Regulation (EU) 2023/1545: new fragrance allergens on the INCI label

Commission Regulation (EU) 2023/1545 of 26 July 2023 amends Annex III of the Cosmetics Regulation (EC) No 1223/2009. It significantly expands the list of fragrances that must be individually named on the label. Anyone placing perfumed cosmetics on the market in the EU must check their formulations and INCI lists (International Nomenclature of Cosmetic Ingredients, the standardised ingredient designations) against these requirements.

What has changed

Under Article 19(1)(g) of Regulation (EC) No 1223/2009, fragrance and aromatic substances are generally listed as Parfum or Aroma in the ingredient list. However, certain allergenic fragrance substances must additionally be listed individually. Until now, this applied to 24 fragrance substances listed in entries 45 and 67 to 92 of Annex III.

The amendment is based on an opinion of the Scientific Committee on Consumer Safety (SCCS, SCCS/1459/11 of 26 and 27 June 2012). The SCCS confirmed that the existing 24 fragrance substances remain relevant and identified 56 additional allergenic fragrance substances that have clearly caused allergies in humans and were previously not required to be individually labelled. These additional substances have now been added to Annex III (new entries 327 to 371). In addition, prehaptens and prohaptens, that is, fragrance substances that can be converted into known contact allergens through air oxidation or bioactivation, are now treated the same as allergenic fragrance substances.

Background: according to the Regulation, a contact allergy persists for life. The proportion of the Union population allergic to fragrance substances is estimated at 1 to 9 percent. Individual labelling is intended to enable sensitised persons to avoid contact with the substance relevant to them.

When individual labelling is required

The labelling obligation applies as soon as an affected substance is present in a concentration exceeding:

• 0.001 percent in leave-on products (products that remain on the skin or hair), or
• 0.01 percent in rinse-off products

These thresholds apply both to the fragrance substances already listed and to the newly added ones. For some substances, the Regulation prescribes a specific designation in the ingredient list to standardise the labelling, such as Citral, Rose Ketones, Myroxylon Pereirae Oil/Extract or Cananga Odorata Oil/Extract.

Examples of newly affected substances

The new entries include individual compounds as well as essential oils and plant extracts. A selection:

In addition to these additions, existing entries were updated (including 45, 46, 70, 73, 86, 88, 154, 157, 324) and several entries were deleted (125, 126, 158, 160 to 163, 165, 167 and 168). The complete list is available in the regulation text on EUR-Lex.

Deadlines and transitional rules

The Regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union (published on 27 July 2023). Two staggered transitional periods apply:

• 31 July 2026: Cosmetic products that do not comply with the new restrictions may only be placed on the market in the Union up to this date.
• 31 July 2028: Such products may still be made available on the Union market up to this date.

The Regulation justifies the length of the transitional periods of three and five years respectively by the large number of newly individually labelled fragrance substances and the significant number of products affected. At the time of writing this article, the first placing-on-market deadline is already approaching.

What to check now

It is advisable to systematically compare your own formulations with the updated and newly added entries of Annex III. The following steps can help:

1. Break down fragrance compositions and perfume oils with the supplier to identify the individual substances and essential oils they contain.
2. For each affected substance, check the concentration in the finished product against the thresholds of 0.001 percent (leave-on) and 0.01 percent (rinse-off).
3. Update the INCI list to include the substances requiring individual labelling, using the designations prescribed by the Regulation.
4. Plan labels and packaging stock so that only compliant products are newly placed on the market from 1 August 2026 onwards.

REGULARUS supports updating INCI labelling including allergen declaration and safety assessment (CPSR under Annex I). An inquiry is the easiest starting point if you would like to check your formulations against the new requirements. This article does not replace a legal assessment of individual cases.