Post-Brexit EU Cosmetics Compliance: What UK Brands Must Resolve Before Selling in France, Germany, or Italy

The transition period ended on 31 December 2020. And yet, through 2025 and into 2026, a consistent pattern keeps emerging among UK cosmetics brands that reach out to us: they’ve been trading informally, relying on outdated arrangements, or simply hoping no one looks too closely. National competent authorities in France, Germany, and the Netherlands have been looking closely.

The commercial logic is understandable. The UK remains one of the EU’s largest cosmetics trading partners, with bilateral trade in cosmetics and toiletries estimated at over €3.2 billion annually (CTPA and Cosmetics Europe trade data). The temptation to carry on much as before is real. But carrying on as before now constitutes a regulatory breach — one that can trigger product withdrawal orders, mandatory recalls, and formal administrative action from national enforcement bodies.

Here’s what Regulation (EC) No 1223/2009 actually requires from UK brands, and where the compliance failures concentrate.

The Responsible Person Is Not a Paperwork Formality

Under Article 4 of Regulation (EC) No 1223/2009, every cosmetic product placed on the EU market must have a Responsible Person (RP) established in the EU. From 1 January 2021, a UK-based entity — even one with a physical presence in London or Birmingham — cannot fulfil this role.

What surprises many UK brands is just how substantive the RP obligation actually is. The RP isn’t simply a named contact on a label. Under Article 5, the RP must ensure the product complies with a broad range of requirements covering safety, restricted substances, claims substantiation, nanomaterial reporting, and post-market vigilance. The RP must maintain the Product Information File (PIF) and make it available to national competent authorities within one working day of request. The RP must report serious undesirable effects (SUEs) to the competent authority in the member state where the effect occurred. And the RP must keep distribution records to allow full traceability for at least three years.

Several UK brands have tried to designate an EU-based distributor as RP through a simple letter of appointment. That arrangement can work — but only if the RP genuinely performs these obligations and holds, or has documented access to, a complete and compliant PIF. A letter alone does not transfer legal responsibility if the file is sitting on a server in Leeds.

France’s DGCCRF (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes) has issued corrective action notices to UK-branded products where the nominated RP could not produce a compliant PIF within the required timeframe. Enforcement outcomes range from mandatory market withdrawal and product suspension to administrative penalties under French consumer protection law.

CPNP Notification Cannot Be Inherited from a Pre-Brexit Account

Before any cosmetic product is placed on the EU market, it must be notified through the Cosmetics Products Notification Portal (CPNP), managed by the European Commission under Article 13 of Regulation (EC) No 1223/2009. Notification must be submitted by — and under the account of — the EU Responsible Person. Not the manufacturer. Not the importer. The RP.

This creates a specific and underappreciated problem for UK brands who notified products under CPNP prior to 2021. Those historical notifications were linked to a UK entity account. After Brexit, they became invalid for EU market purposes. Every product requires a fresh notification under a new, EU-based RP account.

The practical implication is significant. A mid-sized UK cosmetics brand with 80 SKUs needs 80 individual re-notifications, each submitted by an EU-established entity. Each notification requires the full product formula including the function of every ingredient, the product category, the frame formulation where applicable, and CMR substance status. This is not a quick administrative update. It typically takes 4 to 8 weeks for a diligent RP to process a full portfolio, depending on the quality of technical documentation received from the UK brand.

One detail that catches brands off-guard: CPNP notification does not constitute market authorisation. It’s a post-market surveillance tool. The product must already be compliant before notification — the system does not trigger a compliance review by the Commission. Errors in the formula or safety assessment are the brand’s responsibility to catch, not the CPNP’s job to flag.

Labelling: Three Changes That Are Non-Negotiable

Article 19 of Regulation (EC) No 1223/2009 sets out labelling requirements for all cosmetics sold in the EU. Post-Brexit, UK brands face at least three specific changes that cannot be carried over from pre-2021 label artwork.

The RP address must be an EU address. The label must show the name and address of the EU Responsible Person. Printing “Distributed by [EU entity]” alongside a UK manufacturer address does not satisfy Article 19(1)(a). The RP address must be the one that appears on-label, and it must be in the EU. For brands with substantial existing inventory, this means planned reprints — there is no grace period in Regulation 1223/2009 for outdated RP information.

