NCBFAA Asks FDA to Push Back Cosmetic Registration Requirement to 2024
The FDA should push back its deadline for implementation of new cosmetics facility registration requirements of the Modernization of Cosmetics Regulation Act of 2022, the National Customs Brokers & Forwarders Association of America said in a July 13 letter.
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The current deadline of Dec. 31, 2023, does not allow enough time for facilities to "become informed and educated on their responsibilities, obtain a DUNS number, find an agent and complete the registration process," the NCBFAA said. "The December 31 deadline would be daunting under the best of circumstances. Given the fact that a registration process has not yet been completed, this deadline is unrealistic."
Moving the deadline back a year to Dec. 31, 2024, would provide the agency time to develop, roll out and test a registration system, the letter said. An extension also will give overseas cosmetics facilities "time to learn about their obligations, choose an agent, obtain a valid DUNS number and complete the registration process," the letter said. The extension also will align the cosmetic registration process with the biennial food facility registration, which would help avoid "the confusion resulting from having registration and renewals in opposite years," the letter said.
The letter urged the FDA to use the food facility registration process as a "template" for the cosmetic facility registration process. As with food facility registration requirements, the agent should have to accept the agency designation in writing. This avoids a situation where "a customs broker or other U.S. party in the supply chain is unwittingly identified as the agent by a foreign facility," the letter said. While this initially didn't happen with the food facility registration, FDA now can "confirm by email that the designated agent does indeed agree to serve as the agent," the letter said. "This email confirmation is essential for the cosmetic facility registration."
The FDA should also recognize that the facility registration agent is not "the responsible party for the shipment" and should not be the "contact person identified on the cosmetics label," the letter said. "There must be a clear definition of the agent’s role and clear delineation between the 'registration agent' and the 'US contact' for purposes of labeling," the letter said. The letter also said that customs brokers, agents and importers should be able to "query the system" to see which facilities have listed them as an agent.
Another request was that the FDA allow for facilities to write "Applied For" instead of the DUNS number if the facility has not received a DUNS number. This should also apply to customs brokers transmitting the import entry. The use of "applied for" would be used instead of a DUNS number, the letter said. Also, NCBFAA hopes the agency will use the FDA Unified Registration and Listing System (FURLS) for the cosmetic registration. FURLS worked well for food facility and medical device registrations, the letter said. "It makes sense that the cosmetic facility registration also be accessed through FURLS."