Pesticides, Herbicides, Heavy Metals, and Microorganisms in Herbal Products
| Contaminant Type | Regulations and Limits | Testing Methods and Standards | Examples of Contaminants | Legislative Bodies |
|---|---|---|---|---|
| Heavy Metals | - European Pharmacopoeia: Limits for lead, cadmium, arsenic, mercury, etc. | - Limit tests based on sulphide ion coloration method | Lead, cadmium, arsenic, mercury | European Pharmacopoeia, USP |
| - USP: Standards aligned with EP, limits vary by botanical | - Analytical methods specified in monographs | Limits set in ppm (e.g., 10 ppm for some herbs) | US Pharmacopeia, FDA | |
| Pesticides and Herbicides | - FDA: Regulates under Federal Food Drug and Cosmetic Act | - Limits may vary; zero tolerance for some pesticides | Organochlorines (e.g., DDT), organophosphates, pyrethroids | US Environmental Protection Agency (EPA), FDA |
| - USP: Sets limits in monographs not applicable for food labeling | - Harmony with EP standards | Examples include quintozene, procymidone, lindane | US Pharmacopeia | |
| Microorganisms | - European Pharmacopoeia: Limits for aerobic bacteria, fungi, E. coli, Salmonella | - Microbiological testing protocols | Total aerobic count, yeast and mold, absence of E. coli, Salmonella | European Pharmacopoeia, USP |
| - USP: Limits for dried or powdered botanicals | - GMP/GHP compliance required | Bile-tolerant Gram-negative bacteria, specific cfu/g limits | FDA, WHO |
Notes:
- Heavy Metals: Regulations set maximum limits to ensure safety, with testing methods specified in pharmacopoeias.
- Pesticides and Herbicides: Strict regulations aim to minimize residues; USP aligns with EP standards, but applicability varies by country.
- Microorganisms: GMP and GHP ensure microbial limits are met; specific standards for different types of botanical preparations.
These regulations and testing standards are crucial for ensuring the safety and quality of herbal products, protecting consumers from harmful contaminants.
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