"Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations."
US cosmetics legislation
USA MoCRA Responsible Person Support
Regulatory support for cosmetic brands entering the US market
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), cosmetic brands selling products in the United States must comply with applicable regulatory obligations concerning product safety, labelling, product listing, adverse event reporting and recordkeeping.
CE.way provides ongoing regulatory support to cosmetic brands and their designated Responsible Persons, helping them understand and manage applicable MoCRA requirements.
Definition
What is a Responsible Person under MoCRA?
Definition
What is a Responsible Person under MoCRA?
Under MoCRA, the Responsible Person is the manufacturer, packer or distributor whose name appears on the cosmetic product label.
The Responsible Person has several important regulatory obligations, including:
- Ensuring adequate substantiation of cosmetic product safety
- Submitting and maintaining FDA cosmetic product listings, unless exempt
- Receiving and reporting serious adverse events to the FDA
- Maintaining required records and providing information to the FDA when legally required
- Ensuring compliance with applicable cosmetic labelling requirements
Certain requirements and exemptions depend on the product and business concerned.
Our services
CE.way's MoCRA Responsible Person support services
CE.way helps cosmetic brands and their designated Responsible Persons manage applicable US regulatory obligations. Our services can include:
01
Guidance on MoCRA regulatory requirements
02
Support with FDA cosmetic product listing obligations
03
Assistance with safety substantiation documentation
04
Cosmetic ingredient and label compliance reviews
05
Guidance on serious adverse event reporting procedures
06
Support with regulatory enquiries and compliance updates
07
Ongoing regulatory consultation
The exact scope of support is defined in the service agreement.
Regulatory Expert · USA & Canada
Book a call Tjaša Grum
EU, UK, USA & Canada Regulatory Consultant and Safety Assessor
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Who can benefit from this service?
Our services are suitable for:
- Non-US cosmetic brands entering the American market
- Manufacturers and distributors selling cosmetics in the USA
- Companies requiring ongoing MoCRA compliance support
- Established brands seeking assistance with regulatory documentation and obligations
Two different roles
Responsible Person support vs. US Agent services
The MoCRA Responsible Person and a US Agent are different roles.
Responsible Person
The Responsible Person is identified by the manufacturer, packer or distributor named on the cosmetic label.
US Agent
A US Agent may serve as a US-based contact for foreign cosmetic manufacturing facilities in connection with FDA facility registration requirements.
CE.way can provide support with both areas, depending on the client's requirements.
Related services
Related services
CE.way can offer various services related to the MoCRA Responsible Person. We can offer:
Client reviews
Trusted by 1000+ cosmetic brands worldwide.
Pulled from verified Google reviews — independent, unedited, and updated continuously.
"We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced."
"We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services."
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Looking for MoCRA Responsible Person support?
CE.way provides practical regulatory assistance to cosmetic brands operating in the United States.
