What’s the Role of a US Agent Under MoCRA?

Foreign facilities must designate a US Agent, who will:

ARE YOU READY MOCRA COSMETICS REGULATIONS?

DISCOVER THE NEW RULES

Simplify your path to compliance with
new FDA requirements under the Modernization of
Cosmetics Regulation Act of 2022

INTRODUCING MoCRA COSMETICS

Prepare for the upcoming changes mandated by the
Modernization of Cosmetics Regulation Act of 2022 (MoCRA Cosmetics),
as it significantly transforms the regulatory landscape
for cosmetic companies in the United States.
The MoCRA cosmetics regulations, which comes into full effect in 2023,
represents a substantial expansion of the FDA’s authority
over the cosmetics industry.

DON'T STRESS…
…WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements
may seem overwhelming, but we’re here
to make it easy for you.

Our mission is to ensure
you’re fully compliant without the headache.

THESE NEW REQUIREMENTS INCLUDE:

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs
Strict adherence to FDA-issued Good Manufacturing
Practices is mandated.

Compliance with
FDA-issued GMPs
Strict adherence to
FDA-issued Good Manufacturing
Practices is mandated.

Comprehensive Record-Keeping
This involves the maintenance of records, including
adverse events and safety substantiation records.

Comprehensive
Record-Keeping
This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA,
MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES
TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

OUR SERVICES

SWIFT FDA FACILITY REGISTRATION
We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES
If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT
We handle the submission and
management of cosmetic product
listings, ensuring you meet all
necessary obligations.

TIMELY UPDATES
As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

WHAT DOES MoCRA
MEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide range
of regulations that impact every facet of your cosmetic products, from their creation to their marketing.

BENEFIT FOR YOU

Our services are there to meet the needs of
cosmetic manufacturers and brand owners
planning to sell or export cosmetics
in the United States.

We understand the complexities of navigating the
complex FDA regulations, especially in light of these
new requirements.

WHY CHOOSE US

We offer you peace of mind
by assuming responsibility for compliance activities,
allowing you to focus exclusively on the task
of marketing your cosmetics.
With a wealth of experience spanning over a decade
in the field of cosmetic compliance, our agency has
a team of seasoned Safety Assessors and dedication to
exceptional customer support and US Mocra Agent for Cosmetics.

Trust us to guide you through these
regulatory changes with the highest levels of
expertise and professionalism.

Normativa MoCRA Cosmetici FDA Stati Uniti

La Modernization of Cosmetics Regulation Act (MoCRA), firmata a dicembre 2022, rappresenta la riforma più significativa della normativa cosmetica negli Stati Uniti dal 1938. Introdurrà obblighi normativi vincolanti per produttori, distributori e importatori di prodotti cosmetici negli USA.

Che tu sia un marchio statunitense, un produttore estero o un venditore su Amazon, la conformità al MoCRA è ora un obbligo legale. Questa guida ti illustra tutto ciò che devi sapere per rispettare le nuove regole cosmetiche della FDA.

Da Cosmereg, supportiamo marchi cosmetici, produttori e private label nel raggiungimento della piena conformità normativa per il mercato statunitense. Che tu stia lanciando un nuovo prodotto, revisionando le etichette o cercando un US Agent conforme al MoCRA, questa guida ti accompagnerà nei passaggi essenziali per commercializzare legalmente cosmetici negli Stati Uniti.

Cosa è MoCRA?

MoCRA fa parte del Consolidated Appropriations Act del 2023 e amplia l’autorità della FDA nella regolamentazione dei cosmetici.

Obiettivi principali:

Migliorare la trasparenza sulla sicurezza dei prodotti
Applicare pratiche di produzione standardizzate
Consentire alla FDA di richiamare prodotti cosmetici pericolosi
Garantire una corretta dichiarazione degli ingredienti e degli stabilimenti di produzione

Chi deve conformarsi a MoCRA Cosmetici?

MoCRA si applica a tutti i prodotti cosmetici commercializzati negli Stati Uniti, inclusi:

Produttori e marchi privati con sede negli Stati Uniti

Produttori esteri che esportano negli Stati Uniti

Amazon e Ventidori eCommerce

Importatori e distributori di prodotti cosmetici

Conformità ai Cosmetici MoCRA Checklist

Ecco cosa deve fare la tua azienda per rimanere conforme:

Registrazione dello stabilimento Cosmetico

Obbligatorio per tutti i produttori nazionali ed esteri
Deve includere nome dello stabilimento, indirizzo e informazioni di contatto
Richiede la designazione di un US Agent per gli stabilimenti esteri
Deve essere rinnovata ogni due anni
Scadenza: 31 dicembre 2023 (prima registrazione)

Elenco dei prodotti cosmetici

Documentazione sulla sicurezza del prodotto

Segnalazione di eventi avversi gravi

Modifiche all'etichettatura

Buone Pratiche di Fabbricazione (GMP)

Qual è il ruolo di un US Agent Under MoCRA?

