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 on 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.

Chinese regulation:
China Pesticide Regulation
Regulation on Pesticide Administration ( Regulation on the Control of Agrochemicals)
History
8 May 1997	First issued under Decree 216
29 Nov 2001	Revised by Decree 326
20 Jul 2011	Public Consultation on Revised Draft
Main supporting leglislation in force
1 Jan 2008	MoA Order 9 of 2007
8 Jan 2008	MoA Order 10 of 2007
1 Jan 2005	NDRC Order 23
5 Feb 2013	AQSIQ Announcement 23 of 2013
7 Apr 1995	SAIC & MoA Order 30 of 1995
1 Dec 2006	MoA Announcement 739
16 Nov 2012	GB 2763-2012

Contents 1 China Pesticide Legislative Framework 2 Pesticide Registeration 2.1 Field Trial 2.2 Temporary Registration 2.3 Full Registration 3 ICAMA’s Internal Organization 4 Production Management and Quality Control 5 Triplex Identification of Pesticide Products 5.1 Pesticide Registration Certificate Number 5.2 Approval certificate of Pesticide Manufacturing/Production License Number 5.3 Quality Standard Number 6 Import/Export Supervision 7 Franchise Pesticide Marketing 8 News 9 Expert Articles & Ebook

English Translation of "Regulations on Pesticide Administration"

 

China Pesticide Legislative Framework

Ministry/Administration Involved in Pesticide Regulation

Pesticide Registration

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Fig. 2 -Pesticide Registration Procedure

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Fig. 1 -Three Registration Phases of Pesticide

Depending on the novelty and data availability of the product, registration of new pesticide or new formulated product 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.

English Translation of "Data Requirements on Pesticide Registration"-Order 10 of MoA

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.

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

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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 Document 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 document 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 document 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 555,000 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

• 21 Jan 2014: Statistical Increase in Pesticide Regulatory Violations Indicative of MoA’s Heightened Supervision
• 8 Jan 2014: MoA Officials Explains the Ban and Restriction on 7 Active Ingredients
• 30 Dec 2013: ICAMA Mulls Control Measures on Agrochemical Adjuvants
• 31 Oct 2013: China ICAMA Details Import/Export Management of Pesticides at AgroChemEx
• 25 Oct 2013: Control on Pesticide in China: A lot done, more to do.
• 6 Mar 2013: AQSIQ Revised Licensing Rules for Pesticide Manufacturers
• 11 Jan 2013: New Pesticide Inventory of Import/Export Management Updated
• 7 Dec 2012: New Pesticide MRLs Standard to be Implemented on 2013
• 16 Nov 2012: China ICAMA Promotes New Pesticide Regulation in Hangzhou
• 10 Oct 2012: China to Issue New Pesticide Regulation by December 2012

Expert Articles & Ebook