RegaaS

Cosmetics · European Union

What must appear on a cosmetic label in the EU?

Published · Reviewed · Reviewed by Alan Huang, Sr. Compliance Manager · 13 min read

Key points

  • Article 19(1) requires the container and packaging to show the Responsible Person's name and address, the country of origin for imported products, the nominal content, the date of minimum durability or the period after opening (PAO), precautions for use, the batch number, the product's function and the ingredient list.
  • Article 4(1) requires a legal or natural person established in the Union to be designated as Responsible Person, and Article 19(1)(a) requires that person's name and address on the label.
  • The 30-month line decides the date format: up to 30 months, a date of minimum durability; above it, the period-after-opening symbol.
  • An allergen listed in Annex III must be named in the ingredient list when it exceeds 0.001 % in leave-on products or 0.01 % in rinse-off products.
  • Non-compliant products could be placed on the Union market only until 31 July 2026, and may be made available until 31 July 2028. Citral (Annex III entry 70), replaced again by Regulation (EU) 2026/909, has later dates.
On this page · 11
  1. The Article 19(1) checklist, line by line
  2. When the label has no room
  3. How the ingredient list is built
  4. Fragrance allergen labelling after Regulation (EU) 2023/1545
  5. Claims and the six common criteria
  6. What is required but never printed on the label
  7. Common mistakes
  8. How RegaaS checks this
  9. What this guide does not cover
  10. Frequently asked questions
  11. Primary sources

Article 19(1) of Regulation (EC) No 1223/2009 requires the container and packaging of a cosmetic product made available on the EU market to show, in indelible, easily legible and visible lettering: the Responsible Person's name and address, the country of origin for imported products, the nominal content, the date of minimum durability or the period after opening (PAO), precautions for use, the batch number, the product's function and the ingredient list. Since Commission Regulation (EU) 2023/1545, many more fragrance allergens must be named individually in that list; for every entry except Citral (entry 70, replaced again in 2026), non-compliant products could be placed on the market only until 31 July 2026 and may be made available until 31 July 2028.

The Article 19(1) checklist, line by line

Article 19(1) sets out the particulars as points (a) to (g). Points (a) and (c) each split into two lines, so the checklist has nine rows.

#ParticularWhat the label must showExemptions and alternativesProvision
1Responsible PersonName or registered name and address of the Responsible PersonMay be abbreviated if the person and address can still be identified. If several addresses appear, the one where the product information file (PIF) is readily available must be highlightedArticle 19(1)(a)
2Country of originThe country of originRequired for imported products onlyArticle 19(1)(a)
3Nominal contentContent at the time of packaging, by weight or by volumeNot required for packs under 5 g or 5 ml, free samples or single-application packs. For pre-packages normally sold by number of items where weight or volume is not significant, the count on the packaging may replace it, and can be omitted if it is easy to see from outside or the product is normally sold singlyArticle 19(1)(b)
4Date of minimum durabilityThe date, preceded by the hourglass symbol (Annex VII, point 3) or the words "best used before the end of"; month and year, or day, month and year, in that order; storage conditions if needed to guarantee itNot mandatory where minimum durability exceeds 30 months (see line 5)Article 19(1)(c)
5Period after openingFor products with a minimum durability over 30 months: the open-jar symbol (Annex VII, point 2) followed by the period in months and/or yearsNot required where durability after opening is not relevantArticle 19(1)(c)
6Precautions for useParticular precautions, at least those in Annexes III to VI, and any special precautionary information for professional-use productsMay go on a leaflet, tag or card if space makes it impossible (see below)Article 19(1)(d), 19(2)
7Batch numberBatch number of manufacture, or the reference identifying the productIf the product is too small, it need appear only on the packagingArticle 19(1)(e)
8FunctionThe function of the productNot required if clear from the presentationArticle 19(1)(f)
9Ingredient listA list preceded by the term "ingredients"May appear on the packaging alone; alternatives under Article 19(2) and (3)Article 19(1)(g), 19(6)

Two points are easy to miss. By default every particular appears on both the container and the packaging; only the batch number (for very small products) and the ingredient list may be limited to the packaging. And the 30-month line decides the date format: up to 30 months, a date of minimum durability; above it, the period-after-opening symbol.

