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 under this regulation manufacturing or importing chemicals not listed in the Inventory of Existing Chemical Substance in China (IECSC) must submit notification dossiers of new chemicals to the Solid Waste and Chemicals Management Center of MEE (SCC-MEE) for approval. The certificate must be approved before any new chemical substances enter the Chinese market or otherwise they will be subject to strict penalties.

Notification Procedure

Confidential Chemical Inquiry

Chemicals regarded as Unlisted in the Inventory of Existing Chemical Substance in China (IECSC) are identified as new chemicals. However, 3270 chemicals are identified as confidential and only their genic names are disclosed in the public IECSC version. For this reason, if companies cannot find certain chemical in the public IECSC, they must submit a formal inquiry to SCC-MEE to check whether the substance is a new chemical 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 surfactant, plasticizer, preservative, dispersant, flame retardant, etc.;

• Polymers;

• Substances contained in articles which are intended to be released.

Notification Bodies

• Manufacturers of new chemical substance in China

• Importers of new chemical substance in China

• Foreign companies selling new chemical substance to China

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

Notification Types

Our Services

• Comprehensive Regulatory Consulting

• Representative Agent Service

• Formal Inquiry for New Chemical Substance

• New Chemical Substance Notification (Scientific Research Record Notification, Simplified Notification, and Regular Notification)

• Overall Notification Proposal

• Data Assessment/Data Gap Analysis /Exemption Analysis

• Test Monitoring Service

• Risk Assessment Report Preparation

• Communication with Competent Authorities/Experts

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

• Training Service

Why REACH24H?

• Experienced Expert Teams:

Over 150 professionals with extensive academic and practical experience in the field of chemistry, toxicology and eco-toxicology

• Strict quality control system

• Close collaboration with numerous certified test facilities

• Regular communication with competent authorities

• Fast response to clients inquiries and high level of confidentiality

• Excellent Project Management:

2000+     China New Chemical Substance Notifications

6000+     Hazardous Chemicals Registrations

30000+   SDS/MSDS/Label

3000+     EU REACH Registrations

30+          Lead Registrations