A seminar regarding China’s pesticide regulation was held by the ICAMA (the Institute for the Control of Agrochemicals, Ministry of Agriculture) in Hangzhou on Nov 12nd and 13rd. GuBaogen, the deputy director of the ICAMA, together with other government officials in the pesticide management field , have presented detailed information on the new “Regulation on Management of Agricultural Chemicals” and explained their preliminary thoughts on data requirements in the dossiers.
Up to 500 local officials of pesticide control and the representatives from crop protection industry have attended the symposium. As the new pesticide regulations are taking effect, this event had quite a good turnout of pesticide-related companies seeking for information that may affect their future.
Liu Shaoren, chief of the supervision office, stated that final version of the regulation has been approved by the Standing Committee of the State Council and the copies were distributed to other Ministries. However, the issuance was postponed as a result of the delay of the18th National Congress of Communist Party of China. In short, the regulation aims at supporting the R&D and HES oriented companies and eliminating the incompetent players and products. The other goal of the regulation is to encourage China’s pesticide industry to enter the global crop protection market.
- According to the new regulation, the applicants of a new pesticide will not be restricted to manufacturers. Moreover, commission process between the registrants and the manufacturers will be conditionally accepted. A registrant who wishes to quit the market may transfer the dossier data to another applicant to recover some costs;
- More than 20 articles related to penalty have been incorporated to the new regulation in which the misbehaviors and minimum level of penalties were explicated. In serious circumstances, the company may be revoked of the ICAMA registration and manufacturing permit and in that case, it will be suspended for further application for registration in next five years. Furthermore, the responsible persons of the companies will be expelled from the whole pesticide industry for up to 10 years;
- According to the new regulation, the field trial and residual test are required to be carried out in China, while other data such as toxicity or physic-chemical obtained by the overseas GLP-compliant laboratories will be acceptable for registration as long as they have mutual agreement or multilateral acceptance with China;
- Over 349,000 distributors are selling pesticide to the peasants in China and most of them are incapable of instructing the consumers how to properly use the products. The new regulation will introduce licensing system and sales recording system to the distributors. The general pesticide products will be labeled with bar-code and the restricted products will be marked with anti-fake labels for traceability;
Due to the toxic or hazardous nature, some of the pesticide categories will be listed in the Chinese “C&L” inventory (Catalogue of hazardous chemicals), which was under the scope of both the “Measures for the Administration of Hazardous Chemical Registration (SAWS Order 53)” and the “Measures for the Environmental Management of Hazardous Chemical Registration (Trial)” (MEP order 22). The Ministry of Agriculture (MoA) is now participating in the compilation of the inventory with the other Ministries/Departments. The MoA will try to avoid duplication in management by controlling the number of entries of the inventory. An organophosphates insecticide malathion is already listed in the “Inventory of Chinese Highly Toxic Chemicals”.The MoA is also trying to remove the insecticide from the inventory and asking the industry to submit the evidence for its safeness.
Although two staple herbicides, the paraquat and the glyphosate were consecutively restricted in China early this year, the official affirmed that China will not adopt reassessment system on the registered ais as the EU or the US did. However, the authorities will give more consideration to safety, risk controls when assessing a dossier and will carefully monitor the pesticide incidents after the approval.
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