MoCRA US Agent

Responsible Person & US Agent under MoCRA

US Agent: On December 29th, 2022, the most significant amendment to cosmetic requirements (21 U.S.C., Sec. 321-392) since 1938 was enacted.

Who we are

With 15 years of experience as a cosmetics regulatory expert, Biorius can assist your brand in selling products in the US while reducing business risks. We offer a comprehensive service package related to MoCRA, including acting as the US Agent through our legal entity: Biorius, Inc.

Should you have any questions about the MoCRA, please, do not hesitate to contact us.

Under MoCRA, it becomes mandatory to have a Responsible Person designated for each cosmetic product placed on the US market. The Responsible Person can be the manufacturer, packager, or distributor, and their name, domestic address and domestic phone must be labeled on the packaging (Sec. 604 (4) and Sec. 609(a)). While every cosmetic product must be represented by a Responsible Person, the above-mentioned labeling requirement will become mandatory from December 29th, 2024.

The Responsible person does not need to be located in the USA, but foreign Responsible persons must designate an Agent to represent them on the US territory

The Role of the US Agent

Until now, the Regulators have not yet specified the role of the US Agent in detail. Though, this requirement exists for many years in other sectors regulated by the FDA (e.g. food, pharmaceuticals and medical devices), which offers some clarity on what should be the responsibilities of the US Agent in practice. Biorius expects that the FDA will treat any communication to the US Agent or to the company in the same way as it exists today in other industries. Generally speaking, the US Agent is a legal entity or a person in a position to communicate efficiently with the FDA (and other stakeholders) and comply with the legal obligations of the Responsible Person that must be executed from the US territory.

Many leading global brands have already chosen Biorius as their EU and UK Responsible Person. With the introduction of MoCRA, Biorius is proud to offer its support as a US Agent to non-US brands and as a diligent consultant to US Responsible Persons.

The Obligations of the Responsible Person (and its US Agent)

Here are the obligations of the Responsible Person (and its US Agent) such as defined in the MoCRA:

Conclusion about the Responsible Person and the US Agent

The Responsible Person and the US Agent may seem confusing but in summary:

For more detailed information about the MoCRA and its requirements, please, check this MoCRA page.

Get in Touch

Need a piece of advice, a quotation or answers to your questions?

Fill in this form or contact us directly: info@biorius.com – We will answer as soon as possible!

As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:

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⚠️MoCRA Timeline Reminder⚠️

June 2024: Allergen labeling Rulemaking proposed by the FDA