Photo taken by ChemLinked reporter Fang Lin on 24 May 2014.
Over the past five years, the number of biopesticides registered in China has enjoyed a 16% increase while growth of chemical products was just 3%. Currently, the global biopesticide industry is worth 3.2 billion USD annually. Over 60% of the market is dominated by the United State and European enterprises. As the largest chemical pesticide producer and exporter in the world, China wants a bigger piece of this emerging sector. China’s ambition is not limited to securing a market niche in the global biopesticide sector. The Chinese government is also eager to find safer alternatives to the chemicals currently used domestically. Food safety is a massive concern in China and the government has tried to drive substitution of hazardous chemicals domestically by subsidizing biopesticide users and offering favorable registration policies
Overview
In China, biopesticide refers to biochemical, microbial pesticides, botanical pesticide, biochemical pesticide, natural enemy and pest-resistance GMO crops. Both the industry and the academic community believe that agricultural antibiotics should also be classified as biopesticides; however this product category is actually registered as a chemical pesticide a fact reflected in the registration statistics. Nevertheless, the numbers of active ingredient and biopesticide products have grown by 20% in the last couple of years. By the end of April 2014, the number of biopesticide active ingredients and products expressed as a percentage of total pesticides registered with ICAMA were 14.5% and 3.3% respectively.
Numbers of Biopesticide Active ingredient and Products Registered in China | ||
category | Number of Registered Active Ingredient | Number of Registered Product |
microbial pesticide | 31 | 363 |
botanical pesticide | 23 | 256 |
biochemical pesticide | 38 | 373 |
natural enemy | 2 | 3 |
agricultural antibiotics | 17 | 2668 |
Total | 111(94) | 3663(995) |
All pesticide | 650 | 30,000 |
Percentage of Total Registered Pesticide | 17. 1 %( 14.5%) | 12.2 %( 3.3%) |
In the past biopesticide producers looked for governmental support in the form of policies that offered data exemptions and expedited the registration process. In response to this need, the authorities started to draw up a supplementary document for data requirement on biopesticide registration in 2010 and a revised draft of the Data Requirement on Pesticide Registration was released for public consultation the following year. However the consultation never progressed any further similar to its overarching regulation, the “Regulation on Pesticide Administration”. The revised draft of the “Regulation on Pesticide Administration” was released in 2011 for public consultation with ICAMA officials optimistically vowing that the new regulation would be promulgated by the end of 2012. The biggest obstacle facing China’s biopesticide registration policy remains the delay in the legislative process of this overarching regulation. The acceleration of efficacy testing which was set to change the standard field testing protocol which uses 4 sites for 2 years to 8 sites for one year will also not be achieved. However China’s biopesticide registration process is still faster than its global counterparts.
Country/Region | Requirements on Efficacy Test | Time |
United State | No requirement at national level but differs from different State; | 18 months |
Europe | 2 planting season | At least 29 months |
Brazil | 1 planting season | 18 to 36 months |
India | 2 planting season, 3 test sites | 24 months |
Argentina | 1 planting season, 3 test sites | 12-15 months |
Japan | 2 planting season, over 3 test sites | 24-30 months |
China | 2 planting season,4 to 5 test sites | 3 month(temporary registration), 12 months(full registration) |
Similarities and Difference of Registering Biopesticide and Chemical Pesticide | |
Similarities |
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Difference |
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During the National Biopesticide Development and Application Exchange Conference in Shandong, Mr. Yuan Shankui from the Efficacy Review Department of ICAMA outlined the most frequent data problems during the registration process and the different requirements for different biopesticide categories.
Microbial Pesticide
Microbial pesticide consists of fungi, bacterium, virus, protozoan and rickettsia-lick. Currently, there are 10 fungus, 10 bacteria and 11 viruses registered in China and the number of total microbial pesticide reached to 353.
