Dentifrices — Requirements, Test Methods and Marking

ANSI/ADA Standard No. 130 Executive Summary

What is ANSI/ADA Standard No. 130 about?

This standard gives requirements and test methods for acceptable physical and chemical properties of dentifrices. It also gives the requirements for what information needs to be provided to the consumer on the labeling and packaging of the products for informed decision making.

What are the requirements I should know about for dentifrices?

ANSI/ADA Standard No. 130 sets the following requirements to ensure safety of the toothpaste for use by consumer:

  • Maximum total fluoride concentration
    No greater than 0.15% by mass (sodium fluoride 0.33%, sodium monofluorophosphate 1.14%, stannous fluoride 0.615% on toothpaste label)
  • Amount of total fluoride in a single-unit container
    No greater than 300 mg
  • Total maximum concentration of heavy metals
    No greater than 20 mg/kg
  • Acidity
    pH must be below 10.5
  • Abrasivity
    Relative Dentin Abrasivity (RDA) no greater than 250
  • Stability
    Expiration date required if product deteriorates in less than 30 months
  • Readily fermentable carbohydrates
    None allowed in ingredients

What’s the bottom line?

ANSI/ADA Standard No. 130 sets the fluoride concentration, acidity, and abrasivity limits for toothpastes that are safe for consumer use.