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Allergen Analysis: Reporting the 26 EU Allergens in Fragrance Products

A practical guide to identifying, calculating, and declaring the 26 EU-regulated fragrance allergens — from GC-MS detection and IFRA limits to label requirements and B2B documentation.

Esans.com.tr Academy ·✍️ Esans Academy Technical Team ·~9 min read
01

The 26 Allergen Question: Names That Must Appear on the Label

A fragrance leaves a mark on skin. Sometimes a pleasant memory, sometimes a rash. The European Union took the latter seriously and placed certain fragrance substances on a mandatory disclosure list. The rest is your responsibility.

For many years this list was known as the 26 substances. The 2023 revision (EU 2023/1545) expanded it, pushing the total number of declarable substances above 80. So the term "26 allergens" now serves as shorthand for a larger family — yet the core group in industry parlance still consists of those original 26 names.

The critical point here is this: these substances are not "dangerous" — they are "declarable". They are ingredients that sensitive skin types need to be aware of, but which can be used safely at the correct levels. Being on the list is not a ban; it is a demand for transparency.

Common misconception: "Natural fragrance oil contains no allergens." The opposite is true. Some of the most tightly restricted allergens — Citral (in lemon and lemongrass), Eugenol (in clove), and oakmoss — are found in the highest concentrations in natural essential oils. Safety depends not on whether a source is natural or synthetic, but on the molecule itself and the level of use.

The correct approach, therefore, is to know which allergen is present at which level when you formulate your fragrance oil. You cannot put on a label what you do not know; and what you omit from the label creates legal risk.

02

Detection: Seeing the Invisible with GC-MS

Your nose may sense a Citral, but it cannot tell you its proportion. The eyes of this operation are GC-MS: Gas Chromatography–Mass Spectrometry (gas chromatography separates the substance; the mass spectrometer identifies each component).

The working principle is straightforward: a fragrance oil sample is vaporised and separated into molecules that travel at different speeds along a column (a long, narrow tube). Each molecule leaves the column at a different time — this is called the retention time. The mass spectrometer then provides the "fingerprint" of each component. Together, they reveal every allergen in your fragrance oil, both by identity and by proportion.

This follows the same logic as other methods used to characterise a fragrance oil: a refractometer reads the refractive index; a viscometer describes flow. GC-MS is the chemical map of the composition. All three together form the quality profile of a fragrance oil.

Tip: If you do not have a GC-MS instrument, don't worry. Request an allergen declaration from your fragrance oil supplier. Reputable suppliers provide the allergen profile of each batch together with an IFRA compliance certificate. Multiply that data by the proportion of fragrance oil in your own formula to calculate the percentage in the finished product.
Safety note: Sample preparation involves high-grade ethanol and solvents — low flash-point, highly flammable materials. Avoid static electricity, ensure adequate ventilation, and wear gloves and eye protection.
03

Limits: IFRA, SCCS, and the Declaration Threshold

Do not confuse two separate concepts. One is the usage limit (IFRA — how much of a substance you may include); the other is the declaration threshold (SCCS/EU — above what level you must declare it on the label).

The declaration threshold under the classic rule is clear: for leave-on products (those that remain on skin, such as perfume), any allergen present above 0.001% (10 ppm) in the finished product must be named on the label; for rinse-off products (such as soap), the threshold is 0.01% (100 ppm). Allergens below these thresholds do not trigger a declaration requirement.

Important caveat: IFRA limits apply to individual substances within the fragrance oil and to the product category — not to the total fragrance oil proportion. There is no blanket rule such as "any fragrance oil is safe up to 20%." If a fragrance oil contains a high level of Citral, that substance may reach the IFRA ceiling even at a low fragrance oil dosage.

ConceptWhat Does It State?SourceThreshold / Logic
IFRA LimitMaximum amount of a substance you may useIFRA StandardsSubstance- and category-specific; variable
Declaration Threshold (leave-on)Level above which the name must appear on the labelEU 1223/20090.001% (10 ppm)
Declaration Threshold (rinse-off)Level above which the name must appear on the labelEU 1223/20090.01% (100 ppm)
SCCS OpinionScientific safety assessmentSCCS reportsFeeds the list and the thresholds

Finding the allergen percentage in the finished product is a simple chain calculation: allergen proportion in the fragrance oil × fragrance oil proportion in the formula = proportion in the finished product.

