Frequently Asked Questions (FAQ)
Updated in March 2012
Q: Is my product under control of China Pesticide Regulation?
A: If your product is used for the following purposes, you need to comply with China Pesticide Regulation when you export it to China.
- to prevent or control diseases, pests (including insects, ticks and mites), weeds, rodents, mollusks and other organisms harmful to agriculture or forestry;
- to prevent or control storage diseases, pests, rodents and other harmful organisms;
- to regulate the growth of plants and insects;
- to preserve or keep fresh agricultural or forest products;
- to prevent or control mosquitoes, flies, cockroaches, rodents and other harmful organisms;
- to prevent or control organisms harmful to dams, railroads, docks, airports, buildings and other places.
Q: What is the difference between China Pesticide Regulation and EU PPP?
A: The China pesticide regulation is very different in comparison to the EU PPP. In relation to the defined scope, China pesticide regulation is wider than EU PPP. It includes the whole content of EU PPP and also involves parts of products types/uses covered by EU Biocide regulation, i.e. Type14 Rodenticides, Type15 Avicides, Type16 Molluscicides and Type19 Repellents and attractants.
What is New?
August 2012, CIRS will give a webinar about how biocides are regulated in China. The difference between Europe and China will be compared. Click here to register.
Q: Who is in charge of pesticide registration?
A: The Institute for the Control of Agrochemicals under the Ministry of Agriculture (ICAMA) regulates pesticides manufactured and marketed in China. All substances which meet the definition of pesticide, before being exported and marketed to china, must be reviewed and registered by ICAMA.
Q: What regulations do I need to comply when I export pesticide products to China?
A: The main legislation on pesticide in China is the “Regulation on Pesticide Administration”. In accordance with the Regulation, before manufacturing, selling and disturbing a pesticide product in China, one must register it with ICAMA. Meanwhile, after submission, the registration dossiers prepared according with the data requirement for the pesticide registration will be reviewed by the ICAMA and the pesticide registration vetting committee. If the dossiers are complete and approved , registration certificates will be issued, otherwise, the registration application will be rejected.
There are also many other regulations concerning pesticides, including Enforcement Measures of the Regulation on Pesticide Administration,( MOA Decree 9, 2007), Data Requirement on Pesticide Registration( MOA Decree 010, 2007), and Measures for the Administration of Pesticide Labels and Manuals, etc.
Q: What is the current procedure for approving a substance used as pesticide in China?
A: Analysis on registration type/use, data gap, cost and time, shall be carried out before the application of efficacy studies is approved.
All the studies shall be arranged upon approval of the efficacy studies. The registration dossiers shall be prepared after all the study reports are collected. Then the completed dossiers with full information and reports required by the Data Requirement on Pesticide Registration shall be submitted to ICAMA for evaluation and review.
Certificate will be issued if dossier is approved after review.
Q: My company is outside of China, could we apply for the pesticide registration in china?
A: Companies based outside China cannot apply directly for the pesticide registration in China. But you can appoint a representative based in China to apply for the pesticide registration on your behalf.
CIRS specializes in pesticide registration; and can act as a competent third party and/or representative for your pesticide registration in China.
Q: How to categorize the pesticide registration type in china?
A: The China pesticide registration can be categorized into the below types, according to registration stages:
- Field efficacy approval
- Temporary registration
- Full registration
- Renewal registration
- Repacking registration
- Emergency registration
P.S. The temporary registration will be removed according the draft regulation for comments on the Pesticide Administration.
When applying for one new full registration, you shall identify your pesticide registration as “me too”, or “new pesticide”, or “same product with different quality”, and find all the conditions to exempt data requirement for your products.
The pesticide registration is also categorized according with the type of pesticide: General chemical pesticide, public health pesticide, rodenticide, biochemical pesticide, microbial pesticide, botanical pesticide, GMOs, natural enemies.
Q: What is Me Too?
A: This means “Same product with no significant difference in quality” with reference registrations. The products need to have the same AI, the same formulation and the same content with reference registrations which have been out of 6 years registration protection period.
Q: How long will it take to get a registration certificate?
A: The duration of China pesticide registration will be affected by many factors, among which product types and registration types are critical. According to the regulation, 2 years field efficacy studies are essential for new pesticide registration; also, upon receipt of the registration dossier, ICAMA need 1 year to review it. Meet too registration takes approximately 2 years.
Q: What is the total fee for China pesticide registration?
A: The total fee for registration includes registration application fee and data/studies fee. If you appoint a third party as your representative, registration service fee is inevitable.
The registration application fee is 2,500 RMB and the field studies application fee is 200 RMB. Data/studies fee will be the major cost and it is dependent on product type of registration type.
Q: Could my data/reports be accepted for China pesticide registration?
A: Except for the studies that must be carried out in China according to the Data Requirement on Pesticide Registration, the data/reports provided by GLP labs (OECD standards) and authorized labs are acceptable.
