On International Consumer Rights Day 2023, batches of non-compliant beauty injections were exposed in China at the CCTV 3.15 Evening Gala. Makeup products only meant for external application are being illegally used as beauty injections. Medical professionals have warned that such beauty injections can cause swelling, ruptures, repeated inflammation, and deformation of facial skin, which leads to disfigurement instead of beauty. Investigations have also revealed that some of these beauty injections are unregistered and that many factories producing them do not have the necessary production permits.
In face of the chaos that exists in the cosmetics industries, China has placed greater emphasis on the quality, safety, and efficacy of cosmetics, issuing a series of regulations to supervise the industry, e.g. Cosmetics Supervision and Administration Regulation, Technical Standards for Cosmetics Safety, etc. Meanwhile, the National Medical Product Administration (NMPA) has strengthened the inspection of products placed on the market and has published non-compliant cases on the official website.
ZMUni has collected and analyzed non-compliant cases released on NMPA’s official website in 2023, identifying areas where non-compliance is most common and providing regulatory advice. This offers valuable insights to stakeholders in the cosmetics industry to improve their compliance, reduce risks, and meet the expectations of consumers.
I. Common Non-Compliant Cases
1. The inconsistency between the label and actual components
Hair dye and sunscreen are the most common products that are found to be inconsistent between their label and actual components.
* hair dye ingredients that are not labeled but detected in the products: 4-Chlororesorcinol, Phenyl methyl pyrazolone, 1-Naphthol, 4-Amino-2-hydroxytoluene, etc.
* UV filters that are not labeled but detected in the products: Diethylamino hydroxy benzoyl hexyl benzoate, Ethylhexyl methoxycinnamate, etc.
* UV filters that are labeled but not detected in the products: Octocrylene, Ethylhexyl salicylate, Homosalate, Ethylhexyl methoxycinnamate, etc.
2. The use of banned cosmetics ingredients
Corticosteroid is an ingredient prohibited to be added to cosmetic products for its high safety risk to human health. However, the following Corticosteroids, such as Dexamethasone, Clindamycin, Ofloxacin, Clobetasol Propionate, Desonide, Chloramphenicol, flumethasone, Habetasol Propionate, Cyproheptadine, Ciprofloxacin are repeatedly found in skincare products with anti-acne, anti-inflammatory, and skin whitening functions.
While these components have some beneficial effects, such as the powerful anti-inflammatory and anti-allergic properties of corticosteroids, the long-term use of these banned components can cause significant health risks, including steroid-dependent eczema, contact dermatitis, and developing resistance to antibiotics.
3. The excessive amounts of heavy metal
Arsenic is the most common heavy metal to be found with excessive use beyond 2mg/kg in cosmetic products during NMPA inspection.
Arsenic is often used as a preservative, as well as a color and flavor enhancer. This is especially true in products like eyeliners, eyeshadow, and even lipsticks. However, arsenic is a toxic heavy metal that can cause a range of serious health problems, including cancer, skin lesions, cardiovascular disease, and respiratory problems. Therefore, it is under strict regulation with a maximum concentration of ≤2mg/kg.
4. Microbial indicator failures
The most common failure of microbial indicators during NMPA inspection is the microbial colonies above the acceptable limits, which shall be under 500CFU/g for eye products, lip/oral products, and kid products, and under 100CFU/g for other cosmetic products. Another common failure is the detection of pseudomonas aeruginosa, which shall not be detected in cosmetic products.
II. Actionable Advice for Cosmetics Compliance in China
Before entering the Chinese market, it is essential to understand the regulatory landscape.
1. Fully understand the definition of Cosmetics
As stated in the Cosmetics Supervision and Administration Regulation, cosmetics refer to chemical industrial products for daily use that are applied on our human body surfaces such as skin, hair, nails, lips, and so on. Application methods include rubbing, spraying, or other similar techniques for the purpose of cleansing, protecting, beautifying, or grooming.
Under this definition, cosmetics can only be allowed for external use, so the injection of cosmetics is prohibited. Additionally, the function of cosmetics is to enhance beauty, so it is illegal to make any medical claims.
2. Ensure a truthful and comprehensive labeling
To comply with Chinese regulations, manufacturers/brands should ensure that their product labeling is accurate, comprehensive, and compliant with Chinese standards.
The labeling requirement includes the product name, ingredients, net content, manufacturer and distributor's name and address, and batch number. Additionally, the labeling should be in Chinese, and the details should be printed clearly and legibly. Furthermore, manufacturers/brands must ensure that their products' claims are truthful, and the labeling does not contain any misleading or falsified information.
3. Refer to the Technical Standards for Cosmetics Safety for ingredient compliance
Another crucial factor in cosmetics compliance is ensuring that the products meet the chemical and ingredient standards set in the Technical Standards for Cosmetics Safety.
Companies should ensure the ingredients used in their products are permitted in China and comply with the relevant safety and quality requirements.
4. Establish a Cosmetics Quality and Safety Responsibility System
As of 1 March 2023, cosmetic enterprises shall establish a cosmetics quality and safety responsibility system to clarify the responsibility throughout the entire production process. This includes ensuring the quality of raw materials, the safety of production equipment, the quality of the finished products, as well as procedures for the handling of any product recalls or quality-related issues.
The implementation of this regulation has resulted in significant improvements in the quality and safety of cosmetics products in China. Although it sets higher and more specific supervision on enterprises, it ensures the long-term and healthy development of enterprises to reduce non-compliant risks.
In recent years, the Chinese government has established a range of supervisory regulations and measures to ensure the safety and efficacy of cosmetic products. Meanwhile, it also takes active measures to ensure compliance with these regulations. These include on-site inspections, random inspections, and mandatory testing of products, etc. Enterprises that fail to comply with these regulations face penalties, including fines, product seizures, and even criminal charges.
ZMUni, as a leading compliance company in China, is your trustworthy partner to navigate compliantly and successfully in the Chinese market. With one-stop and tailored services, we assist you in gap analysis, ingredient/label review, safety testing, responsible person, notification, registration, adverse event monitoring system audit, compliance training, etc.
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