MoCRA Fragrance Allergen Labeling: What's Coming and How to Prepare Now

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC

One of the most consequential changes coming under the Modernization of Cosmetics Regulation Act (MoCRA) is mandatory fragrance allergen disclosure on cosmetic labels. For decades, brands have been able to list these substances collectively under the single word "fragrance." That is about to change — and the brands that prepare now will avoid a costly, last-minute labeling scramble later.

What does the MoCRA fragrance allergen rule require?

Under Section 609(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, as amended by MoCRA, FDA is directed to identify by regulation the specific substances that qualify as fragrance allergens and to require that they be disclosed individually on the product label, rather than hidden inside the generic "fragrance" declaration. The statute also directs FDA to consider international frameworks — particularly the European Union's — and to set the threshold concentrations that trigger disclosure.

In practical terms: if a finished cosmetic contains a listed allergen above the disclosure threshold, that allergen will need to appear by name in the ingredient declaration.

When does fragrance allergen labeling take effect?

This is the part brands most need to understand: the rule is not yet final, and the timeline has slipped repeatedly.

MoCRA originally required FDA to issue the proposed rule by June 29, 2024. That deadline passed. According to the most recent Unified Agenda, FDA now intends to issue the proposed rule (NPRM) in 2026. Because a proposed rule is followed by a public comment period and then a separate final rule, real compliance obligations are unlikely to bite until 2027 at the earliest.

The delay is a gift, not a reason to relax. Reformulating or relabeling across an entire product line takes months, and the disclosure analysis has to happen at the fragrance-component level — which means coordinating with your fragrance house and suppliers, who have their own lead times.

How to prepare before the FDA rule is final

You do not have to wait for FDA. The smartest move is to prepare against a framework that already exists:

• Use the EU/Canada allergen list as your working benchmark. The EU and Canada already require declaration of a defined set of fragrance allergens, and the EU list has been expanding well beyond the original 26 substances. FDA is statutorily directed to look at the EU approach, so building your disclosure data against that list now puts you ahead of whatever FDA finalizes.

• Audit your fragrance blends today. Ask your fragrance suppliers for an allergen breakdown of every fragrance you use, mapped against the expanded EU list. This is the single longest-lead-time task.

• Map exposure across SKUs. Identify which products, sizes, and label panels would be affected so you can plan label revisions in batches rather than all at once.

• Treat it as part of a broader label review. Fragrance allergens rarely travel alone — if you're opening up label artwork, validate ingredient order, net contents, warnings, and claims at the same time.

Planning a U.S. launch or refreshing artwork? Axentra's regulatory team reviews cosmetic labels against current and anticipated MoCRA requirements so you don't relabel twice. Book a labeling review.

Why a pharma-grade approach matters here

Fragrance allergen disclosure is fundamentally a data-integrity exercise: tracing substances through a supply chain, applying thresholds, and documenting the basis for each labeling decision. That discipline comes naturally to a team trained in pharmaceutical labeling and structured product data — which is the lens Axentra brings to cosmetics. For more on the wider labeling picture, see our guide to MoCRA cosmetic labeling requirements, and for the full obligation set, our MoCRA cosmetics compliance overview.

You can also follow the rule's progress directly on FDA's MoCRA page.

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Frequently asked questions

Is fragrance allergen labeling required under MoCRA right now?

Not yet. FDA must first issue a proposed rule and then a final rule. As of 2026 the proposed rule is still pending, so individual fragrance allergen disclosure is not yet legally mandatory in the U.S. — but it is coming, and EU/Canada already require it.

How many fragrance allergens will need to be disclosed?

The exact U.S. list will be set by FDA's final rule. The EU framework FDA is directed to consider has expanded well beyond the original 26 allergens, so brands should plan against a substantially larger list.

What law requires fragrance allergen disclosure?

Section 609(b) of the FD&C Act, as added by MoCRA, gives FDA the authority and the mandate to require individual disclosure of identified fragrance allergens.

What should brands do before the rule is final?

Audit fragrance blends against the EU allergen list now, gather allergen data from fragrance suppliers, and map which SKUs and labels would be affected so revisions can be planned in advance.