China’s Ministry of Environmental Protection (MEP) announced that the revised data requirements under the “Guidance for New Chemical Substance Notification and Registration” would take effect on October 15, 2017. The revisions were made “to improve the scientific and normative requirements for the declaration of new chemical substances.”
Chemical regulation in China proceeds under two primary enabling decrees/orders: the “Decree of the State Council-People’s Republic of China-Number 591-Regulations on Safe Management of Hazardous Chemicals in China” (Decree No. 591) and the “Order of the Ministry of Environmental Protection (MEP)-People’s Republic of China-Number 7-Environmental Management of New Chemical Substances in China” (MEP Order No. 7).
The Guidance for New Chemical Substance Notification was published in 2010 as the supplementary document for MEP Order No. 7. MEP began to revise the guidance documents in 2014. MEP has released drafts for public comments since that time. On August 31, 2017, MEP released the announcement revising the data requirements of the guidance documents.
“Compared with the current data requirements, the amended data requirements are more scientific and reasonable, conform to the requirements of new chemical substance management and reduce the cost of testing data greatly which apparently ease enterprises’ notification burdens,” according to Chemical Inspection and Regulation Service (CIRS), a product safety and chemical management consulting firm based in Hangzhou, China.
The revisions reduce the data requirements for registration of low tonnage bands, particularly for Level 1 regular registration. The key changes are on data requirements for regular registration:
Level 1 Registration (1-10 metric tonnes/year): Only one of three acute (oral, dermal, or inhalation) toxicity tests is required based on the exposure rate. A 28-day repeated dose toxicity test is no longer required. Only a bacterial reverse mutation test (OECD 471) is needed unless its test result is positive.
Level 2 Registration (10-100 metric tonnes/year): A 90-day repeated dose toxicity test and a 14-day prolonged toxicity test to fish are no longer required.
Level 4 Registration (> 1,000 metric tonnes/year): A carcinogenicity assessment shall be submitted; conducting carcinogenicity testing shall be based on mutagenicity test results and the potential for human exposure. The earthworm reproduction test is added for chemicals with acute terrestrial hazard classification.