The main legislations governing the chemical market in China is Order No. 12 of the Ministry of Ecology and Environment (MEE), Measures for the Environmental Management Registration of New Chemical Substances, also known as MEE Order No.12. This regulation came into force on 1 January 2021 and the previous regulation (MEP Order No.7) was simultaneously repealed.
Anyone who wants to research, produce, import, or process new chemical substances in China has to register before carrying out their activities. They are:
Chinese manufacturers and importers can register the chemical substances themselves. Overseas enterprises, however, must appoint a Chinese agent (Only Representative (OR)) who will share the legal responsibility with them to fulfil the registration and post-registration obligations. The OR should be acknowledgeable and qualified to carry out the registration activities.
Dec-12-2024
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.
Dec-11-2024
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.
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