“Made in the UK” is now a mandatory country-of-origin declaration. Under Article 19(1)(g), where a cosmetic product is manufactured outside the EU, the country of manufacture must be stated on the label. Before Brexit, UK-origin products sold by a UK RP had no such obligation. Post-Brexit, that declaration is required. The standard format is “Manufactured in the United Kingdom” or “Country of origin: United Kingdom” — not simply “UK.”

Language requirements vary by member state, and there are 27 of them. Regulation 1223/2009 requires that labelling information be in a language “easily understood” by consumers. Each member state sets its own language requirements in national transposition. France requires French. Germany requires German. Italy requires Italian. A brand distributing across five EU markets needs at least five language variants of its mandatory label copy — function descriptions, precautionary statements, and instructions for use. INCI ingredient names are standardised internationally, but warnings and application instructions are not.

Brands selling primarily through e-commerce often underestimate this. The product listing language on a marketplace does not substitute for physical label compliance on the product itself.

The Product Information File Must Now Be Accessible from the EU

Under Article 11 of Regulation (EC) No 1223/2009, the PIF must be kept at the address of the Responsible Person and be “readily accessible” to the competent authority of the member state in which the RP is established. If the RP is based in Paris, the PIF must be accessible from Paris — not from a shared drive in Manchester that requires a phone call and a password reset to access.

The PIF must remain accessible for 10 years after the date on which the last batch of the cosmetic product was placed on the market. A compliant file contains:

• A description of the cosmetic product
• The Cosmetic Product Safety Report (CPSR), signed by a qualified safety assessor
• A description of the manufacturing method and a declaration of GMP compliance — typically demonstrated through ISO 22716:2007 certification or equivalent
• Evidence substantiating any efficacy or claims made for the product
• Data on any animal testing conducted, including testing conducted on behalf of suppliers

The safety assessment (Part B of Annex I) must be prepared by someone holding a degree in pharmacy, toxicology, medicine, or an equivalent qualification. This is a legal qualification requirement, not a recommendation. UK-qualified safety assessors are fully acceptable where their credentials are EU-equivalent — but the RP must be able to confirm and document this equivalence. We’ve seen cases where UK brands submitted assessments prepared by individuals without the qualifying degree, creating a PIF that is legally non-compliant even if the document reads well on the surface.

The ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) in France has particular standing to inspect PIFs for cosmetics sold on the French market and to assess the qualifications of the signatory safety assessor. For brands entering France as their primary EU market, the assessor qualification question is worth resolving explicitly before the PIF is finalised.

What a Realistic Compliance Pathway Looks Like

None of this is insurmountable. UK brands with strong technical documentation — well-prepared PIFs, compliant CPSRs, accurate INCI declarations — typically complete an EU market entry compliance review in six to ten weeks. Brands with documentation gaps take longer, sometimes significantly longer if a new safety assessment is required.

The practical sequence for most UK brands approaching EU entry in 2026:

1. Appoint an EU Responsible Person who genuinely performs the obligations under Article 5 — not merely nominally accepts the role. Confirm that they have capacity to manage the PIF and a system for SUE monitoring and reporting.
2. Audit the existing PIFs against the requirements of Annex I of Regulation 1223/2009. Flag any CPSR gaps, outdated toxicological profile data, or missing claims substantiation.
3. Complete CPNP notifications under the new EU RP account for every SKU intended for EU sale, including updated formula data where formulations have changed since any prior UK notification.
4. Update labelling artwork to reflect the EU RP address, the country-of-origin declaration, and correct language variants for each target member state.
5. Establish distribution traceability that allows the RP to identify where products have been supplied per Article 7, with records retained for at least three years.

France tends to be the entry market for UK brands targeting Continental Europe — partly because of commercial familiarity and partly because the French cosmetics market is the largest in the EU by retail value. That means dealing with both ANSM for safety and SUE reporting, and DGCCRF for labelling and commercial compliance. Both agencies run active inspection programmes. Both agencies share intelligence.

The brands that navigate EU entry well treat the RP not as a nominee but as a genuine compliance partner — someone who understands the product portfolio, actively manages the PIF, and has built SUE monitoring into their operational rhythm. That relationship requires real investment in documentation quality and communication. But the alternative — trading into the EU without a compliant regulatory structure — is increasingly untenable as information sharing between national authorities improves through Safety Gate (formerly RAPEX) and the EU cosmetics market surveillance network.

The compliance path is clear. The question is whether brands resolve it before or after they receive a formal notice.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

Talk to our team about EU market entry. Contact us

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