Commission Regulation (EU) 2023/1545 — the most significant change to fragrance allergen labelling in two decades — comes into force on 31 July 2026. There is no grace period for new products, and the compliance checklist is longer than most brands currently recognise.
On 31 July 2026, Commission Regulation (EU) 2023/1545 enters full enforcement as the most significant revision to fragrance allergen labelling requirements in the European Union in two decades. The regulation amends Annex III of Regulation (EC) No 1223/2009 — the foundational EU Cosmetics Regulation — and expands the list of individually declarable fragrance allergens from the familiar 26 entries to approximately 82 substances and substance groups. There is no general grace period for new products. Any cosmetic product placed on the EU market on or after 31 July 2026 must carry a compliant label from that date.
For manufacturers, brand owners, and importers currently supplying or planning to supply the EU market — including Indian exporters — the practical compliance workload is substantially larger than a label redesign exercise.
The expanded Annex III adds 56 new entries to the legacy list, organised into three distinct categories that require different responses from quality and regulatory teams.
These are individual fragrance substances now required to be declared by INCI name above threshold. The list includes vanillin, menthol, linalyl acetate, beta-caryophyllene, methyl salicylate, anethole, carvone, and the rose ketone family. The rose ketone group has been clarified under the 2025 Corrigendum issued to the regulation — the group is now listed under the nomenclature 'Damascenone', replacing an earlier ambiguity in the original text. Brands that have been working from pre-Corrigendum versions of Annex III should verify their nomenclature is current.
A significant expansion covers natural botanical materials that were previously declared only as general INCI terms (e.g., "Lavandula Angustifolia Oil") but which now require individual disclosure of the specific allergens they contribute. Affected materials include bergamot, lavender, rose, ylang-ylang, peppermint, eucalyptus, clove, geranium, patchouli, and Peru balsam.
This category creates the most complex compliance challenge because it requires quantitative knowledge of the allergen content within each natural extract batch — information that must come from the raw material supplier, not from generic INCI databases. Supplier documentation standards for natural ingredients are variable, and obtaining audit-ready allergen quantification data for complex botanical extracts can take several weeks.
This is the most technically nuanced category. Prehaptens are substances that activate into allergens through air oxidation — notably limonene, linalool, geraniol, and alpha-terpinene. Prohaptens activate through skin enzyme activity — including eugenol, isoeugenol, and cinnamyl alcohol. Under EU 2023/1545, these substances are now treated as equivalent to their activated allergen forms for labelling purposes.
The practical implication is that if any of these precursors are present in your formulation above threshold — whether as named ingredients or as components of a natural extract — they must now be individually declared. Formulators who have historically listed only the parent extract without allergen-level disclosure need to revisit every affected product.
The existing threshold concentrations are unchanged: 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinse-off products. Above those concentrations, the allergen must appear by its exact INCI name in the ingredient list, in order of predominance consistent with the requirements of Regulation 1223/2009.
The regulation introduces both stand-alone nomenclature and group names in the new Annex III entries. This dual nomenclature system means that compliance teams must cross-reference the updated Annex III text carefully — not all commercially familiar names map directly to the regulatory INCI without verification.
On inventory, the rules create a two-tier system. Products placed on the EU market before 31 July 2026 carrying pre-amendment labelling have a sell-through window until 31 July 2028, after which any non-compliant stock must be withdrawn. New products — defined as entering EU customs for distribution on or after 31 July 2026 — must comply immediately. There is no transitional grace period for new placements on market.
For Indian manufacturers and exporters supplying EU retail channels, distributors, or own-label buyers: if product batches manufactured before the deadline will not clear EU customs and enter distribution until after 31 July 2026, those batches must carry compliant labels. Customs clearance date, not production date, is the operative moment.
The sequence of tasks required to achieve compliance is specific and non-trivial. Working backwards from the 31 July deadline with realistic lead times:
1. Obtain updated supplier documentation immediately. Contact all fragrance and botanical raw material suppliers to request allergen-specific quantification data — not generic INCI declarations. Ask specifically for IFRA certificates updated to the new Annex III scope and, for natural extracts, batch-level allergen quantification in mg/kg or percentage terms.
2. Conduct a formula-level allergen audit for every affected SKU. Map each formulation against the full 82-entry list. This requires knowing not just which ingredients are present but the contribution each makes to final allergen concentrations in the finished product, particularly for essential oils that contribute multiple allergens simultaneously.
3. Update ingredient lists with correct INCI names. Each newly declarable allergen must appear under its exact Annex III nomenclature. Check the 2025 Corrigendum nomenclature for the rose ketone group specifically. Verify that group entries are handled according to the regulation's specific instructions — some entries permit a group name; others require individual substance disclosure.
4. Update the Cosmetic Product Safety Report (CPSR). The safety assessor must review and revise the CPSR to incorporate new allergen data. In many jurisdictions, including the EU, marketing the product without an updated CPSR aligned to current regulation is itself a compliance breach, independent of the labelling question.
5. Update CPNP notifications. The Cosmetic Product Notification Portal entries for affected products must be updated to reflect current formulation and labelling status. This is a mandatory step for EU market access and must be completed before compliant products enter distribution.
6. Review and replenish packaging stocks on a compliant timeline. Production and procurement schedules for primary and secondary packaging must be adjusted to ensure that only compliant artwork is applied to batches shipped after the deadline.
Indian manufacturers and cosmetics companies exporting to the EU market — whether directly or through intermediary importers — are subject to these requirements in full. The Responsible Person or importer of record in the EU bears the compliance obligation, but in practice the label content, CPSR, and CPNP notification originate with the manufacturer. Contracts that assign responsibility for EU regulatory compliance to the EU importer without ensuring the upstream data chain is complete are a common source of post-deadline exposure.
The same regulatory trajectory is worth monitoring for Indian domestic purposes. The Bureau of Indian Standards and the regulatory architecture under the Drugs and Cosmetics Act continue to evolve, and the EU's expanded allergen disclosure model is a directional indicator for where global regulatory standards are heading on fragrance transparency.
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