China Regulatory News

On  February 15, 2022, the National Medical Products Administration of China (NMPA) published final measures for cosmetic companies to establish systems for monitoring adverse reactions of cosmetic...

On  February 15, 2022, the National Medical Products Administration of China (NMPA) published final measures for cosmetic companies to establish systems for monitoring adverse reactions of cosmetics. It is expected to come into force on October 1, 2022. This measure will apply to all companies who register/notify their cosmetic or cosmetic ingredients under Cosmetics Supervision and Administration Regulation (CSAR).

This measure consists of seven chapters that extensively lay down rules relating to the responsibilities and obligations for notifiers, cosmetics’ adverse reaction report requirements, adverse reaction analysis and evaluation, investigation on adverse reaction, and administration supervision methods.

According to the measure, adverse reaction means a normal and proper use of cosmetics resulting in pathology change in skin and other related health issues. For better monitoring of the adverse reaction, companies are required to establish post-registration adverse reaction monitoring systems. Such systems will be used to collect information on adverse reactions to cosmetics sold via various channels including distributors, shops, and hospitals. Domestic companies are required to report all this collected information to NMPA, while overseas companies comply with this via their Chinese responsible person such as their Only Representative  (OR) and importer. Though the information will be submitted to NMPA, all the collected information must be kept for at least three years.

Further, this regulation categorizes the reactions into three types according to their severity level:

1.  Normal adverse reactions, which means minor ailments such as itchiness and rashes.
2. Severe adverse reactions. It refers to large-scale or deep damage to the skin and organs, including mucous membranes and systemic damage to other organs.
3. Extremely severe adverse reactions. It means those that might impact a lot of people or have a large social impact.

Based on different categories, the notification timeline is different. Normal adverse reactions must be reported to NMPA within 30 days when the adverse reaction is found, while reporting time for severe and extremely severe situations are shortened to 14 days and 3 days respectively.

For more inquiries regarding Chinese cosmetic regulation and compliance issues, please contact us via compliance@gpcregulatory.cn or send a message to our WeChat account of 46 0708381983 (GPC China). 

The Ministry of Environment and Ecology of China (MEE) published a Draft Plan for Digital Transformation in Hazardous Waste Management on the 18th of January 2022. This draft mainly focuses on the...

The Ministry of Environment and Ecology of China (MEE) published a Draft Plan for Digital Transformation in Hazardous Waste Management on the 18^th of January 2022.

This draft mainly focuses on the following aspects:

1.     Digital transformation in hazardous waste environment management

It mainly includes the implementation of the electronic management ledger of hazardous waste, the unified management of the transfer of hazardous waste, the implementation of a paperless operation of the inter-provincial transfer of hazardous waste, the regulation of hazardous waste management reports, and the regulation of hazardous waste export approval.

2.     Improving the intelligent level of environmental supervision of hazardous waste

This aim requires adapting to a new supervision mode on hazardous waste via the Internet of Things (IoT). This includes the construction of an online trading platform for hazardous waste and the pilot of third-party payment, and the deepening of the pilot work of collecting and transferring waste lead-acid batteries.

3.     Strengthen the docking and application of a national information system

This notification focuses on further strengthening the docking and application of a national information system that can clarify the relevant requirements for data docking, reporting, and application.

For further information, please email compliance@gpcregulatory.cn or message the WeChat account of 0708381983 (GPC China).

On the 16th of January 2022, China’s Ministry of Emergency Management (MEM) launched a new online platform for the registration of hazardous chemicals. The previous system launched in 2020 was clo...

On the 16^th of January 2022, China’s Ministry of Emergency Management (MEM) launched a new online platform for the registration of hazardous chemicals. The previous system launched in 2020 was closed on January 28, after which the new Hazardous Chemicals Registration Comprehensive Service Platform became operational.

This new platform solves the fear foreign companies once had about over-sharing their confidential business information, as this site helps secure such information. The new platform is referred to as National Registration Centre for Chemicals (NRCC).

With the new system, foreign companies can decide to either appoint a domestic agent or entrust the process to a third party so that confidentiality can be achieved. Before now, the only available option was the appointment of an agent which companies were wary of disclosing sensitive information to them.

Furthermore, Bryan Zhou says the foreign companies can meet registration obligations by working with the local importers of their substance. They can also appoint these local importers as their agents in China.

Therefore, there are lots of options that come with the new online platform. However, all options still require disclosure of information, some less than others. 

Based on the China cosmetic regulation (Cosmetics Supervision and Administration Regulation, CSAR), the National Medical and Pharmaceutical Agency (NMPA) published the good manufacturing practice &lsq...

Based on the China cosmetic regulation (Cosmetics Supervision and Administration Regulation, CSAR), the National Medical and Pharmaceutical Agency (NMPA) published the good manufacturing practice ‘specifications’ for cosmetics. This notification was published on 7th January 2022, and it is expected to come into force in July 2022.

