EU and UK cosmetic compliance: what brand owners must know
The Global Market Library · Updated · 6 min read
In the EU and UK, a cosmetic must have a Responsible Person based in that market, a safety assessment by a qualified person, a product information file, a notification to the official portal and a compliant label. The brand owner or importer usually carries these duties. The manufacturer supplies formula data and makes to good practice. Confirm details with your regulatory adviser.
The EU and UK are among the most structured cosmetic markets, and they are also the ones where brands most often underestimate the paperwork. The core idea is simple. The law attaches duties to a person in the market, not to the factory. If you are the brand owner, you either take on those duties or appoint someone who does. This guide explains the main building blocks in plain language, names the frameworks, separates brand-owner and manufacturer responsibilities, and points you to the right next step. It is general guidance rather than legal advice. Rules change, so confirm requirements with your importer or regulatory adviser. For market summaries, see our EU export page and UK export page.
Which frameworks apply?
In the European Union, cosmetics are governed by the EU Cosmetics Regulation, Regulation (EC) No 1223/2009. In the United Kingdom, a retained and adapted version applies, the UK cosmetics regulation. The two share a structure, but since the UK left the EU they run as separate systems with separate portals and local requirements. A product on sale in both needs to satisfy both, with a Responsible Person for each market.
Who is the Responsible Person?
The Responsible Person, often shortened to RP, is a legal entity based in the EU or UK that takes responsibility for the product placed on that market. It is typically the brand owner if it is established there, the importer, or a specialist service appointed for the purpose. The RP ensures the product complies, keeps the product information file, and acts as the contact for authorities.
A manufacturer outside the market cannot be the RP unless it has an establishment there. For a brand based in India or elsewhere, appointing a RP is usually the first practical decision. Confirm who it will be before you sign off a formula.
What does the brand owner need to have in place?
- A named Responsible Person in each market.
- A safety assessment carried out by a suitably qualified person for each product, based on the formula and intended use.
- A product information file kept for each product and available to authorities.
- Notification of the product through the official portal for that market before it is placed on sale.
- A compliant label, in the language the market requires, showing the required particulars.
- A system for undesirable effects, so complaints are recorded and acted on.
How is the work split between brand owner and manufacturer?
| Task | Brand owner or Responsible Person | Manufacturer |
|---|---|---|
| Appointing the Responsible Person | Decides and appoints | Not applicable |
| Safety assessment | Commissions and relies on it | Supplies full formula and ingredient data |
| Product information file | Holds and maintains it | Supplies manufacturing information and specifications |
| Notification to the portal | Submits through the Responsible Person | Provides formula details when asked |
| Label content and claims | Responsible for compliance | Applies the approved label |
| Production practice and batch records | Reviews and audits as needed | Makes to consistent working practice and keeps records |
| Complaints and undesirable effects | Receives and records them | Provides batch traceability |
What goes on an EU or UK label?
Labels in these markets generally need the name and address of the Responsible Person, the country of origin for imported goods, the nominal content, the ingredient list using standard naming, the batch reference, any required warnings and the period after opening or a date of minimum durability where relevant. Language requirements depend on the country of sale. Small packs often cannot hold all text, so the rules allow some information on an outer carton or leaflet, which has to be planned from the start.
Because label space is a design constraint, think about it when you choose the pack. Our packaging range and custom packaging service can help match pack size to label content.
How do claims work?
Claims need to be truthful, supported by evidence and not misleading. A cosmetic should not suggest it addresses a medical condition. Keep to descriptions of appearance, feel, cleansing and scent, and keep the evidence for each claim in the product file. Online copy, social posts and packaging all count. Have your adviser review the wording before artwork is final.
Which ingredients need particular care?
Both frameworks restrict or ban certain substances, and some are permitted only with limits or conditions. Colourants, preservatives and ultraviolet filters follow their own lists. Fragrance components that must be declared by name are another point to check. Share your formula with your safety assessor early, and ask whether any ingredient in the ready formula you like needs a change for your market. Our custom formulation service can adjust a formula to a brief.
