At CE.way, we provide complete support for brands entering the United States cosmetics market under the new Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Our dedicated MOCRA Services for US are designed to simplify compliance, reduce risk, and ensure your cosmetic products meet all U.S. FDA regulatory standards.
What Our MoCRA Services Include
With the introduction of MoCRA, every cosmetic brand that wants to sell in the United States must follow strict requirements regarding product safety, documentation, and labeling. CE.way offers a full range of MoCRA compliance solutions, including:
- Formula Review – We evaluate all ingredients and concentrations to confirm compliance with U.S. cosmetic regulations.
- Labeling Review – Our experts verify that your product labels meet all FDA and MoCRA requirements, including contact details of the Responsible Person.
- USA Cosmetics State Legislations – We help you navigate state-level regulations such as California Proposition 65.
- US Responsible Person Support – We act as your designated Responsible Person to ensure regulatory compliance.
- US Agent Service – We provide a registered U.S. contact point for communication with authorities.
- Product Listing – We manage your FDA product listings to ensure all necessary data is correctly submitted.
- Product Safety Substantiation – Our team prepares and maintains the required product safety documentation.
- Facility Registration – We handle the registration of your manufacturing facilities with the FDA.
Learn more about each service on our dedicated page: MOCRA Services for US.
Why MoCRA Matters
MoCRA represents the most significant update to U.S. cosmetic law since 1938. It introduces new mandatory obligations such as:
- Registration of all manufacturing facilities;
- FDA product listing for every cosmetic item placed on the market;
- Appointment of a U.S. Responsible Person;
- Mandatory reporting of serious adverse events;
- Proof of product safety substantiation;
- Clear labeling with contact details for consumer communication.
Failing to comply with MoCRA can result in FDA enforcement actions, import refusals, and product recalls. CE.way ensures your business avoids these risks through proactive compliance management.
Our Step-by-Step Process
- Formula Review – We identify restricted or prohibited ingredients and check for concentration limits.
- Label Verification – We ensure your packaging complies with all FDA and state-specific requirements.
- Facility Registration – We register your manufacturer and processing facilities with the FDA.
- Product Listing – We submit your product information directly to the FDA system.
- Safety Documentation – We prepare the Product Information File (PIF) and ensure that your safety assessments meet MoCRA standards.
- Post-Market Support – We assist with adverse event reporting and annual updates to FDA records.
- Ongoing Consultation – Our team remains available to address any questions or regulatory changes.
Why Work with CE.way
Navigating U.S. cosmetics compliance can be complex, especially for non-U.S. brands. By partnering with CE.way, you gain:
- Expert regulatory guidance from a team specialized in MoCRA compliance,
- A smooth and fast FDA registration process,
- Reduced risk of delays or product holds at customs,
- Continuous support from professionals who understand both EU and U.S. regulations.
Get Ready for the U.S. Market
Now is the perfect time to prepare your brand for MoCRA compliance. Whether you’re planning to launch a new line or update your existing portfolio, CE.way offers the knowledge and experience to get you there efficiently.
Start your MoCRA compliance journey today — explore our MOCRA Services for US and contact us to schedule a consultation.
We’re here to make your entry into the U.S. cosmetics market seamless, safe, and successful.
