11 New Active Ingredients to be Fully Approved in China

11 new active ingredients have been approved by the Committee for full pesticide registration;
Existing registrants and subsequent applicants of brassinolide are required to supplement the data to maintain or obtain the registration;
Restrictions/prohibitions on 5 high-risk active ingredients were also proposed;

On 25 Aug 2016, China MoA released the meeting-minutes of the 19^th session of the 8 National Expert Committee of Pesticide Registration, which was held on 26 Jul in Beijing. A total of 43 pesticides using 21 new active ingredients were reviewed for full registration. 20 pesticides using 11 new active ingredients were approved, of which 3 were submitted by MNCs: halauxifen-methyl herbicide by Dow Agroscience, fluoxastrobin fungicide and amicarbazone herbicide by Arysta.

For brassinolide to comply with national standard GB 4839-2009, “Chinese Common Name for Pesticides”, the Committee deemed it necessary to collect additional data. Existing registrants and subsequent applicants are required to supplement data to maintain or obtain registration:

Registrants of technical products should apply for registration amendment and resubmit the chemistry data on the basis of their actual manufacturing process and molecular structure. Toxicological and environmental data should also be supplemented in accordance with the data requirement on biopesticides. Bibliographic references will be acceptable;
Registrant of formulated product should apply for amendment by renewing their product chemistry data in accordance with their corresponding technical products and technical product sourcing data
The subsequent applicant should provide definite chemistry data and other required data according to their own product category;

The Committee also suggested restriction on 5 high-risk active ingredients:

From a toxicological perspective, acephate, carbosulfan and dimethoate are not yet rated as highly toxic pesticides, but they are metabolically degraded into highly toxic substances: methamidophos, carbofuran and omethoate. The registration reevaluation reveals that even the uses of non-highly toxic acephate, carbosulfan and dimethoate can result in excessive residues of methamidophos, carbofuran and omethoate. The field trial application, registration application, renewal application for their uses on fruits, vegetables, tea and herbal medicines should be terminated;
As the signatory of the Montreal Protocol and Stockholm Convention, China was exempted from endosulfan and bromomethane prohibition until 36 Mar 2019 and 31 Dec 2018 respectively. The Committee reminded that registration cancelation should be implemented on schedule;

Of the 10 active ingredients that were denied registration approval, 3 of them were submitted by MNCs. Dupont’s aminocyclopyrachlor and Nippon Kayaku’s chromafenozide were both rejected due to the Chinese translation of the description on production process. Two domestic producers were rejected for lack of environmental compliance documentation. At least three product/uses were rejected due to unacceptable risks to aquatic organisms. The Committee has become attentive during the dossier process and more inconsistences have been identified in application froms, test report and raw data. Grounds for vetoed actives and technical suggestion for future submission were included in the product lists.(AgroPedia: Chinese Pesticide Legislation Overview)

Table1-List of New Pesticides Approved for Full Registration

No	Product	Target(Crop/Site)	Applicant	Technical Note
1	Triclopyricarb 95% TC	/	Jiangsu Baoling chemical Co.,Ltd.	Triclopyricarb 15% EC was original proposed for both wheat and rice uses. The preliminary risk assessment revealed that the environmental impact on aquatic ecosystem is not acceptable and the uses on rice were excluded.
	Triclopyricarb 15% EC	Powdery mildew(wheat)
2	Folpet 95% TC	/	Yingde Greatchem Chemicals Co.,Ltd.
	Folpet 80% WP	Fungal(wood)
3	Halauxifen-methyl 95 % TC	/	Dow AgroSciences
	Halauxifen-methyl +Florasulam 20% WG	Annual broadleaf weeds(winter wheat)
4	Fluoxastrobin 94% TC	/	Bayar CropScience
	Fluoxastrobin+chlorothalonil 51% SC	Late blight(tomato) Downy mildew(cucumber)	Arysta LifeScience Corporation
5	Cyproconazol 95% TC	/	Jiangsu Fengdeng Pesticide & Chemical Co.,Ltd.
	Cyproconazol 40% SC	Rust(wheat)
6	Coumoxystrobin 96% TC	/	Jilin Bada Pesticide Co.,Ltd.
	Coumoxystrobin 20% SC	Rot(apple)
7	Triflusulfuron-methyl 95% TC	/	Jiangsu Agrochem Laboratory Co.,Ltd.
	Triflusulfuron-methyl 95% WG	Annual weeds(sugar beet)
8	Coniothyrium minitans CGMCC8325 0.2 billion CFU/g	Sclerotinia rot(canola)	Wuxi Jiannong Biotech Co.,Ltd.
9	Amicarbazone 97% TC	/	Arysta North America
	Amicarbazone 70% WG	Annual weeds(corn)
10	Allicin 50% TK	/	Chengdu Newsun Crop Science Co.,Ltd.	Allicin is originated from garlic extract and the substance also approved for food additive use, thus the residue study can be exempted.
	Allicin 5% ME	Bacterial angular leaf spot(cucumber) Soft rot( brassica oleracea)
11	Chlorohemin 0.3% WP	Growth regulating(tomato and potato)	Jiangsu Nantong Feitian Chemical Industrial Co.,Ltd.
12	Oxathiapiprolin 95% TC	/	DuPont USA	The TC and formulated were registered previously and toxicological class was rerated as “slightly toxic”
	Oxathiapiprolin 10% OD	downy mildew(grape) late blight(potato) late blight(tomato) blight(Chili) downy mildew(cucumber)

