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;

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.

Related Reports

Date Title
2022-05-16 China’s National Medical Products Administration answers FAQs about cosmetics management
2022-04-28 China announces program to enhance production safety of hazardous chemicals during 14th Five-Year Plan period
2D barcode-based product management system will be developed
2022-04-22 China drafting revised technical standards for cosmetics safety
Toluene would be added to the restricted material list
2022-04-22 Beijing revises mandatory VOC content limits for architectural coatings and adhesives
2022-04-22 China publishes mandatory national standard related to safety specifications in hazardous chemicals enterprises
2022-04-11 China announces 2022 plan for strengthening quality and safety inspection of hazardous chemicals
2022-03-29 China announces revision plans of RoHS regulations
2022-03-29 China begins public consultation for RoHS-related industry standard
“Measurement of seven phthalates used in electrical and electronic devices: High-performance liquid chromatography”
2022-03-29 China announces national emergency system development program for 14th Five-Year Plan
Stricter regulations on production safety and hazardous chemicals will be introduced
2022-03-22 China Expects to Add Four Phthalates to RoHS Controlled Substances
Revision to Related Standards by End-September 2022
2022-03-22 China’s MEE lists 18 chemicals on its “List of Existing Chemical Substances”
2022-03-20 China is Revising “Measures for the Management of Sudden Accident Emergency Response Plans”
2022-03-20 China’s Hebei and Jiangsu Provinces Announce Hazardous Chemicals Action Plans
Emphasizing Management with 2D Codes for Hazardous Chemicals
2022-03-20 China releases draft amendment of national standard “General requirements for safety of students’ articles”
Proposal for adding short chain chlorinated paraffin to regulated substances
2022-03-18 China investigates domestic usage status of PFHxS
2022-03-18 China Announces Repeal of “Measures for the Supervision and Administration of Imported Paint Inspection”
Notification of imported paints to be abolished
2022-03-10 Hunan, China releases the plan for implementation of “The Yangtze River Protection Law”
2022-02-23 China launches new hazardous chemical registration system supporting generation of 2D barcode for chemicals
2022-02-14 China clarifies how to declare components of hazardous mixtures transported in Port of Shanghai’s Waigaoqiao area
2022-02-14 China issues standards for quality management in cosmetics manufacturing
2022-02-04 China’s Ministry of Ecology and Environment released the “Guidelines for Screening of Priority Assessment Chemical Substances”
2022-01-19 China adds 11 chemicals to the Inventory of Existing Chemical Substances
2022-01-17 China released Inventory for Import Permit Management Goods
2022-01-17 China released draft “Regulations on the Management of Safety Information Codes for Hazardous Chemicals (Trial)”
2022-01-12 China releases draft guidelines for safety risk management in hazardous chemical production facility construction
2021-12-27 China to tighten regulations for heavy metals management
Limits on total discharges proposed for lead, mercury, cadmium, chromium, arsenic
2021-12-27 China plans to add 11 new substances to existing chemicals inventory
2021-12-20 China drafting restriction of VOC emission from electrical and electronic product
2021-12-10 China releases draft list of recommended HCFC alternatives
24 alternative chemicals to 3 HCFCs proposed
2021-12-01 China releases new list of ozone depleting substances regulated for international trade
HFCs have been included
2021-12-01 China adds 23 new substances to its inventory of existing chemicals
2021-11-19 China releases “Environmental protection comprehensive list (2021 version)”
Including VOC and PFOA related products
2021-11-09 Beijing drafting compulsory VOC limits for architecture coatings and adhesives
2021-11-08 China updates list of controlled ozone depleting substances
HFCs were newly added
2021-10-19 China publishes Regulations on Children’s Cosmetics
China’s first legal document on children’s cosmetics
2021-10-18 China releases draft plan for new chemical pollutants management
Regulations on PFOA, decaBDE, other hazardous substances
2021-10-13 China notifies WTO with the “Good manufacture practice for cosmetics (Draft)”
Regulations on setting up the position of quality and safety responsibility and the requirements of the workplace environment
2021-10-06 China publishes “Interim Measures for General Export Permit Management for Monitoring Chemicals”
