Quick Answer
EU cosmetic labels must identify certain fragrance allergens individually in the Ingredients list when their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. Commission Regulation (EU) 2023/1545 expanded the Annex III disclosure rules. Since 31 July 2026, non-compliant new products cannot be placed on the EU market; qualifying stock placed earlier may remain available until 31 July 2028. Assess the finished formula, not just the fragrance concentrate.
This article focuses on fragrance-allergen disclosure, rather than every EU cosmetic label requirement. The authoritative starting points are the European Commission’s fragrance-allergen guidance, Regulation (EU) 2023/1545, and the current Annex III to Regulation (EC) No 1223/2009. Check product-specific entries and later changes before printing.
What changed under Regulation (EU) 2023/1545?
The amendment added individual labelling requirements for 56 additional fragrance allergens and updated existing Annex III entries, including some grouping and identification details. This does not mean every fragrance ingredient must be written out by its chemical name on every cosmetic. The legal decision depends on whether the particular Annex III allergen is present above the relevant threshold in the finished product.
“Parfum” or “aroma” can still identify a perfume or aromatic composition, but those collective terms do not replace separate declaration of a listed allergen when its threshold is exceeded. An ingredient appearing on the label because of this rule is not, by that fact alone, evidence that the product is unsafe; the disclosure helps sensitised consumers identify ingredients they may need to avoid.
| Question | EU rule to apply | Evidence to request |
|---|---|---|
| Is the product leave-on? | For an Annex III allergen, individual labelling is triggered above 0.001% in the finished leave-on product. | Final formula, supplier allergen breakdown and calculated finished-product level. |
| Is the product rinse-off? | For an Annex III allergen, individual labelling is triggered above 0.01% in the finished rinse-off product. | Use classification, final formula and supplier breakdown. |
| Is the name or grouping current? | Use the name and conditions of the current Annex III entry, as amended. | Legal entry, ingredient identity and approved artwork. |
| Is the product new market placement? | Since 31 July 2026, products that fail the new requirements may not newly be placed on the EU market. | Production and first-market-placement records. |
| Is it legacy stock? | Products placed before 31 July 2026 may remain available only within the stated transition, until 31 July 2028. | Traceable batch, inventory and placement evidence. |
How do brands calculate the declaration threshold?
Work from the final product composition. If a fragrance concentrate is added at a given percentage, multiply the allergen’s percentage in that concentrate by the concentrate’s percentage in the finished formula. Then consider the same listed allergen arriving from other inputs, including botanical materials or flavour/aromatic components. The comparison is against the total level in the finished cosmetic. Keep supplier calculations and formula versions traceable.
Do not use an outdated one-line allergen certificate as the only proof. Ask the fragrance house or raw-material supplier for a current, formula-specific allergen declaration and identification details. Grouped Annex III entries may require the supplier to explain which substances are included. The safety assessor and Responsible Person should resolve uncertainty before approving the Ingredients list.
What do the 2026 and 2028 dates mean?
The Commission states that from 31 July 2026, non-compliant products may no longer be placed on the EU market. Products already placed before that date may continue to be made available until 31 July 2028, subject to the regulation’s transition conditions. These are different legal concepts. Producing old packaging before the deadline is not, by itself, proof that finished goods were placed on the market.
| Scenario in September 2026 | Compliance implication | Brand control |
|---|---|---|
| New EU placement of a cosmetic after 31 July 2026 | Use an ingredient list compliant with the revised applicable fragrance-allergen entries. | Approve refreshed artwork before release and retain calculation and supplier evidence. |
| Stock demonstrably placed before 31 July 2026 | May be made available only within the transition conditions until 31 July 2028. | Keep batch-level placement evidence; plan withdrawal or relabelling before the end date. |
| Formula or fragrance substitution | Recalculate allergen totals and reassess label, CPSR and PIF. | Do not assume prior artwork covers the new composition. |
For a brand distributing across several EU countries, distinguish when and where a batch was first placed from later downstream sales. If records are incomplete, seek qualified EU regulatory advice rather than relying on a generic “sell-through until 2028” assumption.
Who provides the allergen information?
The fragrance supplier should identify regulated allergens and their levels in the supplied composition; other ingredient suppliers should disclose relevant constituents. The OEM/ODM manufacturer supplies the final quantitative formula, tracks substitutions and can calculate contributions across inputs. The brand supplies the artwork and market plan. The EU Responsible Person must ensure the marketed label, PIF and CPSR align with the actual product. A handoff contract helps, but does not remove statutory responsibilities.
A five-step label-review workflow
- Lock the exact formula. Identify the fragrance concentrate and every other material that may contribute a listed allergen.
- Collect current supplier data. Request quantitative allergen breakdowns and clarify grouped Annex III names and material revisions.
- Calculate finished-product totals. Sum relevant contributions and apply the correct leave-on or rinse-off threshold.
- Review current Annex III and artwork. Use the legally required ingredient name and check the list on real-size packaging.
- Approve and archive. Retain calculations, source version, supplier statements, signed artwork, CPSR/PIF consistency and batch placement records.
Common allergen-labelling mistakes
- Checking the fragrance concentrate percentage instead of the finished cosmetic concentration.
- Considering only the perfume blend while ignoring other botanical or aromatic sources.
- Using “parfum” as a substitute for a required individual allergen declaration.
- Relying on an old “26 allergens” worksheet without checking the amended Annex III.
- Treating the 2028 legacy-stock deadline as permission to newly place non-compliant products after July 2026.
- Updating artwork but leaving the assessor’s formula, PIF or supplier file on an earlier version.
FAQ
Does every cosmetic with fragrance need individual allergen names?
No. Individual names are required for covered Annex III allergens when their finished-product concentration exceeds the relevant leave-on or rinse-off threshold.
Are the thresholds the same for leave-on and rinse-off products?
No. The relevant thresholds are above 0.001% for leave-on and above 0.01% for rinse-off products.
Can “parfum” replace the allergen list?
No. It can identify the perfume composition generally, but covered allergens above their thresholds require individual identification.
Can old stock still be sold after July 2026?
Qualifying products placed on the EU market before 31 July 2026 may remain available under the transition until 31 July 2028; document placement and check the exact conditions.
Does an allergen label mean the cosmetic is unsafe?
No. The label informs consumers, particularly those already sensitised to a substance. Product safety remains a separate regulatory requirement.
Sources and review
- European Commission: Fragrance allergens labelling, current thresholds, amendment summary and transition dates.
- EUR-Lex: Commission Regulation (EU) 2023/1545, amending Annex III.
- EUR-Lex: Regulation (EC) No 1223/2009, Article 19 and current Annex III.
Last reviewed: 26 September 2026. Editorial responsibility: MOOYAM technical content team, reviewing the official EU sources above. This article is general information, not legal advice. Regulatory requirements may change. Brands should verify current requirements with the relevant authority or a qualified compliance professional before placing cosmetics on the market.
MOOYAM provides OEM/ODM manufacturing and technical-documentation support for international beauty brands. For an EU-market fragrance or skincare project, contact our team with the final formula, supplier allergen data and target markets.