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The recently enacted US registration intends to enhance the safety of cosmetics products distributed within the United States. This legislations entails a substantive expansion of the FDA regulatory over cosmetics that consumers utilize daily. In accordance with the passage of, the FDA MoCRA the FDA mandates registration renewals for cosmetics between October 1 and December 31st.
MoCRA impacts manufactures and processors selling cosmetic products in the US. It includes new and redefined requirements for cosmetics products, manufacturing facilities and distributors. The regulation also sets certain responsibilities for the “Responsible Person” whose name appears on the label of the cosmetic product.
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.
Every foreign manufacture must designate a “responsible person who will be in charge to list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
TechLink International LLC can become your adverse event contact in the US if you are a foreign cosmetic brand.
The role of Responsible Person comes with many obligations… that most companies do not want to cover. Do not forget that you can delegate some of your tasks to Techlink International LLC - as answering consumer. These services can be offered “designed specially to meet your needs” or as a combo, depending on your own needs and objectives.
Here is how TechLink International can help foreign cosmetic companies to comply with MoCra Cosmetic Regulations:
Involves the maintenance of records, including adverse events and safety substantiation records.
Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
These fines are not just one-time fees but can accumulate over time, severely impacting your business's bottom line.
In the event of Safety concerns, mandatory recalls may be required.
Non-compliant products may be barred from being sold, limiting your company's growth and revenue opportunities.