Labelling a balm for the EU: Article 19 worked through on a real pack
Article 19 of Regulation (EC) No 1223/2009 applied to a balm: EU Responsible Person, language rules, allergen listing, durability marks and Northern Ireland.
Article 19 of Regulation (EC) No 1223/2009 names seven things a cosmetic pack must carry, and none of them is complicated until you try to fit all seven onto a 4.5 g lip balm in four languages. This page works the article element by element onto two real packs, a 30 ml aluminium tin of hand salve and a 4.5 g twist-up stick, and then deals with the three things that actually cause reprints: whose language, which allergens, and Northern Ireland.
An EU label carries seven Article 19(1) elements: the Responsible Person's name and address inside the Union, nominal content, minimum durability or period after opening, precautions, batch number, function, and the INCI list under the heading "Ingredients". Packs below 5 g or 5 ml are exempt from nominal content. Fragrance allergens are declared above 0.001 percent in a leave-on product.
Article 19(1), item by item, on two packs
The opening words of Article 19(1) do half the work: the container and packaging must bear the information "in indelible, easily legible and visible lettering". Indelible rules out a sticker that lifts off a warm tin. "Container and packaging" means both the tin and any carton it sits in, with two named relaxations that the table records where they apply.
| Element | Article | 30 ml salve tin | 4.5 g twist-up stick |
|---|---|---|---|
| Responsible Person | 19(1)(a) | Name or registered name and address inside the Union, in full. Country of origin added if the product is imported into the Union | Same, and may be abbreviated provided the person and address stay identifiable. Where more than one address is given, the one holding the product information file is highlighted |
| Nominal content | 19(1)(b) | Required. A balm is a solid, so declare weight, not the tin's capacity: "28 g", not "30 ml" | Not required. The exemption is packs containing less than 5 g or 5 ml, plus free samples and single-application packs |
| Durability | 19(1)(c) | Under 30 months, the hourglass symbol or "best used before the end of" plus a date. Over 30 months, the open jar symbol and a period after opening such as 12M | Identical rule. Most anhydrous balms sit over 30 months, so the open jar is the usual mark |
| Precautions | 19(1)(d) | At minimum the wording that Annexes III to VI attach to any restricted substance you use | Same, and this is the element most likely to force the leaflet route on a small stick |
| Batch number | 19(1)(e) | Required. Ink-jet on the base is normal | Required, but where the product is too small for practical reasons it may appear on the packaging alone |
| Function | 19(1)(f) | Required unless clear from presentation. A plain tin announces nothing, so print "Hand salve" | A twist-up stick with "Lip Balm" on the front has already done it |
| Ingredients | 19(1)(g) | Preceded by the word "Ingredients", in INCI names, descending by weight down to 1 percent. May be given on the packaging alone | Same. On a stick with no carton, "the packaging alone" is not an escape route |
Read 19(1)(g) carefully before you rely on it. "This information may be indicated on the packaging alone" means the outer carton, and it only helps if a carton exists and stays with the product. A stick sold loose from a basket has no packaging, so the ingredient list has to be on the wrap label or on an attached tag. The same trap catches the batch number relaxation in 19(1)(e).
The Responsible Person must be inside the Union
Article 4 requires a Responsible Person designated within the Community for every product placed on the market, and Article 19(1)(a) puts that person's address on the pack. The address has to be a real establishment where the product information file can be produced, not a forwarding service. That single requirement is the reason a British or Swiss maker cannot simply ship into the Union off the back of a domestic label.
Who holds the role follows from what you do rather than what you would prefer. Manufacture inside the Union and sell under your own name and you are the Responsible Person by default. Import from outside the Union and the importer is the Responsible Person for each product placed on the market, unless a distributor or manufacturer takes it on by written mandate. Put your brand on somebody else's balm, or modify one in a way that affects compliance, and you become the Responsible Person for the result. The obligations that follow are set out under selling balms in the UK and EU and under safety assessment and the CPSR.
Two consequences show up on the artwork. Where several addresses are printed, Article 19(1)(a) requires the one holding the file to be highlighted. And imported products carry the country of origin, which is the country of manufacture, not the country the shipment left from.
Nominal content, and where the ℮ mark actually comes from
Directive 2007/45/EC gets cited for this and is doing less than people think. What it did was abolish the old prescribed pack sizes for most goods, so a balm may be sold at 28 g, 30 g or any other fill you choose. It does not set the type height and it does not create the ℮ mark.
