Threshold Limit Values for Mold or Mold Spores Need to Be Set

Without sanitation criteria for medicinal herbs (used for Oriental Medicine), concerns are rising over the possibility of fungal infection of those herbal ingredients. When the Korea Consumer Agency (KCA) conducted a test over how much those dried herbs were infected with mold and mold toxicity, it seems necessary to come up with measures to prevent the possible infection and resulting changes in product quality, although no herb materials were found to have been infected with Aflatoxin B1.
From March to July, 2007, the KCA tested the fungal infection degree of 96 Chinese herbs (12 types) sold in the market. The test results are as follows.

Unit: cfu/g

From left, Dang Quei(unpacked), Dang Quei(packed) Baek-chul(unpacked), Baek-chul (packed), Bok-ryung (Poria Cocos)(unpacked), Bok0ryung(packed), Sanyak(unpacked), sanyak(packed), Yook-gae(Cinnamomum cassia)(unpacked), Yook-gae(packed), Jinpi(unpacked), Jinpi(packed), Chun-goong(Cinidil Rhizoma)(unpacked), Chun-goong (packed), hwang-gi (uppacked), hwang-gi (packed), Hu-bak (Mongloae Cortex)(unpacked), Hu-bak (packed), Hyangbuja (Cyperus Rotundus)(unpacked), Hyangbuja (packed), and Jinseng (packed).   

Among tested 88 herb ingredients (except Sook-ji-hwang, steamed roots of Rehmanniae Glutinosa), 14 exceeded 105 cfu/g, 70 had 101~104 cfu/g, and 4 had less than 10 cfu/g.

While the EU Pharmacopoeia clearly provides the threshold limit values(TLV) for the number of total germs, the number of fungus, and the number of E.coli bacteria, Korea has no standard at the moment regarding the management of bacteria. The KCA, therefore, applied the EU standard to measure mold infection status of oriental medicinal herbs, and the result showed that 1 packed hwang-gi (Korean), 1 packed Jin-pi(Korean), and 4 unpacked herbs including 1 unpacked Hu-bak and 1 Bokryung(North Korean) exceeded the TLV(5*105 cfu/g).

Since these herbs are decocted to be taken as medicine, they have a low risk of causing harms to people. However, it seems necessary to set the threshold limit values for mold or mold spores, in order to prevent the infection from mold toxins and quality changes often caused by metabolic byproducts.

□ Little Difference in the Degree of Mold Infection between Packed and Unpacked Products

Overall, there was little difference in the degree of fungal infection between packed and unpacked herb products, although there was some difference in the distribution of infection. It is because of the poor management of sanitary conditions of both packed and unpacked medicinal herbs. Because herb medicines are distributed through rather a traditional market system, sanitation status is not thoroughly controlled. In particular, it is hard to check the producers or expiry dates when the herbs are sold in bulk and unpacked, which requires practical measures to manage the quality and sanitation status of medicinal herbs.     

□ Aflatoxin B1 Found in 3 Chungoong herbs

When the KCA tested whether the herbs were infected with Aflatoxin B1, 3 chun-goong herbs out of total 96 tested products had 3.97, 2.46, and 1.14ppb, respectively, all of which are less than the threshold limit values (10ppb) that is stated in a legislation which has recently been notified.

Based on the test result, the KCA is planning to propose the relevant authorities to set the standard to better manage sanitary condition of medicinal herbs, and to urge them to provide continuous supervision and education on this matter.  

Sep 5, 2007 [Food & Microbiology Team, Testing & Research Center]