China Regulatory News

On 23 November 2022, the National Medical Products Administration (NMPA) in China released a new supplementary test method ‘BHJ 202203 Determination of 16alpha-hydroxiprednisolone in Cosmetics’. T...

On 23 November 2022, the National Medical Products Administration (NMPA) in China released a new supplementary test method ‘BHJ 202203 Determination of 16alpha-hydroxiprednisolone in Cosmetics’. The test specifies the qualitative and quantitative determination method of the ingredient 16alpha-hydroxyprednisolone in creams, lotions, and liquid cosmetics.

16alpha-hydroxyprednisolone (CAS number of 13951-70-7), is used in the production of steroids such as budesonide and ciclesonide.  According to the EU classification, prolonged or repeated exposure to the substance can cause skin sensitization reactions, impair the fertility of unborn babies, and cause harm to breastfed children. It is banned for use in cosmetics in China.

BJH 202203 is a supplementary test that is a supplement to the conventional test methods specified in the national cosmetic standards and technical specifications. The supplementary tests are established for banned ingredients in cosmetics that lack testing methods and are used in adulterated products. Supplementary testing methods are important for regulators and law enforcement inspecting cosmetics post-market especially when combatting illegal additions.

For further information about the NMPA supplementary tests check the following links:.

• NMPA supplementary tests, 2021 (in English)
• NMPA supplementary test method for 16α-hydroxyprednisolone in cosmetic products (Mandarin)

For more information regarding China regulatory compliance solutions, please contact us at compliance@cn.gpcregulatory.com

According to latest Chinese cosmetic regulation, Cosmetic Supervision and Administration Rules (CSAR), cosmetic products can be exempted from registration obligation if they are sold via cross-border ...

According to latest Chinese cosmetic regulation, Cosmetic Supervision and Administration Rules (CSAR), cosmetic products can be exempted from registration obligation if they are sold via cross-border e-commerce platform. However, e-commerce platforms are required set to cosmetic online rules to regulate online cosmetics. Alibaba international, as the largest Chinese cross-border e-commerce platform, has published “Compliance Rules for Cosmetic Products on Alibaba.com” on the 17^th October 2022. This rule will come into force since 24^th October 2022. 

The compliance rule largely follows the requirements in CASR sets rules. These are two major parts in this rule. 

1. Compliance requirements for listing and trading cosmetic products

• All sellers who want to list cosmetics on the platform, they must strictly adhere to the "Access Rules for Category Qualifications (for Suppliers in the Chinese Mainland)". 
• It is forbideen to sell comsetic products containing cosmetic ingredients prohibited by laws and regulations. Cosmetic ingredients that are in restricted or limited use list have to comply with certain restrictions and requirements. 
• It is forbidden to sell products that are notified by domestic and foreign regulatory authorities to have violated laws and regulations, are at risk of use, or are deemed non-compliant. 
• The description of the products listed online needs to be consistent with the labels of the final products delivered. This including the packaging, labels, ingredients, and the function description of the cosmetics.                        

​​​​​​​2.Control methods 

In "Cosmetics or Cosmetic Ingredients Controlled on Alibaba.com", it mentions that Alibaba.com will comprehensively evaluate the control plan. If the compliance requirements of the same products or ingredients are inconsistent in different countries, the platform will determine the management and control methods based on the actual situation.

If sellers are found to have sold cosmetics in violation of the above-mentioned compliance requirements, penalty might be enforced. The penalty can be removing the product, deleting the product, deducting points from the product, deducting points from the store, restricting the store from using product features on the website, closing the seller's account, and restricting the sale of all products to a destination country according to the platform rules. In addition, sellers shall comply with other compliance and trading rules for products. 

If you are selling or planning to sell cosmetic products via cross-border e-commerce platform, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com for help. 

Recently, the Ministry of Industry and Information Technology of China (MIIT) published a plan about making a national mandatory standard -- Regulations on the Preparation of Chemical Safety Labels....

Recently, the Ministry of Industry and Information Technology of China (MIIT) published a plan about making a national mandatory standard -- Regulations on the Preparation of Chemical Safety Labels. They are seeking input from industries to give comments on this new draft regulation. 

According to MIIT, the enforcement of regulations on the preparation of chemical safety labels will replace the current GHS labelling standard GB15258. However, it will take sixteen months to revise the standard and the new GHS labelling standard is expecting to come into force in 2024. 

The current GB15258 specifies the relevant definitions, content, preparation requirements and application methods for preparing precautionary labels for chemicals in China.

For more information regarding China GHS requirements, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 2nd Sep. 2022, National Institutes for Food and Drug Control of China (NIFDC) published a notification calling for public and indutry opinions on draft new China Cosmetic Safety and Techinical Sta...

On 2^nd Sep. 2022, National Institutes for Food and Drug Control of China (NIFDC) published a notification calling for public and indutry opinions on draft new China Cosmetic Safety and Techinical Standards (CSTS) which was made in 2022. 

