On May 29, 2026, China's Safety and Technical Standards for Cosmetics (STSC) underwent a significant update, with four new and four revised testing methods — a total of eight — all of which will officially come into effect on March 1, 2027. To accompany this update, China's National Institutes for Food and Drug Control (NIFDC) simultaneously released official supporting Q&As addressing the detailed specifications, revision background, and enterprise compliance requirements for the eight testing methods. CIRS Group has compiled and organized the information below for your reference.
Four Newly Added Testing Methods
1. Determination of Trivalent Chromium and Hexavalent Chromium in Cosmetics
Q1: What is the background for developing this standard?
A: Chromium is a naturally occurring substance and the hardest metal in nature. Common chromium compounds exist in trivalent, hexavalent, and divalent forms. Since divalent chromium compounds are extremely unstable, chromium primarily exists as trivalent and hexavalent compounds. Trivalent chromium is beneficial to the human body below certain concentration levels, while hexavalent chromium is a carcinogen.
The Safety and Technical Standards for Cosmetics (2015 Edition) stipulates that chromium, chromic acid, and their salts (calculated as Cr6+) are prohibited cosmetic ingredients. However, no corresponding testing method had been previously included. Domestic standards related to chromium valence states are primarily concentrated in fields such as agriculture, environmental protection, and coal. To safeguard cosmetic product quality and safety, it is necessary to establish relevant testing methods to unify testing technical requirements.
Q2: What are the main contents of this standard?
A: This standard specifies the method for determining trivalent chromium and hexavalent chromium in cosmetics using high-performance liquid chromatography–inductively coupled plasma mass spectrometry (HPLC-ICP-MS). It is applicable to the determination of trivalent chromium and hexavalent chromium in cream and emulsion products, liquid (aqueous and oil-based) products, gel products, powder products, compressed products, and mud/mask products.
During the development process, the actual conditions of production enterprises and testing institutions were investigated, with full consideration given to practical enterprise needs, optimizing sample preparation procedures and enhancing applicability. Meanwhile, under the premise of meeting safety regulatory requirements, necessary limits of detection were reasonably specified to minimize the difficulty and cost for enterprises in implementing the standard.
Q3: What impact will the implementation of this standard have on the industry?
A: On one hand, by performing differentiated testing of trivalent chromium and hexavalent chromium, the toxic and harmful hexavalent chromium can be precisely controlled, thereby strengthening source risk management, reinforcing product safety defenses, and effectively protecting consumer health rights and interests. On the other hand, this standard establishes a testing method for trivalent chromium and hexavalent chromium in cosmetics, effectively addressing the previous lack of unified industry testing methods. The standard adopts analytical techniques commonly available in domestic conventional testing laboratories, selecting appropriate, feasible, and practical analytical conditions to ensure the accuracy and reproducibility of the testing method.
2. Determination of Ethyl Lauroyl Arginate HCl in Cosmetics
Q1: What is the background for developing this standard?
A: In recent years, with consumers' continuous attention to product quality and safety, the increasing requirements of regulations and standards, and the potential allergenicity and irritation associated with traditional preservatives, the cosmetics industry has gradually shifted toward applying novel, natural preservatives to build green and safe preservative systems. On December 28, 2020, the NMPA approved ethyl lauroyl arginate HCl for use as a cosmetic preservative and incorporated it into Table 4 of Chapter 3 of the Safety and Technical Standards for Cosmetics (2015 Edition) (Permitted Preservatives).
The application of ethyl lauroyl arginate HCl in the cosmetics field has been increasing. However, neither the Safety and Technical Standards for Cosmetics (2015 Edition) nor relevant cosmetic national or industry standards contain a testing method for this preservative. Product quality management and regulatory work lack unified testing technical support, creating an urgent need to establish a supporting testing method to underpin regulatory and industry development.
Q2: What are the main contents of this standard?
