Position regarding the detection of Methoxsalen in HemoHIM
1. Angelica cnidium officinale, and peony, which make up HemoHIM, are all natural products listed in the Food Public Code. They were recorded in the herbal medicine books, ‘Dong-uibogam’ and ‘Boncho Gangmok’, and have been consumed for a long time. In particular, angelica, the major raw material used in HemoHIM, is a medicinal ingredient that has been widely used in Korea, China, and Japan, and has been proven through several studies to be a toxicologically safe medicine.
2. The Methoxsalen substance, which has been raised as an issue by the Hong Kong Health Department, is a natural plant ingredient. It is naturally contained in angelica root, and can be easily found in apiaceae family (dill, parsley, parsnips) including lace flower and angelica keiskei, citrus fruit (trifoliate orange, lime), earl gray, green tea, angelica, celery, and lemon.
3. Any functional substance has potential to cause problems if consumed in excess. According to the related literature, excessive intake of more than 240mg of Methoxsalen can cause problems for the human body. This is the amount that would only be problematic when consuming about 1,000 packets of HemoHIM at once. In addition, according to a report within the European Food Safety Administration (EFSA) on women’s menopausal foods containing angelica, the standard for Methoxsalen in the product is set to 3,000 ppm or less.
4. Recently, the manufacturer conducted its own analysis of Methoxsalen on HemoHIM products exported to Hong Kong, and officially requested analysis from two nationally accredited certification agencies. As a result, it was confirmed that trace amounts of Methoxsalen were detected in all 3 sites at levels present in natural substances. And it has been confirmed to be completely harmless to the human body.
5. HemoHIM was developed at the Korea Atomic Energy Research Institute, a national research institute, with the bases as the oriental medicinal raw material composed of angelica, cnidium officinale, and peony. In addition, it was confirmed that there were no abnormal symptoms detected in any organs including liver and kidney as a result of non-clinical and human application tests. It has been officially approved by KFDA in 2006 as an individually recognized health functional food that helps to enhance immunity.
6. According to the clinical trial result report for health functional food ingredient certification application (HemoHIM angelica mixed extract) published in 2006, no biotoxicity was observed as a result of the toxicity test for the HemoHIM angelica mixed extract. In addition, in order to verify the safety of the HemoHIM angelica mixed extract, the US EPA and FDA were requested to and measured the residual pesticide and heavy metal content. As a result, all measurements were below the detection limit or not detected, and its safety was recognized.
7. HemoHIM has been approved by the US FDA as well as Korean food and Drug Administration (KFDA), and is exported to 18 countries including Singapore, Canada, Philippines, Malaysia, Indonesia, and Russia. Since its registration as a health functional food in 2006, it has been consumed by many people for around 15 years, and its safety has been proven through personal experiences.
8. The fact that Methoxsalen was detected in a natural complex cannot determine it as a harmful substance to the human body. In addition, the process of artificially adding the substance does not exist in the manufacturing process and cannot be mixed.
9. Data such as literature research on natural plants and test results of accredited institutions will be separately announced. The head office and manufacturer are conducting scientific and thorough verification procedures for this case, and will work closely with related organizations to respond actively.
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对于从HemoHIM中检测出甲氧沙林这一报道的公司立场：
1. 作为HemoHIM的主要成分，当归、川穹、白芍，是韩国食品公典上记载的天然物，既成药书东医宝鉴、本草纲目中记载的长期摄取的代表性中草药。 特别是用于HemoHIM的主要原料---当归，是中日韩，三国广泛使用的中草药，在毒性学上也是安全的药材。
2. 此次，中国香港卫生署提出的名为甲氧沙林（Methoxsalen）的成分作为天然植物成分。属于在当归根、包括单叶黄水枝、及神仙草在内的水芹菜（迪尔、香芹、帕尼普斯）、小麦土豆（枸橘、青柠）、红茶、绿茶、当归、芹菜、柠檬等多种植物中，天然存在的成分。
3. 任何功能性物质，一般过量摄取都会发生问题。 根据相关文献，只有在摄取240mg以上甲氧沙林时，可能会对人体造成伤害，而这一比例需摄取约1,000包以上的HemoHIM，才能引发毒性。 另外，根据欧洲食品安全局（EFSA）对包括当归在内的女性更年期食品的报告，该产品内的甲氧沙林标准规格设定为3000ppm以下。
4. 近期，制造商对中国香港出口的HemoHIM产品，进行了甲氧沙林检测分析，并正式向两家国家认证机构提出分析委托。 结果确认了三处均检测出，在天然物质中存在极其微量的甲氧沙林。 并确认，这一微小量，对人体完全无害。
5. HemoHIM是以当归、川穹、白芍构成的，以中药材为基础，由韩国国家研究机构，韩国原子力研究所开发。 此外，根据非临床试验及人体适用试验的安全性结果显示，包括肝脏及肾脏在内的所有脏器均无出现异常症状，是有助于改善免疫力的韩国个别认证型，健康食品，并于2006年获得KFDA正式批准的产品。
6. 根据 2006 年发行的健康食品原料成分（HemoHIM当归等混合提取物）进行临床试验的结果报告书中显示，在HemoHIM当归等混合提取物，进行毒性试验结果显示，均未见生物毒性。 此外，为验证HemoHIM归等混合提取物的安全性，委托美国EPA及FDA测定残留农药及重金属含量，其结果在所有项目中均未超过检测限度或未检测到相关农药及重金属，安全性得到了认证。
7. HemoHIM不仅在韩国食品药品安全局(KFDA)获得批准，还出口到新加坡、加拿大、菲律宾、马来西亚、印度尼西亚、俄罗斯等18个国家。 自2006年登记为健康食品以来，流通于市场约15年的时间，证明了其安全性。
8. 天然复合物中检出甲氧沙林的事实，并不能定义相关物质是对人体有害的物质。 另外人为添加相应成分的过程，在制造工艺上是不能存在、不能混入的。
9. 自然界植物类的文献调查等，公认机关的检查结果等资料将另行公告。 本公司与制造商正对本次案例进行彻底的、科学的、验证，并将与有关部门密切合作，积极应对。
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