Ultimo aggiornamento 16 June 2026
Introduction
For manufacturers and importers of cosmetics and fragranced products, the issue of allergens on cosmetic labels can no longer be put off. Regulation (EU) 2023/1545 was adopted as an amendment to Cosmetics Regulation 1223/2009 regarding the labeling of allergenic fragrances. As a result, cosmetic labels must be revised.
Its operational impact involves collecting data from suppliers, reviewing formulas, updating documentation, and planning for reprints.
The issue is not merely regulatory, but also organizational. Under Regulation 2023/1545, the list of allergenic fragrances that must be individually listed on the label is updated, introducing new substances and confirming declaration thresholds of 0.001% in leave-on products and 0.01% in rinse-off products. This means that, for the same formula, a product may now require significantly more information than in the past, with a direct impact onlabel management, packaging readability, and consistency with the technical information received from suppliers.
Companies, however, often make the same mistake: they look at the deadline and think they still have time. In reality, the timeline set by the regulation requires them to act now. Cosmetic products placed on the market after July 31, 2026, must comply with the new requirements, while those already on the market before that date may only be made available until July 31, 2028. After July 31, 2028, even products still on the shelves will no longer be allowed to be sold if they do not comply. The legislator has provided for a transition period precisely because the update involves a large number of products and requires adjustments to formulas, containers, and labels.
Waiting until July 2026 would therefore be a mistake. Between requesting information from suppliers, verifying thresholds, assessing the impact on labels, potentially updating documentation, and managing old inventory, there is a lot of work to be done. And for those who import raw materials or finished products from non-EU suppliers, the timeline could be even longer.
Allergens: What Really Changes Under EU Regulation 2023/1545
The key point of Regulation (EU) 2023/1545 is simple to summarize but very challenging to implement in practice: it significantly increases the number of allergenic fragrances that must be listed individually on cosmetic labels when they exceed certain thresholds. Until now, the regulatory framework required the listing of 26 allergenic fragrances already listed in Annex III of the Cosmetics Regulation; with the new regulatory measure, an additional 56 allergenic fragrances are added to this list, identified by the Scientific Committee on Consumer Safety as substances that have clearly caused allergies in humans. The result is a significant expansion of the list of substances to be monitored and, consequently, of the information that companies must be able to manage.
This means that the change is not just about “more names to list” on the label. It changes how information received from suppliers must be interpreted, it changes the assessment of a fragrance’s impact on the product’s declared composition, and it also changes the operational burden associatedwith updating labels, technical specifications, and supporting documentation. A fragrance that until yesterday generated few entries to list may now result in a much longer list of substances to be declared individually, even in the absence of changes to the finished product’s formula.
Another key point is that the regulation not only introduces new substances but also confirms the declaration thresholds, which continue to serve as the operational benchmark for determining when an allergen must appear on the label. The presence of the substance must be indicated when the concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. These are very low thresholds, and for this very reason, they may result in allergens appearing on the label that were not previously considered in the company’s daily operations.
From an operational standpoint, this is likely the real game-changer in Regulation 1545. Companies cannot simply check whether a fragrance contains “the usual allergens”; instead, they must require their suppliers to provide a much more up-to-date and comprehensive overview of the allergen composition.
There is also another factor that is often overlooked: EU Regulation 2023/1545 also updates the way certain substances must be named on the label. When there are multiple common names for a substance, the regulation specifies the name to be used in the ingredients list, with the aim of simplifying labeling, making it more understandable for consumers, and facilitating the work of businesses and authorities. At the same time, certain similar substances are grouped under a single entry. This means that companies must not only determine whether to declare an allergen but also how to declare it correctly.
This is an important step because many fragrances, essential oils, and plant extracts have complex compositions, with multiple CAS numbers, isomers, or possible names. The regulation has updated several entries in Annex III specifically to align common names with the latest version of the ingredients glossary and to group similar substances under a single entry. In practice, reading the supplier’s technical documentation becomes even more challenging: the same substance may appear in the data sheet under one name but must be listed on the label with a different name or with a group name defined by the regulation.
For companies, all of this boils down to a very concrete conclusion: Regulation 2023/1545 does not merely require a minor formal adjustment, but calls for a genuine review of the available information on the fragrances used. This is why the July 31, 2026 deadline should not be viewed as a distant one. By that date, products placed on the market must comply with the new requirements, and given the large number of new allergenic fragrances that must be listed individually, the legislator has provided for a transition period precisely because the adjustments may involve formulations, containers, and labels. Non-compliant products already placed on the market prior to that date may remain available only until July 31, 2028.
