Fragrance Allergen Labelling: The Expanded EU List, 2026 & 2028 Deadlines and Great Britain Rules

Somewhere in a drawer is a fragrance allergen statement from your supplier, dated two or three years ago, listing the twenty six allergens and ticking the ones present. It is about to become the wrong document. Regulation (EU) 2023/1545 amended Annex III of Regulation (EC) No 1223/2009 to expand the list of fragrance allergens that must be individually named on labels from twenty six to more than eighty, following an opinion of the Scientific Committee on Consumer Safety that identified. many more substances as established contact allergens. The EU gave the industry three years for new products and five for existing stock, and those dates are now here. Great Britain, which retained the twenty six under the Cosmetic Products Enforcement Regulations 2013, has not mirrored the change on the same timetable.

This guide is the practical version of the regulation. It explains what changed and why, what the new entries are in kind including the natural extracts that now count as allergens themselves, the thresholds and how they apply, the two deadlines and what each means for a product you have on sale and a product you are about to launch, the Great Britain and Northern Ireland position, what you need from your fragrance supplier and what to do if you cannot get it, a worked example from allergen statement to printed label, a step by step label workflow, and the CPSR and PIF updates that go with it. The statement in the drawer is not wrong. It is just from before.

What changed and why

For years the regulation required twenty six specific fragrance allergens to be named individually in the ingredient list when present above set thresholds, so that consumers who had been sensitised could avoid them. The scientific committee's review found that many other fragrance materials were established contact allergens in humans on the same evidence base, and recommended that they be labelled too. Regulation (EU) 2023/1545 implemented that recommendation by amending the relevant entries in Annex III. The result is a list of more than eighty substances, including the original twenty six, that must be declared when present above the thresholds. The change is about information, not prohibition: none of the new entries is banned, and their permitted levels are unchanged. What changes is what the label must say.

The new entries, in kind

The new list adds individual fragrance molecules that are common in both synthetic and natural fragrance, and it adds a number of natural extracts and oils as allergens in their own right, so that a product containing them must name the extract itself, not only its constituents. Among the substances now on the list are additional terpenes and their oxidised forms, further aldehydes and alcohols, several materials found in floral, woody and spicy accords, and extracts and oils such as certain citrus, jasmine, rose, ylang ylang, lavender, sandalwood, cedarwood and mint materials. The consequence for a natural perfumer is significant: a lavender essential oil was previously assessed for its linalool and limonene content, and is now potentially declarable as lavender oil itself as well as for its constituents. Your supplier's allergen statement must therefore be issued against the new list, not the old one.

The thresholds, and how they apply

An allergen must be named when its concentration in the finished product exceeds 0.001 percent in a leave on product or 0.01 percent in a rinse off product. The calculation is the same as before: the allergen's percentage in the fragrance concentrate, from the supplier's statement, multiplied by the concentrate's percentage in your product. For an essential oil that is itself an entry, the oil's own percentage in the product is compared with the threshold directly, and its constituents are also assessed individually. Where the same allergen arrives from two sources, a fragrance oil and an essential oil, the contributions are summed. A leave on perfume at fifteen percent concentrate will cross the leave on threshold for almost every allergen present in the concentrate at more than about 0.007 percent, which is most of them; a rinse off shower gel at one percent fragrance will cross the rinse off threshold only for allergens present at more than one percent of the concentrate. This is the core of allergen labeling: whenever the concentration exceeds the relevant limit, the allergen must be declared, whether the product is among the leave-on products that stay on the skin or the rinse-off products that are washed away. The purpose is to help people prone to allergic reactions make informed choices about what they buy.

The two deadlines, and what each means for you

The regulation set two dates. From 31 July 2026, cosmetic products placed on the EU market must carry the expanded allergen declarations. Placing on the market means the first making available of a product, so a product launched after that date, or a new batch of an existing product placed on the market after that date, must comply with no transition. From 31 July 2028, products that were placed on the market before 31 July 2026 under the old rules must also comply, and non compliant stock must be withdrawn. The practical reading for most brands is that 31 July 2026 is the deadline: anything you make and sell after it must have the new label, and the 2028 date is only a grace period for stock that was already in the supply chain. Brands that planned around 2028 have discovered that their reprints came due two years earlier. These dates come from the amendments to Regulation (EC) No 1223/2009, which apply across the European Union, and the gap between them is best understood as a limited transition period for existing stock rather than a general extension.

Great Britain and Northern Ireland

The expanded list is an EU measure. Great Britain retained the twenty six allergen requirement at the end of 2020 and has its own process, through OPSS and its scientific advisory group, for adopting changes. At the time of this guide Great Britain has not mirrored the expanded list on the EU timetable, and makers should check the current OPSS position before finalising labels. A product sold only in Great Britain continues to declare the twenty six above the thresholds. A product sold in the EU declares the expanded list. A product sold in both needs either two labels or one label carrying the longer list, which satisfies both markets because declaring more allergens than Great Britain requires is not a breach. Whichever route a brand chooses, the allergen list on the pack must match the assessed formula, and the ingredient list should show Parfum followed by each named allergen in its correct INCI name. Northern Ireland follows the EU rules and dates, so UK wide sellers are already in the EU regime for that part of the country, and the same regulatory requirements apply there as in the rest of the EU. Our guide to selling in Northern Ireland covers that in full.

