China Regulatory News

On October 14, 2024, the Chinese Ministry of Ecology and Environment (MEE), in collaboration with 16 other government departments, announced new regulations to control eight types of mercury-added pro...

On October 14, 2024, the Chinese Ministry of Ecology and Environment (MEE), in collaboration with 16 other government departments, announced new regulations to control eight types of mercury-added products. These measures, which target eight types of mercury-containing products, aim to strengthen the regulation of mercury-containing products in China in line with the Minamata Convention.

List of Mercury-Added Products Prohibited in China

From December 31, 2025, China will prohibit the production, import, and export of the following mercury-added products:

1. Compact Fluorescent Lamps (≤30W, ≤5 mg mercury) 

2. Cold Cathode Fluorescent Lamps for displays, with mercury limits based on length 

3. Strain Gauges for volumetric devices 

4. Melt Pressure Sensors, with exceptions for certain uses 

5. Mercury Vacuum Pumps 

6. Tire Balancers and Wheel Weights 

7. Photographic Film and Paper 

8. Satellite and Spacecraft Propellants 

Restrictions on Dental Mercury

The regulations also extend to the use of dental mercury, prohibiting its use in children under 15 years of age, pregnant women and breastfeeding mothers, except when deemed medically necessary by a dental professional.

Background Information

These new measures are in line with China’s commitments under the Minamata Convention, which was ratified in 2016 and became effective in 2017. The Convention aims to comprehensively regulate the use, management and trade of mercury. It requires Parties to prohibit the production and trade of mercury-added products from 2020, with a ban on the mining of new primary mercury ores effective from August 16, 2017. By August 16, 2032, all primary mercury mining will be completely prohibited.

On June 28, 2024, the 14th National People's Congress Standing Committee approved an amendment to the Minamata Convention, further reinforcing China’s commitment to international environmental standards and public health protection.

For more information, please refer to: https://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/202410/t20241014_1089122.html

On 14 September 2024, China’s Ministry of Industry and Information Technology (MIIT) announced a consultation to revise the national standard on "Regulations on the Preparation of Chemical Safety La...

On 14 September 2024, China’s Ministry of Industry and Information Technology (MIIT) announced a consultation to revise the national standard on "Regulations on the Preparation of Chemical Safety Labels" to align with the ninth revised edition of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS 9). The Ministry released this announcement on the portal of the National Standards Administration and invited stakeholders to comment on it by 14 October 2024. 

After the official publication of the National Standard on the Provisions on the Preparation of Chemical Safety Labels, the National Technical Committee for Standardization of Hazardous Chemicals Management will work on its implementation. 

Insights of New Labelling Standard 

This new labelling standard will have the following revised information: 

• Alignment with the technical content of the ninth edition of the United Nations GHS, including hazard classification and precautionary statements. 

• Implementation of the "one enterprise, one product, one code" regulation to meet the needs of national safety supervision of hazardous chemicals. Additionally, the means of transmitting hazardous chemical hazard information needed to be strengthened, and the last mile of hazardous chemical hazard information transmission needed to be opened. 

Previous Update  

Previously China’s National Standards Administration revised the Provisions on the Preparation of Chemical Safety Labels in 2009. However, this 2009 version followed GHS 2 while the Ministry has now proposed to align with the provisions of GHS 9. 

Comment Period and Enforcement Date 

Stakeholders are invited to comment on this draft announcement till 14 October 2024. The Ministry has not yet officially announced the enforcement date of the same. 

In a move to strengthen the control over chemicals that can be misused in the production of illicit drugs, China has introduced new regulations that add seven substances to its regulated precursor che...

In a move to strengthen the control over chemicals that can be misused in the production of illicit drugs, China has introduced new regulations that add seven substances to its regulated precursor chemicals list. These substances, including n-phenylpiperidin-4-amine, norfentanyl, and cannabidiol, will be subject to strict oversight from 1 September 2024. The new regulations impact the production, transport, storage, and trade of these chemicals, requiring businesses to adopt tighter compliance measures to align with China's evolving chemical management laws.

Key Points

Overview of the New Substances Added

The seven newly regulated substances include key precursors often used in pharmaceutical and chemical production but with potential for illegal diversion into drug manufacturing. Some notable chemicals include:

• N-phenylpiperidin-4-amine (4-AP): Used in pharmaceutical synthesis, now controlled due to its role in fentanyl production.

• Norfentanyl: A metabolite of fentanyl and a precursor for synthetic opioids.

• Cannabidiol (CBD): Regulated to control non-pharmaceutical uses while allowing research and medical applications under strict supervision.

