Expanded allergen labelling is mandatory since 31 July 2026 — existing stock must comply by — stock by 31 July 2028
Allergen81
Free CalculatorAllergensFeaturesHow It WorksPricingFAQ
EU 2023/1545 · Regulation (EC) No 1223/2009

From IFRA certificates to INCI labels in minutes, not days.

Stop burning €60K–€120K a year on manual allergen tracking. Allergen81 extracts every regulated allergen from your supplier PDFs, runs the EU threshold maths, and writes the compliant ingredient list for you.

Built for indie brands, formulators and responsible persons placing cosmetics on the EU market — 82 substances, grouped isomers and pre-haptens included.

Start free trial Try the free calculator
  • 82 allergens, grouped & pre-haptens
  • 14-day trial · no credit card
  • EU-hosted · GDPR-ready
IFRA_Cert_Lavender_Oil.pdf
✓ 12 allergens · 1.2 s
Product type
Allergenin materialppm in productstatus
Linalool36.20%7,240Declare
Geraniol0.90%180Declare
Limonene0.42%84.0Declare
Linalyl acetate→ Linalool28.10%5,620Declare

Grouped pre-haptens roll up into their parent allergen · oxidisers marked ●

Generated INCI list — excerpt3 to declare

INGREDIENTS: Aqua, Glycerin, Caprylic/Capric Triglyceride, Lavandula Angustifolia Oil, Parfum, Linalool, Geraniol, Limonene, Cetearyl Alcohol, Tocopherol, Citric Acid

2 pre-haptens flagged — oxidation warning onLavender oil @ 2% use level

Switch product type — declarations recompute against 10 ppm.

82
EU allergens coveredAnnex III, Reg. (EU) 2023/1545
30
Essential oils pre-loadedwith constituent profiles
12
SCCS exposure scenariosfor margin-of-safety math
14-day
Free trialno credit card required
The real cost of spreadsheets

Manual allergen tracking is a six-figure tax on every SKU.

€60K–€120K/ year

Re-keying certificates, redoing the threshold maths every time a supplier reformulates, and chasing label versions over email. Across a mid-size range that is a full regulatory headcount spent on data entry — and every supplier change restarts the clock.

A typical manual pass takes 3–5 days per formula and scales linearly with your SKU count. Consultants charge €5K–€15K per product for the same work.

Start free trial
TaskManualAllergen81
Process a supplier IFRA certificate or COA6–11 hours per SKU, transcribed by handUpload the PDF — allergens extracted in seconds
Threshold math per product typeSpreadsheet formulas that break silently on edit0.001% / 0.01% applied automatically, per Annex III
Group isomers and pre-haptens correctlyLooked up in the regulation, entry by entryCitral, Rose Ketones and oxidisers aggregated for you
Relabel after a supplier reformulationDays of chasing certificates — weeks at range scaleFormula recalculates; the INCI list regenerates
Assemble the Product Information FileScattered emails, drive folders, stale file versionsVersioned audit trail, CPSR and PIF bundle export

Exposure: non-compliant products may not be placed on the EU market — enforcement means recalls, market-surveillance notices and retailer delistings.

What it does

Three steps replace the part of compliance that is still done by hand.

Allergen81 covers the workflow existing tools leave to spreadsheets: getting numbers out of supplier PDFs, applying the regulation correctly, and producing a label that survives an inspection.

01 · Extraction

Read supplier documents, whatever shape they arrive in

Drop IFRA certificates, COAs, safety data sheets or photos of a supplier label. Every document is parsed for allergens, CAS numbers and concentrations — inconsistent layouts, scans and multi-page files included. Each value carries a confidence score, so you review the uncertain ones instead of re-reading the whole PDF.

Seconds instead of a working day per SKU

IFRA_Cert_Lavender_Oil.pdf

3 pages · 2.4 MB · supplier A

✓ parsed
Linalool36.2%0.99
Linalyl acetate28.1%0.97
β-Caryophyllene4.8%0.95
Geraniol0.9%0.88
12 allergens identified1.2 s
02 · Calculation

Threshold maths that handles the parts people get wrong

Concentrations are calculated on the finished product, not the fragrance compound, at 0.001% for leave-on and 0.01% for rinse-off. Isomers are summed under their regulated group name — Citral, Rose Ketones, Limonene — and pre-haptens are flagged with their oxidation products. Change one ingredient and every affected product recalculates.

Annex III thresholds applied consistently

Threshold calculation · leave-on (> 10 ppm)

LinaloolDeclare

36.2% × 2% = 7,240 ppm

GeraniolDeclare

0.9% × 2% = 180 ppm

LimoneneDeclare

0.42% × 2% = 84 ppm

CitronellolBelow

0.04% × 2% = 8 ppm

EugenolBelow

0.004% × 2% = 0.8 ppm

Linalyl acetate (pre-hapten) aggregated into Linalool · oxidation warning raised

03 · Labelling

A compliant INCI list you can hand straight to print

Ingredients are ordered by concentration, declarable allergens are placed correctly in the list, and the responsible person, batch number, PAO and net content come through automatically. Export as PDF at three label sizes, as CSV, or copy the list to your artwork file.

Print-ready in under 30 seconds

INCI label · Lavender Dreams v2.1

Leave-on · 100 ml · PAO 12M · batch LVD-2601

Print-ready
INGREDIENTS: Aqua, Glycerin, Caprylic/Capric Triglyceride, Lavandula Angustifolia Oil, Cetearyl Alcohol, Parfum, Linalool, Geraniol, Limonene, Tocopherol, Citric Acid.

