MoCRA, 10 steps to efficiently manage cosmetics compliance and safety in practice in the US

The Modernization of Cosmetics Regulation Act (MoCRA) is here to stay. Not all requirements are fully defined yet, but you need to prepare to ensure your cosmetic products will be compliant under each new requirements once it become effective.

The best approach to avoid rushing from one deadline to another is to understand the requirements; AND to take 10 key steps to manage product information and to assess and monitor product compliance and safety.

By Jasper ten Brinke

Business Development

MoCRA and how to avoid cosmetic products to become non-compliant in 2024?

The Modernization of Cosmetics Regulation Act of 2022(MoCRA) was signed into law on December 29, 2022. The first deadlines are on December 29, 2023. At the same time, the deadlines to comply with individual requirements vary a lot, not all requirements have been exactly defined yet, and the enforcement of the requirements of facility registration and product listing has been postponed with 6 months until July 1, 2024, while the registration system Cosmetics Direct has been launched only very recently on December 18, 2023. Next to MoCRA several “key” states (e.g. California, NewYork) have additional state requirements and continue to do so.

We continuously monitor the evolving requirements under MoCRA and their timelines. The overview table includes the deadline postponement of facility registrations and product listings as communicated by the FDA on November 8, 2023.

From an "ad-hoc" approach to a "system" approach in 10 steps

So, instead of rushing from one regulatory deadline to another and troubleshooting individual requirements on an “ad-hoc” basis, become more effective and efficient by following our practical and comprehensive 10 key steps approach. Choose for this proven effective approach to best manage cosmetics compliance and safety in practice under MoCRA and state level regulations.

5 key steps to manage product information

• Build up your product compositions bottom-up in a database structure. Start with the raw material compositions as the basic building blocks to build your formulations and products. Work with the official INCI substance names and exact percentages and values.
• Link your raw materials to your formulations, and your formulations and packaging components to your products without copying data and documents (one to many approach) to ensure traceability and efficient update/change management.
• Ensure adequate and up-to-date document management. Store technical documentation for each specification (e.g. Certificates of Analysis, stability and preservation efficacy test results, artwork of product labels). Make sure you have dossier completeness and validity date checks in place.
• Work with one-version only for each individual specification (no copies). Ensure appropriate change management with versioning to enable updating specifications while keeping history and traceability overtime.
• Create a central (shared) working environment with pre-assigned roles and access rights. Avoid (outdated) copies of data and documentation being shared and stored outside the central working environment at different departments at all times.

5 key steps to assess and continuously monitor compliance and safety

• Have your regulatory database in place and work with correct threshold values per substance, and when relevant, differentiated for each cosmetic product category. Add regulatory data for all countries/regions where your portfolio is sold. Make sure to timely include updated regulatory data from upcoming regulation amendments.
• Have your toxicology database in place, containing toxicology data for all substances in your product portfolio, and work with exact safety thresholds (toxicological endpoints) and clear literature references.
• Classify each product in your portfolio according to its respective cosmetic product type based on the intended use, product description/presentation and efficacy claims.
• Work with predefined (standardised) exposure scenarios for each cosmetic product type in your product portfolio (e.g., shampoo, mascara, face cream, hair dye) for the compliance assessment and safety substantiation.
• Cross-check the exact product composition against your regulatory and toxicology databases based on the exposure scenario that applies for the specific product type.  Create a “live dashboard” with a 24/7 real-time compliance status overview for each product in your current and NPD portfolio.

How does following these key principles help you to meet the MoCRA requirements in practice?

Instead of meeting individual requirements on a more “ad-hoc” basis, it is much more efficient and future proof to follow these key steps.  Following these 10 steps results in the output that is needed to meet the MoCRA requirements. To give you some examples for each MoCRA requirement:

• Product listing: the product listing and updates thereof must include, the category code, all ingredients, and whether or not the formula contains fragrances and/or flavours. This output, by definition, follows from building up product compositions bottom-up, and classifying each product with its respective cosmetic category in the compliance and safety assessment. Fragrance and/or flavours (including allergens levels) information flows automatically from the raw material and formulation data.
• Facility registration: each facility (if not exempted) must register with the FDA, and for each individual brand, the cosmetic product types produced at that facility must be listed. In the 10 step approach, facility information including the FEI number is compiled and stored for each facility and linked to each product. Reports that list the products and their respective cosmetic category per facility are easily generated.
• Adverse Events Management: key in adverse events management are; detailed collection of information related to the event, relating this information to the product information that you have stored, combining both to perform the root-cause analysis, and storing the findings in your reporting files for the product. This information is easily pulled together, and findings conveniently stored with the product details.
• Safety Substantiation: the EU/UK approach to safety substantiation is generally considered adequate under MoCRA until defined otherwise by the FDA. The detailed safety substantiation is the result of the automatic cross-check of your product data and product type against the regulatory and toxicology databases.
• Label content: the product label must comply with the labeling requirements of the FederalFood, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling(FP&L) Act, and the regulations published by the Food and Drug Administrationunder the Authority of these two laws. The exact information that needs to be included on the product packaging and/or container is easily extracted into a so called US  label content briefing.

Conclusion / Insight

Carefully following these 10 key steps puts you in control, and exactly where you want to be to meet the MoCRA requirements. It is a “system” approach as opposed to a more “ad-hoc” approach, and results in efficiently and effectively meeting current and future MoCRA  and additional state requirements.