Chinese Pesticide Legislation Overview

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The Institute for the Control of Agrochemicals under the Ministry of Agricultural (ICAMA) was established in 1963 to ensure the quality and proper use of crop protection products. After the upheaval witnessed during the Cultural Revolution, ICAMA was reorganized by the State Council in 1978 as the primary administrative body of pesticide management. On April 20 1982, the Ministry of Agricultural (MoA), Ministry of Forests (former), Ministry of Chemical industry (former), Ministry of Commerce (MOFCOM) and the environmental protection panel under the State Council jointly issued the “Provision on Pesticide Registration” and the “Data Requirement on Pesticide Registration”, which initiated China’s registration system of pesticide products. With the promulgation of “Regulation on Pesticide Administration” (also known as “Regulation for the Control of Agrochemicals”) by the State Council on May 8, 1997, China had its first comprehensive legislative and regulatory framework in place to manage pesticides. The foundation this regulation provided allowed other ministries and departments to formulate various supporting measures or rules to regulate all links in the pesticide supply chain.

China Pesticide Regulation:
Regulation on Pesticide Administration ( Regulation on the Control of Agrochemicals)
History
8 May 1997First issued under Decree 216
29 Nov 2001Revised by Decree 326
20 Jul 2011Public Consultation on Revised Draft
Main supporting legislation in force
8 Jan 2008MoA Order 10 of 2007
1 Jan 2005NDRC Order 23
5 Feb 2013AQSIQ Announcement 23
7 Apr 1995SAIC & MoA Order 30 of 1995
1 Dec 2006MoA Announcement 739
1 Aug 2014GB 2763-2014

China Pesticide Legislative Framework

Regulation/MeasuresIssuing BodyScope
Measures for Implementing the Regulation on Pesticide Administration(MoA order 9 of 2007)
《农药管理条例实施办法》
MoAIt stipulated  the entities and the competent authorities involved in registration ,marketing, use and supervision of pesticide:
MoA is responsible for the supervision of registration and use of pesticide nationwide;
ICAMA is responsible for  the  implementation of pesticide registration;
Data Requirement on Pesticide Registration(firstly issued in 2001 and replaced by MoA order 10)
《农药登记资料要求》
MoAData requirement of all types of pesticide registration such as new pesticide, generic, export purpose and repacking, etc.
Measures for the Administration on the Manufacturing of Pesticide(Order 23 of National Development and Reform Commission) 《农药生产管理办法》NDRCAll pesticide manufacturing companies should firstly acquire manufacturing authorization from NDRC (now known as MIIT);
When the national or industrial quality standard for certain kinds of pesticide has not been established, manufacturers should obtain the approval certification of pesticide manufacturing from MIIT;
Depending on the quality standard of the product may alternatively need to acquire a production license from the AQSIQ;
MIIT is responsible for drafting the industrial quality standard of pesticide products and issuing the approval certification of pesticide manufacturing
Rules for Implementing Production License on Pesticide ProductsAQSIQIf China has established a national quality standard or an industrial quality standard  for the product, manufacturers should obtain the production license from AQSIQ;
Measures for the Management of Pesticide Label and Manual
《农药标签和说明书管理办法》
MoA order 8 of 2007
MoAThe Measures specified the content and requirement of pesticide label and use manual, which should be submit the MoA when applying for pesticide registration;

Procedures for Restricting Pesticide Uses-MoA Order 17 of 2002农药限制使用管理规定》
 

MoAThese rules detail the preconditions and procedures of banning/restricting pesticide products locally or nationwide

Measures for Examination of Pesticide Advertisement
SAIC&MoA Order 30 of 1995, revised by SAIC&MoA Order 88 of 1998
《农药广告审查办法》

SAIC,MOAAll advertisement of pesticide products should be reviewed by the competent authorities before placed on the media;
The advertisement should be reviewed by agricultural department under the State Council or the agricultural department at a provincial level, which should be instructed by the advertisement supervision authorities at the same level.
Measures for the Management on Testing Facilities for Pesticide RegistrationMoAThe physicochemical, residual, efficacy, toxicological and environmental data for pesticide registration should be generated by testing facilities approved by the MoA. ICAMA is responsible for both management and supervision of these testing facilities.
Measures for the GLP Accreditation of Pesticide Laboratories -MoA Announcement 739MoAChina is introducing GLP standards for testing facilities. ICAMA is responsible for reviewing and supervising these GLP labs.
GB 2763-2014 National food Safety Standard-Maximum Residue Limits for Pesticides in FoodMoA and MoHThis national compulsory MRL standard is mainly formulated by the MoA and jointly issued by the MoA and the MoH

