On November 4, 2026, the China National Institutes for Drug Control (NIDC) released the Guidelines for the Use of Cosmetic Ingredient Data (Draft for Comments) together with an explanation of the revisions. The Guidelines released this time were formulated by revising the Guidelines for the Use of Cosmetic Ingredient Data issued on April 30, 2024. Public comments are now being solicited, with a deadline of November 30, 2026. CIRS Group has now summarized and organized the main contents for your reference!
The explanation of the revisions contains three “issues requiring key explanation”:
(1) Refining the conditions for use and the supporting-material requirements for an ingredient's 3-year history of safe use
The conditions for using an ingredient's 3-year history of safe use have been refined, and the applicable scenarios for referencing historical use concentrations have been specified. The supporting materials for the same ingredient have been detailed, clarifying that the analysis may be conducted from aspects such as ingredient source, production process, ingredient composition and quality specifications; the materials to be submitted for notified products have been specified; and the requirements for market sales data have been clarified.
(2) Improving the relevant requirements for the history of safe food use
The production process conditions for ingredients with a history of safe food use have been refined; on top of the existing condition that the production process is close to food processing, the scenario of “production involving only physical processing” has been added, making the scope of exemption from systemic toxicity clearer.
(3) Adjusting the assessment-basis requirements for whitening/spot-removing agents and anti-hair-loss agents
It is clarified that ingredients used as whitening/spot-removing agents or anti-hair-loss agents may use the published assessment conclusions of international cosmetic safety assessment bodies, the published safety limits or conclusions of authoritative bodies such as the World Health Organization (WHO), as well as an ingredient's 3-year history of safe use and history of safe food use, as assessment bases.
In addition, where the 3-year history of safe use or the history of safe food use of an ingredient is adopted as the assessment basis for a whitening/spot-removing agent, it is explicitly required to fully analyze whether relevant safety risks exist based on the physicochemical properties of the ingredient and its whitening mechanism of action; where the safety risk of its long-term action on human skin cannot be ruled out, supplementary materials on long-term human trial use tests shall be provided.
CIRS Reminder
The Guidelines further refine the applicable conditions and supporting-material requirements for the 3-year history of safe use and the history of safe food use of ingredients, and also make dedicated provisions on the assessment bases for whitening/spot-removing and anti-hair-loss ingredients.
Enterprises may, in light of their own ingredient assessment plans, provide feedback in a timely manner during the comment-soliciting period and sort out relevant supporting materials in advance; where historical data is used as the assessment basis for a whitening ingredient, it is recommended to focus on evaluating the long-term skin safety risks and, where necessary, prepare materials relating to long-term human trial use. When conducting safety assessment, enterprises may follow the weight-of-evidence principle, properly retain the complete set of supporting materials, and fulfill their primary responsibility for safety.
What Can CIRS Do for You?
Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services, from regulatory compliance, laboratory testing, and R&D to data services across multiple industries.
The CIRS cosmetic team provides expert support to ensure that cosmetic products meet stringent global cosmetic regulations and safety standards. We offer comprehensive, lifecycle-based solutions for personal care products, from early-stage cosmetic ingredient development through to final product registration. Our services include:
- Cosmetic ingredient development and regulatory strategy,
- Physical/chemical and analytical tests,
- Toxicological tests (in vivo & in vitro),
- Efficacy and claim substantiation studies (in vivo & in vitro), and
- Ingredient and product registration across global markets.
With deep expertise in cosmetic regulatory compliance and safety evaluations, our team enables brands to bring products to market efficiently and with confidence.
Our Services
- China Cosmetics Registration and Filing
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- Being a Domestic Responsible Person
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