Labelling a balm for the UK market: every element the regulation requires

The UK Cosmetics Regulation label requirements worked on a lip balm and a tin: Responsible Person address, nominal quantity, INCI list, warnings and date marks.

A Great Britain cosmetic label is a piece of print before it is a legal document, and most of the ones that fail do so because the artwork was designed before anybody counted the characters. This page starts from a 4.5 g twist-up tube and a 30 ml tin, fills in every element the UK Cosmetics Regulation requires, gives the type sizes that are actually fixed by law as opposed to the ones people repeat, and then sets out where Great Britain has stopped following the European Union.

• Assimilated Regulation 1223/2009
• UK RP on pack since 2023
• Under 5 g: no net quantity
• English required
• GB only, not Northern Ireland

What the UK Cosmetics Regulation is now

The instrument is Regulation (EC) No 1223/2009 as it was brought into domestic law at the end of the transition period and then amended, principally by Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, SI 2019/696. Since 1 January 2024 the Retained EU Law (Revocation and Reform) Act 2023 has renamed the whole category, so what used to be called retained EU law is now assimilated law. The text is enforced by the Office for Product Safety and Standards together with local authority trading standards, under the Cosmetic Products Enforcement Regulations 2013.

Three substitutions in SI 2019/696 do most of the practical work. "Community" became "United Kingdom", so the Responsible Person has to be established here. The Cosmetic Products Notification Portal was replaced by a submission service run by the Secretary of State, in practice the OPSS Submit Cosmetic Product Notifications portal. And the annexes were frozen as they stood at the point of conversion, which is where the divergence described further down begins.

The worked label: a 4.5 g twist-up tube

Take a standard oval twist-up tube filled to 4.5 g. The wrap label runs about 55 mm around by 42 mm tall, roughly 23 cm2 of print, of which perhaps 24 mm of width faces the buyer at once. Every required element has to sit somewhere in that.

That totals roughly 20 mm of a 42 mm label height, which is why an English-only GB label fits a lip balm tube comfortably where a four-language EU label does not. The comfort disappears the moment you add mandatory warning wording, a second Responsible Person block for the EU, or a barcode.

The 30 ml tin is easier on space and harder on two other points. It needs a nominal quantity, being over 5 g. And it needs a function statement, because a plain aluminium tin with a logo does not tell an average consumer what the contents are for.

Type sizes: what is fixed and what is convention

This is where most advice goes wrong, in both directions. The cosmetics regulation sets no minimum type size at all. Article 19(1) requires the information to be in "indelible, easily legible and visible lettering", which is a performance standard judged on the finished pack, not a point size.

The UK Responsible Person block

Article 19(1)(a) puts a name and address on the pack, and after the amendments it has to be an address in the United Kingdom. The transition ended on 31 December 2022, so since the start of 2023 every cosmetic made available in Great Britain must carry a UK Responsible Person, not an EU one. That is the most expensive consequence of departure for a small brand selling both ways, because it means paying for a second Responsible Person in whichever territory you are not established in. The role itself is covered under selling balms in the UK and EU.

The address must be a real establishment at which the product information file can be produced, not a mail-forwarding box. Label it explicitly: "UK Responsible Person:" costs three words and removes the ambiguity that appears the moment a second address joins the panel for the EU market. Where more than one address is printed, the one holding the file is highlighted.

Nominal quantity, the 5 g exemption and the ℮ mark

Declare a balm by weight. It is a solid, and the volume printed on the wholesaler's listing is the capacity of the empty tin. A 30 ml tin filled with a balm of density near 0.92 g/mL holds about 28 g, and 28 g is what goes on the label. Printing "30 ml" states a quantity you are not supplying.

Below 5 g or 5 ml no quantity is required at all, which covers every twist-up lip balm and most sample tins. The same threshold is where the Weights and Measures (Packaged Goods) Regulations 2006 begin, so a 4.5 g stick sits outside both the labelling requirement and the average quantity system. Above it, the ℮ mark becomes available and carries three obligations at once.

The three rules behind the mark are that the batch average is not less than the nominal quantity, that only a small proportion of packs fall short by more than the TNE, and that none falls short by more than twice it. Printing ℮ is a statement about your scales and fill consistency, which puts it downstream of weighing and calibration and of the checkweighing habit under batch records. If you hand-pour and do not weigh filled units, do not print it.

The ingredient list and the 1 percent pivot

The list is headed "Ingredients", uses the common ingredient names rather than plain English, and runs in descending order of weight as the materials were added. Below 1 percent the order is free, which is the pivot that makes a list readable in reverse: everything above the first sub-1 percent item is ranked, everything after it is not. That is the trick behind reconstructing a formula from a pack, worked through under reading a balm label, and the naming system itself is explained under INCI names explained.

Four details catch makers out. Fragrance and flavour compositions are declared as "parfum" or "aroma" rather than by their components, but the individually named allergens inside them still have to appear separately. Colourants may be listed in any order at the end, using CI numbers, with "may contain" or "+/-" available for a shade range. Nanomaterials are followed by "(nano)". And there is no percentage disclosure anywhere, which is why an ingredient list is evidence of ranking and not of quantity.

Getting the order right is arithmetic, not judgement, so work from the batch sheet with the INCI list builder rather than from memory. Where a flavour, a sweetener or a plant extract sits depends on the percentage you added, not on its prominence in your marketing: the lip product cases are under lip balm flavour and sweeteners.

