The main contents and development history of Pesticide Registration Data Requirements

Pesticide is an important means of agricultural production, which plays an important role in the prevention and control of diseases, insects, grasses and rodents in agriculture and forestry, the elimination of harmful insects and other harmful substances in the living environment of humans and animals, the guarantee of agricultural production and the protection of people's health. Pesticide is often a toxic commodity, improper use, easy to cause crop damage, human and animal poisoning, agricultural product residues or environmental pollution and other adverse effects. Therefore, the implementation of the pesticide registration system, through the registration evaluation and evaluation, so that efficient, low-toxicity, low-residue pesticides are allowed to enter the circulation and use, high-toxicity and high-risk pesticides are restricted or withdrawn, to achieve the purpose of ensuring human and animal safety, protecting the quality and environmental safety of agricultural products.

This paper introduces in detail the general process of pesticide registration in China, the overall structure and main contents of pesticide registration data requirements, reviews the four development stages of pesticide registration in China and the characteristics of registration in different development stages, analyzes the future trend of pesticide registration, and provides detailed reference materials for the public and enterprises to understand the pesticide registration system in China.

1 Concept, nature and evaluation content of pesticide registration

1.1 Concept and significance of pesticide registration

Pesticide registration refers to the production, sale, import or use of pesticide products, product chemistry, efficacy, residue, toxicology and environmental impact evaluation, and meet the requirements of the pesticide product registration. The purpose of pesticide registration is to ensure that the pesticide products entering the market can play and achieve the intended function of use, while ensuring that the use process will not cause unacceptable risks or hazards to human health and the ecological environment.

In May 1997, China promulgated the "Regulations on Pesticide Management" and began to implement the pesticide registration system, requiring that pesticides produced and imported should be registered. The main body applying for pesticide registration is the domestic pesticide production enterprises or import enterprises. The revised "Regulations on Pesticide Management" in 2017 also clarified that new pesticide researchers can also apply for registration of new pesticides. Pesticides produced, operated and used within the territory of China shall obtain pesticide registration, and pesticide products that do not obtain registration will be treated as fake pesticides. In addition, the regulation clarifies the relevant penalties for the production, operation or use of fake pesticides.

1.2 Evaluation content of pesticide registration

Pesticide registration is mainly through the evaluation of product chemistry, toxicology, efficacy, residue, environmental impact and other test data to judge the effectiveness and safety of pesticides.

The product chemical test data mainly include product quality standard and test report, physical and chemical property determination report, complete component analysis report, storage stability test report, etc.

Toxicological data mainly include acute, subchronic, mutagenic, teratogenic, carcinogenic and chronic toxicity test data.

Efficacy test data mainly include laboratory activity test report or formulation screening test report, crop safety test report, resistance risk assessment test report, field plot efficacy test report, large area efficacy test report, etc.

Residual test data mainly include plant metabolism, animal metabolism, environmental metabolism, storage stability of pesticide residues, pesticide residues in crops, pesticide residues in processed agricultural products and other test reports.

Environmental impact test data mainly include two aspects: environmental regression and ecotoxicology. Environmental regression test data mainly include the degradation and metabolism of pesticides in soil, water and sediment systems, soil adsorption or leaching test reports. Ecotoxicological test data mainly include acute and chronic toxicity test reports on birds, aquatic organisms, terrestrial non-target arthropods and soil organisms.

In addition, at the time of pesticide registration, the content of the pesticide label should be reviewed and the approved label content should be published, and the pesticide enterprise will print the label according to the approved label content.

1.3 Meaning and contents of pesticide labels

The pesticide label refers to all the written instructions on the pesticide package that describe the characteristics, uses, precautions, poisoning first aid, storage and transportation of the pesticide product. If the pesticide package is too small to mark the above provisions, it should be separately attached to the manual, and the manual should be completely marked with the above provisions.

The pesticide label is not only a description of the characteristics and technical requirements of pesticide products, but also an important basis for the safe and reasonable use of pesticides by users, and it is also a proof of the legal relationship between producers and users. The pesticide label shall indicate the name of the pesticide, dosage form, active ingredient and content, pesticide category, product performance, toxicity label, scope of use, method, dosage, use technology, precautions, poisoning first aid, storage and transportation method, production date, quality guarantee period, net content, registration certificate number, quality standard number, production license number, contact information of the pesticide enterprise, image map, etc.

2. General process of pesticide registration

2.1 Test record and sample seal

Before the registration test is carried out, the trial record should be carried out in the local provincial agricultural department, and the record information includes the record person, product overview, test project, test location, test unit, test time, safety precautions, etc. China has established a unified national registration and trial record platform, and has realized online record.

