China China adds 319 substances into List of existing chemical substances

In April. 2021, the Ministry of Ecology and Environment of China added a total of 319 chemical substances into the “List of existing chemical substances” in two times. The reasons are different for the two supplements, but these 319 newly added substances will be exempted from the obligation to apply and register for the new chemical substances. The outline for each is as follows.
1. On April 21, 2021, the Ministry of Ecology and Environment released the list of 115 substances that will be added into “List of existing chemical substances in China” on its homepage. These 115 substances added this time are substances, which registered in accordance with the request of Ministry of Ecology and Environment Ordinance No.7, and were added into the “List of existing chemical substances in China” based on “Measures for environmental management of new chemical substances” (Ministry of Ecology and Environment Ordinance No.12) and the related interpretation document (Ministry of Ecology and Environment Notice No.51 in 2020). The substances added this time include bicycloalkanecarboxylate, etc., and these 115 substances will be exempted from the obligation to apply and register for the new chemical substances.
In addition, some of the new added substances are also including the information of “environmental management scope of new uses”. For example, the environmental management scope of new uses for Pyridinecarboxylic acid, aminosulfenylacyl trihalogenmethyl alkyl ester is industrial use other than permitted use, which is used as pharmaceutical intermediates.

2. On April 15, 2021, the Ministry of Ecology and Environment released the list of 204 substances that will be added into “List of existing chemical substances in China” on its homepage. These 204 substances released this time are the substances that have been examined by the Ministry of Ecology and Environment and are considered have met the supplementary standard, which were made in response to supplementary applications(※) submitted by many enterprises, including Japanese enterprises and other related industrial groups. These substances include N-Isopropyl-N-phenyl-chloracetamide and etc.
※ On June 21, 2019, the Ministry of Ecology and Environment released the “Notice on supplement and improvement the ‘List of existing chemical substances in China’”, it notified that for the substances which are produced or imported before October 15, 2003 and still hasn’t been listed, enterprises and related groups can apply for supplementation.

In addition, substances that are not listed in the “List of existing chemical substances in China” and don’t meet the supplement standard (for example, substances that have not been produced or imported before October 15, 2003) have to register for new chemical substances.
For the list of supplemented substances, please refer to the following URL (in simplified Chinese).
List of 115 substances
https://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/202104/t20210425_830319.html
List of 204 substances
https://www.mee.gov.cn/xxgk2018/xxgk/xxgk01/202104/t20210421_829704.html