With the Measures for the Environmental Management Registration of New Chemical Substances1 (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 FAQs2 to help enterprises fulfill their obligations under the Measures. The fourth batch of 15 FAQs were 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 Substances3 (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.
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?
You shall pay attention to the followings:
The provided identification information, including Chinese name, English name, CAS number, molecular formula, structural formula, etc., shall be consistent.
The generic name shall be prepared as per the Guidelines for the Generic Name of New Chemical Substances (HJ/T 420 - 2008)4 when applying for the CBI protection.
The spaces, hyphens, and subscripts in the chemical name. No punctuation shall be added at the end of the chemical name.
The SMILES (simplified molecular input line entry string) shall be provided for the new chemical substance with unique molecular structure.
The subscripts in the molecular formula.
6. What shall be paid attention to after submitting the application for the record notification?
Check whether the authority requires you to supplement relevant materials. If you receive the notice from the MEE, you shall supplement or correct the relevant content within the allocated time.
7. Is the annual report on the activities involving new chemical substances required to be submitted every year?
Yes. For chemical substances subject to the annual report, relevant activities (manufacture/importation information) in a calendar year shall be reported annually until such substances are listed in the IECSC.
8. For new chemical substances that have been granted the regular/simplified registration certificate under the MEE Order No.7, if they are re-registered under the 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?
The previous regular/simplified registration certificates obtained under the MEE Order No.7 shall be returned to the authority, and the new registration certificates will be issued. There is no need to apply for certificate revocation.
9. For a chiral compound, can its levorotatory form and dextrorotatory form be regarded a same chemical substance?
It should take into consideration of the chemical name, CAS number, structural formula, and other identification information to determine whether they are the same chemical substance.
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