Regulatory Guide

Cosmetic Labelling: Mandatory Particulars Under Article 19

The information a cosmetic label must carry under Article 19 of Regulation (EC) No 1223/2009, the rules where the container cannot hold it, language and allergen requirements, and how the UK and EU differ.

Written by Allison Wild, Clinical Pharmacologist, MSc (University of Oxford)

A compliant formulation in a non-compliant pack is a non-compliant product. Article 19 of Regulation (EC) No 1223/2009 prescribes the information a cosmetic must carry, and it is enforced precisely.

The mandatory particulars (Article 19(1))

The container and packaging must bear, in indelible, easily legible and visible lettering:

Where the packaging cannot carry it (Article 19(2))

Where it is impractical to include the precautions (d) and the ingredient list (g) on the label, they may be given on an enclosed or attached leaflet, label, tape, tag or card, to which the container directs the consumer by abbreviated information or the hand symbol of Annex VII.

Language (Article 19(5))

The Member State in which the product is made available to the end user determines the language of the durability, precautions, function and content information. The ingredient list is given in INCI nomenclature and is not translated.

Allergen declaration

The fragrance allergens listed in Annex III must be declared by name in the ingredient list when their concentration exceeds 0.001 per cent in leave-on products or 0.01 per cent in rinse-off products. Commission Regulation (EU) 2023/1545 substantially expanded this list, from 24 to around 80 substances, with transition periods allowing newly listed allergens until 2026 to be placed on the market and until 2028 to be withdrawn if non-compliant. The complete substance list, with CAS numbers and the reasoning behind the amendment, is set out in our EU fragrance allergen reference.

The formaldehyde-releaser warning

Several preservatives release small amounts of free formaldehyde over a product’s life. Where the released formaldehyde in the finished product exceeds the regulatory threshold, the label must carry the warning “releases formaldehyde”. Both the EU and Great Britain have now moved this threshold down to 0.001 per cent (10 ppm), a fifty-fold reduction from the previous 0.05 per cent: the EU under Commission Regulation (EU) 2022/1181, and Great Britain under SI 2026/23, which also changed the warning wording from “contains formaldehyde” to “releases formaldehyde” and applies to products placed on the GB market from 15 July 2026. The warning attaches to the released formaldehyde across the whole formulation, not to any single named ingredient, so it is assessed against the finished product. The GB substance prohibitions in the same instrument are set out in our SI 2026/23 reference.

Claims on the label (Article 20)

Claims are governed by Article 20 and the six common criteria of Commission Regulation (EU) No 655/2013: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. The accompanying Technical Document constrains “free from” and “hypoallergenic” claims in particular. A label may not attribute to a product a characteristic or function it does not have.

UK and EU differences

Great Britain requires the address of a UK Responsible Person and English-language information; the EU requires an EU Responsible Person and the language of the market of sale. Northern Ireland follows the EU rules. The two markets are also diverging on substance restrictions: SI 2026/23 prohibits the UV filter 4-MBC and a set of newly classified CMR substances on the GB market from mid-2026, on GB-specific timelines (see our UK market page). France adds a sorting-signage requirement that sits outside cosmetics law, the Triman and Info-tri marking, covered in our Triman labelling reference for France. To see the mandatory particulars positioned on a label rather than listed, see our annotated cosmetic label.

Getting the label right

Labelling is where small errors become expensive: a missing particular, the wrong language for a market, or an omitted warning can mean a rejected listing, a relabelling exercise or a recall. Our label review service checks artwork against the mandatory particulars and the market-specific requirements for every country a product will enter, before it goes to print.

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