China cosmetics safety assessment information submission guidelines were issued by the National Institute for Food and Drug Control (NIFDC) on April 30, 2024. The guidelines assist cosmetic registrants and files on:
- how to submit cosmetic safety assessment information
- how to conduct internal self-inspection of cosmetic safety assessment reports
- how to conduct product safety evaluations
- how to identify and assess cosmetic risk substances.
The guidelines are based on the following existing regulations and seek to further improve the safety of cosmetics:
- Cosmetic Supervision and Administration Regulations (CSAR)
- Measures for the Registration and Filing Management of Cosmetics
- Measures to optimize China cosmetic safety assessment management.
1. Guidelines for the submission of cosmetics safety assessment information
According to the CSAR, cosmetic registrants and filers must conduct safety assessments independently or through professional agencies before applying for cosmetic product filing or registration.
Purpose and Scope: This guideline introduces a classification of cosmetics based on the degree of risk of various types of cosmetics. Each category of cosmetics has a specific set of safety assessment documents that must be provided during filing or registration. The guideline also provides an example of a completed cosmetic safety assessment submission form.
Cosmetic Classification:
China cosmetics classification is based on various dimensions such as:
- the efficacy claim
- user population
- product dosage form of cosmetics,
- use of new raw materials or nano raw materials under safety monitoring
- whether the cosmetic is used with instruments or tools.
As a result, there are 2 main classes of cosmetics:
- Class I Cosmetics:
- Special cosmetics.
- Infant and children’s cosmetics.
- Cosmetics with new raw materials under safety monitoring.
- Class II Cosmetics:
- Includes all other cosmetics, categorized further based on higher risk ingredients or cosmetics that require instruments/tools:
- Situation One:
- Cosmetics with nano materials.
- Cosmetics using non-standard UV sunscreens as photostabilizers i.e. sunscreens that are not included in Table of the Safety and Technical Specifications for Cosmetics.
- Cosmetics claiming acne removal, anti-wrinkle (excluding physical anti-wrinkle), deodorizing, dandruff removal, hair removal, exfoliation (excluding physical exfoliation).
- Cosmetics in specific forms (patches, films, aerosols, etc.).
- Cosmetics requiring instruments/tools for application (excluding basic tools like brushes, sponges).
- Situation Two: Other general cosmetics not covered in Class II, Situation One.
- Situation One:
- Includes all other cosmetics, categorized further based on higher risk ingredients or cosmetics that require instruments/tools:
Data Submission Requirements:
As mentioned above, the class and sub-class of cosmetics each have their own requirements for completing and submitting a safety assessment report, listed here:
- Class I Cosmetics:
- Submit a full safety assessment report during filing or registration 0.
- Class II Cosmetics (Situation One):
- Submit basic safety assessment conclusions and additional specific safety assessment data (e.g., for nano materials, photostabilizers, efficacy ingredients) if the quality management system is well-maintained
- or submit a full safety assessment report.
- Class II Cosmetics (Situation Two):
- Submit basic safety assessment conclusions if the quality management system is well-maintained
- or submit a full safety assessment report.
Key Points for conducting a self-inspection of Safety Assessment Report
Cosmetics manufacturers should appoint cosmetic safety assessors, either internally or by outsourcing, to carry out a comprehensive, accurate, scientific and standardized safety assessment of cosmetics according to the specific characteristics and actual use of the products and form a cosmetics safety assessment report.
The Quality and Safety Responsible Person (QSRP) at the registrant/filer must carry out self-inspection of the product safety assessment report in accordance with the “Key Points of Self-Inspection” and form a safety assessment conclusion. The QSRP may also authorize the person in charge of the safety assessment to complete the conclusion of the safety assessment. The cosmetics registrant and filing person is responsible for the product safety and the authenticity of the information provided during filing or registration. The guideline provides detailed information on how to conduct the self-inspection, here are some of the key points to check:
- Usage Instructions: Detail application area and frequency, e.g., “cheek area” for blush, “once a month” for oxidizing hair dyes.
- Daily Usage Amount: Must be reasonable and referenced, using international data or consumer trials.
- Product Retention Factor: Choose based on product type and usage, referencing international data or studies.
- Fragrances: Assess or confirm compliance with IFRA or national standards.
- Nano Ingredients: Provide specifications and assess safety, especially for inhalation risks.
- Trace Ingredients: Evaluate to ensure they do not affect safety.
