Management Requirements for Transfer and Authorization of Pesticide Registration Data, Pesticide Entrusted Processing and Sub-packaging

In 2017, the implementation of the new revised edition of Regulation on Pesticide Administration, Measures on Administration of Pesticide Registration, Data Requirements on Pesticide Registration and other laws and supporting regulations improved the test requirements for registration of various pesticides, resulting in the extension of pesticide product registration time and significant increase in registration costs. However, for pesticides produced, traded and used in China, the registration is mandatory and is an essential step. As a shortcut of registration under the new policy, the transfer and authorization of pesticide registration data, pesticide entrusted processing and sub-packaging are valued by pesticide enterprises. So, what do enterprises need to know about the transfer and authorization of pesticide registration data, and the entrusted processing and sub-packaging of pesticides? What should be paid attention to? CIRS will introduce relevant information as follows.

1. Transfer of pesticide registration data

The content of transfer involved in the Regulation on Pesticide Administration is the transfer of registration data, while the pesticide registration certificate cannot be transferred. As the pesticide registration certificate is the certification document that the national legal authorities approve the pesticide enterprises to produce and sell their pesticide products, it is an administrative license in the sense of law and follows the provisions of the Administrative License Law. According to Article 9 of the Administrative License Law, "the administrative license obtained according to law shall not be transferred except where laws and regulations provide that it may be transferred according to legal conditions and procedures." In addition, according to Article 47 of the Regulation on Pesticide Administration, "it is prohibited to forge, alter, transfer, lease, lend the pesticide registration certificate, pesticide production license, pesticide business license and other license documents." Article 62 stipulates that "in case of forgery, alteration, transfer, lease or lending of pesticide registration certificate, pesticide production license, pesticide business license and other license documents, the license issuing authority shall take over or revoke the certificates or licenses, confiscate the illegal income and impose a fine of not less than 10000RMB but not more than 50000RMB. If a crime is constituted, criminal responsibility shall be investigated according to law." It can be seen that the pesticide registration certificate is an administrative license, which cannot be forged, altered, transferred, leased or lent, otherwise the pesticide enterprises will face severe punishments.

However, according to Article 14 of the Regulation on Pesticide Administration, new pesticide developers can transfer the registration data of new pesticides they have obtained. The pesticide manufacturers can transfer the registration data of registered pesticides to the pesticide manufacturers with corresponding production capacity, which indicates that the pesticide registration data can be transferred. The transferor must be a new pesticide developer or domestic pesticide manufacturers who have obtained the pesticide registration certificate in China, and the overseas enterprise which has obtained the pesticide registration certificate shall not transfer its pesticide registration data. The transferee shall be a pesticide production enterprise with corresponding production capacity, that is to say, the transferee shall obtain the pesticide production license that includes at least the technical material (TC) varieties or formulations of the transferor.

In case of transfer of pesticide registration data, the transferee shall apply for pesticide registration based on the transfer agreement of both parties and the registration data meeting the requirements. After the data transfer, the pesticide registration certificate of the transferor will be cancelled, the transferee can then obtain the registration.

2. Authorization of pesticide registration data

According to Article 18 of the Measures on Administration of Pesticide Registration, the holder of pesticide registration certificate can authorize other applicants to use the complete registration data that meets the new registration data requirements and are independently owned by the holder. The authorizer shall be the new pesticide developer, domestic pesticide manufacturers or overseas enterprise who has obtained the pesticide registration certificate, and the only "obligee" who can authorize the rights externally. The pesticide registration certificate shall be in valid status. The registration data shall not be authorized if the pesticide registration certificate has not been obtained or has expired. The authorized party shall be the new pesticide developer, domestic pesticide manufacturers or overseas enterprise. The authorized party shall not authorize its registration data to other enterprises after receiving the authorization data. The authorized data shall meet the new revised edition of Data Requirements on Pesticide Registration, and shall be independently completed and owned by the authorized enterprise. The authorized data can only be authorized in full, not in part, but can be licensed to multiple enterprises in one time.

Unlike the transfer of pesticide registration data, the authorizer still has the ownership of its pesticide registration certificate after authorizing other enterprises to use the pesticide registration data.

3. Pesticide entrusted processing and sub-packaging

According to Article 19 of the Regulation on Pesticide Administration, if the pesticide is entrusted to be processed or sub-packed, the consignor shall obtain the corresponding pesticide registration certificate, and the consignee shall obtain the pesticide production license. The consignor shall be responsible for the quality of pesticides entrusted for processing and sub-packaging.

3.1 Subject of pesticide entrusted processing

Consignor: The corresponding pesticide registration certificate shall be obtained, and shall be the new pesticide developers or domestic pesticide manufacturers. An overseas enterprise that has obtained the Chinese pesticide registration certificate shall not be the consignor of pesticide entrusted processing, nor shall it entrust a domestic pesticide manufacturers to process pesticides.

Consignee: The corresponding pesticide production license shall be obtained. That is to say, the entrusted processing to be accepted is the pesticide formulation type consistent with the corresponding production license.

3.2 Subject of pesticide sub-packaging

Consignor: The corresponding pesticide registration certificate shall be obtained, and shall be the new pesticide developers, domestic pesticide manufacturers or overseas enterprises.

Consignee: The corresponding pesticide production license shall be obtained. That is to say, the pesticide entrusted sub-packaging to be undertaken shall be within the scope of pesticide production license.

3.3 Legal responsibility

The pesticide consignor shall be responsible for the quality of pesticides entrusted for processing and sub-packaging. If a consignee who has not obtained a pesticide production license is entrusted to process and sub-package pesticides, or to process and sub-package fake pesticides or inferior pesticides, the consignor and the consignee shall be punished in accordance with the relevant provisions on the production of fake pesticides or inferior pesticides. If a crime is constituted, criminal responsibility shall be investigated according to law.

4. Key summary and points for attention

4.1 The pesticide registration certificate cannot be transferred, while the pesticide registration data can be transferred;

4.2 The registration data of each pesticide product can only be transferred once, while the authorization of registration data is unlimited, which can be used by one or more enterprises at the same time;

4.3 Overseas enterprises are not permitted to transfer registration data to domestic enterprises, and are not permitted to entrust domestic pesticide manufacturers to process pesticides. However, overseas enterprises are permitted to entrust domestic pesticide manufacturers to sub-package large package pesticide products into small packages, however the entrusted pesticide manufacturer must have the pesticide production license;

4.4 The pesticide products entrusted for processing and sub-packaging can only be the preparation products(formulations), not the technical material (TC) or technical concentrate (TK) products;

4.5 The label of the entrusted processing or sub-packaging pesticide shall indicate the pesticide production license number, name, contact information of the consignee and the processing and sub-packaging date. The pesticide exported to China may not be marked with the pesticide production license number, but shall be marked with its overseas production place, as well as the name and contact information of the office or agency established in China.

Table 1 Summary of Transfer and Authorization of Pesticide Registration Data and Entrusted Processing and Sub-packaging of Pesticides

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