Overview of China’s New Pesticide Regulations  

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

Contents

 

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:

Regulation/Measures

Type

Scope/General Content

State Council Decree 677 - Regulation on the Administration of Pesticides
中华人民共和国国务院第677号令《农药管理条例》

National legislation

The Decree has entered into force on 1 Jun 2017. It redefines pesticides as substance or mixtures used to “prevent and control” harmful organisms and establishes a 3 element approval system: each product produced by different producers, companies engaged in manufacturing and processing of pesticide and marketing entities of agricultural pesticides and hygienic insecticides. The Decree specifies competent authorities, general administrative procedures, validity, renewal and supervision of these registration/license.

MoA Order 3 of 2017 -"Administrative Measures for the Registration of Pesticides"
中华人民共和国农业部2017年第3号令《农药登记管理办法》

Ministerial implementation regulation

Order 3 provides the administrative procedures of pesticide registration, including the qualification of applicant, general technical requirements of product, competent authorities, timeline, file acceptance, validity, renewal, data review and decision of pesticide registration.

MoA Order 4 of 2017- "Administrative Measures for the Production License of Pesticides"
中华人民共和国农业部2017年第4号令《农药生产许可管理办法》

Ministerial implementation regulation

Indigenous producers involved in TC/TK manufacturing, processing and sub-packing of pesticide formulation are obligated to obtain a pesticide production license. The regulation specifies the general entry criterion, application material, accepting and issuing authorities, timeline and OEM production of production license.

MoA Order 5 of 2017- "Administrative Measures for the Marketing License of Pesticides"
中华人民共和国农业部2017年第5号令《农药经营许可管理办法》

Ministerial implementation regulation

Pesticide sales stores should obtain a pesticide marketing license. The personal qualification, area layout, computer management system, application material and administrative formalities of marketing license are specified in this regulation.

MoA Order 6 of 2017- "Administrative Measures for the Experimentation of Pesticide Registration"
中华人民共和国农业部2017年第6号令《农药登记试验管理办法》

Ministerial implementation regulation

Order 3 provides the administrative procedures involved in regulatory experimentation of pesticide registration, which includes the, application acceptance, duration of laboratory accreditation and filing /approval of registration experimentation

MoA Order 7 of 2017-"Administrative Measures for the Labels and Manuals of Pesticides"
中华人民共和国农业部2017年第7号令《农药标签和说明书管理办法》

Ministerial implementation regulation

The regulation specified the information, content layout, making, use and amendment of pesticide labels and manuals.

MoA Announcement 2567-“Catalogue of Restricted Pesticides(2017)”
中华人民共和国农业部第2567号公告《限制使用农药名录(2017版本)》

Supporting rules

The Catalogue lists 32 active ingredients identified as restricted pesticides. Pesticides containing this active ingredients are subject to additional labeling requirements and “designation marketing management”.

MoA Announcement 2568-“Rules for the Inspection on Pesticide Production License”
中华人民共和国农业部第2568号公告《农药审查许可审查细则》

Supporting rules

The document further specifies the composition and formation of application material, process, scope and conclusion of the inspection. In the annexes, the Rules details the critical point, criterion, method and report template of inspection and as well as the production equipment required for each type of TCs and formulations.

MoA Announcement 2569-"Data Requirements on Pesticide Registration"
农业部第2569号公告《农药登记资料要求》

Supporting rules

In addition to the abolishment of temporary registration and mandatory risk assessment, Announcement 2569 reflects significant changes to provide transparency. 16 instructive tables are newly added in the annexes to provide necessary instruction on definition, test item, animal species, method, test duration, parameters and data acceptance of the “end point” for each registration condition and type of pesticide (new pesticide, me-too product, new combination of active ingredients, new use scope and application method of chemical, biochemical, microbial and botanical pesticides )

China MoA announcement 2570-"Rules for the Accreditation on Testing Facilities for Pesticide Registration & Good Laboratory Practice for the Experimentation of Pesticide Registration"
中华人民共和国农业部第2570号公告-《农药登记试验单位评审细则》和《农药登记试验质量管理规范》

Supporting rules

Announcement 2570 consists of 2 regulations applicable to laboratories engaged in the regulatory study of pesticide registration: the “Rules for the Accreditation on Testing Facilities for Pesticide Registration” and the “Good Laboratory Practice for the Experimentation of Pesticide Registration”. The former provides the classification, study scope, qualification criterion, application material, documental review and on-site inspection, criterion of testing facilities. The latter specifies GLP principles to be implemented within the laboratory: organization and personnel, quality assurance program, facilities, apparatus, materials and reagent, test system, test item, reference item and sample, standard operation practice, performance of studies, result reporting and archiving. 

China MoA announcement 2579-"Announcement concerning the Format and Generation of 2D Codes on Pesticide Labels"
中华人民共和国农业部第2579号公告-《农药标签二维码格式及生成要求》

Supporting rules

The announcement was released under “Administrative Measures for the Labels and Manuals of Pesticides". It specifies the basic information readable from the 2D code of pesticide packages.

GB 2763-2016 Maximum Residue Limits for Pesticides in Foods

National Food Safety Standard

4140 pesticide MRLs of 443 active ingredients in 286 commodities/commodity groups

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

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

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.

Table 2-Registration Catergory Defined in China's New Data Requirements on Pesticide Registration

No.

Registration Condition

Note

1

New TC/TK

Technical material containing new active ingredient which was not yet registered in China

2

Me-too TC/TK

A TC/TK was determined technically equivalent to a previously registered TC/TK

3

Non-me-too TC/TK

A TC/TK was determined technically non-equivalent to a previously registered TC/TK

4

Formulation containing new active ingredient

Formulated pesticide containing new active ingredient which was not yet registered in China

5

formulation in new formulation type

The active ingredient in the formulation was registered but the formulation type was initially applied

6

formulation in new content

The active ingredient(s) and formulation type were all registered but the content level(including same ratio of active ingredients in multiple compounded formulation) was initially proposed

7

formulation in new combination of active ingredients

The active ingredient(s) in a multiple compounded formulation and formulation type of were registered but the active ingredient(s) was initially combined together(including different ratio of active ingredients in multiple compounded formulation)

8

formulation for new use scope

The active ingredient(s) and formulation type were all registered but the crop and target was initially applied

9

formulation in new application method

The active ingredient(s) and formulation type were all registered but the application method initially applied

10

Me-too formulation for same use scope and application method

technically equivalent to a previously registered formulation and proposed for the same crop, target and application method

11

Me-too formulation for different use scope and application method

technically equivalent to a previously registered formulation and proposed for different crop, target and application method

12

Similar formulation for same use scope and application method

The active ingredient, formulation type and content were identical with but non-technically equivalent to a previously registered formulation and proposed for the same crop, target and application method

13

Similar formulation for different use scope and application method

The active ingredient, formulation type and content were identical with but non-technically equivalent to a previously registered formulation and proposed for different crop, target and application method

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.

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