09 Feb, 2024
If you are looking to expand to the USA or you are already selling there, you might have already heard about MoCRA, there is so much information and it can feel overwhelming, at GCRS we have created an FAQ answering the most common questions we have heard from our clients. What is MoCRA? The Modernisation of Cosmetics Regulation Act of 2022 aims to strengthen the authority of the FDA by implementing, Safety Substantiation, Serious Adverse Event reporting, Records Access, Facility Registration, Product Registration, List of fragrance allergens on products labels and comply with GMP. When was MoCRA issued? On 29 December 2022 MoCRA was signed by President Joe Biden as part of a bigger of the Consolidated Appropriations Acts, 2023. When will MoCRA be enforced? The FDA is planning to enforce all the regulations in different times to allow industry to adapt to changes. On December 29, 2023, the Safety Substantiation and Serious Adverse Event Reporting became mandatory. The cosmetic product facility registration and cosmetic product listing will become mandatory on July 1, 2024. Listing of fragrance allergens on products labels will become mandatory by October 2024 Specific GMP regulations will be proposed by December 29, 2024, and finalized by December 29, 2025. How can I comply with MoCRA? In order to be fully compliant with MoCRA your products need to be registered before July 1, 2024. To achieve registration you need to have at hand: Fully compliant artwork Safety Substantiation for your products The FEI (FDA Establishment Identifier) of the company who manufactured your products A US Contact if you are a foreigner company Do I have to register my facility as a distributor with the FDA? Brands are not required to register their facilities this is an exclusive obligation of manufacturers; however product registration will have to be renewed every year. If I’m a manufacturer but I don’t distribute the products myself, do I still have to comply with MoCRA? Yes, manufacturers take part in the Cosmetic Facility Registration they are required to obtain a FEI number from the FDA prior to their registration and have the obligation to update their registration if any changes occur as well as renew their registration biennially. What if I do not have a US Address? Do I need to get one? If you don’t have a US Address, GCRS can provide US contact services, we will liaise with the FDA on your behalf. I’m already compliant in UK and EU, should I have to worry about extra regulations? The EU and UK has some of the strictest regulations in the cosmetic market, if you already have a fully compliant PIF and CPSR, chances are you'll only need to update your artwork to comply with US regulations and do the cosmetic product listing. I’m a small business, are there any exceptions for me? Yes, there is an exception for businesses with average gross annual sales of cosmetic products in the USA for the previous 3-year period of less than $1,000,000 (adjusted for inflation), however, while exempted of Cosmetic Product Listing, Cosmetic Facility Registration and GMP regulations you will be required to comply with the following: Section 605. Adverse Events report (Cosmetovigilance) Section 608. Safety Substantiation (CPSR, PIF) Section 609. Labelling (Allergens declaration, minimum font, RP address, warnings, professional use declaration) Section 610. Records (Any adverse events records) Section 611. Mandatory Recall Authority Become fully compliant with MoCRA The U.S. cosmetic regulatory panorama will bring new challenges for everyone, GCRS has years of experience in countries with even tighter regulations, we know how to navigate and help any size company to get up to speed with new regulations. We are here to help you to the best of our abilities and make your company MoCRA compliant, time does not wait for anybody so contact us today to start working on securing one of the biggest cosmetic markets in the world. Get in contact today