China Pesticide Regulation:
Regulation on the Administration of Pesticides
History
8 May 1997	Firstly issued under Decree 216
29 Nov 2001	Revised by Decree 326
20 Jul 2011	Public Consultation on Revised Draft
8 Feb 2017	Overhauled under Decree 677
Main supporting regulation in force
21 Jun 2017	MoA Order 3 of 2017
21 Jun 2017	MoA Order 4 of 2017
21 Jun 2017	MoA Order 5 of 2017
21 Jun 2017	MoA Order 6 of 2017
21 Jun 2017	MoA Order 7 of 2017
31 Aug 2017	MoA Announcement 2567
3 Sep 2017	MoA Announcement 2568
13 Sep 2017	MoA Announcement 2569
3 Sep 2017	MoA Announcement 2570
5 Sep 2017	MoA Announcement 2579
18 Dec 2016	GB 2763-2016

On 8 Feb 2017, Chinese State Council executive meeting approved the amendment to the Regulation on the Administration of Pesticides (Decree 677). The promulgation of China's new pesticide regulation was just the first step in China’s broader pesticide regulatory reform plan which continued throughout the year and saw 11 ministerial level supporting regulations promulgated. The primary goal of regulatory reform is to improve administrative efficiency, reduce overlap, duplication and redundancy and centralize regulatory authority into the hands of China’s newly formed Ministry of Agriculture and Rural Affairs, now the sole authority tasked with oversight of China’s 3-element approval system of pesticide production, registration and marketing:

• Registration-Indigenous pesticide production companies, overseas companies exporting pesticide to China and R&D entities of new pesticides shall obtain pesticide registration for each of technical material or formulated product they produce, export or invent;

• Production -Companies engaged in the manufacturing, processing and sub-packaging of technical material and end use pesticides within the territory of China shall obtain a pesticide production license from the competent agricultural department at provincial level;

• Marketing - Entities engaged in the marketing of pesticides (excluding hygienic pesticide) shall obtain pesticide marketing license from the competent agricultural department at county level.

1. China’s New Pesticide Legislative Framework

In June 2017, MoA (Now Ministry of Agriculture and Rural Affairs) promulgated 5 administrative measures on registration, production license, marketing license, labeling and laboratory accreditation of pesticides. Technical requirements, inspection scope and formal requirements are detailed in 6 supporting rules which were issued under MoA’s announcement in September. The latest version of GB 2763-2016 National Food Safety Standard-Maximum Residue Limits for Pesticide in Food was also implemented on 18 June 2017. These regulations constitute a comprehensive supervision system stipulating requirements for product registration, regulatory study, production, marketing and food safety:

2. Pesticide Registration

Indigenous producers and overseas company exporters should apply for pesticide registration prior to their business activities in China and research institutes/individuals of new pesticides may also apply for the registration. In order to ensure data authenticity and effectiveness and safety of experimental activities, MoARA adopt licensing management on experimental study, product registration and laboratory accreditation.

2.1 Adminstrative Procedure

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Fig. 1-Flow Diagram of Administrative procedures for the Application of Experimentation License, Lab Qualification and Pesticide Registration in China

All regulatory studies (product chemistry, efficacy, toxicity and environmental impact) performed in China should be approved by MoARA or filed at provincial agricultural department prior to commencement and also should be conducted at qualified labs. Typically, an imported new pesticide will go through 2 stages:

Registration Experimentation License-The applicant should provide administrative information, general technical information and quality inspection test reports of both TC/TK and formulations (for new pesticide, TC/TK and formulation should be submitted together), as well as the proposed target crop/pest, test site and scope, as well as possible risks and available measures for risk mitigation and first aid. The application should be submitted in both online and paper format. ICAMA will undertake technical examination on the application material and present technical comment to the PMA, who will conclude and propose a comprehensive opinion to the Ministry for final approval. Upon the final approval by the MoARA, the applicant will be issued with a license of registration experimentation of new pesticide, which will be valid for 5 years. If the experimentation was performed during the validity period, the license will be granted.