RP: Maison Verte SARL, 12 Rue des Lilas, 75011 Paris, FR

Made in France · ⚠ Best before 03/2028 · e 100 ml

✓ 3 allergens declared·descending concentration order·PDF / CSV / copy
How it works

Certificate in, compliant label out.

One pipeline from supplier paperwork to shelf-ready ingredient lists. No re-keying, no recalculating, no guessing which group name belongs on the label.

01

Create the product

Name, SKU, category and type — leave-on or rinse-off. The type drives which threshold applies to every calculation that follows.

Under a minute

02

Upload supplier documents

Drag in IFRA certificates, COAs, SDS files or label photos — PDF, PNG, JPG. Or pick from 30 pre-loaded essential oils with their constituent profiles instead.

Any format, any layout

03

Review the extraction

Allergens, CAS numbers and concentrations come back with confidence scores. Edit anything uncertain inline, then add the batch to the formula in one click.

≈ 2 minutes per document

04

Export the compliant label

The INCI list regenerates with correct allergen declarations, RP details, batch number and PAO. Export to PDF, CSV or copy it into your artwork file.

Instant

Beyond the label

CPSR & margin of safety

MoS = NOAEL / SED across 12 pre-configured SCCS exposure scenarios, with a signed, versioned Cosmetic Product Safety Report PDF (Annex I, Parts A & B).

Batch traceability (ISO 22716)

Track supplier batches and production lots with bidirectional traceability — find every finished batch that used a raw material, or every raw material in a batch.

PIF bundle

Assemble the Product Information File required by Article 11 — index PDF, CPSR and a machine-readable JSON of every record, in one download.

Audit trail

Every calculation, upload and formula change is timestamped at database level, isolated per account, and exportable for market-surveillance inspections.

Regulatory coverage

Built on the regulation — not somewhere near it.

Commission Regulation (EU) 2023/1545 amends Annex III to Regulation (EC) No 1223/2009. The substance table, grouping rules and threshold engine in Allergen81 track the text and its corrigendum.

Transition watch: products placed on the market since 31 July 2026 must already carry the expanded declaration. Stock placed before that date may be sold through until 31 July 2028. Each SKU in your portfolio is marked with the regime it falls under.

Regulation (EU) 2023/1545 on EUR-Lex CosIng ingredient database
Substances covered
82 fragrance allergens individually declarable under Annex III — up from 26, adding 56 substances including natural extracts, pre-haptens and pro-haptens.
Declaration thresholds
> 0.001% leave-on · > 0.01% rinse-off — assessed on concentration in the finished product, not the fragrance compound.
Grouped substances
Isomers and related substances are summed and declared under the regulated group name — Citral for Geranial + Neral, Rose Ketones for the damascone family, Limonene for its enantiomers.
Pre-haptens
Substances that become allergens through air oxidation or bioactivation are treated as equivalent. Limonene, Linalool, Alpha-Terpinene, Terpinolene and Pinene are flagged with their oxidation products.
Key dates
31 Jul 2026 placing-on-market deadline (passed) · 31 Jul 2028 final date for stock placed before it.
Label position
Allergens appear in the Article 19(1)(g) ingredient list by INCI name, in descending order of concentration. Allergen81 generates the list in that order rather than appending declarations at the end.
Documentation
Every calculation is versioned and exportable for the Product Information File (Article 11), responsible-person records and market-surveillance inspections.

Allergen81 supports compliance work; it does not replace it. Final labelling should always be verified against the current regulation text and your safety assessor's judgement.

Pricing

Priced against what the manual work costs you.

Every tier pays for itself on the first product you stop hand-transcribing. Start free with 5 extractions — enough to test your real supplier documents.

Free

For individual makers

€0

1 Active Product

5 Total (One-time) extractions

  • Basic extraction
  • PDF preview
  • Community support

Indie

For small brands

€490/yr

~€41/mo

10 Active Products

360 / yr extractions

  • Email support
  • INCI label generation
  • EU 2023/1545 compliance alerts
Most popular

Professional

For growing labs

€1,890/yr

~€157/mo

50 Active Products

1,800 / yr extractions

  • Everything in Indie
  • Batch document upload
  • Pre-hapten detection
  • Audit trail logs
  • Priority support

Business

For contract manufacturers

€3,490/yr

~€290/mo

200 Active Products

6,000 / yr extractions

  • Everything in Pro
  • Multi-user access
  • Team collaboration
  • White-label compliance reports

Enterprise

For large scale manufacturers

€5,500+

Unlimited Active Products

Unlimited Extractions extractions

  • Everything in Business
  • API Access
  • Dedicated Success Manager
  • Custom Data Residency (e.g., private cloud)
  • SLA Guarantee

All paid plans include a 14-day free trial · no credit card required to start · cancel any time, your formulations stay accessible

FAQ

Questions worth answering before you trial it.

Can't find what you need? hello@allergen81.com

Get compliant

The deadline passed in July. The work didn't.

Since 31 July 2026, anything you place on the EU market needs the expanded declaration. Start with your real supplier documents on the free plan and see the extraction quality before you pay for anything.

Start free trial Book a demo
  • No credit card required
  • First report in under 5 minutes
  • EU-hosted · GDPR-ready
Allergen81

Automated allergen compliance for cosmetic brands placing products on the EU market — from supplier certificate to print-ready label.

EU-hosted · GDPR-ready · data never leaves the EU

Product

  • Free Allergen Calculator
  • EU Allergen Reference
  • Essential Oil Allergens
  • Features
  • Pricing

Company

  • Privacy Policy
  • Terms of Service
  • Contact

© 2026 Allergen81. All rights reserved.

Built for EU 2023/1545 compliance automation