The labeling of fragrance allergens in cosmetic products is becoming significantly stricter in the European Union. With Regulation (EU) 2023/1545, the list of fragrance allergens that must be declared on cosmetic products has been substantially expanded.
For manufacturers, private-label brands, importers and online shop operators, 31 July 2026 is a key regulatory deadline. From this date, cosmetic products that do not comply with the new requirements may generally no longer be newly placed on the EU market.
Products that have already been placed on the market may, under the transitional provisions, still be made available until 31 July 2028. However, companies should not wait until shortly before the deadline. Labels, formulations, raw material documentation and Product Information Files should be reviewed and updated early.
In this article, we explain what changes under the new EU allergen labeling rules, which products are affected and what companies should do now.
Why was allergen labeling tightened?
Fragrance substances are among the most common causes of allergic reactions to cosmetic products. Consumers with known contact allergies must be able to identify whether a product contains specific allergenic fragrance substances.
Until now, only certain fragrance allergens had to be listed individually in the INCI list when they exceeded defined concentration thresholds. Many other fragrance substances could still appear under general terms such as “Parfum” or “Aroma”.
Regulation (EU) 2023/1545 changes this approach. Its aim is to create greater transparency for consumers and improve the traceability of allergenic substances in cosmetic products.
For companies, this means that the existing INCI declaration will no longer be sufficient for many products.
What exactly is changing?
The new regulation significantly expands the list of fragrance allergens that must be declared. Instead of the previously limited number of declarable fragrance allergens, many more individual allergenic fragrance substances will have to be considered.
This is particularly relevant for:
- Perfumed cosmetic products
- Products containing essential oils
- Natural cosmetics with botanical fragrance components
- Leave-on products such as creams, serums, oils and lotions
- Rinse-off products such as shower gels, shampoos and cleansing foams
- Private-label products with ready-made fragrance mixtures
- Imported cosmetic products from outside the EU
Important: The obligation does not only apply to synthetic fragrance substances. Natural fragrance components from essential oils can also be subject to declaration.
Which thresholds apply?
The labeling obligation depends on whether certain allergenic fragrance substances exceed defined concentration thresholds in the finished cosmetic product.
In general, the following thresholds remain relevant:
- Leave-on products: from 0.001%
- Rinse-off products: from 0.01%
Leave-on products remain on the skin, such as creams, oils, serums or deodorants. Rinse-off products are washed off after use, such as shampoos, shower gels or cleansing gels.
If a declarable fragrance allergen exceeds the relevant threshold, it must be listed individually in the ingredient list.
Why is 31 July 2026 so important?
31 July 2026 is the first central transition deadline.
Until this date, products that are not yet labeled according to the new requirements may generally still be placed on the market. After this deadline, non-compliant products may no longer be newly placed on the EU market.
This mainly affects:
- New productions
- New batches
- Imported goods
- Private-label products
- Products with updated packaging
- Products being sold in the EU for the first time
The second important deadline is 31 July 2028. Until then, products that were already lawfully placed on the market may still be made available under certain conditions.
However, this does not mean that companies should wait until 2028. Late action can lead to unusable packaging stocks, incorrectly labeled inventory, delayed sales and possible objections from authorities or platforms.
Common implementation mistakes
Many companies underestimate the practical effort required to implement the new allergen labeling rules. The following mistakes occur particularly often:
1. Outdated fragrance data from suppliers
Many manufacturers rely on old raw material documentation. This is risky. For the new allergen labeling requirements, current information from fragrance suppliers or raw material manufacturers is essential.
Relevant documents include:
- Updated allergen lists
- IFRA documents
- Composition information for fragrance mixtures
- Information on essential oils
- Raw material specifications
- Safety data sheets for raw materials
Without this data, a correct INCI declaration cannot be reliably assessed.
2. Incorrect assumptions about natural cosmetics
A common misconception is: “We only use natural ingredients, so the new regulation does not affect us.”
This is incorrect.
Natural fragrance substances and essential oils can contain allergenic components that must be individually declared. Natural cosmetics are therefore often particularly affected.
3. No assessment of the finished formulation
The decisive question is not only whether a raw material contains allergens. The decisive question is whether the allergenic substance exceeds the relevant threshold in the finished cosmetic product.
This requires an assessment of the complete formulation. Individual raw material data alone is not sufficient.
4. The INCI list is not updated
If additional allergens must be declared, the INCI list has to be updated. This affects the product label, packaging, folding box, accompanying information and often also online product descriptions.