Gli stabilimenti esteri devono designare un US Agent, il quale:

Agire come contatto ufficiale con la FDA

Assistere con la registrazione dello stabilimento e la notifica dei prodotti

Comunicare le segnalazioni di eventi avversi

Rispondere alle richieste della FDA durante ispezioni o segnalazioni

What’s the Role of a US Agent Under MoCRA?

Foreign facilities must designate a US Agent, who will:

Pronto per essere conforme?

Lascia che i nostri esperti regolatori gestiscano la tua conformità al MoCRA; così tu puoi concentrarti sul tuo brand.

ARE YOU READY MOCRA COSMETICS REGULATIONS?

DISCOVER THE NEW RULES

Simplify your path to compliance with
new FDA requirements under the Modernization of
Cosmetics Regulation Act of 2022

INTRODUCING MoCRA COSMETICS

Prepare for the upcoming changes mandated by the
Modernization of Cosmetics Regulation Act of 2022 (MoCRA Cosmetics),
as it significantly transforms the regulatory landscape
for cosmetic companies in the United States.
The MoCRA cosmetics regulations, which comes into full effect in 2023,
represents a substantial expansion of the FDA’s authority
over the cosmetics industry.

DON'T STRESS…
…WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements
may seem overwhelming, but we’re here
to make it easy for you.

Our mission is to ensure
you’re fully compliant without the headache.

THESE NEW REQUIREMENTS INCLUDE:

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs
Strict adherence to FDA-issued Good Manufacturing
Practices is mandated.

Compliance with
FDA-issued GMPs
Strict adherence to
FDA-issued Good Manufacturing
Practices is mandated.

Comprehensive Record-Keeping
This involves the maintenance of records, including
adverse events and safety substantiation records.

Comprehensive
Record-Keeping
This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA,
MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES
TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

OUR SERVICES

SWIFT FDA FACILITY REGISTRATION
We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES
If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT
We handle the submission and
management of cosmetic product
listings, ensuring you meet all
necessary obligations.

TIMELY UPDATES
As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

WHAT DOES MoCRA
MEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide range
of regulations that impact every facet of your cosmetic products, from their creation to their marketing.

BENEFIT FOR YOU

Our services are there to meet the needs of
cosmetic manufacturers and brand owners
planning to sell or export cosmetics
in the United States.

We understand the complexities of navigating the
complex FDA regulations, especially in light of these
new requirements.

WHY CHOOSE US

We offer you peace of mind
by assuming responsibility for compliance activities,
allowing you to focus exclusively on the task
of marketing your cosmetics.
With a wealth of experience spanning over a decade
in the field of cosmetic compliance, our agency has
a team of seasoned Safety Assessors and dedication to
exceptional customer support and US Mocra Agent for Cosmetics.

Trust us to guide you through these
regulatory changes with the highest levels of
expertise and professionalism.

What’s the Role of a US Agent Under MoCRA?

ARE YOU READY MOCRA COSMETICS REGULATIONS?

DISCOVER THE NEW RULES

Simplify your path to compliance with new FDA requirements under the Modernization of Cosmetics Regulation Act of 2022

INTRODUCING MoCRA COSMETICS

DON'T STRESS… …WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements may seem overwhelming, but we’re here to make it easy for you.

Our mission is to ensure you’re fully compliant without the headache.

THESE NEW REQUIREMENTS INCLUDE:

Compulsory FDA Facility Registration All cosmetic facilities must undergo mandatory registration with the FDA.

Compulsory FDA Facility Registration All cosmetic facilities must undergo mandatory registration with the FDA.

Product Listing Obligations Every cosmetic product marketed in the USA must be listed as per regulatory requirements.

Product Listing Obligations Every cosmetic product marketed in the USA must be listed as per regulatory requirements.

Adverse Event Reporting Companies will be obligated to report adverse events associated with their products.

Adverse Event Reporting Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs Strict adherence to FDA-issued Good Manufacturing Practices is mandated.

Compliance with FDA-issued GMPs Strict adherence to FDA-issued Good Manufacturing Practices is mandated.

Comprehensive Record-Keeping This involves the maintenance of records, including adverse events and safety substantiation records.

Comprehensive Record-Keeping This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures In the event of safety concerns, mandatory recalls may be required

Mandatory Recall Procedures In the event of safety concerns, mandatory recalls may be required

Fragrance Allergen Declaration Companies may be required to declare fragrance allergens in their products.

Fragrance Allergen Declaration Companies may be required to declare fragrance allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA, MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

OUR SERVICES

SWIFT FDA FACILITY REGISTRATION We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT We handle the submission and management of cosmetic product listings, ensuring you meet all necessary obligations.

TIMELY UPDATES As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

WHAT DOES MoCRAMEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide rangeof regulations that impact every facet of your cosmetic products, from their creation to their marketing.

BENEFIT FOR YOU

Our services are there to meet the needs of cosmetic manufacturers and brand owners planning to sell or export cosmetics in the United States. We understand the complexities of navigating the complex FDA regulations, especially in light of these new requirements.

WHY CHOOSE US

Normativa MoCRA Cosmetici FDA Stati Uniti

Cosa è MoCRA?