Active Ingredients of Microbial Pesticide Registered in China | ||
Type | Number of Registered Active Ingredient/Product | Name of Active Ingredient |
fungi | 10/269 | bacillus thuringiensis; bacillus thuringiensis H-14; bacillus sphaericus H5a5b; bacillus subtilis; bacillus cereus; pseudomonas fluorescens; paenibacillus polymyza; empedobacter brevis; bacillus licheniformis; sphaerotheca amyloliquefaciens |
bacterium | 10/36 | metarhizium anisopliae; beauveria bassiana; trichoderma harzianum; trichoderma SP; paecilomyces lilacinus; verticillium chlamydosporium ZK7; conidioblous thromboides; coniothyrium minitans; torula yeast |
virus | 11/58 | EONPV; Euproctis pseudoconspersa Nucleopolyhedogsis Virus; LeNPV; Mamestra brassicae multiple NPV; autographa californica NPV; dendrolimus punctatus cytoplasmic polyhedrosis virus; periplaneta fuliginosa densovirus (PfDNV); pierisrapae granulosis virus(PrGV); plutella xylostella granulosis virus (PXGV); spodopteralitura NPV; heliothis armigera NPV |
Microbial strains are usually infectious and reproductive in their host and/or environmental media,. Mutations can cause unexpected adverse effects. Thus evidence outlining lack of pathogenicity to humans etc. of these microorganisms is required:
Data Requirements on Microbial Pesticide | |
Data Category | General Requirements |
Chemical and biological data | General the same as chemical pesticide; Inoculum(species of the microbe) identification is required; The technical specification and shelf life on certain formulation types are different from chemical pesticide; |
Efficacy | the same as chemical pesticide; |
toxicology | Supporting document that the microbe is non-pathogenic to humans and other mammal(usually a non-pathogenic report issued by MoA authorized microbial testing institute); Basic toxicology data (acute oral, acute skin, acute inhalation, eye irritation, skin irritation and skin sensitization). Additional toxicology data is usually not needed if the microbial pesticide is not highly or extremely toxic in basic toxicology study; |
Environmental Data | Acute toxicity test on fish, daphnia, algal, bee and silkworm; The environmental fate test can usually be exempted; |
residue | Usually exemptible; |
*During the 5th plenary session of the 8th national Expert Committee for Pesticide registration, the experts agreed that if the TC (TK) of the microbial pesticide is low or negligibly toxic, the residue data of TC/TK and formulated product registration can be exempted.
MoA has not yet officially designated testing labs for microbe species identification, Mr. Yuan revealed that the identification report issued by two institutes are generally acceptable for microbial pesticide registration. Another big issue for registering novel microbial pesticide is the nomenclature on the microbe. The applicant of novel microbe pesticide should obtain a letter of pesticide nomenclature from the Secretariat of National Technical Committee on Pesticides Standardization Administration and submit the letter alongside the registration dossier. Some common faults of the dossier were also pinpointed during Yuan’s speech:
The content of microbial pesticide should be normatively described in “CFU/g (mL)”or “IU/mg (mL)”and “PIB (OB)/mg (mL)”;
The control index of undesired microbes should be defined in the dossier. But this requirement is usually omitted or the applicant simply fills in with “less than 0.1%” without consideration. This application material would often be rejected by the reviewing body because ICAMA insists that controlling undesired microbes under 0.1% is unachievable and unrealistic.
All pesticide application materials should include quality specifications. If China has not yet established national or industrial quality standard for the pesticide, the applicant should establish the enterprise standard for the pesticide. If the applicant of microbial pesticide has no idea of how to formulate the quality standard, some recently released national quality standards on microbial pesticide can be referenced
Storage stability report( at least 12 months) should be included；
Botanical Pesticide
China granted registration approval to 23 active ingredients and 256 products to botanical pesticide:
Active Ingredients of Botanical Pesticide Registered in China | ||
Type | Number of Registered Active Ingredient/Product | Name of Active Ingredient |
insecticide | 13/182 | matrine; rotenone; azadirachtin; vertrine; pyrethrins; nicotine; celastrus angulatus; eucalyptol; camphor; d-camphor; oleum anisi stellate; neochamaejasmin; |
molluscacide | 1/2 | TDS |
regulator | 2/50 | brassinolide; propionyl brassinolide |
rodenticide | 2/4 | triptolide; curcumol |
Fungicide | 5/18 | cnidiadin; eugenol; eugenol; physcion; berberine |
Data Requirements on Botanical Pesticide | |
Data Category | General Requirements |
Chemical | General the same as new chemical pesticide; If the full-component analysis is unachievable, the full-component report can be exempted, however a proof issued by MoA approved testing facility is required and the applicant should provide the identification report of at least one major active ingredient of the botanical pesticide; |
Efficacy | the same as chemical pesticide; |
toxicology | Generally the same as full registration of new chemical pesticide; If the pesticide was approved by the national authorities to be registered as food additive, dietary supplement and medicine etc., the reproductive, teratogenic, chronic and carcinogenicity toxic data can be waived; |
Environmental Data | Acute toxicity test on fish, daphnia, algal, bee and silkworm; Over 90% of the botanical pesticide can be waived of environmental fate data; |
The registration of TC/TK of botanical pesticide cannot be exempted even if TC or TK is low or slightly toxic. But the residue data can be exempted for its corresponding formulated product.
If the active ingredient of the botanical pesticide was chemically synthesized, the pesticide should be registered as a chemical pesticide. If the formulated botanical pesticide product was mixed with a chemical pesticide data waiving is not applicable.