A frequent mistake is that only the physical label is changed, while the website, marketplace listings or product data sheets still contain outdated information.
5. CPSR and PIF do not match the label
Labeling must not be reviewed in isolation. The label, formulation, Cosmetic Product Safety Report and Product Information File must be consistent.
If the INCI list on the label does not match the formulation or the PIF, this creates a regulatory risk. Such inconsistencies often become visible during authority inspections, audits or platform checks.
Who is particularly affected?
The new allergen labeling requirements apply to companies that make cosmetic products available or place them on the EU market.
They are particularly relevant for:
- Cosmetic manufacturers
- Private-label brands
- Cosmetic start-ups
- Importers
- Online shop operators
- Amazon and marketplace sellers
- Contract manufacturers
- Natural cosmetic brands
- Brands with perfumed products
- Companies with many product variants
Small brands are also affected. The size of the company does not matter. What matters is whether the product falls under the EU Cosmetics Regulation and whether declarable allergens are present.
What should companies do now?
Companies should now systematically review whether their products are affected by the new labeling obligations.
The most important steps are:
1. Review the product portfolio
First, companies should identify which products contain fragrance substances, essential oils, aromas or perfumed raw materials.
Particularly relevant are products containing terms such as:
- Parfum
- Aroma
- Essential Oil
- Fragrance
- Essential oils
- Botanical extracts with fragrance components
2. Update supplier documentation
Request current documentation from raw material and fragrance suppliers. Old documents should not be reused without review.
Important documents include updated allergen information, IFRA documents and specifications.
3. Calculate the formulation
For each affected product, it must be checked whether individual allergens exceed the relevant thresholds.
This assessment should be based on the complete formulation.
4. Review the INCI list and label
If additional allergens must be declared, the INCI list must be updated. Language, order, readability and packaging size should also be checked.
5. Update CPSR and PIF
If labeling, formulation information or raw material data changes, the product documentation and, where necessary, the safety assessment should also be reviewed.
6. Plan stock and packaging
Companies should decide early which packaging materials can still be used and which products need to be relabeled.
This is especially critical for large packaging stocks, long delivery times or products sold in several countries.
Why an early label check is useful
Many labeling errors are only discovered after packaging has already been produced. This causes unnecessary costs for reprints, relabeling or delayed product launches.
An early label check helps avoid these risks.
The following should be reviewed in particular:
- INCI list
- Fragrance allergens
- Mandatory information
- Warning statements
- Language versions
- Responsible Person
- Batch number
- Date of minimum durability or PAO
- Claims and marketing statements
- Consistency with CPSR and PIF
Especially with the new allergen labeling requirements, an isolated review of the label is not enough. What matters is the connection between formulation, raw material data, safety assessment and final product labeling.
What are the risks of incorrect allergen labeling?
Incorrect allergen labeling can have legal and commercial consequences.
Possible consequences include:
- Objections from authorities
- Sales stops
- Requests from marketplaces
- Suspension of product listings
- Competitor warnings
- Required relabeling
- Recall risks
- Delays in market entry
Labeling errors are particularly problematic because they are directly visible. While many regulatory deficiencies are only found in documentation, an incorrect INCI list can be identified directly on the packaging.
How the Cosmetic Safety Institute can support you
The Cosmetic Safety Institute supports manufacturers, private-label brands, importers and online shop operators with the regulatory review of cosmetic products.
As part of a label check, we review in particular:
- Whether your INCI list is correct
- Whether new fragrance allergens have been considered
- Whether the thresholds for leave-on and rinse-off products have been correctly assessed
- Whether mandatory information is complete
- Whether warning statements are required
- Whether claims are regulatory compliant
- Whether label, CPSR and PIF are consistent
- Whether your products are correctly prepared for the EU market
The objective is not only formally correct labeling, but marketable and robust product documentation.
Conclusion
The new EU allergen labeling requirements are among the most important regulatory changes for cosmetic products in the coming years.
31 July 2026 is the key deadline for many companies. Anyone placing non-compliant products newly on the market after this date risks objections and sales problems.
Perfumed products, natural cosmetics, products with essential oils, private-label products and imported cosmetic products are particularly affected.
Companies should now review their formulations, raw material documentation, INCI lists, labels and product documentation. The earlier the review is carried out, the lower the risk of costly corrections.
If you are unsure whether your cosmetic products are affected by the new allergen labeling requirements, have your labels and product documentation reviewed early.
Request a label check now and gain clarity before 31 July 2026.
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