近年來由於全球回歸自然風潮的興起，中草藥的再度受到重視，愈來愈多的中藥品項被應用於生活週邊產品中，同時造就了多元化的化粧品市場，也衍生出化粧品添加中藥成分應如何定位的問題。本計畫擬蒐集相關資料，並廣徵各界意見，草擬有關可加入化粧品之中藥品項相關規範，作為中藥添加於化粧品管理政策之參考。研究內容包含蒐集目前市面上國內外品牌化粧品之加入中藥品項等現況，擬邀請業界、學界及官方代表組成專家委員會，並就相關法規及使用功效和安全性等因素，探討化粧品加入中藥品項之利弊得失。經過彙整國內外相關資料後，提出具體可行之規範草案與政策建議。本計畫所規劃擬定之中藥添加入化粧品法規草案，全程工作內容如下： 1. 先期預備作業： (1) 組織專家委員會，成員包括產官學代表，其職責為： (a) 研究方針之確定； (b) 商議由工作小組提出之各種起草或建議案； (c) 結案前審定各項草案及研究結果。 (2) 組織工作小組，其職責為： (a) 起草各書面建議文件，包括將來實施時之策略； (b) 由指定專人執行本案之品管及品保作業； (c) 其他本案相關事務。 2. 公會及業界拜訪：拜訪全國性化粧品公會，並且至少訪問五家漢方化粧品業者，進行討論與意見交流。 3. 資料蒐集： (a)市售化粧品添加中藥品項之調查與統計。 (b)醫藥品先進國之中草藥可添加及不得添加於化粧品之品項； (c)美國、日本、歐盟及中國等對於天然物添加於化粧品之管理規範； (d)典籍文獻記載之中草藥應用於化粧品之資料。 4.起草中藥添加於化粧品法規：以國內外化粧品法規為架構，探討中藥可添加(正面表列)或不得添加(負面表列)品項列入草案中之可行性，預定建議40種可加入化粧品之中草藥品項。 5.結案時呈送化粧品添加中藥品項有關之各種規範草案及建議。 Study and the Proposal Drafting of the Application of the Chinese Medicines on the Cosmetic Products In recent years, back to nature is a global trend. Chinese herbal medicine is one of the great herbal systems of the world, many herbal ingredients were applied in the commercial products. Because of the complexity of plant materials it is far more balanced than medicine based on isolated active ingredients and is far less likely to cause side effects. In this plan, the informations related in the application of Chinese herbal medicines were collected and evaluated by the experts. We propose to work on this initiative to establish a draft of a guidance on the application of Chinese herbal medicines on cosmetic products. The study will focus on the following subjects: 1. Preparatory works: (1) organization of an expert committee consisting of experts from industry, government agencies and academics. The duties of this committee are: (a) policy establishment; (b) approval or dispproval of drafts prepared by the task group. (c) Formalizaing draft proposals before concluding this project. (2) Organization of a task force for: (a) drafting of all written proposals including the time schedule of the formal implementation by the government agencies; (b) quality control and quality assurance of this project operated by a designated person. 2. Public hearings before the drafting and the final formalization of the draft guidance and other proposals. (1) Discussion of the issue with the local cosmetic industry association; (2) A public hearing on the general idea regarding the direction of the drafting; (3) A public hearing or conference for the drafted proposals before the formalization. (4) Site visiting for discussions with individual factories. A minimum of five factories will be visited. 3. Drating of guidance and system for the application of Chinese herbal medicines on cosmetic products. (1) The draft proposal of the guidance will be prepared by using the existed related regulations of our country and the existed international guidances and regulations as key references. (2) Drafting of templates that will be used described in literatures. 4. Formalization of the draft and other proposals and 40 species will be proposed. 5. Drating of guidance and system for the responsible government agency by the task group. Key words: Chinese herbal medicine, cosmetic, regulation, draft
