China Regulatory News

On 23rd March 2021, Chinese National Medical Products Administration (NMPA) launched a new platform for the registration and filing of cosmetics to support the implementation of ‘Cosmetic Su...

On 23rd March 2021, Chinese National Medical Products Administration (NMPA) launched a new platform for the registration and filing of cosmetics to support the implementation of ‘Cosmetic Supervision and Administration Regulation (CSAR)’ and ‘Measures for Registering and Filing Cosmetics’,

The platform will be launched in two steps. From 1st of April, the module of ‘information management system’ will be available and users can create accounts on this platform and manage their business information. From 1st of May, the module of record filing and registration of general and special cosmetics will be available. Users can then submit their applications according to NMPA’s data requirements.

In complying with the  CSAR, the platform supports both registration and record filing. For special use cosmetics and new ingredients, Applicants of those dealing with special use cosmetics and new ingredients are required to comply with registration. As for the general use of cosmetics and ingredients, applicants only need to submit record filing. These requirements are applicable to Chinese and overseas applicants.

For further information and inquiries, please contact us at compliance@gpcregulatory.com.

2021-03-31

With the implementation of MEE Order No.12, more and more chemical substances are adding into the Chinese Inventory. On March 17th, 2021, the Ministry of Ecology and Environment of China (MEE) ann...

With the implementation of MEE Order No.12, more and more chemical substances are adding into the Chinese Inventory. On March 17th, 2021, the Ministry of Ecology and Environment of China (MEE) announced that they will add the third batch of chemical substances to the ‘Inventory of Existing Chemical Substances in China’.

MEE reviewed the submissions based on their roles listed in the ‘Notice on the Supplementing and Improving of the  Inventory of Existing Chemical Substances in China’. Among all the requests, 204 chemical substances met the Notice and MEE Order No.12 Article 3 requirements.

In terms of the principle of openness and accepting public supervision, MEE published the 204 chemical substances. See the list here. People can check and provide their opinions regarding those chemical substances from 17th of March to 30th of March. After the public consultation, the chemical substances will be listed in the Inventory formally.

For further information, please check our previous newsletter regarding china REACH or contact us by email: compliance@gpcregulatory.com.

Update: 2021-03-29

  On November 19th, 2020, the Standardization Administration of China (SAC) published the Guidelines for the Use and Control of Key Chemical Substances in Consumer Products (GB/T 39498-202...

On November 19th, 2020, the Standardization Administration of China (SAC) published the Guidelines for the Use and Control of Key Chemical Substances in Consumer Products (GB/T 39498-2020), with its effective date on June 1st, 2021.

The Guidelines provide principles and recommendations for the use and control of key chemical substances in consumer products, including product components, parts, accessories, packaging and instructions for use. Products which are subject to special regulation such as FCM, Medicine, Cosmetics, tobacco, military products are not included in its scope. The competent authorities to implement this Guidelines are National Standardization Management Committee.

A total of 117 chemicals have been identified and listed along with recommendations on controlling their use and scope i.e mostly the limits set on their content and release and migration limits.

The background for preparation of these Guidelines was recall notification of the EU and US for consumer products from China showed that more than half of the product recalls were due to the presence of hazardous chemicals. The main reason was the lack of national standards regarding the restriction of chemical safety hazards in China. So, in 2013 the China National Institute of Standardization in association with academia and industries started the process of drafting the “Restriction Requirements for chemical hazards in Consumer products”

1. In 2014, the drafting group prepared and completed the initial draft standards
2. In 2017, it was open for public consultation
3. In 2020, the “Guidelines for the control of the use of key chemical substances in consumer products” was officially released.

GPC encourages companies to actively review the restricted substances list and related requirements for smoother exports.

Update: 2021-02-23

In late January, after a month of the implementation of the MEE Order.12, China’s Solid Chemical Waste Management Center (SCC) published the first notification of the first activity and annu...

In late January, after a month of the implementation of the MEE Order.12, China’s Solid Chemical Waste Management Center (SCC) published the first notification of the first activity and annual report. This notification provides detailed the requirements outlined by the MEE Order 12. According to the notification, the following documents are required for submission.

GPC is ready to assist companies in submitting First Activity and Annual Report to the MEE, and for further queries please contact us at compliance@gpcregulatory.com

Update: 2021-02-20

On 22 Dec. 2020, the General Administration of Customs  has released an announcement on the inspection of hazardous chemicals subject to import and export. According to the Regulations on the...

