EU cosmetics labelling requirements: label particulars, INCI list, and allergens

Start with the responsible person (Article 4)

A cosmetic product may be placed on the EU market only if a legal or natural person established in the EU is designated as its “responsible person” (RP). The RP ensures compliance, notifies the product, and is named on the label. Who that is depends on where the product comes from.

• Made in the EU by an EU manufacturer: the manufacturer is the RP, or it can mandate another EU-established person in writing.
• Made in the EU by a manufacturer established outside the EU: the manufacturer must designate an EU-established RP by written mandate.
• Imported into the EU: each importer is the RP for the products it places on the market, unless it mandates an EU-established person in writing.
• A distributor becomes the RP if it sells the product under its own name or trademark, or modifies it in a way that may affect compliance. Translating the labelling alone is not a modification.

The seven label particulars in Article 19

Article 19(1) lists the information that must appear on the container and on the packaging, in indelible, easily legible and visible lettering. Several particulars have exceptions for small or awkward packs, summarized below.

Distributors have a checking duty too. Before making a product available, they must verify that the RP name and address, the batch number and the ingredient list are present, that the language rules are met, and that the date of minimum durability has not passed (Article 6(2)).

How to write the INCI ingredient list

Ingredient names follow the common ingredient name glossary established under Article 33, which is INCI-based in practice. An ingredient is any substance or mixture used intentionally in manufacturing; impurities and technical aids that are not present in the finished product are not ingredients. The rules in Article 19(1)(g) are short but easy to get wrong when a formula sheet is converted into artwork:

• Order: descending order of weight at the time the ingredients are added.
• Below 1 %: ingredients at concentrations below 1 % may be listed in any order after those above 1 %.
• Perfume and aromatic compositions are declared as “parfum” or “aroma”. Fragrance allergens flagged for labelling in Annex III must also be named individually in the list.
• Nanomaterials: the ingredient name is followed by “(nano)”.
• Colorants other than hair dyes may be listed in any order after the other ingredients, using Colour Index (CI) numbers. For a shade range, “may contain” or “+/-” can introduce colorants not present in every shade.
• If the list cannot practically appear on the pack, it goes on an enclosed leaflet, label, tape, tag or card, and the pack carries the “hand in book” symbol from Annex VII. For soap, bath balls and other small products, the list can be shown on a notice next to the display container.

Best-before date or PAO symbol?

Article 19(1)(c) ties the choice to the product’s durability. Take that figure from the RP’s safety documentation, not from marketing copy.

Where durability is 30 months or less, the date of minimum durability is mandatory. It is introduced by the hourglass symbol (Annex VII point 3) or the words “best used before the end of”, and written as month and year, or day, month and year, in that order. Where durability exceeds 30 months, the date is optional, but the label must show the period after opening: the open-jar symbol (Annex VII point 2) followed by the period in months and/or years, unless the PAO concept is not relevant to the product.

Behind the label: safety assessment, PIF, and CPNP notification

Three pre-market obligations sit with the responsible person and feed the label: the RP address on the label must be where the product information file can be accessed, and precautions and durability should match the safety report.

Fragrance allergens: what Regulation (EU) 2023/1545 changed

Commission Regulation (EU) 2023/1545 amended Annex III to require individual labelling of more fragrance allergens, following the Scientific Committee on Consumer Safety’s identification of 56 additional allergens. Where a listed allergen is present above 0.001 % in a leave-on product or 0.01 % in a rinse-off product, it must be named in the ingredient list in addition to “parfum” or “aroma”.

Perfume suppliers’ allergen declarations now need to cover the extended list, and label artwork, listings and translations must be updated together. The first deadline has already passed.

Language requirements

The Regulation leaves the language of most label text to the Member State where the product is made available. Under Article 19(5), national law decides the language of the nominal content, the durability or PAO information, the precautions and the function, as well as the text on leaflets and shelf notices.