The 30-month line decides the date format

Minimum durability: 30 months or less

Date of minimum durability

  • Preceded by the hourglass symbol (Annex VII, point 3) or the words “best used before the end of”
  • Month and year, or day, month and year, in that order
  • Storage conditions if needed to guarantee it
Minimum durability: More than 30 months

Period after opening (PAO)

  • The open-jar symbol (Annex VII, point 2) followed by the period in months and/or years
  • Not required where durability after opening is not relevant
Article 19(1)(c) of Regulation (EC) No 1223/2009; Annex VII, points 2 and 3.

Line 1 must name a person established in the Union. Under Article 4(1), a product may be placed on the market only if a legal or natural person within the Union is designated as Responsible Person; for an import, that is the importer unless it designates another EU-established person by written mandate (Article 4(5)).

When the label has no room

Article 19(2) applies only to the precautions in point (d) and the ingredient list in point (g). Where it is impossible for practical reasons to print them as required:

  • the information goes on an enclosed or attached leaflet, label, tape, tag or card;
  • unless impracticable, the label refers to it by abbreviated information or the symbol in point 1 of Annex VII, a hand with an open book.

That symbol must appear on the container or packaging for precautions, and on the packaging for the ingredient list.

Article 19(3) adds a fallback for the ingredient list only: for soap, bath balls and other small products where even a tag or leaflet is impractical, the list may go on a notice in immediate proximity to the container in which the product is displayed for sale.

Article 19(4) leaves products that are not pre-packaged, are packed at the point of sale on request, or are pre-packed for immediate sale to detailed rules adopted by each Member State.

How the ingredient list is built

RuleRequirementProvision
What counts as an ingredientAny substance or mixture intentionally used during manufacture. Impurities in raw materials, and subsidiary technical materials not present in the final product, are not ingredientsArticle 19(1)(g)
HeadingPreceded by the term "ingredients"Article 19(1)(g)
OrderDescending order of weight at the time each ingredient is addedArticle 19(1)(g)
Under 1 %Ingredients below 1 % may be listed in any order after those above 1 %Article 19(1)(g)
ColorantsColorants other than hair colorants may be listed in any order after the other ingredients, using CI (Colour Index) nomenclature where applicableArticle 19(1)(g)
Shade rangesDecorative products sold in several shades may list every colorant used in the range, with "may contain" or "+/-"Article 19(1)(g)
Fragrance and flavourPerfume and aromatic compositions are declared as "parfum" or "aroma", plus any substance whose mention is required in the "Other" column of Annex IIIArticle 19(1)(g); Annex III
NanomaterialsThe ingredient name followed by "(nano)"Article 19(1)(g)
NamesThe common ingredient name from the glossary under Article 33; failing that, a generally accepted nomenclatureArticle 19(6)

Fragrance allergen labelling after Regulation (EU) 2023/1545

Before 2023, 26 fragrance allergens had to be named individually in the ingredient list. They are listed in Annex III entries 45 and 67 to 92: entry 45 sets a limit for benzyl alcohol in other uses, and entry 68 is its allergen labelling entry. Commission Regulation (EU) 2023/1545 of 26 July 2023 amended Annex III to add individual labelling for the 56 further allergens identified by the Scientific Committee on Consumer Safety (SCCS), as recital 6 records. It also regrouped some existing entries and fixed which name to use, for example "Citral" for geranial and neral (entry 70, since replaced again; see below).

The threshold is the same for every entry. The allergen must be named in the ingredient list when its concentration exceeds:

  • 0.001 % in leave-on products (intended to stay in prolonged contact with skin, hair or mucous membranes);
  • 0.01 % in rinse-off products (intended to be removed after application).

