EU Regulation 2023/1545: every new fragrance allergen your label must declare before 31 July 2026

• Regulation (EU) 2023/1545 expands the list of fragrance allergens subject to individual labelling in EU cosmetics: from the 24 substances enforceable today to around 80, through 45 new entries (nos. 327 to 371) in Annex III of Regulation (EC) 1223/2009.
• The deadlines: from 31 July 2026, no product may be placed on the EU market without the updated labelling. Products already on the market may continue to be made available until 31 July 2028.
• The deeper change: for the first time, mass-market essential oils and natural extracts make the list — lavender, rose, jasmine, bergamot, lemon, eucalyptus, mint, patchouli, sandalwood. If you formulate with naturals, this regulation lands squarely on you.
• The thresholds do not change: 0.001 % in leave-on products and 0.01 % in rinse-off products.

1. What Regulation (EU) 2023/1545 changes (and why it took eleven years to arrive)

On 26 July 2023, the European Commission adopted Regulation (EU) 2023/1545, published in the Official Journal on 27 July 2023 and in force since 16 August 2023. It does exactly one thing, but it does it at scale: it amends Annex III of Regulation (EC) 1223/2009 — the list of restricted substances in cosmetics — to more than triple the number of fragrance allergens that must be individually declared in the ingredient list.

The science behind it is not new. It is opinion SCCS/1459/11 of the Scientific Committee on Consumer Safety, adopted at its plenary meeting of 26–27 June 2012. In that opinion, the SCCS confirmed that the allergens already listed remained relevant, and identified 56 additional fragrance allergens "which have clearly caused allergies in humans" and which until then carried no individual labelling requirement.

Do the calendar maths: the science was settled in 2012, the regulation arrived in 2023, and the obligation becomes fully enforceable in 2026. Fourteen years from evidence to shelf. That timeline is not an anecdote — it is precisely why sources that run ahead of the law (like the IFRA Standards, which read the same SCCS science) work as an early signal of what is coming.

And why does it matter this much? The regulation says it itself, in recital 2: an estimated 1 % to 9 % of the EU population is allergic to fragrance allergens. Individual declaration on the label is what lets those people avoid the exact ingredient that triggers their reaction — the generic «Perfume» or «Fragrance» designation tells them nothing.

2. The two dates that matter: 31 July 2026 and 31 July 2028

The exact legal wording — it sits in the footnotes of the regulation's Annex, not in its articles — is this:

"Cosmetic products containing that substance that do not comply with the restrictions may be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028."

Two different verbs, two different dates, two different obligations:

The distinction is not rhetorical. "Placing on the market" is the first making available of a product in the EU; "making available" is any subsequent supply, including retail sale to the end consumer. The regulation gives three years for the first and five for the second.

These two dates drive different calendars inside the same company: the 2026 one governs production, imports and launches; the 2028 one, the management of stock already in the channel. For any decision that depends on them, the reference is the regulation's text on EUR-Lex — the primary source, always.

3. 80, 81 or 82 allergens? What the regulation actually says

Three figures circulate around this regulation: 80, 81 and 82. All three come from different counts over the same data, and understanding what each one counts is the fastest way to understand the regulation itself:

• The regulation states no total. Nowhere in the legal text does "80", "81" or "82" appear. Go look: it is not there.
• What it does say, verbatim, in recital 1: currently, 24 fragrance allergens carry an individual labelling obligation (entries 45 and 67 to 92 of Annex III).
• What it says in recital 6: the SCCS identified 56 additional fragrance allergens.
• 24 + 56 = 80 substances. That is where "~80" comes from.
• And the 26? That is the original list from Directive 2003/15/EC (the "7th Amendment", from 2003), which introduced 26 allergen entries (67 through 92). But three of those substances — HICC (Lyral), atranol and chloroatranol — were banned in 2017 by Regulation (EU) 2017/1410 and dropped off the labelling list: what is prohibited is not declared, it simply cannot be there. That is why today's enforceable list is 24, not 26.
• And the 82? That is 26 + 56: the sum of the original 2003 list plus the 56 new substances, without subtracting the three substances banned in 2017. That is why it lands two above the regulation's own count.
• And the kicker: the 56 new substances do not arrive as 56 rows. They arrive as 45 new entries (nos. 327 to 371), because the regulation groups botanical species and chemical isomers into single entries — the seven rose species are one entry, the pinene isomers are one entry.

As a table, so there is no doubt left:

Any of these figures is accurate as long as it is clear what it counts: substances or entries, the current list or the historical one. This guide uses the ones from the legal text: 24 enforceable today, 56 new, 45 entries added.

4. The complete list: the 45 new Annex III entries

The new entries run from 327 to 371 and split into two very different groups. The names below are the ones from the common ingredients glossary (the ones that go on the INCI label); for the full chemical identification of each entry — several group multiple CAS numbers — the reference is the regulation's annex on EUR-Lex.

4.1. The individual chemical substances

Here are names any formulator will recognise — and several that consumers associate with "nice scent", not with "allergen":

Read it again: menthol, camphor, vanillin, benzaldehyde (the bitter-almond aroma), linalyl acetate (the heart of lavender's scent). These are not niche perfumery rarities — they are materials sitting in toothpastes, lip balms, shower gels and everyday creams.

4.2. The essential oils and natural extracts

This is the half of the list that changes the game for any brand that formulates "with naturals":

If your catalogue has a single product with lavender, rose, mint or lemon essential oil above the threshold, that product needs a new label before 31 July 2026. "Natural" never meant "allergen-free" — and from now on, the label is going to make that visible.

