EU Regulation 2023/1545 Fallback data

82 Allergen Checker

Check if your product contains declarable fragrance allergens

Compliance Deadlines

July 31, 2026: NEW products must comply with 56 new allergen labeling (EU 2023/1545)
July 31, 2028: ALL products (new and existing) must comply
April 12, 2026: Canada Phase 1 -- 24 allergens mandatory (SOR/2024-63)
August 1, 2026: Canada Phase 2 -- 81 allergens for new products
May 2026 (est.): FDA NPRM for US fragrance allergen labeling (RIN 0910-AI90)

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Grouped Allergen Concept (NEW in 2023/1545)

Cross-sensitizing substances can share a single Group Name on the label. Example: Lavandula angustifolia + L. hybrida + L. intermedia = declare as "LAVANDULA OIL/EXTRACT." Sum all concentrations within the group -- if combined total exceeds threshold, the Group Name must be declared.

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Prehaptens & Oxidation Risk

Pure linalool and limonene are not sensitizers -- their hydroperoxides (formed by air oxidation) are the actual allergens. Products can shift from non-allergenic to allergenic during shelf life. IDEA Project validated 3 detection methods: hydroperoxide reduction + GC-MS, LC-chemiluminescence, and LC-Orbitrap-MS. Modern formulations with proper antioxidant systems show no detectable hydroperoxides in normal use.

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Global Allergen Labeling Status

EU -- 80+ allergens mandatory (2023/1545)
Canada -- 81 allergens phased 2026-2028 (SOR/2024-63)
US FDA -- NPRM expected May 2026 (MoCRA RIN 0910-AI90)
South Korea -- 25 allergens (vs EU 82). Lilial still declarable (EU banned). No expansion announced as of Feb 2026.
Taiwan -- Draft regulation Jan 2025, effective ~2027
China -- Children's cosmetics only (24 allergens)
ASEAN -- No harmonized requirement ("Parfum" sufficient)
Japan / India / Australia -- No mandatory requirement
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IFRA 51st Amendment (June 2023)

48 new restricted materials + 11 revised standards. IFRA compliance is a necessary precondition for EU 2023/1545 compliance but not sufficient alone -- IFRA sets max concentration limits (safety), EU requires labeling above 0.001%/0.01% regardless of IFRA limits. Existing formulas deadline: October 30, 2025 (completed). Fragrance houses (Givaudan, dsm-firmenich, IFF, Symrise) have already updated their portfolios.

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Cross-Reactivity: Why Grouped Allergens Matter

Patch testing with individual components detects only ~56% of patients allergic to whole essential oils. 44% react ONLY to the complex mixture, not isolated components -- validating the grouped allergen concept.

Lavender -- Strong (2.8% patch-test positive)
Balsam Peru -- Strong (classical baseline)
Clove -- Mod-Strong (48-72% oil-only)
Ylang-Ylang -- Mod-Strong (48-72%)
Lemongrass -- Moderate (citral dominant)
Rose -- Moderate (limited data)

Source: Acta Derm Venereol 2016; French DAG study 2023 (42 patients, 40% didn't mention EO use)

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EDQM "Perfume-Free" Surveillance (2024)

932 samples from 34 countries: 41% of products tested claiming "perfume-free" contained detectable fragrance allergens. Most common undeclared: linalool, benzyl alcohol, limonene -- present in botanical extracts used for non-fragrance purposes. Overall compliance: 80%, but fragrance-specific compliance only 59%. 3.1% contained prohibited allergenic fragrances. "Fragrance-free" has no harmonized legal definition in EU.

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Labeling Thresholds

Leave-on Products

0.001%
10 ppm (parts per million)

Creams, lotions, serums, foundations, lipsticks, etc.

Rinse-off Products

0.01%
100 ppm (parts per million)

Shampoos, conditioners, body washes, cleansers, etc.

Original 26 Allergens

Established since 2005

56 NEW Allergens

Effective July 2026/2028

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