The widespread use of chemicals has brought great convenience to human beings. At the same time, the accidents caused by the transportation, storage, use, and
disposal of them and the risks to people's lives cannot be ignored. In recent years, China's chemical safety and environmental management have become increasingly
strict. In 2019, some chemicals-related laws and regulations have been formulated and updated in order to gradually realize the scientific management of chemicals
throughout the process.
1. January 2019: Regulations on Environmental Risk Assessment and Control of Chemical Substances (Draft for Soliciting Opinions)
On January 8, 2019, Ministry of Ecology and Environment released the Notice on Publicly Soliciting Opinions on the " Regulations on Environmental Risk Assessment
and Control of Chemical Substances (Draft for Solicitation of Comments)". On September 2, 2019, China formally notified the WTO of " Regulations on Environmental
Risk Assessment and Control of Chemical Substances (hereinafter referred to as the "Regulations"). This is the first legal system that incorporates all chemical substances
manufactured, processed, or imported into a unified environmental risk assessment and control regulation in China. This regulation aims to protect the environment and
public health by assessing the environmental risks of chemical substances and mixtures, implementing environmental risk management activities.
CNCIC sorted out the draft regulations and summarized four points:
1) Enhancing the main responsibility of enterprises
Articles 39 to 47 in Chapter V of the Regulations clear the legal responsibilities, including illegal activities constituted by production and operation activities of production,
process, use, and import and export enterprises, such as suspend production and rectify, suspend or close business, joint punishment for dishonesty according to law,
or take criminal responsibility.
2) Environmental risk assessment of existing chemicals
Through environmental risk screening, chemicals that are persistent, bioaccumulative, harmful to the ecology or human health, or with potentially exposure risks will be
priority assessed. Substances shall be included in the list of priority environmental management chemicals if there are unreasonable risks or the risks cannot be proved
to be within a reasonable range after the assessment.
3) Existing chemical substance environmental risk management and control
Environmental risk control measures such as environmental emissions control should be taken according to the environmental risk of chemical substances included
in the list of priority environmental management chemical substances.
4) Environmental management registration and environmental risk control of new chemical substances
Units that produce or import new chemical substances should register or record to the department of ecological environment of the State Council before production
or import. The production, import and processing of new chemical substances without a registration certificate or record are prohibited.
2. January 11, 2019: Announcement on Supplementing the "Inventory of Existing Chemical Substances in China"(IECSC)
28 kinds of new registered chemical substances that meet the requirements to IECSC are listed and managed according to existing chemical substances. These
include 19 substances registered under MEP Order No. 17 and 9 substances registered under MEP Order No. 7.
3. March 11, 2019: Announcement on Prohibition of Production, Circulation, Use and Import and Export of Persistent Organic Pollutants such as Lindane
1) From March 26, 2019, the production, circulation, use, and import and export of lindane and endosulfan are prohibited.
2) From March 26, 2019, the production, distribution, use, import and export of PFOS and its salts and Perfluorooctylsulfonyl fluoride are prohibited except acceptable
3) Eco-environment, development and reform, industry and information technology, agriculture and rural areas, commerce, health, emergency management, customs,
market supervision and other departments at all levels shall strengthen the supervision and management of production, distribution, use and import and export of the
above-mentioned persistent organic pollutants in accordance with the relevant national laws and regulations.
Any violate to the announcement, will be taken serious investigation and punishment.
4. June 21, 2019: Notice on supplementing and improving the "Inventory of Existing Chemical Substances in China"
Scope of supplement: Chemical substances that have been legally produced or imported in the territory of the People's Republic of China before October 15, 2003
and are not included in the IECSC, except for the substances exempted from the MEP Order No.7.
Supplement progress: More than 1,560 substances were applied for adding to the IECSC by 330 companies till end of 2019, but there are problems such as
irregular substance identification information and incomplete certification documents. The review process is still ongoing. On March 9, 2020, the first batch of 168
chemical substances has been public on the MEE website. The remaining substances are still under review.
Enterprises can continue to submit applications if they have conclusive evidence, but they cannot be reviewed immediately.
5. July 9, 2019: Notice of Public Solicitation of "Measures for Environmental Management of New Chemical Substances (Revised Draft for Solicitation of Comments)"
Since the "Environmental Management Measures for New Chemical Substances" (SEPA Order No. 17) came into effect on October 15, 2003, it has been revised
and implemented as "New Chemical Substances Environmental Management Measures" (MEP Order No. 7, Hereinafter referred to as the " MEP Order 7") in 2010.
With the new problems and situations discovered during the implementation of "MEP Order 7", the Ministry of Ecology and Environment has publicly solicited opinions
on the "Measures for Environmental Management of New Chemical Substances (Revised Draft)" after nearly 9 years.