5. How does it go on the label? Individual entries and group names

One of the regulation's most interesting technical decisions sits in its recital 8: besides adding substances, the Commission took the opportunity to "group similar substances in one entry" and to align names with the common ingredients glossary of Article 33 of Regulation 1223/2009.

In practice, this means several of the new entries are groups, not single substances:

• Rose Flower Oil / Extract (entry 366) covers the flowers of seven rose species: damascena, alba, canina, centifolia, gallica, moschata and rugosa. One entry, one declarable name, seven botanical origins.
• Pinene (entry 371) groups the alpha and beta isomers.
• Lavandula Oil / Extract (entry 360) covers fine lavender, lavandin and their hybrids.
• Lemongrass Oil (entry 354) covers three Cymbopogon species.

For whoever designs the label, the consequence is good news: you declare the glossary name (the one in the table), not the exact botanical species or each isomer. For whoever runs formula verification, the consequence is more work: a single annex entry can now correspond to several distinct CAS numbers in your composition sheet, and your system has to know they all point to the same declaration obligation.

6. What you need to do before July 2026

1. Ask your fragrance suppliers for the updated allergen declaration. Certificates issued before 2023 declare against the list of 24. You need the composition against the new list — any serious fragrance house already provides it.
2. Cross-check your formulas against the 45 new entries. Not against trade names: against CAS numbers. Remember that group entries each bundle several CAS numbers.
3. Recalculate concentrations in the finished product. The threshold is assessed on the final product: 0.001 % leave-on, 0.01 % rinse-off. A fragrance dosed at 1 % in a cream needs the allergen to exceed 0.1 % inside the fragrance compound to reach the threshold — the maths has to be done per product.
4. Redesign the labels that need it. And check the available space: some products go from declaring 2 allergens to declaring 8. On small packaging that is a real design problem.
5. Plan production against both dates. Whatever is manufactured and placed on the market by 31 July 2026 with the old label may sell through until 31 July 2028. Whatever is placed after 31 July 2026 may not. Old label stock has a regulatory expiry date.

7. How BD-API handles it (and why we have not loaded the new allergens yet)

Here is a design decision that explains how we think about the product — and that may look counterintuitive at first glance.

The BD-API CosIng database reflects what is enforceable today, not what is coming. For allergens, that means our database carries the historical Annex III entries that are operative right now — and not the 45 new entries of Regulation 2023/1545.

Why? Because until 31 July 2026, a product that does not declare the new allergens is perfectly legal. If your verification system flagged them today as non-compliance, you would get false positives: compliant products flagged as non-compliant, alerts nobody asked for, and a regulatory team that learns to ignore alerts — which is the fastest way for a compliance system to die.

The correct flow has three phases:

1. Today — the database reflects the operative entries. What you verify against it is what the law requires right now.
2. Already, in parallel — Regulatory Watch notifies you of the changes that are coming. This regulation is exactly the kind of change we monitor: when the Commission publishes an annex amendment, we detect it, run AI analysis on it, and deliver it to you by email and signed webhook with the deadlines and affected substances.
3. On 31 July 2026 — when the EU incorporates the new entries into the operative CosIng annexes, the BD-API synchroniser detects and incorporates them automatically. No manual loading, nobody has to remember, no staleness window.

That gap between "what is in force" and "what is coming" is not a database limitation: it is the difference between a database and a monitoring system. You need both, and you need them not to blur into each other — because blurring them is what produces false positives today, or unrelabelled products in 2026.

8. Frequently asked questions

How many fragrance allergens must be declared in the EU? Today, 24 (entries 45 and 67–92 of Annex III of Regulation 1223/2009). From 31 July 2026, around 80: the current 24 plus the 56 additional substances of Regulation (EU) 2023/1545, organised into 45 new entries (327–371).

When does the new allergen labelling become mandatory? For products placed on the EU market: from 31 July 2026. Products placed before that date may continue to be made available with the previous labelling until 31 July 2028.

What are the declaration thresholds? Unchanged: 0.001 % in leave-on products and 0.01 % in rinse-off products, measured on the finished product.

Is lavender essential oil now a declarable allergen? Yes. Lavandula Oil / Extract is Annex III entry 360. The same applies to rose, jasmine, bergamot, lemon, eucalyptus, mint, patchouli, sandalwood and the rest of the naturals on the list — whenever they exceed the threshold in the finished product.

What is a "group name"? An Annex III entry that bundles several botanical species or chemical isomers under a single declarable name from the common ingredients glossary. For example, Rose Flower Oil / Extract covers seven rose species with one single label designation.

Where does the "82 allergens" figure come from? From adding the original 2003 list (26 substances) to the 56 new ones — without subtracting that three of the originals (HICC, atranol and chloroatranol) were banned in 2017 and are no longer declared. The count the regulation itself uses is 24 + 56 ≈ 80.

Does this also affect products I already have on the market? Yes, but with a longer runway: they may keep selling until 31 July 2028. After that date, non-compliant products may not be made available — they have to be withdrawn or relabelled.

9. The bottom line

Regulation (EU) 2023/1545 is the biggest change to cosmetic allergen labelling in twenty years: from 24 declarable substances to around 80, with natural essential oils entering the list for the first time, and two dates — July 2026 and July 2028 — defining the relabelling calendar of half the industry.

The hard part is not understanding the regulation. It is operationalising it: cross-checking 45 new entries (with their CAS groupings) against every formula in your catalogue, keeping verification aligned with what is enforceable today without losing sight of what is coming, and making sure that on 31 July 2026 your ingredient database updates itself instead of depending on someone remembering.

That last part is exactly what BD-API does.