Biochemical Pesticide
Biochemical pesticides are often natural compound or have the same chemical structure as natural compound. Their most significant characteristic is that they have no direct toxic effect on their target. They usually include pheromone (ectohormone, allomone, kairomone and sex attractant, etc.), hormone, natural plant growth regulator/insect growth regulator and protein/ enzyme. There are 38 active ingredients and 373 products registered as biochemical pesticide in China.
Active Ingredients of Biochemical Pesticide Registered in China | ||
Type | Number of Registered Active Ingredient/Product | Name of Active Ingredient |
regulator | 18/258 | gibberellic acid; 4-indol-3-ylbutyric acid; enadenine, oxyenadenine; 6-benzylamino-purine; triacontanol; (+)-abscisic acid; 1-methylcyclopropene(1-MCP); sodium nitrophenolate; sodium 2,4-dinitrophenolate; sodium 5-nitroguaiacolate; sodium para-nitrophenolate; sodium ortho-nitrophenol; potassium nitrophenolate; potassium ortho-nitrophenolate; potassium para-nitrophenolate; 1-naphthyl acetic acid; aspirin |
Rodenticide | 5/6 | Cholecalciferol; 3-chloropropan-1,2-diol; difennuozhi; barium sulfate; vitamin C |
Pheromone/ Attractant | 5/6 | muscalure; trimedlure; E-8-dodecen-1-yl acetate; Z-8-dodecen-1-ol; Z-8-dodecen-1-yl acetate |
Repellent | 1/27 | ethyl butylacetylaminopropionate |
inductor | 1/2 | methiadinil |
protide | 2/3 | harpin protein; plant activator protein |
saccharide | 5/68 | oligosaccharins; fungous proteoglycan; chltosan; pujuxitang; oligosaccharides |
fatty acid | 1/3 | mixed aliphatic acid |
If the biochemical pesticide has a low exposure risk (non-sex attractant), it is exempted from most data exemption requirements.
Data Requirements on Botanical Pesticide | |
Data Category | General Requirements |
Chemical | General the same as chemical pesticide; |
toxicology | Basic toxicology data (acute oral, acute skin, acute inhalation, eye irritation, skin irritation and skin sensitization); The subchronic and mutagenic data are exemptible unless the biochemical pesticide is highly or extremely toxic during basic toxicology study; |
Environmental Data | TC application need to submit acute toxicity test on fish, daphnia, algal, bee and silkworm; The environmental fate data can generally be waived unless the biochemical pesticide is highly toxic to non-target organism ; |
Other Data | Usually exemptible |
Biochemical pesticides have distinct functional mechanism exposure pathways compared with other pesticide categories and are thus usually tested and evaluated using different criteria. For example, an applicant of a pheromone attractant usually needs to ask ICAMA’s local subordinates for suggestion on the measurement of efficacy. The other issue on this category is whether the biomimetic synthesized (chemical modified from natural biochemical) compound should be classified as biochemical pesticide and enjoys the data exemptible preference. The authority adopts a precautionary approach towards biomimetic compounds and deems azoxystrobin and diflubenzuron as chemically modified and thus subject to registration as a conventional chemical pesticide in China.
Agricultural Antibiotic
Though agricultural antibiotic has the greatest number of registrations compared with other biopesticides, the data requirement are more like chemical pesticides and the test data for medical registration cannot be utilized for pesticide registration.
Active Ingredients of Agricultural Antibiotics Registered in China | ||
Type | Number of Registered Active Ingredient/Product | Name of Active Ingredient |
Insecticide | 5/2168 | abamectin; spinosad; spinetoram; ivermectin; emamectin benzoate; |
rodenticide | 2/5 | Botulinum toxin D; Botulinum toxin C, |
Fungicide | 10/495 | Jingangmycin A; kasugamycin; polyoxin; pyrimidine nucleoside; cytosinpeptidemycin; ningnanmycin; streptomycin sulfate; phenazino-1-carboxylic acid; zhongshengmycin; tetramycin |
Future Trend
Mr. Yuan outlined that ICAMA is very cautiously reviewing each biopesticide registered for the first time in China and also standardizing its preference policy on biopesticide:
The active ingredient in the microbial pesticide will be registered in accordance with the strain instead of the microbial species;
For the biopesticide active ingredients already registered in China, ICAMA will formulate a “dynamic list” and the on-going pesticide based on the included active ingredient can be exempted of residue test;
Explosiveness test can be exempted on all categories of biopesticide;
MoA will publish the name of testing facilities capable of microbe identification test and biopesticide quality test;
