Compliance

EU cosmetics regulation: what a non-EU brand must have in place

Selling cosmetics in the European Union is not a matter of finding the right marketplace. It is a matter of clearing one regulation first. Here is what it actually requires, in the order it applies to you.

One regulation, twenty-seven countries

Cosmetics in the European Union are governed by a single text, Regulation (EC) No 1223/2009. It applies directly in every member state, without national transposition. That is genuinely good news: you comply once, and you can sell in France, Germany, Italy and Spain alike.

There is no licence to obtain and no marketing authorisation to wait for. Nobody grants you permission to sell cosmetics in Europe. What the regulation does instead is place the entire burden of proof on a named party, before the first sale. That party is the Responsible Person.

The Responsible Person, and why you cannot be your own

No cosmetic product may be placed on the EU market without a Responsible Person established within the Union. Their name and address appear on the packaging. They are the point of contact for the authorities, and they carry the legal liability.

The word established is the one that matters for you. A company registered in London or in New York cannot hold this role itself. You either set up an EU entity, or you appoint someone who is already established there, by written mandate that they accept in writing.

The Responsible Person carries a defined set of duties:

• keeping the Product Information File, available to authorities for ten years after the last batch;
• holding a safety assessment signed by a qualified assessor;
• notifying each product on the CPNP portal;
• ensuring the labelling and the claims comply;
• running cosmetovigilance, meaning collecting and reporting undesirable effects;
• withdrawing or recalling a product when needed, and answering the authorities.

This is not an administrative formality with a fee attached. It is a role with administrative and criminal exposure, which is why it is chosen carefully rather than delegated to whoever is cheapest.

CPNP notification comes before the first sale

Every product must be notified on the European Commission's Cosmetic Products Notification Portal before it is made available. The notification is made by the Responsible Person and covers, among other things, the formula, the category, the country of origin and a frame formulation for poison centres.

The order matters and it is often misunderstood: you notify, then you sell. Not the other way round. A marketplace that asks for your CPNP number before activating your listings is not being difficult, it is applying the law.

Labelling: what must appear, and in which language

The regulation lists what the packaging must carry: the name and address of the Responsible Person, the nominal content, the date of minimum durability or the period after opening, precautions for use, the batch number, the product function, and the full ingredient list in INCI nomenclature.

The language rule is the one that surprises brands the most. Several of these items must appear in the language of each country where the product is sold. A single English pack does not cover Germany, Italy and Spain. In practice, this is what turns a European launch into a packaging project rather than a listing project.

Claims: what you may say, and what you may not

Claims are governed by a second text, Regulation (EU) No 655/2013, which sets six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making.

The practical consequence is blunt. A cosmetic acts on the surface: it cleanses, protects, keeps in good condition, perfumes, changes appearance. The moment a claim describes a therapeutic effect, treating a condition, healing, or acting on a disease, the product is no longer a cosmetic in the eyes of the regulator. Claims that work perfectly well in the United States are routinely non-compliant in the Union for that single reason.

Banned and restricted ingredients

The regulation carries annexes listing prohibited substances, and others listing substances allowed only under conditions of concentration, purpose or warning. These lists change, several times a year, as scientific opinions are published.

A formula compliant in your home market is therefore not automatically compliant here, and a formula compliant today is not permanently compliant. Someone has to watch those updates for your products. That someone is, again, the Responsible Person.

Since Brexit, the United Kingdom is a separate system

If you are a UK brand, this is the part that costs the most time. The United Kingdom kept an equivalent framework but runs it separately: its own portal, its own Responsible Person established in the UK, its own lists.

Being compliant in Great Britain therefore gives you nothing in the Union, and the reverse is equally true. Selling in both means holding two Responsible Persons, two notifications and, in most cases, two label versions. Many brands discover this after printing.

What it takes, and what it takes to skip

Put end to end, entering the EU market means having: an EU-established Responsible Person, a complete Product Information File, a signed safety assessment, a CPNP notification per product, compliant multilingual labelling, claims rewritten to European criteria, and a watch on the annexes. Then, and only then, comes the commercial part: seller accounts, catalogues, logistics, VAT, customer service in four languages.

This is where we come in. Shrpa opens and operates the channel: we hold the seller accounts in our own name, we store your stock in our warehouses, we sell to the end customer, we handle after-sales in their language and we send you a single monthly invoice. You keep ownership of your goods until they are sold, and full visibility on every sale.

One boundary matters more than the others: a product that is not compliant does not go on sale. We ask for your CPNP number and your labelling before a product goes live, precisely for that reason. So this is the part to settle before anything else, not after.