The Current Situation of Japanese Medicinal Plants Industry and its Significance on the Pharmaceutical Industry 3-3-1 - 農業知識入口網

3-3 Countermeasure for contaminations of crude drugs

3-3-1 Residual pesticides

Based on the residual pesticide investigation of crude drugs in 1997, the total BHC and DDT limit of 0.2 ppm was established for Ginseng, Powdered Ginseng, Red Ginseng, Senna Leaf, and Powdered Senna Leaf. However, crude drugs were tested again in response to public demand, and the residual pesticides limit level was delineated in the 2006 JP15 as 0.2ppm for total BHC and total DDT each for the following crude drugs (in addition to the former ones in 1997):

Astragalus Root, Polygala Root, Powdered Polygala Root, Glycyrrhiza, Powdered Glycyrrhiza, Cinnamon Bark, Powdered Cinnamon Bark, Asiasarum Root, Cornus
Fruit, Perilla Herb, Jujube, Citrus Unshiu Peel, Loquat Leaf, Moutan Bark, Powdered Moutan Bark.

During 2005-2006, JKMA established the following self-imposed limit for Kampo extract formulations and non-Kampo crude drug products: Organochloric pesticides (total BHC, total DDT: below 0.2ppm) for Kampo formulations and non-Kampo crude drug products containing Ginseng, Senna Leaf, Astragalus Root, Polygala Root, Glicyrrhiza, Cinnamon Bark, Asiasarum Root, Cornus Fruit, Perilla Herb, Jujube, Citrus Unshiu Peel, Loquat Leaf, Moutan Bark.

Organophosphorus pesticides（Parathion：0.5ppm, Methyl Parathion：0.2ppm, Methidathion：0.2ppm, Malathion：1.0ppm） for Kampo formulations and non-Kampo crude drug products containing Polygala Root, Cornus Fruit, Perilla Herb, Citrus Unshiu Peel.

Pyrethroid pesticides（Fenvalerate：1.5ppm、Cypermethrin：1.0ppm） for Kampo formulations and non-Kampo crude drug products containing Polygala Root, Perilla Herb, Jujube, Citrus Unshiu Peel, Loquat Leaf.
For crude drugs that are used as foods, the residual pesticide limit changed from its negative list to a positive list system in 2006, and uniform limit of 0.01ppm was implemented for all residual pesticides of all food products that lack individual limit.

For pesticides that are not legally regulated, in-house limits are established by thecompany and testing is performed accordingly.