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  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



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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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