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Regulation & Compliance

56 New Fragrance Allergens Hit EU Labels by 31 July 2026

From 31 July 2026, EU labels must declare 56 additional fragrance allergens under Regulation (EU) 2023/1545, with leave-on threshold at 0.001% and sell-through to July 2028.

By Rebecca Stone · · 4 min read · 730 words

Composition

  1. 31 July 2026: deadline for declaring 56 new fragrance allergens on EU cosmetic labels under Commission Regulation (EU) 2023/1545.
  2. Leave-on products require allergen declaration above 0.001%; rinse-off products above 0.01% in the finished product.
  3. Products already on the EU market before 31 July 2026 may be sold until 31 July 2028.
  4. Annex III now lists 82 fragrance allergens in total, up from the 26 identified by SCCNFP in 1999.
  5. The rules cover natural allergens in essential oils and plant extracts, not only synthetic fragrance compounds.

From 31 July 2026, every cosmetic product placed on the EU market must individually declare up to 56 additional fragrance allergens on its label, under Commission Regulation (EU) 2023/1545 of 26 July 2023. The amendment expands the allergen list in Annex III of the EU Cosmetics Regulation from 26 entries — set in 1999 — to 82, and the compliance burden falls on the vast majority of cosmetics manufacturers selling scented products in Europe.

The regulatory chain runs back more than a decade. In 2011, the Scientific Committee on Consumer Safety (SCCS), then still operating under its earlier name SCCNFP when it flagged the original 26 substances in 1999, published an opinion identifying new allergens relevant for consumer protection. Ongoing review of clinical and experimental data had shown that many additional fragrance substances act as human sensitizers. The Commission turned that opinion into binding labelling rules twelve years later.

What are the disclosure thresholds?

The trigger points for individual allergen labelling depend on product category:

  • Leave-on products: declaration required above 0.001% (10 ppm) in the finished product.
  • Rinse-off products: declaration required above 0.01% (100 ppm).

The EU Commission's stated aim is to give sensitised consumers the information they need to avoid the specific substance causing their allergy. Repeated skin contact with sufficient quantities of certain fragrance ingredients can induce contact allergies; re-exposure can then trigger eczema, or allergic contact dermatitis.

Do natural fragrances fall within scope?

Yes. The rules are not limited to synthetic compounds. Allergenic substances occur naturally in many botanical ingredients, and essential oils and plant-derived extracts carry the same Annex III labelling obligations. Brands working with high concentrations of essential oils or herbal extracts should assess — and where appropriate analytically test — finished products to verify regulated allergen levels and label accurately.

What documentation does compliance require?

Beyond standard raw material specifications, Safety Data Sheets and Certificates of Analysis, fragrance ingredients need specific support:

  • IFRA Certificate — confirming the fragrance meets International Fragrance Association standards, which set conditions of use based on RIFM scientific evaluations.
  • Allergen declaration — a detailed breakdown of the fragrance composition against all 82 Annex III allergens, from which manufacturers determine which substances require label disclosure.
  • Finished-product analytical testing — advisable to confirm actual presence and concentration of allergens in the final formulation.

What must brands do before the deadline?

COSlaw.eu, which published a compliance FAQ on the deadline, sets out five action points:

  • Update PIFs: obtain revised specifications, IFRA certificates and allergen declarations from raw material suppliers.
  • Assess concentrations: calculate regulated allergen levels in finished products against Annex III thresholds.
  • Revise labelling: add required allergens to ingredient lists before products go to market after the deadline.
  • Refresh CPNP notifications: update the Cosmetic Products Notification Portal entry whenever labelling changes.
  • Review the CPSR: update the Cosmetic Product Safety Report — typically revisited every 3 to 4 years — so the safety assessor works from current allergen data.

What counts as "placing on the market"?

The 2026 cut-off applies only to products placed on the EU market after 31 July 2026. Units already made available before that date can stay on shelves until 31 July 2028.

Under the EU Blue Guide, placing on the market means the first supply of a product — by manufacturer or importer — to a distributor or end user. The concept applies to each individual unit, not a product type. So even a long-marketed product must meet the new rules for every new unit shipped after the deadline. Subsequent distributor-to-distributor or distributor-to-consumer transactions count only as "making available."

Several situations fall outside the definition entirely:

  • Products made for personal own use
  • Consumer purchases outside the EU brought in for personal use
  • Transfers from a third-country manufacturer to an EU authorised representative
  • Transit, warehousing or temporary storage only
  • EU-manufactured export-only goods
  • Pre-production test or validation units
  • Trade-fair displays under controlled conditions
  • Stock not yet supplied for distribution or use

Brands that have not yet begun supplier outreach should treat the first half of 2026 as the working window: allergen declarations, analytical results and revised CPSRs all take lead time, and CPNP updates must follow label changes. The next data point to watch is how quickly suppliers deliver compliant documentation — and whether enforcement authorities begin sampling finished products against the 0.001% and 0.01% thresholds once the deadline passes.

via coslaw.eu (Original)

Filed under

  • fragrance-allergens
  • eu-cosmetics-regulation
  • cosmetics-labelling
  • annex-iii
  • compliance-deadline-2026

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Rebecca Stone

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Staff writer covering industry trends and analytics at INCI File.

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