China Regulatory News

The Standing Committee of the 14th National People's Congress (NPC) has reviewed the draft Hazardous Chemicals Safety Law of the People's Republic of China. To encourage public participation in the le...

The Standing Committee of the 14th National People's Congress (NPC) has reviewed the draft Hazardous Chemicals Safety Law of the People's Republic of China. To encourage public participation in the legislative process, a public consultation on the draft law was launched on December 26, 2024.

The Draft Hazardous Chemicals Safety Law establishes a comprehensive regulatory framework covering the planning and design of hazardous chemicals, as well as safety in production, storage, use, business operations, and transportation. It also outlines registration requirements for hazardous chemicals, emergency response measures, and legal responsibilities.

Key Provisions of the Draft Law

• Mandatory Training: Employees in hazardous chemical units must undergo education and training and pass an assessment before starting work.

• Lifecycle Management: Hazardous chemicals must be electronically tracked and monitored electronically throughout their lifecycle using identification and information management systems.

• Safety Data Sheets (SDS) & Labeling: Manufacturers and importers of hazardous chemicals are required to provide SDS and labels for their products, with penalties for non-compliance.

• Exemptions for R&D and Small-Scale Use: Hazardous chemicals in small low quantities, minimal release, and limited exposure during research, trial production, and market trials are exempt from registration.

• Prohibited Activities: No entity or individual may carry out activities involving chemicals whose hazardous properties have not been determined.

Public Consultation and Feedback

The draft law is available for public review on the NPC official website and the National Database of Laws and Regulations. The public can submit feedback online or by mail to the Legislative Affairs Commission of the NPC Standing Committee at No. 1 Qianmen West Street, Xicheng District, Beijing, 100805. Submissions should be clearly marked as relating to the “Draft Hazardous Chemicals Safety Law Consultation.”

The consultation period will last 30 days, offering stakeholders across industries, regulatory bodies, and the general public an opportunity to shape the future of hazardous chemical safety regulation in China.

For official details and to submit feedback, please visit the NPC official website.

On November 28, 2024, China’s State Administration for Market Regulation published GB/T 45091-2024, a national standard outlining restricted substances in recycled plastics. Effective from June 1, 2...

On November 28, 2024, China’s State Administration for Market Regulation published GB/T 45091-2024, a national standard outlining restricted substances in recycled plastics. Effective from June 1, 2025, the standard provides guidelines for classification, requirements, and testing to ensure material safety.

Development and Scope

The standard, titled "Plastics – Requirements for Restricted Substances in Recycled Plastics," was developed by the Plastic Recycling Branch of the China Synthetic Resin Association (CPRRA).  The drafting process progressed rapidly from its initiation in April 2024 with a public consultation on the draft completed by August 2024.

The standard covers recycled plastic pellets and finished products made from waste plastics through processes such as screening, sorting, crushing, washing, and extrusion or modification. It also covers recycled polyethylene terephthalate (PET) bottle flakes. However, it excludes recycled plastics derived from hazardous waste sources such as medical waste, pesticide packaging, and radioactive materials, as well as recycled plastics intended for food contact or pharmaceutical packaging applications.

Key Provisions

The standard defines "restricted substances" as materials that are prohibited or restricted by law, regulation, or standard in recycled plastics . These substances are not necessarily classified as hazardous or harmful chemicals, but are restricted to ensure the safety, environmental sustainability, and performance of recycled plastics.

Restricted substances are divided into two categories:

1. Voluntarily Declared Substances:

   • Manufacturers or importers are required to declare that recycled plastics, whether domestically produced or imported, do not contain certain restricted substances.

2. Regulated Substances with Specific Limits:

   • The standard mandates monitoring and adherence to specific limits for substances classified as restricted under regulatory oversight.

For more details, visit the National Public Service Platform here.

On December 13, 2024, China’s Department of Food Safety Standards and Risk Monitoring and Assessment announced that two substances, have passed the safety assessment for use in food contact material...

On December 13, 2024, China’s Department of Food Safety Standards and Risk Monitoring and Assessment announced that two substances, have passed the safety assessment for use in food contact materials (FCMs) as new varieties. The safety evaluation was conducted by an expert review organized by the relevant regulatory body in accordance with the requirements of the Food Safety Law of the People's Republic of China.

Background Information

Under China’s Food Safety Law, any substance intended for use in food contact materials and articles must undergo a rigorous safety evaluation before approval. This ensures that materials meet strict standards for safety and suitability for contact with food.

Newly Approved Substances

The safety evaluations resulted in the approval of the following two substances:

1. 1,3,5-Trimethyl-2,4,6-Tris(3,5-Di-tert-butyl-4-hydroxybenzyl)benzene (CAS No 1709-70-2): Approved as an additive for use in carbon monoxide-ethylene-propylene terpolymer plastic materials and products.

2. Poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) (CAS No 147398-31-0): Approved for use in polyhydroxyalkanoate (PHA) plastic materials and products intended to come into contact with food. However, its use is subject to the following conditions:

• It cannot be used in applications where the temperature exceeds 100°C.

• It must not be used in the manufacture of food contact materials and products intended for infants.

• The material must comply with GB 4806.6-2016, China's national food safety standard.

For further information, please refer to the complete announcement and attached documentation here.

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.