EU Regulation 2023/1545: the fragrance allergens you must declare from 31 July 2026 — and the 2028 sell-through window

• Regulation (EU) 2023/1545 expands the list of fragrance allergens subject to individual labelling in EU cosmetics: from the 24 substances enforceable until 30 July 2026 to around 80, through 45 new entries (nos. 327 to 371) in Annex III of the EU Cosmetics Regulation.
• 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.
• If you did not make it in time, that second date is the one that matters — and the trap is that "placed on the market" means the first supply in the EU, not the manufacturing date. Stock produced before the deadline but first supplied after it is not covered by the sell-through window.
• 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 5: "Currently, 24 fragrance allergens listed in entries 45 and 67 to 92 of Annex III to Regulation (EC) No 1223/2009 are to be mentioned in the list of ingredients (individually labelled)."
• 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). Two of those entries are no longer there: 79 — HICC (Lyral), banned in 2017 by Regulation (EU) 2017/1410, and 83 — Butylphenyl Methylpropional (BMHCA), banned as a CMR substance. What is prohibited is not declared: it simply cannot be in the product. Add that Benzyl Alcohol sits at entry 45, not 68, and you land exactly on the regulation's own count — 24 declarable allergens across entries 45 and 67–92.
• 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 up to 30 July 2026, 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 to be placed on the market from 31 July 2026 onward. "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. The operational checklist

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 placed on the market by 31 July 2026 with the old label may sell through until 31 July 2028. Whatever is placed after that date may not. Old-label stock has a regulatory expiry date.

7. After 31 July 2026: what you can still sell

This is where most of the confusion lives, and it comes down to two verbs the regulation uses deliberately.

Stock already placed on the market keeps its runway. If a product was first supplied in the EU before 31 July 2026 with the old labelling, it may continue to be made available — distributed, stocked, sold to the consumer — until 31 July 2028. That is not tolerance or a grace period granted by an inspector: it is written into the regulation. You do not have to recall it, relabel it or destroy it.

Anything placed from 31 July 2026 onward must comply. No transitional relief, regardless of when it was manufactured.

And that is the trap. "Placing on the market" is the first making available of a product in the EU — not its manufacturing date, not its batch date, not the date it left your warehouse for your own distribution centre. A batch produced in June 2026 and first supplied to a customer in September 2026 is placed in September, and must carry the new labelling. Manufacturing early buys you nothing on its own; only actual first supply before the date does.

Some consequences worth writing into your procedures:

• Imports. An importer places the product on the EU market. A product manufactured outside the EU before the deadline but customs-cleared and supplied afterwards is a post-deadline placing.
• Your own stock in the channel. If it was supplied to distributors before the date, the 2028 window applies to it. Keep the evidence — invoices, delivery notes, batch traceability — because the burden of showing when a product was first supplied falls on you.
• Relabelling is always an option. Nothing prevents you from relabelling old stock and continuing to sell it past 2028; the transition simply means you do not have to before then.
• After 31 July 2028 non-compliant products cannot be made available at all: withdrawn or relabelled, no third option.

Note also that this transition governs labelling. It does not create any tolerance for substances that are prohibited or restricted for other reasons — HICC, atranol and chloroatranol have been banned since 2017 and no sell-through window applies to them.

8. How BD-API handles it

The BD-API CosIng database reflects what is enforceable, and it follows the official source rather than anticipating it. The 45 new entries of Regulation 2023/1545 are in it: you can look up entry 338 (Menthol), 346 (Vanillin), 354 (Lemongrass Oil), 366 (Rose Flower Oil / Extract) or 371 (Pinene) in the CosIng search and see the Annex III reference on the ingredient record.

That is deliberate, and it matters more than it looks. Nobody at BD-API typed those entries in when the regulation was published in 2023. They arrived when the official source published them, through the same synchroniser that handles every other annex change — which is the only way a database stays trustworthy over years rather than over one news cycle.

The design principle behind it is worth stating plainly, because it is what separates a database from a compliance tool: what is in the annexes and what is enforceable on a given date are two different questions. An entry can exist in the data while its obligation has not yet bitten, or while an older obligation still runs in parallel — which is exactly the situation between 2026 and 2028. A system that collapses both into a single "allowed / not allowed" flag will produce false positives, and a regulatory team that learns to ignore alerts is a compliance system that has already failed.

So the two layers do different jobs, and they are meant to stay separate:

• The database answers what does the annex say about this ingredient.
• Regulatory Watch answers what changed, when does it bite, and what do I have to do about it — detecting the Commission's amendment when it is published, analysing it, and delivering it by email and signed webhook with its deadlines and affected substances.

You need both. The 2026-to-2028 window is precisely the kind of period where having only one of them is how products end up unrelabelled.

9. Frequently asked questions

How many fragrance allergens must be declared in the EU? Up to 30 July 2026, 24 (entries 45 and 67–92 of Annex III of Regulation 1223/2009). From 31 July 2026, around 80: those 24 plus the 56 additional substances of Regulation (EU) 2023/1545, organised into 45 new entries (327–371).

The 31 July 2026 date has passed — can I still sell my old-label stock? Yes, if it was placed on the EU market before that date: it may be made available until 31 July 2028. What you cannot do is place new non-compliant product on the market, whenever it was manufactured.

What exactly does "placed on the market" mean? The first making available of a product on the EU market — the first supply in the commercial chain. It is not the manufacturing date and not the batch date. A product made in June 2026 but first supplied in September 2026 is placed in September and must carry the new labelling.

Does the 2028 date give me extra time to produce with the old label? No. The 2028 date only covers stock already placed before 31 July 2026. Anything placed afterwards must comply from day one.

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 entries) to the 56 new ones — without subtracting the entries that have since left Annex III, 79 (HICC) and 83 (Butylphenyl Methylpropional), both banned. 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.

10. 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 — 31 July 2026 and 31 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, proving for each batch on which side of 31 July 2026 it was placed on the market, and keeping the ingredient data current without anyone having to remember.

That last part is exactly what BD-API does. Use the CosIng search to cross-check any ingredient by INCI or CAS and see its Annex III entry — including the entries added by this regulation.