Overview

Pesticides manufactured, sold and used in China should apply for pesticide registration in accordance with the Regulations on Pesticide Management. China’s pesticides are mainly under the supervision of the Ministry of Agriculture and Rural Affairs of China (MoA). The Institute for the Control of Agrochemicals Ministry of Agriculture and Rural Affairs (ICAMA), an institute under MoA, undertakes the evaluation of pesticide registration, while provincial authorities are responsible for the preliminary review and supervision of pesticide registration within their jurisdiction.

On 1 April 2017, China amended and promulgated the new Regulation on the Administration of Pesticide  (hereinafter referred to as the new regulations), which was formally implemented from 1 June 2017. To ensure the implementation of the new regulations, some supporting regulations were also issued one after another.

The new regulations provide for a comprehensive evaluation of pesticide registration, not only focusing on product effectiveness, but also on product safety, and following the principle of maximum risk in product risk assessment. Newly registered products must be comparable to or have significant advantages over registered products in terms of effectiveness and safety, which raises the threshold for pesticide registration. In addition to pesticide registration, the new regulations also greatly strengthen the supervision and management of pesticide production and distribution.

Table 1 The Main Regulation about China Pesticide

Competent Authority and Its Functions

MoA: Ministry of Agriculture and Rural Affairs. MOA mainly focuses on issuing pesticide related guidelines, organizing the National Pesticide Registration Review Committee(NPRRC) and granting administrative approvals of registration.

ICAMA: Institute for the Control of Agrochemicals Ministry of Agriculture and Rural Affairs. ICAMA is an agency under the MOARA, and mainly in charge with the technical review of pesticide registration.

Provincial authority: Which is responsible for the supervision and management of pesticides shall conduct a preliminary review within their respective administrative areas.

Scope of China Pesticide Regulation

Pesticides manufactured, sold and used in China are subject to China pesticide regulations, including technical material, technical concentrate and formulation.

Pesticide: means a substance or mixture or other preparation of one or more substances derived from chemical synthesis, or originated from biological and other natural sources, used to prevent or control diseases, insects, weeds, rodents or other organisms harmful to agriculture and forestry, and aimed to regulate the growth of plants and insects.

Technical material (TC): refers to the product obtained from the production process and composed of active compounds and relevant impurities, and if necessary, containing a small volume of additives.

Technical concentrate (TK): refers to the product obtained from the production process, composed of active compounds and relevant impurities, and possibly containing a small volume of necessary additives and moderate diluents.

Formulation: refers to stable pesticide products processed from TC (TK) and appropriate adjuvants or processed by way of biological fermentation, phytoextraction, etc.

Who can Apply for China Pesticide Registration?

The applicant shall be a pesticide manufacturer, an enterprise exporting pesticides to China or a new pesticide developer.

A pesticide manufacturer refers to a domestic enterprise holding a pesticide production permit.

A new pesticide developer refers to a Chinese citizen, legal person or other organization applying for a new pesticide registration.

An enterprise exporting pesticides to China (hereinafter referred to as an overseas enterprise) refers to an enterprise exporting the pesticides produced overseas to China. Please note that, the overseas enterprises could be manufacturers or trade companies and they need to have offices in China or entrust intermediary organizations which have the legal person status in China.

China Pesticide Registration Type

1. TC (technical material)/ TK(technical concentrate) registration;
2. Me-too or similar product registration;
3. New content registration;
4. New formulation registration;
5. New ratio registration;
6. New use scope or method registration;
7. Renewal registration;
8. Alteration registration.

Data Requirement

The applicant shall submit product chemistry, toxicity, efficacy, residue, environmental impact as well as testing reports, risk assessment reports, samples of labels or instructions, product safety data sheet, relevant literature, application form, applicant qualification certificate, and other applicant materials.

Please note that, a registration test report shall be issued by the registration test agency approved by the MoA, or issued by a relevant overseas laboratory under the mutual recognition agreement between the relevant departments of government, provided that the efficacy, residue, environment and other tests closely related to environmental conditions as well as registration tests for unique biological species to China shall be completed in the territory of China.

The Procedure for Pesticide Registration in China

Time and Cost for Pesticide Registration

Preliminary examination: the provincial authority shall perform a preliminary examination within 20 working days upon acceptance of such application, give opinions of the preliminary examination, and report to the MoA.

Technical evaluation: the MoA shall complete technical examinations on the chemistry, toxicity, efficacy, residue, environment impact and label sample of the product within nine months, give examination opinions, and submit them to the Pesticide Registration Reviewing Committee for review.

Others

The pesticide registration certificate is valid for 5 years. Within 180 to 90 days before the expiration of the registration certificate, a renewal application needs to be submitted to the MoA. Enterprises that fail to apply for renewal within the time limit need to re-apply for formal registration.

Our Services

• New Technical Material Registration
• New Product Registration
• Me-too Product Registration
• Alteration Registration
• Renewal of Registration Application
• Public Health Pesticide Application
• Exported-only pesticide Registration
• Human Health Risk Assessment/ Environmental Risk Assessment/ Dietary Risk Assessment/ Pesticide Resistance Risk Analysis
• Product Benefit Analysis
• Regulatory Compliance Analysis
• Customized Training

Why Choose Us？

REACH24H has very rich experience in new pesticide registration (novel chemical pesticides) and bio-pesticides registration. REACH24H has helped the top 100 Chinese pesticide manufacturers as well as many foreign companies in analyzing product compliance strategies, drawing up compliance plans, and finally successfully completing their China pesticide registration. As the first consulting agency that can provide human health risk assessments, environmental risk assessments, dietary risk assessments and pesticide resistance risk analysis, REACH24H has overcome many technical barriers throughout, and successfully helped companies obtain registration under the new pesticide regulations.

Over the years of compliance, REACH24H has developed a very good relationship and close work with ICAMA and testing laboratories, all these relationships would help us access the latest news of regulations, better understand regulation contents, timely know law enforcement actions from competent authorities, speed up the testing process and save testing costs.

Therefore, with rich compliance experience in complying with new pesticide registration in China, REACH24H would be fully capable of helping you address technical barriers under pesticide registration and provide the most practical and customized solutions.

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