EU fragrance-allergen labeling requires a complete-formula calculation and the correct current ingredient names, thresholds and transition conditions. This guide provides a reproducible fictional calculation and artwork annotations for qualified review. It is not a reviewed production formula or approved label.
The Core Regulation: Annex III
Review current Annex III to Regulation (EC) No 1223/2009 together with the changes under Regulation (EU) 2023/1545. Relevant contributions can arise from fragrance mixtures and other ingredients. Do not limit the calculation to an old 26-substance supplier list or assume natural sources are exempt.
What Are the Listed EU Fragrance Allergens?
Use the actual Annex III entry, substance identifiers, grouping rules and required declaration name. Counts such as “26” or “over 80” are not a substitute for that mapping. The examples below illustrate why a name-based checklist needs review:
Map Substances to the Required Declaration Name
- Limonene: Regulation 2023/1545’s replacement entry 88 identifies covered forms and the Limonene declaration; assess the applicable combined contribution, not only one supplier trade name.
- Grouped names: Entries such as Citral and Rose Ketones show why the required label name and grouping need direct comparison with the official text. No frequency ranking is implied.
Track the Applicable Entry and Version
The amendment includes both additions and changes to existing entries, including grouped declarations. Do not call every familiar fragrance ingredient a new addition. For each applicable entry, record:
- Substance identity and CAS/EC information from the supplier.
- Current Annex III entry and required ingredient/declaration name.
- Relevant group membership and contributions from every material.
- Applicable restrictions, labeling threshold and placement/availability transition.
Buyer action: Request versioned composition/allergen information adequate to assess all relevant ingredients in the final product. Keep the supplier source, material revision, calculation basis and any uncertainty or data gap visible.
Key Thresholds for Declaration
The relevant Annex III label trigger is assessed in the complete final product, not solely in the concentrate. Apply the entry’s scope, threshold and grouping rules. A label threshold is not a universal safe-use limit or permission to omit an ingredient that is otherwise required to be declared.
| Product Type | Allergen Concentration Threshold |
|---|---|
| Leave-on products (e.g., face cream, body lotion, perfume) | > 0.001% |
| Rinse-off products (e.g., shampoo, shower gel, hand soap) | > 0.01% |
How to Correctly Calculate and Label
For each contributing raw material, multiply its final-formula percentage by the relevant substance percentage in that material and divide by 100. Sum all contributions on the same basis, avoiding double counting components already included in a mixture declaration. The fictional example below uses Limonene as the mapped declaration name; it is not a recommended formula.
Practical steps for your ingredient list:
- Location: Allergens are declared within the general ingredient list, not separately.
- Order: Apply Article 19 ingredient-order rules and exceptions to the whole list. Allergens are not universally placed immediately after Parfum or always at the end.
- Nomenclature: Use the required common ingredient/declaration name in the applicable current entry; a supplier’s trade or analytical name may differ.
- Raw-material identity versus allergen declaration: A separately added botanical ingredient may have its own ingredient-list identity, and relevant allergen declarations may be required in addition. Do not replace the botanical ingredient with only its allergen molecule or assume every botanical name is omitted.
Working with Fragrance Suppliers for EU Compliance
Agree the following information with the relevant suppliers and qualified reviewer for the actual formula. Receipt of a file does not establish its accuracy or completed label review:
- Versioned fragrance/allergen information mapped to the applicable entries and intended market.
- Quantitative composition data or appropriate evidence for each relevant contribution, with basis and limitations identified.
- Applicable supplier IFRA conformity information as separate intended-use evidence, not a replacement for allergen calculations.
- Relevant material hazard information and SDS where applicable; not a complete allergen declaration by default.
- An agreed change-notification process for formula, supplier or material revisions that may affect the calculation.
Fictional calculation: sum more than one source
| Material | Use in final product, % w/w | Limonene in material, % w/w | Contribution to final product, % w/w |
|---|---|---|---|
| Fragrance mixture F | 10.00 | 0.020 | 10.00 × 0.020 ÷ 100 = 0.0020 |
| Separately added botanical material B | 0.50 | 0.10 | 0.50 × 0.10 ÷ 100 = 0.0005 |
| Other materials in this simplified example | 89.50 | Assumed zero only for this example | 0 |
| Total | 100.00 | Not a concentrate concentration | 0.0025% = 25 ppm |
For the stated fictional leave-on product, 0.0025% is above the 0.001% declaration threshold in the cited Limonene entry. The separate botanical contribution matters even though it is individually below that threshold. Actual data must account for every relevant source and applicable grouping; near-threshold uncertainty needs qualified review. This calculation does not establish safety or compliance with other restrictions.
Ingredient-panel annotation, not approved artwork
| Illustrative label field | Reviewer check |
|---|---|
| Ingredients: [complete ordered base list], Parfum, [separately added botanical’s verified ingredient name], Limonene | Placeholder order is not approved: verify each material’s correct nomenclature and Article 19 ordering/exception rules |
| Limonene | Mapped example declaration under entry 88; calculation and applicable forms need confirmation |
| Botanical ingredient placeholder | Retain its own required identity where applicable; the additional allergen declaration does not erase it |
| Approval record | Formula/material versions ___; entry/version ___; actual calculation ___; reviewer ___; sign-off date ___ |
Source check: 10 October 2026, current Cosmetics Regulation and Regulation (EU) 2023/1545. The conditional placement transition ended 31 July 2026; eligible earlier-rule products may use the conditional availability transition until 31 July 2028. Regulatory reviewer: not yet appointed for an actual product; the calculation and text annotations are illustrative, not final label approval.
Frequently Asked Questions
Are essential oils exempt from the allergen labeling requirement?
No natural-source exemption is established for an applicable listed substance. Assess relevant contributions using supplier data and the current entry; confirm uncertainty, grouping and all other ingredient-label duties with the qualified reviewer.
If my product contains no “fragrance,” do I need to check this list?
Yes. Evaluate the complete formula, including ingredients used for other purposes. A “fragrance-free” or “unscented” claim does not establish that no relevant substances are present; the claim itself also needs appropriate substantiation.
What is the consequence of a labeling error?
An incorrect declaration can be regulatory non-compliance. The responsible person should assess affected artwork/stock and necessary corrective measures with a qualified reviewer; consequences depend on the actual circumstances.
Does the expanded allergen list apply to product safety assessments?
The assessor needs sufficient information to evaluate product safety separately from label thresholds. Being below a declaration threshold is not proof of absence, safety or lack of sensitisation risk.
To discuss the formula-data and manufacturing documentation scope, Request a Quote. Confirm who performs the final Annex III mapping, calculation and artwork sign-off.