EU Fragrance-Allergen Labelling for Natural Ingredients

For a natural cosmetic ingredient, safety and labelling are two different jobs. An essential oil can sit comfortably within its IFRA use level and still oblige you to name several allergens on the pack. That obligation comes from the EU Cosmetic Products Regulation (EC) No 1223/2009, and for anyone formulating with essential oils and absolutes it is one of the most misunderstood parts of a natural brief. This article explains what the rule requires, why naturals are affected disproportionately, and how to turn supplier data into a correct declaration.

What the EU requires and when

Under Regulation (EC) No 1223/2009, specified fragrance allergens must be named individually in the ingredient list when they are present above a set concentration. They are not hidden inside the generic "Parfum" (or "Aroma") term the way other fragrance components are; once over the threshold, each listed allergen appears under its own INCI name so a consumer can recognise it. The duty falls on the finished product, so it is the person placing the product on the market who must run the assessment — using data that flows up from the ingredient supplier.

The thresholds that trigger a declaration

Whether an allergen must be declared depends on how much of it ends up in the product and on the product type. Historically the limits have been 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinse-off products. The lower leave-on threshold reflects prolonged skin contact: a face cream or a fine fragrance stays on the skin for hours, so a smaller amount of an allergen is enough to warrant disclosure than in a product that is quickly washed away. Crucially, the figure refers to the allergen's concentration in the finished product as sold, not its level inside the raw oil — so the raw-material percentage always has to be scaled by the dose in the formula. A material can be 30% linalool, but at a 0.2% dose that contributes only 600 ppm of linalool, and the arithmetic decides the label.

Why naturals declare several allergens at once

This is where essential oils behave unlike a synthetic fragrance compound. A natural oil is a mixture of dozens of constituents, and several of those constituents are themselves on the allergen list. Linalool, limonene, citronellol, geraniol, citral, eugenol and coumarin are all ordinary components of common botanicals. So a single natural ingredient can carry two, three or more listed allergens simultaneously, and a modest dose of one oil can push all of them over the threshold together. A citrus note contributes limonene and citral; a rose or geranium note contributes citronellol and geraniol. The declaration list grows quickly the more natural the fragrance is.

The expanded 2023 list

The original framework named roughly two dozen individual allergens. Regulation (EU) 2023/1545 has significantly expanded this, adding many more named substances that must be declared individually — including further terpenes and specific naturally occurring molecules that are common in essential oils. The change is being introduced with transition periods rather than overnight, so products already on the market and newly placed products follow different timelines. Because the expansion adds molecules abundant in naturals, its practical effect on essential-oil formulations is larger than on synthetic-heavy ones. Always confirm the current list and the applicable dates before signing off a label rather than relying on the historic count.

From supplier data to the declaration

The calculation itself is straightforward once you have the inputs. Each raw material should come with an allergen statement, backed by a batch GC-MS profile that quantifies the relevant constituents, and a CoA confirming identity. Because natural composition varies with species, chemotype, harvest and even distillation batch, batch-level figures matter most when a dose sits close to a threshold — a generic percentage can quietly move an allergen from below the limit to above it. Multiply the allergen's percentage in the oil by the oil's dose in the formula, sum any contributions of the same allergen from different ingredients, and compare each total against the 10 ppm or 100 ppm threshold. Everything at or above the limit is declared; everything below is recorded but not labelled. The HowTo below sets out that workflow step by step, so a natural fragrance ends up with a declaration that is accurate, defensible and easy to recheck when a batch, a dose or a supplier changes.

How to build a fragrance-allergen declaration for a product using a natural ingredient

Gather each ingredient's allergen statement and GC-MS data

For every essential oil, absolute or fragrance compound in the formula, obtain the supplier's allergen statement and batch GC-MS profile. These give the percentage of each listed allergen — linalool, limonene, citronellol, geraniol, citral, eugenol, coumarin and the rest — present inside that raw material.

Decide whether the product is leave-on or rinse-off

Confirm the product category, because the declaration threshold depends on it: 0.001% (10 ppm) for leave-on products and 0.01% (100 ppm) for rinse-off products. A cream and a shower gel using the same oil can end up with different declared lists.

Calculate each allergen's concentration in the finished product

Multiply the allergen percentage in the raw material by that material's dose in the finished formula, then sum contributions where the same allergen comes from more than one ingredient. The result is the allergen's concentration in the product as sold.

Compare each figure against the threshold

Test every calculated concentration against the relevant 10 ppm or 100 ppm limit. Any allergen at or above the threshold for that product type must be declared; those below it need not appear on the label, though records should still be kept.

Compile the allergens to add to the INCI list

List the qualifying allergens by their INCI names and place them at the end of the ingredient declaration, after the fragrance term (Parfum/Aroma), in the appropriate descending-order position where relevant. This is the consumer-facing output of the calculation.

Keep records and recheck against the current regulation

Archive the allergen statements, GC-MS data and calculations in the product information file, and re-run the assessment whenever a formula, supplier or batch changes — and against the expanded list and its transition dates introduced by Regulation (EU) 2023/1545.

Frequently Asked Questions

Why does a single essential oil trigger several allergen declarations?

Essential oils are complex natural mixtures, and several of their major constituents are themselves listed fragrance allergens. A lavender oil naturally carries linalool and limonene; a citrus oil carries limonene and citral. So one natural ingredient can push two, three or more allergens over the threshold at once.

What are the current declaration thresholds?

Historically an allergen must be declared when it exceeds 0.001% (10 ppm) in a leave-on product or 0.01% (100 ppm) in a rinse-off product. These concentrations refer to the allergen in the finished product as sold, not to its level inside the raw fragrance material.

What changed with Regulation (EU) 2023/1545?

It significantly expanded the list of named fragrance allergens that must be individually declared, moving well beyond the original set of around two dozen substances to many more, including further terpenes and specific naturally occurring molecules. It applies with transition periods, so verify the current list and applicable dates before finalising a label.

Is allergen declaration the same as an IFRA limit?

No. IFRA Standards set safe maximum use levels of fragrance materials for skin safety; EU allergen labelling is a separate consumer-information duty about disclosing named allergens on the INCI list. A material can comply with IFRA yet still require one or more allergens to be declared.

How do I get reliable allergen figures for a natural ingredient?

Request the supplier's allergen statement together with a batch-specific GC-MS profile and CoA. Because natural composition varies with species, chemotype and harvest, batch-level data is more dependable than a generic percentage when your dose sits near a threshold.

Do allergens below the threshold need to be recorded at all?

They need not appear on the label, but the underlying data should still be retained in the product information file. If a formula, dose or supplier batch changes, a previously sub-threshold allergen can cross the limit, so keeping the records makes the recheck straightforward.