US Responsible Person

MoCRA THE NEW US COSMETIC REGULATION

On December 29, 2022, the Modernization of Cosmetics Regulation Act (MoCRA) was passed, and it is the first major amendment to Chapter VI of the Federal Food, Drug and Cosmetic Act (FDCA), dating back to 1938.
It will enter into force on December 29, 2023, and provides for the introduction of new obligations that companies selling cosmetic products in the US will have to comply with.

The most important aspects introduced with the MoCRA are:

• Introduction of the US Responsible Person, whose name appears on the label of the cosmetic products

• Recall of the cosmetic products from the market (introduction of traceability principles)

• Allergen labelling

• Mandatory GMP regulation

• Registration of the facilities (located in the US or from foreign countries) that will have to be renewed every two years

• Product registration

• Adverse Effect Reports (introducing the Cosmetic Survey procedures)

• Safety Substantiation (introducing the concept of the Safety Assessment)

We are ready to support you in managing this important update in order to protect your business and your confidential information by guaranteeing the best security.