China Regulatory News

The Ministry of Ecology and Environment of China (MEE) consulted on adding 2024 first batch of chemical substances into the Inventory of Existing Chemical substances in China (IECSC). This includes fo...

The Ministry of Ecology and Environment of China (MEE) consulted on adding 2024 first batch of chemical substances into the Inventory of Existing Chemical substances in China (IECSC). This includes following seven substances: 

• Methane peroxoic acid;
• Methyl ((((1Z)-1-(2-amino-1,3-thiazol-4-yl)-2-(1,3-benzothiazol-2-ylsulfanyl)-2-oxoethyl idene) amino) oxy) acetate;
• Ethyl (αZ)-2-amino-α-(methoxyi mino)-4-thiazoleacetate;
• Vanadium trioxide;
• Dihydroxyaluminum amino acetate;
• Cyclohexyl phenyl ketone; and
• Dicetyl peroxydicarbonate.

This batch of substances were applied to be included in the inventory on condition that they were manufactured or imported in China prior to 15^th October. Once they were listed in IECSC, there is no registration obligation for them under MEE Order No.12. 

For more informaiton, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 3 January 2024, the National Center for Food Safety Risk Assessment of China (CFSA) published a notification to consult public opinions on four food contact materials (FCMs), following approval by...

On 3 January 2024, the National Center for Food Safety Risk Assessment of China (CFSA) published a notification to consult public opinions on four food contact materials (FCMs), following approval by its expert review.

The FCMs are two new additives: 

• chromium iron oxide, with CAS no. 12737-27-8. The given maximum using percentage is 2%, scope of usage is plastic. 
• Bicyclo [2.2.1] heptane-2,3-dicarboxylic acid, calcium salt, with CAS no. 839683-04-4. The given maximum using percentage is 0.25%, scope of usage is PP and PE. 

Two new resins: 

• polybutylene succinic acid-adipate, with CAS no. 67423-06-7. The given scope of usage is plastic. 
• 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid and 1,4-cyclohexanedimethanol, with CAS no. 26124-27-6. The given scope of usage is plastic. 

The CFSA is proposing that the FCMs can be used in plastic materials and articles, with the following requirements:

• not allowed in products intended for infants and young children; and
• labelling must comply with national standard GB 4806.

For further information, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 12th January 2024, the China Oral Care Products Industry Association (COCIA) has published a first national inventory of toothpaste ingredients.  This inventory collected 1026 toothpaste ingre...

On 12^th January 2024, the China Oral Care Products Industry Association (COCIA) has published a first national inventory of toothpaste ingredients. 

This inventory collected 1026 toothpaste ingredients. And the information of the Chinese name, INCI name and maximum historical usage levels have been given. This inventory was codified from COCIA’s members in 2020 and 2022. But they haven’t organized a systemic safety evaluation of the ingredients listed. 

Though it is just an association version, toothpaste manufacturers can still take this inventory as a reference when filing products under CSAR regulation which classified toothpaste as ordinary cosmetic form 1 December 2023. 

For more information, please contact compliance@gcpregulatory.cn or zhengmin@cn.gpcregulatory.com. 

The Chinese Supervision and Management Measures of Toothpaste Products has been enforced since 2023.12.1. To facilitate the enforcement of the Measures, NMPA published and enforced the Management Ru...

The Chinese Supervision and Management Measures of Toothpaste Products has been enforced since 2023.12.1. To facilitate the enforcement of the Measures, NMPA published and enforced the Management Rules for Toothpaste Registration. This Management Rules will guide applicants with relevant registration requirements and procedures.

There are three chapters and three annexes in this Rules. Chapter one gives general information on toothpaste registration. Chapter two illustrates the required documents, the applicants and agent’s conditions, renewal of information and certain timelines for registration. In chapter three, detailed materials requirements for dossier preparation are explained. According to it, the following information must be prepared: 

1. Name, address, and contact information of the filing person.
2. Name, address, and contact information of the production enterprise.
3. Product name information. 
4. Product formula.
5. Product execution standards.
6. Product label sample. 
7. Product inspection report.
8. Product safety assessment information. 

The three annexes are Standard Preparation Instructions for Toothpaste Product Implementation, Toothpaste Product Implementation Standards (sample) and Requirements for Microbiological and Physical and Chemical Inspection Items for Toothpaste Registration.

The Management Rules will be enforced the same time as the Supervision and Management Measures of Toothpaste Products on 1st Dec. 2023. For more information, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com.

The Ministries of Environment and Commerce of China published a revised list of hazardous chemicals for priority control as part of the country’s obligations under the Stockholm and Rotterdam Conven...

The Ministries of Environment and Commerce of China published a revised list of hazardous chemicals for priority control as part of the country’s obligations under the Stockholm and Rotterdam Conventions. Currently, there are nine substances included in this list. 

Under this notification, two substances were added to the hazardous chemicals list: decaBDE and perfluorootanoic acid (PFOA). The list now requires stricter controls on short-chain chlorinated paraffins (SCCPs) and updates to their CAS numbers. 

Additionally, the use of following chemicals has been restricted: 

• Flame retardant hexabromocylododecane (HBCDD)
• Perfluorooctane sulfonic acid (PFOS) and its salts
• Perfluorootane sulfonyl fluoride (PFODF), excluding for the production of firefighting foams. 

The updated list took effect from 18^th Oct. 2023. It will replace the 2020 version.

For companies who are seeking to export the listed chemicals, they need to first apply to MEE for a release order. Once the order is released, it will be valid for 6 months. If you have any questions to this notification, please contact GPC China via compliance@gpcregulatory.cn.

The Ministry of Environment and Ecology of China (MEE) has consulted on the inclusion of four chemical substances to its Inventory of Existing Chemical Substances (IECSC) under MEE Order No.12.  T...

The Ministry of Environment and Ecology of China (MEE) has consulted on the inclusion of four chemical substances to its Inventory of Existing Chemical Substances (IECSC) under MEE Order No.12. 

The concerned substances are: 

• 4-chlorobenzophenone;
• 1,8-naphthalimide;
• (2S,4S)-2-(dimethyl-amino carbonyl)-4-mercapto-1-(p -nitrobenzyloxycarbonyl)- 1-pyrrolidine; and
• cerium (III) acetate hydrate.

These four substances were nominated by the industry on the legal basis that these substances were manufactured in or imported into China before 15^th October 2003 as provided in MEE Order No.12.

The nomination was done on 23^rd October, and it will be opened for consultation for two weeks. From now on, there are no registration or record filling obligations for these four substances under China REACH. For more information regarding China REACH, please contact GPC China via compliance@gpcregulatory.cn. 

On 19th October, China MIIT published a notification which announced 60 standards relating to chemical industry.  Among the 60 standards, there are 20 standards which were made to replace the pre...

On 19^th October, China MIIT published a notification which announced 60 standards relating to chemical industry. 

Among the 60 standards, there are 20 standards which were made to replace the previous standards, covering the area of determination of isocyanate group content in polyurethane prepolymer, the testing for industrial phosphorous acid, industrial strontium carbonate, industrial sodium chlorite, etc. The rest 40 standards are new standards governing the testing for polypropylene series chemical substances and etc. 

The publicity period is from 19^th October 2023 until 19^th November 2023. During this period, if you have any suggestion, you are welcome to contact GPC China via compliance@gpcregulatory.cn. GPC China can help you to report your suggestion to the official.