China New Chemical Substance Registration
Industrial Chemicals

▌About MEE Order No. 12

The Measures for the Environmental Management Registration of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment of the P. R. China, MEE Order No. 12), also widely known as China REACH, was released in April 2020 and comes into force on January 1, 2021. Based on the requirement of this regulation, new chemical substances must be registered before production or import. Upon completion of registration, The Ministry of Ecology and Environment of the P. R. China A (hereinafter referred to as "MEE") will issue corresponding new chemical substance environmental management registration certificates (hereinafter referred to as "registration certificate") to the applicants. 

▌Registration Bodies

◆ Manufacturers/direct importers of new chemical substances in China;

◆ Overseas enterprises (including enterprises from Hong Kong, Macao and Taiwan region of China) that intend to engage in the trade of new chemical substances in China (an agent in Mainland China shall be entrusted to handle registration matters);

◆ Manufacturers, importers, processors and users with products in the category of medicines, pesticides, veterinary, drugs, cosmetics, foods, food additives, feeds, feed additives, fertilizers, etc. that are belong to new chemical substances and intend to be change the use of those products to other industrial applications;;

◆ Manufacturers, importers, processors and users with chemical substances that are intended to be used for industrial applications other than permitted ones, or with highly hazardous chemical substances that have not obtained the regular registration certificate for the intended use ( those chemical substances are subject to new usage environmental management).

▌Substances subject to MEE Order No. 12

◆ New chemical substances that are not listed in IECSC (Inventory of Existing Chemical Substances in China)

(1)General new chemical substances;

(2)Substances contained in products or formulations with specific functions such as surfactants, plasticizers, preservatives, dispersants, flame retardants, etc.;

(3)Chemicals intentionally released from articles during normal use;

(4)UVCB substances, intermetallic compounds and polymers.

◆ Chemicals that are listed in IECSC

(1)Chemicals subject to new usage environmental management.

▌Registration Type
图片1.png▌Registration Procedure

▌Our services

◆ IECSC comprehensive search

◆ New chemical substance registration

◆ New usage environmental management registration

◆ Data-gap analysis/test monitoring 

◆ PBT Properties Identification

◆ Environmental risk assessment report preparation

◆ Social and economic benefit analysis report preparation

◆ IECSC supplementation (add existing chemical substances into IECSC list) 

◆ Customized China REACH training 

▌Our advantages

◆ Expert team with academic and professional backgrounds in toxicology, analytical chemistry, chemical engineering, biology, pharmacology, environment, etc.;

◆ Above 5-year professional experience in the field of China’s new chemical management regulation;under MEP Order No. 7 and MEE Order No. 12;

◆ Rich practical experience in data gap analysis/project design/test supervision;

◆ Deep level cooperation with well-known enterprises such as CAPCHEM and JINCHENG PHARMA.

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