Cosmetic Ingredients in China: NIFDC Releases Final Trial Guidelines on History of Safe Use and Safe Consumption

China has unveiled two final guidelines on the history of safe use of cosmetic raw materials for a trial period. These offer ingredient manufacturers a faster, clearer route to market. Issued on June 24, 2025, by the National Institutes for Food and Drug Control (NIFDC), the two new guidelines are:

Guidelines for the Research and Evaluation of the History of Safe Use of New Cosmetic Ingredients (Trial)
Guidelines for the Research and Evaluation of the History of Safe Consumption of New Cosmetic Ingredients (Trial)

Effective immediately, the guidelines introduce China’s first technical guidance for establishing a history of safe use in new cosmetic ingredient filings. In doing so, they also update the technical framework cascading from the Cosmetics Supervision and Administration Regulation (CSAR).

From Lab Tests to Real-World Evidence

This new guidance shifts how companies demonstrate the safety of cosmetic raw ingredients. Instead of relying on costly and time-consuming duplicate toxicology and safety tests in China, companies can now draw on verified history of safe use data from overseas—either from prior cosmetic applications or from previous consumption as food.

In turn, this streamlined approach reflects regulators’ recognition that well-documented, long-standing consumer exposure can provide safety evidence just as reliable as laboratory data generated locally.

A Quick Comparison: Then and Now

To appreciate the impact more clearly, it helps to compare the new guidelines with the previous system:

Data types: Previously, the system relied mainly on animal toxicology testing, with no standardised templates and no clear rules on what supporting documents were required or how they should be formatted. Under the new guidelines, the requirements for history of safe use and history of consumption data are clearly defined, and this evidence can be used to replace part of the toxicology testing.
Preparation time: With history of safe use and consumption data, dossier preparation time can be shortened compared with the previous system.

In short, the guidelines speed up reviews and reduce reliance on animal testing, while still requiring evidence that is both verifiable and scientifically sound.

Shared Principles Across Both Guidelines

Although one guideline focuses on cosmetic use and the other on consumption, they nevertheless remain aligned on core principles. Both provide a structured way to demonstrate historical safety, streamlining registration without compromising consumer protection.

Key commonalities between the two guidelines include:

Legal foundation: Both guidelines are formulated in accordance with:
- CSAR
- Measures for the Registration and Filing of Cosmetics
- Regulations on the Management of Registration and Filing Data for New Cosmetic Ingredients
Evidence quality: Submissions must be authentic, accurate, complete, and traceable.
Ingredient consistency: The ingredient under review must match the source, process, and composition in the supporting evidence.
Flexibility: Case-by-case assessment is permitted, with scope to include other scientifically valid data.
Special provisions: Whitening or freckle-removing ingredients require long-term human use data from at least 100 consumers over one year.
Additional testing: If historical data and supporting evidence fall short, the guidelines require companies to provide further toxicology testing.

Where the Two Guidelines Diverge

While the principles overlap, the guidelines differ in scope, evidence requirements, and safety emphasis.

Scope and Source

Safe Cosmetic Use History: Applies to marketed cosmetics that meet China’s definition of cosmetics. If products were produced by another company, the source must be identified and authorisation obtained.
Safe Consumption History: Evidence of a history of safe consumption must come from food, agriculture, health, or related regulators, or from recognised technical institutions. Ideally, data should be publicly available and issued by provincial or national regulators in China, or by national authorities overseas.

Evidence Type

Safe Cosmetic Use History: Uses real world data from marketed cosmetics, such as sales records, duration of use, usage levels, and reports of adverse events.
Safe Consumption History: Relies on food consumption records, dietary exposure data, regulatory approvals, official standards, and government announcements. Companies can apply a “dose-exposure” conversion model to translate long-term oral safety data into dermal or oral cosmetic contexts.

Time and Quantity Thresholds

Safe Cosmetic Use History: Requires at least 3 years of marketed use with a cumulative exposure of at least 1,000 individuals and no records of systemic adverse reactions. Specifically, direct retail sales must total ≥10,000 units over three years (≥3,000 per year), or ≥100,000 units over three years (≥30,000 per year) if using indirect sales data (e.g., manufacturer shipments or distributor sales).
Safe Consumption History: No sales thresholds apply. For regional speciality foods, long-standing consumption (typically ≥30 years) in a region may be accepted as valid evidence.

