Short answer: the US and EU ask for largely the same information but place different obligations on who must appear on the label and in what language. The two elements that most often cause a first shipment to be rejected are the absence of a US address for the Responsible Person in the US, and the absence of an EU-based Responsible Person with contact details in the EU. Both are structural problems in the artwork, which means both get expensive after the pack is printed.
Labels are the cheapest part of compliance to get right and the most expensive to get wrong, because correcting them means reprinting packaging and re-labelling inventory.
The mandatory elements, compared
| Element | United States | European Union |
|---|---|---|
| Responsible Person | Required, with a US address | Required, established in the EU |
| Ingredient list (INCI) | Required, descending order | Required, descending above 1%, any order below |
| Net content | Required (dual metric/US customary) | Required (metric, e-mark) |
| Batch code | Required | Required |
| Date / durability | Not always required | Best-before if ≤30 months, else PAO |
| Warnings | Required where applicable | Required, in the market's language |
| Function | Not required | Required unless obvious from the presentation |
| Fragrance allergens | Rule proposed, not final | Required above threshold |
| Nanomaterials | Not separately required | Must be indicated with "(nano)" |
| Language | English (US market) | Official language(s) of the member state |
Read the table as a checklist of artwork elements, and note the two rows that are structural: the Responsible Person and the language requirement.
The Responsible Person is the element people get wrong
Both regimes, for different reasons, require a legal entity with contact details on the label. In the US, MoCRA formalised this: the label must carry the name and address of the Responsible Person — the manufacturer, packer or distributor whose name appears on the label. If your brand name is on the label and you are a US entity, you are the Responsible Person, and the address must be a US address.
If you are not a US entity and your brand is the label name, this is the gap that stops shipments. The fix is structural, not cosmetic: you need a US-based entity or agent to serve in that role, and it has to be decided before artwork, not after.
In the EU, the Responsible Person must be established in the EU. A non-EU brand cannot simply self-appoint; it appoints an EU-based entity that takes on the legal responsibility, and whose name and address appear on the label.
This is the single most common reason we see first-time artwork bounce. We cover the US obligations in more depth in the MoCRA compliance checklist for US importers and the EU notification path in the CPNP notification guide.
Ingredient lists: the same rule, one important difference
Both markets use INCI nomenclature and both require descending order by concentration. The difference is what happens below 1%.
- US: ingredients are listed in descending order of concentration.
- EU: ingredients above 1% must be in descending order; below 1% they may appear in any order. This gives the EU formulator flexibility that the US wording does not explicitly grant.
Three further points apply to both, and are worth checking on every artwork round:
Fragrance and flavour are declared by group name, but must be broken out into individual allergens once they exceed the relevant threshold.
Nanomaterials must be identified as such in the EU — zinc oxide and titanium dioxide in sunscreens are the common cases, and the "(nano)" indicator is a requirement, not a marketing choice.
Colourants follow the market's permitted list and naming convention, and a colourant legal in one market is not automatically legal in another.
The fragrance allergen threshold — the same numbers, often misremembered
The EU requires individual declaration of fragrance allergens when they exceed:
- 0.001% (10 ppm) in leave-on products
- 0.01% (100 ppm) in rinse-off products
The two thresholds are frequently transposed in guidance, including in some supplier documents. Getting them backwards makes you over-label (harmless but ugly) or under-label (a compliance failure). Verify against the regulation, not against a supplier's summary.
The United States does not currently require fragrance allergen disclosure on cosmetic labels in the same way. MoCRA directed the FDA to establish a rule on fragrance allergen labelling, and the rule has been proposed rather than finalised — so this is a requirement to watch, not one to assume.
Language, metric and the small technicalities
Language is where the two regimes diverge most practically. The EU requires label information in the official language of the market where the product is sold. Launching into five member states can mean five artwork variants — a real cost that belongs in your launch plan, not in an appendix.
Net content must be stated in metric in the EU, with the e-mark for pre-packaged goods. US labelling carries dual declaration in metric and US customary units.
Date or durability is handled differently: the EU requires a best-before date when durability is 30 months or less, and a period-after-opening (PAO) symbol when it exceeds 30 months. The US does not impose a general durability requirement on cosmetics, though batch coding is expected practice.
Small pack exemptions exist in both regimes. Very small containers may carry the mandatory information on an attached leaflet, tag or tape rather than on the container itself — but the exemption has conditions, and using it incorrectly is a defect.
The labelling mistakes that cost the most
1. Artwork signed off before the Responsible Person is settled. This is the expensive one. Settle the legal entity, then design.
2. Ingredient order copied from a supplier's draft. Supplier drafts are frequently written for a different market with a different permitted-ingredient list. Reconcile against the regulation for the destination market.
3. Allergen thresholds transposed. See above.
4. One artwork for many languages. The EU language rule is per member state; a single English label does not satisfy every market.
5. Claims the market does not permit. Claims rules differ. A claim legal in one market can be unlawful in another, and label claims are enforced.
6. Missing the function statement — an EU requirement that US-centric artwork suppliers routinely omit because it is not required in the US.
How to sequence labelling so it does not delay your launch
- Decide the Responsible Person for every target market before artwork begins.
- Freeze the formula, because the ingredient list is derived from it and any change invalidates the list.
- Confirm the pack — size determines net content declaration and small-pack exemptions.
- Draft artwork per market, not per product.
- Review against the regulation, not against a previous label.
- Keep version control on artwork; a mislabelled variant shipped in error is a recall.
A manufacturer's role in this is to supply accurate ingredient lists, specifications and the documentation your safety assessment needs. The label itself is the brand's responsibility in both regimes — which is precisely why it is worth handling deliberately rather than inheriting a template.
FAQ
Q: What most often causes a first shipment to be rejected on labelling? A: The Responsible Person. In the US the label must carry a Responsible Person with a US address; in the EU the Responsible Person must be established in the EU. Both are structural artwork decisions, which is why both become expensive once the pack is printed.
Q: What are the EU fragrance allergen declaration thresholds? A: 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinse-off products. The two are frequently transposed, including in some supplier documents, and getting them backwards means under-labelling, which is a compliance failure.
Q: Does the US require fragrance allergen disclosure on cosmetic labels? A: Not currently. MoCRA directed the FDA to establish a rule on fragrance allergen labelling, and that rule has been proposed rather than finalised — so it is a requirement to watch, not one to assume.
Q: Can a single label serve the whole EU? A: No. The EU requires label information in the official language of the market where the product is sold, so launching into five member states can mean five artwork variants — a real cost that belongs in the launch plan.
Q: How do the US and EU ingredient list rules differ? A: Both use INCI nomenclature with ingredients in descending order of concentration. The difference sits below 1%: the EU permits those ingredients to appear in any order, while the US wording requires descending order.