On 1 July 2020, China ICAMA issued an official letter to its provincial subsidiaries regarding the registration amendment to multi-element pesticides. China revamped its pesticide regulation system in 2017 with elevated requirements, aimed to reduce the number of pesticides registered and manufacturers. The multi-element pesticides with the same active ingredients and formulation type can be registered with a maximum of 3 compounding ratios. The new registration and renewal of pesticide with an extra compounding ratio will no longer be acceptable under the new regulation.
The document offers a solution for registrants of these formulations, the registration can be maintained through a technical amendment by adjusting to the closest ratio eligible and completing the ammendment producures with parts of the test data on the previus products and supplemented data based on the adjusted formulation.
1. In case of the adjusted formulation has the same use scope as the previous formulation
- Statement on the amendment;
- Application form based on the adjusted formulation;
- Product Chemistry Data: including the room temperature storage stability test data and the method validation data (the data based on previous data);
- Label sample;
- Document supporting the application rate, application method, maximum number of applications, safety interval, etc.;
- If the adjusted formulation has a higher concentration level, the registration shall submit additional toxicity data including acute oral, dermal and inhalation toxicity,
2. In case of the adjusted formulation has the different use scope from the previous formulation, the registrant shall submit the data listed above, plus:
- 1-year efficacy trial report generated at multiple sites(4 sites for insecticides and herbicides and 5 sites for herbicides and plant growth regulators)
- If the adjusted formulation has a higher application rate, the applicant shall submit the residue trial report based on waived requirements;
- If the ratio was not in the recommended range obtained from laboratory screening, a laboratory activity test report based on the adjusted formulation shall be provided.
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