China Regulatory News

On November 4, 2024, China's State Administration for Market Regulation issued a notification entitled 'General safety technical standards for oral care product'. The proposed standards ai...

On November 4, 2024, China's State Administration for Market Regulation issued a notification entitled 'General safety technical standards for oral care product'. The proposed standards aim to prohibit deceptive activities, protect consumers, maintain human health and safety, and meet quality standards in the oral care sector.

About the notification

The draft defines the terms and definitions, requirements, test methods, inspection rules, decision rules, marking, shipping, and storage of oral care and cleansing products.
It also covers oral care and cleansing products such as toothpaste, tooth powder, oral rinses, tooth strips, tooth whitening gel, denture cleaner, and other daily products used on human teeth, oral mucosa, or dentures.

Comment Deadline

The draft standard was notified to the World Trade Organization (WTO) under document number G/TBT/N/CHN/1938 and the notification is open for public comments until January 3, 2025 via the WTO platform. Once approved, the standard will come into the force after 12 months.

China’s Ministry of Ecology and Environment (MEE) has recently updated the Inventory of Existing Chemical Substances in China (IECSC) by adding 36 new chemical substances. The announcement, made on ...

China’s Ministry of Ecology and Environment (MEE) has recently updated the Inventory of Existing Chemical Substances in China (IECSC) by adding 36 new chemical substances. The announcement, made on November 25, 2024, underscores China’s efforts to strengthen the oversight of chemical substances and mitigate environmental risks.

Inclusion of 30 Registered New Chemical Substances

In line with the "Measures for Environmental Management Registration of New Chemical Substances" (MEE Order No. 12) and related guidelines, the MEE has included 30 registered new chemical substances in the IECSC. These substances, now managed as existing chemical substances, include various compounds such as alkenyl oxy alkyl carbamates and alkyl diisocyanates. In particular, certain substances are subject to New Use Environmental Management requirements, which ensures environmental assessments for all new uses.

Six Additional Chemical Substances Added

In addition to the 30 registered substances, six additional chemical substances have been added to the IECSC following a public consultation process. This inclusion is in accordance with the "Guidelines for Environmental Management Registration of New Chemical Substances". Examples of newly listed substances include calcium tungstate and ammonium vanadium oxide.

Implications for Environmental Management

The expansion of the IECSC highlights China's proactive approach to chemical safety and environmental protection. By adding these substances to the national inventory, the MEE ensures that their production, import and use are effectively regulated, in line with international standards and ecological health is protected.

For detailed information on the listed substances and their management requirements, stakeholders are encouraged to consult the official announcements on the MEE website here and here.

On November 4, 2024, the China National Medical Products Administration (NMPA) approved a new cosmetic ingredient, isobutylamido thiazolyl resorcinol (CAS No 1428450-95-6), submitted by Beiersdorf AG,...

On November 4, 2024, the China National Medical Products Administration (NMPA) approved a new cosmetic ingredient, isobutylamido thiazolyl resorcinol (CAS No 1428450-95-6), submitted by Beiersdorf AG, Germany. This ingredient is chemically synthesized and has been tested for safety and efficacy. It can be used as a whitening agent in leave-on cosmetics, except in products that may cause inhalation exposure. This approval offers a new option for the development of whitening cosmetics in China. 

China’s Cosmetic Regulatory Framework for New Ingredients

Under China's cosmetic regulatory framework, all cosmetics sold in the country must use ingredients listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC). Ingredients outside the IECIC are classified as new cosmetic ingredients. To promote innovation, the Cosmetics Supervision and Administration Regulation (CSAR), implemented in 2021, replaced the previous approval system with a dual-track system of registration and notification based on the risk level of the ingredient. 

New cosmetic ingredients with functions such as preservation, sun protection, coloring, hair dyeing or whitening must undergo a registration process. Other new ingredients are subject to notification. In all cases, new cosmetic ingredients must be registered or notified with the NMPA before being used in cosmetic products. 

Encouraging Innovation in Whitening Products

The approval of isobutylamido thiazolyl resorcinol demonstrates China's commitment to promoting innovation in the cosmetics industry while ensuring consumer safety. It is a significant step forward in expanding the options available for the development of spot removal and whitening products in compliance with China's stringent regulatory standards. 

For more information, please refer to the official announcement here.

On 17 October 2024, China notified the World Trade Organization (WTO) of its proposed Provisions for Cosmetics Safety Risks Monitoring (G/TBT/N/CHN/1931). This nine-page draft, issued by the National ...

On 17 October 2024, China notified the World Trade Organization (WTO) of its proposed Provisions for Cosmetics Safety Risks Monitoring (G/TBT/N/CHN/1931). This nine-page draft, issued by the National Medical Products Administration (NMPA), outlines measures to improve cosmetics safety monitoring, promote industry development and safeguard consumer health.

The draft aims to establish robust mechanisms to identify and mitigate risks associated with cosmetics and to ensure the safety and quality of products on the market.

Scope and Objectives of the Draft

• Main Focus: The proposed provisions apply nationwide to departments responsible for the regulation of cosmetics. These regulations focus on the monitoring of risk factors affecting the safety of cosmetics through inspection, testing and analysis.

• Main Objectives:

  • To identify potential risks in cosmetics.

  • Provide scientific support for the development of risk control measures and safety standards.

  • Enhance safety communication and implement risk alerts.

The draft also emphasizes the monitoring substances harmful to human health, including those likely to affect vulnerable populations such as children.

Implementation Framework and Responsibilities

• National and Local Oversight:

  • The NMPA will lead national monitoring efforts and develop a centralized information system for risk analysis.

  • Provincial, municipal and county-level authorities will organize localized monitoring and contribute to national initiatives.

• Sampling and Inspections:

  • Authorities will conduct targeted sampling based on risk levels, focusing on high-risk products and problem locations.

  • Samples will be analysed in accredited laboratories under strict quality assurance protocols.

The draft mandates confidentiality for monitoring data and sets out procedures for dealing with abnormalities, including unregistered or mislabelled products.

Risk Evaluation and Regulatory Actions

• Follow-Up Measures:

  • Risk monitoring results will guide the development of new safety standards and the revision of to existing ones.

  • Problematic samples may lead to investigations, risk control measures, or communication campaigns to raise consumer awareness.

Authorities are encouraged to use innovative methods to monitor unexplored risks and to improve testing protocols for high-risk substances for which there are no standardized methods.

Consultation and Next Steps

• Public Feedback Period: Stakeholders have 60 days from the date of notification to comment on the draft rules.

• Further Information: Interested parties can access the full draft here and submit feedback through the WTO/TBT National Notification and Enquiry Centre of China.

These draft provisions represent a significant step in ensuring the safety and quality of cosmetics in China, and underscore the government's commitment to consumer protection and industry development.

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​