On 22 Dec. 2020, the General Administration of Customs  has released an announcement on the inspection of hazardous chemicals subject to import and export. According to the Regulations on the Safety of Hazardous Chemicals (Decree No. 591 of the State Council), the Customs is responsible for the inspection of the import and export of hazardous chemicals and their packaging. 

Hazardous chemicals are substances or mixtures that can pose a significant risk to health and safety if not managed correctly. They may have health hazards, physical hazards or both. So, enterprises must provide the following information when importing their products:

1. Declaration of conformity for Enterprises Importing Hazardous Chemicals
2. In terms of products that require the addition of inhibitor/stabilizer(s), name and quantity must be provided
3. Label and SDS in Chinese.

When applying for export declaration:

1. Declaration of conformity for enterprises exporting hazardous chemicals
2. Testing results of transport packaging performance (bulk commodities and products exempted from transport packages of dangerous goods excepted)
3. Hazard Classification report
4. Label and SDS in Chinese
5. In terms of products that require the addition of inhibitor/stabilizer(s), name and quantity must be provided

The import and export enterprises of hazardous chemicals must ensure that the hazardous chemicals meet these requirements:

1. Mandatory requirements of China’s national technical specifications (for application of imported products/goods)
2. Relevant international conventions, rules, treaties, agreements, protocol…. etc
3. Importing national and regional technical regulations and standards (applicable to export products)
4. The technical specifications and standards designated by the General Administration of Customs and the former General Administration of Quality Inspection

The import and export of hazardous chemicals used as food and food additives shall comply with the relevant provisions on food safety

The announcement will be effective from 10 January, 2021 while repealing the notice of 2012.

On the 24 December 2020, China’s Ministry of Ecology and Environment (MEE) released the final versions of technical risk assessment guidelines. These guidelines will guide and regulate risk ...

On the 24 December 2020, China’s Ministry of Ecology and Environment (MEE) released the final versions of technical risk assessment guidelines. These guidelines will guide and regulate risk assessment activities and assisting the implementation of MEE Order No.12.

The recently published guidelines are:

• Environmental and Health Hazard Assessment (trail) – Appendix 1

This guideline uses GB 30000 series standards and GB/T 24782 as the main resources in hazardous assessment. It sets down the general principles and requirements for the assessment procedures and contents of chemical substances.

• Environmental and Health Exposure Assessment (trail) – Appendix 2

The main material referred in this guideline is HJ 2035 standard – Technical Guideline on Solid Waste Disposal. This guideline is supposed to be used for risk assessment of environmental and health exposure evaluation.  

• Environmental and Health Risk Characterization (trail)- Appendix 3

There is no specific standard referred to in this guideline. However, this guideline will rely on MEE Order No.12, Guidelines for MEE Order No.12, and the Technical Framework Guidelines on the Risk Assessment of Chemical Substance which are the common resources for the three guidelines. Specifically, it includes the main principles, procedures, and technical points for environmental and health risk characterization of chemical substances.

All of the three guidelines mentioned above came into force from the day they were enacted. However, as the term ‘trail’ in the name of the guidance indicated, these guidelines can be modified depending on the actual situation of implementation.  

Download Environmental and Health Hazard Assessment (trail) – Appendix 1 (In Mandarin)

Download Environmental and Health Exposure Assessment (trail) – Appendix 2 (In Mandarin)

Download Environmental and Health Risk Characterization (trail)- Appendix 3 (In Mandarin)

Update: 2021-01-20

  On 21 Dec. 2020, China MEE announced that the second batch of 238 substances have fulfilled the requirements for IECSC supplementation and will be managed as existing chemical subst...

On 21 Dec. 2020, China MEE announced that the second batch of 238 substances have fulfilled the requirements for IECSC supplementation and will be managed as existing chemical substances. 

On 17 November 2020, China MEE released a public consultation on 245 substances that have applied for IECSC supplementation. Among them, 238 substances have passed the review and have been added to the IECSC. The rest 7 substances are still new chemical substances and will be managed as new substances. 

MEE also reminds enterprises that substances not listed in IECSC will be regarded as new substances and have to be registered as per the new regulation MEE ORDER 12 effective from January 2021. 

Update: 2021-01-19