China Regulatory News

The National Medical Products Administration of China (NMPA) announced their working plan for the second half of 2021 on 5th July 2021. This working plan is based on the haircare products and chil...

The National Medical Products Administration of China (NMPA) announced their working plan for the second half of 2021 on 5th July 2021. This working plan is based on the haircare products and children’s cosmetics work done in the first half of 2021.

This announcement said that children’s cosmetics and haircare products will still be the focus of the second half of this year. In addition to these are children’s toothpaste, eye and skin care products, anti-wrinkle and whitening creams, anti-acne, and anti-itch products. 16 cosmetics are added into the inspection list. The inspection will be conducted from the perspectives of heavy cosmetics, hormones, antibiotics, micro-organisms and preservatives contained in the products.

The local authorities will take the investigation’s responsibilities and they must finish all the inspection by 10th of October, 2021.

For more inquiries, please contact compliance@gpcregulatory.com.

Ministry of Environment and Ecology of China (MEE) announced that the 3rd batch of chemical substance were added in the IECSC on 16 April. There were 204 chemical substances added this time. Since the...

Ministry of Environment and Ecology of China (MEE) announced that the 3rd batch of chemical substance were added in the IECSC on 16 April. There were 204 chemical substances added this time. Since the announcement of MEE Order No.12, 459 chemical substances were added to the IECSC.  

According to the procedures settled in the ‘Notification of Improving the IECSC (SCC [2019] No.575)’, the inclusion of chemical substances into IECSC is decided by MEE based on the application submitted by individual parties such as companies and industry associations.

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.