Ministry/Administration Involved in Pesticide Regulation

Ministry/AdministrationRegulatory Duties
Ministry of Agriculture (MoA)Pesticide registration;
market supervision;
MRLs formulating and monitoring;

Ministry of Industry and Information Technology (MIIT)

Authorization of pesticide manufacturing companies;
issuing the approval certification for pesticide manufacturing to the manufacturing companies when China has not yet established national quality standard or industrial standard for their product; Quality monitoring of the product, issuing industry quality standard for pesticide products;
General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)Issuing the production license to pesticide manufacturing companies when national quality standard industrial standard of the product has been established and monitoring the quality of the product, issuing national quality standard of pesticide products;
State Administration for Industry and(SAIC)Issuing the business license to pesticide manufacturers or retailers;
trademark registration;
quality supervising of pesticide circulating on crop protection market;
Ministry of Health(MoH)Treatment of pesticide poisoning; issue the MRL standard jointly with the MoA;
Ministry of Environmental Protection(MEP)Environmental impact assessment of pesticide manufacturers;
Monitoring pesticide residue in environment;

 

Pesticide Registration

Fig. 2 -Pesticide Registration Procedure

Fig. 1 -Three Registration Phases

Depending on the novelty and data availability of the product, pesticide registration can be classified into field trial, temporary registration and full registration:

Field Trial

New pesticides need to undergo field trial. The pesticide must firstly undergo a preliminary examination launched by the control institute under the competent authority of agriculture at a provincial level.  Applications should be filed with the MoA for review. Upon approval by the MoA, a field trial contract with the MoA approved testing facilities is signed.  The field trial should be carried out according to the “pesticide field trial efficacy test guidelines”. Overseas application materials are directly reviewed by ICAMA.

 

Temporary Registration

After the Field Trial temporary registration may be necessary under the following circumstances:

  • If the initial field trial warrants a further demonstration trial above 10 hectares;
  • Trial marketing;
  • Use under special exceptional circumstances is needed,

The application material is initially examined by the control institute under the competent authority of agricultural at provincial level. Then the manufacturer should file application to the MoA for further comprehensive review. If the Expert Committee for Pesticide Temporary Registration is satisfied with the dossier, a temporary registration certificate of the technical or formulated product will be issued to the manufacturer. Overseas application materials are directly reviewed by ICAMA.

Full registration

After the demonstration trial and trial marketing the next barrier to commercial release of the product for manufacturers is the full registration application process. The application material will be preliminarily examined by ICAMA and then endorsed by other competent authorities of agricultural, health, environmental protection, industry, Customs. MoA will issue the registration certificate to the applicant if the application material reviewed satisfies the Expert Committee for Pesticide Registration.

 

ICAMA’s Internal Organization

In 2013, the Institute established a new division for pesticide reassessment, which replenish its administrative framework with 13 distinct departments, below is a brief overview of each department:

General Office-Day to day running of the office;

Planning and Finance Department-Responsible for budgeting and internal auditing;

Administration Department-Deal with administrative issues relating to registration review, pesticide label and issuing certificate, etc.;

Quality Control Department-Review chemical data and quality standard of pesticide product. Development of method/validation for chemical test and identifies the "me-too" products;

Efficacy Review Department-Review efficacy data and development of method/validation for efficacy test and registration guidelines for minor-crop pesticides and biopesticide, as well as identification of crop injury incidents;

Toxicological Review Department-Review toxicological data and development of method/validation on toxicological test and registration guidelines for household pesticide, as well as survey on pesticide poisoning incidents;

Residual Review Department-Review residual data and development of MRL and method/validation for residual test, as well as settle of MRL violations in agricultural produce;

Environmental Review Department-Review environmental behavior data and development of method/validation on environmental behavior test;

Registration Review Department (Office)-Deal with registration extension and pesticide restriction/ban. Oversights on plan/guideline of pesticide reassessment;

Inspection and Management Department-This department deals with pesticide regulatory violations and management on testing facilities for pesticide registration, as well as promotes GLP system among these testing facilities;

International Exchange and Service Department- formulating of functioning rules and inventory of pesticide importation/exploration and issuing the Clearance Notification for the Import/Export of Pesticide. Promote and manage international cooperation;

Information and Publicity Department-This department deals with information research on manufacturing, marketing and use of pesticide and changes to the public;

Codex Committee on Pesticide Residue Secretariat-Formulating and implementing CCPR’s working plan and preparing the CCPR’s annual conference as well as other tasks for CCPR’s host country;ICAMA’s Internal Organization

