EU Fragrance Allergen Labelling for Wet Wipes: Regulation 2023/1545

The Regulation amends Annex III of the Cosmetics Regulation. According to the European Commission, it introduces individual labelling requirements for 56 additional fragrance allergens, and updates existing entries, including grouping certain substances (European Commission). Before this change, a much shorter list of fragrance allergens had to be named; others could sit inside the word “parfum”.

Most scented wipes — baby, facial, makeup, hand and body wipes — are cosmetics, and many contain a fragrance blend. A fragrance can contain dozens of materials, several of which may be on the expanded list. The ingredient list on a 2025 pack may therefore be non-compliant for stock first placed on the market after the 2026 deadline.

Leave-on or rinse-off? The threshold depends on how the product is used. Wipes usually leave some product on the skin, which points towards the leave-on threshold, but the classification should be confirmed by your safety assessor for each product. If in doubt, plan for the stricter 0.001% threshold.

The Cosmetics Regulation defines placing on the market as the first making available of a product on the EU market, and making available as any later supply in the course of a commercial activity. Ireland’s HPRA explains the practical effect: new products placed on the market after 31 July 2026 must comply, while products placed before that date may continue to be supplied until 31 July 2028 (HPRA).

HPRA also notes that notifying a product to the CPNP does not by itself place it on the market, and that a rebranded, repackaged, reformulated or relabelled product (for example a white-label formula with new branding) may be considered a new product. For private-label wipes first sold after 31 July 2026, plan compliant artwork before production.

1. Request an allergen declaration from the fragrance supplier, covering the full Annex III list at the dosage used in your wipe liquid.
2. Calculate concentrations in the finished product (allergen % in fragrance × fragrance % in liquid) and compare with the threshold.
3. Update the ingredient list on the artwork with each allergen above the threshold.
4. Update the product information file and safety report so they match the formula and label.
5. Update the CPNP notification where the label or frame formulation changes.
6. Manage old stock so non-compliant packs are sold through before 31 July 2028.

The Responsible Person’s wider duties are explained in EU Responsible Person for wet wipes.

Fragrance-free formulas avoid the allergen labelling question and suit sensitive-skin positioning, which is why many baby and facial wipes are unscented. If scent is part of your brand, ask for a fragrance designed with a low allergen load, and keep the dosage as low as the scent target allows. Either way, “fragrance free” is a claim that must be true for the whole formula, including masking fragrances.

Great Britain has its own cosmetics regime with a UK Responsible Person and SCPN notification (GOV.UK). EU amendments made after Brexit do not automatically apply in GB, so check the current OPSS position on fragrance allergens before relying on one label for both markets. Northern Ireland follows EU cosmetics rules. Listing more allergens than GB requires is a common way to use one label for both, but confirm with your compliance adviser. For other EU labelling requirements, see wet wipes regulations by market.