A: This standard specifies the testing method for ethyl lauroyl arginate HCl in cosmetics, applicable to the determination of ethyl lauroyl arginate HCl content in liquid (aqueous and oil-based) products, cream and emulsion products, powder products, and gel products. The method uses methanol as the solvent to extract ethyl lauroyl arginate HCl from samples, separates it via high-performance liquid chromatography (HPLC), and detects it using a diode array detector (DAD). Qualitative identification is performed using retention time and UV spectra, while quantification is achieved by peak area using the standard curve method. If the HPLC method results show interference or are inconclusive, liquid chromatography–mass spectrometry (LC-MS) is used for confirmation.
Q3: What impact will the implementation of this standard have on the industry?
A: This standard aims to unify testing methods and evaluation criteria without raising industry entry barriers or adding additional compliance costs for enterprises, playing a positive role in promoting standardized, quality-driven, and high-quality industry development. The standard effectively fills the technical gap in ethyl lauroyl arginate HCl detection in the cosmetics field, serving the quality control of this preservative in cosmetics, and providing a unified and authoritative technical standard for cosmetic registration and dossier filing, sampling inspection, enterprise self-inspection, and third-party testing, further improving the cosmetic standards system.
3. Determination of 1-Hydroxyethyl-4,5-diaminopyrazole Sulfate and Other 10 Ingredients in Cosmetics
Q1: What is the background for developing this standard?
A: In recent years, with the improvement of living standards, consumer demand for hair dye cosmetics has grown rapidly, and their quality and safety issues have consistently been a focus of cosmetic regulation and public attention. Currently, multiple permitted hair dye ingredients, including 1-hydroxyethyl-4,5-diaminopyrazole sulfate, have not yet had corresponding testing method standards established, resulting in certain deficiencies in enterprise product quality control and industry safety risk management. To further strengthen cosmetic quality and safety regulation, standardize the use of permitted hair dye ingredients, reinforce cosmetic safety defenses, and effectively protect consumer safety and health, it is necessary to develop relevant testing methods to continuously improve China's cosmetic standards system.
Q2: What are the main contents of this standard?
A: This standard specifies the testing method for 11 hair dye ingredients in cosmetics. The main contents include:
First, quantitative analysis of the target substances using high-performance liquid chromatography (HPLC). The standard specifies reagents and materials, instruments and equipment, standard solution preparation, and chromatographic conditions. The concentration of each ingredient in the test solution is determined through the standard curve method based on peak area, enabling accurate content calculation.
Second, confirmation of sample test results using liquid chromatography–tandem mass spectrometry (LC-MS/MS). When interference exists or results are inconclusive, further confirmation is required to ensure the accuracy and reliability of test results. The standard specifies reference chromatographic conditions, reference mass spectrometry conditions and parameter settings for the confirmation method, and provides qualitative judgment methods.
Third, reference HPLC chromatograms and confirmation mass spectra are provided, along with clarification on how to handle interference with target components, and guidance on adjusting the appropriate concentration range of standard series solutions based on actual laboratory conditions, thereby enhancing the operability and practicality of the standard and facilitating its implementation.
Q3: What impact will the implementation of this standard have on the industry?
A: The implementation of this standard facilitates the standardized management and use of hair dye products. On one hand, it provides an authoritative standard method for testing 11 ingredients, including 1-hydroxyethyl-4,5-diaminopyrazole sulfate, in cosmetics, filling the previous method gap and improving the hair dye testing method standards system. On the other hand, it provides technical support for ensuring the quality and safety of hair dye cosmetics, helping to strengthen product quality management and protect consumer safety, and promoting higher-quality development of the cosmetics industry.
4. Safety Evaluation of Long-term Using Tests of Cosmetics on Human Body
Q1: What is the background for developing this standard?
