Abstract

The EU cosmetic fragrance allergen labeling requirements are entering a critical implementation stage. Under Commission Regulation (EU) 2023/1545, cosmetic products that do not comply with the expanded labeling requirements may be placed on the EU market until July 31, 2026. Relevant products that have already been placed on the market by that date may continue to be made available on the EU market until July 31, 2028.

The new requirements add 56 fragrance allergens subject to individual labeling and update certain existing entries, substance groupings, and prescribed names. Labeling decisions remain based on the concentration of each fragrance allergen in the final cosmetic product: an ingredient must be assessed for labeling when its concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products.

This means that suppliers of fragrances, essential oils, and blended fragrance formulations need to provide composition data that are suitable for calculation, traceable, and linked to the actual product version. A standard SDS, a general COA, or a declaration stating only “contains” or “does not contain” is usually insufficient to support finished-product label calculations.

Quick Overview of the 2026 EU Fragrance Allergen Labeling Milestones

The 0.001% and 0.01% values are labeling thresholds used to determine whether an ingredient must be individually declared in the ingredient list. They are not maximum permitted concentrations for all related substances. Some ingredients may also be subject to restrictions based on product category, area of application, or maximum concentration and therefore require a separate review of the current Annex III.

Regulatory Basis and Supply Chain Responsibility

EU cosmetic fragrance allergen reviews generally involve the following regulations and documents:

Final responsibility for cosmetic labeling, safety assessment, and Product Information File compliance must still be determined based on the finished formulation, product category, and review by the EU responsible person.

Raw material suppliers do not normally determine the final product label directly. However, downstream companies rely on supplier-provided identity, concentration, and version information to calculate the actual concentration of relevant substances in the finished formulation.

The data described below therefore represent information commonly required in the supply chain to support labeling reviews. They do not mean that every supplier must use an identical document title or format.

What Is a Quantitative Fragrance Allergen Declaration?

A quantitative fragrance allergen declaration is a supply chain document that identifies regulated fragrance allergens in a specific raw material and states their concentrations and supporting data basis.

It differs from a general declaration of allergen presence. A document capable of supporting finished-product label calculations should answer at least the following questions:

1. Which Annex III entries are relevant to the raw material?
2. What is the corresponding prescribed regulatory labeling name?
3. What is the concentration of each substance in the raw material?
4. Is the concentration an analytical result, typical value, range, or maximum controlled value?
5. Which product code, formulation version, or production batch does the data apply to?
6. What analytical method and limit of quantification were used for a “not detected” result?
7. How will the supplier update the data and notify downstream users after a composition change?

Minimum Usable Data Package from a Raw Material Supplier

Product Identity and Version Information

The identity and documentation requirements for cosmetic ingredients and personal care materials vary according to ingredient type, formulation use, and target-market requirements.

For compounded fragrances and natural complex substances, a single CAS number is usually insufficient to describe the complete composition. Products sold under the same trade name but supplied with different carriers, concentrations, or fragrance variants should have separate document records.

Quantitative Fragrance Allergen Data

A statement that only says “contains,” “does not contain,” or “complies with EU requirements” does not provide enough information to determine whether the final product exceeds a labeling threshold.

What Different Data Types Can Be Used For

Not all values presented in a supplier report have the same meaning. The data type must be identified before determining how the value should be used in formulation calculations.

Using a typical value as a maximum value may underestimate the risk of triggering a labeling requirement. Using one batch result for all future batches may also overlook variation caused by natural raw materials or formulation changes.

How to Calculate Fragrance Allergen Concentrations in the Final Product

The concentration of an individual fragrance allergen in the finished product can be preliminarily calculated as follows:

Fragrance allergen concentration in the finished product (%)

= Raw material use level in the formulation (%) × Fragrance allergen concentration in the raw material (%) ÷ 100

For example, a leave-on cosmetic contains 1% of a fragrance, and the Linalool concentration in the fragrance is 0.8%.

The calculation is:

1% × 0.8% ÷ 100 = 0.008%

A concentration of 0.008% is higher than the 0.001% labeling threshold for leave-on products and must therefore be included in the ingredient labeling review.

If the same substance is present in a fragrance, essential oil, botanical extract, or another functional ingredient, the contributions from all sources to the final formulation must be combined. The calculation cannot be limited to the primary fragrance alone.

The following conditions must also be standardized during the calculation:

• All data must use the same concentration unit.
• Raw material concentrates, diluted products, and active-content bases must be distinguished.
• Isomers or substance groups must be combined according to the applicable entry.
• The final product must be classified correctly as leave-on or rinse-off.
• It must be clear whether a typical value, upper end of a range, or maximum controlled value is being used.
• The fragrance formulation version and finished-product formulation version used for the calculation must be recorded.

Why “Not Detected” Does Not Directly Mean “Absent”

“Not detected” means that no reportable result was obtained under a specific analytical method and level of analytical capability. It does not mean that the substance is absolutely absent from the sample.

