The deadline for the expanded EU fragrance allergen labelling requirements is approaching.
From 31 July 2026, cosmetic products newly placed on the European Union market must comply with the extended fragrance allergen labelling provisions introduced by Commission Regulation (EU) 2023/1545.
Products that were placed on the EU market before the deadline under the previous requirements may generally continue to be made available until 31 July 2028.
For cosmetic manufacturers, responsible persons, importers and private-label brands, this is not simply a packaging update. Product formulas, supplier information, ingredient lists, safety documentation and regulatory records must remain consistent.
What changes under Regulation (EU) 2023/1545?
The regulation introduces specific labelling provisions for 56 additional fragrance allergens, expanding the previous framework that focused on 26 individually labelled allergens.
Fragrance allergens must generally be listed individually in the cosmetic product’s ingredient list when their concentration exceeds:
- 0.001% in leave-on products
- 0.01% in rinse-off products
These thresholds apply to the finished cosmetic product, not only to the fragrance mixture supplied by the fragrance manufacturer.
The practical impact may therefore extend far beyond perfumes. Potentially affected products include:
- facial creams and serums
- body lotions
- shampoos and conditioners
- shower gels and soaps
- deodorants
- hair care products
- make-up
- sun care products
- products containing essential oils or botanical extracts
What does “placed on the market” mean?
The deadline of 31 July 2026 relates to the first placement of a product on the EU market.
A product that has already been legally placed on the market before that date may generally continue to be distributed or sold until 31 July 2028, provided it complied with the previous requirements.
Companies should not interpret the transition period as permission to continue manufacturing and launching newly labelled non-compliant products until 2028.
The distinction between “placing on the market” and “making available on the market” should be reviewed carefully for existing inventory, distributors and product variants.
What should cosmetics companies check?
1. Request updated allergen information
Fragrance houses, essential-oil suppliers and raw-material suppliers should provide current allergen declarations based on Regulation (EU) 2023/1545.
Older declarations covering only the original allergens may no longer be sufficient.
2. Calculate concentrations in the finished product
Supplier declarations must be assessed against the actual concentration of the fragrance, extract or raw material in the finished formulation.
The presence of an allergen in a fragrance compound does not automatically mean that it exceeds the labelling threshold in the finished cosmetic product.
3. Review the ingredient list
The INCI list should be updated where additional fragrance allergens exceed the relevant threshold.
Care must also be taken with products sold in several languages, different packaging sizes or multiple markets.
4. Check consistency across all documents
The final label should be consistent with:
- the product formula
- supplier documentation
- the Cosmetic Product Safety Report
- the Product Information File
- artwork and packaging files
- relevant CPNP information
A technically correct label can still create a compliance problem when other documents contain outdated information.
5. Review product families and variants
Different fragrances, colours or product variants may contain different allergens.
A label update for one variant should not automatically be applied to the complete product range without checking each formulation.
Common implementation risks
Typical problems include:
- relying on outdated fragrance declarations
- assessing the fragrance oil instead of the finished product
- overlooking allergens originating from essential oils
- updating the packaging without updating the PIF
- applying one ingredient list to several fragrance variants
- ordering new packaging before the final allergen assessment is complete
These errors can result in avoidable relabelling costs, delayed launches and inconsistencies during market surveillance.
How Makrolife can support your fragrance allergen review
Makrolife supports cosmetic companies with the coordinated review of:
- formulations and fragrance documentation
- allergen concentration calculations
- INCI and label information
- CPSR and PIF consistency
- testing and safety-assessment requirements
- regulatory documentation for the EU market
The objective is not only to update an ingredient list. It is to ensure that the formulation, label and safety documentation provide one consistent regulatory record.
Is your product portfolio ready?
Companies placing cosmetic products on the EU market after 31 July 2026 should complete their fragrance allergen review before ordering new packaging or releasing new production batches.
Request a fragrance allergen and cosmetic documentation check from Makrolife.