2021-10-01 China publishes Ozone Depleting Substances list subject to import and export control (draft)
HFCs were added to the list
2021-09-21 China adds 6 substances to its catalog of precursor chemicals
2021-09-07 China releases draft guideline for consumer goods
To determine the maximum allowable content of chemical substances in consumer goods
2021-08-26 China notifies WTO of revised standards for limits on hazardous substances in furniture
Limits on VOCs, hazardous elements, etc. introduced
2021-08-24 China notifies WTO of revised national standards for limits on musical instrument hazardous substances
Recommended standards to become mandatory
2021-07-23 China adds 255 substances to chemicals inventory
2021-07-23 China to add 8 substances to chemicals inventory
2021-06-29 MEE of China comments on VOC materials storage rules
2021-06-25 China adds 6 substances to regulated precursor chemicals list
2021-06-25 China formally accepts Kigali Amendment
2021-06-23 China plans stricter rules for safety control of ammonium nitrate
2021-06-23 China to ban production and use of HBCD under Stockholm Convention
2021-06-18 China revises lists of banned cosmetic ingredients, adding 17 new items
2021-05-31 China adds 319 substances into List of existing chemical substances
2021-05-26 China drafts technical guideline for screening of priority chemical substances
2021-05-26 China announces FAQs related to registration of new chemical substances
2021-04-30 China drafts amendment for regulations on road transportation of dangerous goods
Comments invited until May 1, 2021
2021-04-26 China proposes to add 204 substances to Chemical Inventory
2021-03-31 Shanghai, China strengthens supervision of enterprises registered new chemical substance for environmental management
2021-03-27 Many paint products exceeding reviewed GB’s VOC content limits found by customs across China
2021-02-22 China’s Nanjing city imposes fines on companies illegally handling hazardous chemicals
2021-01-28 China publishes Measures for Administration of Cosmetics Registration and Notification
2021-01-19 China releases draft standards including methodology for determination of 10 halogenated hydrocarbons in gaseous refrigerants
2021-01-19 China releases Technical Guidelines on Health Hazard Assessment, etc. of Chemical Substances
2021-01-15 China issues announcement on inspection for imported and exported hazardous chemicals
2020-12-21 China announces 8 cases of chemical industry and hazardous chemical production safety accidents
2020-11-30 China releases revised guidance for new chemical registration
2020-11-27 China notified WTO a Standard- “Content Limitation of Mercury, Cadmium and Lead for Zinc Anode Primary Battery”
2020-11-24 China submitted WTO/TBT notifications on 3 compulsory national standards
2020-11-16 China released registration rules of new chemical substances
2020-11-10 China publishes second List of Priority Chemicals for Regulation, adding 18 chemicals including PFOA
2020-10-31 China released measures on hazardous chemical enterprises’ responsibility system for safety of major hazard sources (Trial)
2020-10-26 China released three Chemical Substance related Technical Guidelines (Trial) (Draft for Comments)
Including Technical Guideline for Environmental and Health Hazard Assessment of Chemical Substances and etc.
2020-10-22 China notified WTO a National Standard of the P.R.C.
The “Specification for the Limitation of Harmful Substances Found in Watch Casings Contacting Directly with Skin”
2020-10-12 China Released Hazardous Chemical Safety Law (Draft for Comments)
2020-09-26 China’s Dalian City releases third list of companies required to improve VOC management
74 companies on list including Japanese firms
2020-09-26 China announces revised safety requirements for school supplies with updated scope and stricter limits on toxic substances
2020-08-31 China’s Dalian City releases third list of companies required to improve VOC management, 74 companies on list including Japanese firms
2020-08-21 China announced “Guideline for Environmental Management and Registration of New Chemical Substances (Draft calling opinions)”
Clearly stipulates exempt substances and CBI application requirements
2020-06-26 China releases On-Site VOC Inspection Guidelines for Key Industries (Trial Implementation)

Index of China EHS

Framework of EHS laws and regulations in China.

Category Theme
Overall Overview, Environmental Standards
China, Organizations with Governing Environmental Regulations
Chemical Chemical Substances Regulation and Management
Waste Waste management
Energy Energy Conservation
Water Water Pollution Prevention
Air Air Pollution Control
Soil Soil Contamination Prevention
Other Pollution Noise, Vibration, Offensive Odor
OSH Occupational Safety and Health