The test sample should be sealed at the provincial pesticide verification institution, provide pesticide name, active ingredient content, dosage form, sample production date and other information, and provide product quality inspection report. The foreign enterprise seals the sample at the provincial pesticide verification institution where its agency is located.

The sealed test samples shall be retained by the provincial pesticide verification institution and the applicant for a period of not less than 2 years, and the remaining samples shall be sent to the registered testing unit for testing. If the test sample cannot meet the requirements of the test or the test sample has exceeded the storage period and still needs to be tested, the sample shall be sealed up again.

2.2 Conducting pesticide tests

Before submitting the application for registration, the applicant of pesticide registration shall first carry out the relevant tests for pesticide registration. Some of these pesticide tests can be completed by the enterprises themselves, such as formula screening tests, crop safety tests, etc., while others must be completed by qualified testing units identified by the Ministry of Agriculture and Rural Affairs or overseas laboratories that have signed mutual recognition agreements with the Chinese government, such as acute toxicity tests, field efficacy tests, residue tests, etc.

According to the different registration types of the applied products, there are mainly five types of pesticide registration tests. (1) Product chemical test: mainly includes product quality test, original (mother) drug full component analysis test, physical and chemical properties test, 2-year storage stability test at room temperature. (2) Toxicological tests: mainly include acute, subchronic, mutagenicity, teratogenicity, carcinogenesis and chronic toxicity tests. (3) Efficacy test: mainly includes field plot efficacy test, large area efficacy test, etc. (4) Residue test: mainly includes metabolism test in plants, animals and environment, storage stability test of pesticide residue, pesticide residue test in crops, pesticide residue test in processed agricultural products, etc. (5) Environmental impact test: including two aspects of environmental regression and ecotoxicology tests of various pesticides.

When preparing for pesticide tests, the main problems that need to be paid attention to are: First, according to the needs of the application for registration, according to the crop season to promote the field pesticide test, to avoid missing or missing the season. The second is to carry out tests according to the requirements of field trial year and test number required for registration, and avoid doing less or more tests. For pesticides involving new areas of use, it is generally required to carry out 2-year field efficacy tests, and for pesticides used on widely planted or locally planted crops, the requirements for residue test points are also different. Third, before carrying out the pesticide registration test, the test sample should be tested and sealed in the relevant pesticide verification institutions to ensure the accuracy and effectiveness of the registration test results.

2.3 Preparing registration materials

After the completion of the required pesticide tests, the preparation of pesticide registration information can begin, and the following four aspects should be paid attention to.

(1) Preparation of registration information

General information includes registration application form, product summary, pesticide label and instruction manual, copy of business license, origin information of the original drug, and supporting documents related to the product. Test data are generally required to provide original reports, do not require to provide original records. The report shall state the complete contents of the test time, place, personnel, program, samples, objects, results, conclusions, etc.

(2) Data text requirements

General data should be in Chinese. Experimental data can be in Chinese or English. If English is used, Chinese translation should be provided.

(3) Data arrangement requirements

Table of contents and page numbers shall be arranged in order of application form, general information, test data (product chemistry, toxicology, efficacy, residue, environment) and other information. If the data is too thick, it should also be bound in separate volumes.

(4) Paper specifications

A white A4 size paper of 70 g or more should be used.

2.4 Submit the registration application

After the completion of the required test, the test data and related materials will be classified and bound, and after filling in the registration application form, the registration application will be submitted to the provincial agricultural and rural departments. The required information will be attached to the application form as the supplementary information. After the provincial agricultural and rural departments complete the preliminary review, they will give the preliminary review opinions, and then submit the registration application to the government service hall of the Ministry of Agriculture and Rural Affairs. Overseas enterprises directly submit registration applications to the government affairs service hall of the Ministry of Agriculture and Rural Affairs without going through the preliminary examination of provincial registration.

The registration form includes company information and product information. Enterprise information includes the address of the enterprise, business license, legal representative and contact information of the manager. Product information includes active ingredient, content, dosage form, application range and application method of pesticides.

Since 2010, China has begun to submit registration applications from the Internet, accompanied by paper registration data, but it is still mainly to review paper data. Through online application and approval, the results of pesticide registration can be disclosed online at the same time. In the future, under the background of the implementation of the "One Netcom Office" in China, pesticide registration will gradually transition to the review of electronic application data, and eventually achieve electronic approval of the whole process, without having to submit paper data.

2.5 Registration and Approval process

The registration and approval process mainly includes the following steps.

