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Temporary Registration of Pesticides

DATE:2010-08-04       SOURCE:MOA
 

Date:07-26-2010

Source:MOA

 

Project Name: Temporary Registration of Pesticides

Project Category: Approval after Examination

 

Approval Content:

1. Whether confirm to the relevant provisions of regulations and policies of the state

2. Whether the product is effective or its quality is controllable, it is safe to human, animal, environment and other creatures.

3. Whether the application information and data is authentic, conform to relevant test standard requirement

4. The applicant qualifications

 

Legal Bases:

1. Administrative Regulations of the People's Republic of China on Pesticides

2. Methods for the Implementation of Administrative Regulations of the People's Republic of China on Pesticides (Promulgated by the No. 20 Order of Agriculture Ministry in 1999, modified by the No. 18 Order of Agriculture Ministry in 2002, by the No. 38 Order of Agriculture Ministry in 2004, by the No. 9 Order of Agriculture Ministry in 2007 )

3. Data Requirement of Pesticide Registration (Promulgated by the No. 10 Order of Agriculture Ministry in 2007)

 

Business Conditions:

1. Domestic applicant shall submit the opinions signed by the provincial pesticide certification institutions.

2. Shall submit the following materials in two copies with completely uniform content. One copy shall be original; the other shall be the duplicate. (But possess 6 copies of application forms and product abstract information). The duplicate materials on the product chemical information, toxicology information, potency, residue, environment influence, package and label and so on these materials shall be bound in different volumes with application form, product abstract material. The electronic text of application forms, product abstract information and product safety data sheet shall be provided.

⑴ Temporary Registration of Pesticides

 The following materials shall be provided for new pesticides:

Parent drug:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, environment influence, foreign registration status and so on)

B. Product chemical information (effective ingredient, parent drug).

C. Toxicology information

D. Environment influence information

E. Label or attached instructions

F. Product safety data sheet (MSDS)

G. Other materials: The toxicology, environment influence, registration information or comprehensive inquiry report and so on possessed by other countries or areas.

Pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (effective ingredient, parent drug, pharmaceutics).

C. Toxicology information

D. Potency information

E. Residue information

F. Environment influence information

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence, registration information or comprehensive inquiry report and so on possessed by other countries or areas.

The following materials shall be provided for special new pesticide product:

. Patent dug of public health pesticide (rodenticide, biochemical pesticide, botanical pesticide):

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, environment influence, foreign registration status and so on)

B. Product chemical information (effective ingredient, parent drug).

C. Toxicology information

D. Environment influence information

E. Label or attached instructions

F. Product safety data sheet (MSDS)

G. Other materials: The toxicology, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas.

Pharmaceutics of public health pesticide

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (effective ingredient, parent drug, pharmaceutics).

C. Toxicology information

D. Potency information: as including indoor activity determination test report; Mixture purpose instruction and indoor formula selection report (For mixture pharmaceutics); Indoor potency determination test report for more than one year of more than two provincial administrative regions; simulated field test report for more than one year issued of more than two provincial administrative regions (pharmaceutics for indoor usage); field test report (anti-termite pharmaceutics and pharmaceutics for external environment) for more than one year of more than two provincial administrative regions in our country and so on.

E. Environment influence information

F. Label or attached instructions

G. Product safety data sheet (MSDS)

H. Other materials: The toxicology, potency, residue, environment influence, registration information or comprehensive inquiry report and so on possessed by other countries or areas.

Rodenticide pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (effective ingredient, parent drug, pharmaceutics).

C. Toxicology information

D. Potency information: For the rodenticide used in the field, forest, grassland, the potency test report for more than two years of more than two provincial administrative regions shall be provided; For the rodenticide used in other conditions, the potency test report for more than one year of more than two provincial administrative regions shall be provided;

E. Residue information (For the rodenticide applied roundly)

F. Environment influence information

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas. (Domestic enterprises) and so on

. Biochemical pesticide pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (effective ingredient, parent drug, pharmaceutics).

C. Toxicology information

D. Potency information:

E. Residue information (Provide in accordance with the characteristics and usage method of pesticides upon the opinions of the Review Committee)

F. Environment influence information (The silkworm acute toxicity test report shall be provided. For the pesticides producing special risk to the environment, they shall provide the supplemental information on environment influence)

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas. (Domestic enterprises) and so on

Parent drug of microbial pesticides:

A. Product abstract information (Brief descriptions of product chemistry,biological characteristics, toxicology, environment influence, foreign registration status and so on)

B. Information of product chemical and biological characteristics (effective ingredient, parent drug).

C. Toxicology information (The testimonial document on the confirmation that the effective ingredients aren’t known pathogens of human being or other mammals; basic toxicology information; supplementary toxicology information.)