The ingredient list is not covered by Article 19(5), because it uses the common glossary (INCI) names in every market. In practice that means one ingredient list can serve the whole EU, while precautions and function text need a translation per country unless the national rules accept another language.

A distributor that translates labelling on its own initiative to meet national law does not become the RP for that reason, but it has its own notification duty under Article 13(3).

Claims, function, and proof of effect

Function is a label particular unless it is obvious from the presentation, so a “serum” or “balm” with no clear use may need a short function statement. The product information file must also contain proof of the claimed effect where the nature of the effect justifies it (Article 11(2)(d)).

Treat every efficacy or “free from” claim on the label or listing as something the RP must be able to support from the file. More detailed EU criteria for cosmetic claims exist outside Article 19; check them before finalizing wording, and keep listing copy aligned with the approved label.

Online listings: what to show

The General Product Safety Regulation (EU) 2023/988 applies to consumer products to the extent that no specific EU rules with the same objective exist. Its Article 19 lists what an online offer must show: manufacturer details, the responsible person where the manufacturer is not established in the EU, product identification with a picture, and applicable warnings. How this interacts with the Cosmetic Products Regulation is a legal question; check the Commission’s GPSR guidelines.

Either way, buyers and marketplaces expect a cosmetic listing to mirror the label. A practical listing data set includes:

• Product name, function and nominal content, matching the pack.
• The full ingredient list exactly as printed, including named allergens and “(nano)” suffixes.
• Precautions and warnings that apply to the product, in the language of the target market.
• The responsible person’s name and address as shown on the label, and manufacturer contact details.
• Clear images of the front and back label, so symbols and the batch number position are visible.

US contrast: MoCRA and FDA labelling rules

In the US, the FDA regulates cosmetics under the FD&C Act as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). There is no CPNP-style notification before sale; instead facilities register (renewed every two years) and products are listed through FDA Cosmetics Direct within 120 days of first marketing, with annual updates. Certain small businesses are exempt from registration and listing, except for some higher-risk product types.

Since 29 December 2024, every US cosmetic label must give a domestic address, domestic phone number or electronic contact (which may be a website) for adverse-event reports; serious adverse events must be reported to FDA within 15 business days. 21 CFR 701 covers the ingredient declaration (descending order of predominance; fragrance may be declared as “fragrance”), the statement of identity, the name and place of business, and net quantity. Part 740 adds warnings for product types such as aerosols and suntanning preparations without sunscreen.

MoCRA also requires FDA to issue a fragrance-allergen labelling rule. No such rule has been finalized, so collective declaration as “fragrance” remains possible in the US for now.

EU cosmetic label checklist

Run this check on every new label and on every formula or packaging change.

At catalog scale, the slow part is collecting these fields from formula sheets, label artwork and supplier declarations for hundreds of products. Doc2Shelf extracts label and ingredient data from supplier PDFs, drafts EU and US cosmetic declaration documents and listing copy, and marks missing information as required placeholders for a person to review. It does not perform safety assessments, prepare the CPSR, submit CPNP notifications or act as a responsible person.

1. Confirm the responsible person for each market and that their name and address match the place where the PIF is held.
2. Add the country of origin if the product is imported into the EU.
3. Check nominal content and whether the small-pack, sample or multi-pack exceptions apply.
4. Take the durability figure from the safety assessment and choose the best-before date or the PAO symbol accordingly.
5. Copy precautions from the safety report and Annexes III–VI; add a function statement if the use is not obvious.
6. Rebuild the ingredient list from the formula: descending order, under-1 % block, parfum plus named allergens, “(nano)” suffixes, CI colorants last.
7. Check allergen labelling against Regulation (EU) 2023/1545 and identify any stock that falls under the 31 July 2028 cut-off.
8. Translate the nationally required particulars for each target country and keep the INCI list unchanged.
9. Update the CPNP notification and the online listings so they match the final label.