(1) The provincial agricultural department accepts the application for pesticide registration submitted by registration applicants within the jurisdiction, that is, pesticide production enterprises or new pesticide researchers, and conducts preliminary examination and puts forward preliminary opinions.

(2) The government affairs Service Hall of the Ministry of Agriculture and Rural Affairs receives registration application materials and preliminary review opinions submitted by provincial agricultural departments, or directly accepts registration applications submitted by overseas enterprises.

(3) The pesticide verification agency of the Ministry of Agriculture and Rural areas shall conduct technical review. ① Data inspection: According to different pesticide types and application categories, determine the professional fields that need to be reviewed, the professional fields mainly include product chemistry, drug efficacy, toxicology, residue, environmental impact, etc., the specific professional fields may be different due to different products, such as the original drug products do not need drug efficacy and residue field review, health pesticides do not need residue field review. ② Professional review: According to the requirements of registration data, review the professional information in the application data, and give the professional review opinions. ③ Comprehensive review: Summarize the professional review opinions, review the relevant certification materials in the application materials, the source of the original drug, label samples, etc., and review the rationality and compliance of the product, and give comprehensive review opinions. ④ Technical review: the comprehensive review opinions are discussed and signed, and the technical review opinions are given.

(4) Review by the pesticide Registration Review Committee. Conduct comprehensive research and judgment on the rationality and compliance of technical review opinions and products, and form meeting review opinions.

(5) Results publicity. The products reviewed by the meeting will be publicized online and widely accepted by social supervision.

(6) Registration and approval. The examination and approval authority shall give opinions on examination and approval according to the national laws and regulations and the results of examination and approval.

(7) Inform the result or issue a registration certificate. If approved, the pesticide registration certificate will be issued and published online; If the approval is not approved, explain the reason in writing.

2.6 Operation rules of the registration Review Committee

The Registration and Evaluation Committee consists of 6 professional evaluation groups including product chemistry and drug efficacy, and 1 comprehensive policy evaluation group to evaluate pesticide products in the form of committee discussions and executive committee meetings.

The committee meeting is attended by the chairman of the committee, the heads of the professional review groups and the relevant members randomly selected, with no more than 45 members participating, mainly responsible for the review of new pesticides, research related issues, and put forward opinions and suggestions. In principle, two meetings are held each year. The Executive committee meeting is attended by the deputy Chairman, the head of each review group, the deputy head, and the individual professional committee can also be randomly selected according to the need to participate, and the participating members are not more than 25 people, mainly responsible for the review and research of pesticide products other than new pesticides. A meeting is usually held once a month.

The first National Pesticide Registration and Review Committee was established in 1982, with 37 members. It meets 1-2 times a year to review new pesticide products by consensus, and is replaced once every 3-5 years. The first temporary pesticide registration Review Committee of the Ministry of Agriculture was established in 2000, with a total of 15 members (later increased to 17), a meeting is held every 1 to 2 months, and the temporary registered products are reviewed by secret ballot, and the term is changed once every 3 years. The Pesticide Registration Review Committee plays an important role in promoting fairness and science in pesticide registration.

3 Main contents of Pesticide Registration Data Requirements

"Pesticide Registration Data Requirements" is a mandatory requirement for all data such as various test data and materials that should be submitted by the applicant when applying for registration. Due to the revision of the Regulations on Pesticide Management in June 2017, the Requirements for Pesticide Registration Data was also revised again on November 1, 2017, with a total of 10 chapters, about 170,000 words, including general principles, terms and definitions, chemical pesticides, biochemical pesticides, and microbial pesticides. The supplementary provisions include the interpretation and specification of the registration data requirements of pesticide active drug (mother drug), the explanation and specification of the registration data requirements of pesticide preparations, the explanation and specification of the registration data requirements of pesticide preparations for health use, the explanation and specification of the registration data requirements of rodenticide preparations, the explanation and specification of the registration data requirements of registration changes, the pesticide registration data requirements for characteristic small crops, and the field efficacy test There are 14 items such as test area guide, residue test crop classification, residue test number requirements, same product identification criteria, naming principles, content setting principles, quality specifications and physicochemical property requirements of different dosage forms, and toxicity classification standards of pesticide products.

The Requirements for Pesticide Registration Data stipulate the requirements for registration data of different pesticides according to different situations.

3.1 Different registration data requirements shall be stipulated according to the different application time of pesticides

According to the registration time, it can be divided into new pesticides, new preparations (new content, new dosage forms, new mixed preparations), new scope of use, new methods of use, similar preparations, the same pesticides and other different registration types. The "Pesticide Registration Data Requirements" stipulates different registration data requirements for different registration types. New pesticides have the highest registration requirements, new