CIRS Group has compiled authoritative cosmetics compliance Q&A from multiple local Medical Products Administration (MPA) authorities, focusing on two core areas: registration and filing of new cosmetic ingredients, and filing of general cosmetics. The content details post-filing technical review of new ingredients and the declaration of ingredient use purposes, and clarifies technical points such as formula declaration, labeling, testing exemptions, and toxicological assessment — providing a one-stop overview of the full-process compliance rules for filing, labeling, and safety assessment to help enterprises complete their compliance submissions efficiently and properly.
Registration and Filing of New Cosmetic Ingredients
Q1: What conclusions may the post-filing technical review of new cosmetic ingredients involve?
A: According to the Measures for the Administration of Cosmetics Registration and Filing, the cosmetics technical evaluation body of the National Medical Products Administration (NMPA) is responsible for the post-filing technical review of the filing materials for new cosmetic ingredients. Where the post-filing technical review finds that the filing materials of a filed new cosmetic ingredient do not meet the requirements, the filer shall be ordered to make corrections within a specified time limit; where the filing materials related to the safety of the new cosmetic ingredient do not meet the requirements, the filer may simultaneously be ordered to suspend sales and use. Where any of the circumstances specified in Article 59 of the Measures exist, the filing of the new cosmetic ingredient shall be cancelled — including submission of false materials at the time of filing, failure to make corrections within the required time limit, or the ingredient not falling within the scope of new cosmetic ingredient filing.
Q2: Where can I view the post-filing technical review opinions for new cosmetic ingredients?
A: After a new cosmetic ingredient is filed, the cosmetics technical evaluation body conducts a technical review of the filing materials and carries out follow-up assessment of the use and safety of the new ingredient; therefore, the filer should keep abreast of post-filing management developments. The filer should regularly check and stay attentive to post-filing technical review opinions through the Cosmetics Intelligent Declaration and Evaluation System. The viewing path is: New Ingredient Filing → Application Management → View Documents. Pursuant to Article 60 of the Measures, the relevant time limits are counted from the time the opinions are issued through the information service platform. When viewing the post-filing technical review opinion notice, the filer should note the notice’s date and the deadline for ordered corrections, and submit the corrected materials within the specified time limit. The submission path is: New Ingredient Filing → Application Management → Submit Corrected Materials.
Q3: How many cosmetic ingredient use purposes are listed in the Technical Guide for Cosmetic Ingredient Use Purposes (Trial) (hereinafter the “Guide”)?
A: The annex to the Guide is the Catalog of Cosmetic Ingredient Use Purposes (hereinafter the “Catalog”), which includes 72 ingredient use purposes entries together with explanations. The Catalog was developed with full reference to relevant foreign standards and based on China’s current regulations and standards as well as industry usage, and will be adjusted in due course as regulations, standards, and data continue to improve and as science and technology develop.
Q4: May an ingredient use purpose outside the scope of the Technical Guide for Cosmetic Ingredient Use Purposes (Trial) be declared?
A: When registering or filing a cosmetic or new ingredient, in principle an ingredient use purpose from the Catalog of Cosmetic Ingredient Use Purposes (hereinafter the “Catalog”) should be selected first. Taking into account the industry’s innovative development and the practical needs of regulation, if a use purpose is genuinely outside the scope of the Catalog, “other use purpose” may be declared, provided that relevant supporting materials are submitted at the same time. The supporting materials should fully explain the scientific basis, necessity, and compliance of the use purpose, and generally include ingredient use purposes included in foreign cosmetics-related regulations and standards (with both the original text and a Chinese translation to be provided), or relevant functional research materials, etc.
Filing of General Cosmetics
Q1: Which ingredients need not be declared in the formula table?
A: According to the Technical Guiding Principles for Cosmetic Formula Declaration, the following substances are not cosmetic formula ingredients:
(1) Substances added to an ingredient to ensure the quality of the cosmetic ingredient and present in the formula only in extremely trace amounts (e.g., antioxidants);
(2) Trace impurities inherent in or residual from the ingredient that are technically unavoidable in the process;
(3) Processing aids added during the product’s production process that do not chemically react with other ingredients, do not function in the final product, and are removed in subsequent production steps. After analyzing the ingredient information, the cosmetic registrant or filer may, where it determines a substance to be a non-formula ingredient, choose not to declare it in the product formula — except for ingredients on the list of permitted preservatives in the Safety and Technical Standards for Cosmetics and ingredients on the list of permitted sunscreens added to protect the product itself.
Q2: Which ingredients need not be identified on the label ingredient list?
A: (1) Auxiliary ingredients such as water and volatile solvents that must be used during production but are removed in subsequent production steps;
(2) Trace stabilizers, preservatives, antioxidants, and similar ingredients added to an ingredient to ensure its quality need not be identified in the full ingredient list.
To keep the public information consistent with the ingredients labeled on the product, at the time of filing you may manually delete items in the full-ingredient-identification field on the product label page.