D. Environment influence information

E. Label or attached instructions

F. Product safety data sheet (MSDS)

G. Other materials: The toxicology, environment influence test, registration information or comprehensive inquiry report possessed by other countries or areas; the release variation circumstance or its risk statement and so on in the environment.

Microbial pesticide pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Information of product chemical and biological characteristics (effective ingredient, parent drug, pharmaceutics).

C. Toxicology information (The testimonial document on the confirmation that the effective ingredients aren’t known pathogens of human being or other mammals; basic toxicology information; supplementary toxicology information.)

D. Potency information:

E. Residue information (Provide in accordance with the characteristics and usage method of pesticides upon the opinions of the Review Committee)

F. Environment influence information (birds acute oral toxicity test, fish acute toxicity test, bee acute oral toxicity test, bee acute contact toxicity test, silkworm acute toxicity test)

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas; the release variation circumstance or its risk statement and so on in the environment.

Botanical pesticide pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (effective ingredient, parent drug, pharmaceutics).

C. Toxicology information

D. Potency information: as including indoor activity determination report of effective ingredient standard samples or parent drug and pharmaceutics (If have provided in the field test phrase, they shall the duplicate); For indoor safety test report of the present tested crop (If have provided in the field test phrase, they shall the duplicate); The field plot test report.

E. Residue information

F. Environment influence information

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

. Transgenic biological pesticide:

A. Product abstract information (Brief descriptions of genetic engineering body, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Genetic engineering body profile.

C. Toxicology information: (The safety of genetic engineering body to mammal (rat) acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, skin sensitization, agriculture product and so on)

D. Potency information:

E. Residue information (If there are toxicity problems demonstrated by toxicological determination, they shall determine the toxic matter residues of agriculture product.)

F. Environment influence information (The influence of genetic engineering body to the environment, the decomposition characteristics of genetic engineering body residues, the influence of genetic engineering body residues to the environmental creature)

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

. Natural enemy bio-pesticide

A. Product abstract information (Brief descriptions of biological properties, effect, environment influence, foreign registration status and so on these information)

B. Biological property and product quality control requirement and testing method

C. Potency information (The field potency test reports for more than two years of more than two provincial administrative regions; biological activity and safety data; application risk prediction and control measures; product characteristics and precaution in use).

D. Influence to crops

E. Influence to environment (Influence to state protected species, beneficial creature, and non-target creature, the possibility of hybridizing with local species or small species and influence and so on).

F. Label or attached instructions

G. Product safety data sheet (MSDS)

H. Other materials: The biological characteristics, product quality control requirement, potency, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

The following materials shall be submitted for new pharmaceutics:

New formulation:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on these information)

B. Product chemical information (effective ingredient, parent drug, pharmaceutics).

C. Toxicology information

D. Potency information

E. Residue information

F. Environment influence information

G. Label or attached instructions 

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

Minor optimization of pesticide formulations

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on these information)

B. Product chemical abstract information (effective ingredients, pharmaceutics)

C. Toxicology abstract information

D. Potency information

E. Residue information (If complying with one of the following conditions, in the case of providing residue test result abstract information of our country or relevant written statement, it isn’t necessary to provide the residue test report: A. If the registered formulation of the enterprise corresponding with the formulation minor optimization possesses the residue test information, the application amount of effective ingredient of the product applying for formulation minor optimization is lower than 1.5 times of the application amount of effective ingredient of the original formulation; B. The applicant already possessed residue information has formally obtained the registration of the same effective ingredient, formulation, usage scope and method for more than 6 years in our country, the application amount of effective ingredient of the product applying for formulation minor optimization is lower than 1.5 times of the application amount of its effective ingredient; C. If providing the authorization of the registered person possessing the product residue information of the same effective ingredient, formulation, usage scope and method independently, the application amount of effective ingredient of the product applying for formulation minor optimization is lower than 1.5 times of the application amount of its effective ingredient; )

F. Environment influence information

G. Label or attached instructions 

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

New mixture pharmaceutics, new medical fertilizer mixture pharmaceutics

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on these information)

B. Product chemical information (effective ingredients, parent drug, pharmaceutics)

C. Toxicology information

D. Potency information

E. Residue information (If the effective ingredient contained in the product complying with one of the following conditions, in the case of providing residue test result abstract information of our country or relevant written statement, the corresponding residue information requirement can be exempted: A. The applicant already possessed residue information has formally obtained the registration of the same effective ingredient, formulation, usage scope and method for more than 6 years in our country, the application amount of effective ingredient of the product applying for mixture pharmaceutics registration is lower than 1.5 times of the application amount of its effective ingredient; B. If providing the authorization of the registered person possessing the same effective ingredient, formulation, usage scope and method information independently, the application amount of effective ingredient of the product applying for mixture pharmaceutics registration is lower than 1.5 times of the application amount of its effective ingredient;)

F. Environment influence information

G. Label or attached instructions 

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

. New content:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on these information)

B. Product chemical information (effective ingredients, parent drug, pharmaceutics)

C. Toxicology information

D. Potency information (If the applicants apply for new content for the registered product of their enterprise, they shall implement the field plot potency test of more than one year for the product with changed effective ingredient content.)

