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The amendments on data requirements in China’s New Substance Notification Guidance were published on Aug 28th 2017 as an individual announcement (MEP Announcement No.42 of 2017), rather than being published as part of the full document of the revised Guidance. The amendments will take effect from Oct 15th 2017 (CL news).
The revised data requirements consist of the following part:
Annex 1. Minimum requirements of toxicological data
Annex 2. Minimum requirements of eco-toxicological data
Annex 3. Exemption conditions of physico-chemical data,
Annex 4. Exemption conditions of toxicology testing data
Annex 5. Exemption conditions of eco-toxicology testing data
For minimum data requirements, the major amendments are summarized as below:
| Current | Updates | |
| Band 1 regular notification (1-10 t/y) | Acute toxicity by oral, dermal and inhalation routes are required | Only one of the acute toxicity data by oral (preferred), dermal or inhalation route is required according to the corresponding exposure route |
| 28-days repeated dose toxicity test is required | Delete | |
| A bacterial reverse mutation test and an in vitro mammalian chromosome aberration test should be submitted | If test result of bacterial reverse mutation test is positive, other mutagenicity test should be submitted. | |
| Band 2 regular notification (10-100 t/y) | Depending on the test result of 28-days repeated dose toxicity test, the data of 90-days repeated dose toxicity test maybe be submitted | 90-days repeated dose toxicity test for Band 2 regular notification is deleted |
| Data of bacterial reverse mutation test, in vitro mammalian chromosome aberration test and mammalian bone marrow chromosome aberration test should be submitted | Data of bacterial reverse mutation test and in vitro mammalian chromosome aberration test should be submitted, according to which, the data of in vitro mammalian cell gene mutation test and other in vitro mutation data can be supplemented. | |
| A study of the absorption kinetics and other relevant information should be submitted. | Only toxicokinetics assessment report is required | |
| Fish, Prolonged toxicity testing (14-day study) is required | Deleted | |
| Band 3 regular notification (100-1000 t/y) | The requirements of mutagenicity are the same as Band 2 | The requirements of mutagenicity are the same as Band 2 |
| A complete toxicokinetic study and other relevant information should be provided. | Only toxicokinetics assessment report is required | |
| Two-generation reproductive toxicity study should be provided. | Extended one generation reproductive toxicity study or two-generation reproductive toxicity study should be provided. | |
| Band 4 regular notification (above 1000 t/y) | The requirements of mutagenicity are the same as Band 2 | The requirements of mutagenicity are the same as Band 2 |
| The requirements of toxicokinetics are the same as Band 3 | The requirements of toxicokinetics are the same as Band 3 | |
| Carcinogenicity data is required | The uses of the substance, mutagenicity conclusion and repeated dose toxicity will be used to determine whether carcinogenicity data or carcinogenicity assessment report should be submitted. | |
| One of the following tests shall be performed: an early life-stage toxicity test on fish, or a short-term toxicity test on embryo and sac-fry stages on fish, or a juvenile growth test on fish | The juvenile growth test on fish should be performed | |
| No long-term toxicity test on terrestrial organism | Enchytraeid reproduction test or earthworm reproduction test should be submitted when terrestrial acute toxicity test results in hazard classification |