Function, and the two elements a US template leaves out

Article 19(1)(f) requires the function "unless it is clear from its presentation". The test is whether an average consumer picking the pack up would know what it is for. A twist-up stick reading "Lip Balm" has answered it. A square tin with a wordmark and a botanical illustration has not, and neither has a product called "Rescue" or "No. 4". Two words of description are cheap; arguing about presentation with a trading standards officer is not.

Two elements here do not exist in United States federal cosmetic law: the batch number and the durability information. Anyone working from an American template, or from a competitor's imported tube, will be missing exactly those two, and the difference runs the other way as well, since the US requires an adverse event contact that GB does not. The comparison is under US cosmetic labelling. Batch coding also earns its keep beyond compliance, since it is what lets you recall one afternoon's pour instead of a year's stock: a workable scheme is in the batch code generator.

On durability, the 30 month rule decides which mark you print. Under 30 months you give a date preceded by the hourglass symbol or the words "best used before the end of". Over 30 months you give no date and instead show the open jar symbol with a period after opening, usually 12M or 24M on an anhydrous product. The figure has to be supportable from your own stability work rather than borrowed, which is what shelf life testing produces and what your assessor signs against.

Warnings from the annexes, and when a leaflet is allowed

Precautions under Article 19(1)(d) are "at least those listed in Annexes III to VI". Read the conditions of use and warnings column against every restricted substance, colourant, preservative and UV filter in your formula, and print what it says. It is not an invitation to compose your own safety copy.

For balms the entries that bite are few but real. Methyl salicylate carries a restriction and an age warning, which matters because wintergreen and sweet birch oils are almost entirely methyl salicylate and turn up in muscle rubs. Salicylic acid is restricted and not permitted for children under three. Menthol and camphor have their own limits, worked through under menthol, camphor and actives. The terpene entries impose a peroxide value specification on the oil rather than a use level, which is a purchasing condition and not a label line. The formulation consequences are under essential oils in balms.

Two pieces of folklore are worth killing. "Keep out of reach of children" is not a general legal requirement for cosmetics in Great Britain; it appears as specified wording against particular annex entries and nowhere else. Nor is "for external use only" mandated, though it is harmless and near-universal. Neither phrase substitutes for the wording an annex actually specifies, and neither turns a product with a therapeutic claim back into a cosmetic, which is the line drawn under cosmetic versus drug claims.

Where the precautions and the ingredient list genuinely will not fit, Article 19(2) survives in the GB text. Those two elements, and only those two, may move to an enclosed or attached leaflet, label, tape, tag or card, with the hand-pointing-at-an-open-book symbol on the pack to say so. Everything else stays put, and the relief is judged against what could have been printed on the pack you chose, so it will not rescue an undersized tin.

Where Great Britain has stopped tracking the EU

The two regimes started identical and are drifting. The drift is small in wording and large in consequence, because it decides whether one label serves both markets.

The allergen row decides the artwork. A label built to the current EU list declares more than Great Britain requires, and declaring more is not an offence, so an EU-specification ingredient list is normally usable here. The reverse is not true: a GB list built on 24 allergens is short for the Union. If you print once, print to the fuller list, using the thresholds and supplier data set out under fragrance allergen labelling.

The row no label can fix is a restriction that differs in level. Where a substance is permitted at one percentage in Great Britain and another in the Union, you have two formulas rather than one product with clever print, and two sets of notifications, which are compared under cosmetic notification portals.

Northern Ireland, in plain terms

Northern Ireland is not covered by anything above. Under the Windsor Framework the EU cosmetics regulation continues to apply there, so a product made available to consumers in Northern Ireland needs a Responsible Person established in Northern Ireland or the European Union, notification through CPNP rather than the OPSS service, and a label built to the current EU annexes, expanded allergen list included. The GB text, the GB annexes and the GB notification portal have no application in Northern Ireland at all.

For a maker selling across the whole United Kingdom that means one of three things: two labels, one dual label carrying both a UK and an EU or NI Responsible Person block with each identified, or a decision not to supply one market. Most small brands take the dual label, built to the stricter regime throughout. It works only while the formula is legal in both, which returns you to the annex divergence rather than to the print.

What you sign off, and what nobody signs off for you

No regulator approves a cosmetic label before it goes on sale. There is no pre-clearance and no artwork filing. The OPSS notification asks for images of the label, but submitting them is not approval and creates no defence. Somebody has to look at the printed proof and say it is right, and that somebody is the Responsible Person.

Two decisions sit outside what any reference page can settle. Who your Responsible Person is depends on where you are established, who imports and who will carry the liability, and it fixes the address on every unit you make. Whether the artwork is compliant is a judgement on a specific proof, typeface and size against a formula only you have. Legibility is a performance standard, and nobody can assess it from a description.

The decision rule is short. Choose the pack before the artwork, because printable area is the binding constraint. Build the ingredient list from the batch sheet, not from the recipe you remember. Print to the stricter of GB and EU wherever you can, and accept two products where an annex forces it. Then tick the elements against a physical proof, because that is what an enforcement visit does. The pre-market obligations sitting behind the label start under safety assessment and the CPSR.

Reviewed and updated 6 September 2026. Spotted an error? Tell us and we will fix and log it.