• Other substances include BMK glycidic acid esters and PMK glycidic acid esters, which are crucial precursors for synthetic drugs such as MDMA and methamphetamine​ (2-methyl-3-phenyl glycidylic acid and its esters, 3-oxo-2-phenybutyric acid and its esters, 2-methyl-3-[3,4-(methylenedioxy)phenyl]glycidyl] glycidyl)

• 1-tert-butoxycarbonyl-4-(N-phenylamino)piperidine which is a precursor to N-phenylpiperidin-4-amine 

Regulatory Framework and Requirements

The Ministry of Public Security, in cooperation with several other agencies, has categorized these substances as Category II precursor chemicals. The key compliance elements include:

• Licensing and Permits: Businesses must obtain licenses to produce, handle, and distribute these chemicals.

• Transportation and Storage: Special approvals are required to transport and store these chemicals to prevent unauthorized access.

• Import and Export Controls: Importers and exporters need to follow specific protocols, including declaring the intended use and obtaining prior approval from the relevant authorities​

Impact on Businesses

The addition of these chemicals to the regulated list creates significant compliance obligations for businesses involved in their manufacture, handling, or distribution. Key impacts include:

• Increased Compliance Costs: Businesses will need to invest in proper documentation, security systems, and monitoring technologies to comply with the new regulations.

• Supply Chain Disruption: Companies handling these substances will face stricter controls on the movement and storage of goods, potentially slowing down operations.

• Enhanced Scrutiny: Regulatory authorities are expected to impose stringent audits and inspections, requiring businesses to maintain comprehensive records of their activities related to these substances​

On 24 July 2024, GB 30000.1-2024 "Specification for Classification and Labelling of Chemicals—Part 1: General Rules" was officially published on the National Public Service Platform for Standards In...

On 24 July 2024, GB 30000.1-2024 "Specification for Classification and Labelling of Chemicals—Part 1: General Rules" was officially published on the National Public Service Platform for Standards Information. This updated standard, which aligns with the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8), will come into force on 1 August 2025 and will replace the existing GB 13690-2009 "General Rules for the Classification and Hazard Communication of Chemicals."

Draft Release and Public Consultation

On 12 March 2024, China's Ministry of Industry and Information Technology (MIIT) released a draft of the revised standard GB 30000.1. This update aims to align China's chemical classification and labelling standards with the UN's GHS 8. Public comments on this draft were invited until 12 April 2024.

Key updates to GB 30000.1

The revised GB 30000.1 introduces significant updates and new categories:

• Terminology and Definitions: Consistency with GHS 8 ensures clear, internationally recognized terminology.

• Hazard Classification: Adds a new category for desensitized explosives, bringing the total number of hazard classes in China to 29.

• Labeling Requirements: Special provisions are made for labeling, particularly for metals and alloys in non-dispersible forms. GHS labels must be used in workplaces, with alternative methods like area-specific labels allowed.

• Safety Data Sheets (SDS): Updated SDS requirements include detailed hazard communication guidelines and cut-off values for different hazard categories.

Exemptions

Certain products, such as pharmaceuticals, food additives, cosmetics, and pesticide residues in food intended for ingestion, are exempt from these labeling requirements unless workers are likely to be exposed during transport.

Implementation and Compliance

The revised GB 30000.1 will replace the existing GB 13690-2009 standard. Once adopted, it will better align China's chemical safety standards with international practices, improve hazard communication and ensure safer handling and transportation of chemicals within China and in international trade.

The adoption of GB 30000.1 is a significant step in enhancing chemical safety and regulatory compliance in China. By aligning with the UN GHS 8, China is demonstrating its commitment to global safety standards, facilitating smoother international trade and improving overall chemical safety management.

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On July 8, 2024, China’s National Institute for Food and Drug Control (NIFDC) released the "Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials". These...

On July 8, 2024, China’s National Institute for Food and Drug Control (NIFDC) released the "Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials". These guidelines aim to enhance regulatory oversight by ensuring that cosmetic products maintain their safety, effectiveness, and stability, and prevent adverse interactions with packaging materials. By evaluating compatibility, potential risks are identified and mitigated, preserving the quality and functionality of cosmetic products throughout their shelf life. This news highlights the key points, evaluation procedures, and results as outlined in the guidelines.

Key Indicators

• Extractables: These are substances present in packaging materials that can be extracted using solvents, such as additives, residual monomers and degradation products.

• Leachables: These are substances that migrate from packaging materials into cosmetics during migration tests or are generated during testing.

Evaluation Procedure

1. Preliminary Data Collection:

• Identify the packaging materials that come into direct contact with the cosmetics.

• Analyze the composition of these materials and understand the conditions under which they interact with the cosmetics.

• Review theproduction process of the cosmetic.

2. Extraction Test:

• Obtain information on extractables to predict potential leachables.

• Choose extraction solvents with properties similar to those of the cosmetic.

• Conduct extraction under conditions that mimic the cosmetic processing environment to extract as many substances as possible.

3. Interaction Study:

• Assess the migration or reaction of packaging components into cosmetics under accelerated and long-term stability test conditions to obtain information on leachables.

4. Evaluation Conclusion:

• Perform a safety assessment of the leachables.

• Determine if the packaging material is suitable for use with the cosmetic.

