Cosmetic Regulation Handbook

Understanding ISO 9000:2000

Table of Contents
Title	Page
Cosmetic Regulatory Requirements How the Law Defines a Cosmetic Marketing Cosmetics in the U.S. Applicable Cosmetic Regulations FDA Authority Importing Cosmetic Products Exporting Cosmetic Products Voluntary Cosmetic Registration Voluntary Registration of Establishments Voluntary Filing of Cosmetic Product Ingredient & Cosmetic Raw Material Composition Statements Cosmetic vs. Over-the-Counter Drug How the Law Defines a Cosmetic How the Law Defines a Drug Cosmetics that are Also Drugs Intended Use Safety, Sterility, Shelf Life & Packaging Safety Testing Sterility Shelf Life Tamper-Resistant Packaging Prohibited Ingredients & Other Hazardous Substance Hexachlorophene Mercury Compounds Chlorofluorocarbon Propellants Other Prohibited Ingredients Bithionol Halogenated Salicylanilides Chloroform Vinyl Chloride Zirconium Methylene Chloride Additional Health Risks & Concerns Chloroacetamide Ethoxyethanol HC Blue No. 1 p-Hydroxyanisole; 4-Methosy-m-phenylenediamin Fragrance Materials Acetylethyltetramethyltetralin (AETT) Musk Ambrette 6-Methylcoumarin (6-MC) Contaminants Nitrosamines Dioxane Diethanolamine (DEA) Color Additives Cosmetic GMP Guidelines Buildings Equipment Personnel Raw Materials Production Laboratory Controls Records Packaging and Labeling Complaints Other Cosmetic Labeling What is a Cosmetic When is a Cosmetic Also a Drug Soap Laws Regulating Cosmetic Labeling The Principle Display Panel Outer Container Labeling Example Inner Container Labeling Example Declaration of Ingredients Label Warnings General Aerosol Products Feminine Deodorant Sprays Children’s Foaming Detergent Baths Hair Dye Products Products Containing Estrogen Hormones, Placental Extract or Vitamins Suntan Products Other Warnings Depilatories & Hair Straighteners Hair Shampoos, Rinses, Conditioners Nail Buildings, Hardeners, Enamels Flammable Products Products Requiring Child Resistant Packaging Permanent Wave Neutralizers Artificial or Sculptured Fingernail Glue Other Labeling Statement or Claims Hypoallergenic Cruelty Free-Not Tested on Animals Cosmeceutical Alcohol Free	3 3 4 7 8 8 13 13 13 17 17 17 17 18 21 21 21 21 25 25 25 25 25 25 25 25 25 26 26 26 26 26 26 26 26 26 26 27 27 27 27 27 28 31 35 35 36 36 36 37 38 38 39 40 40 43 43 43 44 45 46 46 47 49 49 50 50 50 51 52 53 53 53 53 54 54 54 55 55 55

APPENDIX I

APPENDIX II

APPENDIX III

APPENDIX IV

APPENDIX V

APPENDIX VI

APPENDIX VII

APPENDIX VIII

APPENDIX IX

APPENDIX X

APPENDIX XI

REFERENCES

Form FDA 2511 - "Registration of Cosmetic Product Establishment"
Instructions for Completing Form FDA511

Form FDA 2512 - "Cosmetic Product Ingredient Statement"
Instructions for Completing Form FDA 2512

Form FDA 2512a - "Cosmetic Product Ingredient Statement"
Instructions for Completing Form FDA 2512a

Form FDA 2512 & 2512a
Instructions for Completing Amended Forms 2512 and 2512a

Form FDA 2514 - "Notice of Discontinuance of Commercial
Distribution of Cosmetic Product Formulation"
Instructions for Completing Form FDA 2514

Cosmetic Product Category Codes

Sources for Cosmetic Ingredient Nomenclature

Common Color Additive Terms

21 CFR Part 73 - "Listing of Color Additives
Exempt form Certification"

21 CFR Part 74 - "Listing of color Additive
Subject to Certification"

21 CFR Part 82 - "Listing of Certified
Provisionally Listed Colors and Specifications"

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