Production Management and Quality Control

In China all pesticide manufacturing activities are subject to production management. All new establishments (joint venture, branch-opening, adding pesticide manufacturing program by an existing non-pesticide manufacturers) of pesticide manufacturing companies should be authorized by the MIIT (formerly the NDRC) prior to the application for business license from the administrative department for industry and commerce. Manufacturers must undergo a preliminary examination launched by the competent authorities at provincial level which is then reviewed by NDRC (MIIT). NDRC (MIIT) will evaluate the personnel, production facilities, infrastructure, quality assurance system, pesticide registration, environmental facilities, feasibility study and other materials associated with production. If the manufacturer passes all the testing assessment criteria authorization is granted and publicly announced. Authorization (manufacturing qualification) is valid for five years and can be renewed.

Pesticide manufacturers are obligated to obtain manufacturing approval for each product they produce. Depending on the standard of the product, production license should be obtained from either AQSIQ or MIIT. If China has already established a national (the standard number usually begin with GB or GB/T) or industrial (the standard number usually begin with NY or NY/T, HG or HG/T) quality standard for the product, the manufacturer requires on-site inspection and sampling conducted by the competent authority of quality supervision at a provincial level prior to obtaining a production license from the AQSIQ. According to the “Administration of Production License for Industrial Products-Decree 440 of the State Council”, AQSIQ has detailed procedures and product ranges for pesticide products in the “Rules for Implementing the Production License on Pesticide Products”.

If China has not yet established national or industrial quality standard for the product, the company implements its own quality standards, the enterprise standard. In this instance it has to obtain approval documents from the MIIT by submitting application material as well as test report of the products. Initial approval is valid for two years (trial production period). After the trial production, the approval can be renewed. The renewed approval for technical material (TC/TK) product is valid for five years whereas for formulated or repackaged product the approval is valid for three years. The company should file the enterprise standard of the product to the competent authorities of quality and technical supervision and obtain a filling number of its enterprise standard.

 

Triplex Identification of Pesticide Products

Fig. 3 - A sample of Triplex Identification on Pesticide label

In China, the authenticity of the pesticide manufacturer and the product is verified by three numbers:

Pesticide Registration Certificate Number (also known as the ICAMA Certification Number)-the Number usually begins with two alphabetic characters and eight Arabic numerals. The alphabetic characters consist of four monograms: PD (crop-use pesticide under full registration), LS (crop-use pesticide under temporary registration), WP (household pesticide under full registration) and WL (household pesticide under temporary registration). The first 4 Arabic numerals represent the year when the product was approved for the registration and the other 4 Arabic numerals represents the sequence number of pesticide approved during that year.

ICAMA’s pesticide registration query portal (in Chinese):

http://202.127.42.135/a1.aspx

Approval Certificate of Pesticide Manufacturing/Production License Number

The production license numbers are in the form of “XK13-***-*****”. The “XK” is the abbreviation of pesticide production license and the “13” means the license was granted to a pesticide company. The three Arabic numerals after the first hyphen is the serial ID of the products, which are allocated by the AQSIQ for each kind of pesticide product and the following 5 Arabic numerals after the second hyphen is the company ID assigned by the AQSIQ.

AQSIQ’s production license query portal (in Chinese):

http://www.aqsiq.gov.cn/search/gyxkz/

The approval certificate Numbers are in the form of “HNP *****-A****”. “HNP” is the abbreviation of the approval document of pesticide manufacturing and the following five Arabic numerals represent the administrative region of the company. The alphabetic character after the hyphen represents the category of the product (fungicide, herbicide, insecticide, fumigant and PGR, etc.) and the following four Arabic numerals represent the sequence number allocated by MIIT.

MIIT’s approval certificate query portal (in Chinese):

http://gzly.miit.gov.cn:8080/datainfo/miit/nycpscpzzsmd.jsp

China Pesticide Approval Directory

ChemLinked Launched an online search toolbox called China Pesticide Approval Directory (CPAD), which collected over 55,000 records of pesticide products and its manufacturers approved by the above authorities andAll data in CPAD toolbox was exactly translated and displayed in English-Chinese Bilingually upon each query:

https://www.chemlinked.com/cpad

Quality Standard Number

If the standard of the product is established by the AQSIQ (national standard), the numbers are usually in the form of “GB (/T) *****-****”. The Arabic numerals before the hyphen represent the sequence number of the product and the last four numerals represent the issuing year of the standard. If the standard of the product is established by its producer, the quality standard number would be the filing number of the enterprise standard of the product, which was issued by the competent authorities of quality and technical supervision.

