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.

Get ready for MoCRA!

To continue selling cosmetics on the US market, both US and non-US companies have to meet the following requirements:

  • Facility registration (enforcement postponed until July 1, 2024)
  • Product listing (enforcement postponed until July 1, 2024)
  • Safety substantiation (FDA authorized to order an unsafe product recall)
  • Additional labeling requirements
  • Adverse event reporting and handling

Contact and appoint The Regulatory Company as your US Agent and get highly-qualified and highly-experienced support to fulfil these requirements on time. Get continuous support to meet future requirements and deadlines. Have the best possible support on product compliance and safety.

Our pricing is simple, transparent and very affordable:

US Agent service for facilities

  • €750,- per facility per year

Product listing service for responsible persons (manufacturer, packer, distributor whose name appears on the product label)

  • €750,- per responsible person per year
  • €150,- per product listing per year (volume discounts may apply)
contact us for a quote, or a MoCRA service call >

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.

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 overview requirements and timelines by TRC
Find out what MoCRA requirements apply, and how to meet them
And contact us to discuss in-person >

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.

Manufacturing facilities/production facilities

1). US agent service for manufacturing facilities

US agent service = facility registration, brand listings and updates, and FDA communication according to MoCRA.

Production facilities that produce cosmetic that are to be sold on the US market may have to register with the FDA, and can do so through a US-based agent. The Regulatory Company provides this service through TRC USA Inc.

We advise all production facilities to register with the FDA, and if non-US based, appoint TRC USA Inc. as your agent. Also when the facility qualifies as a small business under MoCRA, there are some clear advantages to register as a facility: it may be unclear if you will (continue to) qualify as a small business, it gives higher credibility towards responsible persons/supply chain, it gives better control over communication with the FDA, you have 1 single entry of facility information irrespective of the number of products listed with the FDA, and it is very affordable.

·      €750,- per facility per 10 brands per year (2023 + 2024 = 1 year)

read more

Responsible persons (manufacturer, packer, distributor)

2). US product listing service

Product listing service = basic scan of the product listing on consistency and quality, product listing, and processing any updates.

You have full compliance management in place, as is for example required under the EU and UK Cosmetics Regulations. Product Information Files (PIFs) contain detailed information for ingredients, formulations, packaging, products, and product testing. Recent product compliance and safety assessment reports have been signed off. Quantitative and qualitative formulations are managed and continuously assessed on compliance and safety in a software/solution with data that can easily be updated, reported, and exported. Products are manufactured in a GMP/ISO certified facility. Adverse advents are reported and adequately managed.

·      €750,- per customer per 10 brands per year,  not applicable in combination with the US agent service fees
·      €150,- per product listing per year

read more

3). US product compliance & safety services

Product compliance & safety services = initial and continuous technical dossier/Product Information File (PIF) building and management, cosmetic product safety and compliance assessment and monitoring, label compliance review, claim compliance review, product listing, and regular review of cosmetovigilance records received from client. 

You need support with Product Information Files (PIFs) building and management for raw materials, formulations, packaging and products. You need compliance and safety assessment/substantiation reports, guidance on product testing, monitoring of product compliance and safety, support with label reviews and claim formulation, and advise on high-quality adverse event reporting and handling.

·      €750,- per customer per 10 brands per year,  not applicable in combination with the US agent service fees
·      €350,- per product per year (discounted in combination with services for the EU and/or the UK)

read more

4). US product listing PLUS services (product listing + product compliance & safety services)

This service includes both the product listing services as well as the product compliance & safety services. All within one comprehensive and transparent service package.

·      €750,- per customer per 10 brands per year,  not applicable in combination with the US agent service fees
·      €400,- per product per year (discounted in combination with services for the EU and/or the UK)

read more

Cosmetics USA (MoCRA) - Where to start?

It depends on how much you know about MoCRA and the requirements and timelines, how you currently manage the safety and compliance of your products, and when you (or clients of your production facility) will be selling cosmetic products into the USA.

Get ready for MoCRA!

Contact us to discuss the requirements in more detail, what level of support you need, and/or to be invited to one of our next webinars.

Contact us to take your next step towards MoCRA compliance.