E. Residue information (If complying with one of the following conditions, in the case of providing residue test result abstract information of our country or relevant written statement, the requirement for relevant residue information can be exempted: A. The applicant already possessed residue information has formally obtained the registration of the same effective ingredient, formulation, usage scope and method for more than 6 years in our country, the application amount of effective ingredient of the product applying for registration is lower than 1.5 times of the application amount of its effective ingredient; B. If providing the authorization of the registered person possessing the product residue information of the same effective ingredient, formulation, usage scope and method information independently, the application amount of effective ingredient of the product applying for registration is lower than 1.5 times of the application amount of its effective ingredient;

F. Environment influence information

G. Label or attached instructions 

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

. New penetrant (or synergist) and pesticide mixture pharmaceutics

A. Common name, chemical name, structural formula, basic physicochemical properties, content, test method, source, safety, domestic and foreign usage circumstance and so on of relevant penetrant and synergist.

B. Indoor formula selection report of relevant penetrant and synergist.

C. While the applicants apply for the product registration as having the same effective ingredients, categories, content and formulation with the product of its own enterprise, but adding the product registration of penetrant or synergist, they may submit the information in accordance with new content registration, but submit other information in accordance with new formulation or new mixture pharmaceutics.

The following materials shall be submitted for the same pesticide products:

For the pesticide containing effective ingredients obtained the registration in our country and with the registered information being within protection period, they shall submit materials in accordance with the regulations of new pesticide registration information.

For the same pesticide product aside from the item as obtained the temporary registration requirements, they shall submit the single- pharmaceutics materials in accordance with the temporary registration requirements of new content pharmaceutics; they shall submit mixture pharmaceutics materials in accordance with the temporary registration requirements of new mixture pharmaceutics.

The following materials shall be submitted for the pesticide product with expanded usage scope and changed usage method:

. Expand usage scope:

  A. Product abstract information (Brief description of potency, residue, environment influence, foreign registration status and so on these information)

  B. Potency information

  C. Residue information (Being the same as the temporary registration residue information requirement of the registered pesticide varieties to which the products applied for registration belong.)  

  D. Environment influence information (While adding the registered usage scope or usage method, the materials provided for previous pesticide registration product can’t meet the environment safety evaluation requirement, relevant environment influence test information shall be added. )

  E. Label or attached instructions 

  F. Other materials

Change usage method:

  A. Product abstract information (Explain the potency, residue, environment influence, foreign registration status and so on these information simply, and purpose and meaning for changing usage method)

  B. Potency information

  C. Residue information (Being the same as the temporary registration residue information requirement of the registered pesticide varieties to which the products applied for registration belong.)

  D. Environment influence information (The change of usage method results in that the materials provided for previous pesticide registration product can’t meet the environment safety evaluation requirement, relevant environment influence test information shall be added. )

  E. Label or attached instructions 

  F. Other materials

 

Handing Procedures:

1.  Materials Acceptance. The comprehensive administrative examination and approval office of Agriculture Ministry shall accept the Application Form of Temporary Registration of Pesticidesand other relevant materials submitted by the applicant (foreign products) or provincial pesticide certification institutions (domestic products).  .  

2. Technology Examination. The Institution for the Control of Pesticides of Ministry of Agriculture shall implement the technology examination to the application materials in accordance with relevant regulations of the state.  

3. Expert Evaluation: The pesticide temporary registration evaluation committee of Agriculture Ministry shall evaluate the application information. 

3. Handing Approval Document. The Department of Crop Farming Administration of Agriculture Ministry shall propose approval plan in accordance with the evaluation opinions, submit these for examination and approval of the Minster and handle the approval document.

 

Time Commitment: 10 business days (The term for technology examination and expert evaluation shall not exceed 3 months)

Fee Scale: 500 Yuan/per product (change usage scope: 100 Yuan/crop)

1. The Notice of Administrative Institutional Fees Items and Standards of Agriculture System of previous State Price Control Bureau and Finance Ministry ( Jia Fei [1992] No.452 )

2. The Notice of the State Planning Commission and Finance Ministry on Pesticide Registration Fees Standard Adjustment (Ji Jia Fei [1996] No.1718)

3. The Notice of the State Planning Commission and Finance Ministry on Uniting Domestic and Foreign Dual Fees Standards (Ji Price [2001] No.523)

 

Contact Information

Mail:   To: Pesticide Desk

Address: Administrative Examination and Approval Office

Ministry of Agriculture

No.11 Nongzhanguan Nanli, Chaoyang District, Beijing, China

Postcode: 100125  

 

(All information posted in this website is authentic in Chinese. English version is provided for reference only.)

 

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