According to a State Council announcement made on September 2nd 2015, the revision of pesticide administration regulations is a priority agenda for 2015. The announcement states.
“The data requirements for pesticide registration is formulated according to relevant provisions of “Regulations in Pesticide Management and Measures on the Implementation of the Regulation on Pesticide Management”, to regulate pesticide registration, ensure the quality of agricultural products and the safety of humans and animals while protecting the ecosystem.” The Ministry of Agriculture has been tasked with drafting new regulatory requirements to fulfill this broad agenda.
The current “Regulation on Pesticide Administration” was promulgated on May 8, 1997, “Measures on the Implementation of the Regulations on Pesticide Management” and “Data Requirement on Pesticide Registration” was promulgated on January 8, 2008. According to the State Council agenda and MoA’s 2015 work plan, China’s new Regulation on Pesticide Administration and Data Requirements on Pesticide Registration will be promulgated by the end of this year.
A brief comparison between current and pending pesticide regulations:
In order to standardize pesticide registration procedures, temporary pesticide registration will be canceled in the new regulation.
Raw material origin and production processes should be described in detail. There are more requirements for formulating and analysis of impurities. Quality control of pesticides will become more stringent.
Enterprise must stipulate the lowest contents of active substances and the maximum limits of impurities according to the technical requirements of the compositional analysis report. The qualitative analysis reports must be separate from the quantitative analysis report.
There is more experimental assessment criteria used during residue assessment analysis in the new regulation.
In some cases, residue tests can be waived. For example, there is no need to carry out tests on biochemical pesticides and microbial pesticides. For low toxicity botanical pesticides, tests could also be waived.
The new Regulation on Pesticide Administration will incentivize the development of microbial, biochemical, botanical pesticides (biocides). The test duration requirements for botanical pesticides will be reduced from two years to one year.
The main change in the data requirements of Pesticide Registration is the introduction of environmental risk assessment. Environmental risk assessment is required during pesticide registration. More extensive toxicity testing on organisms should be carried out in order to register pesticides. Toxicity tests for fish, bee, silkworm and earthworm should be carried out during environmental risk assessment.
Acute inhalation experiments on technical ingredients are a mandatory requirement. An occupational health and safety risk assessment for pesticides must also be undertaken for registration.
The new regulation will be based on a pesticide business license system in an effort to end the previous monopoly held by companies under the pesticide registration certificate system.
