On April 6 2014, the MIIT issued a notice that the regulatory responsibility of renewing pesticide manufacturing approval will be decentralized to competent authorities of industrial management at a provincial level.
The Ministry will no longer be responsible for reviewing the application material instead, the provincial industrial departments will be responsible for the assessment, granting the approvals of pesticide producers and guaranteeing the quality standard and safety production of pesticide within their respective administrative area. The validity period of all renewed certificates of each product category has also been specified as 5 years. MIIT will still have oversight on all application and every month MIIT will choose one or two provinces for random inspection.
The decentralization will take effect as of May 1 2014. In five provincial administrative areas (Tianjin, Fujian, Henan, Guangxi and Ningxia) decentralization will be postponed until January 1 2015.
MIIT’s supervision of pesticide producers was based on the “Measures for the Administration on the Manufacturing of Pesticide”, which required that all new establishments (joint venture, branch-opening, adding pesticide manufacturing program by an existing non-pesticide company) of pesticide manufacturing facilities should first obtain a designation certificate of pesticide manufacturing from the MIIT. Depend on the quality standard of the product, the producer should either obtain the approval certificate of pesticide manufacturing from the MIIT or the production license from the AQISIQ. If China has not established national or industrial quality standard for the product, the manufacturing company should obtain the approval certificate of pesticide manufacturing prior to the production of the product. The major obligation involved in obtaining approval certificates is to prepare necessary application material and undergo on-site inspection, sampling and testing.
It is worth noting that if the certificate was initially obtained by the manufacturer, the approval will be valid for two years (trial production) after which the manufacturer should renew the approval. The validity period of the renewed certificate will be extended to 5 years. All pesticide products should be labeled with the number of approval certificate, or else the product would be identified as substandard or counterfeits and the manufacturer subject to financial or criminal punishments.
Depending on the product category and the production type, the applicant should provide different kinds of material when applying for renewals. MIIT also provide data requirements and review criteria for each of the circumstances listed below:
Summary of Data Requirement on Renewing Different Product Category/Production Type | |||
Item | TC/TK | Formulating | Repackaging |
application form of approval certificate for pesticide manufacturing | √ | √ | √ |
copies of the business license | √ | √ | √ |
product standard and the explanation of making them | √ | √ | √ |
quality test report of the product | √ | √ | √ |
certificate of origin of the pesticide technical material if the product is formulated |
| √ |
|
license agreement for pesticide repacking within two years prior to the date of application |
|
| √ |
copy of the registration certificate of the product; | √ | √ | √ |
Report of the on-site inspection | √ | √ | √ |
copy of designation certificate of pesticide production | √ | √ | √ |
other material specified by the MIIT |
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|
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The Chinese pesticide management authorities have decentralized some power to their provincial subordinates. This move will relieve central authorities from data reviewing duties and allow more resources to be allocated to post-approval supervision. ICAMA has also initiated a similar action (see ChemLinked News Release on Mar 1 2014).
