China Publishes Final Regulation on Handling with New Chemicals

At the beginning of May, the Chinese Ministry of Ecology and Environment (MEE) published the final version of its regulation on handling with new chemicals. The new MEE Order 12 (Chinese only) replaces MEP Order 7 and takes effect on January 1, 2021. The previous Order remains in force until then. 

The new Order distinguishes among three types of registration: 

  1. Full registrationfor all chemicals that are not on the current list and that are imported or manufactured in quantities of more than 10 tons per year.  
  2. Simplified registration for chemicals manufactured or imported in quantities between 1 and 10 tons per year.  
  3. Arecord filing notificationfor chemicals that are manufactured or imported in quantities less than one ton, for polymers that meet the criteria of polymers of low concern (PLC) and polymers whose monomers are already on the Inventory of Existing Chemical Substances in China (IECSC). However, the amount of new monomers may not exceed 2%. Approval from the Ministry is not required for such chemicals. If a company has submitted the required information to the MEE, it can produce, use, and/or import the chemical.  

Use of PBT Chemicals 

MEE Order 12 regulates treatment of persistent, bioaccumulative, and toxic (PBT) chemicals differently than the previous Order. The new Order does not authorize chemicals that fulfill all three criteria. Chemicals that fulfill two criteria can be authorized if the company submits an Annual Report that must cover exposure and  
emissions scenarios, risk reduction measures, and so on.  

Usage restrictions must also be entered into the IECSC. If a company plans a new use for a substance  
already listed, a notification process is required. The process is similar to that of the Toxic Substances  
Control Act (TSCA) in the United Sates that regulates significant new use rules (SNURs).  

Notification Requirement for Downstream Users 

According to the Order, downstream users of new chemicals must provide a notification when they: 

  • Use exempt chemicals like pharmaceuticals or pesticides for industrial purposes 
  • Use an existing chemical in a manner not specified in the IECSC 

 Confidential Information Protected for Five Years 

The company is issued a certificate after successful registration. From that time on, the confidential business information (CBI) about the new chemical is protected for five years. This protection ends on December 31, 2025 for all fully registered chemicals listed in the inventory with a CBI claim. After that date, they will be added to the IECSC and thereby become public.

Chemicals subject to simplified registration will not be listed in the inventory and will always be considered as new chemicals.

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