Cosmetics Compliance in the USA (MoCRA)

On December 23, 2022, The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) passed the United States congress and was signed into law on December 29, 2022. As a result, a new set of requirements was introduced with a first deadline on December 29, 2023.

‍These new requirements impact cosmetics manufacturers, importers, packers, brand owners, distributors and other stakeholders involved in the production and selling of cosmetics in the USA.

These requirements apply to both US and non-US based organisations.

Modernization of Cosmetics Regulation Act (MoCRA)

The Act is the result of a more than a decade long process to give the US FDA more authority and more effective control to provide safety reassurances to consumers. It gives the FDA additional tools to protect consumer health. It also brings more alignment with global regulatory frameworks and practices.

For more information you can also visit the Personal Care Products Council (PCPC) webpage dedicated to MoCRA.

For the full published MoCRA bill, click to view

In addition to MoCRA at the federal level, several key states have set their own state level requirements for cosmetic products, such as Proposition 65 in California. When conflicting, MoCRA prevails over state level regulations.

However, when not specified in or regulated through MoCRA, states have the freedom to set specific requirements, for example related to restrictions or bans of ingredients, and the labelling and reporting of specific ingredients.

MoCRA implementation timelines

Not all new requirements have the same implementation timeline. The implementation timelines for each requirement are included in the overview below.

December 29, 2023 was the first deadline. This deadline applies to facility registration and product listings (enforcement postponed until July 1, 2024), safety substantiation, (several) labeling requirements, and adverse event reporting and handling.

Deadlines in 2024 and beyond relate to (additional) labelling requirements (e.g. inclusion of the responsible person’s contact information on the label and the inclusion of fragrance allergens in the ingredient list), restrictions for talc (asbestos) and PFAS, and compliance with (to be detailed) GMP standards. Several of these topics are still in the detailed rulemaking phase which will be followed by an implementation/transition period.  

MoCRA - TRC services

The Regulatory Company (TRC) has provided full cosmetic product safety and compliance services for 15+ years. We have provided these services to many local, international and global brands, importers and manufacturers in the USA, the UK, the EU, South Korea, India, Dubai, Australia and many other countries. For TRC, it is a natural step to provide the needed services to our existing clients, and to new clients to meet the requirements under MoCRA to produce for and sell on the US market.

Consumer products that fall into the product category cosmetics under the EU definition, may or may not meet the definition of a cosmetics under MoCRA. To provide comprehensive services to our clients, we provide compliance services for all products that meet the EU definition of a cosmetic, but may be qualified differently in the USA. For example, SPF products and anti-perspirants are classified as cosmetics in the EU, but as OTC products in the USA.

You may or may not be based in the US. You are a manufacturing facility and/or you may be a manufacturer, packer or distributor whose name appears on the product label. And we understand that you may or you may not already have comprehensive cosmetic product compliance and safety management in place.

To meet these varying needs, we have these service options available to comply with MoCRA in the USA.