- Chemical Substances Regulation and Management (This page)
1. Management of new chemicals
1.1 Current status of new chemical substance management in China
In China, new chemical substance management is pursued by “company’s own application and registration” based on the new chemical substance declaration registration guideline and catalog, including the “New Chemical Substance Environmental Management Law“. The Ministry of Ecology and Environment announces the status of companies’ application and registration of new chemical substances on its website as necessary. In the announcement, acceptance number, Chinese name of the chemical substance, applicant (company), application type, and management type will be disclosed.
In China, the Ministry of Ecology and Environment is primarily in charge of the total management of new chemical substances, and the Ministry of Ecology and Environment’s Solid Waste and Chemicals Management Technology Center is in charge of routine administrative activities such as receiving and processing documents submitted by the applicants.
In addition, physicochemical properties, toxicology tests, and ecotoxicology tests will be conducted according to the New Chemical Substance Environmental Management Law. At the moment, only 11 testing institutions have been approved by the Ministry of Ecology and Environment.
For the details, please refer to the following URLs;
- Eight testing institutions were certified by the Ministry of Ecology and Environment 2012 No. 77.
- Ministry of Ecology and Environment certified 3 testing institutions in the 5th public notice in 2015.
Recent major trends
Revised version of “New Chemical Substance Environmental Management Registration Law” was promulgated and enforced from January 1, 2021
The Ministry of Ecology and Environment promulgated the revised “New Chemical Substance Environmental Management Registration Law” in the Ministry of Ecology and Environment Ordinance No. 12 dated on April 29, 2020. The law will come into effect on January 1, 2021. At the same time, the current ” New Chemical Substance Environmental Management Law ” (promulgated on January 19, 2010, former Ministry of Environmental Protection Ordinance No. 7) will be abolished. Due to this amendment, if the annual production or import is 1 ton or more and less than 10 tons, the current normal registration will be changed to simple registration; and in the cases of the mixture or low-concern polymer with its annual production or import of less than 1 ton and low content of 2% or less, the registration procedure will be simplified due to the change from the current simple registration to just submitting an application form.
“China Existing Chemical Substances List“: as of the end of November 2019, totally 45,716 types of chemical substances are recorded, and chemical substances are further being added one after another.
(1) March 10, 2016; 31 types of substances were added
(2) November 22, 2018: 45 types of substances were added
45 kinds of substances have been added to the existing chemical substance list by the supplementary announcement of “China Existing Chemical Substance List” dated November 22, 2018. These 45 types include 2 types registered based on the ” New Chemical Substance Environmental Management Law ” (Environmental Protection Department Ordinance No. 7) and 43 types registered based on the ” New Chemical Substance Environmental Management Law” (National Environmental Protection Bureau Ordinance No. 17) . Registration is no longer required for the chemicals already listed in the “China Existing Chemicals Substances List”.
1.2 Framework of laws and regulations related to chemical substance management
In China, new chemical substance management is implemented based on the “New Chemical Substance Environmental Management Law”. Based on the law, “New Chemical Substance Declaration Registration Guidelines (Guidelines)” and “China Existing Chemical Substances List” have been formulated. A legal framework for these laws is very simple.
- Revised “New Chemical Substance Environmental Management Registration Law”( April 29, 2020)
- New Chemical Substance Declaration Registration Guidelines (Guidelines)
- China Existing Chemical Substances List(newly issued in 2018)
2. Hazardous chemicals management
2.1 Current status of dangerous chemicals management in China
In China, the “Dangerous Chemicals Safety Management Ordinance” is recognized as a higher-level law regarding the management of dangerous chemicals. Based on this ordinance, many laws such as “Dangerous Chemicals Registration Control Law”, “Chemicals Physical Hazard Appraisal and Classification Control Law” and “Dangerous Chemicals Management License Control Law” as well as “Dangerous Chemicals List” and the related national standards (GB), have been enacted.
In addition, various administrative agencies, including the Emergency Management Department (former Directorate General of Safety Production Supervision and Management), have jurisdiction over dangerous chemicals within their respective responsibilities.
However, the current legal frame work for safety management of dangerous chemicals is enormous and complicated. However, since there have been introduced no high-dimensional laws yet, nine relatively serious accidents related to dangerous chemicals and the chemical industry have occurred since 2014. According to the information released at the “China National Hazardous Chemicals and Fireworks Safety Supervision and Control Work Video Conference” held in February 2017 by the former General Administration of Safety Production Supervision and Management, in 2016, as a total 12 relatively large accidents associated with dangerous chemicals happened throughout China, and41 people were killed.
Accordingly, Chinese government has recognized that it is necessary to establish a supervisory management system covering the entire life cycle of dangerous chemicals (production, import, use, storage, disposal, etc.) and to show the legal framework more firmly.
2.2 Legal and regulatory framework related to dangerous chemicals management
In China, as the main laws related to dangerous chemicals management, the “Safe Production Law” and the “Import / Export Commodity Inspection Law” can be mentioned; however, in fact, the “Dangerous Chemicals Safety Management Ordinance” involves individual stages such as manufacturing, import, sale, storage, transportation and use of dangerous chemicals, To this end, this Ordinance is recognized as a superordinate law in the management of hazardous chemicals as an important regulation for the management of hazardous chemicals. Based on this Ordinance, many laws such as “Dangerous Chemicals Registration Control Law”, “Chemicals Physical Hazard Appraisal and Classification Control Law”, “Dangerous Chemicals Management License Control Law”, and “Dangerous Chemicals List” and many related national standards (GB) have been enacted.