China Regulatory News

On 12 Jan. 2023, National Medical Products Administration of China (NMPA) published the final Measures for the Administration of Sampling and Testing of Cosmetics. This new rule will come into force f...

On 12 Jan. 2023, National Medical Products Administration of China (NMPA) published the final Measures for the Administration of Sampling and Testing of Cosmetics. This new rule will come into force from 1 Mar. 2023. 

According to the new rule, the following cosmetic products will be the key products of sampling and testing: 

(1) Children's cosmetics and special cosmetics.

(2) Cosmetics using new raw materials.

(3) Many problems are found in supervision and inspection, case investigation, adverse reaction monitoring, safety risk monitoring, complaints and reporting, and public opinion monitoring process.

(4) The unqualified rate of previous sampling inspections was relatively high.

(5) Those with a wide range of circulation and high frequency of use.

(6) Other products with relatively high safety risks.

But if cosmetic products meet the following situations, then it can be exempted from sampling and testing requirement: 

(1) The product is only for export.

(2) The product has been opened, damaged or contaminated, which may affect the inspection results.

(3) The remaining validity period of the product is less than 6 months, except for products with a validity period less than 6 months.

Overseas manufactures who exported their cosmetic products to China shall ask their Chinese agent to help them with the sampling and testing requirement which will be enforced from 1 Mar 2023. For more cosmetic and REACH compliance in China, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 23 and 26 Dec. 2022, National Medical and Pharmaceutical Administration of China (NMPA) released two tests, BJH 202204 and BJH 202205, to detect six hazardous chemicals in cosmetic products. Both o...

On 23 and 26 Dec. 2022, National Medical and Pharmaceutical Administration of China (NMPA) released two tests, BJH 202204 and BJH 202205, to detect six hazardous chemicals in cosmetic products. Both of the test methods use qualitative and quantitative methods to determine the hazardous substance contained in cosmetic products. 

Test BJH 202204 is for detecting the presence of the following hazardous chemicals in cream, liquid, gel and wax-based cosmetics:

• tetrahydroimidazoline;  
• naphazoline;
• oxymetazoline;  
• antazoline; and  
• xylometazoline.  

Test BJH 202205 is for cream, liquid, gel and film cosmetics to detect the presence of dehydroandrographolide succinate half ester.

Both test methods are created to strengthen the conventional testing methods through targeting prohibited ingredient. Entities who wish to submit a supplementary test themselves can do so via the NMPA Technical Guidance for Research and Drafting Cosmetics Supplementary Testing Methods. 

For more information regarding China cosmetic regulation and REACH compliance, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

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.