Fragrance Allergen Labelling Under EU Cosmetic Regulation 1223/2009: What Regulation (EU) 2019/1966 Actually Requires

The sell-through deadline for old-format fragrance allergen labels passed in August 2023. Nearly three years on, we still encounter cosmetic product information files where brands are listing only 26 fragrance allergens — the pre-2019 list — when the current Annex III of EU Cosmetics Regulation 1223/2009 requires individual declaration for 82 specific substances. In some cases the label is technically compliant, but the PIF contains no allergen assessment at all. Both scenarios create meaningful enforcement exposure.

Commission Regulation (EU) 2019/1966, published in November 2019, amended Annexes III and V of Regulation (EC) No 1223/2009 based on the Scientific Committee on Consumer Safety’s evaluation of fragrance allergens. It added 56 new fragrance substances to the mandatory declaration list. For products placed on the EU market from 23 August 2021, compliance was required. The sell-through period ended 23 August 2023. There are no exceptions, no further grace periods, and no derogation for small brands or artisan producers.

What the Expanded Annex III List Actually Means for Your Labels

Before the amendment, a brand needed to declare 26 specific fragrance allergens on consumer labels when present above threshold concentrations. The 2019/1966 amendment brought that number to 82. These substances range from well-known terpenes — Linalool, Limonene, Geraniol — to less familiar entries that may be present in functional or botanical ingredients that brands have never thought of as “fragrance.”

The labelling obligation is triggered by concentration thresholds defined in Annex III of EC Regulation 1223/2009:

• 0.001% (10 ppm) for leave-on products: moisturisers, serums, body lotions, facial oils, leave-in hair conditioners, lip care
• 0.01% (100 ppm) for rinse-off products: shampoos, shower gels, face washes, rinse-out conditioners, bath products

That ten-fold difference is not theoretical. A fragrance blend might contain a particular allergen at 0.005% in the finished product — above the leave-on threshold, below the rinse-off threshold. A brand using the same fragrance in both a body lotion and a shower gel must declare it on the lotion label and omit it from the shower gel label. Applying a single threshold across all product types is one of the most common compliance failures we see.

Multi-purpose products introduce additional complexity. A hair oil that can be used as a leave-in treatment or rinsed out after application should, in practice, be evaluated against the leave-on threshold. DGCCRF market surveillance guidance and French ANSM interpretation both lean toward this conservative position, and it’s the one that protects brands from challenge under Article 21 of EC 1223/2009.

The Supplier Information Gap That Creates Compliance Risk

The practical difficulty with fragrance allergen compliance is that brands rarely formulate directly from raw fragrance molecules. They purchase proprietary blends, which appear on the finished product ingredient list simply as “Parfum” or “Aroma.” That listing is entirely legitimate. But it means the Responsible Person — who carries the compliance obligation under Article 10 of Regulation (EC) No 1223/2009 — must independently verify which of the 82 Annex III allergens are present, and at what concentrations.

A standard Safety Data Sheet from your fragrance supplier is not sufficient for this purpose. An SDS is prepared under CLP Regulation (EC) No 1272/2008 and discloses hazardous components above CLP-specific concentration limits, which are typically far higher than the 0.001% cosmetic labelling threshold. You can receive a clean SDS and still have a non-compliant label.

What you need is a dedicated allergen declaration from your fragrance house: a document listing every EU Annex III substance present in the fragrance concentrate, with its concentration expressed as a percentage of that concentrate. You then multiply by the fragrance use level in your finished product to arrive at the finished-product concentration. Larger international fragrance houses routinely provide this alongside IFRA compliance certificates. Smaller suppliers may need to be specifically requested — and sometimes guided on what format is required.

If a supplier declines to provide full allergen disclosure, you have a genuine compliance problem. As Responsible Person, you cannot substantiate your label declaration. You either reformulate with a supplier who will provide the documentation, or you cannot place that product on the EU market with confidence.

Botanical Extracts: The Allergen Source Most Brands Overlook

Here’s the scenario that catches brands off guard most consistently: a product formulated without any added fragrance — marketed as “fragrance-free” — that still requires Annex III allergen declarations.

Certain plant-derived ingredients naturally contain regulated allergens at concentrations well above the labelling thresholds. Lavender essential oil (Lavandula angustifolia) typically contains 25–45% Linalool. At a 0.5% use level of lavender oil in a leave-on facial serum, the Linalool concentration in the finished product will likely fall between 0.12% and 0.22% — roughly 120 to 220 times the 0.001% labelling threshold. Citrus peel oils carry Limonene, Citral, and Geraniol in similar proportions. Chamomile extracts, rose absolute, and neroli oil each bring their own Annex III content.

