11 New Active Ingredients to be Fully Approved in China

On 25 Aug 2016, China MoA released the meeting-minutes of the 19th session of the eight 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. Twenty pesticides using 11 new active ingredients were approved, of which three 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 five 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 romomethane 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)