July 2023: 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.
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:
- Ensuring and maintaining records substantiating the adequate safety of the cosmetic product (Sec. 608), which must be available to the authorities if needed (Sec. 610).
- Managing Adverse Events (Sec. 605), including:
- Recording Adverse Effects and Serious Adverse Effects 24h a day, 7 days a week.
- Reporting Serious Adverse Events to the FDA within 15 business days.
- Maintaining up-to-date Adverse Events records (for at least 3 or 6 years depending on the business size).
- Be available in case of inspection of records by the FDA and effectively cooperate.
- Providing competent authorities with information on fragrances and flavors in case of Serious Adverse Events.
- Ensuring proper labeling of contact details on product labels, allowing consumers to report Adverse Events either by regular mail, email, or telephone.
- Registering facilities (Sec. 607 (a)), updating registrations whenever necessary, and renewing them every 2 years.
- Listing cosmetic products (Sec. 607 (c)) and updating them annually.
- Ensuring accurate labeling of cosmetic products and, notably with regard to fragrance allergens (yet to be identified by the FDA).
- Ensuring compliance with Good Manufacturing Practices (GMPs) and keeping records at the disposal of the FDA in case of an inspection.
- Generally speaking, handling FDA inspections/questions and assisting the brand and the FDA in market withdrawal or recalls of products on the US market when deemed necessary.
- Ensuring general compliance with the other provisions of the MoCRA.
Conclusion about the Responsible Person and the US Agent
The Responsible Person and the US Agent may seem confusing but in summary:
- The responsible person is the entity that places the products on the market. The responsible person does not need to be in the United States.
- The US Agent is mentioned in the establishment registration. The US Agent is located in the USA and stay available 24 hours a day for Adverse Events reporting, questions, health emergencies, controls and inspections.
For more detailed information about the MoCRA and its requirements, please, check this MoCRA page.
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