MoCRA: What is the Modernization of Cosmetic Regulation?

The regulation of cosmetics in the USA has undergone a significant transformation since the introduction of MoCRA - Modernization of Cosmetic Regulation. Passed in 2022, MoCRA is the most critical reform of U.S. cosmetics regulation since the Federal Food, Drug, and Cosmetic Act of 1938. The goal? To strengthen the safety and transparency of cosmetic products by giving the FDA (Food and Drug Administration) new powers.

For cosmetic laboratories wishing to market their products in the United States, MoCRA is a must: it imposes new obligations such as facility registration, product declaration, and adverse reaction reporting. To meet these obligations, companies must implement robust, rigorous processes to ensure compliance and avoid significant penalties.

This article will give you a better understanding of MoCRA and provide you with the keys to meeting all the obligations it imposes. You'll find the key requirements to meet, the players involved, and the solutions available, such as PLM solutions, to help you market your products with peace of mind and meet these obligations.

MoCRA: Legislation history and objectives

Over the years, consumers have become increasingly concerned about the quality of the products they use. The Modernization of Cosmetics Regulation Act (MoCRA) was passed in the United States to bring greater safety and transparency to the cosmetics industry. This significant development represents the most far-reaching reform since the Federal Food, Drug, and Cosmetic Act of 1938!

For the sake of consumers and in response to their expectations, it was necessary to dust off the legislation and impose stricter rules to fill any gaps. MoCRA aims to ensure consumer safety by providing clear information and protecting consumers from potentially harmful products. It imposes new obligations on companies to improve the safety of their products while strengthening the powers of the FDA. The FDA aims to protect public health by ensuring safe, effective, and accurately labeled products.
 

MoCRA: a major challenge for cosmetics laboratories

This new legislation will require cosmetic companies that wish to market their products in the United States to adapt quickly. As a result, existing processes may need to be overhauled to ensure compliance. Failure to comply could have serious consequences, including completely withdrawing products from the market. Therefore, players in the cosmetics sector must fully understand the MoCRA requirements and implement the appropriate internal measures to meet them best. We take a closer look at these new requirements.
 

Provisions and key MoCRA requirements to be met      

MoCRA introduces a stronger regulatory framework. To ensure compliance, cosmetic companies operating in the U.S. must adhere to strict requirements covering manufacturing and product surveillance. Here are the key requirements to consider:
 

Reporting Adverse Reactions

One of the most important requirements of MoCRA is the reporting and monitoring of adverse reactions after using a cosmetic product. Cosmetic companies are required to keep records of all adverse reactions associated with the use of the product.

Severe adverse reactions (death, hospitalization, disability, significant infection or disfigurement, second or third-degree burns, acute and persistent skin rashes, considerable hair loss, significant change in appearance) must be reported within a maximum of 15 working days.

Records must be kept for at least six years (three years for small companies), and the FDA has the right to access this information.

A Responsible Person must be designated to collect information related to adverse effects. The Responsible Person designates the manufacturer, packager, or distributor of a product, and their name must appear on the label. However, the Responsible Person does not necessarily have to be based in the United States.
 

Compliance with Good Manufacturing Practices

To ensure product safety, MoCRA legislation requires cosmetics companies to comply with Good Manufacturing Practices (GMP). These requirements, developed by the FDA, have been published for review and are expected to be finalized soon. They ensure that national and international standards manufacture products. GMPs cover the entire process, from the procurement of raw materials to the packaging intended for marketing. Adherence to GMPs prevents contamination and production errors and ensures product quality for consumers.

Companies must rigorously document and monitor every manufacturing process step to remain compliant. They must also conduct regular audits to ensure their facilities meet the most stringent standards. In the event of an FDA audit, companies must be able to demonstrate GMP compliance. This requirement is designed to minimize risks to consumer health by ensuring that each product is manufactured under controlled, safe conditions.
 

Registering facilities

Any company that develops or processes cosmetics for the U.S. market must register its facilities.

The registration allows facilities to be identified worldwide and includes detailed information such as name, physical address, and email and phone contact information.

Companies must also provide information such as brand names, categories of products manufactured, and individuals responsible for each product. The registration must be renewed every two years.

This gives the FDA greater oversight and the ability to respond quickly to any problems, for example, if the FDA determines that a locally manufactured product poses a health risk to its users.