Table2- List of New Pesticides Rejected for Full Registration

No	Product	Target(Crop/Site)	Applicant	Technical Note
1	Oxytetracyclin hodrochloride 88% SP	Erwinia carotovora PV.Carotovo-ra	Chengdu Puhui Bio-Engineering Co.,Ltd.	The applicant need to explain how the harmful emissions were collected and how the filter residue was disposed during the product process. Registration of the technical product is required;
2	Bromacil 95% TC	/	Jiangsu Luye Agrochemical Co.,Ltd.	The applicant need to provide the environmental impact evaluation document approved by the regional government for the production establishment; Absent of data on environmental risk assessment on underground water;
2	Bromacil 80% WP	Weeds(citrus)	Jiangsu Luye Agrochemical Co.,Ltd.
3	Glufosinate-P 90% TC	/	Meij Seika	The active ingredient should be registered as glufosinate-P sodium; Missing pages in application form of the TC registration; non-consistence melt point value in the applicant form, the MSDS and summary on the melting point test; Absent of the description on the compiling of enterprise standard for product specification; absent of the chemical equation and narrative explanation on production process;
3	Glufosinate-P 10% AS*	Annual and perennial weeds(citrus)	Meij Seika
4	Triclopyricarb+Tebuconazole 15% SC	rice blast and banded sclerotial blight(rice)	Jiangsu Baoling chemical Co.,Ltd.	The preliminary risk assessment revealed that the environmental impact on aquatic ecosystem is not acceptable and full registration on rice usage was rejected
5	14-hydroxylated brassinosteroid 5% TC	/	Chengdu Newsun Crop Science Co.,Ltd.	The scheme of industrial waste disposable was not convincing: The origination, composition and emission of toxic effluents should be specified; The applicant declares that residue is as safety as food raw materials ,thus the marketing proof of the food use purpose should be provided;
	14-hydroxylated brassinosteroid 0.01% AS*	Growth Regulating(rice)
	14-hydroxylated brassinosteroid +gibberellin 40% SG	Growth Regulating(cirtus) Seed treatment(rice)
6	Folpet+ Gosetyl-aluminium 75% WG	Downy mildew(grape)	Guangdong Yinde Greatchem Chemicals Co.,Ltd.	The test protocol for field trial is unjustified. For the field trial of multiple compound formulation, folpet single compounded formulation should be served as control.
7	Sex pheromone mating disruptor 95% TC	/	BIOGLOBAL	Absent of environmental data on fish: the applicant should provide exposure data of fish.
7	Sex pheromone mating disruptor 240mg/piece	Grapholitha molesta	BIOGLOBAL
8	Novaluron 98.5% TC	/	ADAMA-MAI	Errors in chemical name, production process and appearance of suspension concentration; Inconsistence density value in chemistry data and test report; Inconsistent information in the application form and original data and several test reports were absence( carcinogenicity to dog); This active ingredient is highly toxic to daphnia magna. Although it was proposed for dry land use, the product may cause risk to aquatic organisms and the risk assess data on daphnia magna should be provided;
	Novaluron + Bifenthrin 10% SC	diamond back moth(Brassica oleracea)
	Novaluron+acetamiprid 16% EC	leaf roller(apple)
9	Aminocyclopyrachlor 88.7% TC	/	Dupont USA	In conformity of the description on production process in Chinese copy between English copy.
9	Aminocyclopyrachlor 50% SG	Broadleaf weeds(non-crop land)	Dupont USA
10	Chromafenozide 92% TC	/	Nippon Kayaku	The residue data only cover the information on chromafenozide itself. The chemical structure, chemical name on its metabolites should be provided. The applicant should provide definition on pesticide residue and recommended ADI; The description on production process should be provided in Chinese;
10	Chromafenozide 5% SC	rice leaf roller, chilo suppressalis(rice)	Nippon Kayaku
11	Paichongding 95% TC	/	Jiangsu Kesheng Group Co.,Ltd.	Chromatographic peaks of the active ingredient were inconformity in 2 of the residue test reports and the applicant should justify; the chemical name is inconsistent with national standard;

11 new active ingredients have been approved by the Committee for full pesticide registration;

Existing registrants and subsequent applicants of brassinolide are required to supplement the data to maintain or obtain the registration;

Restrictions/prohibitions on 5 high-risk active ingredients were also proposed;

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