 

Import/Export Supervision

Import/export of pesticides included in the “Pesticide Inventory under Import/Export Management” are subject to joint supervision managed by customs and ICAMA. The inventory contains the pesticide active ingredients registered or permitted for import/ export in China. It was drafted and amended by customs and ICAMA and the last update was made at the end of 2012. The new inventory contains 1157 active ingredients, which includes all the active ingredients registered in China and 98% of the active ingredients commercially available worldwide.

All importers and exporters should obtain the Clearance Notification for the Import/Export of Pesticide, which indicate the name, volume, HS code, CAS No., toxicity, manufacturer, importer/exporter, exporting/importing country, use of the pesticide. Customs are responsible for inspecting the authenticity of imports including the information on the Custom Notification on a “one notification one custom declaration” basis. The identity and authenticity of pesticide is ensured as ICAMA can verify the registration status before each pesticide is cleared through customs.

The authorities also acknowledged that several of the chemicals included in the inventory are imported for other uses such as disinfectant, preservative and antifouling agent in other forms of final product. In this instance, they can be imported without pesticide registration as long as the importers submit sufficient documentation to ICAMA that the chemicals are for non-pesticide use. ICAMA will issue an “Archive-filling Certificate of Non-Pesticide Use Product” and customs will release the product.

 

Franchise Pesticide Marketing

According to the “Regulation on Pesticide Administration” and the “Measures for Implementing the Regulation on Pesticide Administration”, the following organizations listed below are allowed to engage in pesticide marketing activities:

Among them, the warehousing and transporting companies under state-owned food supply system are allowed to market pesticides for grain storage and the department store/supermarket are allowed to sell household pesticide.

China adopts franchised management on pesticide marketing. All other entities are excluded from marketing of pesticide. However due to the inefficiency of state-owned distribution channels in reality nearly 100% of pesticides are supplied through private channels.

According to MoA officials, a new marketing license system will be implemented to resolve the current predicament and state-control will no longer be the precondition of pesticide marketing. Entities who comply with requirements for appropriate operating premises, warehouse safety and appropriately qualified staff will be permitted to market pesticides. 

 

News

 

Expert Articles & Ebook

  1. Fang Lin, 27 April 2016, "China Pesticide Registration Hampered by Major Deficiency in Field Trial Application and Efficacy Study", AgroPortal
  2. Yingzhu Wu, 13 Nov 2014, "Chinese Pesticide GLP Compliance", AgroPortal
  3. Fang Lin, 8 Jul 2014, "Natural Selection By Regulation: Survival of China’s Fittest Glyphosate Producers", AgroPortal
  4. Fang Lin, 17 Dec 2013, "A Rationale for ICAMA’s Establishment of the Pesticide Registration Review Office" , AgroPortal
  5. TSEPRC of ACEF 11 Nov 2013, "Comparing Global Air Emission Standards Governing the Pesticide Industry", AgroPortal
  6. Fang Lin, 25 Sep 2013, "China Pesticide Regulation: Current Status and Future Direction", AgroPortal
  7. Fang Lin, 22 Aug 2013, "Rising Glyphosate Prices: Interpreting the Trend", AgroPortal
  8. Serena Song, 8 Jun 2013, "Environmental Risk Assessment of Pesticides in China", AgroPortal
  9. Fang Lin, 14 May 2013, "Maximum Residue Limits for Pesticides in Foods (GB 2763-2012):Interpretation and Advice", AgroPortal
  10. Fang Lin, 28 Feb 2013, "Biopesticide Development in China Hindered by Regulatory Uncertainty", AgroPortal
  11. Fang Lin, 27 Dec 2012, "New Pesticide Regulation May Increase Global Reputation of Chinese Products", AgroPortal
  12. Fang Lin, 25 Sep 2012, "Agrochemical IP Protection", AgroPortal
  13. Fang Lin, 22 Aug 2012, "Biocidal Products Regulations in China", AgroPortal
  14. Serena Song, 20 Apr 2012, "Overview of China Pesticides Regulation", AgroPortal
  15. 16 May 2014, "GB 2763-2014 National Food Safety Standard-Maximum Residue Limits for Pesticides in food", AgroPortal
  16. 9 Jun 2013, "Ebook20: China Pesticide Regulation:"Data Requirements on Pesticide Registration"-Order 10 of MoA", AgroPortal
  17. 8 Jun 2013, "Ebook19: China Pesticide Regulation-" Regulations on Pesticide Administration", AgroPortal