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MoCRA Small Business Exemption

MoCRA: This information is applicable to: All Cosmetic Manufacturers

Thanks to the long and hard work of the HSCG and others, there is an exemption in MoCRA for a "small business." If your business qualifies, you are exempt from several provisions of MoCRA, including:

  • Compliance with Good Manufacturing Practices to be issued in regulations
  • Facility Registration
  • Product Registration
  • Keeping records of any adverse events for 6 years

What qualifies as a “small business”?

There are two requirements to qualify as a “small business.” The first is a maximum annual revenue amount, and the second is that you don’t make certain types of cosmetic products.

Small Business Annual Revenue

Your business is considered a “small business” if your sales revenue from cosmetic products is less than the annual cap amount. In 2023, the cap amount is $1 million per year. It will be increased annually based on the rate of inflation.

The amount is calculated on the average of the income for the previous 3 years.1

Example 1:2022         $1,100,000
2021             $750,000
2020            $850,000
Total:       $2,700,000
Average:    $900,000  Less than $1 million - IS a small business
Example 2:2022         $1,250,000
2021:            $950,000
2020:            $725,000
Total:         $2,925,000
Average:       $975,000  Less than $1 million - IS a small business
Example 3:2022              $950,000
2021            $1,275,000
2020              $850,000
Total:          $3,075,000
Average:    $1,025,000  More than $1 million - NOT a small business

Restricted Cosmetic Products

In order to qualify as a small business, you cannot make the following products:

  • Cosmetic products that regularly come into contact with the mucous membrane of the eye during normal use. For example, eyeliner, mascara, and possibly eye shadow.2
  • Cosmetic products that are injected.
  • Cosmetic products that are intended for internal use.
  • Cosmetic products that are intended to alter appearance for more than 24 hours and are not normally removed by the consumer. For example, brow or eyelash dye, acrylic or gel nails, or gel nail polish.

1 The average is calculated by ADDING the totals for each year and then DIVIDING by the number of years.
2 There is likely to be additional clarification to this point as the FDA issues regulations pursuant to MoCRA.

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