Key takeaways
- EU fragrance allergen labelling 2026 is driven by Commission Regulation (EU) 2023/1545, which amends the Cosmetics Regulation (EC) No 1223/2009 and adds roughly 56 new fragrance allergens to Annex III — taking the total list of individually declarable allergens from 24 to about 80.
- The declaration thresholds are unchanged: an allergen must be named on the label when it exceeds 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinse-off products. The list of substances triggering that rule is what expanded.
- The transition runs on two dates. Non-compliant products may be placed on the EU market until 31 July 2026 and made available (sold through) until 31 July 2028. In practice, anything first placed on the market after 31 July 2026 must already carry the new declarations — so 2026 is the milestone that bites for new production.
- For buyers of natural raw materials, the regulation lands on the supplier document pack: you need a current quantitative allergen declaration (e.g. the exact % of Linalool, Limonene, Citral, Geraniol, Eugenol), an IFRA conformity certificate, an SDS, and a batch COA that lets your Responsible Person and safety assessor do the maths.
- Arovela supplies Turkish essential oils and extracts from a Sındırgı (Balıkesir) facility with a warehouse in Solingen, Germany, providing per-batch COA, SDS, and a quantitative allergen breakdown, under an ISO 22000 / ISO 9001 / ISO 27001 quality system — the documentation EU formulators need to label correctly under 2023/1545.
Introduction: why 2026 is a hard date for fragrance allergens
If you formulate, import, or sell cosmetics in the European Union, EU fragrance allergen labelling 2026 is the compliance deadline that has been circled on regulatory calendars since 2023. It is the year the first transitional cut-off under Regulation (EU) 2023/1545 takes effect, and it changes which substances must appear by name in your ingredient list.
The headline is simple to state and laborious to implement: the EU has expanded the list of fragrance substances that must be individually declared on the label. For more than a decade, 24 named allergens (plus two prohibited tree-moss extracts) had to be called out when present above set thresholds. The Scientific Committee on Consumer Safety (SCCS) reviewed the evidence and identified dozens more substances that cause contact allergy in consumers but had no individual labelling duty. Regulation 2023/1545 closed that gap by adding roughly 56 new entries to Annex III of the Cosmetics Regulation.
For brands and Responsible Persons, the work is reformulation-light but documentation-heavy: most companies do not need to change their fragrance, they need to re-declare it correctly. And that is impossible without accurate, current data from the raw-material supplier. This guide explains what Regulation 2023/1545 actually requires, the exact thresholds and deadlines (verified against the official text, with the legal nuance spelled out), and — most importantly for a procurement reader — the supplier documents you must demand so your labels are right by the 2026 deadline. If you are new to selling botanicals into the bloc, pair this with our EU market entry guide for natural products for the wider regulatory picture.
What Regulation (EU) 2023/1545 actually changes
Commission Regulation (EU) 2023/1545 was adopted on 26 July 2023 and amends Annex III of Regulation (EC) No 1223/2009, the EU Cosmetic Products Regulation. The full legal text is published on EUR-Lex, and any compliance decision should ultimately be checked against that source and your safety assessor's interpretation.
Three things are worth separating clearly, because they are often blurred in summaries.
1. The list of declarable allergens expanded — the thresholds did not
The mechanism is unchanged. Under Annex III, certain fragrance substances must be listed by their INCI name in the ingredient list whenever their concentration in the finished product exceeds:
- 0.001% (10 ppm) in leave-on products (creams, serums, lotions, perfumes, lip products, deodorant sticks), and
- 0.01% (100 ppm) in rinse-off products (shampoos, shower gels, soaps, conditioners).
What changed is the number of substances subject to that rule. The previous 24 named allergens are joined by roughly 56 additional substances, bringing the total of individually declarable fragrance allergens to around 80. So the same 10 ppm / 100 ppm logic now has to be checked against a much longer list — which means a fragrance or essential oil that was fully compliant in 2022 may now carry one or more newly declarable allergens that have to appear on the label.
