원료정의
(Definitions) |
Hamamelis Virginiana (Witch Hazel) Water is an aqueous solution containing natural volatile oils obtained by the distillation of twigs, bark and leaves of Hamamelis virginiana. In the United States, Hamamelis Virginiana (Witch Hazel) Water may be used as an active ingredient in OTC drug products. See Regulatory and Ingredient Use Information, regarding the labeling names for U.S. OTC Drug Ingredients in Volume 1, Introduction, Part A. See Regulatory and Ingredient Use Information, regarding the labeling names for botanical ingredients in Volume 1, Introduction, Part A. When used as an active drug ingredient, the established drug name is Witch Hazel. |
원료수재근거 |
■ Botanicals
In previous editions of the Dictionary, botanical ingredients were identified using two differing conventions. One, preferred by the U.S. FDA, identified the ingredient by common name (where appropriate), or genus and species, and the plant part and type of preparation. The other, accepted in the EU with the publication of its Inventory, used only the genus and species names to identify the botanical ingredient.
To begin harmonizing the botanical nomenclature, the International Nomenclature Committee began assigning genus and species names to all botanicals, and common names were only included in the names proposed for labeling in the U.S., when it was determined that such would assist identification of the ingredient for safety purposes. In addition, a cross reference of common and more specific genus and species names was made available to the dermatology community through CTFA On Call, through the American Contact Dermatitis Society, and to the public through the CTFA Web site at http://www.ctfa.org. At the same time, the European industry began adding the plant part and type of preparation information used in the U.S. to its listing of botanical ingredients for the first update of its Inventory.
Since the first update of the EU Inventory was published by the EU Commission on February 9, 2006, (Commission Decision 2006/257/EC), the editors have removed the genus and species only names for botanicals since the tenth edition of the Dictionary. The number of botanical ingredients in the initial EU Inventory was limited to about 150, and it is hoped that any Member State finding one of these botanicals listed with the additional information, before formal adoption of the first update, will forgo any regulatory action. However, the user is directed to contact his European National Association, or Colipa the European Cosmetic, Toiletry, and Perfumery Association, to ascertain the latest status of the first update of the Inventory, before deciding on the use of the botanical nomenclature provided in this edition.
Note: (EU) must not be used on finished product labels as part of the INCI name.
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