This revision of the " MEP Order 7" mainly follows the two principles of "simplification of administration and decentralization" and "problem-oriented". Under the premise
of ensuring that environmental risks are controllable, it optimizes the types of registrations, reduces the requirements for registration data, and optimizes post-registration
management; further highlighting management key points, centrally control new chemical substances with high environmental risks, and to compact the main responsibility
The main amendments are to optimize the application types and data submission requirements without reducing the environmental risk control requirements:
a. For the purpose of research, the original record filling is no longer required when the annual production or import volume is less than 100kg;
b. The original simplified notification is adjusted to the record, and the notifier can start activities after submitting the complete record materials;
c. Level 1 of the original regular notification was adjusted to simplified registration, reducing the registration data requirements, and only submitting a few test data
or information related to environmental hazards; PBT chemicals and with accumulative environmental risks cannot be registered.
d. The data requirements for general registration are no longer simply set on the tonnage magnitude, but focus on environmental risk assessment and management
and control requirements instead, and comprehensively consider the hazards and exposures to put forward data requirements. Long-term chronic toxicity and other
test reports or data are required for new chemical substances that are persistent or bioaccumulate and with exposure routes.
The amendment of the "MEP Order 7" deletes each activity report and five-year activity report. Only chemical substances with the environmental management
requirements on registration certificate are required to submit annual reports. The retrospective evaluation is cancelled for the application of adding into IECSC.
New chemicals will be announced for inclusion in the IECSC after five-year period from the date of the first activity by MEE. The revision of MEP Order 7 has
strengthened the main responsibility of enterprises for controlling environmental risks of new chemical substances and the pertinence of environmental risk control
of new chemical substances. The new chemical substance supervision methods and priorities were clarified. The national and local ecological environment authorities
should conduct random inspections on new chemical substance activities, and focus on random inspections to check whether new chemical substances are registered
or the authenticity of records and registration, the implementation of the items recorded in the registration certificate and other relevant provisions of these measures.
The frequency of inspections should be increased for enterprises that have found more problems, and the report information related to new chemical substances should
be promptly organized for verification and processing.
6. On February 17, 2020, Minister Ganjie Li of MEE presided over a department meeting to review and adopt in principle the revised "Measures for Environmental Management and Registration of New Chemical Substances" and other documents.
It is expected to be announced and implemented soon. Companies concerned with new chemicals production, import or processing stay tuned.
7. September 3, 2019: Notice on Printing and Distributing the Framework Guidelines for Environmental Risk Assessment Methods for Chemical Substances (Trial)
In order to strengthen the environmental management of chemical substances, establish and improve a technical method system for environmental risk assessment of
chemical substances, and standardize and guide the environmental risk assessment of chemical substances, the Ministry of Ecology and Environment and the National
Health Committee have compiled the "Framework Guidelines for Environmental Risk Assessment Methods for Chemical Substances ( Trial).
Scope of application: Applicable to environmental risk assessment of different exposure routes during the normal production and use of a single chemical substance,
not applicable to risk assessment in the case of accidental leakage.
Main content: It specifies the basic framework of chemical substance risk assessment, and clarifies the basic points, technical requirements and report preparation
requirements of environmental risk assessment of chemical substances. The "Framework Guideline" also specifies the key points of uncertainty analysis, data quality
assessment, and spatial scale of exposure assessment in the risk assessment; it also highlights factors that need to be considered in risk assessment, such as PBT
and vPvB chemicals.
8. November 19, 2019: The Ministry of Ecology and Environment made an announcement and issued a penalty notice for three enterprises in Shandong and Jiangsu that produce new chemical substances without obtaining registration certificates.
According to the draft "Regulations on the Environmental Risk Assessment and Control of Chemical Substances" submitted to WTO and the revised draft of the
"Measures on the Environmental Management and Registration of New Chemical Substances", the descriptions on penalties for illegal enterprises show that authority
has strengthened the supervision and crackdown on illegal behavior in environmental management of chemical substances, increased punishment for unreported
behavior of the new chemicals. Companies will bear more and more serous punishments for non-compliant production or import.
9. January 3, 2020: Announcement on Supplementing the "Inventory of Existing Chemical Substances in China"
Announcement content: 18 new chemical substances registered under the “Administrative Measures for Environmental Management of New Chemical Substances”
(SEPA Order No. 17) and 29 new substances registered under the MEP Order No. 7 are listed in the "Inventory of Existing Chemical Substances in China" and are
managed as existing chemical substances.
Note: This supplement is still for new substances been registered and have been five years from the first activity. After the application materials are submitted, new
chemicals are passed the review and listed on the list. This has been the fourth supplement to IECSC from March 2016 till Jan 2020.