2. Some entries were renamed or consolidated
The regulation also tidies and updates existing Annex III entries — for instance aligning nomenclature and merging or splitting some substances. Citral, for example, is associated with its isomers (geranial and neral); certain natural extracts and the prepared forms of substances are clarified. The practical effect for a buyer is that your allergen declaration from the supplier must use the current naming that matches the 2023/1545 Annex III, not a legacy list.
3. It is a labelling change, not (mostly) a ban
With limited exceptions, 2023/1545 does not prohibit these substances — it requires transparency so allergic consumers can avoid them. The duty is to declare, not to remove. That is why the workload is concentrated in re-checking concentrations and re-writing ingredient lists and Product Information Files (PIFs), rather than reformulating away from natural aromatics.
Some of the newly declarable allergens
The 56 additions include a number of substances that occur naturally and abundantly in essential oils — which is exactly why this regulation matters so much to buyers of natural raw materials. A non-exhaustive sample:
| Newly relevant allergen (INCI) | Commonly found naturally in | |---|---| | Vanillin | Vanilla, some balsams | | Acetylcedrene | Cedarwood-type materials | | Carvone | Spearmint, caraway, dill | | α-Damascone / δ-Damascone | Rose-type fragrance materials | | Menthol | Mint oils (peppermint, cornmint) | | Linalyl acetate | Lavender, bergamot, clary sage | | Pinene (α- and β-) | Pine, many conifer and citrus oils | | Terpineol / α-Terpineol | Numerous essential oils |
These sit alongside the long-established declarables such as Linalool, Limonene, Citral, Citronellol, Geraniol, Eugenol, Coumarin, and Benzyl alcohol, several of which are present at high percentages in common essential oils. A citrus oil can be a double-digit-percent Limonene; a lavender oil can be rich in Linalool and Linalyl acetate. That is why a credible quantitative allergen breakdown from the supplier is the single most useful document in the whole pack — see our walk-through on how to read a GC-MS report for essential oils for how those percentages are derived.
The deadlines, stated precisely (and hedged)
This is where summaries online frequently muddle the two dates, so here is the careful version. The regulation sets a dual transitional period for products that do not comply with the new labelling:
- Such products may be placed on the EU market until 31 July 2026, and
- may be made available on the EU market until 31 July 2028.
The two phrases are legal terms of art, and the distinction is the whole point:
| Phrase | Meaning under EU product law | The deadline that applies | |---|---|---| | Placing on the market | First making the individual product available in the EU (manufacturer/importer's first supply to a distributor or end user) | 31 July 2026 | | Making available on the market | Any subsequent supply in the course of commercial activity (e.g. distributor → retailer → consumer; selling through existing stock) | 31 July 2028 |
Read together: from 31 July 2026, every cosmetic product newly placed on the EU market must already comply with the updated Annex III declarations. Stock that was already on the market before that date benefits from a sell-through runway until 31 July 2028. The transitional periods are commonly described as roughly 3 years and 5 years from the regulation's 2023 entry into force.
A precise hedge, because regulatory timing has edge cases: the operative legal dates are those in the published Regulation (EU) 2023/1545, and the way "place on the market" applies to a given batch depends on when that specific unit was first supplied in the EU. Treat the table above as the planning rule, and confirm borderline cases (long-shelf-life inventory, private-label runs already in a distributor's warehouse) with your Responsible Person against the EUR-Lex text. The direction of travel is not in doubt: 2026 is the milestone for new production, and a buyer placing orders today should be sourcing materials with 2023/1545-ready allergen documentation now.
How this lands on natural raw materials specifically
Synthetic fragrance houses hand brands a finished fragrance compound with an allergen declaration attached. When you buy a pure essential oil or a natural extract, you are effectively buying a complex natural fragrance — and you (with your supplier) are responsible for knowing which declarable allergens it contains and at what level.
