美国化妆品合规要求指南(英文版)

Acknowledgements
The lead author for this document is Lisa M. Benson, Strativia, under contract to the Standards
Coordination Office of NIST. Additional guidance, initial research, and review of the document
were provided by the staff of the Standards Coordination Office of NIST including Karen Reczek,
Mary Donaldson, Erik Puskar and Cheryl Levey. Invaluable support was also received from the
knowledgeable experts of the Consumer Product Safety Commission (CPSC), Environmental
Protection Agency (EPA), Food and Drug Administration (FDA), Federal Trade Commission (FTC),
International Cosmetics Manufacturers and Distributors Association (ICMAD), International
Trade Administration (ITA), the Personal Care Products Council (PCPC), and UL, Inc. who
provided input into the document and conducted a thorough review. From the CPSC: Mary
Boyle, Patricia Pollitzer, and Mary Toro; From the EPA: Keith Mason and Alexander Metcalf;
From the FDA: Jeffrey Read, Linda Katz, and Tracy DuVernoy; From the FTC: Stephen C. Eckland
and Julia Ensor; From ICMAD: Craig Weiss; From ITA: Tracy Gerstle.
Disclaimer
Certain commercial entities are identified in this paper to specify the experimental procedure
adequately. Such identification is not intended to imply recommendation or endorsement by
the National Institute of Standards and Technology, nor is it intended to imply that the
materials or equipment identified are necessarily the best available for the purpose.

1. How To Use This Guide 1
1. Scope 1
2. Overview of U.S. Federal Regulatory Framework .... 2
3. Federal Regulatory Authorities and Technical Regulations (Mandatory).... 2
3.1. Consumer Product Safety Commission (CPSC) . 3
3.1.1 Consumer Product Safety Act (CPSA) ........ 3
3.1.2. Child-Resistant Packaging ........ 3
3.1.3. Soap...... 4
3.1.4. Consumer Product Safety Improvement Act of 2008 (CPSIA)... 4
3.1.5. Children’s Cosmetics....... 5
3.1.6. Federal Hazardous Substances Act (FHSA) 5
3.2. Customs and Border Protection (CBP) ..... 6
3.2.1. Country of Origin: Marking of Imported Articles and Containers. 6
3.3 Environmental Protection Agency (EPA).. 6
3.3.1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).. 6
3.3.2. Non-Essential Products Containing Chlorofluorocarbons (CFCs) and
Hydrochlorofluorocarbons (HCFCs)........ 7
3.3.3. Volatile Organic Compounds (VOCs) and High-Volatility Organic Compounds
(HVOCs) ..... 8
3.4 Federal Trade Commission (FTC) .... 8
3.4.1 The FTC Act ... 8
3.4.2. Environmental Marketing Claims ..... 9
3.4.3. Made in the USA Claims.. 9
3.5. Food and Drug Administration (FDA)....... 9
3.5.1 Food, Drug, and Cosmetics Act (FD&C Act) ...... 10
3.5.2. Cosmetic Labeling 11
3.5.3. Cosmetic Ingredients.... 11
3.5.4. Cosmetic Warning and Caution Statements..... 12
3.5.5. Color Additives..... 14
3.5.6. Prohibited or Restricted Ingredients ....... 15
3.5.7. Microbeads. 17
3.5.8. Tamper-Resistant Packaging.. 17
3.5.9. Voluntary Cosmetic Registration .... 18
3.5.10. FDA Warning Letters. 19
3.5.11. FDA Cosmetics Guidance Documents.. 19
3.6. United States Department of Agriculture (USDA).... 19
3.6.1. Organic Claims - Organic Foods Production Act of 1990 (OFPA). 19
4. Overview of U.S. State Regulatory Frameworks .... 20
5. State Regulatory Authorities and Technical Regulations (Mandatory)...... 20
5.1. Packaging and Labeling (Multi-State)..... 21
5.1.1. Uniform Laws and Regulations (UPLR) .... 21
5.1.2. Toxics in Packaging Legislation ....... 21
5.1.3. Nonwoven Disposable Wipes Labeling.... 21
5.2. Chemicals (Multi-State)........ 21
5.2.1. Chemicals of Concern ... 21
5.2.2. Volatile Organic Compounds (VOC) 22
5.3. State of California........ 22
5.3.1. Lead and Other Toxic Substances... 22
5.3.2. California Safe Cosmetics Act 23
5.3.3 The California Toxic Free Cosmetics Act.. 24
5.3.4. Organic Cosmetics 24
5.3.5. Cosmetic Animal Testing Ban. 24
5.3.6. Professional Cosmetics Labeling..... 25
5.3.7. Safety Data Sheet. 25
5.3.8. Made in the USA .. 25
5.4. State of Florida ... 25
5.4.1. Cosmetic Product Manufacturer Permit.. 25
5.5. State of Illinois.... 26
5.5.1. Lead.... 26
5.6. State of Louisiana ........ 26
5.6.1 Cosmetics Laws.... 26
5.7. State of Minnesota...... 27
5.7.1 Formaldehyde in Children’s Products .. 27
5.7.2. Triclosan...... 27
5.8. State of New York........ 27
5.8.1 1,4-Dioxane. 27
6. Overview of the U.S. Voluntary Standards Framework .. 28
7. Standards Developing Organizations (SDOs). 28
7.1. ASTM International ..... 28
7.2. UL Standards ...... 29
7.3. U.S. Pharmacopeial Convention (USP)... 29
7.4. International Standards Organization (ISO).... 30
8. Testing and Certification Bodies.. 31
8.1. Testing ....... 31
8.1.1 Laboratories 31
8.1.2 Testing Procedures ....... 31
8.2. Certification........ 31
8.2.1 Products Subject to Consumer Product Safety Rules 31
8.2.3 Organic Certification.. 32
8.3. Certification Bodies..... 32
9. Relevant U.S. Government Agencies.... 33
9.1. U.S. Consumer Product Safety Commission (CPSC). 33
9.2. U.S. Customs and Border Protection (CBP)..... 33
9.3. Environmental Protection Agency (EPA) 34
9.4. Federal Trade Commission (FTC) .. 34
9.5. Food and Drug Administration (FDA)..... 34
10. Cosmetic Industry and Market Data. 34
10.1. Industry Trade Associations....... 34
10.1.1. Cosmetic Ingredient Review (CIR)........ 34
10.1.2 International Nomenclature for Cosmetics Ingredients (INCI).... 35
10.1.3. Independent Beauty Association (IBA) 37
10.2. Cosmetic Market Data...... 37

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