Mastering Active Ingredient Content Requirements in China Pesticides
Understanding the regulations and requirements for active ingredient content in technical material (TC), technical concentrate (TK) and formulation products is crucial for ensuring compliance and successful pesticide registration. In this article, we will delve into the key considerations and guidelines for setting active ingredient content, empowering you to navigate the complexities of China\’s pesticide registration process with confidence.
Part 1: Setting Active Ingredient Content in Technical Material / Technical Concentrate
- The minimum active ingredient content (% W/W) should be specified for the technical material (TC), which normally should not be less than 90%. The lower limit of the active ingredient content is usually the mean value of the five-batch analysis minus three times of the standard deviation (- 3SD). If the TC has multiple isomers, and the content of one or more isomers has been purposefully increased, the ratio of the isomers should also be indicated.
- The content of the technical concentrate (TK) should indicate the upper and lower limits of the active ingredient content. The indicated content is usually the average of the test results of five batch analysis of representative samples. The allowable tolerance range should comply with the requirements of formulation.
- The content of botanical pesticide TK is usually the average of the test results of five batch analysis of representative samples, and the tolerance range is ±25% of the final average.
Part 2: Setting the Content of Formulation Products
- According to Article 8 of the \”Administrative Measures for the Registration of Pesticide\”, for single formulation products with the same active ingredient and dosage type, the content gradient of active ingredient shall not exceed three levels; for the mixtures with the same active ingredients and formulation type, the ratio of active ingredients shall not exceed three, and the total content gradients of the same ratio shall be no more than three.
- If the active ingredient content is greater than or equal to 10% (or 100g/liter), the value of content interval should be no less than 5% (or 50g/liter), and the number of significant digits in the content shall not exceed 3. If the active ingredient content is less than 10% (or 100g/liter), the content interval should not be less than 50% of the active ingredient content, and the number of significant digits in the content shall not exceed 2.
- For different formulations with different contents, the content range of active ingredient in the formulation product should follow the requirements below:
|The labeled content of formulation (x), (20±2)℃
Unit: % or g/100mL
|The tolerance range|
|x≤2.5||Homogeneous formulations such as emulsifiable concentrate, suspensions, soluble concentrates, etc.: ± 15%x
Non-homogeneous formulations such as granules, water-dispersible granules: ± 25%x
|x＞50||±2.5% or 2.5g/100mL|
- For products whose content is expressed in terms of effective amount (e.g., electric mosquito-repellent mats, the content is expressed in mg/piece), the tolerance range of the content needs to be converted into mass fraction first, and then select the appropriate value from the above table.
- The content of emulsifiable concentrate, micro-emulsion, and wettable powder formulations shall not be lower than that of approved formulation products (including mixtures with the same ratio).
- The content of active ingredients in liquid formulation should be expressed in both mass fraction (%) and mass concentration (g/L).
- For the pesticide formulations containing penetrants or synergists, the content of active ingredient should be set at the same level as that required for similar products without penetrants or synergists.
- The tolerance range of the active ingredient content in botanical pesticides is ±25%, but for the tolerance range of the content in formulations made from botanical technical material (TC), please refer to the third point of part 2 in this article.
- The quality specifications of microbial pesticides should specify a minimum value of active ingredient, usually expressed as the number of microorganisms per unit mass or volume of product. (Viral products are expressed in PIB/g or mL, OB/g or ml, bacterial products are expressed in CFU/g or mL, IU/mg orμL, fungal products are expressed in spores/g or mL, CFU/g or mL, with viable spore rates specified when necessary.)
In addition, if there are specific regulations on active ingredient content in national or industry standards, the corresponding requirements should be followed. In exceptional cases, the applicant may submit scientific, rational, and valid statements and relevant certification materials to the Pesticide Registration Review Committee.
Stay informed about the latest regulations and industry standards and leverage our comprehensive knowledge to meet the necessary criteria for active ingredient content in technical material and formulation products.
As a compliance consulting company with extensive experience in the Chinese pesticide market, REACH24H can provide valuable assistance to global companies. For further assistance and expert advice on pesticide compliance in China, please reach out to REACH24H’s expert.
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