The national expert committee approved 12 products and 6 active ingredients for full registration in China;
Syngenta, Dow Agroscience and BASF outline their market strategy for isopyrazam, aminopyralid and intium in China;
On 8 Oct 2014, MoA’s official website published the meeting minutes of the 15th session of the 8th National Expert Committee for Pesticide Registration which announced the approval of full registration on 15 new pesticides of 9 novel active ingredients in China, which includes Syngenta’s isopyrazam, Dow’s Aminopyralid and BASF’s Intium.
The meeting was concluded on 17 Jul 2014 and totally 40 pesticides of 24 new active ingredients were thoroughly reviewed, including 10 fungicides, 4 insecticides, 8 herbicides and 2 plant growth regulators. The experts reached a consensus on the following aspects:
The full registration of isopyrazam, bacillus marinus, thiacloprid, initium, aminopyralid and metamitron and their associated formulated products is permitted while the approval of etridiazole, oryzalin and bifenox should be granted for export only purposes
The full registration of sodium 4-CPA, meptyldinocap, triflusulfuron-methyl, methane dithiocyanate, cytosinpeptidemycin, tolfenpyrad, sulfoxaflor and allicin and their associated formulated products should be suspended subject to further data submission. The affected applicants can supplement data in accordance with the suggestion made by the committee and then reapply for registration;
The full registration of fenpropidine TC and fenpropidine SC was rejected due the risks associated with eye health .Both the technical and suspension formulations have been rejected.
The applications under export-only purpose category of folpet, sintofen, teflubenzuron, EPTC, asulam and flurtamone and their formulated products were rejected as the application material did not conform to requirements. According to the decision made by the 14th session of the 8th National Expert Committee for Pesticide Registration, the export only registration should be terminated (see ChemLinked News Release on 24 Jan 2014). The Committee suggested these applicants should undertake full registration for their products;
On 21 Jan, China ICAMA suspended the acceptance of new applications for export-only purpose registration (new application filed before 21 are still reviewed and approved under the approval procedure) and suspended registration extension from 9 Apr 2014, which was all under the proposal made by the 14th session. The Committee seemed made paradox decision on r export-only purpose registration of different active ingredient. In fact, the new application field before 21 Jan were reviewed and approved under existing procedures, as the latest explanation from ICAMA official on CRAC Shanghai(see ChemLinked news on 16 Oct 2014)
The committee pointed to the data flaws present in the registration dossiers for each rejected product highlighted some precautions that should be taken with certain pesticides:
Table 1: Committee Full Registration Decisions | |||||||
AI | No. | Product Name | Content | Formulation type | Crop(pest) | Applicant | Comment |
1 | 1 | lsopyrazam | 92% | TC |
| Syngenta Switzerland | The label should specify that the product is highly toxic to aquatic organisms and prevent adverse effects on aquatic organisms. |
2 | Lsopyrazam+ azoxystrobin | 29% | SC | Cucumber(powdery mildew) | |||
2 | 3 | Bacillus marinus | 5 billion CFU/g | TC |
| Zhejiang Tonglu Huifeng Bio-technology Co.,Ltd. |
|
4 | Bacillus marinus | 1 billion CFU/g | WP |
Tomato(bacterial wilt) Cucumber(grey mould) | |||
3 | 5 | Thiacloprid | 95% | TC |
| Jiangsu Flag Crop Protection Co.,Ltd. | The label should specify that the product is highly toxic to silkworm and forbid the use around mulberry tree. |
6 | Thiacloprid | 40% | SC | Rice(planthopper) | |||
4 | 7 | Initium | 98% | TC |
| BASF |
|
8 | Dimethomorph+initium | 47% | SC | Cucumber(downy mildew) Grape(downy mildew) Potato(late blight) | |||
5 | 9 | Aminopyralid | 91.6% | TC |
| Dow AgroScience | The label should specify that the product should use with caution in broadleaf-meadow. |
10 | Aminopyralid | 21% | AS* | Meadow(gremineae weeds) (broadleaf weeds) | |||
6 | 11 | Metamitron | 98% | TC |
| Jiangsu Agrochem Laboratory Co.,Ltd. |
|
12 | Metamitron | 70% | WDG | sugar beet field(annual broadleaf weeds) | |||
7 | 13 | Etridiazole | 96% | TC |
| Guangdong Yinde Greatchem Chemicals Co.,Ltd. | Export-only |
8 | 14 | Oryzalin | 96% | TC |
| Zhejiang Rosi Chemical Co.,Ltd. | Export-only |
9 | 15 | Bifenox | 97% | TC |
| Jiangsu Huifeng Agrochemical Co.,Ltd. | Export-only |
Table 2:Products Temporarily Not Granted Full Registration(the applicant can supplement the data and re-apply) | |||||||
AI | No. | Product Name | Content | Formulation type | Crop(pest) | Applicant | Data to be Supplemented |
1 | 1 | Sodium 4-CPA | 96% | TC |
| Sichuan Guoguang Agrochemical Co.,Ltd. | The applicant should supplement the metabolism data and submit the data to the health review panel. |
2 | Sodium 4-CPA | 8% | SP | Tomato(growth regulating) | |||
2 | 3 | Meptyldinocap | 90% | TC |
| Dow AgroSciences | The applicant should illustrate the safety risk of the residue in cucumber and submit the data to the agricultural review panel. |
4 | Meptyldinocap | 36% | EC | Cucumber(powdery mildew) | |||
