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.
The Federal Unified Agenda of Regulatory and Deregulatory Actions for Spring 2024 was just released. It lists all the regulatory actions administrative agencies have in the works. The FDA has 67 rules (regulations) on the list. Of all those, only one is pertinent to cosmetic makers: Disclosure of Fragrance Allergens in Cosmetic Labeling. Finally!
Timeline to Final Implementation
According to the list, the FDA has scheduled their notice of proposed rulemaking (NPRM) for October 2024.
If everything goes according to the schedule (which, granted, it frequently doesn’t), we’ll have the proposed rule, with the list of fragrance allergens, sometime in October. From there, it’s still a long road to when you’ll be required to have fragrance allergens included on your labels.
The timeline looks something like this:
| October 2024 | Proposed rule published |
| + 2 – 6 months | Comment period (which could be extended) |
| + 6 months (MoCRA gave the FDA 6 months after the comment period to issue the final rule) | Issuance of Final Rule (with “effective date” by which your labels must be compliant.) |
| + 12 – 36 months (guesstimate) | Implementation period |
| TOTAL: 20 to 48 months |
If the proposed rule is actually issued in October, your labels will have to be updated to include fragrance allergens sometime between June 2026 and October 2028 — longer if the comment period is extended or there are any challenges to the regulations, or the FDA doesn’t meet its 6-month deadline for publishing the final rules.
What should you do now?
The FDA’s proposed regulations will most likely follow the same rules other countries have; 24 allergens that must be declared if they are present at more than 0.001% in rinse-off products or 0.01% in leave-on products.
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. 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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