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Navigating the complexities of cosmetic product compliance in the U.S. market requires meticulous attention to regulatory requirements, especially under the Modernization of Cosmetics Regulation Act (MoCRA). The introduction of MoCRA has brought significant changes to how cosmetic products are regulated, emphasizing the need for stringent adherence to safety and labeling standards. This regulatory landscape demands a dedicated Responsible Person (RP) for each cosmetic product, a role pivotal in ensuring that all products meet the necessary legal and safety standards before they reach consumers.
According to the MoCRA, it is 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 and address must be labeled on the packaging. Additionally, the label must contain a domestic phone number, a domestic address or an electronic contact information (such as a website) as a way to contact the RP in case of any adverse events, The US RP can’t be formally outsourced to a third party (like for example in the EU), but a consulting company can be hired as a “silent RP” who manages all responsibilities in the background.
CE.way can support your company as a regulatory expert to assist with Responsible Person’s duties, ensuring compliance with all applicable regulatory requirements.
This includes:
Advice on establishments of product safety substantiation
Keeping safety substantiation documentation available to the authorities
Free regulatory consultation on US regulatory requirements for future products
Receive, evaluate, and record adverse events
Report and record serious adverse events
Represent you before the FDA
Support you in case of recalls, registration suspensions, inspections
Inform you about any potential regulatory changes
Ensuring general compliance with the other provisions of the MoCRA
Handling FDA inspections/questions and assistion the brand and the FDA
Need help with the cosmetics regulations and testing?
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