MoCRA: US Cosmetics Compliance and Regulatory Modernization Act 2022

Ensure the compliance of your products in the USA with MoCRA standards with the help of EcoMundo's regulatory experts.

Prepare for MoCRA with EcoMundo's regulatory experts

EcoMundo regulatory and toxicology experts can help you ensure compliance of your cosmetic products in the United States.

Product listing and installation registration

Labeling

FDA notification portal

Safety justification

US agent and responsible person

Good Manufacturing Practices (GMP)

Secure your cosmetics in the U.S. with our experts now!

Support with safety justification

MoCRA introduces a safety check for cosmetic products. EcoMundo's regulatory experts can carry out the safety analysis for you and draw up the corresponding reports:
Evaluation of first stage

Calculation of safety margin (MoS)

- The first step in assessing the safety of your products
- Get results and recommendations within 10 days
- All you need to do is supply the formula and its exposure

Preliminary safety assessment

Toxicological Risk Assessment (TRA)

- Assess the toxicological profile of your products
- Gather documents and safety data
- Get your ERT ready in 3 weeks, performed by toxicology experts in Paris

Complete safety assessment

Complete cosmetic safety report

- Get a complete safety assessment for your products
- Gather all the data needed to justify safety
- Safety report inspired by the EU's CPSR and produced by toxicology experts in Paris

Contact us to assess the safety of your products with our regulatory experts and toxicologists.

Contact an expert

Agent and responsible person in the USA

If your facility is located outside the U.S. and manufactures cosmetic products for the U.S. market, you will need to designate a U.S. agent.

Designate EcoMundo as your U.S. agent now to meet MoCRA requirements.

Drapeau américain

La réglementation des produits cosmétiques selon la MoCRA

Listing des produits et enregistrement des installations

Justification de la sécurité

Agent américain et personne responsable

Étiquetage

Événements indésirables

Bonnes Pratiques de Fabrication (BPF) pour les cosmétiques

Petites entreprises

Portail de notification

Qu'est-ce qu'EcoMundo propose pour assurer la conformité réglementaire de mes produits cosmétiques, soins et parfums?
Comment EcoMundo peut m'aider dans le développement de ma stratégie réglementaire?
Quels sont les services de consulting d'EcoMundo pour répondre aux exigences de MoCRA ?
Quels avantages offre le logiciel COSMETIC Factory de EcoMundo dans la gestion des produits cosmétiques, soins et parfums ?
Quelles sont les étapes clés pour la mise en conformité mondiale avec EcoMundo ?
Comment EcoMundo assure la mise en marché sécurisée de mes produits cosmétiques, soins et parfums ?
En quoi consiste le service "EcoTeam" de consulting réglementaire?
Est-ce que EcoMundo peut assurer la conformité des textes de packaging et étiquettes de mes produits cosmétiques, soins et parfums aux normes mondiales ?
Comment EcoMundo simplifie le processus réglementaire pour les entreprises internationales?
Comment puis-je contacter EcoMundo pour démarrer le processus réglementaire?

Frequently Asked Questions

Product listing and plant registration

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Existing products and facilities must be registered by December 29, 2023. After this date, new facilities must be registered within 60 days of commencing operations, and new cosmetic products must be registered within 120 days of being placed on the U.S. market. Biennial updates are required for facility registration, and annual updates for the product list.

👉 Consult this guide to find out more about the information you need to provide.

Justification of safety

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Under MoCRA, the Responsible Person must ensure that the safety of a cosmetic product is sufficiently justified and keep records to this effect.  Adequate substantiation: tests or studies, research, analysis or other evidence or information that are considered, by experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, to be sufficient to support a reasonable certainty that a cosmetic product is safe.  

Safe: not harmful to users under the conditions of use prescribed by the labeling, or under customary conditions of use. At present, the FDA has not been exhaustive on how to justify safety under MoCRA.  

💡 Advice from EcoMundo's regulatory experts: Gather all the documents and data you need to justify the safety of your cosmetics. You will certainly need to carry out additional reports and analyses to prove that your products are safe for consumers.

U.S. agent and responsible person

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A U.S. Agent is required for foreign cosmetics facilities. This person must be based in the United States. EcoMundo can provide this service, contact us to find out more.   The responsible person may be the manufacturer, packager or distributor of a cosmetic product whose name appears on the label of that cosmetic product.

Labeling

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Adverse events: The label of each cosmetic product must include a national address, a national telephone number or electronic contact details, which may include a website, enabling the Responsible Person to receive reports of adverse events relating to that cosmetic product. This information must appear on both the outer and inner packaging. (It is possible to over-label the packaging to bring it into line with the new requirements).  

Fragrance allergens: Fragrance allergens must be indicated on the label. A notice of proposed rulemaking listing fragrance allergens will be published by the FDA no later than June 29, 2024, and a final rule must be published no later than 180 days after the closing date of the public comment period on the proposed rule. The FDA may establish quantity thresholds (we could see something similar to the EU allergen disclosure rule).  

Professional use: The label must contain a clear and prominent statement that the product is to be administered or used only by licensed professionals.

Professional: refers to a person authorized by an official state authority to practice in the field of cosmetology, nail care, hairdressing or aesthetics.  

Our regulatory experts can help you review your labels. Contact us to check your packaging.

What are the new requirements for fragrance allergen labelling?

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Fragrance allergens must be listed on the label. A notice of proposed rulemaking establishing a list of fragrance allergens will be published by the FDA no later than June 29, 2024, and a final rule must be published no later than 180 days after the closing date of the public comment period on the proposed rule. The FDA may establish quantity thresholds (we could see something similar to the EU allergen disclosure rule).

What declaration must appear on the label for professional use of cosmetic products?

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According to MoCRA, the FDA is now imposing mandatory reporting of cosmetic major adverse events from December 29, 2023. Responsible persons must report incidents within 15 business days, including the product label. Additional information received within one year must also be reported within 15 business days.

When does the reporting of major adverse events become mandatory under MoCRA?

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Selon la MoCRA, la FDA impose désormais la déclaration obligatoire des événements indésirables majeurs liés aux produits cosmétiques à partir du 29 décembre 2023. Les personnes responsables doivent signaler les incidents dans les 15 jours ouvrables, y compris l'étiquette du produit. Les informations supplémentaires reçues dans un délai d'un an doivent également être signalées dans les 15 jours ouvrables.

When must cosmetics facilities comply with FDA GMPs?

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Les installations devront respecter les BPF pour les cosmétiques publiées par la FDA d'ici à la fin de 2025, dans un délai que la FDA déterminera.  
La certification par une tierce partie ne devrait pas être exigée, mais les autorités peuvent effectuer un audit à tout moment.

What are the exemptions for small businesses under FDA regulations?

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Small businesses are responsible persons, owners and operators of facilities, whose average annual gross sales in the United States of cosmetic products over the preceding three years is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacture or processing of cosmetic products.   Small businesses are exempt from facility registration and product listing. They can also benefit from simplified GMP or extended lead times.

What is the Cosmetics Direct platform and when was it launched?

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The FDA launched the Cosmetics Direct platform to facilitate the registration of cosmetic establishments and products, in line with the Cosmetic Regulatory Modernization Act of 2022, and the portal went live on December 18, 2023.
- Cosmetics Direct
- Industry Guide: Registration and Listing of Cosmetic Establishments and Products 
- Guide to implementing structured product labeling (SPL)