ICAMA Registration Expert Review Statistics Released - H2 of 2012

ICAMA CHINAChinese National Expert Committee for Pesticide Registration consists of more than thirty specialists from agricultural, forestry, chemistry, hygiene, environmental etc. The experts are summoned up once or twice every year to issue expert opinions for authorizing full registration for new pesticides. Latest conference, the 11th plenary session of the 8th National Expert Committee was concluded in Urumqi, China. Of all the 29 applications, 12 of them have been granted the ICAMA’s approval of full registration. The name, ai(s), formulation, range, uses, applicant, validation period of the applications and the results were summarized in the tables below.

Table 1. New pesticides approved by the 11th plenary session of the 8th National Expert Committee

 

ICAMA certificate number (validation period)

Ai(s) and Content(s)

Type of formulation

Target(s) and Crop(s)

Registrant[type]

PD20121663

(05/11/2012-05/11/2017)

JS399-19 95%

Technical

 

Jiangsu Pesticide Research Institute Company(JPRIC)

[Fungicide]

PD20121670

(05/11/2012-05/11/2017)

JS399-19 25%

suspension concentrates

Foot rot on wheat and bakanae disease on rice

PD20121674

(05/11/2012-05/11/2017)

orthosulfamuron 98%

Technical

 

Isagro

[Herbicide]

PD20121667

(05/11/2012-05/11/2017)

orthosulfamuron 50%

Water dispersible granules

Cyperus, Barnyard grass and

Broadleaved Weeds in

transplanted paddy field

 

WP20120209

(05/11/2012-05/11/2017)

Disodium octaborate tetrahydrate 98%

Water soluble powder(SP)

 

Rot and ant on wood

Borax

[Biocide]

PD20121673

(05/11/2012-05/11/2017)

fluopyram 96%

Technical(TC)

 

Bayer CropScience

[Fungicide]

PD20121664

(05/11/2012-05/11/2017)

fluopyram 41.7%

suspension concentrates (SC)

powdery mildew on cucumber

 

PD20121675

(05/11/2012-05/11/2017)

maleic hydrazide 99%

Technical(TC)

 

Chemtura

[Fungicide]

PD20121672

(05/11/2012-05/11/2017)

Fufenozide

98%

Technical(TC)

 

JPRIC

[Insecticide]

PD20121676

(05/11/2012-05/11/2017)

Fufenozide

10%

suspension concentrates (SC)

beet armyworm on cabbage

Note:

JPRIC originally applied for the crop ranges of cruciferous vegetables and tea plant, the Committee finally agreed the pesticide to be only applied on cabbage as lack of residual data on the tea plant.

PD20121671

(05/11/2012-05/11/2017)

picoxystrobin  97%

Technical(TC)

 

DuPont

[Fungicide]

PD20121668

(05/11/2012-05/11/2017)

picoxystrobin 22.5%

suspension concentrates (SC)

Anthracnose and gummy stem blight on watermelon;

black spot and leaf spot on banana

DuPont’s application of black spot and leaf spot on banana was rejected as the residue of the fungicide in banana has exceeded the EU’s MRL requirement.

 

 

Table 2. 3 Applications pending upon supplementary submission

 

name

Ai(s) and Content(s)

Type of formulation

Target(s) and Crop(s)

Applicant

Chlorempenthrin and permethrin combination

 

chlorempenthrin 0.2%+permethrin   0.2%

aerosol

Hygienic use against the fly

 

Jiangsu Youth Chem

[Insecticide]

Screening study of the formulation type shall be supplemented. The MOA is anticipating reasonable design of the combination

novaluron

novaluron 98.5%

Technical(TC)

 

Jiangsu Jiannong Agchem

[Herbicide]

novaluron 10%

emulsifiable concentrate(EC)

Against wiggler in ditch and etange

FMC Suzhou

[Herbicide]

Further submission of the risk assessment report conducted in the United State and 28 Day inhalation toxicity test of the ai.