When reviewing a “not detected” result, the following information must also be confirmed:

• The analytical method used;
• Whether the method is suitable for the complex matrix of a fragrance, essential oil, or extract;
• The limit of detection and limit of quantification;
• The reporting unit;
• Whether the relevant substance group and isomers are covered;
• Whether the data apply to a specific batch or to the general product;
• Whether co-elution or matrix interference may occur;
• Whether the LOQ is low enough to support the finished-product labeling threshold assessment.

For example, the labeling threshold for a leave-on product is only 0.001%. If the LOQ of the raw material testing method is too high, a “not detected” result may still be insufficient to demonstrate that the final formulation falls below the labeling threshold.The suitability of the analytical method, matrix, and LOQ should be confirmed using appropriate cosmetic analytical standards where applicable.

Claims such as “allergen-free,” “contains no fragrance allergens,” or “zero allergen risk” therefore require adequate and applicable supporting data and should not be based only on a screening report.

Why Essential Oils and Botanical Extracts Require Separate Review

The composition of essential oils, absolutes, concretes, and botanical extracts may be affected by plant variety, geographical origin, harvest season, plant part, and processing method.

These ingredients usually require review at two levels.

Regulatory Identity of the Natural Complex Substance

The following information should be confirmed:

• Botanical name;
• Plant part used;
• Extraction or distillation method;
• Corresponding INCI name;
• Whether Annex III specifies a common labeling name;
• Which botanical sources, derivatives, or substance groups are covered by that name.

Specific Constituent Substances in the Raw Material

Natural ingredients may also contain Limonene, Linalool, Citral, Eugenol, or other substances that require individual assessment.

Supplier data should preferably include:

• Representative composition ranges;
• Maximum values or controlled ranges for key constituents;
• Whether the data are based on batch testing or historical trends;
• How natural variation is incorporated into specification control;
• Whether changes in origin, variety, or processing method trigger a document update.

Using only a traditional fixed fragrance allergen list may fail to reflect the regulatory entry and prescribed name of the natural complex substance itself or its actual batch-to-batch variation.

How SDS, TDS, Specifications, COA, and Quantitative Declarations Work Together

These documents address different issues and cannot replace one another.

The presence of a substance in an SDS does not mean that it necessarily exceeds the labeling threshold in the final cosmetic product. Similarly, the absence of a substance from the SDS does not mean that it can be excluded from cosmetic labeling assessment.

Possession of an SDS also does not mean that the product is absolutely safe or automatically compliant with the regulations of every country or every cosmetic application.

Version and Batch Management from Sample to Commercial Supply

A label calculation completed for an R&D sample does not mean that the same conclusion can be applied indefinitely to future commercial purchases.

Common sources of differences include:

• The sample and commercial product use different product codes;
• The fragrance formulation has been substituted or adjusted;
• The origin, variety, or season of an essential oil has changed;
• The carrier, dilution ratio, or antioxidant system has been modified;
• An upstream raw material supplier has changed;
• The analytical method or LOQ has been updated;
• The fragrance allergen declaration still refers to an older regulatory version;
• Commercial data use a wider range than the typical value provided for the sample.

A complete traceability chain generally includes:

Sample code → Commercial product code → Fragrance formulation version → Fragrance allergen declaration version → Product specification version → COA batch → Finished-product label calculation version

A change at any point in this chain may affect a previously completed label calculation.

What to Monitor for Batch Consistency

Batch consistency for fragrances and essential oils includes more than odor, color, density, and refractive index. It also includes whether regulatory data remain within the previously assessed range.

Key points include:

• Whether fragrance allergen concentrations remain within the declared range;
• Whether typical values are gradually approaching a labeling threshold;
• Whether the natural composition shows a significant trend change;
• Whether the scope of substance groups or isomers has been revised;
• Whether an old document continues to be used after a formulation change;
• Whether the batch number, product label, and COA can be matched.

Batch consistency does not require every constituent to remain completely unchanged. It requires changes to be controlled and traceable and to be communicated promptly when they may affect labeling or safety assessment.

Impurities and Stability Indicators Directly Related to This Topic

The core of a fragrance allergen labeling review is the identity and concentration of relevant substances. It is not necessary to add every common chemical raw material parameter mechanically.

Oxidation Status

Certain terpene substances may oxidize when exposed to air, heat, or light. For relevant essential oils and fragrance ingredients, the applicable Annex III entry should be reviewed to determine whether a peroxide value requirement applies, together with the following information:

• Whether an antioxidant is used;
• Whether the packaging reduces exposure to air and light;
• The period of use after opening;
• Whether retesting is required after storage;
• Whether the analytical data were generated from a properly stored sample.

Residual Solvents

Absolutes, concretes, and botanical extracts may be produced using solvents. Residual solvents do not normally determine fragrance allergen labeling directly, but they may affect raw material quality, safety assessment, and target-market documentation.

The specific solvent name, specification limit, analytical method, and reporting basis should be clearly stated instead of using only a general statement such as “complies with requirements.”

