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Revised Data Requirements for China New Chemical Notification Released

The Ministry of Environmental Protection of China (MEP) released on August 31, 2017, the Amendment on Data Requirements to the “Guidance for New Chemical Substance Notification and Registration.”  The revisions are expected to become effective on October 15, 2017.  As explained below, the new requirements reduce the data requirements for registration of low tonnage bands, particularly for the Level 1 regular registration but, as the amendment is in abbreviated table format, the requirements and procedures on carcinogenicity and toxicokinetic (TK) assessments lack clarity.  

Overview of the Amendment

The Amendment on Data Requirements consists of the following 5 tables:

  • Table 1. Minimum toxicological data requirements;

  • Table 2. Minimum eco-toxicological data requirements;

  • Table 3. Exemption conditions of physico-chemical data;

  • Table 4. Exemption conditions of toxicology testing data; and

  • Table 5. Exemption conditions of eco-toxicology testing data.

Key Changes

The key changes are on data requirements of regular registrations:

  • Level 1 Registration (1-10 metric tons/year):  Only one of three acute (oral, dermal, or inhalation) toxicity tests is required based on the exposure route.  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 tons/year):  A 90-day repeated dose toxicity test and a 14-day prolonged toxicity test to fish are no longer required.

  • Level 4 Registration (> 1000 metric tons/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.

  • Mutagenicity Tests for Level 2 and above Registrations:  A bacterial reverse mutation test (OECD 471), in vitro mammalian cell chromosome aberration/micronucleus test (OECD 473/487), and in vitro mammalian cell gene mutation test (OECD 476) are required.  Additional mutagenicity tests including an in vivo gene mutation test, (e.g., transgenic rodent somatic and germ cell gene mutation assays (OECD 488)) or DNA damage and repair test, (e.g., unscheduled DNA synthesis test with mammalian liver cells in vivo (OECD 486), and in vivo comet assay (OECD 489)) may be required if the test results are positive.

  • TK for Registrations at Level 2 and above: TK assessment based on existing data shall be performed, but it is unclear whether a TK study is required for the TK assessment.

The MEP release does not disclose when or if the full final revision of “Guidance for New Chemical Substance Notification and Registration” will be issued.  The Solid Waste and Chemical Management Center (SCC) of China will hold a Training on the Amendment on September 25-27, 2017, in Beijing. 

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About this Author

J. Brian Xu, China, Toxicology, Specialty Chemicals, Pharmacology

Dr. Brian Xu is a board-certified toxicologist with Bergeson & Campbell, P.C. (B&C®) who assists clients in developing and managing international projects involving U.S. Food and Drug Administration (FDA) and U.S. Environmental Protection Agency (EPA) regulated consumer products, cosmetics, industrial and specialty chemicals, agrochemicals, and antimicrobials. Dr. Xu is also an M.D. in pathology, holds a Ph.D. in pharmacology and toxicology, and has over 15 years of industry experience as a senior toxicologist and...

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