This electronic document was downloaded from the GPO web 5.docx

1、This electronic document was downloaded from the GPO web 5This electronic document was downloaded from the GPO web site, October 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regul

2、ations may be found at the GPO web site or from the current printed version. Code of Federal RegulationsTitle 21, Volume 7Revised as of April 1, 2002From the U.S. Government Printing Office via GPO AccessCITE: 21CFR701.1 Page 132-133 TITLE 21-FOOD AND DRUGS CHAPTER I-FOOD AND DRUG ADMINISTRATION, DE

3、PARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 701-COSMETIC LABELING-Table of Contents Subpart A-General Provisions Sec. 701.1 Misbranding. (a) Among representations in labeling of a cosmetic which rendersuch cosmetic misbranded is a false or misleading representation withrespect to another

4、cosmetic or a food, drug, or device. (b) The labeling of a cosmetic which contains two or moreingredients may be misleading by reason (among other reasons) of thedesignation of such cosmetic in such labeling by a name which includesor suggests the name of one or Page 133 more but not all such ingred

5、ients, even though the names of all suchingredients are stated elsewhere in the labeling. Code of Federal RegulationsTitle 21, Volume 7Revised as of April 1, 2002From the U.S. Government Printing Office via GPO AccessCITE: 21CFR701.2 Page 133 TITLE 21-FOOD AND DRUGS CHAPTER I-FOOD AND DRUG ADMINISTR

6、ATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 701-COSMETIC LABELING-Table of Contents Subpart A-General Provisions Sec. 701.2 Form of stating labeling requirements. (a) A word, statement, or other information required by or underauthority of the Act to appear on the label may lack

7、that prominence andconspicuousness required by section 602(c) of the Act by reason (amongother reasons) of: (1) The failure of such word, statement, or information to appear onthe part or panel of the label which is presented or displayed undercustomary conditions of purchase; (2) The failure of suc

8、h word, statement, or information to appear ontwo or more parts or panels of the label, each of which has sufficientspace therefor, and each of which is so designed as to render it likelyto be, under customary conditions of purchase, the part or paneldisplayed; (3) The failure of the label to extend

9、 over the area of thecontainer or package available for such extension, so as to providesufficient label space for the prominent placing of such word,statement, or information; (4) Insufficiency of label space (for the prominent placing of suchword, statement, or information) resulting from the use

10、of label spacefor any word, statement, design, or device which is not required by orunder authority of the Act to appear on the label; (5) Insufficiency of label space (for the prominent placing of suchword, statement, or information) resulting from the use of label spaceto give materially greater c

11、onspicuousness to any other word, statement,or information, or to any design or device; (6) Smallness or style of type in which such word, statement, orinformation appears, insufficient background contrast, obscuring designsor vignettes, or crowding with other written, printed, or graphicmatter. (b)

12、(1) All words, statements, and other information required by orunder authority of the Act to appear on the label or labeling shallappear thereon in the English language: Provided, however, That in thecase of articles distributed solely in the Commonwealth of Puerto Ricoor in a Territory where the pr

13、edominant language is one other thanEnglish, the predominant language may be substituted for English. (2) If the label contains any representation in a foreign language,all words, statements, and other information required by or underauthority of the Act to appear on the label shall appear thereon i

14、n theforeign language. (3) If the labeling contains any representation in a foreignlanguage, all words, statements, and other information required by orunder authority of the Act to appear on the label or labeling shallappear on the labeling in the foreign language. Code of Federal RegulationsTitle

15、21, Volume 7Revised as of April 1, 2002From the U.S. Government Printing Office via GPO AccessCITE: 21CFR701.3 Page 133-139 TITLE 21-FOOD AND DRUGS CHAPTER I-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 701-COSMETIC LABELING-Table of Contents Subpart A-Gener

16、al Provisions Sec. 701.3 Designation of ingredients. (a) The label on each package of a cosmetic shall bear a declarationof the name of each ingredient in descending order of predominance,except that fragrance or flavor may be listed as fragrance or flavor. Aningredient which is both fragrance and f

17、lavor shall be designated byeach of the functions it performs unless such ingredient is identifiedby name. No ingredient may be designated as fragrance or flavor unlessit is within the meaning of such term as commonly understood byconsumers. Where one or more ingredients is accepted by the Food andD

