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 This regulation came into force on 1 January 2021 and the previous regulation (MEP Order No.7) was simultaneously repealed.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.
Nov-13-2024
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
Oct-02-2024
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.
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