Those come from Directive 76/211/EEC on the making-up by weight or volume of certain prepackaged products, which is also where the average quantity system lives. Its minimum figure heights are the only mandatory type sizes anywhere on a cosmetic pack.
| Nominal quantity | Minimum figure height | Applied to a balm |
|---|---|---|
| Up to 50 g or 5 cl | 2 mm | Covers a 28 g tin and every lip product |
| Over 50 g to 200 g, or 5 cl to 20 cl | 3 mm | A 100 g body balm jar |
| Over 200 g to 1 kg, or 20 cl to 1 l | 4 mm | A 250 g refill tub |
| Over 1 kg or 1 l | 6 mm | Bulk and professional sizes |
| The ℮ mark itself | 3 mm | Optional. Must sit in the same field of vision as the quantity |
The ℮ is a claim, not a decoration. Applying it states that you fill to the average system: the mean contents of the batch are at least the nominal quantity, only a small proportion of packs fall below the tolerable negative error, and none falls below twice it. That is a statement about your filling line and your scales, so do not print it until you have read weighing and calibration and can show the checkweighing records. The regime starts at 5 g and 5 ml, which is the same threshold Article 19(1)(b) uses, so a 4.5 g stick sits outside both.
Durability: the hourglass, the open jar and the 30 month line
Article 19(1)(c) defines the date of minimum durability as the date until which the product, stored properly, continues to fulfil its initial function and stays in conformity with Article 3. It is preceded by the hourglass symbol from Annex VII or by the words "best used before the end of", and the date runs month and year, or day, month and year, in that order.
Where durability exceeds 30 months, no date is required at all. Instead you give the period after opening, shown as the open jar symbol from Annex VII followed by a figure in months, typically 12M or 24M on a balm. Anhydrous products usually clear 30 months comfortably, so the open jar is the mark most balm makers print. What the Regulation does not do is let you invent the number: the period has to be supportable from your own stability and compatibility work, which is what shelf life testing is for, and it has to be consistent with what your safety assessor concluded.
The 30 month relief is about durability, not about escaping traceability. The batch number under 19(1)(e) is separate and is never waived on the strength of a long shelf life. A pack with an open jar symbol and no batch code cannot support a partial recall, so run a scheme like the one in the batch code generator from your first pour. Neither the batch number nor the durability mark is required in the United States, which is precisely where an imported artwork template comes up short: see US cosmetic labelling.
The ingredient list, and the Article 33 glossary
Article 19(6) is the sentence that makes an ingredient list international: the names used must come from the common ingredient glossary provided for in Article 33, published as Commission Decision (EU) 2019/701 and maintained in CosIng. Those names are not translated into national languages, which is why an INCI list is the one block on the panel that survives every market unchanged. A working introduction to the naming system is under INCI names explained.
Within the list, four rules do most of the work. Ingredients go in descending order of weight as added, with anything at 1 percent or less free to follow in any order. Colourants other than hair colourants may be listed in any order after everything else, by CI number, and a shade range may use "may contain" or the "+/-" convention, which matters if you sell tinted balms. Perfume and aromatic compositions and their raw materials are declared as "parfum" or "aroma" rather than by their constituent chemistry. Nanomaterials are followed by "(nano)" in brackets.
Two things people expect are absent. There is no percentage disclosure, so nobody outside your file knows whether the beeswax is 12 percent or 22. And impurities in raw materials and processing aids not present in the finished product are not ingredients. Building the list in order from a percentage formula is mechanical work for the INCI list builder, and the reverse operation is set out for buyers under reading a balm label.
Fragrance allergens at 0.001 and 0.01 percent
Annex III carries a column requiring certain substances to be named in the ingredient list whatever function they serve in the product. The thresholds have not moved: an individual declaration is required above 0.001 percent in a leave-on product and above 0.01 percent in a rinse-off. Balms, salves and lip products are leave-on, so the tighter figure is the one that applies to almost everything in this trade.
0.001 percent is 10 parts per million. It is a far smaller number than it looks when the allergens arrive inside a natural material rather than as additions. Lavender oil runs roughly 25 to 45 percent linalool, so 0.003 percent lavender oil in a balm already crosses the linalool threshold. Citrus oils carry limonene at similar orders. This is arithmetic you cannot do without a full composition breakdown from the supplier, which is the argument for buying oils that come with one, and it is why the calculation belongs next to your dilution work in the essential oil dilution calculator.
The list itself expanded under Commission Regulation (EU) 2023/1545, which took the individually named substances from 24 to 80 across 81 Annex III entries and swept in materials that makers had assumed were safe from declaration, including menthol, camphor, vanillin and several whole essential oils. The dates, the entries and how to read a supplier allergen sheet are worked through under fragrance allergen labelling, with the substances themselves under fragrance allergens and the formulation consequences under essential oils in balms.
Language: whose law decides
Article 19(5) hands this question to the member states. The language of the nominal content, the durability information, the precautions, the function and anything on a leaflet under Article 19(2), (3) or (4) "shall be determined by the law of the Member States in which the product is made available to the end user". The Regulation itself names no language.