Critical Parameters/Indicators

1. Extraction Test:

• Solvent selection should consider compatibility with the cosmetic, focusing on pH, polarity and ionic strength.

• Extraction conditions should mimic the processing conditions of the cosmetic.

2. Migration Test: Determine key indicators based on the type of packaging material:

3. Adsorption Test: Conducted if necessary to further assess interaction.

Results

The results are based on the analysis of extractables and leachables obtained from the tests. The types and quantities of leachables are identified, and their safety is evaluated. If the leachables fall within the limits specified in the Cosmetic Safety Technical Specification, the packaging material is deemed suitable. For substances without specified limits, a safety risk assessment ensures that they do not cause harm to human health under normal conditions of use. Stability tests further support the evaluation of the interaction between the cosmetic and the packaging materials, ensuring that the quality and safety of the cosmetic is maintained.

This structured approach ensures comprehensive assessment and compliance with safety standards, safeguarding consumer health and maintaining product integrity.

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China has updated its Restriction of Hazardous Substances (RoHS) regulation by adding four new phthalates to the list of restricted substances. On June 29, 2024, the "Announcement on the Approval and...

China has updated its Restriction of Hazardous Substances (RoHS) regulation by adding four new phthalates to the list of restricted substances. On June 29, 2024, the "Announcement on the Approval and Release of 109 National Standards and 4 National Standard Amendments" (National Standard Announcement [2024] No. 14) was released. 

The move reflects China's commitment to environmental protection and is in line with global standards. The new restrictions will come into effect on January 1, 2026 

Newly Restricted Phthalates: 

The four new phthalates added to the restricted list are: 

1. DEHP (Bis(2-ethylhexyl) phthalate) 

2. BBP (Butyl benzyl phthalate) 

3. DBP (Dibutyl phthalate) 

4. DIBP (Diisobutyl phthalate) 

Each of these phthalates must not exceed a concentration limit of 0.1% in electronic information products (EIPs). 

Impact on Manufacturers  

Manufacturers and suppliers of Electrical and Electronic Products  must ensure compliance with these new restrictions in order to legally sell their products in China. Non-compliance may result in penalties and restricted market access. 

Steps to Compliance 

• Review Product Composition: Assess current product formulations to ensure that the concentration of the restricted phthalates is within the permissible limit. 

• Update Testing Protocols: Implement updated testing protocols to include the newly restricted substances. 

• Documentation and Reporting: Maintain appropriate documentation and reporting to demonstrate compliance. 

This update aligns China’s RoHS with global regulations (i.e. EU RoHS 2.0)  and improves the safety and environmental sustainability of electronic products. 

On July 8, 2024, China’s National Medical Products Administration (NMPA) announced the comprehensive implementation of electronic submission for cosmetics and new cosmetic ingredients, effective fro...

On July 8, 2024, China’s National Medical Products Administration (NMPA) announced the comprehensive implementation of electronic submission for cosmetics and new cosmetic ingredients, effective from September 1, 2024. This significant regulatory change, outlined in Announcement No. 91 of 2024, aims to enhance efficiency and facilitate the registration process for companies involved in the cosmetics industry.

Background

In accordance with the Cosmetics Supervision and Administration Regulation (CSAR) issued by the NMPA, China applies a registration management system for higher risk new cosmetic ingredients and a filing management system for other new cosmetic ingredients. New cosmetic ingredients are defined as natural or synthetic raw materials used in cosmetics for the first time in China. Registration entities can determine whether an ingredient is a new cosmetic ingredient by consulting the Inventory of Existing Cosmetic Ingredients in China (IECIC).

Key Points of the Announcement

1. Full Implementation of Electronic Submission:

Starting from September 1, 2024, all relevant entities, including registrants, filers, domestic responsible persons and manufacturing enterprises, must submit all documents electronically via the Cosmetics Registration and Filing Information Service Platform. Paper documents will no longer be accepted but must be archived by the relevant domestic entities for future reviews or inspections.

2. Submission of Original Documents:

Original documents, third party certification materials, and other required paper documents must be signed and confirmed for authenticity by the registrant, filer, or domestic responsible person before being submitted electronically through the Information Service Platform.

3. Procedural Adjustments:

The NMPA’s cosmetic technical institutions and provincial drug supervision departments will adjust their submission procedures to optimise the acceptance, technical review and management of registration and filing dossiers.

Recommendations for Enterprises

1. Apply for Certificate Authority Certificates Early:

Companies are advised to apply for Certificate Authority (CA) certificates in advance to facilitate online electronic signing. This preparation will allow efficient handling of multi-page documents with electronic signatures, thereby eliminating the need to print, sign and scan documents and significantly improving workflow efficiency

2. Organize and Archive Documents:

Companies must meticulously organise and archive all electronic documents in accordance with the new regulations. Given that these documents will be critical for future reviews or inspections, it is essential to ensure their completeness and accuracy.

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