Access the North American market with confidence

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.

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.

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.

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.

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).

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.

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.

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.

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.

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)