Normativa MoCRA Cosméticos FDA Estados Unidos

La Ley de Modernización de la Regulación de Cosméticos (MoCRA), firmada en diciembre de 2022, representa la reforma más significativa de la regulación cosmética en Estados Unidos desde 1938. Introduce requisitos obligatorios para fabricantes, distribuidores e importadores de productos cosméticos en el país.

Ya seas una marca estadounidense, un fabricante extranjero o un vendedor en Amazon, cumplir con MoCRA es ahora una obligación legal. Esta guía resume todo lo que necesitas saber para cumplir con las nuevas normas cosméticas de la FDA.

En Cosmereg, apoyamos a marcas de cosméticos, fabricantes y marcas privadas en el logro del cumplimiento normativo completo para el mercado estadounidense. Ya sea que estés lanzando un nuevo producto, revisando el etiquetado o necesites un Agente en EE. UU. conforme a MoCRA, esta guía te acompañará en los pasos y requisitos esenciales para comercializar legalmente cosméticos en Estados Unidos.

¿Qué es MoCRA?

MoCRA es la sigla de Modernization of Cosmetics Regulation Act, una ley estadounidense promulgada en diciembre de 2022, que representa la actualización más importante de la regulación cosmética desde 1938. Establece requisitos obligatorios para fabricantes, importadores y distribuidores de productos cosméticos en EE. UU.

¿Quién debe cumplir con el MoCRA Cosmetic?

MoCRA se aplica a todos los productos cosméticos comercializados en Estados Unidos, incluidos:

Fabricantes y marcas privadas con sede en EE. UU.

Fabricantes extranjeros que exportan a EE. UU.

Amazon y Plataformas eCommerce

Importadores y distribuidores de productos cosméticos

Lista de verificación para el cumplimiento de MoCRA

Esto es lo que tu empresa debe hacer para mantenerse en cumplimiento:

Registro de instalaciones

Obligatorio para todos los fabricantes nacionales y extranjeros
Debe incluir el nombre, la dirección y la información de contacto de la instalación
Requiere designación de un Agente de EE. UU. para instalaciones extranjeras
Debe renovarse cada dos años
Fecha límite: 31 de diciembre de 2023 (primer registro)

Notificación de productos cosméticos

Justificación de seguridad

Informe de eventos adversos graves

Cambios en el etiquetado

Buenas Prácticas de Fabricación (GMP)

¿Cuál es el rol de un Agente de EE. UU. bajo MoCRA?

Las instalaciones extranjeras deben designar un Agente en EE. UU., quien:

Actúa como contacto oficial con la FDA

Asiste en el registro de instalaciones y la notificación de productos

Comunica informes de eventos adversos

Responde a consultas de la FDA durante inspecciones o alertas

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

Foreign facilities must designate a US Agent, who will:

¿Listo para cumplir con la normativa?

Deja que nuestros expertos en regulación gestionen tu cumplimiento con MoCRA, para que tú puedas enfocarte en tu marca.

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 Cosméticos FDA Estados Unidos

¿Qué es MoCRA?

¿Quién debe cumplir con el MoCRA Cosmetic?

Lista de verificación para el cumplimiento de MoCRA

Registro de instalaciones

Notificación de productos cosméticos

Justificación de seguridad

Informe de eventos adversos graves

Cambios en el etiquetado

Buenas Prácticas de Fabricación (GMP)

¿Cuál es el rol de un Agente de EE. UU. bajo MoCRA?

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

¿Listo para cumplir con la normativa?

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

COSMEREG

ENLACES RÁPIDOS

POPULAR

CONTACTS

US FDA Regulations

Health Canada Regulations

EU/UK Regulations

CONTACTS

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.