In a move that could significantly impact the cosmetics industry, especially for cruelty-free brands eyeing the Chinese market, the National Medical Products Administration (NMPA) of China has released a crucial draft opinion for public consultation. This announcement, titled “Usage information of Raw Materials from marketed Products (Revised Draft for Opinions),” was made public on November 15, 2024, and it may alleviate concerns of many cruelty-free brands who feared being unable to enter the Chinese market due to potential gaps in safety data.

The Draft Opinion: Expanding Safety Data

The draft opinion proposes to expand the safety data for cosmetic ingredients by an impressive 3,578 raw materials. This addition is not just a number—it’s a potential solution to what was anticipated to become a new barrier for cruelty-free brands entering the Chinese market due to upcoming regulatory changes.

Let’s break down the numbers:

• Current safety data (April 2024): 3,651 raw materials
• Proposed addition in the Draft Opinion: 3,578 raw materials
• Existing data in Cosmetic Safety Technical Specification (STSC): 700+ raw materials

If approved, this would bring the total number of ingredients with safety data to approximately 8,000. To put this into perspective, the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021 Edition) lists 8,972 approved ingredients. This means that if the draft opinion is implemented, nearly 90% of all approved cosmetic ingredients in China would have recognized safety data.

Grace Period and New Safety Assessment Requirements

It’s crucial to note that this draft opinion is part of a broader regulatory shift in China’s cosmetics industry. On April 22, 2024, the NMPA unveiled the “Announcement on Issuing Several Measures to Optimize Cosmetic Safety Assessment Management.” This announcement introduced a significant grace period for the industry:

Until May 1, 2025, cosmetics registrants and notifiers can continue to submit a simplified version of the safety assessment report when applying for registration or notification.

This grace period is a response to the anticipated challenges faced by the industry in transitioning to the full version of safety assessment reports, which was originally set to be mandatory from May 1, 2024. The extension recognizes the time required for cosmetics research and development and aims to alleviate the burden on enterprises, facilitating a smooth transition to the full version of the safety assessment.

For companies preparing for these new requirements, Knudsen&CRC can assist with the development of full version safety assessments that will be required after the grace period.

Current Status of Animal Testing and Safety Documentation

The current regulatory landscape for cruelty-free cosmetics in China is complex and multifaceted. While there have been significant changes since 2021, it’s important to understand that the requirements go beyond just Good Manufacturing Practice (GMP) certificates and safety assessments.

As of 2024, here’s a more comprehensive overview of the requirements for cruelty-free cosmetics in China:

1. General Cosmetics vs. Special Cosmetics: Only general cosmetics (such as skincare, makeup, and haircare) are eligible for exemption from animal testing. Special cosmetics (including hair dyes, perming products, whitening products, sunscreens, and anti-hair loss products) still require animal testing.
2. GMP Certification: Companies must provide a GMP certificate issued by the relevant authority in the country of origin.
3. Safety Assessment: A comprehensive safety assessment report must be submitted, which includes toxicological data and risk assessments for all ingredients.
4. Efficacy Claims: Products must adhere to strict regulations regarding efficacy claims. Exaggerated or new efficacy claims may trigger additional testing requirements.
5. Ingredient Restrictions: Certain ingredients are restricted or prohibited in China. Products containing new cosmetic ingredients or those not listed in the IECIC may require additional safety data or testing.
6. Product Formulation: The complete qualitative and quantitative formulation of the product must be disclosed to Chinese authorities.
7. Labeling and Packaging: Products must comply with China’s labeling requirements, including Chinese language labeling.
8. Post-Market Surveillance: Companies must have a system in place for monitoring and reporting any adverse effects.
9. Cross-Border E-Commerce Exception: Products sold through cross-border e-commerce platforms are currently exempt from animal testing requirements, providing an alternative route to market for some cruelty-free brands.

It’s important to note that while these regulations have opened up possibilities for cruelty-free brands, the process of entering the Chinese market remains complex and requires careful navigation of regulatory requirements. To support this transition, Knudsen&CRC offers free consultations and compliance screenings specifically for cruelty-free brands looking to enter the Chinese market, aiming to help these companies avoid potential animal testing requirements.

Implications for Cruelty-Free Brands

This development is particularly significant for cruelty-free cosmetics brands. Here’s why:

1. Potential Reduction in Animal Testing: With comprehensive safety data available for a vast majority of ingredients, the necessity for additional animal testing could be significantly reduced once the new regulations take effect.
2. Preparation Time: The grace period until May 2025 allows companies more time to gather necessary safety data and prepare for the full safety assessment requirements.
3. Alignment with Global Standards: This move brings China’s cosmetic regulations closer to international standards, potentially facilitating global trade and partnerships in the future.
4. Market Opportunity: If implemented, these changes could pave the way for more cruelty-free brands to enter the Chinese market after May 2025, meeting the growing demand for ethical products among Chinese consumers.

The Road Ahead

While this draft opinion is a step in the right direction, it’s important to note that it’s currently open for public consultation. The NMPA is accepting feedback on this draft until November 30th, 2024.

If implemented, this could reduce the gap in raw material evaluation data to approximately 10%, a remarkable improvement from the current situation. However, it’s crucial for industry stakeholders to actively participate in this consultation process to ensure that the final implementation addresses the needs of both the industry and consumers.

What This Means for Regulatory Professionals

For regulatory directors and professionals in the cosmetics industry, this development warrants close attention. Here are key points to consider:

• Timeline: Keep an eye on the May 1, 2025 deadline for the transition to full safety assessment reports.
• Data Verification: Ensure that your ingredient lists align with the expanded safety data once it’s finalized.
• Strategy Adjustment: Consider how this change might affect your product development and market entry strategies for China post-May 2025.
• Preparation: Use the grace period to gather comprehensive safety data for your products and ingredients.

Conclusion

The NMPA’s draft opinion, coupled with the grace period announcement, represents a potential solution to what was anticipated to be a new barrier for cruelty-free cosmetics in China. While it’s not yet set in stone, it offers a glimpse into a future where cruelty-free brands might find it easier to navigate the world’s largest cosmetics market after May 2025.

As we await the final implementation, it’s clear that the cosmetics regulatory landscape in China is evolving. The extended timeline to May 2025 provides a valuable opportunity for companies to adapt and prepare for these significant changes, potentially paving the way for more ethical and diverse product offerings in the future.

Stay tuned for further updates on this critical development. Your voice matters—consider providing feedback to the NMPA before the November 30th deadline.