Under the revised Provisions on Environmental 博华娱乐app下载 of New 博华娱乐app下载 Substances (MEE Order 12) issued in 2020, companies must submit new chemical substance registrations for substances not listed in the Inventory of Existing 博华娱乐app下载 Substances in 博华娱乐app下载 (博华娱乐app下载). The registration not only applies to new substances, substances in a preparation, or substances contained in articles that are intended to be released, but also applies to new substances used as ingredients or intermediates for a variety of uses including pharmaceuticals, pesticides, veterinary drugs, cosmetics, food additives, feed, and feed supplements.
For existing substances that are listed in 博华娱乐app下载 but are subject to new use management, new use registration must also be submitted if the substances are to be used for purposes other than the listed uses.
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As of August 18, 2021, 博华娱乐app下载 contains 46,782 existing substances.
The 博华娱乐app下载 is made up of two parts:
- the public part and
- classified/confidential part where the substances are presented as category names, neither CAS number nor molecular structure is given.
You could quickly check the public part by using CIRS's ChemRadar.
If it is not listed in the public section, you can submit a formal inquiry to the Solid Waste and 博华娱乐app下载s Management Centre (SCC) in order to check whether a substance is listed in the confidential part of 博华娱乐app下载. The SCC then issues a letter of confirmation (usually within two weeks) and a 3,000 RMB fee will be charged by SCC for the inquiry. CIRS Group can assist by submitting the inquiry to SCC on your behalf.
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Manufacturers of new substances in 博华娱乐app下载;
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Importers of new substances in 博华娱乐app下载;
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Companies who intend to apply for new use registration or to change the registered uses of the preparations managed by other laws and regulations to other industrial uses; and
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Foreign companies introducing new substances to 博华娱乐app下载.
Companies in 博华娱乐app下载 can submit a new substance registration or appoint a local agent to do so. Foreign companies can appoint a local Chinese agent to submit new chemical registrations. The local agent must be knowledgeable and qualified to carry out the registration. The role of the agent is similar to the role of "only representative" under EU 博华娱乐app下载.
博华娱乐app下载 Types
There are three types of registrations under MEE Order 12:
- regular registration;
- simplified registration; and
- record.
Record |
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Simplified 博华娱乐app下载 | New chemical substances to be manufactured or imported above the annual volume of one ton, yet no more than ten tons. |
Regular 博华娱乐app下载 | New chemical substances to be manufactured or imported above the annual volume of ten tons. |
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According to MEE Oder 12, a chemical risk assessment report must be submitted at the same time for regular registration.
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After registration is complete, a registration certificate containing the specific management category will be issued. The certificate holder needs to fulfill different post-registration obligations depending on the management category of the substance.
博华娱乐app下载 Type | Post-registration Obligation |
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Regular 博华娱乐app下载 |
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Simplified 博华娱乐app下载 |
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Record |
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After registering new substances under MEE Order 12, if the applicants change the registration information, they must apply for registration certificate change or re-register their substances by one of the following approaches:
博华娱乐app下载 Information Change | Regular 博华娱乐app下载 | Simplified 博华娱乐app下载 | Record Filling | |
---|---|---|---|---|
Applicant/Agent Name | Apply for registration certificate change | Apply for registration certificate change | Apply for a change via the online registration system, and obtain a new receipt No. | |
Agent Transfer | ||||
Substance Identity Information | ||||
Activity Type | Manufacture -> Import | |||
Manufacture -> Manufacture & Import | ||||
Import -> Manufacture | Re-registration | |||
Quantity Increase | ||||
博华娱乐app下载 Use | ||||
Environmental Risk Control Measures | ||||
Other circumstances leading to increased environmental risks (including changes in process conditions, production site, or environmental management requirements.) |
Our Services
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Only Representative (OR);
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博华娱乐app下载 Enquiry and Inventory Adding;
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New 博华娱乐app下载 registration (Typical registration, Simplified registration, Record);
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博华娱乐app下载 Safety Report (CSR) Compilation;
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Testing Coordination/Supervision;
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Alternative methods (QSAR, Read-Across, In-vitro, Waiver, Evaluation);
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Post-registration (Annual Report, Certificate Renew)
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博华娱乐app下载 博华娱乐app下载 Training Service;