A: China implements a registration management system for new skin-whitening and freckle-removing ingredients. The Technical Guidelines for Registration Materials of Cosmetic New Ingredients (Draft for Comment) specifies that new ingredients with skin-whitening and freckle-removing functions should submit long-term human use safety test data. Against this background, the development of the Safety Evaluation of Long-term Using Tests of Cosmetics on Human Body further refines the safety evaluation requirements for high-risk new skin-whitening and freckle-removing ingredients, helping to improve the scientific rigor, standardization, and operability of relevant evaluation work.
Skin-whitening and freckle-removing ingredients typically exert their effects through mechanisms such as inhibiting tyrosinase or interfering with melanosome maturation or transport. However, if an ingredient has excessively strong interference with melanocyte physiological metabolism, it may trigger pigment abnormalities and other adverse skin reactions during long-term use. The Rhododendrol incident in Japan revealed that rhododendrol-related products caused numerous reports of vitiligo-like depigmentation, and the associated risks were not all short-term, reversible changes. White patches can appear weeks to months after initial exposure to skin-whitening products, with an average onset time of 19 months in some refractory cases, and residual white patches may persist even after discontinuation. The above circumstances indicate that for new skin-whitening and freckle-removing ingredients, relying solely on short-term human use testing or general safety observations is insufficient to detect such serious adverse reactions, making long-term human use testing necessary.
Q2: What are the core technical requirements of this standard?
A: This method sets a minimum observation period of 52 weeks, requires at least 100 completed test subjects, and emphasizes professional observation and evaluation. These requirements correspond to the risk characteristics reflected by the Rhododendrol incident — "manifesting only after long-term use, with a low incidence rate but severe consequences." By setting a longer observation period and a certain sample size, the method helps improve the ability to identify delayed and persistent adverse skin reactions, providing clearer and reproducible technical evidence for the safety evaluation of new skin-whitening and freckle-removing ingredients.
Q3: What is the relationship between this standard and international practices and industry development?
A: From an international practice perspective, Japan requires, in principle, 12-month safety data with at least 100 subjects for new active ingredients in quasi-drugs applied to the skin and used repeatedly in daily life, with observations by dermatology specialists. The requirements of this method regarding test duration, sample size, and professional observation are consistent with the above risk control approach, while also aligning with China's cosmetic new ingredient management system.
Incorporating this standard into the Safety and Technical Standards for Cosmetics aims to provide clearer, predictable, and reproducible technical requirements for high-risk new ingredients. For the industry, this standard helps reduce repeated corrections and compliance uncertainty caused by unclear evaluation methods, and supports enterprises in pursuing innovation and high-quality development within a compliant framework.
Four Revised Testing Methods
1. Bacterial Reverse Mutation Test
Q1: What is the background for the revision of this standard?
A: This method is based on the Bacterial Reverse Mutation Test in the Safety and Technical Standards for Cosmetics (2015 Edition), revised following the principles of scientific rigor, standardization, and public transparency. The revision primarily references the Organisation for Economic Co-operation and Development (OECD) updated guideline TG 471 Bacterial Reverse Mutation Test (2020) and China's National Food Safety Standard — Bacterial Reverse Mutation Test (GB 15193.4-2014). Combined with the actual circumstances encountered in China's cosmetic regulatory work and the practical experience from registration and dossier filing testing, the original test method has been revised and improved to ensure the method is scientific, standardized, and aligned with international standards.
Q2: Are test substances containing histidine or tryptophan suitable for the bacterial reverse mutation test?
A: The Bacterial Reverse Mutation Test uses histidine- or tryptophan-requiring test strains to determine whether the test substance causes bacterial reverse mutations. When the test substance contains histidine or tryptophan, it may affect test results and produce false positives. Therefore, for test substances known or confirmed to contain histidine or tryptophan that may affect test results, it may be necessary to remove histidine and tryptophan from the test substance through pretreatment or to use other gene mutation test methods for detection.
Q3: What modifications were made to the test substance dose setting?
