US Fragrance Allergen Labeling vs the EU Allergen List

A brand selling into both the US and the EU asked me why their EU label lists individual fragrance chemicals by name while their US label just says "fragrance" and stops there. The answer is that these two markets have taken genuinely different approaches to allergen disclosure, and if you're formulating once and trying to label for both, you need to understand where the rules diverge rather than assuming one label format satisfies both regulators.

The EU approach, long established

Under Regulation (EC) No 1223/2009, the EU has for years required specific fragrance allergens to be individually named on the label when they exceed defined concentration thresholds, rather than being folded silently into a generic "parfum" or "fragrance" listing. This is the well-known 26 allergen list, covering substances like limonene, linalool, citronellol, geraniol, eugenol, and coumarin among others, the same chemical families that keep showing up across global allergen frameworks because they're common, well-documented sensitizers found naturally in many essential oils and widely used in synthetic fragrance compounds.

Under this system, your Product Information File and Cosmetic Product Safety Report, signed off by a qualified safety assessor, already need to account for these allergens as part of demonstrating the product's safety, and the label reflects what that assessment found above threshold.

The US position under MoCRA

MoCRA, the Modernization of Cosmetics Regulation Act, brought meaningful new obligations to US cosmetics: facility registration and product listing with the FDA, a named responsible person, safety substantiation, and adverse event recordkeeping. What it has not historically included is an EU-style requirement to individually name fragrance allergens on the label. "Fragrance" as a single listed ingredient has generally been acceptable in the US in a way it isn't in the EU.

This is a genuine substantive gap between the two markets, not just a labeling style difference, and it's exactly the kind of area that can shift as US cosmetic regulation continues to evolve. Anyone formulating for both markets should treat the current absence of a US requirement as the present state of play, and check current FDA and MoCRA guidance directly before assuming it will stay that way indefinitely.

What this means if you sell into both markets

The practical move for a dual-market brand is usually to build to the stricter standard once rather than maintaining two separate safety assessments. If your EU documentation already breaks out allergen concentrations against the 26 allergen list, you have most of what you'd need if the US framework moves toward similar disclosure, and your US label can voluntarily include allergen information even without a current mandate, which some brands do simply because it's good practice for customers with known sensitivities.

Element	EU (1223/2009)	US (MoCRA, current)
Named fragrance allergens on label	Required above defined thresholds	Not currently a general labeling mandate
Overall fragrance ingredient disclosure	Detailed within PIF/CPSR, allergens named on label	"Fragrance" as a single listed term is generally acceptable
Safety documentation behind the label	CPSR signed by a safety assessor	Safety substantiation under MoCRA, different format
Facility and product-level registration	Notification via CPNP, Responsible Person required	FDA facility registration and product listing, responsible person named

A practical habit worth building anyway

Even absent a current US mandate, tracking your finished product's allergen-relevant constituents by percentage, the same exercise the EU already requires, sets you up well no matter which direction US labeling requirements move. It also happens to be useful customer-facing information for anyone managing a known fragrance sensitivity, regardless of what's strictly required.

If you're building a product that's headed to Canada as well, note that Canada is adding its own mandatory fragrance allergen disclosure on a defined timeline, with an initial list becoming mandatory in spring 2026 and a broader, internationally aligned list following later that year, so the allergen tracking habit is becoming useful across more markets at once, not just the EU.

Cosmetic Comply currently handles Canadian notification, with US, EU, and Australian support coming, and one advantage of centralizing your ingredient data early is that the same allergen-relevant percentage breakdown carries across markets rather than getting rebuilt from scratch for each one. Regulatory specifics shift, so treat any market-by-market comparison, including this one, as a starting point for your own verification rather than a final answer.