Q: What studies must be carried out in China?
A: Field efficacy studies and residue studies must be carried out in China; and the labs should be authorized by The Institute for the Control of Agrochemicals.
Q: What are the standard data protection periods for the different types of data (eg. phys-chem, tox, mutagenicity, residue)?
A: The protection period is six years for all types of data.
Q: When does the protection period start?
A: The protection period starts since the registration certificate is issued.
Q: Is it a problem if a company wants to register in China a product that is not registered elsewhere?
A: It is not an issue. China does not require registration certificate from other countries.
Q: Is it common that tox studies are requested at the stage of application for field trials? What are the conditions for that?
A: No, the toxicity studies are not requested at the stage of application for field trials. Only summaries of toxicity studies are requested.
Q: Also, if a product has already been registered and is now applied for label extension, is it likely that some tox or eco-tox studies are requested (eg. trichogramma, silkworm, bees, etc.)
A: Yes. According to the data requirements, you should provide additional studies if you have not provided relevant studies during your previous registrations.
Q: When is it compulsory to make two years of efficacy trials and when a company can make them for only one year?
A: It depends on registration types and product categories. Only one year efficacy trial is required for Me Too registration. For new registrations, two years of efficacy trials is compulsory. Under the revised data requirements of pesticide registration, one-year field efficacy trial is enough for some types of low-risk pesticides (botanical pesticide, micro-pesticide or bio-pesticide).
Q: Is there still an option to apply for temporary registration, or is it already removed and now all registrations should be applied as permanent?
A: You can apply for temporary registration at present if all required data is ready. The temporary registration will be removed until the new version of regulation comes into force in the near future.
Q: Whether there is biocide regulation (For example, active ingredients, which are fungicide, moldicide, insecticide, is for Industrial market use) in China or not. If the answer yes, please follow the raw name and regulation’s information with related website.
A: No. There is no specific biocide regulation in China. Some biocides are covered by pesticide regulations in China.
Q: Whether there is pest control product’s regulation (For example, the usage places are chckroachcide, rodenticide at storage, restaurant. It will be excepted agro-farm.) or not. If the answer yes, please follow the raw name and regulation’s information with related website.
A: Yes, all products fall under the scope of pesticide regulations in China.
Q: Whether there is biocide regulation for Sanitized product’s active ingredients: antibacterial agents, disinfectants (For example, the usage fields are for diapers, sheets and disinfectant and so on.) or not. If the answer yes, please follow the raw name and regulation’s information with related website.
A: Those products are regulated as disinfectant and hygienic products in China and are subject to different regulations issued by the Ministry of Health. Registration is also required for this type of product. You can find more information from this website: http://www.jdzx.net.cn/
Q: How are inert ingredients dealt with?
A: Inert ingredients in pesticides are not regulated. However, suppliers of inert ingredients need to comply with chemical legislation in China. For example, they need to prepare SDS and labels. They also need to register the inert ingredients if they are new chemical substances.
Q: If there is approval in other countries, how does that translate to acceptance in China?
A: Other counties’ approvals are not accepted in China. However, the data submitted for approval in other countries might be helpful for pesticide registration in China.
Q: What type of efficacy data is required on the antimicrobial products e.g. handwash, or household antimicrobial spray?
A: Handwash and household antimicrobial spray is out of the scope of China Pesticide Regulation. In China, antimicrobial/disinfection products are regulated by the Ministry of Health of China.
Q: May we say that the China system is similar to EPA USA system?
A: No, there are a lot of differences.
Our Services
We provide free initial consultation regarding your obligations under this legislation. We will provide pre-service assistance with regard to compiling a registration strategy and estimating the registration costs. If registration is required, we can then prepare a detailed registration schedule with cost estimation included, registration strategy analysis, study monitoring, report collection and dossier preparation.
Our expert team have many years experience with pesticide registration in China and we are confident that we can help you register your products in China in a cost-efficient manner. Click the following picture to view our comprehensive pesticide registration services for China.
About Us
Initially set up by China Inspection and Quarantine(CIQ) Bureau in 2007 to provide REACH compliance services to Chinese chemical industry, CIRS has grown to be a leading provider of comprehensive chemical compliance services for companies doing businesses in/with China.
Our services cover new substance notification, registration of the import and export of toxic chemicals, registration of hazardous chemicals, classification and labeling in according to China GHS, Chinese SDS, risk assessment of industrial chemicals, pesticides, food additives and cosmetic ingredients. We provide one-stop solutions to your regulatory issues in China. We also deliver the most up-to-date regulatory information about chemical control laws in China.
- Mr. David Wan, China Office
11F Building 1, Dongguan Hi-Tech Park, 1288 Chunbo Road, Binjiang District, Hangzhou 310052, China
Tel: +86-571 8720 6555 | Fax: +86-571 8720 6533
Email: david@cirs-reach.com
