative burden without contributing to regulatory objectives.

The Committee therefore recommends that the TFDA waive or adjust such fees where revisions are required solely due to regulatory changes. Adopting a more proportionate approach would facilitate timely compliance, reduce administrative friction, and support effective implementation of new regulatory requirements.

Suggestion 4: Strengthen incentive mechanisms for green design in the cosmetics industry and align cross-ministerial sustainability policies.

The transition toward a circular economy and more sustainable production models is a key policy objective under Taiwan’s Resource Circulation Promotion Act. As a consumer-facing industry with complex product formulations and packaging requirements, the cosmetics sector has a significant role to play in advancing green design, material reduction, and the use of recycled inputs across the product lifecycle.

The Committee recognizes the MOENV’s efforts to promote circular economy principles and establish incentive mechanisms to encourage industry participation. However, current incentive structures are largely designed with other sectors in mind, particularly the food and beverage industry, and do not adequately reflect the technical and regulatory requirements of cosmetic products.

For example, preferential recycling fee conditions for plastic containers, such as no-label designs or simplified packaging structures, are often not applicable to cosmetics. Cosmetic products typically require more complex packaging to ensure product stability, safety, and shelf life, which can extend from three to five years. Requirements related to material opacity, durability, and labeling also differ significantly from those of simpler consumer goods. As a result, many cosmetics companies are unable to benefit from existing incentive schemes, limiting industry participation in green design initiatives.

Without adjustments to these policies, current incentive mechanisms may have limited effectiveness in driving sustainable practices within the cosmetics sector, despite the industry’s willingness to contribute to Taiwan’s environmental objectives.

The Committee therefore recommends that the MOENV strengthen and adapt incentive frameworks to better reflect industry-specific conditions. In particular, the Committee recommends that regulators engage with cosmetics industry stakeholders to develop feasible and targeted incentive measures, including adjustments to recycling fee structures and design criteria that encompass product safety and performance requirements.

In addition, closer coordination between the MOENV and TFDA would support the development of integrated sustainability policies. Aligning environmental and product safety regulations, for example through the promotion of digital labeling and other innovative approaches, would enable more effective implementation of green design strategies while maintaining consumer protection.

A more tailored and coordinated policy approach would improve industry participation in sustainability initiatives, enhance the effectiveness of existing regulatory frameworks, and support Taiwan’s broader transition toward a circular economy.