What You Need to Have in Place Now for MoCRA Cosmetic Product Substantiation
While FDA cosmetic product safety has always been required, MoCRA ups the ante and ensures that companies can no longer hide behind cover-up. As we discussed in our June 26 News and Insights issue, “Prep + Prime for MoCRA”, MoCRA’s new safety substantiation requirement provides that responsible persons are required to ensure and maintain records supporting adequate product safety substantiation of cosmetic products by December 29, 2023. This requires Responsible Persons to show a cosmetic product is safe to be marketed in the U.S. and meets established safety standards to avoid being considered adulterated (prohibited U.S. entry or sale).
To be clear, this applies to all cosmetics products, and should be in place before December 29, 2023.
Although neither MoCRA nor the FDA prescribe required tests, the optimal way for businesses to establish product safety is to have a certified Safety Assessment. As several other countries require this to place a product on the market, having a complete product information file as required by the EU or UK is likely to provide adequate safety substantiation.
Short of a Safety Assessment, a cosmetics business may use the following sources in combination, as appropriate, to help substantiate safety:
- CIR reports (as long as you are in the “safe as used” category with recommended use levels
- EU Scientific Committee on Consumer Safety (SCCS Opinions)
- Raw Material Specifications, SDS and Safety Test Data
- We recommend having consumer in use tests to support claims, with information concerning any physiological reactions to the product
- HRIPT Sensitization (recommend 100 or 200-member panel)
- Products should have some indication of microbiological acceptability-either preservation testing or if nonaqueous, a water activity test is recommended. All aqueous products should be subject to microbiological activity testing as a product release requirement.
Businesses must readily have this information available and have the information stored in an organized way, not just on file. Additionally, the Responsible Person is responsible for reviewing the data, maintaining it, and acting if there is questionable information.
We recommend putting these Safety Assessment together and maintaining records now by adopting the following approach:
- Conducting a GAP analysis of your records for each of your cosmetic products/SKUs and identify what you need
- Arrange and conduct testing: If testing is required, it can take 6-8 weeks or more to complete. Identify and work with testing labs to have this in place in a timely manner
- Receive and assess results
- Develop recordkeeping system
- Maintain records
So don’t hide under concealer – prepare now and have cosmetic product substantiation in place before December 29, 2023.
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For more information on MoCRA and cosmetic product safety substantiation, please contact us at info@garg-law.com.Â