With nine chapters and two attachments, the notification document details the requirements for the whole process of cosmetics production and usage, from the purchasing of raw materials to producing, experimenting, storing, selling and recalling cosmetics. It aims to ensure that high quality cosmetics are placed in the China market.

According to these specification requirements, it will apply to all companies that register or manufacture cosmetics in China. For those who secure manufacturing licenses or certificates before 1st July 2022, they are required to update their facilities, equipment, and management rules to meet the new specifications before 1st July 2023.

You can download the full specification requirements here. For more information or inquiry regarding China cosmetic regulations, you can email compliance@gpcregulatory.cn (for general business inquiry) or zhengmin@cn.gpcregulatory.com (for personal inquiry).

Last Update: 2022-01-21

On 22nd December 2021, the Ministry of Environment and Ecology announced that 11 chemical substances will be added to the Inventory of Existing Chemical Substance list (IECSC) of China. For chemica...

On 22nd December 2021, the Ministry of Environment and Ecology announced that 11 chemical substances will be added to the Inventory of Existing Chemical Substance list (IECSC) of China.

For chemicals included in the chemical inventory list, there is no compliance obligation for manufacturing or exporting them to China. But if chemicals fall under the new use management system, then they must comply with China REACH regulation according to general registration conditions. To check if your concerned substance falls under the new use management category, you can check it on GPC compliance advisor for free.

The 11 chemicals are as follows:

For more information regarding China REACH and China regulations requirements, please contact us by email: compliance@gpcregulatory.cn (general business inquiry or zhengmin@cn.gpcregulatory.com (personal inquiry).

Last Update: 2022-01-21

On the 1st of December 2021, China’sNational Medical Products Administration  (NMPA) published a special label for cosmetics that are intended for use by children under 12 years old. Fro...

On the 1st of December 2021, China’sNational Medical Products Administration  (NMPA) published a special label for cosmetics that are intended for use by children under 12 years old.

From 1 May 2022, newly registered children’s cosmetics must attach the logo. If the cosmetic is already registered or filed when the notification is published, companies must update their labels before 1 May 2023.  

According to the requirements, the label must be at least 1cm wide if the outer surface area of a product is smaller than 100cm2, while if it is larger, then the label must be at least 2cm wide.

Children’s cosmetics are defined as cosmetics made for children under 12 years old. NMPA defines children’s cosmetics as those products that have functions such as cleansing, moisturizing, and sun protection. China’s NMPA announced children's cosmetic working plan in October which is planned to come into force on January 1, 2022. 

For more inquires relating to China REACH and cosmetic regulation, please contact compliance@gpcregulatory.com  

Last update: 2021-12-15

On 27th October, the National Centre for Food Safety Risk Assessment (CFSA) of China published a consultation on the approval of food additives and resins and the ex...

On 27th October, the National Centre for Food Safety Risk Assessment (CFSA) of China published a consultation on the approval of food additives and resins and the expanded use of FCM additives.  

There are three food additives being considered for use in FCMs. They are:  

• acids, aliphatic, monocarboxylic (C10-C22), esters with polyglycerol – for use in plastic at a maximum use level of 0.35%; 
• 2-propenoic acid, 2-methyl-, 1,2-ethanediyl ester, polymer with methyl 2-methyl-2-propenoate – for use in polyethylene (PE) and polypropylene (PP) plastics up to 1%;  
• hexanedioic acid, polymer with N-(2-aminoethyl)-1,3-propanediamine, aziridine, (chloromethyl)oxirane, 1,2-ethanediamine, N,N''-1,2-ethanediylbis[1,3-propanediamine], formic acid and α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) – for use in paper and paperboard up to 0.12% (counts as the dry weight*). 

And the food contact resins that are also being considered are: 

• polymer of ethyl acrylate, acrylic acid and styrene – for use in coating and coating film at a maximum use level of 2%; 
• 1,3-benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol and hexanedioic acid – for use in coating and coating film up to 10%; 
• 1-isocyanato-3-isocyanatomethyl- 3,5,5,-trimethylcyclohexane homopolymer, methyl ethyl ketone oxime-blocked – for use in coating and coating film up to 15%; 
• 1,3-benzenedicarboxylic acid, polymer with azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid, dodecanedioic acid and 4,4'-methylenebis [2-methylcyclohexanamine] – for use in plastic; and 
• propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,3-diisocyanatomethylbenzene and α-hydro-ω-hydroxypoly [oxy(methyl-1,2-ethanediyl)] – for use in adhesives with indirect contact with food. 

In addition to the addictives and resins, CFSR is considering the additional uses of the following FCM addictives:  

• C.I. solvent red 52 – for use in in plastic polycyclohexylenedimethylene terephthalate (PCT) at a maximum use level of 0.03%; and 
• C.I. pigment yellow 180 – for use in PCT up to 0.3%.

After the consultation period which ended on November 18, if the substance gets approved, it will be put in the positive list of GB 9685-2016 and must adhere to GB 4806.1 requirements before they can be used in FCMs.  

Last Update: 2021-11-30