Ingredient and Processing Requirements

Safe Cosmetic Use History: Covers chemically defined substances, plant extracts, microbial fermentation products, polymers, and mixtures. A full analysis of any changes in content, impurities, or other properties of chemically defined ingredients is required if process adjustments are made for quality or environmental reasons.
Safe Consumption History: Includes common food ingredients, new food ingredients, dual-use food and medicine, health food ingredients, and regional speciality foods. Processing of new ingredients should generally match edible use (e.g. water extraction, boiling). For microbial fermentation products, the final composition itself must demonstrate safe edible use.

Safety Focus

Safe Cosmetic Use History: Demonstrates topical safety directly in cosmetic use by examining ingredient concentration, application site, application method, contact time, and adverse event monitoring.
Safe Consumption History: Supports systemic safety by comparing cosmetic exposure against dietary intake levels, identifying unsuitable populations, and applying regulatory restrictions. While it may reduce systemic toxicology testing, it cannot replace assessment of skin-related risks.

3 Essential Compliance Measures for Ingredient Companies

For overseas ingredient companies, attention to detail is critical. In particular, four key factors can significantly impact the success of a filing. Addressing each carefully helps ensure compliance, avoid delays, and build a credible safety record.

1. Sales Documentation Must Be Complete and Accurate

Invoices and contracts must display the INCI name, specification, and batch number of the raw material. Otherwise, missing or inconsistent information can trigger requests for supplementary evidence, potentially delaying the filing process.

2. Exposure Data Must Be Provided Separately for Each Product Category

When a raw material appears in multiple categories, such as hair care or makeup, companies must submit exposure data for each category individually. This requirement prevents the misuse of “one certificate for multiple uses” and ensures regulators receive complete documentation for every application.

3. Updates and Reporting Must Be Timely

Finally, any significant changes in history of safe use evidence—for example, a new adverse reaction—must be reported within 30 days. Prompt updates are essential to maintain regulatory compliance and uphold the credibility of submissions.

Together, these three compliance measures highlight the importance of precise documentation, proactive monitoring, and timely reporting for overseas cosmetics brands leveraging history of safe use data.

The Bottom Line: Cost, Time, and Risk Implications

The new history of safe use guidelines for cosmetic raw ingredients has clear, practical implications for ingredient companies and ultimately international cosmetics brands seeking to register products in China. These impacts can be grouped into three key areas:

Cost savings: Established cosmetic materials already marketed in mature markets may avoid additional toxicology testing, reducing expenses.
Time savings: Ingredients meeting history of safe use requirements can expect shorter registration timelines, therefore reaching the market faster.
Risk management: Incomplete or poorly structured evidence chains may trigger supplementary requests or even rejection, leading to delays and additional costs.

While these guidelines create new opportunities for ingredient companies, they also establish the need for meticulous preparation and credible, verifiable safe history of use evidence.

Next Steps for Overseas Ingredient Manufacturers

To leverage the new framework effectively, international companies should be proactive and take prompt action:

Review Existing Ingredient Lists

Conduct a thorough review of current ingredient portfolios and identify candidates with a documented history of safe use or safe consumption that may qualify under the new guidelines.

Collect and Organise Evidence

Systematically gather, scan, and translate overseas sales records, adverse event monitoring reports, and market surveillance documents. Make sure to present all evidence in a standardised and traceable format suitable for submission.

Collaborate with Brand Clients

Work with cosmetic brand clients to obtain product records, sales data and regulatory filings that demonstrate history of safe use and history of safe consumption across product lines, ensuring comprehensive and traceable evidence for NIFDC submissions.

For international cosmetic raw material suppliers with questions about evidence requirements, filing strategies, or registration timelines in China, get in touch with Cisema today.

With over 20 years’ experience supporting ingredient manufacturers and global brands in the Chinese market, our team provides expert guidance on documentation, compliance and regulatory strategy—helping you navigate the process efficiently and confidently.