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COMPLY WITH FDA’S NEW COSMETIC REGULATIONS QUICKLY AND EASILY.


The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) gives U.S. FDA
greater control and oversight of the cosmetic industry. Many regulations,
including FDA cosmetic registration, go into effect December 29th, 2023.

Register Now




NOT SURE WHICH MOCRA REGULATIONS APPLY TO YOU?




Find out with our exclusive MoCRA Wizard. Answer a few short questions, and in
less than two minutes, the MoCRA Wizard will show you exactly which FDA
requirements you must meet.

Try The MoCRA Wizard



U.S. FDA COSMETIC COMPLIANCE SOLUTIONS


Registrar Corp assists over 30,000 companies each year across 175+ countries to
achieve FDA compliance.
We know how to help you meet MoCRA requirements before FDA enforcement begins.




FACILITY REGISTRATION

We can help you achieve MoCRA compliance by registering your cosmetic facilities
with FDA. We can also act as your U.S. Agent if your facilities are located
outside the USA.

Register Today


PRODUCT LISTINGS

FDA cosmetic listings can be complicated to file. We help you save time, money,
and the frustration of doing it yourself by making product listings quick and
easy.

List Products


ADVERSE EVENT REPORTING

Use Registrar’s Adverse Events Reporting Software to quickly and easily collect
adverse event reports, get branded URLs or QR codes for your product label, and
receive organized reports to review.

Get Started


LABEL & INGREDIENT REVIEW

MoCRA imposes new changes on how cosmetic product labels are handled. Our
experienced team of labeling specialists make it easy for your company to remain
compliant with all labeling regulations.

Discover How

COSMETIC FORMULATION SOFTWARE

Cosmetri empowers cosmetic and personal care product companies by accelerating
product development, assuring compliance, and streamlining operations. 

Learn More

COSMETIC COMPLIANCE TRAINING

Become an expert in MoCRA and cosmetic GMPs. Our online training courses are
built by industry experts to fit your busy schedule.

Explore Courses



HEAR FROM OUR INDUSTRY EXPERTS

Webinar
January 10, 2024
1:00PM ET
Calling All Beauty Brands: Have You Met MoCRA’s Compliance Deadlines?
In this webinar, global regulatory compliance leader Registrar Corp will outline
what the updates and new requirements mean for beauty companies and the industry
in the years ahead.
Register
On-Demand Webinar

Requisiti MoCRA per i prodotti cosmetici negli USA
Requisiti MoCRA per i prodotti cosmetici negli USA: Principi fondamentali ed
esempi pratici di applicazione Speaker: Chiara Remonti, Senior Regulatory...
Watch Now
On-Demand Webinar

MoCRA Draft Guidance Update from FDA
In this webinar, our industry experts delve into FDA's released draft guidance
on cosmetic facility registration and cosmetic product listings with key
definition updates and exemption clarification.
Watch Now
See our full list of events




FREQUENTLY ASKED QUESTIONS




WHAT IS MOCRA?

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


HOW WILL MOCRA AFFECT COSMETIC FACILITIES?

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.


WHO IS CONSIDERED THE RESPONSIBLE PERSON UNDER MOCRA?

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


ARE THERE ANY EXEMPTIONS FOR FACILITY REGISTRATION?

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.


WHEN ARE FACILITY REGISTRATIONS AND PRODUCT LISTINGS REQUIRED?

For existing facilities, facility registration and product listings are due by
December 29, 2023. 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. 


WHAT IF I HAVE MULTIPLE COSMETIC PRODUCTS? HOW DO I LIST THEM ALL?

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.


WHAT CAN I DO TO PREPARE FOR MOCRA NOW?

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.


WHAT ARE THE NEW LABELING REQUIREMENTS?

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.


WHEN DO THE NEW LABELING REQUIREMENTS GO INTO EFFECT?

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.



Phone: +1-757-224-0177
Fax: +1-757-224-0179
info@registrarcorp.com


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