
Naomie Halioua
Co-founder & CRO, AI Research

The EU's cosmetics allergen list grows from 26 to 82 substances on 31 July — and the Commission corrected three entries eight months after most brands had already locked their mapping
From 31 July 2026, any cosmetic product placed on the EU market for the first time must declare fragrance allergens against an Annex III list that has grown from 26 substances to 82, under Commission Regulation (EU) 2023/1545 — adopted in July 2023, but reaching its first hard compliance date only now. Products already on EU shelves before that date get a second deadline, 31 July 2028, to sell through. Most coverage has filed this as a single, static list update: add 56 substances, update the label, done. What that framing misses: the Commission itself was still correcting that list eight months ago. A corrigendum published in the Official Journal in November 2025 renamed one allergen, split another into three separately-declarable variants, and added a new one outright — after most brands had already built their SKU-level allergen mapping against the original 2023 text.
What actually changes, and when
Directive 2003/15/EC introduced the individual-labelling duty for 26 fragrance allergens (24 individual substances plus two natural extracts — oakmoss extract and treemoss extract) above 0.001% in leave-on products and 0.01% in rinse-off products. That list had not moved in two decades. Commission Regulation (EU) 2023/1545 of 26 July 2023 (OJ L 188, 27.7.2023; entered into force 16 August 2023) added 56 new fragrance allergens to Annex III of Regulation (EC) No 1223/2009, taking the individually-declarable list to 82 substances. The concentration thresholds themselves were not touched — still 0.001% / 0.01%. The regulation split the transition into two dates: cosmetic products may be placed on the EU market for the first time without declaring the new allergens only until 31 July 2026; products already placed on the market by that date may continue to be made available for sale until 31 July 2028. Then, in November 2025 — about eight months before the first deadline — the Commission published a corrigendum in the Official Journal (OJ 2025/90876) making three changes to the Annex III text itself: renaming "Rose ketone 4 (Damascone)" to "Rose ketone 4 (Damascenone)"; splitting the "Pelargonium Graveolens Flower Oil" entry to separately cover Oil, Flower Oil and Leaf Oil; and adding a wholly new entry, Pogostemon Cablin Leaf Oil (patchouli leaf oil). The corrigendum left both deadlines untouched.
Three nuances that separate signal from noise
01
It's not a static list, it's a moving one
The Commission corrected 3 Annex III entries in November 2025, eight months after the base regulation and still inside the compliance runway it set.
02
Two deadlines for two different populations
New SKUs entering the market versus stock already on shelves: a two-year gap between 31 July 2026 and 31 July 2028.
03
The thresholds didn't move — only what crosses them did
0.001% leave-on / 0.01% rinse-off is the same math the industry has run since 2003; only the list of substances measured against it grew.
2003
Directive 2003/15/EC establishes individual-labelling duties for the original 26 fragrance allergens.
26 Jul 2023
Commission Regulation (EU) 2023/1545 is adopted, adding 56 new fragrance allergens to Annex III.
16 Aug 2023
The regulation enters into force, 20 days after publication in the Official Journal.
Nov 2025
A corrigendum (OJ 2025/90876) corrects 3 Annex III entries — renames one, splits one, adds one new.
31 Jul 2026
Deadline: products placed on the EU market for the first time must comply with the full 82-allergen list.
31 Jul 2028
Deadline: products already on the market by 31 July 2026 must be fully compliant or withdrawn.
From 26 to 82
Before 31 July 2026, the compliance question was already familiar to the industry: the 2003 directive required individual declaration of 26 fragrance allergens above the same thresholds that still apply today. What changes with Regulation 2023/1545 is not the mechanism — it's the scale. 56 additional substances join the list at once, more than doubling the original count, on detection thresholds that have not moved in two decades. For a brand selling fragrance, scented body care or fragranced leather-care products into the EU, that means a formula that has been stable for years can fall into a declaration obligation simply because the reference annex expanded around it — without a single ingredient in the formula changing.
