Understanding and fulfilling the obligation on “New Substances” and “Hazardous Chemical Substances”

MEE Order 12

In 2021, China’s “REACH-like” regulation MEP Order 7 was replaced by MEE Order 12: Provisions for the Environmental Management of New Chemical Substances (commonly referred to as MEE Order 12; Order 12 or “China REACH”).

Decree 591 - Hazardous Chemical Management

The Regulations on Safe Management of Hazardous Chemicals (Decree 591) came into force in 2011 and is the overarching law on the control of hazardous chemicals in China.

Decree 591 is supported by several catalogues and ministerial regulations that help to manage hazardous chemicals across the supply chain. These include the “Catalogue of Hazardous Chemicals”, registration of hazardous chemicals under “SAWS Order 53” and various other SAWS regulations on hazardous Chemical testing and licensing.

China’s Globally Harmonised System

China implements the 4th revised edition of the UN Globally Harmonised System of Classification and Labelling of Chemicals (GHS). There are requirements under Decree 591 and MEE Order 12 to provide SDS according to China GHS for hazardous and new chemical substances.

With more than a decade of experience, Yordas can support your company in fulfilling the obligations under MEE Order 12, Decree 591 and China GHS. To find out if your product falls under the scope of MEE Order 12, contact our regulatory experts today and we will provide you with a solution.

Frequently Asked Questions

We’ve put together some commonly asked questions to give you more information about Taiwan TCCSCA & OSHA. If you have any questions that we haven’t been able to answer, we would love to hear from you! Leave us a question here.

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).
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).
Yordas can help our clients to check substance status under IECSC. With Yordas Hive, users can access global regulatory data on 270,000+ substances, actively maintained by our team of experts on a daily basis to ensure clients always have the latest updates at their fingertips. Learn more about Yordas Hive here.
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.