A businessman reviews the FDA’s MoCRA definition for a cosmetics responsible person and wonders how it differs from the EU.
Author

Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

Author

US FDA Cosmetics Responsible Person vs EU Responsible Person

Sep 20, 2023

The U.S. cosmetic and personal care industry is currently going through the largest regulation shift ever seen in history.

With the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), U.S. Congress expanded FDA’s authority over how cosmetics are distributed and marketed in the United States and has detailed the new role of the cosmetics responsible person.

With MoCRA, Facility Registration, Product Listings, Good Manufacturing Practices, Safety Substation, new Product Labeling, and Adverse Event Reporting requirements will be mandatory for the entire industry.

MoCRA places full liability liability on a “facility” and a “responsible person” to confirm who will be accountable for assuring completion of the mandatory requirements.

What is an FDA cosmetics responsible person?

The cosmetics responsible person (RP) terminology can be new language for those who currently only market cosmetic products within the United States, but for companies that have already been marketing cosmetics throughout the European Union (EU), this is a familiar term that has been required under the EU Regulation.

Critical distinctions between the two definitions are how the responsibilities differ and where the RP needs to be located.

The European Union’s Responsible Person

The EU’s long-standing term following EU Regulation (EC) No 1223/2009 of the European Parliament and of the Council on Cosmetic Products defines the ‘responsible person’ as a legal or natural person designated within the EU who shall ensure compliance with the relevant obligations set out in the regulation for each cosmetic product on the market.

FDA’s Cosmetics Responsible Person

FDA’s MoCRA defines the “responsible person” as “the manufacturer, packer, or distributor of a cosmetics product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.”

This of special significance for Adverse Event Reporting as the RP’s contact information must be on the label for collecting and record-keeping of submitted adverse events.

Responsibilities of the Cosmetics Responsible Person: FDA vs EU

Under MoCRA, the U.S. RP will be responsible for Product Listings, Product Labeling requirements, Safety Substantiation, Fragrance Allergen Disclosures, Recalls, and Adverse Event Reporting.

The RP can be located anywhere in the world and can hire an authorized agent to handle certain requirements under MoCRA including adverse events; however, a company cannot designate just anyone to act as their RP. Companies outside the United States should consider hiring a qualified authorized agent to help with those responsibilities under MoCRA.

The EU requires the RP to collect the product’s EU Declaration of Conformity documentation which includes Formula Review, Cosmetic Product Safety Reports, safety information, labels, and claim reviews to build and maintain the Product Information File (PIF).

The RP is also required to inform authorities of any risk and cooperate with market surveillance authorities to ensure that all corrective measures to remedy any non-compliance of the product are properly dealt with by the brand owner. The European RP must be located in the EU, meaning those outside of the European Union must obtain an RP based in the EU to handle their cosmetic registrations. The EU RP can be a 3rd party that performs the functions of the Responsible Person.

If you need an FDA cosmetics responsible person as defined in MoCRA that can help you navigate the  FDA cosmetics landscape and handle the new cosmetic adverse event reporting requirements, Registrar Corp can help.

We’ve assisted over 30,000 companies across 190+ countries with leading FDA regulatory compliance specialists, and we have a 100% online & instant adverse events reporting and collection tool that eliminates human error, assuring easy compliance with the new regulation.

Discover how we can help your cosmetic business with adverse events today.

Author


Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

A seasoned expert on the cosmetic industry, Jaclyn's deep understanding and insights on cosmetic regulations brought on with the passage of the Modernization of Cosmetics Regulation Act (MoCRA) are unmatched. Her experience and reputation throughout the global cosmetic industry helps companies worldwide meet the newly enacted FDA regulations under MoCRA.

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