The deadline for complying with this registration requirement is July 1, 2024, after an extension granted at the end of 2023.

Good to know: Companies that only label, package, store, repackage, distribute, or manufacture raw materials are not affected by this obligation.
 

Listing of cosmetic products

Each year, companies (through responsible parties) must be able to provide a complete listing of their products, including detailed information about each product, such as cosmetic category, ingredients, facility registration number, and contact information for the responsible party.

With this requirement, the FDA aims to improve transparency regarding products marketed on U.S. soil. As with the previous section, companies have been given an extension until July 1, 2024, to give them enough time to prepare properly. Companies will have one year to submit their listing for products marketed before that date and 120 days for products sold after that date.

It should be noted that a single registration may cover several similar products if they differ only in color or size, for example.
 

Provide safety justification

To sell their products in the U.S. market, companies must prove to consumers that their products are safe. To do this, they must maintain documents that prove that the product will not cause harm when used under normal or reasonably foreseeable conditions.

Each company must be able to produce these documents at any time if requested by the FDA. This requirement forces cosmetic companies to establish rigorous processes to evaluate the quality of their products (research analysis, testing, and safety evaluation studies).

Inadequate documentation can lead to corrective action or product recall.
 

Compliance with Labeling Standards

MoCRA contains requirements for the labeling of cosmetics. The contact details of the person responsible must be displayed clearly and legibly. This is to ensure that any adverse effects can be quickly reported.

Other mandatory information includes fragrance allergens and a statement that the product is for professional use only, where applicable.

Cosmetics companies must ensure their labels comply with these new requirements when marketing their products.
 

MoCRA: Who's affected?

MoCRA applies to all companies that manufacture, import, and distribute cosmetics in the United States. This includes international companies.
 

Some exemptions

Smaller companies (with annual sales of less than million) are subject to MoCRA but will benefit from flexibility through simplified requirements and an extended compliance period. The recordkeeping and product listing requirements will be relaxed, and the record retention period will be reduced from six to three years.

However, this exemption does not apply to companies marketing the following products

• Cosmetics in contact with the ocular mucosa
• Injectable cosmetics
• Cosmetics for internal use only
• Cosmetics that change the appearance for more than 24 hours.

Ensure MoCRA Compliance with Coptis Lab PLM Solution

The Modernization of Cosmetic Regulations has led to increased regulation of cosmetic products in the USA. Companies wishing to market products here have no choice but to ensure compliance to protect consumers.

However, meeting all MoCRA's requirements can be complex, especially for companies with a wide range of cosmetic products. This is where product lifecycle management (PLM) software comes in!

A PLM solution is a tool that helps cosmetic companies manage the entire lifecycle of their products, from marketing brief to commercialization. This includes formulation, raw material sourcing, quality control, test tracking, and regulatory validation.

Cosmetic laboratories can ensure MoCRA compliance and optimize their development projects by integrating a PLM solution. PLM software reduces the risk of errors and speeds up time to market by improving operational efficiency. Discover the benefits of our solution below:
 

Centralize data and documents

With Coptis Lab, all your R&D documents and data are centralized in a single solution. You can easily find all the key information about your cosmetic products. This is an essential asset in terms of the transparency required by MoCRA legislation and ensures that everything is current and compliant.
 

Guarantee the international compliance of your cosmetic formulas

Coptis ensures global formula compliance by centralizing all regulations and generating compliance-related alerts in real-time. This is an essential feature when dealing with ever-changing regulations in different markets.
 

Formula development tracking

The Coptis PLM Raw Materials module allows you to select the most appropriate raw materials for your project and to monitor and manage the entire formulation process. This ensures compliance with the latest requirements.

Collaboration

By centralizing information in real-time, different departments can access the latest information and collaborate effectively throughout the development project.
 

Automation tools

Coptis Lab integrates automation tools to handle low-value-added tasks, such as editing regulatory files to maintain compliance. As a result, companies reduce the time spent on these tedious tasks and the risk of manual errors!

The Coptis Lab solution, designed by business experts in cosmetics and I.T., is dedicated to any company wishing to develop cosmetic products. It allows them to focus on innovation while ensuring compliance with all MoCRA regulatory requirements.

Would you like to know more about our solution? Please feel free to contact our team.