Moisture and Volatile Loss

Moisture may affect the stability and concentration basis of certain natural ingredients, while the loss of volatile components may alter the fragrance composition and quantitative results.

Moisture, metal ions, or particulate matter should only be included in the specification when justified by the product characteristics, process, or application. They are not default core items in every fragrance allergen document review.

How Packaging and Storage Affect Data Reliability

A raw material that complies with its declaration at the time of release may not retain the same composition after inappropriate storage.

Depending on their specific stability, fragrances, essential oils, and natural extracts may require confirmation of:

• Container material compatibility;
• Seal integrity;
• Protection from light;
• Storage temperature;
• Period of use after opening;
• Risk of volatile component loss;
• Air exposure in partially filled containers;
• Batch number and label traceability during repacking;
• Product code, batch number, and expiry date on the packaging label.

Typical values, ranges, or stability data provided by the supplier should correspond to the specified packaging, storage conditions, and shelf life.

Supplier Document Review Checklist

Common Risk Signals

Regulatory Changes Must Continue to Be Reviewed after the 2026 Milestone

Regulation (EU) 2023/1545 mainly addresses the expansion of fragrance allergens subject to individual labeling and the related transition arrangements.

Subsequent regulations may continue to revise conditions of use, maximum concentrations, product categories, or labeling names for specific substances. For example, Regulation (EU) 2026/909 further revises certain conditions of use for Benzyl Salicylate, Citral, and other substances.

These subsequent amendments must be assessed separately from Regulation (EU) 2023/1545:

1. Whether the concentration exceeds the fragrance allergen threshold requiring individual labeling;
2. Whether the substance complies with the maximum concentration or other restrictions for the specific product category;
3. Whether the labeling name in the supplier document is consistent with the current glossary of common ingredient names;
4. Whether the raw material declaration and finished-product label calculation still correspond to the latest regulatory version.

Declaring a substance on the label does not mean that its use level automatically complies with all Annex III restrictions.

How ChemicalCell Supports Fragrance Raw Material Document Confirmation

For specific fragrances, essential oils, botanical extracts, or fragrance-containing cosmetic ingredients, ChemicalCell can assist in organizing the product identity, specifications, and document scope that need to be confirmed during the RFQ stage.

Relevant support may include:

• Confirming the product name, INCI, CAS number, or product code;
• Communicating requirements for an updated EU quantitative fragrance allergen declaration;
• Reviewing the availability and versions of the SDS, TDS, specification, COA, and related documents;
• Confirming concentration data, units, analytical methods, and LOQ;
• Communicating requirements for samples, commercial supply, and formulation change notification.

Final labeling and EU market compliance decisions must still be based on the finished formulation, product category, safety assessment, and review by the EU responsible person.

FAQ

Must all products with old labels be removed immediately after July 31, 2026?

Not necessarily. Relevant products that do not comply with the expanded labeling requirements may be placed on the EU market until July 31, 2026. Products that have already been placed on the market by that date and meet the applicable transitional conditions may continue to be made available on the EU market until July 31, 2028.

Companies must still retain records capable of demonstrating the product batch, placing-on-the-market date, formulation version, and label version.

Can an older fragrance allergen report still be used?

An older report may be retained for historical traceability, but it should not be used directly to support the new requirements without verifying its scope.

The report should be checked to confirm whether it covers the 56 fragrance allergens added by Regulation (EU) 2023/1545, the updated substance groups, isomers, and prescribed labeling names, and whether the data still correspond to the product currently being supplied.

Does a COA that does not list every fragrance allergen mean that the documentation is unacceptable?

Not necessarily.

The primary purpose of a COA is to demonstrate whether a specific batch meets the product specification. Complete fragrance allergen data may be provided through a separate quantitative declaration, analytical report, or controlled formulation data.

The key requirement is that the COA, specification, and fragrance allergen declaration correspond to the same product code and version and explain how the relevant composition is controlled from batch to batch.

If the supplier reports “not detected,” can the substance be omitted from the finished-product label?

A decision cannot be based only on the words “not detected.”

The analytical method, LOQ, raw material use level, final product category, and possible contribution of the same substance from other ingredients must also be reviewed. The result has practical value for labeling assessment only when the analytical capability is sufficient to support the finished-formulation threshold determination.

Do natural essential oils only require assessment for Limonene and Linalool?

Not necessarily.

Natural essential oils may contain multiple fragrance allergens that require assessment. Certain natural complex substances may also correspond to specific Annex III entries or prescribed names.

The review must consider the regulatory identity of the essential oil itself, the concentration of each relevant constituent, and the total contribution of those constituents to the final formulation.

Document Request and RFQ

When sourcing fragrances, essential oils, botanical extracts, or fragrance-containing cosmetic ingredients, the following information may be included in the RFQ:

To confirm whether a specific product can be supplied with data suitable for the 2026 EU fragrance allergen labeling review, the RFQ may include the raw material name, expected use level, final product type, and required document version so that the available supplier documentation can be reviewed in advance.