A: First, it clearly requires "the highest dose for each strain should be determined through preliminary testing, taking into account the solubility of the test substance and its toxicity to bacteria." Second, for the two scenarios where the test substance is a raw ingredient or a finished product, detailed principles for the highest dose design under different circumstances have been formulated. Third, the number of dose groups for the test substance has been revised from "at least 4" to "at least 5."
Q4: Is repeat verification required for suspicious positive results and negative results?
A: To ensure the reliability and accuracy of test results, the revised Bacterial Reverse Mutation Test requires that "if suspicious positive results appear during the test, repeat testing should be conducted on the suspicious positive test substance by altering test conditions (such as adjusting the concentration of the test substance or S9, changing culture conditions)" and "negative results require verification (i.e., one repeat)," meaning that both suspicious positive results and negative results require repeat verification.
2. In Vitro Mammalian Cells Chromosome Aberration Test
Q1: What is the basis for revising this standard?
A: This standard is based on the In Vitro Mammalian Cells Chromosome Aberration Test in the Safety and Technical Standards for Cosmetics (2015 Edition), revised following the principles of scientific rigor, standardization, and public transparency. The revision primarily references the OECD updated guideline TG 473 In Vitro Mammalian Chromosomal Aberration Test (2016). Combined with the actual circumstances encountered in China's cosmetic regulatory work and the practical experience from registration and dossier filing testing, the original test method has been revised and improved to ensure the method is scientific, standardized, and aligned with international standards.
Q2: What is the scope of application of this standard?
A: This method is used to detect chromosome aberrations in cultured mammalian cells to evaluate the potential mutagenicity of test substances. This method is not suitable for detecting numerical chromosome aberrations.
Q3: What adjustments were made to the number of cells for chromosome analysis?
A: The original method applied differentiated cell counting standards for test samples, where finished cosmetic products selected 100 well-spread metaphase cells for chromosome analysis, while cosmetic raw ingredients required 200 metaphase cells, with relatively brief recording requirements for cell analysis. The revised method unifies the counting standard, specifying that under routine test conditions, at least 300 well-spread metaphase cells should be selected for chromosome analysis, and the cell count should be evenly distributed among replicate cultures in each group. Additionally, the revised method explicitly states that if a large number of cells with chromosome aberrations are observed during the test and the test substance results can be judged as positive, the number of metaphase cells counted may be reduced (generally no fewer than 100).
Q4: Why was the analysis of experimental results added?
A: To standardize experimental data analysis and recording and enhance operability, the revised method provides more detailed provisions for chromosome analysis and result recording. This includes: the percentage of cells with structural chromosome aberrations should be evaluated. Chromatid-type and chromosome-type aberrations classified by subtype (breaks, exchanges) should be listed separately with their numbers and frequencies in experimental and control groups. Gaps should be recorded and reported separately but not included in the total aberration frequency. When polyploid and/or endoreduplicated cells are observed, their percentage should be reported. Concurrent cytotoxicity measurement data for all treatment groups and negative and positive controls in the main aberration test should be recorded.
3. 90-Day Oral Toxicity Test
Q1: What is the background for the revision of this standard?
A: With the continuous improvement of China's cosmetics industry regulatory system, the demand for cosmetic ingredient testing has continued to grow. During the implementation of the subchronic oral toxicity test in the Safety and Technical Standards for Cosmetics (2015 Edition), different testing institutions had varying interpretations and implementation standards for the original method provisions, causing certain difficulties for cosmetic ingredient registration, dossier filing, and routine testing. Against this background of industry regulation and technical application, there was an urgent need to revise and improve the original standard content to meet the standardized requirements for cosmetic ingredient safety evaluation.
This method is based on the subchronic oral toxicity test in the Safety and Technical Standards for Cosmetics (2015 Edition), combined with the OECD updated guideline TG 408 Repeated Dose 90-Day Oral Toxicity Study in Rodents (2025), the 28-Day Repeated Dose Oral Toxicity Test Method (NMPA Announcement No. 12 of 2024), and the National Food Safety Standard — 90-Day Oral Toxicity Test (GB 15193.13-2015). It provides specific and clarified guidance on test substance dose design, test substance administration, clinical observations, hematological examination parameters, blood biochemistry examination parameters, urine examination, and pathological examination, helping to improve the scientific rigor, standardization, and operability of relevant evaluation work.
