Regulation (EU) 2023/1545 requires cosmetic manufacturers to indicate a much larger set of fragrance allergens in the ingredient list whenever those allergens are present above the applicable thresholds. The purpose is to give sensitized consumers clearer information, so that people who react to particular substances can identify and avoid them.
The change works by amending Annex III of the Cosmetics Regulation, and its practical effect falls on the ingredient list that cosmetic products must carry under Article 19(1)(g) of Regulation (EC) No 1223/2009. Before the amendment, companies worked with a short list of individually labeled fragrance allergens, and the expanded framework of more than 80 entries now includes both individual substances and grouped allergen entries.
Regulation (EU) 2023/1545 requires cosmetic products to declare a much larger set of fragrance allergens in the ingredient list whenever they exceed set thresholds, so that sensitized consumers can identify and avoid them.
August 16, 2023: Regulation (EU) 2023/1545 entered into force.
July 31, 2026: The transition period for placing compliant new products on the EU market ended, so new products now need updated labels.
July 31, 2028: The transition period for withdrawing non-compliant products from the market ends, so products already on shelves must carry the new labeling or come off the market.
These dates separate the products that can still be launched from the products that must be removed if the label has not been updated. They also create two distinct workloads, with new product development on one side and a review of the entire existing portfolio on the other, and the second workload grows with the size of the range a company sells.
Since July 31, 2026, only cosmetic products with the updated fragrance allergen labels can be placed on the EU market. Products placed before that date can stay on the market until July 31, 2028.
The obligation falls on companies placing cosmetic products on the EU market, which includes responsible persons, cosmetic brands, manufacturers, and importers, with fragrance suppliers and anyone responsible for cosmetic formula data and label compliance closely involved. A company based outside the EU is covered as soon as it sells into the EU.
Any company placing cosmetic products on the EU market is responsible for fragrance allergen labeling, including responsible persons, brands, manufacturers, and importers based outside the EU.
A fragrance allergen must be declared when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. These thresholds remain central to every assessment, and because the figures are so low, small contributions from several raw materials can combine to push a product over the line.
A fragrance allergen must be declared above 0.001% in leave-on products and 0.01% in rinse-off products, counting its contribution from every raw material in the formula.
Fragrance allergen labeling requires formula-level and raw-material-level data because the obligation is triggered by the presence of an allergen above the threshold, regardless of whether the allergen was added intentionally as a fragrance ingredient. An allergen can arrive through a fragrance mixture, a perfume, an aroma, a natural complex substance such as an essential oil or botanical extract, an impurity or contaminant, or a combination of these sources, and a review that covers only the fragrance compound will miss part of the picture.
Customers usually reach this conclusion at the moment they first read the regulation, when it becomes clear that the work reaches well beyond label artwork and into the allergen information held by each supplier. Reliable data on every raw material has to be in place before the label wording can be settled.
The labeling obligation is triggered by an allergen's presence above the threshold, not by its use as a fragrance, so the data has to cover every raw material and not only the fragrance compound.
The first misconception is that fragrance allergens only come from fragrance mixtures. The Cosmetics Europe Guidelines on the Fragrance Allergens Requirements note that the term can be misleading, because allergens must be labeled regardless of their source once the legal conditions are met.
The second is that compliance can be assessed by matching ingredient names against the entries listed in the regulation. According to the same guidance, scope is defined by the four substance identification columns together, and where they are inconsistent, Column B (chemical name/INN) leads. Columns C and D are best treated as examples, so the chemical name can cover substances no listed example mentions, and a database match against example names will miss them.
The difference matters most for natural oils and extracts, where companies have to decide whether the regulatory scope reaches beyond the examples named in the Annex. In practice, these interpretation discussions often take longer than the allergen calculations themselves.
Under the Cosmetics Europe guidance, Column B (chemical name/INN) defines what an Annex III entry covers, so matching ingredient names against the listed examples is not enough to assess compliance.
Grouped allergen labeling allows similar substances to be declared under a common group name, which is an INCI name, and the concentration assessment may need to consider the relevant grouped substances together when calculating the labeling percentage. A group can therefore exceed the threshold even when no single substance within it does, so grouped entries need to be calculated explicitly and cannot be checked one substance at a time.
Grouped fragrance allergens are declared under one INCI group name, and a group can cross the labeling threshold even when no single substance in it does.
Day-to-day compliance becomes much more data-driven, because regulatory teams need to collect and validate allergen information from fragrance suppliers and raw material suppliers, calculate allergen concentration in the finished cosmetic product, check whether the leave-on or rinse-off threshold is exceeded, and make sure the correct allergen or group name appears on the label. Each of those steps depends on the one before it, so gaps in supplier data tend to surface late, at the label stage.
