The EU's fragrance-allergen labeling list now names 81 substances after Regulation (EU) 2023/1545, published July 26, 2023, took effect. Cosmetics companies must complete compliant labeling of new products by July 31, 2026, with existing stock required to conform by July 31, 2028.

What does the regulation actually change?

The amendment to Annex III of the EU Cosmetics Regulation (EC) No 1223/2009 replaced 17 entries, added 12 new substances via replacement, and inserted 45 entirely new entries under Nos. 327–371. The leave-on threshold of 0.001% (10 ppm) and rinse-off threshold of 0.01% (100 ppm) remain unchanged.

The arithmetic is direct: 26 original entries minus the 2 moved to the prohibited list (Annex II) plus 12 replacements plus 45 new entries equals 81 substances requiring individual disclosure above the thresholds. Lyral (HICC, CAS 51414-25-6 / 31906-04-4) shifted to Annex II in 2017 via (EU) 2017/1410, and Lilial (BMHCA, CAS 80-54-6) followed in 2021 via (EU) 2021/1902.

Which existing entries drew the most attention?

CIRS Group's analysis flagged two existing entries for isomer-specific tightening. Entry No. 70 (Citral) and No. 88 (Limonene) now require labeling of multiple isomers rather than the parent compound alone. Formulators working with citrus profiles and fragrance accords built on these materials must reassess disclosure scope.

Mergers also reshape the list. Former entries No. 45 and No. 68 collapsed into new entry No. 46. Substances tied to entries 109, 114, 122, 124, 131, 133, 154, 157, 175, 196, and 324 received updated specifications. The result: 17 entries now read differently than they did before July 2023.

What sits inside the 45 new additions?

Entries 327–371 introduce substances ranging from single-chemical entities to plant-extract groups. CIRS Group noted that Menthol and Camphor — both workhorse materials across skincare, haircare, and topical analgesics — appear among the new entries. Procurement, R&D, and regulatory teams exporting to the EU need a line-by-line review against every formula.

How do the transitional periods break down?

The regulation splits compliance work into three categories, each with identical outer deadlines. New products must clear compliance hurdles by July 31, 2026. Existing products already on shelves can remain until July 31, 2028. Category B carries an additional condition: products must meet the restriction conditions applicable on August 15, 2023, to qualify for the longer placement window.

What is the global trajectory?

CIRS Group flagged parallel moves outside the bloc. Health Canada, referencing EU standards, will require 24 fragrance allergens from April 12, 2026, then expand to 81 substances on August 1, 2026. South Korea's MFDS has proposed amendments to allergen-labeling and precautions-for-use rules. Export-oriented brands now track three or more fragrance-allergen regimes simultaneously.

What should compliance teams do first?

Three operational priorities stand out:

• Audit every EU-bound formula against the full 81-substance list, not just the historic 26.
• Quantify packaging inventory and schedule label redesigns to avoid stockout of compliant SKUs.
• Lock the July 31, 2026 milestone into the product-launch calendar and back-solve the 2028 sell-off timeline.

CIRS Group's Global CosIng database has now been updated to include the 81 substances with their INCI names, CAS numbers, and use restrictions. The tool covers ingredient data for more than 40,000 entries across the EU, US, China, Canada, ASEAN, South Korea, and Japan.

What is the next data point to watch?

Watch the EU Commission's Cosmetic Ingredients database and the CosIng portal for any implementing guidance before August 2026. Health Canada's transition from 24 to 81 allergens on August 1, 2026, will be the first major test of whether non-EU regulators can synchronize labeling in real time. South Korea's MFDS draft amendments remain the third variable in an increasingly fragmented compliance picture.