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■ 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.
■ Reported Ingredient Functions - The Cosmetic Drug Distinction
Many countries have regulatory requirements for cosmetics that are different from those for products that may function as drugs or that have medicinal properties. Frequently, countries also define the cosmetic and drug functions differently. In general, a substance or product that is intended to significantly affect the structure or function of the body or to treat or cure disease is regulated as a drug. In contrast, a substance or a product that is intended to cleanse, promote attractiveness, or temporarily alter the appearance of the body is regulated as a cosmetic. The intended function for an ingredient is determined on the basis of claims made by the supplier of the ingredient; in the case of a finished product, claims made for the product.
The functions for an ingredient listed in the Dictionary are primarily those that are provided by the supplier. The function of an ingredient may be found in each monograph and the Function Section of the Dictionary.
Some functions listed in the Dictionary, applied to the cosmetic product, may cause products containing them to be subject to drug, quasi-drug, Functional,? or other regulations in addition to the basic regulations required for cosmetics. Examples of such functions in the U.S. are: antiacne, anticaries, antidandruff, antifungals, antimicrobials, antiperspirants, corn/callus/wart removers, drug astringents, oral healthcare drugs, skin protectants, external analgesics, oral care agents, oral healthcare drugs, skin bleaching agents, skin protectants, and sunscreens. In addition, a product, based on labeling claims, may be subject to both the cosmetic and drug regulations in some countries.
Functions of ingredients listed in the Dictionary are classified on the basis of the function each may perform in a finished product. Many ingredients have multiple functions in formulations and therefore are included in several functional groupings. The definition and scope of each function listed in the Dictionary is provided in the Function Section, under Functions. The use of an ingredient for a function other than those listed in the Dictionary is acceptable. The inclusion of an ingredient under a given function in the Dictionary does not imply that the ingredient is approved,? certified,? or endorsed for that use by the CTFA or any other organization or governmental body in the U.S., the EU, Japan, or any other country.
The regulatory approach dealing with the distinction of a cosmetic from a drug varies from country to country. In the United States, drug ingredients are regulated by the Food and Drug Administration under regulations associated with U.S. Over-the-Counter (OTC) Drug ingredients. U.S. OTC drugs require premarket approval for safety and efficacy. Some U.S. OTC active drug ingredients have been reported to have a purely cosmetic purpose in cosmetic formulations in addition to being safe and effective drug ingredients.
Some U.S. OTC drug functions may be regulated as cosmetics in other countries. Such functions may therefore be assigned to ingredients not approved for such use in the U.S. In the Function Section of the Dictionary, ingredients approved for use as U.S. active ingredients are identified with an asterisk. When the U.S. drug name differs from the INCI name, the U.S. drug name is listed parenthetically.
In the EU, the key legislation is provided in the Cosmetic Directive that contains a series of Annexes setting out the lists of substances subject to prohibitions as well as substances that are subject to restrictions or are provisionally allowed. Medicinal products are regulated in the EU by Directive 2001/83/EC. In the EU, as in the U.S., labeling claims made for a product define how the product will be regarded under the Directive. Annex I of the Cosmetic Directive identifies products such as antiperspirants, oral care, and skin whitening agents as illustrative of products that belong to the cosmetic category in the EU, categories that are regarded in the U.S. as OTC drugs.
In Japan, cosmetics are regulated by the Ministry of Health, Labor, and Welfare (MHLW) under the Pharmaceutical Affairs Law and the amended Enforcement Regulations of the Pharmaceutical Law of 2001. Japan has a similar cosmetic and drug distinction as in the U.S. and the EU. In addition, it has a category of products referred to as Quasi-drugs? that by definition have a mild effect on the human body.
Many other countries follow the regulations of the EU, Japan, or the U.S. for selected requirements of those countries.
Users of the Dictionary must consult the regulatory requirements of the country in which they intend to market their products. Sources of additional information for regulatory requirements in many countries may be found in the CTFA International Regulatory Resource Manual, Sixth Edition (2007). Information on the requirements for marketing cosmetics and OTC drugs in the U.S. may be found in the CTFA Labeling Manual: A Guide to Cosmetic and OTC Drug Labeling and Advertising, Eighth Edition, 2006.
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