The elements not on that list are the tell. The Responsible Person's address, the batch number and the ingredient list are absent, because an address is an address, a code is a code, and INCI is already common nomenclature. So the translated part of your panel is smaller than it first appears: content, durability, precautions, function. That is the block you multiply by the number of markets.
| Market | Language expected | Effect on a small pack |
|---|---|---|
| France | French | Enforced consistently. Assume no English-only route |
| Germany, Austria | German | One language covers two markets, which is why German is usually the second one added |
| Italy | Italian | Long warning wording; the first element to overflow a stick label |
| Spain | Castilian Spanish | Regional languages may be added but do not replace it |
| Belgium | Dutch and French, with German in the German-language area | Two or three languages for one small market. Check before committing artwork |
| Finland | Finnish and Swedish | Both, on the same pack |
| Netherlands | Dutch | Pairs with the Belgian Dutch panel |
| Ireland | English | The usual first EU market for a British or Irish maker |
Where a multilingual panel fails is arithmetic, not law. A 4.5 g twist-up stick carries a wrap label of roughly 55 by 42 mm, about 23 cm2, of which the ingredient list and the Responsible Person block already consume a third. Adding function, durability, nominal content and one Annex III warning in four languages does not shrink the type below legibility, it stops fitting at all. At that point you have three honest options: fewer markets per stock-keeping unit, a multi-layer peel label, or the Article 19(2) leaflet.
Before commissioning translations, set the longest warning you need at 6 pt and measure the block. Multiply by the number of languages, add the untranslated blocks, and compare against the printable area of the pack you already bought. That exercise changes pack choices more often than it changes translation budgets, which is the argument in the packaging guide.
Small packs: Article 19(2) and the hand-in-book symbol
Article 19(2) is the relief valve, and it is narrower than its reputation. Where it is impossible for practical reasons to label the precautions under (d) and the ingredient list under (g), those two elements alone may be moved to an enclosed or attached leaflet, label, tape, tag or card. Nothing else in the article may be relocated: the Responsible Person, nominal content, durability, batch number and function stay on the pack.
Moving them is not silent. Unless that too is impossible, the pack must carry either abbreviated information or the symbol from point 1 of Annex VII, a hand pointing at an open book, telling the buyer that the information is elsewhere. For the precautions the reference goes on the container or the packaging; for the ingredients it goes on the packaging.
Article 19(3) covers the genuinely tiny case, soap and bath balls and the like, where even a tag is impossible: the ingredients then go on a notice in immediate proximity to the product at the point of sale. That works in a shop and fails online. The test applied to "impossible for practical reasons" is whether the information could have been carried legibly on the pack you chose, not whether it fits the pack you preferred, so a leaflet is a poor substitute for a slightly larger tin.
Northern Ireland, and the dual label
Northern Ireland is the part of the United Kingdom where EU cosmetic law still applies. Under the Windsor Framework, Regulation (EC) No 1223/2009 continues to have effect in Northern Ireland, so a product made available to consumers there needs a Responsible Person established in Northern Ireland or in the Union, notification through the Cosmetic Products Notification Portal rather than the British service, and an Article 19 label built to the current EU annexes, expanded allergen list included. Great Britain, meaning England, Scotland and Wales, runs the separate assimilated regime described under UK cosmetic labelling, and the two notification routes are compared under cosmetic notification portals.
A single label can serve both, and many small brands print one. It carries a UK Responsible Person block and an EU or Northern Ireland Responsible Person block, each labelled so it is obvious which is which, with the address holding the product information file highlighted as Article 19(1)(a) requires. What makes it work is that declaring more than a market requires is generally permissible, while declaring less is not. So the workable rule is to build to the stricter of the two regimes on every element and print once.
The rule breaks where the divergence is in the formula rather than the wording. If a substance is restricted at a different level in Great Britain and in the Union, or permitted in one and not the other, no amount of label engineering fixes it and you need two products. That is the difference worth testing early, because it decides whether your range is one stock-keeping unit or two.
What this page cannot decide for you
Three decisions on an EU label are yours or your adviser's, and no reference page can make them.
Who your Responsible Person is. Whether you appoint yourself, a distributor by written mandate or a paid service inside the Union depends on where you are established, who imports, and who is willing to carry Article 4 liability. It is a commercial and legal choice with real consequences, and it fixes the address printed on every unit you make.
Your translated warnings. The Annex III wording exists in the official language versions of the Regulation, but the precautions your assessor specifies are product-specific, and a translation that is merely accurate is not necessarily the phrasing a national authority expects. Translate from the official text where one exists, and have the result checked by someone who reads the market's enforcement guidance.
