China Regulatory News

The Ministry of Industry and Information Technology (MIIT) has announced a public consultation on eight mandatory national standards, including “Requirements for Restricted Use of Hazardous Substanc...

The Ministry of Industry and Information Technology (MIIT) has announced a public consultation on eight mandatory national standards, including “Requirements for Restricted Use of Hazardous Substances in Electrical and Electronic Products”, a key technical standard supporting the China RoHS 2 regulatory framework. China RoHS 2, implemented in July 2016, restricts the use of hazardous substances in electrical and electronic products to reduce environmental and health risks, similar to the EU RoHS 2 Directive. The draft standard is consistent with these principles, including restrictions on substances such as lead, mercury and newly added phthalates.

The consultation opened on 19 November 2024 and will close on 18 January 2025. Stakeholders are invited to provide feedback by emailing to KJBZ@miit.gov.cn.

The draft standards aim to improve safety, align with global regulations, and reduce environmental and health risks from hazardous substances. The finalstandards are expected to take effect 12 months after publication.

Key Focus: Expanded Restrictions on Phthalates in Electrical and Electronic Products

The new draft standard updates and integrates two existing standards:

• GB/T 26572-2011: Requirements on Concentration Limits for Certain Hazardous Substances in Electrical and Electronic Products.

• SJ/T 11364-2014: Marking for the Restricted Use of Hazardous Substances in Electrical and Electronic Products.

A significant update is the addition of four new phthalates to the list of restricted substances:

• DBP: Dibutyl phthalate (CAS No 84-74-2)

• DIBP: Diisobutyl phthalate (CAS No 84-69-5)

• BBP: Butyl benzyl phthalate (CAS No 85-68-7)

• DEHP: Di(2-ethylhexyl) phthalate (CAS No 117-81-7)

These phthalates are widely used as plasticizers in electrical and electronic products, but are associated with environmental and health risks, including endocrine disruption. The draft standard aligns their restriction limits with the EU RoHS Directive, setting maximum concentrations of ≤1000 mg/kg for each.

Highlights of the Draft Standard

• Expanded Scope: Covers the manufacture, sale and import of electrical and electronic products in China.

• Updated Limits for Hazardous Substances: Expands the number of restricted substances from 6 to 10, ensuring compliance with global standards.

• New Labeling Options: Introduces QR codes and digital formats for hazard information, reducing compliance costs.

• Conformity Documentation: Requires test reports for high-risk components to improve the reliability of compliance declarations.

Development Process and Industry Collaboration

The standard was developed by the China Electronics Standardization Institute, in collaboration with manufacturers, industry associations, and research institutions. Key steps in its development include

• Research on phthalate restrictions in global RoHS regulations.

• Industry surveys showing that over 90% of products already meet the proposed phthalate limits, ensuring feasibility.

• Collaboration with international standards such as IEC 62321 for test methods.

The one-year transition period after publication will allow industry to adapt to the stricter requirements.

Implementation and Future Impact

Once in effect, this standard will replace

• GB/T 26572-2011: Previously defined limits for hazardous substances.

• SJ/T 11364-2014: Covered marking requirements for restricted substances.

The inclusion of phthalates reflects China’s commitment to stricter environmental controls and is in line with global practices. This update will significantly reduce the risks associated with these substances, promote green production, and support the goals of the 14th Five-Year Plan for Industrial Green Development.

The revised standard will improve compliance, simplify regulatory oversight, and position China as a leader in sustainable electronic product manufacturing.

Other Standards under Consultation

In addition to the RoHS 2-related standard, the consultation includes revisions to standards on:

• Limits of Hazardous Metal Elements Leachable from Wall Materials: Defines content limits and test methods for hazardous metals in wall materials used in industrial and residential buildings.

• Limits of Hazardous Elements in Graphite and Fluorite: Establishes limits for hazardous elements in graphite and fluorite materials.

• Limits for Heavy Metals in Ink: Establishes maximum allowable concentrations for heavy metals, including lead, cadmium, and mercury, in ink products.

• Limits of Hazardous Metal Elements Leachable from Wall Materials: Establishes content limits and test methods for hazardous metals in wall materials used in industrial and residential buildings.

These updates reflect China's commitment to modernizing safety, environmental, and technical regulations across multiple sectors.

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.