China’s new data requirements display significant improvements in text structure and information transparency;
Pesticide registration expense and time requirements are more volatile depending on the novelty of the product chemistry, target crop/site, pest, application rate and method comparing with existing registered products;
Uncertainty over the workload of the regulatory study and data acceptance will likely continue until China clarifies the technical capacities of labs accredited to run tests and also provides adequate guidance documents on test protocols and testing requirements for newly added tests.
Since the Nov 1st 2017 implementation of "MoA Announcement 2569-Data Requirements on Pesticide Registration", subsequent registration applications have been subject to increased data requirements and elevated criteria. Other changes include but not limited to the abolishment of temporary registration and mandatory risk assessment. Compared with the previous regulation, MoA Order 10 of 2008, Announcement 2569 includes significant improvements in text structure and information transparency. A comparative analysis between the new and old version offers useful information to aid companies in adapting to new requirements.
Chapter Reorganization in Regulation Text
In the 2008 version, hygienic pesticides, rodenticides, biochemical pesticides, microbial pesticides, botanical pesticides, GMOs and natural enemy pesticides are defined as special pesticides and their registration requirements were incorporated in an independent chapter similar to the individual chapters detailing requirements of new active ingredients, new formulated pesticides, me-too and technical concentrations(TKs). In the main body, each of these chapters consists of 3 sub-chapters, corresponding to the requirements for field trial application, temporary registration and full registration.
In the new data requirements, three types of biopesticide have equal chapter allocation as chemical pesticides. The requirements for manufacturing “use product” (TC/TK) and end-use product (formulation) are respectively compiled in 2 sub-chapters. Furthermore, “atypical” products including agricultural GMOs and natural enemies have been removed from the new data requirements. GMOS are regulated under agricultural GMO regulations and natural enemies are subject to significantly decreased registration data requirements.
Conditions for post registration including use scope expansion, amendment to application method and dose are refined in Chapter VIII and conditions for amendment to quality specification and toxicological class are added.
Chapter Comparison of the Main body between China’s Old and New Data Requirements for Pesticide Registration
MoA Order 10 (2008)
MoA Announcement 2569(2017)
Chapter I General Provision
Chapter II Terminology and Definitions
Chapter III Registration of New Active Ingredients
Chapter IV Registration for New Special Pesticides
Chapter V Registration for New Formulated Products
Chapter VI Registration for Me-too Pesticide Products
Chapter VII Registration for Expansion of Application Scope, Change of Application Method and Alteration of Application Dosage
Chapter VIII Repacking Registration
Chapter IX Renewal Registration
Chapter X Registration of Technical Concentrates
Chapter VI Other Issues Related to Pesticide Registration
Chapter VII Supplementary Provisions
Chapter I General Provision
Chapter II Terminology and Definitions
Chapter III Chemical Pesticides
Chapter IV Biochemical Pesticides
Chapter V Microbial Pesticides
Chapter VI Botanical Pesticides
Chapter VII Hygienic Formulated Product
Chapter VIII Registration Amendment
Chapter IX Registration Renewal
Chapter X Supplementary Provision
2008 version provided informative instructions and templates, including minimum number of trial sites and crop grouping for residue study, criteria for technical equivalence determination and physical & chemical properties and quality indicators of different formulation type required to be included in product chemistry data, etc.
In the new data requirements, two templates relevant to administrative formality have been removed, which includes the "template for the declaration on the authenticity and legality of the application data" and the "template for the statement on the source of TC/TKs in formulated product". The template for MSDS was also deleted because its technical relevance to pesticide registration in China is very low and hazard communication is already well regulated and implemented in China's hazardous chemical regulations. Note that these 3 documents are still required under new data requirements.
The minimum numbers of residue trial sites for different crops and crop categories are updated in ANNEX VIII and IX of Announcement 2569. The residue trials required for major food crops and staples increased from 3 sites for 2 years in 2008 version to 12 sites in the 2017 version. Applicants seeking registration on rice, wheat, maize, potato, cucumber, tomato, chili, head cabbage, citrus and apple/pear will require double the previous financial investment to conduct the residue test.
