Newsletter Issue 1, 2020 20200613

 

 

  Announcement No. 269 of the Ministry of Agriculture and

  Rural Affairs, China 

 

     In order to implement the State Council's " Streamline administration, delegate powers,

    and improve regulation and services", promote pesticides export, and optimize the

    business environment, according to the” Regulations on the Management of

    Pesticides” and the “Measures on the Management of Pesticide Registration”, the

    relevant matters concerning the registration of exported pesticides which are not used

    in China (hereinafter referred to as " Export-only Pesticides ") are hereby announced as

    follows.

 

    I. Scope of registration application for export-only pesticides
    If one of the following conditions is met, a pesticide production enterprise may apply

    for export-only pesticide registration when a product has obtained a pesticide

    registration abroad or obtained an import permit from the importing country (region).
 

  (1)The enterprise has already obtained the registration of the TCs within the territory

    of  China,and applies for registration of different contents of the TCs with the same

    active ingredients.

 

  (2)The enterprise has obtained the registration of TCs or single formulation within the

    territory of China, and applies for registration of different content and different

    formulation type of the single formulation with the same active ingredient,.
 

   (3)The enterprise has obtained the registration of ready-mixtures within the territory

    of China, and applies for registration of different contents and different formulation

    types of the ready-mixture with the same active ingredients,.

 

    If the number of active ingredients in the ready-mixture exceeds the relevant provisions

    of Article 8 of the “Measures on the Management of Pesticide Registration”, the

    exceeding active ingredients shall be registered within the territory of China.
 

  (4)The enterprise that produces the new pesticide applies for the TC and its

    formulation registration.


   (5) Other conditions prescribed by the Ministry of Agriculture and Rural Affairs.
 

    II. Data requirements of registration application for export-only non-new

    pesticides.  

 

  (1) Pesticide registration application form (select export-only option).

 

  (2) Valid documents of overseas registration certificate or import approval issued by

    the importing country (region) (if the name of the application enterprise in the

    documents are inconsistent, persuasive materials of business cooperation shall be

    provided).
 

  (3)Letter of commitment that enterprise does not sell or use the export-only

    pesticides in China (signed by the legal representative and stamped with the seal of

    the enterprise).
 

  (4) Product overview, summary of overseas registration data, description of TC source

    and other relevant materials.
 

  (5) Product chemical data (product quality standard, quality test report, TC shall also

    provide the full component analysis report), toxicology test data (acute oral, dermal,

    inhalation toxicity test report), poisoning symptoms, first aid and treatment measures.

 

  (6) A copy of the pesticide production license in line with the production scope of the

    product applied for.

  

    III. Data requirements of registration application for export-only new pesticides.
    Where to apply for registration application of export-only new pesticide, in addition to

    the items (1) to (5) of application requirements for export-only non-new pesticides , the

    following information shall also be provided:

 

   (1) The physical and chemical properties data of the active ingredient and the TC, as

    well as the standard substance.
 

  (2)Abstract or inquiry data of skin irritation, eye irritation, skin sensitization, acute

    neurotoxicity, subchronic oral toxicity, subchronic (acute) dermal and inhalation toxicity,

    mutagenicity, teratogenicity, two generation reproductive toxicity, chronic and

    carcinogenicity, metabolism and toxicokinetics of the TC.
 

  (3) Copies of the approval documents for the environmental impact and safety

    production evaluation of the TC.
 

    Where to apply for the registration of export-only new pesticide formulation, the data

    shall be provided according to the application requirements for export-only non-new

    pesticide
 

    IV. Others
  (1) Export-only pesticides shall be supervised with the procedures of pesticide

    registration, registration change, registration renew application and data review, and its

    pesticide registration certificate number code is "EX + year + serial number", such as

    EX20200001. "Export-only" is indicated on the pesticide registration certificate.

 

  (2) Where the same or similar formulations have been registered within the territory

    of China, the pesticide product shall not be approved for export-only, and for those

    already approved, registration application for export-only shall not be renewed more

    than once.
 

  (3) The enterprise applies for registration of export-only TK, it shall be the TC

    production enterprise of the applied TK, and the data requirements shall be as same

    as those of the formulation.
 

 (4) Where the registration of export-only new pesticide is approved, it can be

    produced and exported after obtaining the corresponding production license.
 

  (5) Export-only pesticide products can be exported to the countries (regions)

    where they have obtained the registration certificates or import approvals.

 

  (6) It is prohibited to sell export-only pesticide products in China. If it’s found

    violating the rules, it shall be punished pursuant to the Regulations on the

    Management of Pesticides with the relevant provisions of not obtaining the

    registration of domestic use.
 

  (7) This announcement shall be implemented as of the date of promulgation.

 

   

                                                                  Ministry of Agriculture and Rural Affairs
                                                                                                    June 8, 2020

      

 

  Contact: 

   Croplife China

   Tel: 8610-65254970;
   Fax: 8610-65254771;
   Email:
info@croplifechina.org;
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www.croplifechina.org;
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   Avenue, Beijing, P.R.China 100004