This electronic document was downloaded from the GPO web 9.docx

1、This electronic document was downloaded from the GPO web 9This 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: 21CFR720.1 Page 146 TITLE 21-FOOD AND DRUGS CHAPTER I-FOOD AND DRUG ADMINISTRATION, DEPART

3、MENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 720-VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS-Table of Contents Sec. 720.1 Who should file. Either the manufacturer, packer, or distributor of a cosmeticproduct is requested to file Form FDA 2512 (Cosmetic ProductIngredi

4、ent Statement), whether or not the cosmetic product entersinterstate commerce. This request extends to any foreign manufacturer,packer, or distributor of a cosmetic product exported for sale in anyState as defined in section 201(a)(1) of the Federal Food, Drug, andCosmetic Act. No filing fee is requ

5、ired. 57 FR 3129, Jan. 28, 1992 Code of Federal RegulationsTitle 21, Volume 7Revised as of April 1, 2002From the U.S. Government Printing Office via GPO AccessCITE: 21CFR720.2 Page 146 TITLE 21-FOOD AND DRUGS CHAPTER I-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

6、 PART 720-VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS-Table of Contents Sec. 720.2 Times for filing. Within 180 days after forms are made available to the industry, FormFDA 2512 should be filed for each cosmetic product being commerciallydistributed as of the effective dat

7、e of this part. Form FDA 2512 shouldbe filed within 60 days after the beginning of commercial distributionof any product not covered within the 180-day period. 57 FR 3129, Jan. 28, 1992 Code of Federal RegulationsTitle 21, Volume 7Revised as of April 1, 2002From the U.S. Government Printing Office v

8、ia GPO AccessCITE: 21CFR720.3 Page 146 TITLE 21-FOOD AND DRUGS CHAPTER I-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 720-VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS-Table of Contents Sec. 720.3 How and where to file. Forms FDA 251

9、2 and FDA 2514 (Discontinuance of CommercialDistribution of Cosmetic Product Formulation) are obtainable onrequest from the Food and Drug Administration, Department of Health andHuman Services, Washington, DC 20204, or at any Food and DrugAdministration district office. The completed form should be

10、mailed ordelivered to: Cosmetic Product Statement, Food and Drug Administration,Department of Health and Human Services, Washington, DC 20204, accordingto the instructions provided with the forms. 57 FR 3129, Jan. 28, 1992 Code of Federal RegulationsTitle 21, Volume 7Revised as of April 1, 2002From

11、the U.S. Government Printing Office via GPO AccessCITE: 21CFR720.4 Page 146-148 TITLE 21-FOOD AND DRUGS CHAPTER I-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 720-VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS-Table of Contents Sec. 7

12、20.4 Information requested about cosmetic products. (a) Form FDA-2512 requests information on: (1) The name and address, including post office ZIP code of theperson (manufacturer, packer, or distributor) designated on the label ofthe product. (2) The name and address, including post office ZIP code,

13、 of themanufacturer or packer of the product if different from the persondesignated on the label of the product, when the manufacturer or packersubmits the information requested under this paragraph. (3) The brand name or names of the cosmetic product. (4) The cosmetic product category or categories

14、. (5) The ingredients in the product. Page 147 (b) The person filing Form FDA-2512 should: (1) Provide the information requested in paragraph (a) of thissection. (2) Have the form signed by an authorized individual. (3) Provide poison control centers with ingredient information and/or adequate diagn

15、ostic and therapeutic procedures to permit rapidevaluation and treatment of accidental ingestion or other accidental useof the cosmetic product. (4) Provide ingredient information (and, when requested, ingredientsamples) to a licensed physician who, in connection with the treatmentof a patient, requ

16、ests assistance in determining whether an ingredientin the cosmetic product is the cause of the problem for which thepatient is being treated. (c) One or more of the following cosmetic product categories shouldbe cited to indicate the products intended use. (1) Baby products. (i) Baby shampoos. (ii)

17、 Lotions, oils, powders, and creams. (iii) Other baby products. (2) Bath preparations. (i) Bath oils, tablets, and salts. (ii) Bubble baths. (iii) Bath capsules. (iv) Other bath preparations. (3) Eye makeup preparations. (i) Eyebrow pencil. (ii) Eyeliner. (iii) Eye shadow. (iv) Eye lotion. (v) Eye m

