Fragrance allergens in cosmetics 2026/2028 – INCI, supplier certificates & older stock | Word/PDF/Excel

Do you sell shampoo, skin cream, perfume, deodorant, or other cosmetics containing fragrance substances? The EU's new requirements for the individual labelling of fragrance substance allergens already affect products placed on the EU market. This Swedish document package helps cosmetics brands, contract manufacturers, and importers request the correct allergen profile from the supplier, calculate the relevant levels in the finished product, check the INCI label, and manage older inventory batches without incorrectly extending the transitional period.

General legal rule: The Commission Regulation (EU) 2023/1545 amended Annex III of the Cosmetics Regulation and added 56 additional fragrance substance allergens to the individual labelling requirements. Affected products that do not meet the new rules could be placed on the EU market until 31 July 2026. Products that were already subject to an earlier actual market placement may, under certain conditions, continue to be supplied until 31 July 2028. New market placements after 31 July 2026 must already meet the applicable new labelling requirements.

Five document templates for the actual labelling work

1. A01 – Product classification and labelling deadline: document the responsible person, product category (leave-on/rinse-off), current formula, allergens listed in Annex III, and relevant market placement date.
2. A02 – Fragrance supplier's allergen certificate: request each relevant fragrance allergen, CAS, INCI, presence in the raw material blend, and level. Assess whether the perfume certificate and IFRA data actually cover the requirement. Request an update if the perfume revision has changed.
3. A03 – Allergens and INCI label: summarise relevant sources in the finished product. Check the combined declaration names for grouped substances and the correct ingredient list, print sample, and packaging.
4. A04 – Inventory and first EU market placement: track lot numbers, label version, actual market placement documentation, and the special transition until July 2028 without confusing the production date with the market placement.
5. A05 – Batch hold and manual release: stop mislabelled goods, manage supplier supplementation, separate cosmetic safety check, and a signed decision before resuming delivery.

Excel workbook with nine Swedish tabs

Overview, Products, Allergens, Suppliers, Labels, Inventory Batches, Release, Actions, and Sources. The workbook contains 422 formulas and empty customer fields. Each allergen row has product ID, INCI/group name, product category, level in the finished product, correct threshold, source evidence, and whether the name is declared on the label. It shows administrative flags such as ABOVE THRESHOLD – REVIEW LABEL or MISSING EVIDENCE. Neither a low level nor the status "labelled" implies automatic legal or cosmetic approval.

Which labelling limits apply?

For the relevant new fragrance substance allergens, individual labelling in the ingredient list is required when the relevant finished product level exceeds 0.001% in leave-on cosmetics or exceeds 0.01% in rinse-off cosmetics, according to the conditions in the respective Annex III entry. Excel uses percent as a unit: 0.002 means 0.002%, not 0.2%. Exactly at the general limit, the wording "exceeds" is used; other relevant substance restrictions, measurement uncertainty, and safety requirements must be assessed separately.

An important detail is that some substances are listed as a group under a common INCI name, for example Citral and Pinene. If the same allergen comes from perfume, essential oil, and an additional raw material, the relevant contributions must be added together. A single name on an ingredient list or a general IFRA certificate is not a verified finished product calculation.

The 2026–2028 transition: what happens to old labels?

On 31 July 2026, the deadline passed for first placing affected non-adapted cosmetic products on the EU market under the special transitional provisions in (EU) 2023/1545. Until 31 July 2028, affected products previously placed on the market may continue to be made available under certain conditions. The fact that a batch was manufactured, printed, imported, or held in own inventory before the date does not automatically prove that it had been placed on the market. Save actual invoices, delivery and recipient details, and label and batch IDs for review.

This is a separate labelling obligation under the Cosmetics Regulation and should not be confused with the REACH restriction on microplastics or the cosmetic safety report (CPSR), product information file (PIF), CPNP notification, and other Annex III prohibitions. The package does not include a certified allergen library and does not replace a chemist or the conclusion of a responsible person.

Frequently Asked Questions

Is it prohibited to sell cosmetics with fragrance allergens?

Not generally. The rules primarily entail special obligations to individually declare relevant substances in the INCI list when the conditions are met. Some substances also have their own restrictions, which must be checked separately.

Can a small Swedish webshop sell its old labelled goods until summer 2028?

Only if the specific product is covered by the transitional rule and has already actually been placed on the EU market within the permitted time. The purchase date or print date is not necessarily sufficient evidence.

Is an IFRA certificate from the perfume supplier enough?

Not necessarily. The labelling assessment requires the correct allergen profile with grouped names and proven level in the finished product, including all relevant constituent sources.

What do we do if the allergen level is exactly 0.01 percent in shampoo?

The general labelling threshold is expressed as "exceeds 0.01%" for rinse-off. Therefore, exactly the same level does not trigger that specific basic rule; but measurement uncertainty, other ingredient conditions, and full label check are assessed separately.

Can Excel automatically create a complete new allergen label?

No. It helps the user organize facts and identify rows that require action. It contains no guaranteed fully comprehensive current Annex III database or automatic print/release function.

Are all work templates in English and the PDF files fillable?

The five work templates and Excel are in Swedish; one Swedish and one English user guide are included. Word is editable. PDFs are searchable and printable, not interactive forms.

Legal sources and transparency

Primary source: Commission Regulation (EU) 2023/1545; Cosmetics Regulation (EC) 1223/2009, especially Article 19 and current Annex III. Application guidance: European Commission page on fragrance substance allergens.

Version 1.0, internal AI-assisted legal source check 9 November 2026. No independent external legal review, chemical analysis, cosmetic safety assessment, authority certification, or automated CPNP notification has been carried out. The customer package is documentation support, not a guarantee of labelling or market compliance. The customer ZIP is not linked to Shopify Digital Products in this production round.