MoCRA - FDA 2024
Modernization of the Cosmetics Regulation Act
MoCRA is the most significant expansion of the FDA’s authority to regulate cosmetics and ensure the safety of the cosmetic products we consume every day.
Complying with MoCRA regulations is more complex than it seems, if you want us to do it in an easy and professional way, do not hesitate to contact us.
Cosmetic Regulation: MoCRA/FDA
MoCRA: Modernization of the Cosmetics Regulatory Act
What is MoCRA?
Last December 2022, the US Senate approved the MoCRA (Modernization of the Cosmetic Regulatory Act) regulations, introducing significant changes to the requirements that cosmetics and the companies that manufacture them must meet in order to be sold in the United States.
The main new features of MoCRA are:
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Strengthening the FDA 's role in market control, supervision of products and manufacturers.
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Mandatory registration of products and companies.
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The need to have a point of contact in the USA.
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Strengthening market surveillance through the US Responsible Person.
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The obligation to prepare a product assessment report (CPSR).
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Strengthening the role of GMP.
Requirements affecting cosmetic products
Each cosmetic product must have a designated Legal Representative .
The name and address of the Representative must be clearly displayed on the product label, along with a contact agent located in the United States who will be responsible for market surveillance.
Legal Representative - Market Surveillance Contact in the USA
Product Listing
All cosmetic products must be registered on the new MoCRA registration portal by the Legal Representative.
At the time of registration, products whose manufacturer is not registered with the FDA cannot be registered.
Product Compliance
Product Compliance in the United States is the process by which manufacturers, importers, and distributors ensure that their products comply with the country's regulations and regulatory standards, such as those established by the FDA , CPSC, and other agencies. Under recent laws such as the Modernization of Cosmetics Regulation Act (MOCRA) , compliance includes strict requirements regarding safety, labeling, product registration, and Good Manufacturing Practices. Ensuring Product Compliance is essential to operating legally in the US, protecting consumers, and avoiding sanctions or product recalls.
Label Review
Claims Review
Ingredient Review
State regulations
Prop 65 California
FDA: Manufacturers
Requirements for manufacturers
Facility registration
Manufacturers and processors must register their facilities with the FDA through a US agent.
The FDA will have the authority to suspend a facility's registration if it determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable likelihood of causing serious adverse consequences, thereby prohibiting the entry or sale of its products in the United States.
Adverse Event Reporting and Record Keeping for MoCRA
With the implementation of MoCRA , effective December 29, 2023, cosmetic manufacturers, packagers, and distributors in the United States must comply with strict reporting regulations for serious adverse events. A serious adverse event is defined as one that results in death, hospitalization, infection, significant disfigurement, or serious medical interventions. These events must be reported to the FDA within 15 business days of receipt.
In addition, companies must keep records of all serious and nonserious adverse events for at least six years, or three years for small companies. This information can be requested by the FDA at any time as part of an inspection. In addition, the responsible party's contact information (address, telephone number, or email) must be clearly indicated on product labels to facilitate the receipt of reports by consumers.
Compliance with these requirements not only ensures consumer safety, but also protects companies from sanctions and makes it easier to identify potential health problems related to their products.
MoCRA Timeline / Deadline 2024
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With over 10 years of experience in cosmetic safety assessments and USA regulation, BELAB SERVCES offers a comprehensive and reliable solution to effectively verify and register cosmetic products.
Our solution, based on a deep knowledge of the legislation, has a team of scientific consultants and advanced IT tools, making it the fastest and most reliable way to access the European market.
FDA/MoCRA: Frequently Asked Questions
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EU Responsible Person and UK Responsible PersonAnother important aspect of regulation is that of the responsible person. In Europe, the responsible person is someone who has legal responsibility for ensuring that a product meets legal requirements. The same goes for the UK responsible person in the UK. Experts in cosmetics and healthcare product regulation can help companies understand the roles and responsibilities involved in this process.
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CPNP and SCPN and PIF registrationCPNP Registration (Cosmetic Product Notification Portal) is a legal requirement for cosmetic products in Europe. SCPN is the UK equivalent. In order to register on these portals, detailed information about the product is required, including ingredients and formulations. Experts in cosmetics and healthcare product regulation can help companies complete these registrations and ensure they are complying with legal requirements.
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Technical dossier for product authorization in EuropeA technical dossier is a document that describes the technical and safety aspects of a product. It is a legal requirement for most cosmetic and health products in Europe. Experts in cosmetics and medical device regulation can help companies complete a technical dossier for product authorization in Europe.
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Who is responsible for the regulation of cosmetic products in Europe?In Europe, the regulation of cosmetic products is the responsibility of the European Commission, which establishes regulations and requirements to guarantee the safety and quality of the products that are marketed
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What are the requirements that a cosmetic product must meet in order to be marketed in Europe?A cosmetic product must comply with a series of requirements established in European Regulation 1223/2009. These requirements include aspects related to safety, labeling, permitted ingredients, animal testing and prior notification before marketing.
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What products are not considered cosmetics according to European Regulation 1223/2009?According to European Regulation 1223/2009, products that have a medical purpose, such as medicines, medical devices or health products, are not considered cosmetics. These products are regulated by other specific regulations.