Cosmetic Safety Obligations are important in keeping consumers, the environment and the general population safe. In this series, we will delve into the safety obligations across the globe.
Safety Obligations of Cosmetic Products Series
To learn more about the differences in safety obligations across regional regulations, explore our safety obligations of cosmetic products series:
Cosmetic Ingredient Safety Obligations
The Inventory of Existing Cosmetic Ingredients in China (IECIC) is an official list of cosmetic ingredients that have been historically used in cosmetic products within China and are permitted for use in product formulations. This inventory serves as a reference database for cosmetic manufacturers and regulatory authorities, ensuring that only safe and approved substances are used in cosmetics. Companies formulating cosmetic products in China must ensure that all ingredients are included in the IECIC to simplify the regulatory approval process and avoid the lengthy safety assessment required for new ingredients.
Introducing New Cosmetic Ingredients
If a company wishes to introduce a new cosmetic ingredient (NCI) that is not listed in the IECIC, it must undergo a comprehensive safety evaluation and a mandatory three-year safety monitoring period before it can be officially approved for unrestricted use. This process ensures that the new ingredient does not pose risks to consumer health.
The approval process for NCIs includes:
- Pre-market submission: Companies must submit toxicological data, stability studies, microbiological test results, and clinical safety evaluations to the National Medical Products Administration (NMPA) for review.
- Three-year monitoring period: Once preliminary approval is granted, the new ingredient enters a provisional monitoring phase, during which it may be used in cosmetic formulations, but its performance, safety profile, and adverse effects must be closely tracked.
- Adverse event reporting: Companies are required to report any incidents of irritation, allergic reactions, or other health concerns related to the ingredient’s use. These reports help regulatory authorities assess whether the ingredient remains safe for long-term application.
- Final approval or restriction: After three years, if no significant safety concerns arise, the ingredient is officially approved and added to the IECIC, making it available for unrestricted use. However, if risks are identified, the ingredient may be restricted, banned, or subject to further regulatory control.
This stringent monitoring process aligns with China’s commitment to cosmetic safety and public health, ensuring that new ingredients meet the highest safety standards before being widely adopted by the industry.
Restricted and Prohibited Ingredients Under the STSC
In addition to listing approved ingredients, Chinese regulations also define prohibited and restricted substances that cannot be used in cosmetics. These are specified in the Safety and Technical Standards for Cosmetics (STSC), a set of technical guidelines that outline ingredient safety limits, testing methods, and product formulation requirements.
The STSC includes:
- Banned substances: Ingredients that are known to be toxic, carcinogenic, or otherwise hazardous to human health. Examples include mercury compounds, certain colorants, and heavy metals beyond safe limits.
- Restricted substances: Ingredients that may be used only under specific conditions, such as preservatives, UV filters, and stabilizers, which must comply with maximum concentration limits and approved usage scenarios.
- Permissible active ingredients: Certain active ingredients, such as those used in whitening or anti-aging products, are subject to strict regulations on concentration levels and efficacy claims.
Manufacturing Safety Obligations
CSAR mandates compliance with Cosmetic Good Manufacturing Practices (GMP) to ensure the quality and safety of cosmetic products. Manufacturers are required to establish quality management systems (QMS) that regulate every stage of production, from sourcing raw materials to packaging the final product.
GMP Certification
Domestic manufacturers must obtain a cosmetic production license from the NMPA and undergo periodic GMP inspections. The NMPA conducts random factory audits and market surveillance to verify GMP compliance. International brands exporting to China must ensure their manufacturers follow equivalent GMP standards recognized by Chinese regulators.
GMP Requirements Under CSAR
Production Facility and Equipment Standards
- Manufacturing facilities must meet hygiene and safety requirements, with dedicated areas for raw materials storage, production, and packaging.
- Equipment should be regularly maintained, calibrated, and sanitised to prevent contamination.
- Manufacturers must implement measures to control air quality, temperature, and humidity to protect product stability.
Personnel and Training
- All personnel involved in cosmetic manufacturing must undergo GMP training to ensure compliance with safety and hygiene standards.
- Manufacturers must appoint qualified professionals responsible for overseeing production, quality assurance, and safety assessment.
- Hygiene protocols must be strictly followed, including the use of protective clothing and proper sanitation procedures.
Raw Material and Ingredient Control
- Manufacturing processes must follow standard operating procedures (SOPs) to ensure consistency.
- Batch tracking and recording must be implemented to trace product origin in case of quality issues.
- Any deviations from standard production protocols must be documented and justified.
Quality Control and Testing
- Finished products must undergo microbiological, stability, and safety testing before being released to the market.