3 | 5 | Triflusulfuron-methyl | 95% | TC |
| Jiangsu Agrochem Laboratory Co.,Ltd. | The applicant should substantiate the safety when used for sugar beet plantation and submit the data to the agricultural review panel. |
6 | Triflusulfuron-methyl | 50% | WG | sugar beet field(annual broadleaf weeds) | |||
4 | 7 | Methane dithiocyanate | 5.5% | EC | Rice(white-tip nematode; bakanae disease) | Jiangsu Changshu Yinong Agrochemical Co.,Ltd. | 1. The exemption of TC registration is not applicable and the applicant should simultaneously apply for the TC registration of methane dithiocyanate, which was stipulated in the “Data Requirement on Pesticide Registration”. If the methane dithiocyanate TC was graded as high toxic the application would be totally rejected. 2. The chemical name of the product is incorrect and the applicant should revise the application material in accordance with GB4893. 3. The applicant should provide the demonstration trial data, which should be carried out at one site in one year. 4. The applicant should supplement the efficacy study report, which should be carried out under the “Guideline for Pesticide Efficacy Test” 5. The applicant should supplement the environmental behavior of methane dithiocyanate TC. |
5 | 8 | Cytosinpeptidemycin | 4% | AS* | Tomato(morbus virosus) Tobaco(morbus virosus) | Liaoning Dalian Guanfa Parmacy Co.,Ltd. | The exemption of TK registration is inappropriate and the applicant should simultaneously apply for the TK registration with the formulation registration |
6 | 9 | Tolfenpyrad | 97.4% | TC |
| Nippon Nouyaku Co.,ltd | 1. The information production process filled in the application form was inconsistent with that in product chemical dossier. The applicant should verify the information and resubmit the material. 2. The applicant should supplement the wastes treatment information during formulation production. 3. The in vitro mammalian cells gene mutation test report should be supplemented. 4. The applicant should provide the assessment report of the risk to aquatic organism as tolfenpyrad showed extremely toxicity to carp, fleas and African clawed frog. |
10 | Tolfenpyrad | 30% | SC | Tea plant(Empoasca Pirisuga Matsumura) | Jiangsu Rotam Chemical Co.,Ltd. | ||
7 | 11 | Sulfoxaflor | 95.9% | TC |
| Dow AgroSciences | 1. The residue test of the 22% SC formulation on cucumber was not in conform with the “Guideline for Pesticide Residue Test”; 2. The applicant should supplement the assessment report of the risk to bee; |
12 | Sulfoxaflor | 50% | WG | Cotton(fleahopper; bemisia tabaci gennadius) | |||
13 | Sulfoxaflor | 22% | SC | Rice(rice planthopper) Cucumber(aleyrodidae) | |||
8 | 14 | Allicin | 50% | TK |
| Chengdu Newsun Crop Science Co.,Ltd. | 1. The applicant should supplement the study report of pesticide residue on the registering crops; 2. The applicant should supplement the risk assessment on aquatic organisms; |
15 | Allicin | 5% | ME | Cucumber(bacterial angular leaf spot); Cabbage(soft rot); Rice(false smut); | |||
Table 3:Products Rejected by the Committee for Full Registration | |||||||
AI. | No | Product Name | Content | Formulation type | Crop(pest) | Applicant | Comment on Data Deficiency |
1 | 1 | Fenpropidine | 96% | TC |
| Syngenta Switzerland | 1. Absence of demonstration trial report, which should be carried out at 2 sites in one year; 2. Both the TC and the formulation are corrosive to eye, which pose unacceptable risk to pesticide operator; |
2 | Fenpropidine+ Propiconazol | 42% | EC | Wheat(powdery mildew) | |||
2 | 3 | Folpet | 95% | TC | Export-only | Guangdong Yinde Greatchem Chemicals Co.,Ltd. | Absence of the registration certification of 95% TC in EU |
3 | 4 | Sintofen | 98% | TC | Export-only | Shanghai Heteng Fine Chemicals Co.,Ltd. | 1. Absence of the registration certification of 98% TC in EU; 2. Absence of the controlling relationship certification between the applicant and its controlling company; |
4 | 5 | Teflubenzuron | 94% | TC | Export-only | Jiangsu Heye agrochemical Co.,Ltd. | The quoted information provided by the applicant cannot reflect the environmental impact caused by the pesticide. |
6 | Teflubenzuron | 150g/L | SC | Export-only | |||
5 | 7 | EPTC | 96% | TC | Export-only | Jiangsu Nantong CAC Chemical Co.,Ltd. | 1. The Chinese version of the quoted toxicity data is inconsistent with the English version provided by the applicant 2. The quoted information provided by the applicant cannot reflect the environmental impact caused by the pesticide; |
6 | 8 | Asulam | 95% | TC | Export-only | Jiangsu Nantong CAC Chemical Co.,Ltd. | 1. Absence of the valid registration certification of 95% TC in foreign country; 2. Absence of the original data of 90-days sub-chronic toxicity and teratogenicity of asulam TC; 3. The quoted information provided by the applicant cannot reflect the environmental impact caused by the pesticide; |
9 | Asulam | 36.2% | AS* | Export-only | |||
7 | 10 | Flurtamone | 98% | TC | Export-only | Shanghai Heteng Fine Chemicals Co.,Ltd. | 1. Absence of the valid registration certification of 98% TC in EU; 2. Absence of the sub-chronic toxicity data. The abstract of 13-weeks rat toxicity study is inadequate and unacceptable; 3. Absence of the chronic toxicity, productivity and metabolism test data; |