The transition dates sit in footnotes to the amended Annex III entries, not in an article of the regulation.

DateWhat it meansSource
31 July 2026Last date on which products not complying with the new requirements could be placed on the Union market (all entries except entry 70, Citral; see below)Regulation (EU) 2023/1545, Annex, footnotes to amended Annex III entries
31 July 2028Last date on which such products may be made available on the Union market (all entries except entry 70, Citral; see below)Same

"Placing on the market" means the first making available in the Union (Article 2(1)(h) of Regulation 1223/2009). As of October 2026, any product placed on the market must already name the allergens required by the entries that the 2023 regulation added or replaced (see the entry 70 exception below); stock placed before the deadline can be sold until 31 July 2028. For the existing entries that the 2023 regulation replaced, the transition covers only products that met the restrictions applicable on 15 August 2023.

Fragrance allergens: transition dates

Regulation (EU) 2023/1545

All entries except entry 70, Citral

  1. 26 Jul 2023

    Commission Regulation (EU) 2023/1545 amends Annex III

  2. 31 Jul 2026

    Last date on which products not complying with the new requirements could be placed on the Union market

  3. As of October 2026

    Any product placed on the market must already name the allergens required by the entries that the 2023 regulation added or replaced

  4. 31 Jul 2028

    Last date on which such products may be made available on the Union market

Regulation (EU) 2026/909

Entry 70, Citral

The labelling rule is unchanged: Citral, geranial and neral are indicated as “Citral”.

  1. 31 Dec 2026

    Products not complying with the restrictions of entry 70 may be placed on the market until this date

  2. 30 Jun 2028

    Citral (CAS 5392-40-5): made available until this date

  3. 31 Jul 2028

    Geranial and neral: made available until this date

Regulation (EU) 2023/1545, Annex, footnotes to amended Annex III entries; Commission Regulation (EU) 2026/909. “Placing on the market” means the first making available in the Union (Article 2(1)(h) of Regulation 1223/2009). For the existing entries that the 2023 regulation replaced, the transition covers only products that met the restrictions applicable on 15 August 2023.

Claims and the six common criteria

Article 20(1) prohibits text, names, trade marks, pictures and other signs that imply characteristics or functions a product does not have. Commission Regulation (EU) No 655/2013 sets the common criteria every claim must meet, on the label and in advertising. Under its Article 2, the Responsible Person must ensure the wording complies with the criteria and matches the proof of effect held in the product information file.

CriterionWhat it requires, in shortProvision
Legal complianceNo claim that a product is authorised or approved by a competent authority within the Union; no claim presenting mere legal compliance as a specific benefitRegulation 655/2013, Annex, point 1
TruthfulnessA claimed ingredient must be deliberately present; ingredient properties must not be implied for the finished product if it lacks themAnnex, point 2
Evidential supportAdequate, verifiable evidence proportionate to the claim; obvious hyperbole needs noneAnnex, point 3
HonestyPerformance not overstated; no "unique" characteristic that similar products share; conditions of use statedAnnex, point 4
FairnessNo denigration of competitors or of legally used ingredients; no confusion with a competitor's productAnnex, point 5
Informed decision-makingClear and understandable to the average end userAnnex, point 6

Claims that no animal tests have been carried out are governed separately by Article 20(3).

What is required but never printed on the label

These obligations leave no trace on the artwork but must be in place before, or at the latest when, the product is placed on the market.

