Registration and regulation of cosmetic products for
USA
From our office in Miami, we help companies from all over the world to export their products to the American market with agility and professionalism. If you want to export your cosmetic products to the USA to boost your business in this great market, we will accompany you in the process!
Expert Agents in MoCRA, FDA and US Agent
Regulation of Cosmetic Products in the United States
The MOCRA (Modernization of Cosmetics Regulation Act) is a piece of legislation passed in December 2022 in the United States that seeks to modernize and strengthen the regulation of cosmetics by the FDA (Food and Drug Administration) . This law marks a significant change in the way cosmetics are monitored and regulated in the US market, with a focus on consumer safety.
Here we explain the most important aspects of the MOCRA Act and the steps to follow to register cosmetics in the US under this regulatory framework.
Step by step for the application to MoCRA
Identify if your product is cosmetic
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Before proceeding with any registration, make sure the product meets the definition of "cosmetic" under FDA regulation . A cosmetic product is one that is applied to the human body to cleanse, beautify, promote attractiveness, or alter appearance, but is not intended to treat or prevent disease.
Good Manufacturing Practices (GMP)
We ensure that your manufacturing plant complies with Good Manufacturing Practices that will be overseen by the FDA under MoCRA .
The FDA may conduct inspections at manufacturing facilities to ensure compliance with these standards.
Company and facilities registration
MOCRA requires that all facilities that manufacture cosmetics, both in the U.S. and abroad, be registered with the FDA.
Facilities must provide information about the cosmetic products manufactured and the production process.
Labeling and safety
Labeling must be accurate and comply with FDA requirements. The label must include complete ingredient information as well as any warnings or recommendations.
You must ensure that your product is safe for use, based on scientific evidence and safety data.
Product List
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Manufacturers must list the cosmetics they sell in the U.S., providing details such as the ingredients in each product.
Adverse event reports and safety evidence
If you receive reports of serious adverse events, such as severe allergic reactions or injuries, you must report them to the FDA within 15 days.
Safety studies must be made available if requested by the FDA , and it is important to maintain complete documentation of all testing performed.
US Agent for manufacturers
The US Agent figure for manufacturers
The US Agent for manufacturers is an entity or person designated by foreign companies wishing to market regulated products in the United States, including cosmetics, medical devices, food, and pharmaceuticals. This agent acts as a local representative before the FDA (Food and Drug Administration), serving as the main point of contact between the agency and the foreign manufacturer.
The role of the US Agent is crucial, as it facilitates communication on regulatory matters, including notices of inspections, requests for additional information, and handling emergency situations related to product safety. In addition, the US Agent must be available to respond in a timely manner to any FDA requests, ensuring that companies comply with US regulations.
For foreign companies wishing to enter the US market, the appointment of a US Agent is an indispensable legal requirement. Their role has become even more important with the new regulations imposed by laws such as MOCRA on the cosmetics industry.
US 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
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Prop 65 California
Product listing and US Representative
Product Listing in the United States is the process by which manufacturers register their products with the FDA, providing details about the ingredients and characteristics of the product to ensure its compliance with US regulations. It is a key requirement, especially in the cosmetics industry under the MOCRA Act, which requires complete transparency on product composition and safety.
The US Representative is the legal entity that acts as responsible for regulatory compliance and market surveillance of products placed on the market before the FDA and consumer authorities.
Where can you export your cosmetic products with Belab Services?
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 legislation, has a team of scientific consultants and advanced IT tools, making it the fastest and most reliable way to access the European market.
Frequently asked questions about cosmetic regulation in the United States
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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.