Fragrance allergens have become one of the main regulatory review points for cosmetic companies marketing products in the European Union. Regulation (EU) 2023/1545 expanded individual labelling requirements, updated several entries in Annex III to Regulation (EC) No 1223/2009 and introduced new names that must be used in the list of ingredients.
But in 2026, the issue is no longer simply understanding what changed.
On 31 July 2026, the transitional period for placing new products on the Union market that do not comply with the new requirements came to an end. Since then, cosmetic products newly placed on the market must comply with Regulation (EU) 2023/1545.
Non-compliant products that had already been legally placed on the market before that date may continue to be made available during the remaining transitional period, which ends on 31 July 2028.
This means that not only perfumes and aromas need to be reviewed. Essential oils, natural extracts, INCI names, supplier documentation, PIFs, CPSRs and final labelling may all be affected.
What Changed With Regulation (EU) 2023/1545?
Regulation (EU) 2023/1545 amended Annex III to the European Cosmetics Regulation to provide more information to consumers who are sensitised to certain fragrance allergens.
Previously, 24 fragrance allergens were subject to individual labelling requirements under the conditions established by Regulation (EC) No 1223/2009.
The Scientific Committee on Consumer Safety (SCCS) subsequently identified 56 additional fragrance allergens that had demonstrated the potential to cause allergies in humans and were not yet subject to individual labelling requirements.
The new Regulation incorporates these substances into the labelling system and introduces other important changes:
- Updates existing entries in Annex III.
- Aligns common ingredient names with the cosmetic ingredient glossary.
- Adds new isomers and updates CAS and EC numbers.
- Groups certain similar substances within the same entry.
- Establishes specific names that must be used for certain groups in the ingredient list.
Therefore, compliance does not simply involve adding new allergens to the previous INCI list.
Each substance must be reviewed according to its corresponding entry in the updated Annex III.
Do The Same Labelling Thresholds Still Apply?
Yes. The Regulation maintains the established thresholds for the individual declaration of fragrance allergens.
A substance must appear in the ingredient list when its concentration in the finished cosmetic product exceeds:
| Product Type | Concentration |
| Leave-On Product | 0.001% |
| Rinse-Off Product | 0.01% |
These limits apply to substances subject to individual declaration according to the conditions established in Annex III.
There is an important detail here: the legal text refers to concentrations that “exceed” the applicable threshold. Using the same terminology when interpreting regulatory limits helps avoid ambiguity.
Why Is “Parfum” Or “Aroma” No Longer Enough?
Regulation (EC) No 1223/2009 generally allows perfume and aromatic compositions and their raw materials to be referred to using the terms “Parfum” or “Aroma”.
However, these general terms do not replace the individual declaration requirements established in Annex III.
When a fragrance allergen subject to individual labelling is present above the applicable threshold, it must also be identified in the ingredient list.
Therefore, reviewing a label correctly requires more than knowing how much fragrance has been added to the formulation.
It is necessary to determine which allergens are contributed by that fragrance and at what concentration they are present in the finished cosmetic product.
The assessment becomes even more complex when the same allergen may originate from several different raw materials.
Fragrance Allergens And Essential Oils: A Key Point
One of the aspects requiring particular attention under Regulation (EU) 2023/1545 is the treatment of essential oils and other complex natural substances.
A natural origin does not exempt a raw material from labelling requirements.
Annex III itself includes several natural oils and extracts among the entries subject to individual declaration.
These include, for example, Citrus Aurantium Bergamia Peel Oil, Citrus Limon Peel Oil, Cymbopogon oils, Eucalyptus Globulus Leaf Oil and Mentha Piperita Oil, among others.
In certain cases, the Regulation also specifies the common name that must appear in the ingredient list when the applicable thresholds are exceeded.
This changes the way many formulations need to be reviewed.
A cosmetic product may contain no conventional perfume composition and still include essential oils capable of triggering specific labelling requirements.
The review should therefore consider all possible sources:
perfumes, aromas, essential oils, botanical extracts and other complex raw materials that may contribute substances listed in Annex III.
For more information on this aspect, see our article on the use of essential oils in cosmetic products and their regulatory and safety challenges.
Natural Origin Does Not Change The Regulatory Threshold
Another mistake to avoid is assuming that a compound only needs to be declared when it has been deliberately added as an isolated substance.
What matters is its presence in the finished cosmetic product and the conditions established for the relevant Annex III entry.
For example, when a substance subject to declaration is naturally present as a constituent of an essential oil, that contribution must be considered during the regulatory review.
If the same substance originates from several raw materials, its overall presence in the finished product must also be assessed appropriately.
In practice, this makes the quality and level of detail of supplier documentation increasingly important.
INCI Review: It Is Not Simply A Matter Of Adding Ingredients
The Regulation also introduces important changes regarding INCI and the names used on cosmetic labels.
Some entries have been updated to align common ingredient names with the cosmetic ingredient glossary.
In addition, certain similar substances have been grouped together, with the Regulation specifying which name must be used in the list of ingredients.
A proper INCI review should therefore answer at least three questions:
Which allergens are present? Do they exceed the applicable threshold? Under which name must they be declared?
Simply taking an old label and adding the new names supplied by a fragrance manufacturer is not sufficient.
The complete ingredient list should be reviewed again against the updated Annex III.
An Example Of The New Grouping Approach
The amendment to Annex III shows how certain related substances can now be managed under a common designation.
The aim is to avoid creating unnecessarily complex ingredient lists while still providing consumers with the information required to identify the allergen.
The Regulation includes entries where several related substances must be identified using a specific common name.
This means that the chemical name of each component and the name that ultimately appears on the cosmetic label do not necessarily correspond one-to-one.
