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US Cosmetics Regulation

SGS’s US cosmetics regulation services ensure cosmetic products meet the country’s regional and national regulatory requirements.

Companies and individuals who manufacture and market cosmetics have a legal responsibility to ensure the safety of their products. The regulatory body for the United States is the Food and Drugs Administration (FDA), it verifies that cosmetic products meet requirements including:

  • Food, Drug and Cosmetics Act (FD&C Act)
  • CFR Title 21 & 16
  • Fair Packaging and Labeling Act (FPLA)
  • Safe Cosmetics Act 2011 (HR 2359)

These requirements cover restricted substances, allowable colorants and labeling. Cosmetics packaging is not considered a cosmetic, however it does need to meet the Toxics in Packaging Clearing House (TPCH) requirements.

Certain state law also covers requirements on certain cosmetic categories:

  • California Proposition 65 – lead in cosmetics
  • California Air Resources Board (CARB) – established limits for Volatile Organic Compounds (VOCs) in hairspray and fragrance

Cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. If your products do not comply with US cosmetic regulations, you will not be able to market them and failure to comply will result in enforcement action being taken by the FDA.

Our US cosmetic regulation compliance services include:

  • Testing & assessment: chemical analysis, microbiological testing, stability study, physical testing, ingredient and label review, toxicological risk assessment (TRA)
  • Panel study: dermatological and ophthalmological testing, functional claim support, consumer panel study, etc.
  • Inspection & auditing: inspection (pre-production, initial production, during production etc.), final random inspection, cosmetics GMP compliance (ISO 22716, US FDA, etc.)
  • Testing of cosmetic & personal care accessories & packaging: chemical analysis, physical testing, etc.

Bring cosmetic products to market in the US with SGS. Contact your local office for more detail.

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Standards & RegulationsLeafletCosmetic & Personal Care Products: Major Standards & Regulations ...


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