56 new allergens
added to Annex III by Regulation 2023/1545, alongside the 26 already requiring individual declaration since 2003
0.001% / 0.01%
concentration thresholds triggering individual declaration in leave-on / rinse-off products, unchanged since 2003
2-year gap
between the two compliance dates: 31 July 2026 for new products, 31 July 2028 for products already on the market
The real subject: Annex III is a living dataset, not a text you read once
What used to be a single compliance question — "does our label carry every Annex III allergen above threshold?" — became a moving target during the very runway the Commission gave industry to answer it. The original 2023 text is no longer the current text: brands and labs that built their formula-to-Annex-III mapping directly from the July 2023 regulation, without tracking corrigenda since, are working from an allergen list that no longer matches what a market surveillance authority will check against from 1 August 2026. The gap concerns only three entries, but it is representative of a broader pattern for this kind of "living annex" regulation: Annex III is not a document a brand can capture once and label against for two years — it is a reference dataset that keeps moving until the day compliance is actually checked. For any brand mapping SKU-level fragrance formulations against Annex III, the compliance question isn't just "did we cover the 56 new substances" — it's "is our reference copy of Annex III even the current one."
Why it matters for brands
Any brand selling fragrance, eau de toilette, scented body care, home fragrance, or fragranced leather- or textile-care products into the EU needs SKU-level formulation data that can be checked, ingredient by ingredient, against the current 82-entry Annex III list before 31 July 2026 for any product entering the market for the first time — a scented leather-care spray or a new fragrance launch is squarely in scope. Products already sitting in EU distribution get until 31 July 2028, but only if they were genuinely placed on the market before the first cliff-edge — a brand that assumes it is covered because a product "already shipped" needs the paperwork to prove the placement date, not just the shelf date. And because the reference list itself moved eight months before the deadline, the operational risk is not only formulation gaps; it includes compliance debt baked into a mapping exercise finished against a text the Commission has since corrected.
Two ways to read 31 July
The narrow read
The EU added new allergens to a cosmetics labelling rule. Reformulate the label, ship it, done — the kind of update the industry has absorbed on a two-to-three-year cycle since 2003.
The structural read
The Commission treated Annex III as a living document even inside the compliance runway it set for it, correcting three entries eight months before the deadline without moving either date — meaning a brand's compliance posture at the cliff-edge doesn't depend only on the regulation it read in 2023, but on whether it kept re-checking the reference dataset the regulator kept revising underneath it.
Sources
- EUR-Lex — Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in cosmetic products
- EUR-Lex — Corrigendum to Commission Regulation (EU) 2023/1545 (OJ L, 2025/90876)
- European Commission — Fragrance allergens labelling (Internal Market, Industry, Entrepreneurship and SMEs)
- EUR-Lex — Regulation (EC) No 1223/2009 on cosmetic products, Annex III
- SGS — EU Expands the List of Fragrance Allergens in Cosmetic Products
- UL Solutions — EU Amends Cosmetics Regulation Regarding Fragrance Allergens
- Cosmeservice — Corrections to Regulation (EU) 2023/1545: Updated Ingredients and Key Deadlines
- ALS Global — Navigating EU Regulation 2023/1545: A Guide for Cosmetics and Personal Care Companies on Fragrance Allergen Labeling
Frequently asked questions
What changes for cosmetics sold in the EU on 31 July 2026?
From 31 July 2026, under Commission Regulation (EU) 2023/1545, any cosmetic product placed on the EU market for the first time must individually declare on-label any of the 56 newly regulated fragrance allergens present above 0.001% (leave-on) or 0.01% (rinse-off), on top of the 26 allergens already required since 2003 — a total Annex III list of 82 substances. Products already placed on the EU market before that date can continue to be sold until 31 July 2028 under the previous rules.
Does the 31 July 2026 deadline apply to cosmetics already on shelves?
No. The 31 July 2026 date applies only to products placed on the EU market for the first time from that date onward. Cosmetic products already placed on the EU market before 31 July 2026 can continue to be made available for sale until 31 July 2028, even if their label does not yet reflect the expanded allergen list.
What did the November 2025 corrigendum change, and why does it matter?
In November 2025, the European Commission published a corrigendum (OJ L, 2025/90876) to Regulation (EU) 2023/1545 correcting three entries in Annex III: it renamed 'Rose ketone 4' from 'Damascone' to the chemically distinct 'Damascenone', split the Pelargonium Graveolens entry into three separately declarable variants (oil, flower oil, leaf oil), and added Pogostemon Cablin Leaf Oil (patchouli leaf oil) as a new allergen. It did not change either compliance deadline. Brands that mapped their formulations against the original 2023 text without tracking this correction are working from an outdated reference list eight months before enforcement.
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