Because many of the 24 original and 56 new allergens are natural oil constituents, this regulation disproportionately affects natural-products formulators. A few worked principles:
- It is concentration in the finished product that matters, not in the oil. An essential oil might be 35% Limonene, but if you dose that oil at 0.2% in a leave-on cream, the Limonene in the finished product is ~0.07% — above the 0.001% leave-on threshold, so it must be declared. The arithmetic only works if you have the quantitative % of each allergen in the oil.
- Different oils, different allergen fingerprints. Lavender, citrus, mint, rose, and conifer oils each carry their own set of newly relevant allergens. There is no shortcut — each material needs its own current declaration.
- Crop-year variation is real. The exact allergen percentages in a natural oil shift with harvest, region, and distillation. This is why a per-batch declaration beats a generic, one-time spec sheet. Figures vary by crop year; a responsible supplier states the actual values for the lot you receive.
For the broader mechanics of qualifying a natural-products supplier and building a compliant spec, our essential oils B2B sourcing guide covers the document flow end to end.
The supplier document pack you need for 2023/1545
Here is the practical checklist a procurement or regulatory reader should send to any essential-oil or extract supplier when preparing for EU fragrance allergen labelling 2026.
| Document | What it must show | Why 2023/1545 needs it | |---|---|---| | Quantitative allergen declaration | The % (w/w) of each Annex III allergen present in the material — e.g. Linalool, Limonene, Citral, Geraniol, Eugenol, Coumarin — using current INCI naming | Lets you calculate finished-product concentration against the 0.001% / 0.01% thresholds and build the ingredient list | | IFRA conformity certificate | Conformity of the material with the relevant IFRA Standards (usage restrictions for fragrance ingredients) | Underpins safe-use levels for fragrance applications; routinely requested by retail and brand buyers | | Batch Certificate of Analysis (COA) | GC-MS volatile profile tied to the exact lot, plus physical constants and contaminants | Supports identity, purity, and the allergen percentages for that batch | | Safety Data Sheet (SDS) | Hazard classification, handling, storage, transport | Required for import, handling, and the PIF | | GC-MS / chromatographic data | The underlying chromatogram and component table | Evidence base behind the quantitative allergen figures | | Country-of-origin / specification sheet | Origin (Türkiye), botanical name, agreed grade and tolerances | Customs, traceability, and contractual conformity |
Two notes that save time during qualification:
- Ask for the allergen declaration in the format your safety assessor expects — ideally a clean table of "allergen / % in material," not a buried line in a GC-MS PDF. It speeds up the PIF and the label.
- Match the naming to the 2023/1545 Annex III. A declaration that still uses superseded names creates avoidable back-and-forth. Confirm the supplier issues declarations on the updated list.
A precise note on certification claims
Buyers preparing EU labels often ask suppliers about COSMOS, ECOCERT, organic, GMP, halal, or kosher status because their own brand or retailer demands it. Be exact about what a supplier actually holds versus what it can document per batch.
Arovela's certifications are ISO 22000, ISO 9001, and ISO 27001. We provide per-batch COA, SDS, an IFRA conformity certificate where applicable, and a quantitative allergen declaration to support your 2023/1545 labelling. We do not claim COSMOS, ECOCERT, organic, GMP, halal, or kosher certification. If your specification requires one of those scheme certificates, raise it during qualification so the correct sourcing route is confirmed rather than assumed — never inferred from an ISO certificate, which is a different kind of standard.
A practical compliance workflow
For a brand or contract manufacturer working backward from the 2026 milestone, the path is methodical rather than dramatic:
Step 1 — Inventory your fragranced products and materials
List every SKU that contains fragrance or fragrant naturals, and every essential oil / extract / fragrance compound feeding them. Natural materials need special attention because their allergen content is intrinsic.
Step 2 — Get current quantitative allergen data per material
Request an up-to-date allergen declaration for each raw material, on the 2023/1545 Annex III naming, ideally per batch. This is the input that makes everything else possible.
Step 3 — Recalculate finished-product allergen levels
For each product, multiply each material's allergen % by its dosage and sum across materials, then compare against 0.001% (leave-on) or 0.01% (rinse-off). Anything over threshold must be declared.
