[Updated August 1, 2025]
The Modernization of Cosmetic Regulations Act of 2020 (MoCRA) was passed in December 2022. It required the FDA to identify fragrance allergens and issue regulations mandating that the allergens be disclosed on cosmetic product labels. MoCRA set an 18-month deadline for the FDA to take the first step of issuing proposed regulations. The deadline, June 29, 2024, passed without the proposed regs being issued.
When the Federal Unified Agenda of Regulatory and Deregulatory Actions for Spring 2024 was released, the FDA said October 2024 as the estimated time of publishing the proposed rule. In the Fall 2024 issue, they said January 2025 for the proposed rule. As of now, it has not been published and the planned date to publish the proposed regulation is unknown.
Timeline to Final Implementation
Once the proposed regulation is published, there is a comment period. Following that, MoCRA specified 6 months after the close of comments to issue the final rule. Then there will be a period before the rule takes effect, to allow companies to update their label.
The timeline looks something like this:
| Publication of proposed rule | (unknown) |
| Comment Period | + 1 – 6 months |
| Issuance of final rule | + 6 months |
| Implementation period | + 12 – 36 months (guesstimate) |
| Time to final rule being in effect | 19 – 48 months AFTER the publication of the proposed rule. |
What should you do now?
Orginally, the thought was that the FDA’s proposed regulations would most likely follow the same rules that other countries have for fragrance allergens.
However, FDA has said that they might consider a more general allergen statement and/or shortening the compliance date.
You can get ready now by checking if any of your products contain those allergens at a high enough level to trigger the need to declare them on your product label based on the existing standards for other countries. If you use essential oils, it can take some detailed math to work it out.
The EU has named an additional 56 fragrance allergens that will also need to be declared on cosmetic product labels. The deadline for label compliance for those new allergens is 2026. It’s possible (but unlikely) that the FDA will include all those fragrance allergens as well.
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