Comprendre la Nouvelle Réglementation MoCRA : Loi FDA sur les Cosmétiques et Assurez votre Conformité Totale

La Loi de Modernisation de la Réglementation des Cosmétiques (MoCRA), signée en décembre 2022, constitue la réforme la plus importante de la réglementation des cosmétiques aux États-Unis depuis 1938. Elle introduit des exigences obligatoires pour les fabricants, distributeurs et importateurs de produits cosmétiques sur le territoire américain.

Que vous soyez une marque américaine, un fabricant étranger ou un vendeur sur Amazon, la conformité à MoCRA est désormais une obligation légale. Ce guide vous explique tout ce que vous devez savoir pour vous conformer aux nouvelles règles de la FDA sur les cosmétiques.

Chez Cosmereg, nous accompagnons les marques cosmétiques, les fabricants et les marques en marque blanche dans leur conformité réglementaire complète pour le marché américain. Que vous lanciez un nouveau produit, que vous révisiez vos étiquetages ou que vous ayez besoin d’un Agent aux États-Unis conforme à MoCRA, ce guide vous présentera les étapes essentielles pour commercialiser légalement vos cosmétiques aux États-Unis.

Qu’est-ce que MoCRA ?

MoCRA fait partie de la Loi de Finances Consolidée de 2023 et élargit l'autorité de la FDA en matière de réglementation des cosmétiques.

Objectifs principaux :

Améliorer la transparence sur la sécurité des produits
Faire appliquer des pratiques de fabrication standardisées
Permettre à la FDA de rappeler les produits cosmétiques dangereux
Garantir la transparence des ingrédients et des informations sur les installations

Qui doit se conformer à MoCRA Cosmetics ?

MoCRA s’applique à tous les produits cosmétiques commercialisés aux États-Unis, y compris :

Les fabricants et marques de distributeur basés aux États-Unis

Les fabricants étrangers exportant vers les États-Unis

Les vendeurs sur Amazon et les plateformes de commerce en ligne (e-commerce)

Les importateurs et distributeurs de produits cosmétiques

Liste de Contrôle pour la Conformité MoCRA des Cosmétiques

Voici ce que votre entreprise doit faire pour rester en conformité :

Enregistrement de l’installation

Obligatoire pour tous les fabricants nationaux et étrangers
Doit inclure le nom de l’installation, son adresse et ses coordonnées
Nécessite la désignation d’un Agente aux États-Unis (US Agent) pour les sites étrangers
Doit être renouvelé tous les deux ans
Date limite : 31 décembre 2023 (premier enregistrement)

Notification des Produits Cosmétiques

Justification de la Sécurité

Notification des Événements Indésirables Graves

Modifications d’Étiquetage

Bonnes Pratiques de Fabrication (BPF)

Quel est le rôle d’un Agente aux États-Unis selon MoCRA ?

Les installations étrangères doivent désigner un Agente aux États-Unis (US Agent), qui aura pour mission de :

Servir de contact officiel avec la FDA

Aider avec l’enregistrement des installations et la notification des produits

Transmettre les rapports d’événements indésirables

Répondre aux demandes de la FDA lors des inspections ou alertes

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

Foreign facilities must designate a US Agent, who will:

Prêt à vous mettre en conformité ?

Laissez nos experts en réglementation gérer votre conformité MoCRA — pour que vous puissiez vous concentrer sur votre marque.

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.

Comprendre la Nouvelle Réglementation MoCRA : Loi FDA sur les Cosmétiques et Assurez votre Conformité Totale

Qu’est-ce que MoCRA ?

Qui doit se conformer à MoCRA Cosmetics ?

Liste de Contrôle pour la Conformité MoCRA des Cosmétiques

Enregistrement de l’installation

Notification des Produits Cosmétiques

Justification de la Sécurité

Notification des Événements Indésirables Graves

Modifications d’Étiquetage

Bonnes Pratiques de Fabrication (BPF)

Quel est le rôle d’un Agente aux États-Unis selon MoCRA ?

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

Prêt à vous mettre en conformité ?

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

LIENS RAPIDES

POPULAIRE

CONTACTS

US FDA Regulations

Health Canada Regulations

EU/UK Regulations

CONTACTS

Qui doit se conformer à MoCRA Cosmetics ?

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.