The Modernisation of Cosmetic Regulation Act of 2022, also known as MoCRA, is a new law introducing an expansion of the cosmetic regulation to ensure product safety in the industry.
The last change to the cosmetic regulation was the Federal Food, Drug, and Cosmetic (FD&C) Act passed in 1938. The FD&C Act established standards for the cosmetics industry to help prevent adulteration or misbranding of products and established post-market authority to the FDA, whereas the new MoCRA law has presented a significant expansion to the regulation and will likely cause a shift in the cosmetics landscape. Eurofins can act as a partner to support businesses of all sizes through these new regulatory changes.
The changes include both new industry requirements and new authorities given to the FDA. Below is a list of the key changes for the cosmetics industry, and what this will mean for you.
Already Enacted MoCRA Requirements
Adverse event reporting
Serious adverse events are health related events that result in death, a life-threatening experience, require medical intervention, or similar health related effects. It is now required under MoCRA that a Responsible Person (RP) for the company reports any serious adverse event associated with the use of the product within 15 business days of the event occurring. The label of the product must be submitted to the FDA and records must be maintained by the RP.
How can Eurofins help?
Adverse events should be submitted via a downloadable form along with supporting information, available on the FDA website. Before launching your product to market, Eurofins can assist in performing toxicological risk assessments to assess potential toxicity of the product. We can assist with standard operating procedures that will define the adverse event reporting and record keeping requirements.
Facility registration
Any business or facility that processes or manufactures cosmetics products must be registered with the FDA, and registration must be renewed every two years. The FDA has the power the suspend this registration if the establishment and its products are associated with any serious adverse events, prohibiting the company from distributing products on the US market.
How can Eurofins help?
The FDA have released a Decision Tool online to help facilities determine whether they are required to register under MoCRA. Their website details options for both electronic and paper submissions along with guidance documents. Eurofins can act as a compliance partner to assist with facility registration.
Product listing
Any cosmetics product sold on the US market must be listed with the FDA including its ingredients, providing annual updates highlighting changes.
How can Eurofins Help?
As with facility registrations, products can also be listed either electronically or via paper submissions, with guidance documents available on the FDA website. Eurofins can perform toxicological risk assessments, label reviews, and safety data sheets to assist with listing your
product.
Safety substantiation
Any products released on the US cosmetics market will have to have testing that adequately substantiates the product’s safety. The responsibility falls on the company or manufacturer that produced the cosmetics product and the responsible person must also maintain the testing records.
How can Eurofins Help?
The specific type of safety testing required for cosmetic products under MoCRA is currently unspecified. The new regulation states that products must have an adequate substantiation of safety, specifically tests, studies, or evidence that are considered by qualified experts to be sufficient in supporting the safety of the product with reasonable certainty. A product is considered safe if its ingredients do not cause injury to users under the intended usage conditions, as stated on the label or under customary conditions of use.
Eurofins are experts and can provide testing services sufficient to validate a product as safe with reasonable certainty, including primary irritation testing, Human Repeat Insult Patch Testing (HRIPT), and safety in use. We can also perform a wide range of in vitro safety tests including mutagenicity, genotoxicity, reproductive toxicity, cytotoxicity, phototoxicity and many more.
Asbestos
The FDA has released standardised testing methods to detect asbestos in cosmetics containing talc.
How can Eurofins help?
Any talc-containing products must undergo the specified testing to assess the presence of asbestos. Eurofins have capabilities to assist with these testing services according to the new methods when published.
Mandatory recall authority
The new MoCRA regulation grant the FDA the right to recall any products deemed as unsafe or evidenced to or likely to result in a serious adverse event. They may also recall products if there is reason to believe a cosmetic product has been misbranded or adulterated.
How can Eurofins help?
The authority given to the FDA to recall products means that companies should be prepared for any instances of serious adverse events. In these cases, Eurofins can perform toxicological reviews and provide physical safety evaluations. We can support throughout the recall management process and assist with standard operating procedures for mandatory recall requirements.
Records access
Finally, MoCRA allows the FDA to access records associated with any cosmetic product under certain conditions.
How can Eurofins help?
As with mandatory recall authority, cosmetics companies should perform toxicological risk assessments to ensure the safety of the cosmetic product and reduce the likelihood of encountering serious adverse events. Eurofins can assist with the necessary testing and with navigating requests from the FDA.
Upcoming MoCRA Requirements
Labelling compliance (professional use) and Fragrance allergens
Any professional use cosmetics products must have a specific label with information conforming with the requirements of the secretary for cosmetics labelling. The FDA also plans to release a list of fragrance allergens that must be identified on all cosmetics labels along with the RP’s contact information.
How can Eurofins help?
All labels must be produced according to new compliance regulations, containing all required information. Eurofins can assist in developing new cosmetic product labels, signal words, hazard statements, and pictograms that should be included on the package label. Similarly, we can test for allergens on both finished cosmetic products and raw materials.
Good Manufacturing Practices
The FDA will establish new GMP regulations for the cosmetics industry in 2025.
How can Eurofins help?
Any cosmetic products manufactured in the US must follow GMP requirements. Eurofins can review GMP certificates to ensure that traces or impurities will not harm the end user. We can also provide audit services to assess compliance with new requirements and assist with GMP setup of manufacturing sites.
PFAS
The use of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) in cosmetic products is going to be reviewed under MoCRA. The safety associated with the use of PFAS along with any risks will be analysed and results published.
How can Eurofins help?
Cosmetics companies will need to identify and monitor emerging contaminants including PFAS. Eurofins laboratories support standard and proprietary in-house methodology with all necessary validation data to support the precision and accuracy of our methodology. Our PFAS testing can be performed on both product formulations and packaging.
Key dates to be aware of
The new MoCRA regulations became effective on December 29th 2023, one year after they were enacted on the December 9th 2022. However, certain elements of the new MoCRA bill will come into effect at later dates.
As of December 2023, the changes that have come into effect include facility registration, mandatory product listing, mandatory recall authority, serious adverse event reporting, professional use labelling requirements, safety substantiation, records access, and asbestos in talc-containing products.
On June 29th 2024 the list of fragrance allergens required on labels of cosmetics products will be released. By the 29th of December 2024, allergens must be included on labels, as well as the RP’s contact information.
On December 29th 2024 the GMP requirements will be established and the final rule will come into place on December 29th 2025.
Who will MoCRA apply to?
MoCRA applies to any company or brand that makes and/or manufactures products sold in the US as cosmetics and personal care products, meaning most cosmetics companies must take action. However, the FDA has released a small company exemption excluding businesses whose gross annual sales are less than $1,000,000 for the previous 3-year period. The exemption excludes these businesses from facility registration, mandatory product listing and GMP rules. Some small businesses are excluded from the exemption, including those that make products that are injected, those intended for use with the mucous membrane of the eye, intended for internal use or those that aren’t intended to be removed.
Whilst the new requirements enacted under MoCRA may seem daunting, Eurofins can act as a compliance partner to guide you through all necessary changes. For more information on MoCRA or our capabilities, feel free to contact us at MoCRAUS@cpt.eurofinsus.com or click here for more information.
