Special forms of registration of new chemical substances - series registration and joint registration
China New Chemical Substance Registration
2022-07-12

China's new chemical substance environmental management registration is divided into regular registration, simple registration and filing.


For regular registration and simple registration, in addition to an applicant applying for registration of a substance, there are other special forms.


1)Series registration


2) Joint registration



 


▌Series Registration


The original guidelines: The same applicant can apply for the registration of new chemical substances in the environmental management series if multiple new chemical substances with similar molecular structures, the same or similar uses and similar test data are applied together. The application registration volume is determined by the sum of the application registration volume of each substance.


Interpretation: When multiple new chemical substances applied for registration of new chemical substances by the same enterprise meet the following conditions at the same time.


① similar molecular structure.


② the same or similar uses.


③ test data are similar.


Can be registered for a series of registration, registration of multiple (not more than 6) new chemical substances.


 


Registration type.


According to the total amount of each substance applied for registration in the series registration to determine the type of registration.


The total sum of the application for registration volume of 10 tons or more for regular registration.


If the total amount of application for registration is 1-10 tons, apply for simple registration.

 

Data requirements for series registration.


Each new chemical substance in the series registration should provide all physicochemical property data separately. Health toxicology and ecotoxicology data can be jointly composed of test data of multiple new chemical substances in the series registration, but all new chemical substances in the series registration should submit at least one same health toxicology and ecotoxicology data.


Note: If a property (e.g., health toxicity) does not indicate that a series of substances have similar test results, all health toxicology and ecotoxicology data for each substance should be submitted separately.


Series of registered substances in addition to chemical substance identification and physicochemical properties, the implementation of data sharing within the series, the classification of strict and tight, the principle of application for registration of the cumulative amount of environmental risk assessment, only one environmental risk assessment report needs to be prepared.



After completing the registration, the applicant obtains a registration certificate for each new chemical substance in the series registration.



▌ Joint Registration


The original guideline: If more than two applicants apply for registration of the same new chemical substances for environmental management at the same time, they can jointly submit application materials for joint registration of new chemical substances for environmental management. The application registration volume is determined according to the sum of each applicant's application registration volume.


Interpretation: If multiple applicants apply for registration of the same new chemical substance at the same time, joint registration can be carried out.


 

Registration type.


The registration type is determined according to the sum of the registration volume applied for by each applicant in the joint registration.


For regular registration if the sum of the application for registration volume is 10 tons or more.


Application for registration of the sum of 1-10 tons, for simple registration.


 

Data requirements for joint registration.


In joint registration, all applicants jointly submit a complete application package with only one set of minimum required data for physicochemical property data, health toxicology and ecotoxicology data.


 

Upon completion of registration, all applicants for joint registration are issued separate registration certificates.


 

Advantages of series registration and co-registration.


Series registration and co-registration, both by reducing the reproducibility of test data, result in.


1) saving test costs and reducing registration costs.


2) reduce duplicate animal testing, contributing to animal welfare.


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