What should you do in what order?
- Choose the market and the product. Browse the skincare, body care and hair care ranges.
- Appoint the Responsible Person.
- Share the formula with the safety assessor.
- Finalise claims and label with your adviser.
- Approve a sample in the final pack.
- Complete the file and notification before sale.
- Ship and keep records. See fulfilment and export.
Our testing and documents service describes what we can supply to support these steps, and the guide to exporting cosmetics from India covers the wider export picture.
What mistakes cause delays?
- Placing the order before a Responsible Person is appointed.
- Treating the EU and UK as one market.
- Finalising claims after the artwork is printed.
- Leaving no room on the pack for required text.
- Assuming the manufacturer holds the legal duty.
What is the safety assessment, in practice?
The safety assessment is a written conclusion by a suitably qualified person that the product is safe for its intended use. It draws on the full formula, the properties of each ingredient, how the product is applied, who is likely to use it and the pack it sits in. It cannot be done from a marketing description alone. The assessor needs complete formula data, including fragrance composition information, and details such as the intended users and where on the body the product is used.
This is why changes after the assessment matter. A new fragrance, a different preservative or a changed pack can alter the conclusion. Treat the assessed formula as locked, and ask your adviser before you change anything. We can supply the formula information the assessor needs through our testing and documents service, and we keep batch records so lots can be traced.
What does the product information file hold?
The file is a living record, not a one-off form. It generally includes a description of the product, the safety assessment, a statement of the manufacturing method and the working practice followed, the evidence supporting claims and data on any undesirable effects reported. The Responsible Person keeps it and makes it available to authorities on request. Building it well from the start saves time, and keeping it current is part of the ongoing duty rather than a launch task.
What about notification and after-sale duties?
Before a product goes on sale, the Responsible Person notifies it through the official portal for the market. After sale, duties continue: handling complaints, recording undesirable effects, correcting problems and acting if a product needs to be withdrawn or recalled. These are brand-side tasks. The manufacturer's contribution is traceability, so that a specific batch can be identified and investigated quickly.
How should multi-market brands organise this?
If you plan to sell in several countries, build one clear master file per product and add market-specific layers. Keep the formula and safety information consistent, then adapt labels, language, Responsible Person details and notifications for each market. A single spreadsheet that lists each product, market, Responsible Person, notification status and label version helps a small team stay organised. Our export guide and the export market pages give an overview of other markets we ship to.
Next step
Tell us the product, target market and whether you have a Responsible Person. We will confirm what formula data and documents we can supply, and you can pass them to your adviser. Read how it works and use the inquiry form.
Frequently asked questions
Who is the Responsible Person and can the manufacturer be one?
The Responsible Person is the legal entity in the EU or UK that is answerable for the product placed on that market. It is usually the brand owner or importer based there, or a specialist service. An overseas manufacturer cannot fill the role unless it has a presence in that market. Confirm your arrangement with an adviser.
Do I need separate EU and UK processes?
Treat them as separate markets. The two frameworks are similar in structure but are now distinct, with their own Responsible Person, notification portal and labelling details. Do not assume that complying in one covers the other. Your adviser can tell you how to handle both.
What is a product information file?
It is the record the Responsible Person keeps for each product. It typically holds the product description, the safety assessment, manufacturing information, evidence behind claims and relevant data. It must be available to authorities on request. The brand owner holds it, with input from the manufacturer.
What can I claim on an EU or UK cosmetic label?
Claims must be truthful, supportable and fair, and a cosmetic should not claim to treat or prevent a condition. Keep wording to appearance, feel, cleansing and fragrance. Have evidence on file for each claim, and have your adviser review labels and online copy before you print.
What can the manufacturer do to help?
We supply the formula and ingredient information your safety assessor needs, make the product under consistent working practices, keep batch records and apply your approved label. We do not act as your Responsible Person or decide your claims. Agree the split before production.