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Cosmetic Regulation: MoCRA / FDA
Modernization of the Cosmetics Regulation Law
MoCRA is the most significant expansion of the FDA's authority to regulate cosmetics and thus ensure the safety of the cosmetic products we consume every day.
In December 2022, the U.S. Senate passed the Modernization of the Cosmetic Regulatory Act (MoCRA) 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.
Steps to Register Cosmetics under MoCRA
01
Company Registration and Responsible Person (RP)
Companies that manufacture or distribute cosmetics in the U.S. must register with the FDA, including:
Company name and address.
Contact information of the Responsible Person (RP).
04
List of Cosmetic Products
Every cosmetic product marketed in the U.S. must be reported to the FDA with:
Product name and its function.
Complete list of ingredients (optional concentrations).
Manufacturer and Responsible Person Data.
This list must be updated when there are major changes in formulation or labeling.
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MoCRA-compliant labeling
Labeling must include:
Complete and clear information on ingredients and warnings.
Contact details of the Responsible Person.
Mandatory warnings if the product contains restricted ingredients or allergens.
02
Appointment of a US Agent
If the company is located outside the United States, it must designate a US Agent, who will act as an intermediary with the FDA to:
Receive official notifications and communications.
Coordinate FDA inspections, if necessary.
Assist in the management of adverse events or security alerts.
The US Agent must be located in the U.S. and be available to respond to the FDA in the event of regulatory requests.
05
Compliance with Good Manufacturing Practices (GMP)
The FDA will establish mandatory Good Manufacturing Practices (GMP) standards to ensure product safety and quality.
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Mandatory Security Assessment
Each cosmetic product must undergo a safety assessment conducted by a qualified expert, ensuring its safety before being marketed.
03
Registration of the Cosmetic Establishment
Facilities where cosmetics are manufactured, processed, or packaged must register with the FDA and renew their registration every two years.
06
Adverse Event Management
Brands must:
Keep a record of consumer complaints.
Report any serious adverse events (severe allergies, extreme irritations, infections, etc.) to the FDA.
09
Ingredient Restrictions and Prohibitions
MoCRA gives the FDA the authority to:
Create lists of prohibited or restricted ingredients.
Request additional testing for certain suspicious ingredients.
Companies must ensure that their formulations comply with permitted ingredients.
With over 10 years of experience in cosmetic safety assessments and US regulations, BELAB SERVCES offers a comprehensive and reliable solution for effectively verifying and registering cosmetic products.
Our solution, based on a deep understanding of the legislation, relies on 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.
