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. This would include:
- Eye Shadow
- Mascara
- Eye makeup remover
- Liquid or mucosal eyeliner (such as eyeliner pencil applied to the waterline)
- Eyelash adhesive.
It doesn’t include moisturizers, creams, or serums that are applied in the eye area (but not close to the waterline or in the eye). - 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.
