Q&A: Answering your questions about China MEE Order 12
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Are you confused about CHINA MEE Order 12? The following are commonly asked questions about China MEE Order 12. Here are answers to some of your questions about the current and future status of China MEE Order 12:
What is MEE Order 12 and what are the scope and exemptions?
MEE Order 12 (China REACH) The Measures for the Environmental Administration Registration of New Chemical Substances is the main chemical regulation in China. The competent authority of MEE Order 12 is the Ministry of Ecology and Environment (MEE). MEE Order 12 regulates “new substances” as single chemical substances, in mixtures or articles with an intentional release. The exemptions under Order 12 are summarised in Section 1.1 of the Guidance for MEE Order 12 (e.g. naturally-occurring substances).
What is IECSC inventory and how can I check my substance in the IECSC?
IECSC inventory is the Inventory of Existing Chemical Substances. IECSC includes the IECSC public list which can be accessed freely on the MEE website and the IECSC confidential list which can be checked only by sending an application to MEE. If a substance is listed in either the IECSC public list or IECSC confidential list, the substance does not need to be registered or notified under MEE Order 12 (unless it is subjected to new use management in Article 11 of Order 12).
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What is the basic process to meet the MEE Order 12 obligations and how can Yordas help?
The following steps are necessary. Yordas is able to support all the following activities from the appointment of a Chinese Representative to commissioning testing and submission of dossiers.
The first step is to check the substance status under IECSC. If a substance is listed in IECSC, the substance is not required to be registered/notified under MEE Order 12 (unless it is subjected to new use management in Article 11 of Order 12).
If it is not listed in the IECSC, the importer/manufacturer needs to calculate the tonnage of the substance. If the annual tonnage is <1 tonne/year, the applicant can apply for a record notification, which is relatively inexpensive and has fewer data requirements.
If the tonnage is ≥1 t/y, the persistence, bioaccumulation and toxic properties (PBT) of the substance need to be assessed so that the applicant can select the relevant registration type and understand the data requirements.
After the registration type is determined, a data gap analysis will help the applicant to identify whether existing data is available or whether new data needs to be generated.
When all the data are prepared, a registration dossier can be created following the Guidance of MEE Order 12 and the dossier will be submitted to MEE.
The MEE will evaluate the dossier and provide their decision regarding the registration. Once registration is approved, the registration holder also needs to meet the post-registration requirements.
What are the registration/notification types for new substances?
Registration/notification types are in Article 10 of MEE Order 12. Including:
General record notification: for all substances less than 1 t/y
Polymer record notification: For polymers meeting the 2% rule polymers of low concern (PLC) (no tonnage limit).
Simplified registration: For substances manufactured or imported 1-10 t/y
Regular registration: For substances manufactured or imported ≥10 t/y
Who should register/notify new substances under MEE Order 12?
Importers or manufacturers of the new substances based in China must apply for approval for the new substance from the MEE before the import/manufacture. Manufacturers based outside China can also apply for registration by appointing a China-based representative.
What is the validity of registration under MEE Order 12?
Record notification and simplified registration under Order 12 are valid until the notification holder or the MEE cancels the notification;
Regular registration is valid for 5 years and after that, the substance will be added into IECSC and become an existing substance. The registration holder can keep supplying the substance after 5 years.
Can we use the data for EU-REACH for MEE Order 12 registration?
This needs to be discussed on a case-by-case basis. The data requirements under MEE Order 12 are not the same as those under EU-REACH. For testing data, full study reports are preferred under Order 12 and MEE requires explanation if non-testing methods are used (e.g. read-across). Some of the eco-toxicology tests must be performed in China-based labs with specific species.
Are there obligations after our registration is approved?
Yes, there are. For example, the registration certificate holder or a representative shall follow Article 41 of Order 12, submit an annual report for new chemical substances before April 30 each year starting from the year following registration.
For polymers with annual tonnage ≤1t, can we apply for a general record notification?
Yes, it is possible to apply for a general record notification.
How can Yordas help?
Yordas continues to monitor developments so we can help our clients achieve compliance around the world. If you wish to discuss how our team of experts can help you navigate compliance under China REACH, send us a message here.
Reference: MEE Order 12 and the MEE-SCC website