Focusing on frequently seen typical problem cases in general cosmetic filing, CIRS Group draws on official regulatory Q&As to comprehensively unpack the key compliance points of cosmetic filing. This issue covers two core sections: the filing application form and the basis for product naming, and the filling-in of the product formula, listing various non-compliant scenarios together with the corresponding regulatory bases and rectification reminders, to help cosmetic companies precisely avoid the risk of filing rejection and efficiently complete general cosmetic filing applications and routine dossier quality management.
Filing Application Form and Basis for Product Naming
Issues Concerning Entrustment Documents
Issue 1: The entrustment document does not indicate the date of entrustment
Reminder: For cosmetics entrusted to an overseas enterprise for production, the filing applicant or the domestic responsible person shall submit entrustment documents in accordance with Article 27 (III) of the Provisions on the Administration of Cosmetic Registration and Filing Documents. The entrustment documents shall at least specify the product name, the entrusting party, the name of the entrusted manufacturing enterprise, the manufacturing address, the date on which the enterprise accepted the entrustment for this product, and the signature or seal of the legal representative or the authorized representative of the entrusted manufacturing enterprise.
Issue 2: The manufacturing address in the commissioned production agreement is inconsistent with the information filled in the system
Reminder: The same item of content appearing in cosmetic filing documents shall remain consistent throughout; where supporting documents are available, such content shall be consistent with that stated in the supporting documents.
Issues Concerning Overseas Quality Management System Certification Documents
Issue 1: The quality management system certificate of the overseas manufacturing enterprise has expired
Reminder: Article 24 (2) of the Provisions on the Administration of Cosmetic Registration and Filing Documents stipulates that where the supporting documents on overseas production quality management practices have a validity period, such documents shall be updated in a timely manner, and in no case later than 90 days after the expiry of the validity period; where there is no validity period, the latest version shall be submitted every five years.
Issue 2: The manufacturing address in the proof of prior market launch is inconsistent with the information filled in the filing system
Reminder: The same item of content appearing in cosmetic filing documents shall remain consistent throughout; where supporting documents are available, such content shall be consistent with that stated in the supporting documents.
Issues Concerning Product Name Explanation
Issue: The product is named "small molecule water", but no explanation is given for "small molecule" in the name, nor is an explanatory note marked at the corresponding position on the product's outer packaging
Reminder: Article 18 of the Measures for the Administration of Cosmetic Labeling stipulates that where innovative terms that are not yet widely used in the industry and therefore not easily understood by consumers, but do not constitute prohibited labeling content, are used on cosmetic labels, their meaning shall be explained at an adjacent position.
Issues Concerning Trademark Registration Certificates
Issue: Where the trademark name in the Chinese product name uses letters, Hanyu Pinyin, numerals or symbols, no trademark registration certificate is provided, or the uploaded trademark registration certificate has expired, or the trademark name on the certificate is inconsistent with the trademark name on the packaging
Reminder: Article 28 (2) of the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data stipulates that where the trademark name in the Chinese product name uses letters, Hanyu Pinyin, numerals or symbols, a trademark registration certificate shall be provided.
Product Formula
Issues Concerning Basic Ingredient Information and Remarks
Issue 1: Iron oxides are used as colorants in the formula, but the CI numbers are not filled in
Reminder: Where colorants are used, the colorant index numbers (CI numbers) as set out in the Safety and Technical Standards for Cosmetics shall be filled in the ingredient name column of the formula in accordance with Article 29 of the Provisions on the Administration of Cosmetic Registration and Filing Documents, except for colorants without CI numbers.
Issue 2: The INCI name of Glyceryl polyacrylate is incorrect
Reminder: The names of ingredients in the formula shall be the standard Chinese names, INCI names or English names as set out in the Inventory of Existing Cosmetic Ingredients, in accordance with Article 29 of the Provisions on the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data.
