China's New Chemical Substances Regulation Full Analysis——New Chemical Substances Concepts and Regulations

一、The concept of new chemical substances

New chemical substances refer to chemical substances that are not included in the Inventory of Existing Chemical Substances in China (IECSC)". The IECSC is organized, formulated, adjusted and announced by the ecological environment department of the State Council.

The IECSC search website: Click here to search

New chemical substances should be registered for environmental management in accordance with the "Measures for the Registration of Environmental Management of New Chemical Substances" before production or import. New chemical substances, whether in the form of pure substances or components of mixtures, are covered by the register. Chemical substances with no unique and undetermined molecular structure, such as variable component substances and complex reaction products, as well as polymers, are new chemical substances and also fall within the scope of registered substances.

二、Regulations relating to new chemical substances

The New Registration System for the Environmental Management of Chemical Substances is an internationally accepted system for the environmental management of chemicals, which has been implemented in my country since 2003. This regime governs both new substances and new uses of substances. On January 1, 2021, the "Measures for the Registration of Environmental Management of New Chemical Substances" (Order No. 12 of the Ministry of Ecology and Environment) (hereinafter referred to as the "Measures") came into effect.

The Measures require new chemical substances to identify environmental hazards, assess potential environmental risks throughout their life cycle, such as production, processing, use, and disposal, before production or import, implement registration and licensing, prevent and control the entry of new chemical substances with unreasonable environmental risks into the economy and society, and establish a “firewall” for source management of environmental risks of chemical substances. At the same time, it is also an important measure to implement the decisions and arrangements of the CPC Central Committee and the State Council on the control of new pollutants.

In addition, the "Guidelines for Environmental Management Registration of New Chemical Substances" (Ministry of Ecology and Environment Announcement No. 51 of 2020) is a supporting normative document for the implementation of the "Measures". It refines the relevant provisions of the "Measures" and clarifies the specific implementation requirements. This guide mainly includes the scope of registration, registration types, registration procedures, registration application material requirements, polymer special provisions and new use environmental management registration, re-registration, registration certificate changes, withdrawal and revocation, and post-registration tracking management requirements.

"Supporting Form and Instructions for Filling in the New Chemical Substances Environmental Management Registration" (Announcement No. 51 of the Ministry of Ecology and Environment in 2020), which provides a detailed introduction to the new chemical substances registration application form, registration management form, information report form and use code form and provides guidance on filling in the form.

Our Services:

🔹New chemical substances consultation/new inspection services

🔹New chemical substance registration services (regular registration/simple registration/filing/new use management registration)

🔹Domestic agent services

🔹Data assessment/gap analysis services

🔹Laboratory testing consulting services

🔹Risk assessment report/Sioeconomic benefit analysis report

🔹Regulation Training Services

🔹Post-registration management services for new chemical substances