 

 



Table 3. 14 applications temporarily rejected for full registration

 

Ai(s) and Content(s)

Type of formulation

Target(s) and Crop(s)

Applicant

Bacillus thuringiensis 10 billion cfu/g+ PuGV 3 billion cfu/g

 

Wettable Powder

Diamondback moth  on cruciferous vegetables

Jiangsu Yangzhou Luyuan Bio-Chemical

[Insecticide]

The Committee temporarily rejected the applications from Luyuan Bio-Chemical in that absence of the following data:

toxicity test report on silkworm and fish of the two ais;

Reproduction data on Bacillus thuringiensis and PuGV;

Proof of PuGV’s efficacy on diamondback moth

Pythium Oligandrum 5 million cfu/g

Technical(TC)

 

Biopreparaty Co. Ltd. [Fungicide]

Pythium Oligandrum 1 million cfu/g

Wettable Powder

late blight on tomato

Two applications from Biopreparaty for full registration were temporarily disapproved as absence of the following data:

1.Pathogenicity tests through oral, inhalation and injection are needed;

2. Non-pathogenic statement issued by the expert from Chinese domestic institute.

3. Environmental data

Empedobacter brevis 30 billion cfu/g

Technical concentrates

 

Zhenjiang Runyv Biological Technology Co. , Ltd

[Insecticide]

Empedobacter brevis 10 billion cfu/g

suspension concentrates (SC)

Against Diamondback moth and Spodoptera litura on cruciferous vegetables and  leaf folder on rice

The committee disapproved full registrations of Empedobacter brevis as reports of sepsis in babies and lung infections in adults caused by Empedobacter brevis. The applicant shall further provide the information of the classification and pathogenicity of the products and illustrate that the ingredient is non-pathogenic to human.

Ethirimol 95%

Technical

 

Jiangxi Heyi Chemical

[Fungicide]

Ethirimol 25%

suspension concentrates (SC)

Powdery mildew on cucumber

The committee temporarily disapproved full registrations of ethrimol in that:

1.         The applicant shall data of two years’ soil residue test conduct on one site;

2.         The applicant shall refill the application form to complete the information such as chemical name, physico-chemical properties, etc;

3.         The applicant need to submit the data of inhalation toxicity data and toxicokinetics

Berberine 0.5%

 

aqueous solution(AS)

gray mold and  leaf mold on tomato;

powdery mildew and downy mildew on cucumber;

Phytophthora caprice on pepper

Zhejiang Jinghua Biological Technology Co. , Ltd

[Fungicide]

 

The committee disapproved the application from Jinghua in that:

1.         The application shall apply the registration of the technical concentration other than the aqueous solution;

2.         The applicant shall submit the data of mutagenicity test. Explanation of why toxicity data sharing for technical concentration and the preparation are applicative and data exempting of reproductivity, teratogenicity, chronic toxicity and carcinogenicity

Physcion 85%

Technical concentration

 

Qingyuanbao Bio-tech of

Inner Mongolia

[Fungicide]

Physcion 0.5%

aqueous solution(AS)

powdery mildew on cucumber

 

The committee disapproved the applications from Qingyuanbao for the following reasons:

The applicant need to refill the application form as the form was not properly completed. The applicant need to further explained the data gaps, such as the flash point of pure ingredient is 215.4℃,while that of the technical concentrates is >150℃; The boiling point of the pure ingredient is 560℃and that of the technical concentrates is 478℃; The vapor pressure of pure ingredient is 4.8×10-11Pa while that of the technical concentrates is 1.5×10-13Pa.

The pesticide is applied through spraying, but the applicant has not provide sufficient data of droplet and data exemption of acute inhalation toxicity test is not applicative; The Committee agreed to exempting on data of reproductivity, teratogenicity, productivity, teratogenicity, chronic toxicity and carcinogenicity, but the applicant need to further submit the data of vitro mutagenicity test on  mammal.

Isxaben

Technical

Export purpose

Zhejiang Shangyu nutriechem Fine Chemical

[Herbicide]

Isxaben

 

Water dispersible granules

The committee temporarily disapproved full registrations of Isxaben in that:

The applicant need to submit the  environmental report and the approve document;

The applicant need to submit data of mutagenicity, sub-chronic toxicity, teratogenicity, chronic toxicity, carcinogenicity and metabolism;

The applicant shall submit the toxic data on algea, flea, natural enemy and soil microbes and data of environmental behavior;

The applicant needs to explain the inconsistency level of the ingredient between its registration in the United State and its application in China.

Documentary evidence of the products have been registered in the United State is needed.

Cyantraniliprole 93%

Technical

 

Dupont

[insecticide]

Cyantraniliprole 10%

Dispersible oil-based suspension

Bemisia tabaci on cucumber;

Diamondback moth on cabbage;

Bollworm on cotton;

beet armyworm on scallion;

Etiella zinckenella on

Cowpea;

Bemisia tabaci on tomato;

Bollworm on watermelon

The committee temporarily disapproved full registrations of Cyantraniliprole as the ai is highly toxic to bee and the applicant need to supplement the risk assessment carried out in China and study the risk on bee if the ai was applied on honey crops.

 

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