NIFDC Seeks Feedback on 6 Draft Cosmetic Standards Affecting Safety Assessment & Ingredient Management

On 14 October 2025, the National Institutes for Food and Drug Control (NIFDC) announced a public consultation on six draft cosmetic standards, including the “90-Day Oral Toxicity Test Method (Draft for Comment).” Feedback is due by 7 November 2025 — contact Cisema for support in submitting comments or interpreting the proposed changes.

The drafts address key areas of cosmetic safety assessment and ingredient management, comprising four safety testing methods and two management guidelines. This marks another step in China’s efforts to strengthen its regulatory framework for cosmetics.

Given the potential impact on product registration timelines, testing costs, and formulation management, overseas companies in the cosmetics sector should closely monitor these developments to ensure they are prepared for any changes.

Regulatory Context

Since the implementation of the “Cosmetic Supervision and Administration Regulation” (CSAR), China’s cosmetics regulatory framework has continued to evolve into a more scientific and stringent system. In 2025 alone, the NIFDC, as the technical lead for national standardisation, has released several batches of draft standards, including:

• 9 in June (e.g., General Rules for Physicochemical Testing Methods)
• 3 in July (e.g., Human Skin Patch Test Method)
• 18 in September (e.g., Microbial Limits for Eye, Lip, and Children’s Cosmetics)

These six current drafts are part of a broader initiative to establish a comprehensive set of cosmetic standards, emphasising safety evaluation and ingredient management, while aligning with international best practices.

Implications for Overseas Companies

China’s evolving draft standards present several considerations for overseas companies looking to enter or expand within China's cosmetics market. Here’s a closer look at what these proposed changes mean:

Key Updates in Safety Assessment Requirements

The draft standards introduce updated protocols for cosmetic safety assessments, aiming to enhance the consistency and rigour of evaluations.

Four of the six drafts focus specifically on safety assessment methods, including:

• “90-Day Oral Toxicity Test Method” and “90-Day Dermal Toxicity Test Method”
  • Core approaches for repeated-dose toxicity evaluation.
  • Particularly relevant for ingredients intended for long-term use or with potential systemic exposure.
  • Once implemented, these methods may influence safety assessment strategies for new cosmetic ingredients.
• “Bacterial Reverse Mutation Test Method” and “In Vitro Mammalian Cell Chromosomal Aberration Test Method”
  • Key genotoxicity tests—typically required for new ingredient registration—to determine whether ingredients may cause gene mutations or chromosomal damage.

For overseas companies introducing new ingredients to the Chinese cosmetics market, these standards signal that safety assessments will become more standardised and specific.

Building a Stronger Foundation for Compliance

The “General Rules for Cosmetic Product Standards (Draft for Comment)” provides foundational guidelines for cosmetic product standards. Although the specific content has not yet been finalised, such general rules typically address critical areas such as:

• Technical specifications
• Labelling
• Claim requirements

The “Technical Guideline for Cosmetic Ingredient Use Purposes” will also clarify the definition and categorisation of ingredient use, which directly impacts product classification, labelling, and safety assessment requirements. Accurate classification is essential for avoiding delays, registration rejections, or post-market compliance issues.

Cost and Timeline Considerations

Standardised testing methods will ultimately reduce inconsistencies between laboratories and improve the comparability of results. However, companies may initially need to allocate time and resources to familiarise themselves with the new requirements and ensure that their testing partners are prepared.

Businesses planning product launches in China should stay informed about the official implementation dates for these standards. Proactively adjusting testing and registration schedules will help prevent delays and ensure a smooth transition to the new regulatory framework.

Consultation Timeline

The public consultation on the six draft cosmetic standards will remain open until 7 November 2025. To ensure your feedback is considered, all comments must be submitted via the Cosmetic Standards Development and Revision Management System, an online platform for feedback submission. Stakeholders should follow this process to ensure their input is captured and reviewed in the final version of the standards.

Next Steps for Companies

To prepare for the implementation of these draft cosmetic standards, overseas companies should act promptly. The following steps will help ensure compliance with the new standards:

Conduct Internal Evaluation and Gap Analysis

• Form a cross-functional team: Include regulatory affairs, product development, and safety assessment personnel to study the six draft standards in detail.
• Perform a gap analysis: Compare existing product safety assessment reports against the new requirements to identify compliance gaps.
• Assess supply chain impact: Communicate new requirements to raw material suppliers to ensure overall compliance.

Adjust Product Registration Strategies

Based on developments with these draft standards, companies may need to modify their registration and filing strategies:

• New ingredient registration plans: Ensure safety testing programs align with new standard requirements.
• Product safety assessment updates: Update or supplement existing safety assessment reports accordingly.
• Testing resource evaluation: Verify that testing partners are qualified and capable of performing tests under the new standards.

Participate in the Public Consultation

The public consultation period offers a valuable opportunity to influence the final versions of the standards. If any provisions appear unclear, impractical, or significantly divergent from international norms, submit constructive feedback. Suggestions that are scientifically supported and aligned with global standards are more likely to be considered by regulators.

Final Thoughts

As China’s NIFDC develops its draft cosmetic safety and ingredient management standards—focusing on toxicity testing, ingredient classification, and safety evaluation—overseas companies must stay vigilant to forthcoming regulatory updates and implementation requirements. Staying ahead of these changes is essential for maintaining smooth market access, avoiding delays in product approvals, and ensuring continued compliance in China’s increasingly sophisticated cosmetics sector.

For companies navigating China's cosmetics market, Cisema offers a comprehensive range of services, including:

• Standard interpretation and gap analysis: In-depth analysis of the six draft standards to help companies understand the requirements and identify compliance gaps.
• Feedback support: Assistance in drafting and submitting scientifically sound and persuasive comments.
• Testing strategy consulting: Developing efficient testing strategies aligned with the new standards to avoid redundant testing.
• Safety assessment services: Preparation of safety assessment reports compliant with Chinese requirements.
• Registration and filing services: End-to-end support to ensure smooth market entry for cosmetic products.

Get in touch with Cisema today for expert support in submitting feedback or navigating the NIFDC's draft cosmetics standards.

Further Information

Explore Cisema’s cosmetics registration services in China: Cisema Cosmetics Registration Services

References

Read the NIFDC announcement in Simplified Chinese:

• Notice of the Central Inspection Institute on publicly soliciting opinions on 6 cosmetic standards, including the "90-day oral toxicity test method (draft for comments)"

Read the 6 Draft for Comments in Simplified Chinese:

• "90-Day Oral Toxicity Test Method (Draft for Comments)" and drafting instructions
• "90-day Percutaneous Toxicity Test Method (Draft for Comments)" and drafting instructions
• Test Method for Bacterial Recovery Mutation (Draft for Comments) and Drafting Instructions
• "In vitro mammalian cell chromosomal aberration test method (draft for comments)" and drafting instructions
• General Principles for Cosmetic Product Standards (Draft for Comments) and Drafting Instructions
• Technical Guidelines for the Purpose of Use of Cosmetic Raw Materials (Draft for Comments) and Drafting Instructions