- Quality control units must ensure that products meet national safety and efficacy standards, such as the Safety and Technical Standards for Cosmetics (STSC).
- Products that fail quality tests must be discarded or reprocessed, and corrective actions should be taken.
Record-Keeping and Traceability
- Manufacturers must maintain detailed production records for at least three years.
- Records should include raw material sources, batch numbers, test results, and distribution details.
- A recall system must be in place to trace and withdraw defective products from the market efficiently.
Consequences of GMP Non-Compliance
Non-compliance with GMP obligations can lead to:
- Product recalls and removal from the market.
- Fines up to 30 times the illegal earnings or suspension of business operations.
- License revocation for manufacturers failing repeated inspections.
- Criminal liability for severe violations that result in consumer harm.
Labelling & Claims Safety Obligations
Cosmetic labeling is mandated by the Administrative Measured on Cosmetic Labelling and must include detailed information such as the product name, ingredients, manufacturer details, production date, shelf life, and usage instructions. This transparency allows consumers to make informed decisions about the products they use.
Advertising regulations such as the Standards for Cosmetic Efficacy Claim Evaluation prohibit misleading claims, such as assertions of “medical efficacy”, unless they are scientifically proven and supported by clinical evidence. Companies that violate advertising standards may face fines, public warnings, or a ban on their marketing campaigns.
Cosmetic Labelling Requirements in China
Product Name
- Must be written in simplified Chinese.
- Should not include misleading terms (e.g., implying medical efficacy).
Product Classification
- Must specify whether the product is a special cosmetic (e.g., sunscreen, hair dye) or a general cosmetic.
Ingredients List
- Ingredients must be listed in descending order of concentration (if below 0.1%, they can be listed in any order).
- Names should follow the International Nomenclature of Cosmetic Ingredients (INCI) or Chinese IECIC (Inventory of Existing Cosmetic Ingredients in China).
- Allergens (e.g., preservative allergens, fragrance allergens) must be clearly identified.
Manufacturer and Responsible Entity Information
- Name and address of the manufacturer (for domestic products) or the importer’s name and address (for imported products).
- The Domestic Responsible Person (DRP) must be listed for imported products.
Production License Number
- Domestic manufacturers must include their cosmetic production license number issued by the NMPA.
- This is only required for domestic manufacturers, not imported products.
Batch Number and Expiry Date
- Either a production batch number or manufacturing date & shelf life must be clearly stated.
- Expiry date should be in the YYYY/MM/DD or YYYY.MM.DD format.
Usage Instructions and Precautions
- Clear guidance on how to use the product safely.
- Warning labels if the product has potential skin irritants or requires special usage precautions.
Storage Conditions
- Required if the product is sensitive to temperature, humidity, or sunlight.
Language
- Simplified Chinese is mandatory (other languages can be used, but Chinese must be dominant).
- Imported cosmetics must have a Chinese translation of foreign text.
Legibility
- Labels should be clear, durable, and easy to read.
Online Sales
E-commerce platforms must ensure that product descriptions match the approved labels. The Regulation on the Supervision for Cosmetics’ Online Operation mandates that online retailers verify and display compliant product labels.
Monitoring and Reporting Safety Obligations
Companies must establish an adverse event monitoring system to track consumer complaints and potential health risks in compliance with the Measure for the Management of Cosmetic Adverse Reaction Monitoring . If a product causes adverse reactions in consumers, the company must take immediate action to investigate and address the issue.
Serious adverse reactions must be reported to the NMPA within 72 hours. This ensures that regulatory authorities can respond swiftly to protect public health and, if necessary, initiate product recalls or further investigations.
Adverse Events in Cosmetics
According to the National Medical Products Administration (NMPA), an adverse event in cosmetics refers to any harmful reaction or unexpected side effect caused by the normal and intended use of a cosmetic product. These reactions can range from mild skin irritation to severe allergic reactions and systemic health issues.
The adverse events are classified into two categories:
- General adverse events: Mild and temporary skin reactions such as redness, dryness, or itching.
- Serious adverse events: Severe reactions like persistent inflammation, infections, or systemic health effects requiring medical intervention.
Responsibility of Cosmetic Enterprises
Under the CSAR and the Measures for the Administration of Cosmetic Adverse Reaction Monitoring, cosmetic enterprises—including manufacturers, importers, and the Domestic Responsible Person (DRP)—are required to establish an adverse event monitoring and reporting system to track product safety and consumer complaints.
Key responsibilities include:
- Collecting and recording adverse event reports from consumers, medical institutions, and distributors.
- Assessing the severity of adverse reactions and determining potential causes.