In other words, here’s what really changes with Regulation 1545: the number of allergens to be monitored increases, the amount of information that can appear on labels grows, the use of correct terminology becomes more important, and there is less leeway to address the issue at the last minute. For those working with scented products—and in particular with detergents and formulations that use complex fragrances—the transition must begin now, not just before July 2026.
Cosmetics labeling: why updating allergen information is a pressing issue
The issue of allergens on cosmetic labels becomes a practical concern when the focus shifts from regulatory requirements to the day-to-day management of the product. Regulation (EU) 2023/1545 formally amends the regulatory framework for cosmetics.
The first issue is a very practical one: even if the formula remains the same, the label may become longer. Regulation 1545 significantly expands the number of allergenic fragrances that must be listed individually when they exceed the established thresholds, which remain set at 0.001% in leave-on products and 0.01% in rinse-off products.
When a supplier updates the allergen profile of a fragrance, the amount of information the company must analyze increases, and the amount of information that needs to be included in product documentation and communications may also increase. In other words, the detergent formula doesn’t always change, but the amount of information that needs to be managed often does.
This is the real issue. Many cosmetics already have dense labels, as they must include commercial information, instructions for use, safety information where applicable, and the elements required by industry regulations. If we add to this a more extensive list of fragrance-related allergens, the impact is not only regulatory but also visual and logistical. The label needs to be redesigned in terms of space, readability, and consistency of information. And when a company manages a large number of product lines, the problem ceases to be a minor detail and becomes a full-fledged update project.
There is also a second critical issue: it is not enough to know that an allergen is present; one must also know how to list it correctly. Regulation 2023/1545 clarifies that, when there are multiple common names for a substance, the name specified in the regulation must be used in the list of ingredients, in order to simplify the labeling and make it more understandable. Furthermore, in some cases, related substances or variants of the same substance are grouped under a single name. This means that detergent manufacturers must not only receive data from their suppliers but also interpret it correctly: a substance may appear in technical documentation under a specific name or CAS number and then need to be listed on the label under a different name or a group name.
This is exactly what happens with many complex fragrances, essential oils, and natural extracts. Some provisions of the regulation clearly show that multiple substances or variants can be grouped under a single label term, as in the case of “Rose Ketones,” “Lavandula Oil / Extract,” or “Pinus Mugo.”
Time is of the essence. The legislator has provided for a transition period because the large number of new allergenic fragrances that must be listed individually on labels, and the significant number of products affected, require economic operators to have sufficient time to adapt their formulations, labels, and packaging. Non-compliant products may be placed on the market only until July 31, 2026, and made available only until July 31, 2028.
Labels on imported cosmetics: why the risk is even higher
The issue of allergens becomes even more sensitive when it comes to imported products or raw materials purchased from suppliers outside the EU.
In the case of cosmetics, Regulation (EU) 2023/1545 directly amends Regulation 1223/2009 regarding the labeling of allergenic fragrances and sets out a very clear timeline: cosmetic products placed on the market after July 31, 2026, must comply with the new requirements, while those already on the market before that date may continue to be made available only until July 31, 2028.
For those who import cosmetics, this means that simply waiting for a new cosmetic label from the supplier is not enough. It is necessary to verify in advance whether the technical documentation is up to date, whether the fragrance composition has been reassessed in light of the new list of allergens, whether the names used are consistent with the regulation, and whether the packaging material currently in use can still be used after July 31, 2026. Otherwise, there is a risk of finding oneself in a situation where products have been formally placed on the market or purchased but can no longer be properly managed on the European market under the new rules.
With imported products, however, the situation becomes even more complicated. A non-EU supplier may not be fully familiar with European regulations, may not have updated the fragrance documentation yet, or may provide incomplete data—with trade names or descriptions that are insufficient to determine which allergens actually exceed the applicable thresholds. This slows down verification, extends label review times, and makes it more difficult to plan for packaging replacement and stock depletion. In practice, what may already be a challenging update project for a European manufacturer easily becomes a problem of coordination between the supply chain, documentation, and time-to-market for an importer.
For this reason, when it comes to imported cosmetics, the work should begin well in advance of the deadlines.
Conclusions
If you manufacture or import cosmetics and want to understand in advance how updates to allergen requirements, labeling, and technical documentation might affect you, now is the time to take action. A timely review of the fragrances used, data received from suppliers, and update timelines can help avoid delays, urgent reprints, and commercial issues as we approach July 2026.
With our consulting services, we can assist you in reviewing documentation, verifying which allergens must be declared, revising labels, and planning regulatory updates for cosmetics and detergents—ensuring you’re fully prepared for upcoming deadlines rather than scrambling at the last minute.
Leave the technical work to us. You focus on your business.
