I. Strengthened Control of Pesticide Residues and Growth Regulators
1. Number of Prohibited Pesticide Varieties Increased to 47
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Based on the 33 prohibited pesticides in the 2020 edition, 14 new types have been added, covering categories such as organophosphorus, organochlorine, and pyrethroids. For the first time, pesticide residue limits for Chinese medicinal materials have been established, forming a more systematic safety control system.
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Variety adjustments: Detection items for specific organochlorine pesticides in materials like ginseng, American ginseng, and astragalus have been removed, and General Chapter 0212 standards are uniformly implemented to reduce redundant testing.
2. Growth Regulators Included in Testing for the First Time
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Paclobutrazol limit standard for Ophiopogon japonicus: Addressing risks of ingredient variation and residue due to paclobutrazol abuse, a limit indicator has been established (e.g., paclobutrazol in Ophiopogon japonicus ≤ 0.1 mg/kg), providing a reference for testing other regulators such as chlormequat.
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Risk warning: Emphasis on the dual harm of "root-strengthening" type regulators to medicinal quality and the environment, forcing standardization in cultivation practices.
II. Optimization of Heavy Metal and Harmful Element Standards
1. General Chapter Covers 52 Types of Medicinal Materials
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Unified limits for heavy metals and harmful elements (lead, cadmium, arsenic, mercury, copper) in 52 Chinese medicinal materials; varieties with high compliance rates (e.g., astragalus and licorice) can exempt batch-by-batch testing, reducing costs for enterprises.
2. Dynamic Adjustments in Specific Monographs
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Deletion of detection items: Thirteen materials with high compliance rates (e.g., American ginseng and angelica) now follow general chapter standards.
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Addition of detection items: Ligusticum wallichii and Coptis chinensis require batch-by-batch testing due to higher risks.
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No change: Five materials including ginseng and honeysuckle continue with the 2020 edition standards.
III. Improvement of Mycotoxin Detection System
1. Addition of Ochratoxin A Inspection
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Materials like astragalus and areca are included in ochratoxin A testing for the first time, filling previous gaps in mycotoxin control.
2. Special Control for Citrinin in Red Yeast Rice
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In response to the 2024 safety incident involving red yeast rice health products, red yeast rice in Xuezhikang series preparations requires detection of citrinin (limit ≤ 5 μg/kg) to prevent nephrotoxicity risks.
3. Expanded Testing for Stir-fried Coix Seed
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New inspection for aflatoxin B1 (≤ 5 μg/kg) and zearalenone (≤ 50 μg/kg) under decoction pieces, ensuring safety in processing.
IV. Advantages of the Sixth Method Detection Technology
1. High Sensitivity and Multi-residue Screening
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Using HPLC-MS/MS technology, with detection limits reaching pg levels; a single experiment can simultaneously detect hundreds of pesticide residues, improving efficiency by tens of times.
2. Specificity and Anti-interference Capability
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Mass spectrometry adopts multiple reaction monitoring (MRM) mode to accurately identify targets, reducing interference from complex matrices in Chinese medicinal materials (e.g., pigments and alkaloids), with false positive rates reduced by over 90%.
3. Internationalization and Green Standard Support
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Method principles aligned with USP and EP, enhancing international recognition; promotes reduced pesticide use and increased efficiency in cultivation, supporting high-quality development of the TCM industry.
Summary
The 2025 edition pharmacopoeia adopts three strategies—"expanding varieties, tightening limits, strengthening testing"—to build a more scientific safety control system for TCM. The new growth regulator and mycotoxin detection items, along with the sixth method technology, mark China's shift from "single indicators" to "panoramic screening," providing a Chinese solution for setting global standards in TCM quality.
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