Fragrance Allergens: EU List and U.S. MoCRA Labeling Rules

Fragrance allergen labeling requirements diverge sharply between the European Union and the United States. In the EU, manufacturers must name each listed allergen individually on the label once it exceeds a set concentration in the finished product. In the U.S., the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) creates the same obligation in statute, but the FDA has not yet published the final rule that tells companies which substances to disclose or at what levels. Until it does, American labels can legally continue to group these ingredients under the word “fragrance” or “parfum.”

What the EU Requires on the Label

The European Union’s Cosmetics Regulation (EC) No. 1223/2009 was the first major framework to require individual fragrance allergens on product labels rather than hiding them behind the generic term “parfum.” Under Annex III, a listed allergen must be named on the label once its concentration in the finished product exceeds a defined threshold.

Two thresholds apply, and they turn on how long the product stays on your skin:

Rinse-off products such as shampoos and body washes: 0.01 percent (100 parts per million).
Leave-on products such as lotions, sunscreens, and perfumes: 0.001 percent (10 parts per million).

The stricter leave-on standard reflects the fact that these products sit on skin for hours, giving even trace amounts time to provoke a reaction. Below the applicable threshold, the allergen can remain inside the “parfum” or “fragrance” grouping and does not need its own line on the label.

Which Substances Are on the EU List

The EU originally identified 26 chemically defined fragrance substances as potential allergens requiring individual labeling. That list is expanding to 82 allergens, with the new requirements taking effect on July 31, 2026.¹

Some of the most familiar names on the list are terpenes and alcohols that pull double duty as scent molecules and mild preservatives. Linalool occurs naturally in lavender and citrus plants; limonene is extracted from orange peels; geraniol and citronellol appear constantly in floral-scented products. Oakmoss extract, common in earthy and woody perfume profiles, carries one of the highest allergenic potentials in the group.

What MoCRA Requires in the United States

MoCRA is the most significant expansion of FDA authority over cosmetics since 1938.² Section 609(b) of the amended Federal Food, Drug, and Cosmetic Act requires that each fragrance allergen in a cosmetic product be individually identified on the label. A product that fails to meet the requirement is considered misbranded.³

The catch is procedural. MoCRA directed the FDA to issue a notice of proposed rulemaking that will identify which specific substances qualify as fragrance allergens for U.S. purposes and set the disclosure conditions.³ As of 2026, the FDA has not published a final rule. The statutory duty exists on paper, but the implementing regulation that tells manufacturers exactly what to disclose is still being developed. Until that rule is final, companies can lawfully continue to group fragrance ingredients under “fragrance” on U.S. labels. The FDA has referenced the EU’s research in developing its approach but does not yet maintain a finalized U.S.-specific list.¹

For consumers wanting full allergen transparency on American products right now, the practical options are voluntary industry disclosure or products formulated to EU compliance standards.

Small Businesses Are Not a Loophole Here

MoCRA exempts certain small businesses from good manufacturing practice requirements, facility registration, and product listing.² The law does not explicitly extend those exemptions to the fragrance allergen labeling requirements under Section 609. Once the FDA finalizes the rule, small cosmetic companies should assume the disclosure obligations apply to them unless the final rule says otherwise.

Enforcement Tools That Already Exist

Even before the allergen-specific rule is finished, the FDA has real leverage. Introducing a misbranded cosmetic into interstate commerce is a prohibited act under federal law.⁴ The consequences a company can face include:

Seizure of misbranded cosmetics found in interstate commerce.
Federal court injunctions restraining further distribution.
Criminal penalties of up to one year in prison and a $1,000 fine for a first violation. A prior conviction or intent to defraud raises exposure to up to three years and a $10,000 fine.⁴
Mandatory recall under MoCRA when a cosmetic has a reasonable probability of causing serious adverse health consequences and the manufacturer refuses to recall voluntarily.²
Suspension of a facility’s registration when products from the site pose a reasonable probability of causing serious harm, which effectively bars the company from selling cosmetics in the United States.²

The FDA also inspects cosmetic manufacturing facilities to verify products are neither adulterated nor misbranded, and it can pursue enforcement from those inspections.⁵

Adverse Event Reporting Duties

MoCRA created an obligation that did not exist before. Manufacturers must report serious adverse events to the FDA within 15 business days of learning about them. If additional medical information surfaces within one year of that initial report, the company has another 15 business days to submit the follow-up.²

A “serious adverse event” means an outcome resulting in death, a life-threatening experience, hospitalization, significant disability, a birth defect, an infection, or significant disfigurement. Disfigurement specifically covers serious and persistent rashes, second- or third-degree burns, significant hair loss, and persistent changes in appearance. It also covers any situation where medical or surgical intervention is needed to prevent one of those outcomes.² A mild rash that clears up on its own does not qualify. A persistent allergic reaction requiring medical treatment does.

How to Report a Reaction as a Consumer

If you develop a skin reaction after using a cosmetic, stop using the product and see a healthcare provider before filing anything. Once the medical side is addressed, you can report the problem to the FDA in several ways:⁶

Online through the electronic MedWatch Online Voluntary Reporting Form on the FDA’s website.
By mail or fax using Form FDA 3500B, sent to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852, or faxed to 800-332-0178.
By phone at the FDA’s Food and Cosmetics Information Center: 1-888-723-3366.

Consumer complaints are one of the main ways the agency identifies patterns of harm linked to specific ingredients. A single report rarely triggers action on its own, but a cluster tied to the same product or ingredient can lead to inspections, warning letters, or recalls, and the data feeds directly into decisions about which substances end up on the final regulated list.

Facility Registration and Product Listing

Compliance with the coming allergen rule sits on top of MoCRA’s structural obligations. Manufacturers and processors of cosmetic products must register their facilities with the FDA and renew that registration every two years, calculated from the initial registration date. Renewals go through the FDA’s Cosmetics Direct portal, either as a full renewal that updates registration information or an abbreviated renewal if nothing has changed.⁷

Separately, responsible persons must list each marketed cosmetic product with the FDA, including its ingredients, and provide annual updates.² Companies must also maintain records supporting the safety substantiation of their products. For manufacturers relying on fragrance blends from third-party suppliers, this practically means obtaining detailed composition data from the supplier now, so that when the FDA’s allergen labeling rule is final, the information needed to identify each disclosable substance on the label is already in hand.

1
U.S. Food and Drug Administration. Allergens in Cosmetics
2
U.S. Food and Drug Administration. Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
3
Reginfo.gov. View Rule
4
Office of the Law Revision Counsel. 21 USC Chapter 9, Subchapter III – Prohibited Acts and Penalties
5
U.S. Food and Drug Administration. FDA Authority Over Cosmetics – How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated
6
U.S. Food and Drug Administration. How to Report a Cosmetic Product Related Complaint
7
U.S. Food and Drug Administration. Registration and Listing of Cosmetic Product Facilities and Products