Announcement No.269 of the Ministry of Agriculture and Rural Affairs of the People’s Republic of China

In order to implement the principle of the State Council’s reform to streamline administration, delegate powers, and improve regulations and services, promote the export trade of pesticides, and optimize the business environment, measures on the registration of pesticides that are not used within the territory of China (short for Export-only Pesticide) are announced as follows in accordance with ‘Regulation on Pesticide Administration’ and ‘Administrative Measures on Pesticide Registration’.

1. The application scope for Export-only Pesticide Registration
For pesticides registered abroad or licensed by the importing country or region, manufacturers may apply for the registration of Export-only Pesticide when meeting one of the following conditions
(1)  A manufacturer that can apply for the Export-only registration for TC of an active ingredient with contents other than the registered content within the territory of China, must hold the registration certificate of a Technical Material (TC) of the same active ingredient within the territory of China.
(2)  A manufacturer that can apply for the Export-only registration for the formulation of single active ingredient with contents or formulation types other than those registered within the territory of China, must hold the registration certificate of a TC or a formulation with the same active ingredient within the territory of China
(3) A manufacturer that can apply for the Export-only registration for the mixture of some active ingredients with contents, ratios or formulation types other than those registered within the territory of China, must hold the registration certificate of a mixture with the same active ingredients within the territory of China
If the number of active ingredients in the mixture exceeds the specified quantity of the Article 8 of the ‘Administrative Measures on Pesticide Registration’, the excess part of active ingredients shall be registered within the territory of China.
(4) Manufacturers that produce a new TC can apply for the registration of this TC and its formulations.
(5) Other circumstances specified by the Ministry of Agriculture and Rural Affairs.

2.  Data requirements on Non-new Pesticide Export-only Registration
(1) Application form for Pesticide Registration ( Export only option).
(2) Valid overseas Registration certificates, Import license or other verification documents by the importing country or region to acknowledge the import (Manufacturers shall submit the convincing documents to verify the business partnership in the case of inconsistencies of applicants and the documentation.).
(3) Commitment letter for not selling or distributing within the territory of China( Signed and sealed by the company’s legal person).
(4) Product overview, summary of overseas registration data, explanation on the source of TC and other relevant materials.
(5) Product chemistry (Product quality specifications and product quality test report. Full component analysis shall also be submitted in the case of TC) and toxicology (Acute oral toxicity, acute percutaneous toxicity and acute inhalation toxicity test reports) data as well as information on toxicity symptom, the first aid and therapeutic measures.
(6) A copy of the Pesticide Production License and its production range should be consistent with the product being applied for.

3.  Data requirements on New Pesticide Export-only Registration
Manufacturers that apply for the Export-only registration for new TC shall submit the following data, in addition to the data required by Article 1 (1) to (5) for non-new pesticides:
(1) Physic-chemical properties of the active ingredient and TC as well as the reference samples.
(2) Test report abstract or information inquired on skin irritation, eye irritation, skin sensitization, acute neurotoxic, subchronic oral toxicity, subchronic (acute) transdermal and inhalation toxicity, mutagenicity, teratogenicity, two-Summary generation reproduction toxicity, chronic and carcinogenicity, metabolism and toxicokinetics of the TC.
(3) Copy of the approval documents on the Environment Impact Assessment and Safety Production Evaluation of the TC.
Manufactures that apply for the Export-only Registration for new pesticide formulations shall submit data according to Data Requirements on Non-new Pesticide Export-only Registration.

4. Supplementary Provision
(1) The application, examination and approval procedures of Registration, Registration Change and Registration Renewal for Export-only Pesticide shall be in accordance with the procedures pertaining to Pesticide Registrations, Registration Change and Registration Renewal within in the territory of China. The Pesticide Registration Certificate Number shall be “EX + Year + Serial Number”, such as ‘EX20200001’. ‘Export-only’shall be remarked on the certificate.
(2) In the event of an identical or similar formulation being granted registration in China, no Export-only registrations shall be granted, and renewals of granted registrations shall be approved for no more than once.
(3) Applicants that can apply for Export-only registration of TK must be its TC manufacturers. Data requirements should be the same as those on the formulation with single active ingredient.
(4) Manufactures that have the Export-only Registration Certificate of a new pesticide TC can produce and export the product only after a corresponding Pesticide Production License has been obtained.
(5) Manufacturers that have the Export-only Registration Certificate of pesticides can only export pesticides to the countries or the regions in which they have obtained the registration certificate or import license..
(6) Manufacturers are prohibited to sell or distribute any Export-only pesticide product within the territory of China. Violators shall be dealt with in accordance with the ’Administrative Measures on Pesticide Registration’.
(7) The Regulation shall become effective as of the date of issuance.

                                                                                                                                                                Ministry of Agriculture and Rural Affairs

                                                                                                                                                                                                                   8th June,2020

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