What you need from your fragrance supplier

The document that makes compliance possible is an allergen statement for each fragrance concentrate, issued against the expanded list, giving the percentage of each listed allergen in the concentrate rather than merely ticking presence. Reputable fragrance houses reissued these statements as the regulation approached, and most now provide them as standard alongside the IFRA certificate and the Safety Data Sheet. For essential oils, a constituent breakdown or a gas chromatography analysis for the batch serves the same purpose, and because natural oils vary, batch specific data are far more useful than a generic profile. The same documents show whether any of the fragrance ingredients are also restricted under Annex III of the regulation, where a maximum concentration may apply regardless of the labelling threshold. The expanded list itself follows the opinion of the Scientific Committee on Consumer Safety, whose assessment identified these substances as fragrance allergens of concern. If a supplier cannot provide percentages against the new list, the assessor cannot calculate your declaration, and our allergen compliance review can derive it from constituent data where the supplier will disclose them. If the supplier can provide nothing, the honest answer is to change supplier before the deadline rather than after.

A worked example: from statement to label

A brand sells a rose and geranium body oil at three percent fragrance, leave on, in Great Britain and Ireland. The old allergen statement listed citronellol, geraniol, linalool and limonene. The new statement, issued against the expanded list, adds two further molecules present in the rose accord, and notes that the geranium oil in the blend is itself an entry. The assessor calculates each at three percent of the concentrate's figures: citronellol 0.45, geraniol 0.3, linalool 0.24, limonene 0.15, the two new molecules at 0.006 and 0.004, and geranium oil at 0.6 percent of the product. All exceed the leave on threshold of 0.001 percent. The GB label, under the twenty six, names the first four. The EU label names all six molecules and the geranium oil. The brand chooses one UK wide label carrying the full EU declaration, which is compliant in Great Britain, in Northern Ireland and in Ireland, reprints it before 31 July 2026, and files the new statement, the calculation and the artwork in the PIF with a change log entry. Declaring these allergens clearly on the ingredients list matters because repeated exposure can lead to allergic contact dermatitis in sensitised users, and it is one of the simplest ways a brand can address product safety and wider consumer safety. Getting the declaration right at the outset also avoids later safety concerns when a retailer, marketplace or authority checks the label against the formula.

A label workflow that meets both markets

• Inventory. List every product, its fragrances and essential oils, and its markets.
• Collect. Obtain an allergen statement with percentages against the expanded list for each fragrance, and constituent data for each essential oil.
• Calculate. For each product, each allergen's concentration in the finished product, summed across sources, against the threshold for leave on or rinse off.
• Decide the label strategy. GB only, EU only, or one label with the longer list.
• Update the CPSR. An addendum recording the new declaration and confirming no change to the safety conclusion, since levels are unchanged.
• Redesign. Ingredient lists with the new allergen names after Parfum, checked for order and INCI nomenclature.
• Review. Artwork against Part B and the labelling rules before print.
• Schedule. Reprint so that products placed on the EU market from 31 July 2026 carry the new label, and existing stock is cleared or relabelled by 31 July 2028.
• File. Statements, calculations, addendum and artwork in the PIF; notification label images updated.

The CPSR and PIF updates

The expanded list changes labelling, not the safety conclusion, because the permitted levels of the substances are unchanged. The assessor therefore issues an addendum recording the new allergen declaration for each variant and confirming that Part B's conclusion stands, rather than a new report. The PIF change log records the regulatory change, the addendum, the new supplier statements and the label versions, with superseded artwork archived. Notification label images are updated through CPNP for EU products. This is a textbook example of the review cycle our guide to keeping the CPSR current describes, and of why an ingredient register that lists every fragrance across the range makes a regulatory change a morning's work rather than a month's.

Label space and small products

Longer allergen lists are a real problem on small packs, and perfume and lip products are where the lists grow most. The regulation's existing solutions apply: the ingredient list may go on the outer packaging or, where impracticable, on a leaflet, tag or card indicated by the hand and book symbol on the container. Brands relabelling for the expanded list should plan the space at the same time. Our label review checks the new declarations against the regulation and the artwork against the available space.

Myths we hear

• The deadline is 2028. For new products and new batches it is 31 July 2026; 2028 is only for stock already on the market.
• My allergens have not changed so my label is fine. The list of what counts as an allergen changed; your declaration almost certainly grows.
• Natural fragrance is exempt. Several essential oils are now allergens in their own right.
• The UK adopted the same change. Not on the same timetable; check the OPSS position.
• I can just add Parfum and be done. Parfum has never been enough; the allergens above threshold must be named.

What to do this week

• Pull every allergen statement and check its date and which list it was issued against.
• Request updated statements with percentages from every supplier.
• Decide your label strategy for each market.
• Ask your assessor for allergen addenda across the range.
• Book the reprint so it lands before 31 July 2026.

This is the largest single labelling change in a decade, and it is one the industry saw coming for three years. A consultation will scope the work across your range in one call, and the free Fragrance Allergens Checker lets you test a statement against the new thresholds before you order a single label. Open the drawer, find the old statement, and replace it.

Official sources and legislation

• Regulation (EU) 2023/1545 on fragrance allergen labelling
• Regulation (EC) No 1223/2009 on cosmetic products, Annex III
• Cosmetic Products Enforcement Regulations 2013
• Scientific Committee on Consumer Safety (SCCS)
• OPSS guidance on cosmetic products regulations

Disclaimer: This article is general information, not legal advice. Regulations change and product decisions depend on your exact formulation, claims and market. Have your product assessed by a qualified professional before sale.