Updated on 28 May 2021
Recently, Chinese has started to review whether the products contain new substances via automatic check or on-site spot check. If the products are found containing new substances, related enterprises need to provide registration/ record certificates before exporting, otherwise the cargos might be detained or ordered to be delivered back and the exportation could be affected.
China Ministry of Environment and Ecology (MEE) has sent notices to local authority of some provinces to check on some manufactures doubt with problems, penalties might be imposed on those local manufactures which violates the Environmental Administration of New Chemical Substances (MEE Order No. 12).
In order to make enterprises better understand the obligations under new substances registration in China, CIRS is to provide the answers to some questions of concern as follows:
What is the definition of new chemical substances? What kind of products requires new chemical substance registration in China?
Under the Measures for Environmental Management Registration of New Chemical Substances (MEE Order 12) released by Ministry Ecology and Environment, substances that have not been listed in China existing chemical substance inventory (IECSC) will be regarded as new substances. Registrants need to complete new chemical substances registration for these substances. Besides, products containing new substances or articles that are designed to intentionally release new chemical substances contained therein are also subject to the obligations under MEE Order 12.
IECSC, also known as the Inventory of Existing Chemical Substances in China, is made up of two parts: the public part and the classified/confidential part. There are 45612 substances listed in IECSC (2013), including 3270 confidential substances.
IECSC (2013) has been updated for several times, please click here to know more information.
Enterprises may also search if there substances are listed in the IECSC by using CIRS’s free APCISS system.
What kind of enterprises shall register for new substances?
Under the MEE Order 12, the following enterprises need to complete new chemical substances registration in China:
- Enterprises or institutions registered within the territory of the People’s Republic of China and intend to involve in the production of new chemicals substances;
- Enterprises or institutions registered within the territory of the People’s Republic of China and intend to involve in the import of new chemical substances;
- Enterprises that intend to apply for new uses registration or change the registered uses of finished products subject to other laws and regulations to other industrial uses;
- Overseas enterprises that intend to export new substances to China shall appoint enterprises or institutions registered within the territory of the People’s Republic of China to act as their representative;
CIRS warmly reminds that Source Access is adopted for new chemical substances registration in China, namely, enterprises that introduce the new chemical substances shall register for the substances.
What are the registration types? How long is the registration cycle and how much will it cost?
Based on the properties of substances and the tonnage band, there are 3 types of registrations: regular registration, simplified registration and record.
For new substances with the annual import or production volume exceeding 10 ton, related enterprises shall apply for regular registration. Physiochemical, toxicological, as well as ecological data shall be submitted and the data requirements vary with the substance properties (namely, whether the substances are accumulative, bio-accumulative or highly toxic). Normally, the regular registration will last 1-2 years with the testing expense between hundreds of thousands and millions CNY.
For new substances with the annual import or production volume exceeding 1 ton but less than 10 ton, related enterprises shall apply for simplified registration. Physicochemical and eco-toxicological data shall be submitted. Normally the simplified registration will last six months to one year with the testing expense between 200 thousand and 500 thousand CNY.
For new substances with an annual import or production volume less than 1 ton, polymers of low concern or polymers containing no more than 2% monomers or reactants of new chemical substances, enterprises only need to submit application for record before any activities. Normally it takes 1 to 2 weeks for the enterprises to complete record applications, which includes the time for information collection, dossier preparation and dossier submission.
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New Chemical Substances Registration in China