The 2017 version makes numerous adjustments on crop grouping and sub-classification in ANNEX VIII. For example, tropical fruits and medicinal plants are newly added and representative crops are designated for each group/sub-group. If a residue study has been conducted on representative crop and 1 or 2 other crop of the group/sub-group, then the usage scope can be expanded on all crops within the same group/sub-group.
To improve the credibility of the efficacy trial data, Announcement 2569 emphasizes the requirement on experimental planning and consideration on crop acreage, pest occurrence, crop variety, plantation mode and climate, etc. A guideline on distribution for efficacy trial has been newly compiled under the Annex VII, which designates the eligible administrative areas and number of trial sites for major pests on 20 crops covering food crop, economic crop, oil crop, fruit and vegetables. Efficacy data gathered from trial sites outside these areas might not be accepted. For usage not yet specified, the applicant shall take similar consideration on crop plantation and pest status and the dossier shall additionally include a justification on trial site selection.
Comparing with crop use registration, the new requirements include preferential treatments for minor crop use registration such as reduced number of trial sites and wider data extrapolation on residue and efficacy, which were newly included into ANNEX VI.
Two Annexes for me-too product equivalence determination in 2008 version have been merged into ANNEX X of Announcement 2569 and the criteria are dramatically elevated. (See AgroAnalysis: China's New Pesticide Regulation: Elevated Criteria for “Me-too” Pesticide Registration)
Instructive Tables of Data Endpoints
Under the old regulation, pesticide registration involved 3 steps: field trial, temporary registration and full registration. Requirements were reflected in 3 subchapters of each product category and registration type, which list the tests and detailed instructions on definition, test animal, method, conditions of experimental and data exemption. Each subchapter followed very similar structure and contents. Confusing terminology stating “please refer to section X” was also widely utilized in the 2008 version.
In the 2017 version, the main body only offers the general information on the required data while the detailed requirements for each data item are presented in “tables of definitions and instruction on the data requirements” for each product and use category. A total of 16 instructive tables are included from ANNEX I to ANNEX IV:
- ANNEX I Tables of definitions and instruction on the data requirements for the registration of TC/TKs (chemical, biochemical, microbial and botanical)
- ANNEX II Tables of definitions and instruction on the data requirements for the registration of formulated Products (chemical, biochemical, microbial and botanical)
- ANNEX III Tables of definitions and instruction on the data requirements for the registration of hygienic formulated Products (chemical, biochemical, microbial and botanical)
- ANNEX IV Tables of definitions are instruction on the data requirements for the registration of rodenticides (chemical, biochemical, microbial and botanical)
In each table, data items are presented in a column and detailed instructions for each item are arranged in another column and the requirements are shown by a tick or cross representing different registration conditions: new pesticides, new formulation type, new content, new combination, new use scope, new application method, me-too product with same use scope and application method, me-too product with different use scope and application method, similar product with same use scope and application method and me-too product with different use scope and application method.
The instructions for particular use category are supplemented in remarks. Through these instructive tables, users may readily identify the product and registration category and the required tests and even estimate the financial and time investment required.
DEFINITION AND INSTRUCTION
Name of Test/Data
Further explanation and instruction on the content, test item, test animal species, method, duration, condition of test and condition, as well as data acceptance, etc.
Name of Test/Data
Name of Test/Data③
Points of Attention
Although the new data requirement displays considerable progress in scientificness and transparency, new requirements have also increased overall complexity due to increased testing, more stringent criteria and newly required risk assessment. Financial and time investments are increasingly varing depending on novelty in product chemistry, target crop/site, pest, application rate and method compared with existing registered products. Second, for some of the newly added tests China has not yet published any officially recognized test method or designated any labs qualified for the tests. Uncertainty over the technical capacities of existing labs and data acceptance will be problem until these testing requirements and associated issued are clarified, especially as China has ceased the unilateral acceptance of overseas GLP data.
- English Translation of China MoA Announcement 2569-Data Requirements on Pesticide Registration
- CPAD database: 36000+ Entries of Pesticides Information Registered in China
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