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Major Changes in the New Guidance (draft for public comments)
2015-06-26 13:58:00
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The new "Guidance for New Chemical Substance Notification and Registration (draft)" was issued on June 25, 2015 on the website of MEP-SCC and open for public opinions and Suggestions!
Changes of this new draft cover various aspects specified as follows:
* Provide code list of chemicals;
* Redesign the "New Chemical Substances For Each Activity Report" , "New Chemical Substances Annual Report Form", "Registered New Chemical Substance Actual Activity Report Of Five-year" etc.
English Consulting Hotline： 86-10-87671126
Changes of this new draft cover various aspects specified as follows:
* Changes regarding management policy:
- Even business bodies without legal personality, (such as sole proprietorship enterprise, partnership enterprise, enterprise branch etc.,) are also qualified for a domestic notifier.
- Requirement on registration capital (no less than RMB 3,000,000) for Local Representative is deleted.
- Oversea notifier will be the holder of the Registration Certificate after Registration. (local representative used to be certificate holders)
- Management of the China Pilot Free Trade Zones is equivalent to the Bonded Zone.
- Changes on notification procedure and after registration management
- There is no tonnage limits for polymers of simplified notification, and the registration certificate will not list the registration tonnage. There is no need for the notifier to re-notifiy for increased tonnage caused by market adjustment.
- When applying for regular notification, the notifier does not need to notify for a specific tonnage quantity any more (except for level IV where specific tonnage is required). In this case, the situation of changing registration quantity shall decrease.
- Set minimum amount limits of the transfer. When Key Hazardous New Chemical Substances for Environmental Management are transferred to a different downstream user at lower than 10kg, the notifier does not need to submit the New Chemical Substances for Each Activity Report.
- Test report conducted within the territory of China should be completed within the validity of their qualifications in the test report issued. Where the testing method followed has been updated for more than five years, the test report should be performed in accordance with the current test method.
- It is clarified that Chinese local test fish refers to Gobiocypris rarus (Rare minnow).
- Fish 14-day toxicity study is cancelled in Level II notification.
- Requirements of mutagenicity are redesigned according to different endpoints:
For level I notification, AMES and in vitro Chromosome Aberration test (or In Vitro Micronucleus test) shall be submitted. If any one of the results is positive and the substance has a wide exposure risk, higher level’s requirements shall be adopted. Starting from Level II, further testing shall be conducted according to the results of level I items: - For toxicokinetics, it is clarified that in Level II notification relevant information shall be submitted; starting from Level III, classified substances shall submit complete testing report while substances not classified can submit relevant information.
- Open the possibility of using evaluation report to replace carcinogenicity study:
If a substance has a wide dispersive uses and there is evidence of frequent or long-term human exposure; and the substance is classified as Globally Harmonized System of Classification and Labeling of Chemicals (GHS) mutagenicity category 2, or there is evidence from the repeated dose study (ies) that the substance has potential to induce hyperplasia and/or pre-neoplastic lesions, carcinogenicity study data should be required.
Outside of the circumstances mentioned in the preceding paragraph, shall submit the carcinogenicity study data or carcinogenicity evaluation report. However, if the evaluation concludes that further carcinogenicity study is needed, carcinogenicity study data should be provided. ) - Cancel the waiving condition of chronic toxicity study in Level IV notification.
- Add long-term toxicity test on terrestrial organism in Level IV Notification. OECD220 Enchytraeid Reproduction Test, or OECD 222 Earthworm Reproduction Test is required when terrestrial acute toxicity test result shows GHS classification.
* Provide code list of chemicals;
* Redesign the "New Chemical Substances For Each Activity Report" , "New Chemical Substances Annual Report Form", "Registered New Chemical Substance Actual Activity Report Of Five-year" etc.
English Consulting Hotline： 86-10-87671126