Whether your durability figure is defensible. A 24M open jar is a claim about your product in your pack, supported by your stability data, and signed off in your safety report. Copying the figure off a competitor's tin tells you what their assessor concluded about their formula.
Trebalm is a technical reference, not a law firm. Cosmetic law changes, member states enforce differently, and Great Britain, Northern Ireland and the Union are on separate tracks. Read the current consolidated text of Regulation (EC) No 1223/2009 before you commit artwork to print, and take advice where the answer has commercial consequences. Last checked 6 September 2026.
What the page can settle is the shape of the problem: seven elements, four translated and three not, one exemption below 5 g, one relief valve that moves exactly two elements, and one allergen threshold at 0.001 percent that decides how much composition data you need from suppliers. Get the pack size right first and the rest fits. Keep the claim side inside the cosmetic definition too, because a balm that starts treating something stops being governed by Article 19 at all, as set out under cosmetic versus drug claims.
Frequently asked questions
What has to be on a cosmetic label in the EU?
Seven elements under Article 19(1) of Regulation (EC) No 1223/2009: the Responsible Person's name and address inside the Union, the nominal content, the date of minimum durability or the period after opening, precautions for use, the batch number, the function of the product unless it is obvious, and the ingredient list in INCI names under the heading "Ingredients". Imported products also carry the country of origin.
Do I need to put the weight on a lip balm under 5 g?
No. Article 19(1)(b) exempts packs containing less than 5 grams or 5 millilitres from the nominal content statement, along with free samples and single-application packs. A 4.5 g twist-up stick is inside that exemption. If you print a weight voluntarily it still has to be accurate, and the same 5 g threshold is where the ℮ mark and the average quantity system begin.
What language does an EU cosmetic label have to be in?
Whichever the member state where the product reaches the consumer requires, because Article 19(5) leaves the choice to national law. The rule covers nominal content, durability, precautions, function and any leaflet text. It does not cover the Responsible Person's address, the batch number or the ingredient list, since INCI names are common nomenclature and are never translated.
When do I have to declare a fragrance allergen individually?
Above 0.001 percent in a leave-on product such as a balm or lip balm, and above 0.01 percent in a rinse-off. The named substance goes in the ingredient list alongside "parfum" or "aroma", not instead of it. Because these substances occur naturally inside essential oils, you need a composition breakdown from your supplier to work out whether you have crossed the threshold.
What is the hand pointing at an open book symbol on a lip balm?
The symbol from point 1 of Annex VII to Regulation (EC) No 1223/2009. It tells the buyer that information which would normally be printed on the pack is on an enclosed or attached leaflet, label, tape, tag or card instead. Article 19(2) allows only the precautions for use and the ingredient list to be moved that way, and only where labelling them on the pack is genuinely impractical.
Do EU rules still apply in Northern Ireland?
Yes. Under the Windsor Framework, Regulation (EC) No 1223/2009 continues to apply in Northern Ireland, so products made available there need a Responsible Person established in Northern Ireland or the EU, notification through CPNP, and a label built to the current EU annexes including the expanded fragrance allergen list. Great Britain runs a separate assimilated version of the same regulation.
Can one label cover both the UK and the EU?
Often, but not always. Print both Responsible Person blocks, label each clearly, and highlight the address where the product information file is kept. Then build every element to the stricter of the two regimes, since declaring more than a market requires is generally acceptable and declaring less is not. Where the two regimes restrict an ingredient differently, you need two formulas rather than one clever label.
Sources and further reading
- European Parliament and Council, Regulation (EC) No 1223/2009 on cosmetic products, Articles 4, 19 and 33 and Annex VII, Official Journal L 342, 22.12.2009.
- European Commission, Commission Implementing Decision (EU) 2019/701 establishing a glossary of common ingredient names for use in the labelling of cosmetic products, Official Journal L 121, 8.5.2019.
- European Parliament and Council, Directive 2007/45/EC laying down rules on nominal quantities for prepacked products, Official Journal L 247, 21.9.2007.
- Council of the European Communities, Directive 76/211/EEC on the making-up by weight or by volume of certain prepackaged products, Annex I, Official Journal L 46, 21.2.1976.
- European Commission, Commission Regulation (EU) 2023/1545 as regards labelling of fragrance allergens in cosmetic products, Official Journal L 188, 27.7.2023.
- Office for Product Safety and Standards, Making cosmetic products available to consumers in Great Britain, GOV.UK, on the Great Britain and Northern Ireland split.
- European Commission, CosIng database of cosmetic substances and ingredients, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, accessed 2026.
Reviewed and updated 6 September 2026. Spotted an error? Tell us and we will fix and log it.