MoCRA requires the responsible person to identify each fragrance allergen on a cosmetic's label, but the requirement cannot apply until FDA decides by regulation which substances count. As of today, FDA has not proposed that rule. Congress gave the agency until June 29, 2024 to do so. FDA's current regulatory agenda targets November 2026 for the proposal, which means it could appear any week, or slip again as it has before.
What the law says
Section 609(b) of the FD&C Act, added by MoCRA, tells FDA to issue a final rule within 180 days after the comment period on its proposal closes. In writing the rule, FDA must consider international, state and local disclosure requirements, and the statute names the European Union specifically. FDA may also set threshold levels. FDA describes the coming proposal as one that would identify certain substances as fragrance allergens and require their disclosure on labels. Until a final rule is out, nothing in U.S. law requires these disclosures, and the compliance date will come from that rule.
Why the EU and Canada matter now
The EU expanded its list in Regulation (EU) 2023/1545. The EU previously required 24 fragrance allergens to be labeled individually and added roughly 56 more, for about 80 in total. Disclosure is required in the ingredient list when an allergen exceeds 0.001% in a leave-on product or 0.01% in a rinse-off product. The transition gives companies three years for products newly placed on the market and five years for products already there, which works out to July 2026 and July 2028.
Canada adopted the EU approach. Since April 12, 2026, 24 fragrance allergens above the same thresholds must appear in the ingredient list on Canadian labels, named individually rather than folded into "parfum." Health Canada says the list grows to 81 allergens for new cosmetics starting August 1, 2026, and existing products must disclose the expanded list as of August 1, 2028.
We would not assume FDA will copy either list exactly. But given what the statute tells FDA to consider, the EU list is the most reasonable working assumption, and any brand already selling in Canada or Europe has done much of the work.
What to do now
Ask your fragrance suppliers for allergen breakdowns by concentration for every fragrance you buy, measured against the full EU list, not the old 24. Suppliers are often slow on this, and confidentiality terms in fragrance supply agreements can get in the way, so start the conversation before a rule forces it. Then calculate concentrations in each finished product, flag which SKUs would cross the leave-on and rinse-off thresholds, and look at label space. Packaging is usually ordered well ahead, and a long allergen list on a small container is a design problem as much as a legal one. When FDA's proposal does publish, read it for its list, its thresholds and its compliance date, and consider commenting. That alone is a good reason to have your data ready.
How MDRXLaw can help
We help cosmetics brands, manufacturers and importers with MoCRA labeling, supplier documentation and comments on FDA rulemaking, and we will track the proposal when it publishes. To discuss your products, contact us at info@mdrxlaw.com or 212-668-0200.
Sources: reginfo.gov, Disclosure of Fragrance Allergens in Cosmetic Labeling (RIN 0910-AI90); Cornell LII, 21 U.S.C. 364e, Labeling; EUR-Lex, Commission Regulation (EU) 2023/1545; Health Canada, Cosmetic advertising, labelling and ingredients. This alert is for general information and is not legal advice.