18、rug Administration as exempt from public disclosure pursuant to theprocedure established in Sec. 720.8(a) of this chapter, in lieu of labeldeclaration of identity the phrase and other ingredients may be usedat the end of the ingredient declaration. (b) The declaration of ingredients shall appear wit

19、h such prominenceand conspicuousness as to render it likely to be read and understood byordinary individuals under normal conditions of purchase. Thedeclaration shall appear on any appropriate information panel in lettersnot less than 1/16 of an inch in height and without obscuring design,vignettes,

20、 or crowding. In the absence of sufficient space for suchdeclaration on the package, or where the manufacturer or distributorwishes to use a decorative container, the declaration may appear on afirmly affixed tag, tape, or card. In those cases where Page 134 there is insufficient space for such decl

21、aration on the package, and itis not practical to firmly affix a tag, tape, or card, the Commissionermay establish by regulation an acceptable alternate, e.g., a smallertype size. A petition requesting such a regulation as an amendment tothis paragraph shall be submitted pursuant to part 10 of this

22、chapter. (c) A cosmetic ingredient shall be identified in the declaration ofingredients by: (1) The name specified in Sec. 701.30 as established by theCommissioner for that ingredient for the purpose of cosmetic ingredientlabeling pursuant to paragraph (e) of this section; (2) In the absence of the

23、name specified in Sec. 701.30, the nameadopted for that ingredient in the following editions and supplements ofthe following compendia, listed in order as the source to be utilized: (i) CTFA (Cosmetic, Toiletry and Fragrance Association, Inc.)Cosmetic Ingredient Dictionary, Second Ed., 1977 (availab

24、le from theCosmetic, Toiletry and Fragrance Association, Inc. 1110 Vermont Ave.NW., Suite 800, Washington, DC 20005, or available for inspection at theOffice of the Federal Register, 800 North Capitol Street, NW., suite700, Washington, DC 20408), which is incorporated by reference, exceptfor the fol

25、lowing deletions and revisions: (a) The following names are not adopted for the purpose of cosmeticingredient labeling: Acid Black 58Acid Black 107Acid Black 139Acid Blue 168Acid Blue 170Acid Blue 188Acid Blue 209Acid Brown 19Acid Brown 30Acid Brown 44Acid Brown 45Acid Brown 46Acid Brown 48Acid Brow

26、n 224Acid Orange 80Acid Orange 85Acid Orange 86Acid Orange 88Acid Orange 89Acid Orange 116Acid Red 131Acid Red 213Acid Red 252Acid Red 259Acid Violet 73Acid Violet 76Acid Violet 99Acid Yellow 114Acid Yellow 127Direct Yellow 81Solvent Black 5Solvent Brown 43Solvent Yellow 63Solvent Yellow 90 (b) The

27、following names are adopted for the purpose of cosmeticingredient labeling, provided the respective monographs are revised todescribe their otherwise disclosed chemical compositions, or describetheir chemical compositions more precisely, and such revised monographsare published in supplements to thi

28、s dictionary edition by July 18,1980. Acid Black 2Benzophenone-11Carbomer 934Carbomer 934PCarbomer 940Carbomer 941Carbomer 960Carbomer 961Chlorofluorocarbon 11SDimethicone CopolyolDisperse Red 17Pigment Green 7Polyamino Sugar CondensateSD Alcohol (all 27 alphanumeric designations)Sodium Chondroitin

29、SulfateSynthetic Beeswax (c) The following names are adopted for the purpose of cosmeticingredient labeling until January 19, 1981. Amphoteric (all 20 numeric designations)Quaternium (all 49 numeric designations) (ii) United States Pharmacopeia, 19th Ed., 1975, and SecondSupplement to the USP XIX an

30、d NF XIV, 1976. (Copies are available fromthe U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway,Rockville, MD 20852, or available for inspection at the Office of theFederal Register, 800 North Capitol Street, NW., suite 700, Washington,DC 20408.) (iii) National Formulary, 14th Ed., 1975,

31、and Second Supplement tothe USP XIX and NF XIV, 1976. (Copies are available from the U.S.Pharmacopeial Convention, Inc., 12601 Twinbrook Page 135 Parkway, Rockville, MD 20852, or available for inspection at the Officeof the Federal Register, 800 North Capitol Street, NW., suite 700,Washington, DC 20408). (iv) Food Chemicals Codex, 2d Ed., 1972; First Supplement, 1974, andSecond Supplement, 1975, which are incorporated by refer