- New Ingredients: Ensure compliance with technical requirements.
- Colorants in Hair Dyes: Assess safety in oxidizing conditions.
- Aerosols: Assess propellants and other ingredients separately.
- Combined Use Products: Evaluate mix combinations.
- Instrument-Assisted Products: Assess based on tool effects.
- Children’s Products: Ensure ingredient suitability for children.
2. Technical Guidelines for Identifying and Evaluating Risk Substances in Cosmetics
Identifying and assessing harmful substances in cosmetics is a crucial step in ensuring product safety. These harmful substances can come from raw materials, packaging, production processes, transportation, or storage. When these substances come into contact with the human body, they can pose health risks. By thoroughly identifying and assessing these potential hazards, registrants and filers can effectively evaluate the safety of cosmetic products.
This guideline assists cosmetic registrants, filers, and safety assessment professionals into identifying and evaluating potential risk substances in cosmetics. It requires analyzing ingredients based on their source, properties, and manufacturing process, and using toxicological data, clinical studies, and epidemiological surveys.
Key Risk Substances and Test Report Requirements:
Identification and Evaluation of Cosmetic Risk Substances
- Required Inspection Reports:
- Special Cosmetics: which has appropriate testing qualifications.
- General Cosmetics: Provide an inspection report from the same agency or a report per the 2023 Announcement on filing and inspection measures.
- Specific Test Reports:
- Heavy Metals: Test reports for mercury, lead, arsenic, and cadmium are required with specific limits: mercury (1 mg/kg), lead (10 mg/kg), arsenic (2 mg/kg), cadmium (5 mg/kg).
- Dioxane: Required for products with ethoxy-containing raw materials, limit 30 mg/kg.
- Asbestos: Necessary for talcum powder-containing products, must be asbestos-free.
- Free Formaldehyde: Required for formaldehyde-releasing raw materials, tested and evaluated.
- Methanol: Required for products with ≥10% ethanol or isopropanol, limit 2000 mg/kg.
- Assessments via Raw Material Specifications or Safety Documents:
- Nitrosamines: For specific hair dyes and alkanamines, ensure purity, avoid nitrosamine formation, and store in nitrite-free containers.
- Semi-Chain Alkanamines and Nitrosamines: Similar assessment for products with certain alkanamines and fatty acid derivatives.
- Additional Evaluation Requirements:
- Acrylamide: Evaluate for polymers synthesized with acrylamide, with specific limits for residual monomers.
- Risk Substance Evaluation in Raw Materials or Products:
- Diethylene Glycol: Evaluate in products with glycerin, propylene glycol, and related compounds.
- Phenol: Evaluate in raw materials like phenoxyethanol.
- Methanol: Evaluate in formulations with ethanol, denatured ethanol, or isopropanol.
- Pesticide Residues: Evaluate for plant-derived raw materials.
- Hydroquinone: Evaluate for raw materials like α-arbutin and β-arbutin.
- Benzene: Evaluate in raw materials like carbomer, with a limit of ≤2 mg/kg in the product.
- Certification from Raw Material Manufacturers:
- Prohibited Raw Materials: Confirm non-carcinogenic status for substances like petrolatum, and ensure butadiene content in propellants is ≤0.1% (w/w).
- Mixed Alkanes: Provide CAS numbers and certification for petroleum and coal tar-derived alkanes, ensuring safety and compliance.
- Additional Assessments for Children’s Cosmetics:
- Anthraquinone: Evaluate for aloe vera-containing products.
- Cocamidopropyl Betaine: Evaluate for dimethylamine, 3,3-dimethylaminopropylamine, and monochloroacetic acid.
- Allergenic Ingredients: Evaluate flavors, plant essential oils, and fragrance ingredients for allergens like methyl eugenol.
- Glycerol: Ensure purity ≥95.0% and diethylene glycol content ≤0.1%.
By adhering to these structured requirements, quality compliance managers can effectively identify and evaluate risk substances in cosmetics, ensuring product safety and regulatory compliance.
Further information
Read the original NIFDC announcement on China cosmetics safety assessment information submission technical guidelines.
Read our previous blog posts on cosmetics safety assessment:
- Measures to optimize China cosmetic safety assessment management
- Guidelines on Cosmetic Ingredient Safety Information via Annex 14
- Submission of safety information for cosmetics raw materials – Draft guidelines issued
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