These allergens must be declared on the consumer label even though they originate from a botanical ingredient, not an added perfume. The obligation is tied to the substance’s presence above threshold, not to its source. Regulation (EC) No 1223/2009 makes no distinction based on whether the allergen is naturally occurring or synthetically added.

Cosmetic safety assessors sometimes overlook this because a botanical INCI declaration — Lavandula Angustifolia (Lavender) Oil — doesn’t signal “check for fragrance allergens” in the same way that “Parfum” does. But the allergen content of botanical ingredients must be reviewed with exactly the same rigour as purchased fragrance blends.

Five Labelling Errors That Appear Repeatedly in PIF Reviews

Incorrect INCI nomenclature. The Annex III list uses specific, controlled names. Hexyl cinnamaldehyde in supplier documentation must appear as “Hexyl Cinnamal” on the label; a substance listed in a COA as “p-Methoxybenzyl alcohol” needs to appear as “Anise Alcohol.” Mismatches between supplier naming conventions and Annex III INCI entries are flagged immediately in PIF audits.

Single-threshold application across multi-format portfolios. Applying the 0.01% rinse-off threshold to leave-on products in the same fragrance family understates the declaration requirement for every leave-on SKU in the range.

No re-evaluation after minor reformulations. Reducing the fragrance load by 10% might drop an allergen from 0.0012% to 0.0009% — pushing it below the leave-on threshold. But adding a new botanical extract might introduce a different allergen that wasn’t previously tracked. Allergen assessments are not a one-time exercise; they must be revisited whenever a formulation changes, even marginally.

Allergen assessment absent from the PIF. The Cosmetic Product Safety Report prepared under Annex I should address the toxicological profile of fragrance components. But the PIF should also contain standalone documentation supporting the label’s allergen declarations — specifically the supplier allergen certificates and the concentration calculations. National competent authorities conducting market surveillance are increasingly requesting this documentation directly, and its absence in the technical file is increasingly treated as a substantive gap rather than a procedural oversight.

Post-2019 allergens absent from internal compliance systems. Brand label management databases and internal ingredient flagging tools sometimes weren’t updated when 2019/1966 was transposed. Substances added in 2019 simply don’t appear as triggers in internal compliance workflows. A full audit of your label management tooling against the current 82-entry Annex III list is worth conducting if it hasn’t been done within the last two years.

Where Fragrance Regulation Is Heading

The SCCS continues to evaluate fragrance allergens, and the historical trend is unambiguous. Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC/Lyral) was restricted to trace levels in leave-on products and effectively prohibited as a sensitiser by Commission Regulation (EU) 2017/1410. Butylphenyl methylpropional — widely used under the trade name Lilial — was banned outright via Commission Regulation (EU) 2021/1902, effective March 2022. Several brands that reformulated to remove Lilial received replacement blends from their fragrance suppliers that introduced new Annex III substances, without realising the substitution created new labelling obligations.

Several substances currently sitting in the “must-label” column of Annex III are undergoing active SCCS review and may migrate to prohibition within the next amendment cycle. Brands with allergen tracking built into their formulation management processes — supplier disclosure requirements written into procurement contracts, automatic allergen re-evaluation triggered by any formula change — consistently absorb these amendments with far less operational disruption than those treating allergen compliance as a one-time label update.

The direction of travel in EU fragrance regulation is toward greater restriction, not relaxation. Treating the August 2023 deadline as a closed chapter is a mistake. It was the floor, not the ceiling.

What to Do If You Haven’t Fully Audited Your Portfolio

Start with fragrance blend documentation. Pull every fragrance concentrate used across your range and request updated allergen disclosure certificates from your suppliers — specifically listing concentrations of all 82 EU Annex III substances in the concentrate. If you’re using natural extracts in leave-on products at use levels above 0.1%, identify which allergens they contribute and at what typical concentrations.

Calculate finished-product concentrations for every allergen present. Apply the correct threshold — 0.001% for leave-on, 0.01% for rinse-off — and compile a declaration list for each product SKU. Cross-reference your current consumer labels against the full Annex III INCI nomenclature. Document the calculation in the PIF.

Then build the process rather than just fixing the output. An allergen audit that produces a snapshot but no ongoing mechanism is likely to fall out of date within 18 months. The brands that stay consistently compliant are those that have made allergen tracking a standing part of their formulation and procurement workflow, not a periodic exercise triggered by a regulatory deadline.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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