China Reach Regulation For Various Sectors

Background

Pesticides are primarily regulated in China by the "Pesticide Administration" Regulation (Decree No. 326, hereinafter referred to as Regulation), including technical material, technical concentrates and formulation. The Regulation became effective on May 8, 1997, and was amended in 2017, together with 11 supporting regulations and regulatory papers.

The registration of pesticides is mainly under the supervision of the Ministry of Agriculture and Rural Affairs of China (MOA). The Institute for the Control of agrochemicals under MOA undertakes the evaluation of pesticide registration.

The change to the Regulation on the Administration of Pesticides was approved by the Chinese State Council executive meeting on February 8, 2017. (Decree 677). The adoption of China's new pesticide regulation was only the first stage in the country's broader pesticide regulatory reform strategy, which saw 11 ministerial-level supporting regulations enacted during the year. The primary goal of regulatory reform is to improve administrative efficiency, reduce overlap, duplication, and redundancy, and consolidate regulatory authority in China's newly formed Ministry of Agriculture and Rural Affairs, which is now the sole authority in charge of China's three-part approval system for pesticide production, registration, and marketing:

• Registration: For each technical material or formulated product they make, export, or invent, indigenous pesticide production firms, overseas companies exporting pesticides to China, and R&D entities developing novel pesticides must get pesticide registration.
• Production: Companies participating in the manufacture, processing, and sub-packaging of technical materials and end-use pesticides on Chinese soil must get a pesticide production license from the provincial agricultural department.
• Pesticide marketing licenses must be obtained from the appropriate agricultural department at the county level by entities engaged in the selling of pesticides (except sanitary pesticides).

Product Registration

Prior to conducting business in China, indigenous producers and abroad, companies exporting pesticides should apply for pesticide registration, as might research institutes and persons developing new pesticides. Ministry of Agriculture and Rural Affairs (MoARA) has used licensing management on experimental study, product registration, and laboratory certification in order to ensure data validity, efficacy, and safety of experimental operations.

Administrative Process

All regulatory studies (product chemistry, efficacy, toxicity and environmental impact) performed in China should be approved by MoARA or filed at the 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 pesticides, 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 the 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 the 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.

Data Requirement

Substance Categories

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 environment,  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 radiolabelled pesticide metabolic are required from new TC/TK and non-me-too TC/TK.

Data Acceptance 

Even though China is not an OECD member nor a signatory to the OECD MAD (Mutual/Multilateral Acceptance of Data) programme, test results from abroad OECD-GLP laboratories were previously accepted. China has decided to "level the playing field" in the new regulations by including a new clause that requires test reports supporting pesticide registration to be issued by a MoARA-designated lab or an oversea lab from a country or organisation that has signed a MAD (Mutual/Multilateral Acceptance of Data) agreement with China. Additional requirements for international corporations include conducting plot and large plot efficacy trials, in-crop residue tests, in-field exposure tests, and other research with China-specific organisms in China.

Production License for Pesticide Number

The numbers for the development licence are in the form of 'XK13-***- * * * * * *.' 'XK' is the abbreviation for a licence for the development of pesticides, and '13' means that a licence has been given to a pesticide company. The serial ID of the products to be allocated by the AQSIQ for each type of pesticide product is the three Arabic numerals after the first hyphen, and the following 5 Arabic numerals after the second hyphen are the company ID assigned by the AQSIQ.

The numbers for the clearance certificate are in the form of 'HNP * * * * * -A * * * *.' 'HNP' is the abbreviation of the pesticide manufacturing approval document and the following five Arabic numerals reflect the company's administrative area. The product group (fungicide, herbicide, insecticide, fumigant and PGR, etc.) reflects the alphabetic character after the hyphen and series number assigned by MIIT is expressed by the following four Arabic numerals.