Pesticide Registration-After the experimentations and dossier preparation, the applicant should apply for product registration. In addition to the technical examination by ICAMA, all applications will be reviewed and discussed at board meeting (plenary session) of the National Pesticide Registration Committee, which is held biannually each year. All pesticide registrations are valid for 5 years and renewal and amendable;
Besides, only test reports obtained from qualified testing facilities can be recognized for registration review. The reform has stopped ICAMA from unilaterally accepting OECD GLP report from overseas laboratories until the   organization/authorities of these countries signed MAD (mutual/ multilateral acceptance of data) agreement with China. Indigenous laboratories shall comply with the GLP principles and received on-site inspection for operation status of quality assurance system, facilities, equipment and technical capacity and granted with corresponding qualifications. The qualification is valid for 5 years and shall be reapplied 6 months prior to each expiry.

2.2 Data Requirements

English Translation of China MoA Announcement 2569"Data Requirements on Pesticide Registration"

On 1 Nov 2017, China implemented the “Announcement 2569- Data Requirements on Pesticide Registration”. Applications made after implementation of this announcement have required more test data and have been subject to more stringent criteria than previous regulation. Registration categories of minor amendment to formulation type, new synergist-pesticide and repacking registration were removed and all conditions are categorized into 13 categories.

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Fig. 2-Procedures for the Technical Equivalence Determination of Me-too TC/TK under China’s New Pesticide Regulation

Compared with previous regulation, the expansion in regulatory requirements are:

1. Product Chemistry-Methods and validation for identification and content determination of limited components such as softener, stabilizer and synergist were added. Conformity between data/sample and actual production process will be carefully scrutinized: Applicants are required to analyze the formation of presence and possible impurities based on chemical theory, actual raw material and production process, etc.;

2. Efficacy-Criteria has been changed from efficacy rating to comprehensive benefit analysis and reports of substitutability and benefit analysis and pest risk assessment are additionally required. Test duration can be reduced from 2 year to 1 year for bio pesticides and other registration categories.

3. Residue-Dietary risk assessment report will be required for food crop use pesticide. The minimal numbers of test sites are also increased for staple crops and vegetables such as rice, wheat, maize, tomato, chili, cabbage, citrus and poems. Metabolism study in plant, animal and envroment,  residue storage stability and residue study in processed food are conditionally required for new active ingredient, new formulation type, new content and new combination.

4. Toxicity-Acute neurotoxicity, sub-acute/chronic dermal toxicity, sub-acute/chronic inhalation tests are newly required for TC/TKs. Teratogenicity and carcinogenicity studies are increased from 1 rodent to 2 rodents. Health risk assessment on pesticide applicators and residents are required for field use pesticides and hygienic pesticides respectively. If preliminary assessment suggests unacceptable health risks to human, simulated and field exposure tests would be required.

5. Environmental Impact-Impacts on environmental organisms are stringently evaluated from acute effect to long-term effect and direct impact/indirect impact. For example, fish life-cycle and bioaccumulation study, tests of reproductive toxicity to daphnia magna and chronic toxicity to silkworm are conditionally required for certain pesticide types. Toxicity tests on predatory and parasitic natural enemies, environmental fate test and ecotoxicity study on radiolabeled pesticide metabolic are required from new TC/TK and non-me-too TC/TK. Spicatum toxicity and duckweed growth inhibition test will be required from Herbicide TC/TK against dicotyledon and monocotyledon weeds respectively. Environmental risk assessment report will be required for almost all field and environmental chemical pesticides. If preliminary assessment suggests unacceptable risks to any environmental organisms, additionally test data such as mesocosm, semi-field and field study would be required.

In June 2017, China implemented a program to reduce generic pesticide and new approval of me-too registration by 2020 and the new data requirements imposed tighten rules on generic pesticides.

2.3 Data Acceptance and GLP Adherence

Previously, test reports from overseas OECD-GLP labs were acceptable even though China is neither an OECD member nor an adherent to the OECD MAD (Mutual/ multilateral Acceptance of Data) program. In the new regulations, China has decided to "level the playing field" by adding the new clause: test reports supporting pesticide registration must be issued from a MoARA-designated lab or an oversea lab from a country or organization which have signed a MAD (Mutual/ multilateral Acceptance of Data) agreement with China. International companies are also subject to additional requirements including: plot and large plot efficacy trial, in-crop residue test, in-field exposure test and other studies involved with China-specific organisms must be conducted in China. MoA had issued 2 GLP-related regulations: Good Laboratory Practices for Toxicity Studies of Pesticides (NY/T 718-2003) and Good Laboratory Practices for Physical and Chemical Testing of Pesticides (NY/T 1386-2007), targeting only toxicity and physical& chemical labs. After this legislative reform, these GLP regulations were collective renewed as “Good Laboratory Practice for the Experimentation of Pesticide Registration” and enforce for all study scope including physical chemistry, toxicity, efficacy, residue and environmental fate and impact.

