Updated FAQs for China New Chemical Substance Registration
With the Measures for the Environmental Management Registration of New Chemical Substances (a.k.a. MEE Order No.12, hereinafter referred to as the Measures) in effect, the Solid Waste and Chemical Management Center of the Ministry of Ecology and Environment (SCC-MEE) has released a series of FAQs to help enterprises fulfill their obligations under the Measures. The fourth batch of 15 FAQs was recently published on June 30.
ChemLinked has selected some of the FAQs to facilitate your understanding of the compliance with the Measures.
1. 🆀: What are the requirements for the testing institutes that generate GPC and other spectra for the application of regular/simplified registration of polymers?
🅰: The requirements for such institutes are the same as the qualification requirements specified in the Guidance on Environmental Management Registration of New Chemical Substances (hereinafter referred to as the Guidance) for the domestic and oversea testing institutes engaged in testing of physicochemical properties.
2. 🆀: What should I pay attention to when providing chemical identification information for the application of the addition of substances into the Inventory of Existing Chemical Substances in China (IECSC)?
🅰: The applicant shall provide with the following identification information of the chemical substance, including Chinese name, English name, CAS number, molecular formula, structural formula, etc. Note that such information shall be accurate and normative information obtained from authoritative institutes, or from the published literatures, authoritative databases, etc. Common names, common industry names, etc. can be provided as aliases. The chemical identification information shall be consistent with the chemical information in the evidentiary materials.
3. 🆀: In the case that the evidentiary materials for applying for the addition of substances into the IECSC are invoices, and the invoices only indicate internal code (or abbreviation) which is not consistent with the chemical name of the chemical substance, what should I do?
🅰: Other evidentiary materials shall be provided to fully prove that the chemical information on invoices is consistent with the chemical substance which is applying for the addition to the IECSC.
4. 🆀: What should I pay attention to when filling in the simplified registration application form?
🅰: The form shall be filled in completely in accordance the corresponding requirements, with emphasis on the followings:
- Fill in the contents consistently.
- Fill in the information of the actual domestic processors or users if the use purpose is not for export.
- Provide detailed information, including the details of intermediates, downstream processing and use information, and final product information, etc., if the use purpose is for pesticide intermediates, pharmaceutical intermediates or veterinary drug intermediates.
- Fill in the relevant information on the test data consistent with the test reports.
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Data that can be exempt according to the Guidance shall be explained in the corresponding column.
5. 🆀: What should be paid attention to when submitting chemical identification information for the regular/simplified registration?
6. 🆀: What shall be paid attention to after submitting the application for the record notification?
7. 🆀: Is the annual report on the activities involving new chemical substances required to be submitted annually?
8. 🆀: For new chemical substances that have been granted the regular/simplified registration certificate under MEE Order No.7, if they are re-registered under MEE Order No.12, how to deal with the previous registration certificates under MEE Order No.7? Do I need to apply for certificate revocation?
9. 🆀: For a chiral compound, can its levorotatory form and dextrorotatory form be regarded a same chemical substance?
Reprinted from: ChemLinked
Reference Links
Measures for the Environmental Management Registration of New Chemical Substances
Guidance on Environmental Management Registration of New Chemical Substances
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