New Data Requirement For China New Substance Registration Enacted

The key point in the new data requirement is that toxic data for typical registration is somehow lightened

  

1). For Level 1 (1Q < 10ton/year) registration, based on the exposure route, now only one of acute toxicity data (oral, dermal, inhalation) should be provided, which normally is acute oral toxicity.

2). For Level 1 (1Q < 10 ton/year) registration, 28d repeated toxicity data is not required anymore.

3). For Level 2  (10Q < 100 ton/year) registration, 90d repeated toxicity data is not required anymore.

4). From Level 2  (10Q < 100 ton/year) registration, Toxicokinetics study data is not required anymore, instead toxicokinetics assessment based on available information is required.

5). For Level 2  (10Q < 100 ton/year) registration, 14d test on prolonged toxicity to fish is not required anymore.

6). For Level 1 (1Q < 10 ton/year) registration, in vitro chromosome aberration test is not required but required from  Level 2  (10Q < 100 ton/year) registration; In vivo test maybe required if result of in vitro test is positive.

7). For Level 4 (1000 ton/yearQ) registration, the requirement on carcinogenicity study is changed to that the carcinogenicity study or carcinogenicity assessment report could be required based on mutagenicity test result and on exposure situation.

8). Enchytraeid reproduction test or earthworm reproduction test is newly added but only required when terrestrial biological acute toxicity test data result in hazardous classification.


Download the announcement: 

English: www.randis.cn/html/ywb/Exwzx_266_283.asp

Japanese: www.randis.cn/html/rwb/Jxwzx_283_169.asp