ObligationWhat it involvesProvision
Responsible Person designatedA legal or natural person established in the Union: the manufacturer, importer or own-brand distributor by default; another EU-established person only by written mandate, accepted in writingArticle 4(3)–(6)
Responsible Person dutiesEnsures compliance with the safety, PIF, notification, labelling and claims articles, among othersArticle 5(1)
Cosmetic product safety report (CPSR)Safety assessment and report under Annex I before placing on the market; Part B by a suitably qualified assessorArticle 10(1), 10(2)
Product information file (PIF)Kept for ten years after the last batch is placed on the market, readily accessible at the address on the labelArticle 11(1), 11(3)
PIF contentsIncludes the CPSR, manufacturing method and GMP statement, and proof of claimed effect where justifiedArticle 11(2)
CPNP notificationElectronic notification to the Commission before placing on the marketArticle 13(1)
Labelling notificationOriginal labelling and, where reasonably legible, a photograph of the packagingArticle 13(2)

Common mistakes

How RegaaS checks this

For a cosmetic label for the EU market, RegaaS applies Regulation (EC) No 1223/2009 and cites the provision behind every finding. Its coverage includes:

  • the Article 19 particulars on container and packaging, and the alternatives available where the label has no room;
  • the ingredient list rules: descending order, latitude below 1 % and for colorants, "parfum" or "aroma", and "(nano)";
  • the prohibited and restricted substances, colorants, preservatives and UV filters of the annexes;
  • individual fragrance allergen labelling as expanded in 2023, with its transition dates;
  • product claims against the six common criteria.

The Responsible Person, the product information file, the safety report and CPNP notification cannot be read from artwork. RegaaS returns them as a checklist for the Responsible Person to confirm. Findings are marked on the label image with a suggested revision.

Every rule applied gets one of four results: Compliant, Needs review, Potential risk or Not applicable. Where the information provided is not enough to decide, or the case is borderline, RegaaS marks the rule Needs review and refers it to regulatory staff instead of reaching a conclusion. Each Potential risk shows where the issue is on the label, the provision and the version in force, and a suggested revision. Whether a finding stands, and what to do about it, is decided by regulatory staff. When a provision is amended, RegaaS identifies the products already reviewed against it so they can be checked again.

What this guide does not cover

  • Member State language requirements. Article 19(5) leaves the language of the nominal content, durability, precautions and function, and of the information given under Article 19(2) to (4), to the law of the Member State where the product reaches the end user. RegaaS does not assess them and reports them as out of scope.
  • National rules under Article 19(4) for products that are not pre-packaged or are packed at the point of sale. These are not described in this guide.
  • Great Britain and Northern Ireland. Great Britain has operated its own cosmetics regime since EU exit. Northern Ireland continues to apply EU rules. Both are outside current RegaaS coverage and are reported as out of scope.
  • Switzerland, which is also outside RegaaS coverage.

Frequently asked questions

Which regulation governs cosmetic labelling in the EU? Regulation (EC) No 1223/2009 on cosmetic products. The label particulars are in Article 19, claims are in Article 20, and the common criteria for claims are in Commission Regulation (EU) No 655/2013.

When do I use the period-after-opening symbol instead of a date? When the product's minimum durability exceeds 30 months. At 30 months or less, a date of minimum durability is required, preceded by the hourglass symbol or "best used before the end of" (Article 19(1)(c)).

What are the fragrance allergen thresholds? An allergen listed in Annex III must be named in the ingredient list when it exceeds 0.001 % in leave-on products or 0.01 % in rinse-off products.

When do the expanded fragrance allergen rules apply? Non-compliant products could be placed on the Union market only until 31 July 2026, and may be made available until 31 July 2028 (Regulation (EU) 2023/1545). Citral (Annex III entry 70), replaced again by Regulation (EU) 2026/909, has later dates: products not complying with that entry may be placed on the market until 31 December 2026 and made available until 30 June 2028 (31 July 2028 for geranial and neral).

Must the Responsible Person be established in the EU? Yes. Article 4(1) requires a legal or natural person established in the Union to be designated as Responsible Person, and Article 19(1)(a) requires that person's name and address on the label.

Does CPNP notification show on the label? No. The Responsible Person, the product information file, the safety report and the CPNP notification leave no trace on the artwork, so RegaaS returns them as a checklist.

Primary sources

A RegaaS report is a documented review against these provisions. It is not legal advice, and does not replace sign-off by a qualified regulatory professional, the Responsible Person or the safety assessor.

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