Management of Non-agricultural Pesticides in China
Original Article from CIRS
Non-agricultural pesticides, regulated as biocides within OECD countries, are regulated as public health pesticide and rodenticide in China. This article summarizes how non-agricultural pesticides are regulated in China.
As defined in the Regulations on Pesticide Administration, all of the following products are regulated as non-agricultural pesticides in China.
- Insecticides to kill mosquito, flies and cockroaches
- Rodenticides
- Termiticide
- Insecticide to control the storage pest
- Personnel care products containing repellents to repel mosquito
- Molluscicide
- Wood preservatives
- Insecticides to control red ants, mites, bug and other harmful insects
- Other pesticides to control the harmful organisms on dams, railways, docks, airports, buildings and other sites.
Please note: some disinfectants for humans, drinking water, medical equipment and hospitals are not regulated as non-agricultural pesticides. Those products are regulated by the Ministry of Health. More info can be found here.
What is New?
26 Aug 2013, CIRS now provides 30% off regulatory analysis report on China Pesticide Registration. More info about this service can be found here
15 Jan 2013, CIRS publishes China Chemical Regulatory Update Report 2012. To download this report, please click here.
10 August 2012, CIRS held a webinar about how biocides are regulated in China. Click here to request a copy of presentation.
Main Administrative Departments
There are too many departments involved in the management of pesticide in China. The main administrative departments of non-agricultural pesticides and their responsibilities are listed as below:
- MOA(Ministry of Agriculture): Issuing relevant regulations;
- ICAMA(Institute for the control of agrochemicals under the Ministry of Agriculture: Pesticide registration and management;
- MIIT(Ministry of Industry and Information Technology of the People’s Republic of China): Supervision and management of pesticide manufacturers;
- PHCCO(Patriotic Health Campaign Committee Office): Application management;
- CCDCP(Chinese Center for Disease Control and Prevention): Technical guidance;
- CPCA(The Chinese Pest Control Association):Application recommendation;
Non-agricultural pesticides are strictly regulated by ICAMA. Some uses are restricted and some uses are banned.
Restricted use
- The high toxic and extra toxic technical material cannot be used to manufacture public health pesticide;
- The median toxic public health pesticide can only be used for outdoor applications;
- The lambda-cyhalothrin cannot be approved for indoor use;
- The chloroflurocarbon is limited to be used as propellants for aerosol;
- The appearance and shape of some public health pesticide needs to meet certain requirements. For example, a cockroach killing pen shall be different from the general chalk and it can’t be designed with the shape of children toys;
- Chlorpyrifos shall not be easily reached at the indoor sensitive area. The bait must be designed in the form of a bait box which shall not be reached by children;
Banned use
- Fenobucarb is not allowed to be used as public health pesticide;
- The use of sodium pentachlorophenate to control oncomelania is prohibited in consideration of the high risk to environment;
- The use of synergist octachlorodipropyl ether is banned;
- The registration and application of terallethrin is banned;
- The registration of fly incense is banned;
- The registration of repellent dimethyl phthalate is banned;
- For the rich-d- Pyrethroids, only technical material registration of rich-d-transallethrin and rich-d-prallethrin can be retained;
- The use of the following biocides is prohibited by the regulations on pesticide administration:
- To kill fish
- To kill bird
- To kill shrimp
- To kill beast
Requirements on Product Formula
Several measures to strengthen the safety management of public health pesticide were concluded by the 9th plenary session of the eighth pesticide registration committee. Those measures have set detailed requirements on product formulation.
- The content of an active ingredient in a single active ingredient formulation of public health pesticide shall not be greater than the upper limit set by WHO;
- The sum of the percentage of active ingredient in the mixture and the upper limit of the corresponding active ingredient recommended by WHO shall not exceed 100%. If the sum is greater than 100%, 28-days sub-acute toxicity shall be supplied to prove the safety of the product. The content of each active ingredient in the mixture shall not be greater than the upper limit of a single active ingredient formulation.
