China New Chemical Substance Notification


Overview


In China, chemical substances are regulated by the Measures on the Environmental Management of New Chemical Substance (MEP Order No.7), enacted by the Ministry of Environmental Protection (MEP) of China on 15 Oct 2010. Currently, companies who plan to manufacture or import chemicals not listed in the Inventory of Existing Chemical Substance in China (IECSC) must submit notification dossiers of the chemicals to the Solid Waste and Chemicals Management Center of MEE (SCC-MEE) and apply for approval. A certificate should be granted before any new chemical substance enter the China market, otherwise relevant companies will be subject to severe penalties.

IECSC Comprehensive Search


Chemicals not listed in the Inventory of Existing Chemical Substance in China (IECSC) are regarded as new chemicals in China. Meanwhile, there are 3270 confidential chemicals that are not disclosed in the public version of IECSC. Therefore, when certain chemical could not be found in the public version of IECSC, a comprehensive search is still recommended to be submitted to SCC-MEE to check whether the chemical is new or not.

Scope of Applicable Substances


New chemical substance (not listed in IECSC):

  • Raw materials or intermediates of pharmaceuticals, pesticides, veterinary medicine, cosmetics, food additives, feed additives, etc.;
  • Functional ingredients of surfactants, plasticizers, preservatives, dispersants, flame retardants, etc.;
  • Polymers;
  • Substances contained in articles which are intended to be released.

Notification Bodies


  • Manufacturers of new chemical substances in China
  • Importers of new chemical substance in China
  • Foreign companies selling new chemical substances to China

Note: foreign companies and companies in HongKong, Macao and Taiwan shall appoint a Chinese representative agent to complete notification on their behalf;


Notification Types

Scientific Research

Record Notification

Manufactured/imported <0.1t/a for R&D purpose

Testing samples imported to do eco-toxicological tests in China;

Simplified Notification Basic Case Manufactured/import <1t/a

Special Case

 

Manufactured in China for export only <1t/a;

Intermediates manufactured/imported <1t/a;

Manufactured/imported <1t/a for R&D purpose;

Polymer of low concern (PLC) or polymer with low new substance monomer content (<2%, w/w), no tonnage limit;

Manufactured/imported <10 t/a for PPORD purpose, valid for no more than 2 years

Regular Notification Manufactured/imported ≥ 1 t/a

4 tonnage levels in total: Level 1: 1-10 t/a, Level 2: 10-100t/a, Level 3: 100-1000t/a, Level 4: 1000+ t/a;

Notification Procedure


Our Services


• Comprehensive Regulatory Compliance Consulting

• Representative Agent Service

• IECSC Comprehensive Search

• Dossier Preparation and Process Tracking for New Chemical Substance Notification

• Overall Notification Scheme

• Data Assessment/Data Gap Analysis/Exemption Analysis

• Test Monitoring

• Risk Assessment Report Preparation

• Communication with Competent Authorities/Experts

• Post-notification Obligations (Annual Report, Certificate Renewal, etc.)

• Customized Training