Example calculation: The supplier declaration states "Limonene 4%." You are using that fragrance oil at 15% in a perfume. Limonene in the finished product: 0.04 × 0.15 = 0.006 (0.6%). This is well above the leave-on declaration threshold of 0.001% — it must appear on the label.
The density trap: Always calculate on a mass (gram) basis, not a volume (ml) basis. Fragrance oil densities vary considerably — a citrus-dominant fragrance oil may be ~0.84 g/ml, while a heavy resin/synthetic base can exceed 1.10 g/ml. Calculating by ml will skew your ratios. Keep a specific gravity table to hand.
04

Label Declaration and Providing Documentation to Customers

You have gathered the data and done the calculations. Now you need to transfer that information correctly — both to the label and to your B2B customers. The process follows a step-by-step sequence.

  1. Collect supplier declarations

    File the allergen percentage table and IFRA compliance certificate for every fragrance oil you use. Values may change between batches; always base your work on the document for the current batch.

  2. Multiply by the formula proportion

    Multiply the proportion of each allergen in the fragrance oil by the proportion of that fragrance oil in your formula to obtain its percentage in the finished product. Work on a mass basis.

  3. Compare against the threshold

    Flag every substance that exceeds 0.001% for leave-on products or 0.01% for rinse-off products.

  4. Add to the ingredients (INCI) list

    Include allergens that exceed the threshold in the ingredients list by their INCI names (Limonene, Linalool, Citronellol, etc.), positioned in the correct descending-order-of-quantity sequence.

  5. Prepare an Allergen Statement

    Provide your B2B customer with a document showing the allergen levels in the finished product and whether each threshold has been exceeded. This enables the customer to complete their own labelling.

  6. Link to the safety file

    Connect this data to the product's safety assessment and technical dossier — this is what will be requested during an audit.

FIGURE 01Process Strip — Step by Step
🔹1. Collectsupplier…🔹2. Multiply by theformula…🔹3. Compare againstthe threshold…🔹4. Add to theingredients🔹5. Prepare anAllergen…🔹6. Link to thesafety file…
Allergen (INCI)Level in Fragrance OilFragrance Oil in FormulaIn Finished ProductDeclare? (leave-on)
Limonene4.0%15%0.600%Yes
Linalool2.0%15%0.300%Yes
Citral0.05%15%0.0075%Yes
Eugenol0.005%15%0.00075%No (below threshold)
Turkey note: If you are selling within Turkey, your product must be notified via the ÜTS (Product Tracking System). Note that the process (notification steps) and responsibility (obligations of the responsible person/manufacturer) are separate matters. In addition, ÜTS company registration and product notification are subject to official fees — they are not free of charge. For current procedures and fee amounts, refer to the TİTCK as the authoritative source.
05

Common Mistakes and Frequently Asked Questions

The pitfalls where manufacturers stumble in allergen reporting are well-known. Let's flag a few traps, then answer three fundamental questions.

The biggest mistake is taking the allergen percentage as it appears in the fragrance oil and writing it directly on the label. What goes on the label is the proportion in the finished product, not in the fragrance oil. The second mistake is calculating by ml and ignoring the density difference. The third is being stuck on the old "26 allergens" list and overlooking the 2023 expansion.

Tip: Create an allergen table template and populate it with the supplier declaration for every new fragrance oil you use. When you change the formula, the proportions update automatically. Make it a living document, not a one-off exercise.
Can I produce an allergen report without my own GC-MS instrument?
Yes, you can. An instrument is not mandatory; your fragrance oil supplier's allergen declaration is a perfectly valid starting point. Multiply the percentages in that declaration by your own formula proportions to calculate the values in the finished product. If independent verification is required, you can commission GC-MS analysis from an accredited laboratory. For most manufacturers, a supplier document combined with a correct calculation chain is sufficient.
Am I exempt from allergen declaration if I use natural fragrance oil?
No — if anything, you need to be more careful. Many of the declarable allergens (Citral, Eugenol, Geraniol, oakmoss) are found in the highest concentrations in natural essential oils. Being natural confers no exemption; every substance that exceeds the threshold must be declared regardless of its source. Furthermore, some natural oils (such as bergamot) may be phototoxic, which introduces a separate usage restriction.
May I declare an allergen voluntarily even if it falls just below the threshold?
Yes. Voluntary additional disclosure does not create any legal problem; on the contrary, it is regarded as a positive transparency measure. However, the accuracy and readability of the ingredients list must not be compromised. For values close to the threshold, also consider the possibility that batch variation could push the level above it — in which case including the declaration is the safer choice. For a definitive decision, base your judgement on the product's safety assessment.

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