Issue 3: The plant parts used are not clearly specified for ingredients directly derived from plants
Reminder: According to the notes to Part I of the Inventory of Existing Cosmetic Ingredients in China I (IECIC I), where an ingredient name in the Inventory takes the form of "XX plant extract", it means in principle that the whole plant and its extracts are existing ingredients, and the specific parts used shall be indicated when the ingredient is used. Where an ingredient name takes the form of "XX flower/leaf/stem extract" or "XX flower/leaf/vine extract", it means in principle that the above-ground parts of the plant and their extracts are existing ingredients, and the specific parts used shall likewise be indicated.
Issue 4: "Liquid paraffin", "C13-14 isoparaffin" and "mineral oil" are petroleum cracking products, but their CAS numbers are not indicated
Reminder: Where hydrocarbons derived from petroleum or coal tar are used (except single components), the CAS numbers of the relevant ingredients shall be indicated in the remarks column of the product formula table in accordance with Article 29 of the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data.
Issues Concerning the Purposes of Use of Ingredients
Issue 1: The product's common name contains an ingredient name, but the purpose of use of the ingredient is inconsistent with the product's main efficacy
Reminder: Article 8 (2) of the Measures for the Administration of Cosmetic Labeling stipulates that the common name shall be accurate and objective, and may be text indicating the ingredients of the product or describing the product's use, usage site, etc. Where the name of a specific ingredient or a term indicating an ingredient category is used, it shall be consistent with the ingredients of the product formula, and the efficacy of that ingredient in the product shall be consistent with the product's efficacy claims.
Issue 2: The product claims anti-wrinkle efficacy, but the corresponding efficacy ingredients are not indicated in the purpose-of-use column of the formula
Reminder: For cosmetics claiming hair dyeing, hair perming, spot removal and whitening, sun protection, anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff or deodorizing efficacy, as well as cosmetics claiming new efficacy (except those intended for special populations), the corresponding efficacy ingredients shall be indicated in the purpose-of-use column of the formula table in accordance with the Technical Guiding Principles for Cosmetic Formula Declaration; where such efficacy ingredients to be indicated are not single components, their specific efficacy substances shall be specified in the purpose-of-use column.
Issue 3: The purpose of use of Hydroxyacetophenone is filled in as preservative, which exceeds the scope of use specified in the Safety and Technical Standards for Cosmetics
Reminder: Cosmetic filing applicants shall, in accordance with the Safety and Technical Standards for Cosmetics, select ingredients that comply with laws and regulations, mandatory national standards and the relevant technical requirements, and the purposes of use shall not exceed the scope of use specified in the Safety and Technical Standards for Cosmetics.
Issues Concerning Ingredient Quality Specifications
Issue 1: The compounded ingredient contains "animal placenta protein", but no documents on its source, composition and preparation process, or on its permission for use in the country of production, are provided
Reminder: Where extracts of animal organs and tissues or blood products are used as ingredients in the product formula, the source, composition and preparation process of such ingredients shall be provided, and documents proving that they are permitted for use in the country of production shall also be provided, in accordance with Article 29 of the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data.
Issue 2: Oligopeptide-1 is added to the formula, but no supporting documents including the amino acid sequence of Oligopeptide-1 are submitted
Reminder: Oligopeptide-1 is included in China's Inventory of Existing Cosmetic Ingredient Names (2015 Edition) and is generally used as a skin conditioning agent. Human oligopeptide-1, however, is not included in that inventory and is mainly used in the medical field, with clinical indications for the topical treatment of burns, wounds and surgical wound healing, and for accelerating the growth of transplanted epidermis. Therefore, supporting documents on the amino acid sequence of oligopeptide-1 shall be provided to prove that the ingredient is indeed oligopeptide-1.
CIRS Reminder
The filling-in of general cosmetic filing documents involves multi-dimensional compliance requirements. When carrying out filing work, companies should strictly benchmark against current regulations and the specific technical guidelines, standardize the preparation of the complete filing dossier, and precisely avoid risks such as non-compliant documentation, so as to ensure compliant filing and safe market launch.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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