- The scientific basis of the product formula, relative safety study data and risk assessment report shall be provided for the active ingredient to be registered for the first time;
- No registration of mixture containing three or more active ingredients can be approved;
Many standards for non-agricultural pesticide are also introduced to promote the registration and use of non-agricultural pesticide in China. Some of those standards are listed as followed for references:
- GB 24330-2009 General safety technique specification of household public health pesticide
- GB/T 13917-2009 Indoor efficacy test and assessment of public health pesticide for pesticide registration
- GB/T 27779, GB/T 27781-GB/T27783-2011 Guideline on safety application of public health pesticide (pyrethroid, propellant, aerosol, bait)
- GB/T 27777-2011 Guideline of safety application of rodenticide (Anticoagulant)
- GB/T27778-2011 On-site efficacy test and assessment of rodenticide (poison bait)
- GB/T 23795-2009-GB/T23798-2009 Surveillance and testing method for vector density (cockroach, flies, mosquito, rodent)
- GB/T 27654-2011 Wood preservative
- GB/T 27653-2011 Analytical method used in testing for wood preservative (Two-phase titration method)
- NY 1153-2006 Efficacy testing method for the control of termites
- NY1152-2006 Efficacy testing method for the controls of commensal rodents
- NY/T 1617-2008 Efficacy test and assessment of molluscicide for pesticide registration
- LY/T 1283-2011 Lab toxic testing method of wood preservative to decay fungi, Etc.
Registration of non-Agricultural Pesticides
All pesticides must be registered with ICAMA before being placed on Chinese market. Data requirements depend on the product type and registration type. In general the following data is required for formal registration of a new active ingredient and new formulated public health pesticide products. Some data can be exempt.
New public health pesticide – active ingredient
- Product chemistry data
- Five batch analysis report
- Physical-chemical study report of the active ingredient
- Physical-chemical study report of the technical product
- Product quality test report and analytical method validation
- Product quality standard
- Manufacturing process
- Package information
- Toxicity study reports
- Six pack
- Subchronic toxicity study (90 days rat feeding study, 28-days dermal or inhalation toxicity study)
- Mutagenicity studies
- Reproduction toxicity study
- Teratogenicity study
- Chronic/carcinogenicity study
- Delayed neurotoxicity
- Metabolism in animal
- Six-month rat feeding test report
- Environmental fate study reports
- Volatility study
- Soil absorption study
- Soil degradation study
- Hydrolysis study
- Photolysis in water
- Water-sediment degradation study
- Ecotoxicity study report
- Avian acute oral toxicity
- Fish acute toxicity study
- Daphnia acute toxicity study
- Algae acute toxicity study
- Honey bee acute oral toxicity study
- Honeybee acute contact toxicity study
- Amphibians acute toxicity study
- Silkworm acute toxicity study
- MSDS
- Label or product manual
- Application form
- Product summary report
- Comprehensive research report
- Others
New public health pesticide - formulated product
- Product chemistry data
- Physical-chemical study report
- Product quality test report and analytical method validation
- Product quality standard
- Three batch real time storage study report
- Package information
- Efficacy study
- Indoor bioassay test report
- Indoor efficacy study report
- Simulated-spot test report
- On-spot test report
- Toxicity study reports
- Six pack according to product information
- Eco-toxicity study report
- Avian acute oral toxicity
- Fish acute toxicity study
- Daphnia acute toxicity study
- Algae acute toxicity study
- Honey bee acute oral toxicity study
- Honeybee acute contact toxicity study
- Silkworm acute toxicity study
- SDS
- Label or product manual
- Application form
- Product summary report
- Comprehensive research report
- Others
Risk assessment
The risk assessment of public health pesticide is required on mosquito-repellent incense in 2012. Risk assessment has been conducted on the product “QIFUJIAMIJUZHI” developed by a Chinese company. That’s the first risk assessment case in pesticide registration in China, and this will be the initial step of risk assessment in Chinese pesticide registration.
As the new regulations on pesticide administration will be issued later this year (May be before October), data requirements on pesticide registration will also be amended. Non-agricultural pesticide companies shall monitor those changes closely to see if there are new requirements.
About the Author
Ema Huang graduated from China Agricultural University, the most prestigious agricultural university in China with a degree in applied chemistry. She has almost 10 years’ experience in the area of China Pesticide Registration since her graduation. Before joining CIRS, she worked for several well-known Chinese pesticide manufacturers as a pesticide registration specialist. She has built up much expertise through practical involvement in pesticide registrations in China and abroad.
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