Q3: Which cosmetics may be exempt from microbial-indicator testing?
A: According to the Specifications for Cosmetics Registration and Filing Inspection, the following types of cosmetics may be exempt from microbial-indicator testing:
Products with an ethanol content ≥ 75% (w/w): Due to the high ethanol concentration, such products have a natural bacteriostatic effect, making it difficult for microorganisms to grow and reproduce; they may therefore be exempt from microbial-indicator testing.
Oxidative hair dyes: Oxidative hair dyes usually consist of a hair dye (Part 1) and an oxidizer (Part 2); their product characteristics (strongly alkaline, highly oxidizing) are unfavorable to microbial growth, and they may be exempt from microbial-indicator testing.
Perming products: Perming products (e.g., perm agents) usually contain ingredients such as thioglycolic acid and are strongly alkaline (high pH); this environment is unfavorable to microbial growth and reproduction, and they may be exempt from microbial-indicator testing.
Chemical depilatory products: Similar to perming products, chemical depilatory products usually contain active ingredients such as thioglycolic acid and are strongly alkaline (high pH); this pH environment is unfavorable to microbial growth, and they may be exempt from microbial-indicator testing.
Nail polish removers: Nail polish removers typically use organic solvents as the main ingredient, and microorganisms are difficult to grow and reproduce in such environments, so they may be exempt from microbial-indicator testing.
It should be noted that, although the above types of products may be exempt from microbial-indicator testing, enterprises should still ensure the microbial safety of their products through measures such as production-process control and ingredient control. Physical depilatory products and non-oxidative hair dye products do require microbial testing.
Q4: Which cosmetics need not undergo preservative-efficacy (challenge) evaluation?
A: According to the Technical Guidelines for Cosmetic Safety Assessment, products whose characteristics make them resistant to microbial contamination may be exempt from preservative-efficacy evaluation — i.e., non-aqueous products, products based mainly on organic solvents, and aqueous products with a water activity < 0.7, ethanol content > 20% (v/v), or high/low pH (≥ 10 or ≤ 3); products filled at temperatures above 65°C; single-use products or products in packaging that cannot be opened; and other such product types. However, the relevant basis and specific circumstances should be explained in the safety assessment report. An example follows:
This product’s formula contains 30% ethanol, which falls under the circumstance of “ethanol content > 20% (v/v)” in Section 7.3.3 of the Technical Guidelines for Cosmetic Safety Assessment (2021 edition); pursuant to the Technical Guidelines for Cosmetic Safety Assessment, it need not undergo preservative-efficacy evaluation.
Q5: Under what circumstances may the assessment of certain toxicological endpoints be waived?
A: (1) For ingredients with a history of safe food use, where a comprehensive and thorough study of their food-use history and production process confirms that the ingredient, or the raw materials used to prepare it, are safe for human consumption, the systemic-toxicity assessment may be waived for such ingredients.
(2) Based on the chemical-structure characteristics of an ingredient, where thorough analysis or testing demonstrates that the ingredient does not have UV-absorption properties, the assessment of skin phototoxicity may be waived. For example, if the molar extinction coefficient (MEC) in the 290 nm–700 nm wavelength range is less than 1000 L/mol/cm, the substance’s photoreactivity is low and insufficient to cause skin phototoxicity.
(3) Where an ingredient’s toxicological test results at both the gene and chromosome levels show no genotoxicity, repeated-dose toxicity testing reveals no abnormalities in carcinogenicity-related indicators, and no other existing evidence indicates a relevant hazard — and a thorough analysis of the above materials confirms no potential carcinogenic risk — the assessment of its carcinogenicity toxicological-test data may be waived.
(4) Based on the product’s use characteristics, the assessment of certain toxicological endpoints may be waived; for example, where a product has no possibility of exposure to strong outdoor UV irradiation (e.g., rinse-off general cosmetics and cosmetics for nighttime use), the assessment of skin phototoxicity and photosensitization may be waived.
(5) Chemically synthesized polymers composed of one or more structural units linked by covalent bonds, with an average relative molecular mass greater than 1000 Daltons and an oligomer content below 1000 Daltons of less than 10%, and with a stable structure and properties (excluding ingredients with high biological activity), need not be considered for dermal absorption — i.e., the systemic-toxicity assessment may be waived.
CIRS Reminder
The filing of new cosmetic ingredients and of general cosmetics involves numerous detailed regulatory requirements-post-filing technical review, declaration of ingredient use purposes, formula and labeling, testing exemptions, and toxicological-assessment waivers. In practice, enterprises should continuously benchmark against current regulations, strictly standardize the preparation of their submission materials, and avoid risks such as non-compliant materials or overdue rectification, so as to ensure compliant product submission and smooth market launch. If you have needs related to new-ingredient registration and filing, China cosmetics registration and filing, or other relevant business, please feel free to contact us at any time!
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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