When reviewing supplier documentation, it is therefore not enough to look for an exact textual match between substance names.
The relevant legal entry and the required labelling name must also be checked.
Regulation 2023/1545 Deadlines: Where Are We Now?
Regulation (EU) 2023/1545 established two separate transitional periods to allow the industry to adapt products, labels, packaging and regulatory documentation.
Understanding the difference between these two deadlines is essential.
Until 31 July 2026: Placing Products On The Market
Until this date, certain cosmetic products that did not yet comply with the new requirements could still be placed on the Union market, provided that the restrictions already applicable were respected.
That deadline has now passed.
A cosmetic product being placed on the European Union market for the first time must now comply with the new fragrance allergen labelling requirements established by Regulation (EU) 2023/1545.
Until 31 July 2028: Making Existing Stock Available
The second transitional period applies to products that had already been legally placed on the market before the end of the first deadline.
These products may continue to be made available on the market until 31 July 2028.
This deadline should therefore not be interpreted as an extension allowing companies to continue manufacturing or placing newly introduced products on the market with the previous labelling until 2028.
It is a transitional period intended to allow the distribution of stock that had already been placed on the market under the previous rules.
2026–2028: Different Ingredient Lists May Still Coexist On The Market
As a consequence of these transitional periods, apparently identical cosmetic products may temporarily be found on the market with different ingredient lists.
A unit that was placed on the market before the 2026 cut-off may retain its previous labelling during the permitted transitional period, whereas newly placed units must use the updated labelling.
This makes traceability of batches, dates of placing on the market and labelling versions particularly important.
Knowing only when a cosmetic product was manufactured is not necessarily sufficient.
From a regulatory perspective, companies should be able to demonstrate which units fall within the relevant transitional arrangements.
How To Review A Formula For The New Fragrance Allergens
Compliance should begin well before the graphic artwork of the label is changed.
The starting point should be the actual composition of the finished product, together with updated documentation for all relevant raw materials.
A practical review process can include:
- Review the complete formula, identifying perfumes, aromas, essential oils, extracts and other raw materials that may contribute allergens.
- Request updated documentation from suppliers, specifically reflecting Regulation (EU) 2023/1545.
- Identify the allergens present and their concentrations in each raw material.
- Calculate their concentration in the finished product, taking into account every source that may contribute the same substance.
- Apply the corresponding threshold depending on whether the product is leave-on or rinse-off.
- Confirm the required labelling name under the relevant Annex III entry.
- Update the INCI list and artwork.
- Review consistency with the PIF, CPSR and other regulatory documentation, assessing whether additional product information must also be updated.
The purpose is to avoid treating the regulatory change merely as a graphic modification to the packaging.
The INCI Review Must Be Accompanied By A Technical Documentation Review
Changing the INCI affects more than the product label.
Qualitative and quantitative composition forms part of the information used in the cosmetic product safety assessment.
Therefore, when updated documentation for a fragrance or essential oil provides new information about substances present in the product, its consistency with the PIF and CPSR should also be assessed.
The Cosmetic Product Safety Report (CPSR) must remain consistent with the formulation, raw material information, intended use and labelling of the cosmetic product.
This is particularly relevant for products that have been on the market for several years and whose regulatory dossiers were originally prepared using raw material documentation issued before Regulation 2023/1545.
Does The New Regulation Require Reformulation?
Not necessarily.
The main objective of the amendment is to strengthen the information provided to consumers through the individual labelling of fragrance allergens.
Identifying a newly declarable allergen therefore does not automatically mean that it must be removed from the formulation.
In many cases, compliance will involve updating the ingredient list.
However, each Annex III entry must be reviewed individually because some substances may also be subject to additional conditions or restrictions.
For example, some entries include requirements relating to peroxide values or other technical conditions.
The appropriate question is therefore not simply:
“Does My Product Contain This Allergen?”
It should be:
“What Exactly Does Annex III Require For This Substance, At This Concentration And In This Product?”
What Should Cosmetic Companies Do Now?
In late 2026, the approach should be different from when the Regulation was first published.
We are no longer in the phase of “preparing for 2026”.
The first deadline has already passed.
Companies placing cosmetic products on the market now should already have processes in place to ensure that new units comply with the updated requirements.
At the same time, companies that still have stock carrying previous labelling should make sure they can demonstrate that those products were placed on the market before the applicable deadline and manage their remaining availability before 31 July 2028.
How SHAPYPRO Can Help
Applying Regulation (EU) 2023/1545 requires information from formulation, suppliers, labelling and technical documentation to be coordinated correctly.
Through its cosmetic regulatory consultancy services, SHAPYPRO can provide support with:
- Formula and raw material documentation review.
- Review of fragrance allergens and essential oils.
- INCI review and updating.
- Cosmetic labelling review.
- Assessment of consistency with the CPSR and PIF.
- Regulatory advice concerning Regulation (EC) No 1223/2009 and its amendments.
The objective is to ensure that regulatory adaptation is consistent across every level of the product:
formula, supplier documentation, safety assessment, technical dossier and final labelling.
Conclusion
Fragrance allergens represent one of the most significant cosmetic labelling changes introduced in recent years in European cosmetics regulation.
Regulation (EU) 2023/1545 does more than expand the substances that require individual identification. It also updates names, groups certain related substances and changes how information from perfumes, essential oils and other raw materials must be translated into the final INCI list.
The regulatory context has also changed in 2026: new non-compliant products can no longer be placed on the Union market, while 31 July 2028 marks the end of the transitional period for making previously placed stock available.
For this reason, the review should not be limited to the design of the label.
Formula, supplier documentation, essential oils, INCI, PIF, CPSR and labelling should be reviewed as parts of the same regulatory process.