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Expandly Blog

EU Fragrance Allergen Labeling – 56 New Substances Mandatory on EU Cosmetic Labels by 31 July 2026

Regulation (EU) 2023/1545 expands the declared allergen list from 24 to 80 substances, with a hard label deadline of 31 July 2026.

In This Article

01What changes on 31 July
02Which products are affected
03Leave-on and rinse-off thresholds
04PIF and supplier obligations
05What to do before July

Key Takeaways

►56 new allergens, taking the list to 80
►Leave-on threshold is just 0.001%
►Responsible Person must update the PIF
►Stock in distribution has until July 2028

From 31 July 2026, every cosmetic product placed on the EU market must declare 56 additional fragrance allergens on its label where those allergens are present above threshold concentrations. The current declared list covers 24 substances. After July 31, the full list reaches 80. For US beauty brands entering the EU, this is not optional, because label changes are legally required before a single unit can be placed on the market after the deadline.

80fragrance allergens that must now be declared on EU cosmetic labels, expanded from 24 to 80 under Regulation (EU) 2023/1545, effective 31 July 2026

Regulation (EU) 2023/1545 amends Annex III of the EU Cosmetics Regulation (EC) 1223/2009. The 56 new substances cover a broad range of fragrance raw materials including atranol, chloroatranol, and a range of terpenes and aromatic compounds that appear across perfume, lotion, hair care and rinse-off formulations. The declaration threshold for leave-on products is 0.001%, so even low-concentration fragrance ingredients in moisturizers, serums and body lotions may trigger a labeling obligation. For rinse-off products, the threshold is 0.01%. Brands relying on fragrance-blend INCI names alone may now be non-compliant, because individual allergen declaration is required where thresholds are exceeded.

Products already placed on the EU market before 31 July 2026 have a sell-through window until 31 July 2028, but that window covers stock already in distribution channels, not new shipments from that date. Any product manufactured and placed into the EU supply chain after July 31 must carry the updated label. For brands planning EU launches or restocking between now and that date, the 12-week countdown is effectively a production-cycle question, because if label artwork changes require a full print run, the lead time is now.

  • 56 additional fragrance allergens must be declared from 31 July 2026, with a leave-on threshold of 0.001% and a rinse-off threshold of 0.01%
  • The total declared allergen list expands from 24 to 80 substances, so brands using complex fragrance blends face the broadest label update
  • Supplier documentation must confirm the concentration of each new allergen in finished formulations, and existing fragrance supplier data may not cover the expanded list
  • The Responsible Person must update the Product Information File (PIF) to reflect the new label declarations
  • The sell-through window to 31 July 2028 applies to stock already in EU distribution, while new shipments placed after the July 2026 deadline must carry the updated label

The fragrance allergen update is one of three active EU cosmetics compliance deadlines hitting in 2026. Brands entering the EU now need to confirm current formulation status against the expanded list and feed any updates through to artwork, PIF documentation and EU Responsible Person sign-off before July. Expandly's compliance onboarding runs label audit and documentation review as the first step, before marketplace or fulfillment setup.

Expandly helps US ecommerce brands expand into Europe — compliance, marketplaces and fulfilment, all handled. We’ve supported 2,000+ brands make the move.

  • EPR compliance managed from day one — packaging, WEEE, batteries and beyond
  • Product label review and Responsible Person service for EU and UK market entry
  • 17 years' experience, 2000+ brands expanded — Andy Hooper, Founder

The bigger picture

What the allergen expansion signals for beauty brands

The EU Cosmetics Regulation has been widening its mandatory disclosure scope for over a decade, and the jump from 24 to 80 declared allergens is the largest single revision to the fragrance allergen list, reflecting EFSA scientific opinions that have built since 2012. For a US beauty brand, the direction of travel is clear: EU cosmetics compliance is getting more granular, not less. Expandly's compliance-first onboarding begins with CPSR and label review against EC Regulation 1223/2009, then sequences PIF documentation, Responsible Person sign-off and marketplace setup, so the expanded allergen list is handled before stock ships rather than after a rejection. Brands that build formulation documentation and a credible Responsible Person relationship now can absorb the next update without a restart.

  • Supplier fragrance documentation must specifically cover the 56 new allergens, and standard safety data sheets from fragrance houses may not yet include the expanded list
  • The EU CPNP notification and PIF must be updated to reflect new label declarations, so products with unchanged formulations but non-compliant labels still need a PIF revision
  • UK cosmetics rules currently align on fragrance allergens, but divergence after July 2026 is possible if the UK does not adopt the expanded list, so monitor via the CTPA

EU Beauty and Personal Care Market

The EU beauty and personal care market is valued at over €80 billion, with France, Germany and the UK among the top five global markets by consumer spend. For US beauty brands, EU access requires a Responsible Person, CPNP notification and full product documentation before a single unit can be sold, and that baseline must now account for the expanded allergen list.

€80B+

EU beauty and personal care market value (Statista, 2026)

EU Cosmetics Compliance Scope

Under Regulation (EC) 1223/2009, every cosmetic product placed on the EU market requires a Safety Assessment, a Product Information File and a designated Responsible Person based in the EU. From July 2026, the Responsible Person is also accountable for applying the expanded allergen declaration list correctly across every affected product in the portfolio.

1223/2009

EU Cosmetics Regulation under which all fragrance allergen obligations sit

Compliance-First Onboarding

For beauty brands, Expandly begins with CPSR and label review against EC Regulation 1223/2009. From there, VAT registration, marketplace setup and EU-local fulfilment follow in the right order.

2,000+

brands expanded with Expandly

If this sounds like your world,
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Expandly helps US ecommerce brands expand into Europe — compliance, marketplaces and fulfilment, all handled.

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