The Asia-Pacific (APAC) region continues to be a dynamic regulatory landscape for the cosmetics industry in 2024. With significant regulatory updates across various countries from this year in particular, it feels like a night before a war. Here is a brief overview of the latest and most impactful cosmetic regulations in the APAC region that should be on your radar:
1. China: Extended Transition Periods and Stringent Ingredient Controls
Under China’s Cosmetic Supervision and Administration Regulation (CSAR) framework, a transition period was set for submitting full safety assessment reports. Companies can continue submitting simplified reports until May 1, 2025, provided the assessment started before May 1, 2024. New guidelines issued by the National Medical Products Administration (NMPA) in April and July 2024 clarified submission requirements and outlined comprehensive risk assessment protocols. Global brands should ensure they are prepared for the full safety report mandates and seek expertise to address any data gaps or ingredient reviews.
Just last week on November 4, 2024, the NMPA of China officially approved Isobutylamido Thiazolyl Resorcinol (Thiamidol 630), an innovative whitening ingredient developed by Beiersdorf Group. This marks the first whitening ingredient to be approved under the Cosmetic Supervision and Administration Regulation (CSAR), a key milestone for the industry. It is considered a new step forward in new ingredient entry in China -- not only for the limited claims category.
2. South Korea: Going Rapidly Towards Safety Assessment Implementation
The Ministry of Food and Drug Safety (MFDS) has outlined legislative measures to align with global regulations and boost the competitiveness of South Korea's cosmetics industry. These measures include the preparation and maintenance of pre-sale safety documentation, which must be reviewed and approved by a qualified safety assessor. While the responsible seller must prepare and retain these documents, submission to the MFDS is only required upon inspection if necessary. The requirements cover all products, including those for export and import, and allow for external institutions to be commissioned for safety evaluations. In such cases, having an in-house safety assessor is not mandatory, and assessments conducted by internationally qualified reviewers will be accepted. The MFDS has also proposed diverse qualification standards for safety assessors, emphasizing the need for regulatory alignment and a steady supply of domestic evaluation professionals. According to the officials, this new safety assessment will be effective from 2028.
3. Japan: Approval of New Ingredients for Specific Applications
In March 2024, Japan's Ministry of Health, Labour and Welfare (MHLW) proposed updates to the Standards for Cosmetics, ultimately approving the use of Cysteamine Hydrochloride for rinse-off hair styling products in July 2024. This is a positive sign for manufacturers seeking to innovate in the hair care segment, provided their use aligns with specified limits.
According to unofficial sources, Japan is reportedly considering the introduction of a Product Information File (PIF) system in response to the mandatory implementation of safety assessment regulations by Chinese and South Korean authorities. The industry is closely watching whether Japan will proceed to legally mandate safety assessments, a step that builds on the voluntary safety evaluations already being conducted by the industry.
4. ASEAN: Ongoing Updates to Ingredient Annexes
Regulatory movements within ASEAN countries have also been gaining momentum recently. Authorities in countries such as the Philippines are reportedly discussing the adoption of a “functional cosmetics system,” recognizing it as one of the key factors behind the development of South Korea’s cosmetics industry. It remains to be seen whether this will remain a topic of discussion or lead to actual implementation, and if so, whether its influence will spread to other ASEAN regions.
5. New Zealand: PFAS Ban Implementation
A significant move came from New Zealand’s Environmental Protection Authority (EPA), which announced a phased ban on PFAS in cosmetics starting December 31, 2026 for manufacturing, and extending to sales by December 31, 2027. This regulation signals New Zealand’s precautionary stance on emerging environmental and health concerns linked to persistent chemical substances.
6. Australia: Enhanced Sunscreen Regulations
Australia updated its sunscreen standards in April 2024, incorporating new ISO methodologies for SPF testing and adding detailed labeling instructions. This move aligns Australia’s regulations more closely with international standards and highlights the importance of accurate, consumer-friendly product labeling.
Key Takeaways for Global Brands
- Proactive Preparation for Transitions: While extended transition periods in markets like China offer some leeway, companies should proactively prepare for the mandatory full safety report requirements. Early adaptation ensures compliance and avoids last-minute complications.
- Ingredient Vigilance: Monitor regulatory changes regarding newly approved, banned, or restricted substances, such as the approval of Isobutylamido Thiazolyl Resorcinol in China and PFAS bans in New Zealand. Keeping ingredient lists up to date helps maintain product marketability and compliance.
- Adapting to Regional Standards: With South Korea advancing its safety assessment requirements and Japan potentially introducing a PIF system, brands must align their product development and documentation to meet diverse regional standards.
- Strategic Industry Engagement: Collaborating with local industry associations and regulatory consultants can provide insights and guidance on navigating complex regulations, ensuring that brands stay ahead of regulatory shifts.
- Unified Regulations and Global Consistency: With Taiwan and ASEAN countries reconsidering their approaches to cosmetic regulations, companies should anticipate shifts toward more unified and comprehensive systems. This might require updates in GMP practices, labeling, and compliance frameworks.
Conclusion
The APAC regulatory landscape in 2024 continues to evolve rapidly, marked by both stricter safety standards and new ingredient approvals. For global cosmetic brands, staying informed and adaptable is essential. Whether it’s aligning with China’s stringent safety protocols, preparing for South Korea’s forthcoming safety assessments, or monitoring the expansion of functional cosmetics discussions within ASEAN, a well-prepared approach will be the difference between merely complying and thriving. Continuous engagement with industry experts, proactive compliance strategies, and a commitment to understanding regional nuances will help brands navigate this complex yet opportunity-rich market.
Need additional help or advice around APAC regulations? Check out REACH24H's website here to learn about their services.
To find the latest innovative ingredients that meet regulatory standards, leverage Covalo's platform for free to search and filter by any requirement.