Chi deve conformarsi a MoCRA Cosmetici?

Conformità ai Cosmetici MoCRA Checklist

Registrazione dello stabilimento Cosmetico

Elenco dei prodotti cosmetici

Documentazione sulla sicurezza del prodotto

Segnalazione di eventi avversi gravi

Modifiche all'etichettatura

Buone Pratiche di Fabbricazione (GMP)

Qual è il ruolo di un US Agent Under MoCRA?

What’s the Role of a US Agent Under MoCRA?

Pronto per essere conforme?

ARE YOU READY MOCRA COSMETICS REGULATIONS?

DISCOVER THE NEW RULES

Simplify your path to compliance with new FDA requirements under the Modernization of Cosmetics Regulation Act of 2022

INTRODUCING MoCRA COSMETICS

DON'T STRESS… …WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements may seem overwhelming, but we’re here to make it easy for you.

Our mission is to ensure you’re fully compliant without the headache.

THESE NEW REQUIREMENTS INCLUDE:

Compulsory FDA Facility Registration All cosmetic facilities must undergo mandatory registration with the FDA.

Compulsory FDA Facility Registration All cosmetic facilities must undergo mandatory registration with the FDA.

Product Listing Obligations Every cosmetic product marketed in the USA must be listed as per regulatory requirements.

Product Listing Obligations Every cosmetic product marketed in the USA must be listed as per regulatory requirements.

Adverse Event Reporting Companies will be obligated to report adverse events associated with their products.

Adverse Event Reporting Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs Strict adherence to FDA-issued Good Manufacturing Practices is mandated.

Compliance with FDA-issued GMPs Strict adherence to FDA-issued Good Manufacturing Practices is mandated.

Comprehensive Record-Keeping This involves the maintenance of records, including adverse events and safety substantiation records.

Comprehensive Record-Keeping This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures In the event of safety concerns, mandatory recalls may be required

Mandatory Recall Procedures In the event of safety concerns, mandatory recalls may be required

Fragrance Allergen Declaration Companies may be required to declare fragrance allergens in their products.

Fragrance Allergen Declaration Companies may be required to declare fragrance allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA, MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

OUR SERVICES

SWIFT FDA FACILITY REGISTRATION We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT We handle the submission and management of cosmetic product listings, ensuring you meet all necessary obligations.

TIMELY UPDATES As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

WHAT DOES MoCRAMEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide rangeof regulations that impact every facet of your cosmetic products, from their creation to their marketing.

BENEFIT FOR YOU

Our services are there to meet the needs of cosmetic manufacturers and brand owners planning to sell or export cosmetics in the United States. We understand the complexities of navigating the complex FDA regulations, especially in light of these new requirements.

WHY CHOOSE US

Simplify your path to compliance with
new FDA requirements under the Modernization of
Cosmetics Regulation Act of 2022

DON'T STRESS…
…WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements
may seem overwhelming, but we’re here
to make it easy for you.

Our mission is to ensure
you’re fully compliant without the headache.

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs
Strict adherence to FDA-issued Good Manufacturing
Practices is mandated.

Compliance with
FDA-issued GMPs
Strict adherence to
FDA-issued Good Manufacturing
Practices is mandated.

Comprehensive Record-Keeping
This involves the maintenance of records, including
adverse events and safety substantiation records.

Comprehensive
Record-Keeping
This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA,
MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES
TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

SWIFT FDA FACILITY REGISTRATION
We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES
If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT
We handle the submission and
management of cosmetic product
listings, ensuring you meet all
necessary obligations.

TIMELY UPDATES
As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

WHAT DOES MoCRA
MEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide range
of regulations that impact every facet of your cosmetic products, from their creation to their marketing.

Our services are there to meet the needs of
cosmetic manufacturers and brand owners
planning to sell or export cosmetics
in the United States.

We understand the complexities of navigating the
complex FDA regulations, especially in light of these
new requirements.

Simplify your path to compliance with
new FDA requirements under the Modernization of
Cosmetics Regulation Act of 2022

DON'T STRESS…
…WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements
may seem overwhelming, but we’re here
to make it easy for you.

Our mission is to ensure
you’re fully compliant without the headache.

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs
Strict adherence to FDA-issued Good Manufacturing
Practices is mandated.

Compliance with
FDA-issued GMPs
Strict adherence to
FDA-issued Good Manufacturing
Practices is mandated.

Comprehensive Record-Keeping
This involves the maintenance of records, including
adverse events and safety substantiation records.

Comprehensive
Record-Keeping
This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA,
MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES
TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

SWIFT FDA FACILITY REGISTRATION
We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES
If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT
We handle the submission and
management of cosmetic product
listings, ensuring you meet all
necessary obligations.

TIMELY UPDATES
As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

WHAT DOES MoCRA
MEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide range
of regulations that impact every facet of your cosmetic products, from their creation to their marketing.

Our services are there to meet the needs of
cosmetic manufacturers and brand owners
planning to sell or export cosmetics
in the United States.

We understand the complexities of navigating the
complex FDA regulations, especially in light of these
new requirements.