Cosmetics - US FDA

Toxicological Risk Assessment (TRA) is a detailed scientific assessment report prepared by an expert toxicologist that looks at each individual ingredient within the context of the nature of the product, its dosage/concentration, and exposure scenario for potential to cause acute and chronic effects.

USP 51
USP 51 is an Antimicrobial test method that determines the antimicrobial efficacy of a material's antimicrobial preservatives. Similar to other preservation challenge methods, USP 51 is commonly used to evaluate the performance of preservatives used in cosmetics and personal care products.

USP 61/62
USP 61 test determines whether a product is contaminated with bacteria, yeast, mold, or fungi in it.
USP 62 tests for other specified microorganisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia species, Salmonella species and/or Candida albicans.

Cosmetics Labelling Requirements – FDA
The cosmetics distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the FD&C Act and the FP&L Act. 
The labeling requirements are codified at 21 CFR 701 and 740. Cosmetics bearing false or misleading label statements or otherwise not labeled in accordance with these requirements may be considered misbranded and may be subject to regulatory action.

Information that must be on the Principal Display Panel (PDP) are:
  • Identity statement
  • Net Quantity of Contents
- semisolid cosmetic must be in terms of the avoirdupois pound and ounce, 
- liquid measure must be in terms of the U.S. gallon of 231 cubic inches and the quart, pint, and fluid ounce subdivisions thereof. 

The remainder of the required cosmetic labelling information can be displayed on portions of the label other than the PDP; the Information Panels. The Information Panels must include:
  • Name and Place of Business: The address must state the street address, city, state, and zip code. If a firm is listed in a current city or telephone directory, the street address may be omitted. 
  • Distributor Statement: If the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase "Manufactured for ......" or "Distributed by ......" or similar, appropriate wording.
  • Material Facts
  • Warnings and Precautions
  • Ingredients
The ingredients must be declared in descending order of predominance. Color additives (21 CFR 701.3(f)(3)) and ingredients present at one percent or less (21 CFR 701.3(f)(2)) may be declared without regard for predominance. The ingredients must be identified by the names established or adopted by regulation (21 CFR 701.3(c))