Summary of Precautions for Registering Mixed Preparations in China
Registering mixed preparations in China requires careful attention to various factors due to their complex nature. Compared with single active ingredient preparation, mixed preparation offers advantages such as improved control effect, expanded control range, reduced pesticide dosage, and lower production cost, and it delays the development of resistance.
However, the registration process for mixed preparations involves detailed documentation. In this article, we provide a comprehensive summary of the precautions and considerations necessary for successfully registering mixed preparations in China.
Content Proportion and Formula Design
To ensure successful registration, adhere to the following guidelines:
- Limit the number of active ingredients to two in mixed preparations.
- Mixed preparations involving herbicides, seed treatment agents, and pheromones should not exceed three active ingredients.
- Avoid registering mixed preparations with three or more components for pesticides and fungicides, except for seed treatment agents.
- Limit the number of proportion types to three for mixed preparations with the same active ingredients and dosage forms.
- Avoid registering other mixed preparations with different proportions but the same type of active ingredients and scope of usage, except when the proportions are the same and the total contents differ.
Proportion and Combination Guidelines
Follow these principles when combining insecticides and fungicides:
- Ensure that all active ingredients are effective against the target pests.
- Reserve the blending of different active ingredients primarily for expanding the control spectrum in herbicides, plant growth regulators, seed treatment agents, and granules.
- Set the proportion of mixed preparations by the Administrative Measures for the Registration of Pesticides.
- Provide a formula screening report for new mixed preparations with new formulas or proportions.
- Synergistic or additive effects should be present in compound products with combined active ingredient effects, favouring synergistic effects for pesticide blends.
- When blending preparations to delay resistance, mix agents with different mechanisms of action while avoiding agents with cross-resistance.
- For preparations aimed at improving quick-acting or long-lasting effects, consider mixing agents with different characteristics in these aspects.
- Limit the use of compound preparations to expand the control spectrum primarily to herbicides, plant growth regulators, and seed treatment agents.
- Generally, avoid mixing chemical pesticides with botanical pesticides, except for azadirachtin and rotenone with single components and high content of technical pesticides.
General Information and Product Chemistry
- Express the name of the mixed preparation using the Chinese generic name or simplified generic name of the active ingredient, with a maximum of nine characters. If fewer than nine characters are available, use the Pinyin order of the common names.
- When the total content and the content of each active ingredient of the mixed preparation cannot meet the requirements on the effective amount of content in the Pesticide Registration Data Requirements at the same time, prioritize meeting the requirements for the total active ingredient content. The content of the less active ingredient may not meet the requirements for the effective amount.
- The dosage form of the mixed preparation shall comply with the requirements of Nomenclature and Codes of Pesticides Formulations GB/T 19378-2017.
- Specificity detection of mixed preparation should include corresponding specificity spectra for each active ingredient. Different analysis methods should also have distinct specificity spectra.
- For precision detection of the mixed preparation, ensure that if multiple active ingredients are present under the same analysis method, the weighed samples should theoretically be the same across five repetitions.
Efficacy Test and Selection of Control Agent
Consider the following guidelines:
- When using mixed seed treatment agents for controlling diseases and pests simultaneously, conduct separate insecticidal and bactericidal tests during efficacy testing.
- Preferably select a single agent as the control agent for the mixed preparation. If the scope of use includes partially registered single doses of active ingredients, utilize those doses. Otherwise, use a single dose of each active ingredient and supplement with commonly used local control agents as appropriate.
- Ensure that the effective dosage of each active ingredient in the mixture does not exceed the registered dosage of its corresponding single agent. The control effect of the mixed preparation should be equivalent to or superior to that of the control agent.
- When the same proportion of mixed preparations does not involve new scope and method of use, the reference product can be the one registered under the original policy, and a one-year efficacy test may be exempted.
- Conduct resistance risk assessments primarily for single agents. Additionally, if the mixed preparation aims to delay resistance, a resistance risk assessment is also necessary.
Registering mixed preparations in China requires meticulous attention to various factors outlined in this comprehensive summary. It is crucial to carefully analyze and address all aspects before initiating the registration project. Adhering to the specified precautions will enhance the chances of successful registration and enable the benefits offered by mixed preparations in terms of control efficacy, range, and cost-effectiveness.
As a compliance consulting company with extensive experience in the Chinese pesticide market, REACH24H can provide valuable assistance to companies seeking to register mixed preparations in China. Contact us to learn more about how we can help you navigate the pesticide registration process in China.
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