On April 29, 2020, the Ministry of Ecology and Environment of China (MEE) promulgated the Measures on Environmental Management Registration of New Chemical Substances (MEE Order 12) (link in Chinese), which will come into effect Jan. 1, 2021, and replace the Measures for the Environmental Management of New Chemical Substances (promulgated by the Ministry of Environment Protection of China, MEP Order 7). MEE Order 12 focuses on mass-use of new chemicals, and highly hazardous chemicals, chemicals with persistence and bioaccumulation (PB), chemicals with persistence and toxicity (PT), and chemicals with bioaccumulation and toxicity (BT).
Background: MEE the ‘China REACH
MEE is sometimes also called the ‘China REACH’ for short. ‘China REACH’ references the EU Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. Both the Chinese and EU legislation aim to improve human health and the environment through the identification of chemical substances. Both pieces of legislation make distinctions in their application depending on annual tonnage and may restrict the usage of highly hazardous chemicals. The main difference between MEE and the EU REACH is that EU REACH focuses on the chemical registration requirement whereas MEE focuses on new substance notification.
1. Scope of Application of MEE Order 12
Under MEE Order 12, any entity involved in research, production, importation and processing of new chemicals in China (except for areas under special customs regulation, such as a bonded area) shall obtain filing or registration of such new chemicals prior to production or importation. New chemicals refer to chemicals not yet included in the Inventory of Existing Chemical Substances in China (IECSC). “New chemicals” do not include medicine, pesticide, veterinary medicine, cosmetics, food, food additives, fodder, fodder additives and fertilizers, except when they are used for other industrial usage.
When applying for filing or registration, the applicant may also apply for trade secret protection on information related to the new chemicals. MEE Order 12 provides the longest protection term – five years from the date of filing or registration.
2. Simplified Classification of Chemical Registration Types
Compared with MEP Order 7, MEE Order 12 entails a more simplified filing and registration process for new chemicals. The application types mainly depend on the annual tonnage of the chemicals. See the table below comparing MEP Order 7 and MEE Order 12.
3. Being Listed in the Inventory of Existing Chemical Substances in China
According to MEE Order 12, five years after a new chemical has obtained regular registration, it will be automatically added by MEE to IECSC. Under MEP Order 7, a new hazardous chemical would not be included in IECSC unless (1) the holder of the registration of such new hazardous chemical submits the record of use of such chemical since its first activity; and (2) a retroactive evaluation has been conducted on such new hazardous chemical. MEE Order 12 cancels these two conditions; as such, a new hazardous chemical will also be added to IECSC after five years of regular registration but may be further subject to its restricted usage, as mentioned below.
New chemicals subject to filing or simplified registration will not be listed in IECSC. Being listed in IECSC means the use of such chemical in China is in principle not subject to the regulation of MEE Order 12 (i.e., no registration or filing under MEE Order 12 is required), and only ordinary environmental regulation applies to it.
However, as to highly hazardous chemicals, PB, PT and BT, their restricted usage will be recorded in IECSC, and regulation on new usage applies. Under MEE Order 12, if the holder of the registration of a highly hazardous chemical proposes to change the usage of such chemical, or any other entity proposes to use it for any usage, a new usage registration under MEE Order 12 must be obtained; if any entity proposes to use a registered PB, PT or BT chemical for a new usage, a new usage registration under MEE Order 12 must also be obtained. Failure to obtain such new usage registration may lead to a fine of RMB 10,000 to RMB 30,000, and in serious cases, a responsible entity will be subject to joint disciplinary measures by which a variety of government departments may deny its application for certain licenses, and all application of registration of new chemicals of such entity will not be reviewed within one year.
Before utilizing a chemical, a chemical enterprise should check the IECSC to determine (i) if the chemical such enterprise proposes to use is listed in the IECSC and (ii) if the chemical is classified as a highly hazardous chemical, or PB, PT or BT, and only restricted usage of the chemical is recorded in IECSC.
Annex: Comparison between MEP Order 7 and MEE Order 12
|MEP Order 7||MEE Order 12|
|Types of Application||Scope of Application||Time for the Procedure||Types of Application||Scope of Application||Time for the Procedure|
|Filing for Scientific Research||
1. For scientific research, annual production or import is less than 0.1 ton;
2. Test samples imported for the test of eco-toxicological properties in China
|MEP will issue a filing notice, but the applicants may utilize the new chemicals once the filing materials are submitted.||Filing||
1. Annual production or import is less than 1 ton; or
2. The polymer in which the content of monomer or reactant of new chemical substances is no more than 2% or low-attention polymers
|MEE will issue a filing notice, but the applicants may utilize the new chemicals once the filing materials are submitted.|
|Simplified Application – Special||
1. Used as intermediate or for export only, and annual production or import is less than 1 ton;
2. For scientific research, annual production or import is at least 0.1 ton but less than 1 ton;
3. The polymer in which the content of monomer of new chemical substances is less than 2% or low-attention polymers; and
4. For R&D of process and products, annual production or import is less than 10 tons, lasting for no more than two years
|30 days for technical review + 20 days for final decision|
|Simplified Application – Basic||Annual production or import is less than 1 ton|
|Regular Application – Level 1||Annual production or import is at least 1 ton and less than 10 tons||60 days for technical review + 20 days for final decision||Simplified Registration||Annual production or import is at least 1 ton and no more than 10 tons||30 days for technical review + 20 days for final decision|
|Regular Application – Level 2||Annual production or import is at least 10 tons and less than 100 tons||Regular Registration||Annual production or import is at least 10 tons||60 days for technical review + 20 days for final decision|
|Regular Application – Level 3||Annual production or import is at least 100 tons and less than 1000 tons|
Regular Application – Level 4
|Annual production or import is at least 1000 tons|