FDA fragrance-allergen labeling is the next MoCRA requirement coming for anyone selling cosmetics in the United States — and for importers of Korean beauty, it’s the one most worth preparing for now. The rule isn’t final yet, but its direction is clear, and the suppliers who get ahead of it will avoid a scramble later. Here’s what’s coming, when, and what to do about it in 2026.
What the rule requires
The Modernization of Cosmetics Regulation Act of 2022 directs the FDA to issue regulations identifying fragrance allergens that must be disclosed individually on cosmetic labels, with threshold levels. In plain terms: the familiar catch-all “fragrance” or “parfum” on an ingredient list is on borrowed time. Once the rule takes effect, specified allergens within that fragrance will have to be named on the label.
This matters because fragrance allergens are a leading cause of cosmetic skin reactions, and the US is moving toward the transparency that other major markets already require.
The timeline — and why “delayed” doesn’t mean “ignore”
The statutory deadline for a proposed rule was June 29, 2024, and the FDA missed it. Per the agency’s most recent Unified Agenda, the proposed rule (regulatory identifier RIN 0910-AI90) is now expected around May 2026, with a final rule and compliance date realistically landing in 2027 or later.
That long runway is exactly the trap. Because labeling changes ripple all the way back to formulation disclosure from suppliers, the work has to start well before the compliance date. A brand that waits for the final rule will be reformulating its labels under deadline pressure; a brand that prepares now simply updates a system it already built.
The EU is the model to prepare against
Since the FDA hasn’t published its US allergen list or thresholds yet, the strongest available proxy is the European Union’s rule — which the US is widely expected to track. Under EU Regulation 2023/1545 (published July 2023):
- The list of individually labeled fragrance allergens expanded from 24 to roughly 80 substances.
- Disclosure is triggered above 0.001% in leave-on products and 0.01% in rinse-off products.
- Compliance dates: new products by July 31, 2026, and existing products by July 31, 2028.
For a Korean brand already selling in Europe, much of this groundwork exists. For one focused only on Asia or the US, the EU’s 80-allergen framework is the safest baseline to build toward.
What importers of Korean cosmetics should do now
The preparation is unglamorous but straightforward, and starting in 2026 makes it painless:
- Get full allergen breakdowns from suppliers. Request IFRA/EU fragrance-allergen declarations from each Korean manufacturer now, so the data exists before the rule forces it.
- Map formulations against the EU 80-allergen list at EU thresholds as a forward-compatible baseline — anything compliant there is likely close to US-ready.
- Plan label space and listing data. Individual allergen call-outs need room on the label and fields in your FDA product listing; design for them before reprinting packaging.
- Track RIN 0910-AI90. Watch for the proposed rule and its comment period so you can adjust to the final US list and thresholds when they publish.
The operator’s view
The fragrance-allergen rule is a reminder that US compliance for Korean cosmetics is a moving target — and that the cost of staying ahead is far lower than the cost of catching up. At Luxmetics, we handle MoCRA registration and compliance end to end, and we work upstream with Korean manufacturers to collect the formulation and allergen data importers will need. If you’re bringing Korean beauty into the US, we’ll make sure your labels are ready before the rule is, not after.