Fragrance allergen compliance runs as a chain: supplier data, concentration calculation, threshold check, then label wording. Gaps in supplier data tend to surface late, at the label stage.
Regulatory Affairs usually feels the impact first, since that team must interpret Annex III, decide whether entries are standalone or grouped, and define the correct label wording. R&D, product stewardship, quality, packaging, and marketing or artwork teams become involved next, because formula data and labels need to align before products are launched or updated.
Regulatory Affairs feels fragrance allergen labeling first, because it interprets Annex III and defines the label wording. R&D, product stewardship, quality, packaging, and artwork teams follow.
Products that do not meet the new labeling requirements cannot continue to be placed on the EU market once the relevant transition period has ended. From a business perspective, that translates into relabeling work, delayed launches, product withdrawal, and disruption to product lifecycle planning.
After the transition periods, cosmetic products without the new fragrance allergen labeling cannot continue to be placed on the EU market, which means relabeling, delayed launches, and withdrawals.
New allergen names appearing on a label reflect the expanded disclosure requirement and say nothing about a formulation change, since the product may be exactly the same as before. What has changed is the obligation to disclose a larger number of fragrance allergens, individually or under grouped names.
That creates challenges beyond Regulatory Affairs. A multinational company may find the same product carrying different ingredient declarations in different regions, because the EU requires disclosure of allergens that may not need to be declared elsewhere. Consumers who see unfamiliar ingredient names may also assume that new substances were added, so companies need to be prepared to explain label changes both internally and externally.
A new allergen name on a cosmetic label reflects the expanded EU disclosure rule, not a new ingredient: the formula can be exactly the same as before.
A cosmetic formula can exceed 100% when it contains 100% essential oil plus an additional allergen contribution, and discussions with a sector association indicate that many companies find these scenarios hard to manage. They complicate allergen calculations and compliance activities, since traditional formulation systems are often built around compositions that total 100%.
A formula with 100% essential oil plus an additional allergen contribution goes over 100%, and traditional formulation systems are often built for compositions that total 100%.
Fragrance allergen labeling is a data governance challenge as much as a labeling challenge. The expanded list, the grouped entries, the natural complex substances, and the multi-source allergen contributions all demand structured data that can be traced, checked, and reused across formulas.
The regulation is well-intentioned from a consumer protection perspective, because it gives sensitized individuals more precise information about the substances they may need to avoid. Implementation brings a level of interpretive complexity that many companies underestimate, and the biggest source of confusion lies in understanding exactly what falls within the scope of certain Annex III entries, with the allergen calculations themselves coming second.
The expanded list, grouped entries, natural complex substances, and multi-source contributions make Regulation (EU) 2023/1545 a data governance challenge as much as a labeling one.
Trace One treats fragrance allergen compliance as a structured data and calculation process instead of a manual label review exercise. The Fragrance Allergens Module allows customers to screen formulations, identify fragrance allergens and their concentrations, and generate reports that can be shared across regulatory, R&D, quality, and product stewardship teams. The Cosmetic Label Module generates and maintains compliant ingredient declarations by automatically considering the fragrance allergens present in the formula, their concentrations, the INCI ingredient declaration requirements including grouped allergen names, and the different labeling thresholds for leave-on and rinse-off products.
The value is strongest where allergen information comes from complex natural substances or grouped entries, because the compliance question covers whether the total allergen contribution exceeds the threshold and which name must appear on the label, in addition to whether one ingredient is present. Trace One also supports formula compositions that go over 100%, which allows accurate allergen assessments without the limits of traditional formulation systems. Together, these capabilities reduce manual work, limit the risk of inconsistent interpretation and missed allergens, and cut down on late label changes.
"The companies that will navigate the 2026 and 2028 deadlines most smoothly are those that establish a robust process for collecting supplier data, screening formulas, calculating allergen concentrations, and maintaining compliant ingredient declarations. That's exactly where Trace One can help."
- Claudia Boselli, Trace One
The data takes time to collect, and the 2028 withdrawal date applies to every product already on the market.
See how Trace One helps regulatory and R&D teams screen formulas for fragrance allergens and keep ingredient declarations current.
Trace One is a global provider of AI-native Product Lifecycle Management (PLM) and regulatory compliance software for the food & beverage, cosmetics & personal care, and specialty chemical industries. With more than 30 years of industry expertise, the company helps over 9,000 brands worldwide develop, launch, and manage remarkable products faster. Purpose-built for formula-based product development, its platform connects the entire product lifecycle from ideation to launch, with integrated regulatory intelligence spanning 170+ countries. Learn more at traceone.com.