3. Production License

The former MoA absorbed responsibilities previously designated to MIIT and AQSIQ. MoA then delegated a substantial portion of its responsibilities to its subordinate provincial departments. Provincial departments are responsible for accepting the applications, formality check and document examination, as well as on-site inspection if necessary. China’s ambitions on industrial restructuring and revitalization are also reflected in production management regulations: Newly established chemical pesticide factories (including new producers or an expansion by an existing producer) must be located in chemical industry /industrial park at or above provincial level. New establishment of a pesticide factory and hygienic pesticide factory, relocation and TC/TK production expansion of an existing producer must be located in chemical industry /Industrial park at or above provincial level
Domestic producers and new pesticide developers are allowed to use an OEM producer which has not yet obtained the pesticide registration to process or repack pesticide. Overseas registrant can only use OEM packers.
Adherence to national industrial and economic policies are also fully considering during qualification, which includes:  "Made in China 2025", “13th Five-Year National Plan on Environmental Improvement (State Council Circular 65 of 2016)”, “Guidance on the Restructuring and Revitalization of Petrochemical Industry (State Council Office Circular 57 of 2016)”, “Policy on Pesticide Industry (Jointly Issued by 4 Ministries in 2010)”, “Catalogue of Outdated Production Capacity, Technology and Product subject to Elimination” and “Inventory of Industries subject to Structural Adjustment” and other pesticide revoked or suspended by MoA/MoARA.

4. Marketing Management

Licensing management was initially imposed on pesticide distributors. Non-hygienic insecticide retailers and producers inter-provincially selling their own pesticides to growers are required to obtain a marketing license from county or provincial agricultural department. If a pesticide was included in the “List of Restricted Pesticide”, the marketing license should be issued by provincial authorities which require the following conditions are met:

• Real-name purchase

• The distribution will be oriented only to cotton, oil crop and non-food crop planted regions;

• The number of shops will limited to only 20 per county;

The establishment marketing restricted pesticide should be distant from vegetable, fruit, tea and Chinese herb cultivation regions;
Compared with previous labeling requirement, QR code tracking will be mandatorily enforced on each product retail unit, which enable public enquiry on production batch and quality inspection information.

News

• 21 Nov 2018 China Accelerates Development of Testing and Assessment Guidelines for Pesticide Registration

• 10 Oct 2018 China MoARA Accredits 26 Labs to Generate Pesticide Registration Data

• 8 May 2018 China NATESC Warns against Pest Resistance to Chlorantraniliprole and Penoxsulam

• 7 May 2018 China to Compile Pesticide MRL Standard for Imported Agricultural Commodities

• 3 May 2018 China MoARA Starts National Butachlor Production Survey

• 20 Apr 2018 ICAMA Publishes Pesticide Risk Assessment Model “COPrisk”

• 23 Mar 2018 2017 Annual Review of Pesticides Newly Registered in China

• 6 Feb 2018 China Promulgates 21 Agricultural Standards for Registration and Testing of Agrochemicals

• 1 Feb 2018 China MoA Releases 6 Guidance Documents on Administrative Procedures of Pesticide and Fertilizer Registration

• 12 Jan 2018 China ICAMA Drafts Pesticide Registration Large Area Efficacy Trial Guidelines

• 12 Jan 2018 China Consults on Pesticide Packaging Waste Regulation

• 14 Dec 2017 China Formed 9th National Pesticide Registration Committee

• 24 Nov 2017 China Consults on New Pest Control Regulation

• 17 Nov 2017 China to Renew Pesticide Residue Trial Guideline

• 10 Nov 2017 ICAMA Drafts 3 Guidelines for Pesticide Health Risk Assessment

• 25 Oct 2017 China MoA Developed Guideline for Pesticide ARfD Establishment

• 13 Oct 2017 China to Form New Authority for Pesticide Management

• 13 Oct 2017 China MoA Releases New Data Requirements for Pesticide Registration

• 28 Sep 2017 China ICAMA Consults on 9 Testing Guidelines for Pesticide Environmental Impact Study

• 28 Sep 2017 Chinese Pesticide Registration Fully Granted to 21 New Active Ingredients

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