- Taking corrective measures, such as reformulating products, improving labeling, or recalling unsafe products.
- Reporting serious adverse events to the NMPA within strict timeframes.
Reporting Requirements and Timeframes
The NMPA mandates specific timeframes for reporting adverse events:
- General adverse events: Must be recorded and analyzed internally by the company. If a pattern emerges, it should be reported to regulatory authorities.
- Serious adverse events:
- Preliminary report: Must be submitted within 72 hours of discovering the case.
- Detailed investigation report: A comprehensive safety evaluation must be provided within 30 days.
Reports must include details such as:
- Product information (brand name, ingredients, batch number).
- Consumer details (age, gender, medical history).
- Description of the adverse reaction (symptoms, severity, onset time).
- Usage method (how the product was applied).
- Corrective actions taken (withdrawal, reformulation, or recall).
Corrective Actions
If a cosmetic product is linked to multiple or serious adverse events, authorities may:
- Order the suspension of sales or recalls.
- Conduct on-site inspections of the manufacturer.
- Mandate reformulation or enhanced safety testing.
- Impose fines or legal penalties for non-compliance.
Repeated safety violations can lead to the revocation of business licenses and permanent product bans.
Product Recalls & Penalties
If a cosmetic product is found to be non-compliant with CSAR regulations, it may be recalled voluntarily by the manufacturer or mandated by regulatory authorities. The recall process involves notifying consumers, removing the product from the market, and implementing corrective measures to prevent future safety issues.
Companies that violate CSAR regulations may face severe penalties, including fines up to 30 times the illegal earnings, license suspension, or even criminal liability in cases of serious violations. These strict penalties underscore the importance of adhering to China’s cosmetic safety regulations.
Regulatory Authorities
National Medical Products Administration (NMPA)
The National Medical Products Administration (NMPA) is the primary regulatory authority responsible for the supervision, registration, and approval of cosmetics in China. It plays a crucial role in implementing CSAR, setting national safety standards, and ensuring compliance with ingredient safety assessments, manufacturing regulations, and labeling requirements.
Before a cosmetic product is introduced to the market, the NMPA evaluates its safety, efficacy, and compliance with national standards. It reviews and approves the registration of special cosmetics (such as sunscreens, whitening products, and anti-hair loss treatments) and oversees the notification process for general cosmetics. Additionally, the NMPA is responsible for approving new cosmetic ingredients (NCIs) and monitoring their three-year safety observation period before they can be officially listed in China’s Inventory of Existing Cosmetic Ingredients (IECIC).
Beyond pre-market approval, the NMPA also conducts post-market surveillance, including random product testing, factory inspections, and the investigation of consumer complaints. It collaborates with provincial and municipal drug administrations to enforce cosmetic regulations at different levels of governance.
State Administration for Market Regulation (SAMR)
The State Administration for Market Regulation (SAMR) is responsible for overseeing market compliance and consumer protection related to cosmetic products.
Its duties include monitoring:
- Product labeling: Ensuring that all cosmetics comply with the Administrative Measures on Cosmetics Labeling, which require accurate ingredient disclosure, safety warnings, and shelf-life information.
- Advertising claims: Preventing misleading or exaggerated marketing statements, such as false promises of medical efficacy or permanent cosmetic effects.
- Consumer safety and complaints: Investigating reports of unsafe or non-compliant cosmetic products and coordinating recalls when necessary.
SAMR works closely with the NMPA and other local regulatory agencies to combat illegal cosmetic production, counterfeit products, and false advertising. It has the authority to penalize businesses that violate advertising laws or fail to meet national cosmetic safety standards, imposing fines, product recalls, and even business shutdowns in severe cases.
China National Institutes for Food and Drug Control (NIFDC)
The China National Institutes for Food and Drug Control (NIFDC) serves as the scientific and technical arm of China’s cosmetic regulatory system. It is responsible for conducting safety assessments, laboratory testing, and toxicological research to evaluate cosmetic ingredients, raw materials, and finished products.
NIFDC’s primary responsibilities include:
- Evaluating the safety of cosmetic ingredients: Conducting risk assessments on new and existing cosmetic ingredients to determine their potential impact on human health.
- Developing and updating national safety standards: Establishing testing methods and limits for heavy metals, microbiological contamination, and restricted substances in cosmetics.
- Supporting adverse event monitoring: Analyzing consumer reports of adverse reactions to identify potentially harmful products or ingredients.
- Providing technical guidance for enforcement agencies: Assisting the NMPA and SAMR in developing scientific protocols for product testing, regulatory inspections, and quality assurance measures.
