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The amendment of data requirements is the most important factor directly impacting the notification strategy of industry and the cost and time required by enterprise to fulfill notification requirements. Below are some revisions in the new revision draft of China New Chemical Substance Notification Guidance relating to testing data summarized from a presentation delivered by Mr. Liu from the Solid Waste and Chemicals Management Center under the Ministry of Environment (SCC-MEP, formerly the CRC-MEP) at ChemCon 2015 in Hong Kong on 15 Jun 2015.
1. Delete the fish prolonged toxicity test (14-day) of Band 2 regular notification
In the current China NCSN guidance, the fish prolonged toxicity test (14-day) is a minimum data requirement for Band 2 regular notification. It can be replaced by chronic toxicity testing (fish). However, this endpoint does not adequately define acute toxicity or chronic toxicity, and is not so helpful to classification or risk assessment. The OECD also deleted “Test Guideline 204 Fish, Prolonged Toxicity Test: 14-Day Study” on 2nd April 2014. So the new draft will delete this endpoint.
2. Redesign data requirements of mutagenicity and carcinogenicity
Mutagenicity: More flexible combination of mutagenicity tests will be adopted to fully appreciate the mutagenic properties of a substance
Carcinogenicity: Carcinogenicity is a minimum data requirement for Band 4 regular notification. In the revision draft more exemption conditions are introduced. Mutagenicity conclusion will be used to determine whether carcinogenicity data should be submitted. Mechanism of carcinogenicity assessment will be introduced to demonstrate whether the notified substance is carcinogenic.
3. Add long-term toxicity test on terrestrial organisms for Band 4 regular notification
The revision draft will add long-term toxicity test on terrestrial organisms as a minimum eco-toxicological data requirement for Band 4 regular notification. According to the current guidance document, only seed germination and root elongation toxicity testing is required which cannot effectively determine the long-term effects of chemicals on terrestrial organisms.
In addition, Mr. Liu from the SCC-MEP also mentioned that toxicokinetics requirements will be clarified in the revision draft. The current criteria of exemption conditions for auto-ignition temperature, acute toxicity via inhalation route, eye irritation, mutagenicity, carcinogenicity, activated sludge respiration inhibition test, absorption/desorption, etc. will be modified. For acute/28-days repeated dose toxicity via dermal route, 90-days repeated dose toxicity, etc. more waiving condition will be added. However, the details are still waiting to be specified until the issuance of the revised draft.
4. Refine Simplified Notification Scope of Polymers
Simplified notification applies to the (1) new polymers classified as polymers of low concern (“Polymers of Low Concern”) or (2) polymers with low new chemical substance concentration of monomer which are<2 % w/w. However, the revision draft will narrow down the applicable scope of the simplified notification. Simplified notification will no longer apply to unstable or degradable polymers, or water absorbing polymers. More details haven’t been issued yet as the draft revision is still under review by MEP.
The requirements of test sample, data sources and data quality will be redefined. It will be mandatory to use Gobiocypris Rarus as an eco-tox test model species when generating data under China NCSN, although the corresponding testing standard is a GB/T standard (recommended standard) (ChemLinked news). Test reports generated within the territory of China should be completed within the accreditation validity period of the testing institutes (ChemLinked news). In addition, if the testing method used has been updated more than five years, the test report is unacceptable and should be performed in accordance with the current standardized test method.
