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On April 10, 2024, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on four technical guidelines concerning cosmetics safety assessment.1 These documents focus on stability testing, preservative challenge testing, packaging compatibility testing, and skin sensitization testing. Following the consultation period, on July 8, 2024, NIFDC released the finalized guidelines along with relevant Q&As, offering more comprehensive guidance on the safety assessment of cosmetics and cosmetic ingredients.2-7
The key points of the four guidelines are as follows:
1. Technical Guidelines for Stability Testing and Assessment of Cosmetics
Cosmetics stability testing aims to monitor changes in cosmetics over time when exposed to conditions such as temperature and humidity. The testing should be designed reasonably based on the physical and chemical properties of ingredients, product form, product formula, production process, and packaging materials. It can include influencing factor test, accelerated test, and long-term test.
This new document specifies the test requirements, test methods and result evaluation for cosmetic stability testing. It requires cosmetics registrants and notifiers to use at least one batch of samples when conducting influencing factor test, accelerated test, and long-term test, and set up multiple experimental time points to assess the quality changes of cosmetics. Additionally, the product formula, production process, packaging materials in direct contact with samples used in influencing factor and accelerated tests should, in principle, align with those of the marketed cosmetics. The long-term test samples should be entirely consistent with the marketed products. According to this document, for cosmetics with similar formula systems and identical packaging materials, cosmetics registrants and notifiers can perform stability testing based on existing information and test data, provided they justify their decisions. Following the completion of accelerated testing, registrants and notifiers are eligible to proceed with their registration and notification applications, while ensuring proper archiving of the long-term test report.
2. Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics
Cosmetics preservative challenge testing is employed to assess the effectiveness of cosmetics preservative systems. Currently, the standards utilized in China for assessing cosmetics' preservative efficacy include the group standards T/SHRH 017-2019 Antimicrobial Effectiveness Testing of Cosmetics, T/GDCDC 010-2019 Test Method for the Preservative Challenges of Cosmetics, and the General Principles 1121 "Bacterial Efficacy Test Method" of the Pharmacopoeia of the People's Republic of China (2020 Edition).
This new document prescribes the test methods for cosmetics preservative challenge testing, and details requirements for equipment, materials, culture mediums and reagents, test strains, and procedural standards. For cosmetics with the same preservative system and similar formula, registrants and notifiers can rely on existing information and test data to assess the effectiveness of the product's preservative system and compile an assessment report. In addition, they are required to provide explanatory documentation concerning the preservative and formula systems.
3. Technical Guidelines for Compatibility Testing and Assessment of Cosmetics with Packaging Materials
Compatibility testing of cosmetics with their packaging materials examines the interaction between them. When selecting packaging materials for cosmetics, registrants and notifiers should evaluate the compatibility based on the actual conditions of cosmetic ingredients and related risks. If any interactions that could impact product quality or safety are identified, the compatibility testing should be performed.
This new document provides instructions on the requirements, test methods, and result evaluation for conducting compatibility evaluation between cosmetic contents and the containers/carriers that directly contact with them. For cosmetics with similar formula systems and containers/carriers made of the same material from the same source, registrants and notifiers can conduct compatibility evaluation based on existing information and test data, provided they provide explanations for their decisions.
4. Technical Guidelines for Integrated Approaches to Testing and Assessment (IATA) of Skin Sensitization
Skin sensitization testing is used to assess the allergenic potential of cosmetics and cosmetic ingredients. The Safety and Technical Standards for Cosmetics (STSC) includes several existing alternative methods for testing skin sensitization, including:
Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA)
In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)
In Chemico Skin Sensitization: Amino acid Derivative Reactivity Assay (ADRA)
In Vitro Skin Sensitization: Human Cell Line Activation Test (h-CLAT)
Keratinocyte Based ARE Reporter Gene Assay (LuSens)
This new document is applicable to the skin sensitization assessment of cosmetic ingredients. The assessment employs alternative toxicological tests capable of detecting the key events (KE1-KE3) within the skin sensitization Adverse Outcome Pathway (AOP), forming a "2 out of 3" integrated testing strategy (ITS). It involves selecting at least two of the first three key events in the skin sensitization AOP, using alternative test methods to evaluate them, and assessing the skin sensitization risk of the ingredients based on the results. When employing this strategy, in addition to the alternative methods specified in STSC, registrants and notifiers can refer to methods validated by internationally recognized alternative method validation agencies and the Organisation for Economic Co-operation and Development (OECD). However, it is essential for registrants and notifiers to provide clear explanations of the data interpretation procedures and uncertainty analysis, such as the threshold boundary ranges.
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