The current CSTS was in force since 2015. In 2021, the new Cosmetic Supervision and Administration Regulation (CASR) was published. To keep cosmetic standards in line with the latest regulation requirements and the overarching aim of cosmetic regulation, CSTS (2015 version) was modified. The main modifications are the followings: 

• List of limited cosmetic raw ingredients 

Based on the list of forbidden cosmetic raw ingredient, the definition of certain terms in list of limited ingredient and scope of list of limited ingredients have been modified in accordance with CSAR (2021). 

• List of allowed raw ingredients 

Adding Lauroyl arginine ethyl ester hydrochloride as allowed ingredients and deleting Mercury-containing preservatives from this list. 

• Test 

12 new test methods have been added, among which eight of them are toxicological tests and four of them are physical chemical tests. In addition, there 15 physical chemical tests have been modified and two toxicological tests have been modified. 

For more information relating to China cosmetic compliance activities, please contact GPC at compliance@gpcregulatory.cn. 

State Administration for Market Regulation of China (SAMR) and National Standardization Administration of China (NSA) issued the final version of national skin disinfection standard – General Requir...

State Administration for Market Regulation of China (SAMR) and National Standardization Administration of China (NSA) issued the final version of national skin disinfection standard – General Requirements for Skin Disinfectant GB 27951-2021. This standard will enter into force from 1^st November 2022. After entering into force, it will replace the previous standard of GB 27951-2011 Hygiene requirements for skin disinfectants and will be under the supervision of National Health Commission of China (NHC). 

The main change in this new standard is that it sets new limits on heavy metals used in the disinfection. 

• 10mg per litre (L) or kilogram (kg) for lead;  
• 1mg/L or kg for mercury; and  
• 2mg/L or kg for arsenic.  

In addition, it also specified several terms definitions, such as skin conditions, revised testing requirements for microbials, toxins and heavy metals in finished products, active ingredients etc. It will be clearer for companies to understand new toxicological testing requirements and limitations for heavy metals. 

For more information relating to China chemical and cosmetic regulation, please contact GPC via compliance@gpcregulatory.cn or follow our WeChat account at 46 0708381983. 

On August 19, 2022, National Medical Products Administration of China (NMPA) published a notification announcing that cosmetic digital certificate will be formally implemented. This notification was m...

On August 19, 2022, National Medical Products Administration of China (NMPA) published a notification announcing that cosmetic digital certificate will be formally implemented. This notification was made based on the rules of ‘Digital Signature Law of China’ and ‘Measures for the Administration of Electronic Certificates of National Integrated Online Government Service Platforms’. 

This notification requires that from October 1, 2022, 

• For special cometic products and cosmetic new ingredients which are registered under Measures for Cosmetic Registration and Notification (part of CSAR, Cosmetic Supervision and Administration Rules) and those certificates which are extended and changed under Measures for Cosmetic Registration and Notification, digital certificates will be granted. Paper-based certificates which were granted before, it will be valid within the validation period. But it won’t be renewed. 
• For special cosmetic products certificate which are allowed to change under Measures for Cosmetic Registration and Notification, the registrants shall return the paper-based certificates to NMPA according to CSAR requirements. 

Additionally, this notification specifies the way and place for picking up the digital certificates. Once the digital certificates are prepared, it will be uploaded to the registrants’ NMPA accounts. Registrants can pick up it by log into NMPA online service center. The digital certificates can be used in many forms, including certificate authorization, scan to check, online verification, online sharing etc. 

If you have any inquires relating to cosmetic products and ingredients registration and submission in China, please contact GPC China via compliance@gpcregulatory.cn or follow our WeChat account 46 0708381983.

To implement ‘New Pollutant Management Action Plan’, on July 20, MEE (Ministry of Environment and Ecology of China) published a notice regarding public comments on chemicals that should be assesse...

To implement ‘New Pollutant Management Action Plan’, on July 20, MEE (Ministry of Environment and Ecology of China) published a notice regarding public comments on chemicals that should be assessed of environmental risks with priority. It seeks to collect suggestion and opinions from public for chemicals to be listed in the first band for prioritize environmental risk assessment of chemicals. 

The ‘New Pollutant Management Action Plan’ was released in May 2022. The aim of it is to assess the environmental and health hazard of chemicals, with a primary focus on substances produced or used in large quantities, detected frequently in the environment, or used for various purposes, while developing an assessment database. Within this Action Plan, it outlined a plan to assess important chemicals which will be formulated and prioritized for environmental risk assessment. As a result of the plan, the notice was published to circulate public opinions. The estimate deadline for compiling these substances is the end of 2022. 

According to the requirements mentioned in this notice, proposed chemicals must meet the requirements of the guidelines for screening of priority assessment chemical substances (HJ 1229-2021). Meanwhile, this notice also enclosed an attached form which is Chemical Substance basic information list. Proposed chemicals need to include the following information: 

• Chemical name in Chinese and English
• CAS 
• Eco-toxic features and health toxic features 
• PBT characters 
• Hazardous classification 
• Use history in China and overseas 
• Risk and risk control measures 
• Others 

If you have any inquiry relating to China REACH, please contact us via compliance@gpcregulatory.cn.