On 31 July 2026, the European Union (EU) will begin the hard enforcement of Commission Regulation (EU) 2023/1545, the most significant change to fragrance allergen labelling in two decades.
The amendment expands Annex III of Regulation (EC) No 1223/2009 from the familiar list of 26 entries (commonly referenced as ‘the 26’) to approximately 82 substances and substance groups that must be individually disclosed on cosmetic product labels above threshold.
There is no general grace period.
From that date, any new cosmetic product placed on the EU market crossing into EU customs for distribution must comply.
Existing inventory placed on the market before 31 July 2026 has until 31 July 2028 to be withdrawn if it does not comply.
For brands and manufacturers that have not yet started the work, the timeline is unforgiving.
Here is what matters most in the weeks ahead.
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What has changed that beauty brands need to know?
The expanded Annex III adds 56 new entries on top of the legacy list.
These additions fall into three groups:
- New allergens, such as vanillin, menthol, linalyl acetate, beta-caryophyllene, methyl salicylate, anethole, carvone and the rose ketone family (now clarified as ‘Damascenone’ by the 2025 Corrigendum).
- New natural extracts and essential oils, including bergamot, lavender, rose, ylang-ylang, peppermint, eucalyptus, clove, geranium, patchouli and Peru balsam.
- Prehaptens and prohaptens – substances that activate into allergens through air oxidation (limonene, linalool, geraniol, alpha-terpinene) or skin enzyme activity (eugenol, isoeugenol, cinnamyl alcohol). Under the 2023 amendment, these are now treated as equivalent to their activated forms.
Thresholds remain unchanged: 0.001% in leave-on products and 0.01% in rinse-off products.
Above those levels, every declared allergen must appear by its exact INCI name in the ingredient list.
Consumer reading a beauty product label
What does this mean in practice for beauty businesses?
This is not a label change exercise. It is a regulatory file refresh.
Consider a leave-on body lotion using just 0.5% bergamot oil.
Bergamot oil contains roughly 30% limonene. That puts limonene in the finished product at 0.15% – 150 times the leave-on threshold.
The product label now requires a ‘limonene’ declaration.
The Cosmetic Product Safety Report (CPSR) needs an updated composition table; an updated Sensitisation or Quantitative Risk assessment; an updated toxicological profile; and a re-signed Part B.
For brands and manufacturers that have not yet started the work, the timeline is unforgiving
The Product Information File (PIF) needs the supplier's allergen declaration and the refreshed CPSR.
The CPNP record needs to be updated to reflect the new label.
For products built on lavender, rose, ylang-ylang or any citrus, the same exercise produces multiple declarations per ingredient.
A typical lavender oil at common use levels will surface linalool and linalyl acetate, often also limonene, geraniol and trace coumarin.
A bergamot top note frequently surfaces limonene, linalool and linalyl acetate together.
And, because limonene and linalool are also prehaptens, the safety assessor must address oxidation behaviour, including antioxidant strategy and packaging selection in the CPSR narrative.
What are the common pitfalls to be aware of?
We see the same misconceptions across brands of every size:
- "Our IFRA certificate is enough” – it is not. An IFRA Certificate of Conformity confirms maximum usage levels. It does not list the specific allergens inside the fragrance or their percentages.
Brands need a separate Allergen Declaration aligned with Regulation (EU) 2023/1545 from every fragrance and essential oil supplier.
- "Natural products are exempt” – they are not. The Annex III obligation attaches to the chemistry present in the finished product, regardless of source.
A 100% natural perfume can require a longer allergen disclosure than a synthetic one.
- "Our formula did not change, so the CPSR does not need to” – it does. Even with an unchanged formula, the safety assessor must rework composition, exposure math, oxidation analysis and toxicological references against the current regulatory framework.
The European Union will begin the enforcement of Commission Regulation (EU) 2023/1545 next month
What should beauty brands be doing right now?
A realistic per-sku cycle runs six-to-16 weeks depending on supplier responsiveness.
With weeks remaining, the priority sequence is:
- Inventory affected skus. Identify every product on the EU or Northern Ireland market containing ‘parfum’, ‘aroma’ or any essential oil.
- Request supplier allergen declarations. Demand a per-allergen breakdown aligned with regulation (EU) 2023/1545 – not just an IFRA certificate.
- Update each CPSR. A qualified safety assessor recalculates exposure per allergen, refreshes the toxicological profile, addresses prehapten and prohapten behaviour, and re-signs Part B.
- Refresh PIF, label and CPNP. Use the exact Annex III INCI names. Coordinate multi-language artwork across EU markets. Re-notify CPNP.
- Sequence production. Ensure no non-compliant batch enters EU customs after 31 July 2026.
Where suppliers cannot or will not provide allergen data, a scenario we see frequently with small or single-source natural suppliers, brands have options.
ISO 17025 accredited laboratories can perform GC-MS/MS analysis against all 82 Annex III substances, typically within two-to-four weeks per sample, producing a defensible allergen profile usable in the CPSR.
What are the costs of delay?
After 31 July 2026, non-compliant new products are subject to customs detention at the EU border, and Safety Gate (RAPEX) alerts that propagate across all 27 member states within hours.
The reputational impact of a public Safety Gate alert often exceeds the direct cost of remediation – retail partners and future regulators see it, and the record is permanent.
Preparedness beats panic.
We see the same misconceptions across brands of every size
The EU is not banning fragrance. It is forcing transparency at the molecular level.
Brands that align supplier data, CPSR updates, label artwork and CPNP records now will move into the second half of 2026 cleanly.
Brands that wait will be making decisions at the border instead of in the lab.
The time spent gathering supplier data, updating safety assessments and filing the right regulatory documents pays for itself the first time a shipment (and every shipment thereafter) clears customs without delay.
This article was written by Jaclyn Bellomo, Senior Director of Cosmetic Science and Regulatory Affairs for Registrar Corp, a compliance company that helps beauty businesses meet regulatory requirements for the US, Canada, EU and UK markets.
Bellomo has more than 15 years of experience in technical formulation, regulatory compliance, product development and brand management.
Image credits: Adobe Stock.
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