18、akeup remover. (vi) Mascara. (vii) Other eye makeup preparations. (4) Fragrance preparations. (i) Colognes and toilet waters. (ii) Perfumes. (iii) Powders (dusting and talcum) (excluding aftershave talc). (iv) Sachets. (v) Other fragrance preparations. (5) Hair preparations (noncoloring). (i) Hair c

19、onditioners. (ii) Hair sprays (aerosol fixatives). (iii) Hair straighteners. (iv) Permanent waves. (v) Rinses (noncoloring). (vi) Shampoos (noncoloring). (vii) Tonics, dressings, and other hair grooming aids. (viii) Wave sets. (ix) Other hair preparations. (6) Hair coloring preparations. (i) Hair dy

20、es and colors (all typesrequiring caution statement and patch test). (ii) Hair tints. (iii) Hair rinses (coloring). (iv) Hair shampoos (coloring). (v) Hair color sprays (aerosol). (vi) Hair lighteners with color. (vii) Hair bleaches. (viii) Other hair coloring preparations. (7) Makeup preparations (

21、not eye). (i) Blushers (all types). (ii) Face powders. (iii) Foundations. (iv) Leg and body paints. (v) Lipstick. (vi) Makeup bases. (vii) Rouges. (viii) Makeup fixatives. (ix) Other makeup preparations. (8) Manicuring preparations. (i) Basecoats and undercoats. (ii) Cuticle softeners. (iii) Nail cr

22、eams and lotions. (iv) Nail extenders. (v) Nail polish and enamel. (vi) Nail polish and enamel removers. (vii) Other manicuring preparations. (9) Oral hygiene products. (i) Dentifrices (aerosol, liquid, pastes,and powders). (ii) Mouthwashes and breath fresheners (liquids and sprays). (iii) Other ora

23、l hygiene products. (10) Personal cleanliness. (i) Bath soaps and detergents. (ii) Deodorants (underarm). (iii) Douches. (iv) Feminine hygiene deodorants. (v) Other personal cleanliness products. (11) Shaving preparations. (i) Aftershave lotions. (ii) Beard softeners. (iii) Mens talcum. (iv) Preshav

24、e lotions (all types). (v) Shaving cream (aerosol, brushless, and lather). (vi) Shaving soap (cakes, sticks, etc.). (vii) Other shaving preparation products. (12) Skin care preparations, (creams, lotions, powder, and sprays).(i) Cleansing (cold creams, cleansing lotions, liquids, and pads). Page 148

25、 (ii) Depilatories. (iii) Face and neck (excluding shaving preparations). (iv) Body and hand (excluding shaving preparations). (v) Foot powders and sprays. (vi) Moisturizing. (vii) Night. (viii) Paste masks (mud packs). (ix) Skin fresheners. (x) Other skin care preparations. (13) Suntan preparations

26、. (i) Suntan gels, creams, and liquids. (ii) Indoor tanning preparations. (iii) Other suntan preparations. (d) Ingredients in the product should be listed as follows: (1) A list of each ingredient of the cosmetic product in descendingorder of predominance by weight (except that the fragrance and/or

27、flavormay be designated as such without naming each individual ingredient whenthe manufacturer or supplier of the fragrance and/or flavor refuses todisclose ingredient data). (2) An ingredient should be listed by the name adopted by the Foodand Drug Administration (FDA) for the ingredient pursuant t

28、oSec. 701.3(c) of this chapter. (3) In the absence of a name adopted by FDA pursuant toSec. 701.3(c) of this chapter, its common or usual name, if it has one,or its chemical or technical name should be listed. (4) If an ingredient is a mixture, each ingredient of the mixtureshould be listed in accor

29、dance with paragraphs (d)(2) and (d)(3) of thissection, unless such mixture is a formulation voluntarily registered onForm FDA 2512, in which case such mixture should be identified asfragrance, flavor, fragrance and flavor or baseformulation, as appropriate, and by stating its FDA-assigned cosmeticp

30、roduct ingredient statement number. (5) When the manufacturer or supplier of a fragrance and/or flavorrefuses to disclose ingredient data, the fragrance and/or flavor shouldbe listed as such. The nonconfidential listing of the product name and/or trade name or name of the manufacturer or supplier of

31、 eachproprietary fragrance and/or flavor mixture is optional. (e) A separate Form FDA-2512 should be filed for each differentformulation of a cosmetic product. However, except for the hair coloringpreparations listed in paragraph (c)(6) of this section for which astatement for each shade of such product is required, a single Form FDA-2512 may be filed for two or more shades of a cosmetic