Pesticide registration is complex, time-consuming and sometimes expensive. CIRS Group summarizes frequently asked questions (FAQ) about pesticide registration in China for those who wish to sell pesticide active ingredients and formulations to China.
1. How do I know whether my products are regulated as pesticides in China?
You shall firstly check the definition of pesticide in China. 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.
Typical products that require pesticide registrations include herbicides, insecticides, fungicides, plant growth regulators, seedcare products, biopesticides and public health pesticides such as mosquito repellants, wood preservatives, snail-killing agent and termite control agent.
2. Who can apply for pesticide registrations in China?
Pesticide manufacturers: a domestic enterprise holding a pesticide production permit.
Enterprises that export pesticides to China: an overseas enterprise exporting a pesticide produced overseas to China.
Developers of new pesticides: a Chinese citizen, legal person, or other organization applying for new pesticide registration.
Overseas pesticide registration applicant shall appoint a Chinese agent to facilitate the registration work.
3. How much does it cost and how long does it take to register a pesticide in China?
Depending on product type and registration type, the costs and timelines vary significantly. The total costs of pesticide registration consist of testing fee and consultancy fee, among which testing fee accounts for a large proportion. China ICAMA does not charge administrative fees for pesticide registration applications. It takes about 4-5 years (including testing time) to register a new chemical pesticide TGAI, 2-3 years to register a new biopesticide or a new formulation or label extension in China.
Estimated fees and timelines for various types of registration is listed as below assuming all studies are carried out in Chinese GLP labs.
|Application Type||Product Type||Estimated Testing Fee (USD)||Estimated Total Time (Year)|
|New Formulation||Public Health||25K-30K||3|
4. Are OECD GLP study reports accepted in China?
China currently only accepts test data generated in overseas labs that have been accredited by the Ministry of Agricutlure and Rural Affairs (MARA) in China or generated in GLP labs in countries/regions that have signed Mutual Acceptance of Data (MAD) agreement with China. So far, China has not signed the MAD with OECD which means that studies done in OECD GLP labs are not accepted in China for pesticide registration.
For new active ingredients, all product chemistry, toxicology, environment, efficacy and residue data must be generated in Chinese GLP labs certified by MARA. For new formulations containing already registered active ingredients , only formulation data needs to be generated in Chinese GLP labs.
Luckily the costs of GLP testing in China are much lower than OECD GLP labs in EU & US.
5. Are there any requirements on inert ingredients?
Yes, certain inert ingredients are restricted or even banned in pesticide formulations. Please check with us whether an inert ingredient is restricted or not in China.
6. What are the easiest types of pesticide registration in China?
Export-only registration and label extension.
7. How do I search pesticide registrations approved by China MARA?
You can search approved pesticide registrations by company name or active ingredients via the following database provided by ICAMA.
8. What types of risk assessment reports need to be submitted?
Depending on product type, registration type and intended use, the following 3 types of risk assessment reports need to be submitted.
- Operator/Residential health risk assessment;
- Dietary risk assessment;
- Environmental risk assessment.