MoCRA is the Modernization of Cosmetics Regulation Act of 2022 and was signed into law on December
29th, 2022. MoCRA is the largest reform of existing cosmetic regulations in the United States in 84
years and establishes many new requirements, such as:

• Facility Registration
• Product Listings
• Good Manufacturing Practices (GMPs)
• Safety Substantiation
• New labeling requirements
• Adverse Event Reporting
• Record Keeping

Under MoCRA, the term “facility” includes any establishment that manufactures or processes cosmetic
products
distributed in the United States. Most facilities will need to register and comply with GMPs issued
by FDA.

Find out which requirements your company will need to meet. Registrar Corp’s industry experts created
the MoCRA Wizard to help companies determine which requirements they must
meet. Answer a
few short questions and in less than two minutes, know exactly which you’ll need to comply with and
how we can help.

The term “responsible person” means the manufacturer, packer, or distributor of a cosmetic product
whose name appears
on the cosmetic label.

The “responsible person” will be responsible for:

• Cosmetic product listings
• Adverse event reporting and record keeping
• Safety substantiation
• Labeling updates
• Recalls
• Fragrance allergen disclosures

Yes, small businesses will have more flexible and simplified requirements. FDA defines a small
business as a business
with average gross annual sales in the U.S. for the previous 3-year period of less than $1,000,000,
adjusted for
inflation. This does not apply to any responsible person or facility engaged in manufacturing
cosmetic products
that:

• Come into contact with eyes,
• Are injected,
• Are intended for internal use,
• Or alter the appearance for more than 24 hours under conditions of use that are customary or
  usual.

Wondering if you’re exempt? Find out if you’re exempt by answering a few questions using our MoCRA Wizard,
developed by our
industry experts to help you find out which, if any, requirements you must meet.

New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60
days of marketing the product or 60 days after the deadline for existing facilities, whichever is later.

MoCRA allows for flexible listings where companies can submit a single listing for cosmetic products with identical
formulations or formulations that only differ with respect to colors, fragrances or flavors, or quantity of
contents.

In the Draft Guidance, FDA announced that
Cosmetics Direct will be using the same electronic submission system as drugs, meaning all listings will need to be
submitted through the Structure Product Labeling (SPL Format). The SPL will require to list all shades, fragrance
and quantity variations.

Not sure where to start? Our industry professionals created a simple tool to help companies determine which
requirements apply to them. Answer a few short questions and in less than two minutes, the MoCRA Wizard will show exactly
which requirements you must meet to maintain FDA compliance.

By December 29, 2023, companies must provide electronic contact information in which a responsible person can receive
adverse event reports.

Cosmetic products that contain fragrance allergens must update their label to list those allergens. For professional
cosmetic products, labels must indicate a clear and prominent statement that the product is administered or used
only by licensed professionals and is in conformity with the existing cosmetic labeling requirements.

Learn more about adverse
event requirements and how we can help you comply.

Within 1 year: Professional cosmetics product labels must include all required information and state
that only licensed professionals may use the product.

Within 2 years: Labels must include responsible person’s contact information for adverse reporting
and must identify fragrance allergens determined by FDA.