Products newly placed on the EU market must meet the expanded fragrance allergen labelling requirements. The deadline for new market placement was 31 July 2026. Eligible products placed on the market before that deadline can continue through the supply chain until 31 July 2028, subject to the transition conditions.[1][3]

Check that the formula, current supplier declarations, ingredient list and stock history agree. An old allergen statement may no longer cover the requirements. This guide covers the EU rules, but your responsible person needs to review the specific product. Include that review in your EU cosmetic compliance checklist.

What the law requires

Regulation (EU) 2023/1545 expanded individual labelling to 56 additional fragrance allergens and updated existing Annex III entries. It also groups certain substances and specifies names for their declaration. Check the current legal entries rather than relying on a spreadsheet described only as an “old” or “new” allergen list.[1][3]

The applicable declaration thresholds are concentrations in the finished cosmetic product, not in its perfume concentrate:[1][3]

These thresholds determine when disclosure is required. They are not general permitted-use limits and do not establish that a sensitised consumer will tolerate the product. Annex III can impose separate restrictions, and the finished product still needs a safety assessment. Adding an allergen name does not make an otherwise non-compliant formula acceptable.[1][11]

Perfume and aromatic compositions can generally appear as “parfum” or “aroma”, but those terms do not replace the required individual allergen declarations. Check the exact entry and required name before approving the cosmetic INCI ingredient list.[1][3]

Classify stock by market placement, not manufacture date

Placing on the market means the first making available of a cosmetic product on the EU market. Making available includes commercial supply for distribution, consumption or use, whether paid or free. A production date, purchase order or notification date alone does not establish that first supply.[11]

Use the distinction to sort stock as shown below. This is a suggested approach, not a statutory record format:

The Commission describes the sell-through route as applying to products placed before 31 July 2026. The transition notes for each entry set the legal conditions, including compliance with earlier rules where stipulated. If records leave the placement date uncertain around the cut-off, ask the responsible person to review them before claiming an exemption.[1][3]

Get allergen data for the materials you buy

Ask suppliers for quantitative allergen data that covers the expanded requirements and identifies the exact commercial material and revision. Include fragrance blends, essential oils and other raw materials that may contribute a listed substance. A formula without added perfume still needs this review if its botanical ingredients supply declarable allergens.[1]

Ask each supplier to identify:

• The trade name, supplier code and document revision for each material.
• The listed substances present, their identities and concentrations or justified upper bounds.
• How grouped substances are reported, including whether totals already combine individual constituents.
• Whether carriers, solvents or blended components contribute additional allergens.
• The supplier’s change-notification arrangements and any unresolved data gaps.

These purchasing controls are recommendations, not a mandatory EU declaration template. If a supplier gives a range, assess the upper bound or obtain data supporting a narrower value. Do not assume the midpoint is suitable for the calculation. Keep the approved declarations with the formulation record and raw-material documentation.

Calculate all contributions before choosing label names

For a single contribution, multiply the percentage of a raw material in the product by the percentage of the allergen in that material, then divide by 100. Add contributions from every relevant raw material. Keep the unrounded results until the threshold comparison is complete.

Hypothetical calculation: one allergen, two sources

A fictional leave-on body lotion contains 0.80% fragrance. Its supplier reports 0.40% Limonene in that fragrance. A separate botanical ingredient contributes another 0.0004% Limonene to the finished lotion.

At 0.0036%, the total exceeds the 0.001% leave-on threshold, so Limonene must be declared. It falls below the 0.01% rinse-off threshold, but the lotion is still a leave-on product; the comparison says nothing about compliance of a different rinse-off formula. All figures in this example are hypothetical, not results from a tested product.[1]

Annex III entry 371 combines alpha- and beta-pinene under the declaration name “Pinene”. If a fictional leave-on product contains 0.0007% of one covered constituent and 0.0006% of another, the combined 0.0013% exceeds the leave-on threshold even though neither contribution does alone. Map the supplier’s identities to the legal entry and avoid counting a reported group total twice.[1]

The legal trigger is “exceeds”. If a calculation appears exactly on a threshold, investigate precision and material variability before deciding that no declaration is needed.

Check corrected names and later restrictions

Do not approve artwork against the original 2023 annex in isolation. The November 2025 corrigendum corrected entry 157’s identification of Rose ketone 4 to “Damascenone”, expanded the glossary names in entry 364 for Pelargonium graveolens oil and added Pogostemon Cablin Leaf Oil in entry 365. The individual entries, including their declaration wording, remain the reference for label decisions.[2]

Regulation (EU) 2026/909 also changes Annex III entries for Citral and Benzyl Salicylate, among other substances, with product-category restrictions and entry-specific transition provisions. Its relevant notes include a 1 January 2027 placement cut-off and July or August 2028 availability cut-offs. These separate formulation restrictions do not postpone the July 2026 expanded-labelling deadline.[4]

Ask the responsible person to review applicable use restrictions as well as label thresholds. If the formula must change, handle that through cosmetic reformulation and change control, rather than treating it as an artwork correction.

Review the release records together

Before releasing new EU stock, assign an owner to each check:

1. Regulatory confirms the current Annex III entries, amendments and required declaration names.
2. Formulation confirms the approved recipe and all relevant supplier data.
3. Quality checks the calculation, group mapping and unresolved concentration ranges.
4. The responsible person checks consistency with the safety assessment, product information file and final label.[3][11]
5. Operations links the approved artwork version to the units being supplied and separates transitional stock.

This allocation of tasks is a recommendation. The regulatory duties still apply if the brand, contract manufacturer and fragrance house divide the work differently. Hold release if the supplier data or market-placement evidence cannot support the decision.

Keep the approved ingredient list with its calculation and stock records. Recheck that file when a supplier revises a material or the brand orders a reprint.