China Regulatory News

On 22 April 2024, the National Medical and Pharmaceutical Administration of China (NMPA) announced an updated Technical Guidelines for Cosmetic Safety Assessment, which will be implemented from 1 May ...

On 22 April 2024, the National Medical and Pharmaceutical Administration of China (NMPA) announced an updated Technical Guidelines for Cosmetic Safety Assessment, which will be implemented from 1 May 2024. This update will further assist companies currently preparing Cosmetic Product Safety Reports (CPSRs) to achieve faster registration.

Details of Rules 2024 nr 50 (updated on 22 April 2024 based on Rules 2021 nr 51):

• The updated technical guideline for cosmetics has published examples of both the detailed and simplified format. This change will further facilitate the process of submitting CPSRs.

• Before 1 May 2025, the legal representative or recordation of the registration can follow the officially published technical guideline to provide the required information for CPSR directly in the simplified format.

• All the registration and recordation shall follow the Safety Evaluation Capacity and Standard proposed by the Cosmetic Safety Evaluation Measures. This Cosmetic Safety Evaluation Measures addresses the importance of the following matters: strengthening technical instruction and providing a safer foundation for the supervision of cosmetic-related products.

For more information on how to comply with China’s cosmetic regulations, please contact GPC regulators  jingyan@cn.gpcregulatory.com or annie@cn.gpcregulatory.com.

On 12 March 2024, the National Health Commission of China (NHC) released a new standard GB 4806.15-2024 for adhesives in materials used for food preparation and storage. This new standard introduces c...

On 12 March 2024, the National Health Commission of China (NHC) released a new standard GB 4806.15-2024 for adhesives in materials used for food preparation and storage. This new standard introduces controls on food contact materials (FCMs) including composite materials and pressure-sensitive adhesives.

Categorization of Adhesive

The standard divides adhesives into two categories: direct and indirect food contact applications. Direct food contact applications which have a higher migration risk will be more strictly regulated. For indirect food contact applications which have lower migration risks, the requirements will be less stringent.

Requirements and Implementation

The new standard also includes a list of substances that can be used for direct and indirect food contact and the requirements for their use in the annexes. According to the annexes, 51 raw materials are approved for direct food contacts and 341 substances are permitted for indirect food contact materials. Materials approved for direct contact applications are also approved for indirect contact materials.

Adhesive products must indicate on the label which category they fall into. Additionally, additives used in adhesives must meet the requirements of standards GB 4806.1-2016, GB 9685-2019, and any further announcements.

Implementation Date and Contact Information

The new standard will come into force on 8 February 2025. For further information, please contact Global Product Compliance (GPC) at compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com.

On 12th March 2024, The Ministry of Industry and Information Technology of China (MIIT) published a notification soliciting public comments on the draft standard of GB 30000.1: Rules for classificati...

On 12^th March 2024, The Ministry of Industry and Information Technology of China (MIIT) published a notification soliciting public comments on the draft standard of GB 30000.1: Rules for classification and labelling of chemicals—Part 1 General specifications. According to the notification, once the new standard is approved, it will be effective 12 months after the publication and the previous standards GB 13690-2009 will be appealed. 

Basis for technical requirements in GB 30000.1 

The technical content of this standard is mainly derived from the GHS system. This standard specifies the terms and definitions involved in the classification and labeling of chemicals, categories of hazardous properties of chemicals, classification standards for substances and mixtures, guidance on the preparation of chemical safety labels, and guidance on the preparation of chemical safety data sheets (SDS). regulations etc.

The main content of this standard consists of the following parts: 

1. Terms and definitions 
2. Chemical hazard classification
3. Label 
4. Chemical Safety Data Sheet

Main changes to GB 13690-2009

Firstly, the name of this standard is changed to Rules for classification and labelling of chemicals—Part 1:General specifications. 

Secondly, it added "United Nations Globally Harmonized System of Classification and Labeling of Chemicals (Eighth Revised Edition)" and "United Nations Model Regulations on the Recommendation on the Transport of Dangerous Goods (Twenty-second Revised Edition)" as cited documents, deleted Referenced documents "GB/T 22272~ GB/T 22278". 

Thirdly, it adjusted the regulations on chemical hazard classification: 4.1.1 Hazard Category a) Added desensitizing explosives to physical hazards. 

Fourthly, it deleted sample sheets in the appendix: 

1. Deleted Informative Appendix A "Examples of Precautionary Statements", while added Informative Appendix A "Definitions and Abbreviations Specified in GHS". 
2. Deleted Informative Appendix B "Pictograms of Protective Measures". 
3. Deleted Informative Appendix C "Sample GHS Label"; 
4. Deleted informative Appendix D "Minimum Information on Safety Data Sheets". 

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

The Solid Waste and Chemicals Management Center (SCC) under the Ministry of Ecology and Environment of China (MEE) published a notification to remind new chemical substance registrants to submit 2023 ...

The Solid Waste and Chemicals Management Center (SCC) under the Ministry of Ecology and Environment of China (MEE) published a notification to remind new chemical substance registrants to submit 2023 annual reports before 30th April via the online registration system. 

According to MEE Order No.12, the following types of new chemical substance registration have annual report obligation. 

• Certificates obtained under MEP Order No.7, and the new substance belongs to key environmental management categories; and 
• Certificates obtained under MEE Order No.12, and the annual report obligation was specified in the regular registration certificate. 

As required, registrants shall include the following information in the annual report.  

• Actual production in 2023.
• Import volume of chemical in 2023.
• Environmental release details, the implementation status of environmental risk control measures.
• Environmental management requirements.

The registrants or their agents in China shall log into the system and fill in the report form online. SCC also disclosed a list of registrants subject to annual report obligation. If you are not sure if you have annual report obligation, please submit a query to GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com, we will help to you to check. 

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.