Step 4 — Update labels and the Product Information File
Add the newly triggered allergens to the ingredient list (in the correct INCI form) and update the PIF and safety assessment. Remember that the safety assessment of the finished product is a separate, non-negotiable obligation under EC 1223/2009 — "natural" does not exempt a formula from the dossier.
Step 5 — Align to the deadline
Ensure products first placed on the market from 31 July 2026 carry the updated declarations, and manage sell-through of existing stock within the 31 July 2028 window.
Frequently asked questions
What is Regulation (EU) 2023/1545?
It is the Commission Regulation, adopted on 26 July 2023, that amends Annex III of the EU Cosmetics Regulation (EC) No 1223/2009 to expand the list of fragrance allergens that must be individually declared on cosmetic labels. It adds roughly 56 new substances to the previously declarable list of 24, bringing the total to about 80, and updates the naming of several existing entries. It does not change the long-standing declaration thresholds. The authoritative text is on EUR-Lex.
What is the deadline for EU fragrance allergen labelling in 2026?
The key 2026 date is 31 July 2026. From that date, cosmetic products first placed on the EU market must comply with the updated Annex III declarations. Products that were already made available on the market before then may continue to be sold (sell-through) until 31 July 2028. So 2026 is the milestone for new production, and 2028 is the final sell-through cut-off. Confirm borderline inventory cases against the published regulation with your Responsible Person.
What are the declaration thresholds for fragrance allergens?
They are unchanged by 2023/1545: a listed allergen must be named in the ingredient list when its concentration in the finished product exceeds 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinse-off products. The regulation expanded which substances are subject to this rule, not the percentages themselves.
Which new allergens affect essential oils the most?
Many of the additions occur naturally in essential oils, so natural-products formulators are disproportionately affected. Examples include Vanillin, Carvone, Menthol, Linalyl acetate, α-/β-Pinene, Terpineol, and the Damascones, alongside the high-impact established declarables such as Linalool, Limonene, Citral, Geraniol, Citronellol, and Eugenol that are abundant in citrus, lavender, mint, rose, and conifer oils. Each oil has its own allergen fingerprint, so each material needs its own current quantitative declaration.
What documents do I need from my essential oil supplier?
At minimum: a quantitative allergen declaration (the % of each Annex III allergen in the material, on current INCI naming), an IFRA conformity certificate, a batch COA with the GC-MS profile, and an SDS. Country-of-origin and specification sheets round out traceability. The quantitative allergen declaration is the most important, because it is the input for calculating finished-product levels against the thresholds.
Does Arovela provide allergen declarations and IFRA certificates?
Yes. Arovela supplies a quantitative allergen declaration, an IFRA conformity certificate where applicable, a per-batch COA with GC-MS data, and an SDS for its essential oils and extracts — the document set EU formulators need to label correctly under 2023/1545. Arovela holds ISO 22000, ISO 9001, and ISO 27001 certifications; it does not claim COSMOS, ECOCERT, organic, GMP, halal, or kosher certification. Materials ship from a Sındırgı (Balıkesir) facility with stock held in a Solingen, Germany warehouse for short EU lead times.
Source 2023/1545-ready materials with the right paperwork
Getting EU fragrance allergen labelling 2026 right is mostly a documentation exercise — and it stands or falls on the data your raw-material supplier provides. The brands that will clear the 31 July 2026 milestone smoothly are the ones already buying essential oils and extracts with a current quantitative allergen declaration, IFRA conformity, SDS, and a per-batch COA in hand.
Arovela supplies Turkish essential oils, natural extracts, and aromatic plants from a Sındırgı (Balıkesir) facility with a warehouse in Solingen, Germany for short EU lead times, under an ISO 22000 / ISO 9001 / ISO 27001 quality system with per-batch COA. Tell us the oils you use, your destination market, and your label requirements, and we will match the materials and the allergen documentation your Responsible Person needs. Request grades, samples, and a quote through our wholesale page, or contact the Arovela team to start a compliant sourcing conversation.