Q2: What are the main contents of this standard?
A: This method specifies the basic principles, requirements, and procedures for the 90-day oral toxicity test of cosmetic ingredients. The main contents include: scope, test objectives, definitions, basic test principles, test animal requirements, dose design, test substance administration, clinical observations, ophthalmic examination, clinical examinations, pathological examinations, and other content.
Q3: What are the key points requiring special attention in this standard?
A: 1. Animal sex and number: Strictly implement the animal groups and numbers required by the standard to ensure the sample size for toxicity evaluation and reversibility observation meets the test requirements.
2. Test substance administration: The test substance administration schedule is 7 days per week. If an alternative administration schedule is adopted (e.g., 5 days per week), the reasons for deviating from the standard schedule should be explained and supporting data provided, clearly demonstrating that the selected schedule can meet the study's intended objectives.
3. Clinical and pathological examinations: The method has improved hematological examination, blood biochemistry examination, and pathological examination parameters. It also adds targeted testing indicators based on the toxicological characteristics of the test substance and clinical manifestations in animals.
4. 90-Day Dermal Toxicity Test
Q1: What is the basis for the revision of this standard?
A: This method is based on the subchronic dermal toxicity test method in the Safety and Technical Standards for Cosmetics (2015 Edition), following the principles of standardization, scientific rigor, and operability. The revision primarily references the OECD guideline TG 411 Subchronic Dermal Toxicity: 90-Day Study and the updated guideline TG 408 (2025). Combined with domestic cosmetic ingredient safety evaluation regulatory needs and practical experience from registration and dossier filing testing, the original test method has been revised and improved to ensure the method aligns with internationally recognized technical systems while adapting to China's cosmetic industry regulatory context.
Q2: What are the main revisions in this standard?
A: Compared with the subchronic dermal toxicity test method in the Safety and Technical Standards for Cosmetics (2015 Edition), the main revisions include: updating the standard name, optimizing test objectives and terminology definitions, improving basic test principles, refining test animal admission and housing requirements, standardizing dose design and grouping principles, clarifying test substance administration methods, specifying clinical examination parameters, adding endocrine toxicity-related evaluation parameters, and improving gross necropsy and histopathological evaluation requirements, thereby enhancing the standardization and scientific rigor of cosmetic ingredient dermal toxicity evaluation.
Q3: What impact will the implementation of this standard have on the cosmetics industry?
A: The implementation of this standard facilitates the standardization of 90-day dermal toxicity test data and improves the efficiency of cosmetic ingredient regulation. On one hand, while retaining the classical dermal toxicity evaluation framework, this standard revision incorporates updated technical elements from OECD guidelines, further improving the cosmetic toxicology evaluation standards system. On the other hand, this standard provides technical support for the quality control of new cosmetic ingredients, helping to strengthen product safety management and protect consumer safety.
CIRS Reminder
The update of these eight testing methods further improves China's cosmetic safety standards system, drives domestic testing technology toward alignment with advanced international standards, and continuously enhances the scientific and regulatory rigor of cosmetic safety oversight.
The new regulations will officially take effect on March 1, 2027. Enterprises are advised to make full use of the transition period to complete compliance adaptations in an orderly manner. It is recommended to comprehensively conduct product self-inspections, assess key items such as chromium components, novel preservatives, and hair dye ingredients, proactively prepare for long-term human use testing related to new skin-whitening and freckle-removing ingredients, and complete product verification and validation in accordance with the new standards to ensure stable compliance operations after the new regulations take effect.
CIRS Group will continue to monitor changes to the Safety and Technical Standards for Cosmetics and promptly release the latest updates.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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