What You Need to Sell Cosmetics in the EU: A Step List

Who must be the Responsible Person to sell cosmetics in the EU?

Every cosmetic placed on the EU market needs a Responsible Person designated within the EU (Article 4(1)). A business established in the EU can hold the role itself, and a seller based outside the EU needs an EU Responsible Person.

Articles 10, 11 and 13 then place the safety report, the file and the notification on that person. For a cosmetic made in the EU, the manufacturer established in the EU is the Responsible Person (Article 4(3)). For an imported cosmetic, each importer is the Responsible Person for the product it places on the market (Article 4(5)).

Eldris offers the Responsible Person as a separate service, priced per market, so it is not part of the formula fee. With Eldris as your EU Responsible Person, your label carries EldrisAi OÜ, Ruunaoja tn 3, 11415 Tallinn, Estonia, while your monthly plan runs. One appointment per country covers every product type. Great Britain has its own rules, set by Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, and needs a UK Responsible Person.

Which safety documents must exist before placing on the market?

Before placing the product on the market, the Responsible Person must ensure a safety assessment and a cosmetic product safety report (CPSR) set up under Annex I (Article 10(1)).

The CPSR has Part A, the safety information, and Part B, the safety assessment. Among other contents, the Product Information File (PIF) holds the CPSR, the manufacturing method and a good manufacturing practice (GMP) statement (Article 11(2)). The Responsible Person keeps it for ten years after the last batch is placed on the market.

Eldris's CPSR and notification service prepares the CPSR and PIF for one formula, and at Eldris a qualified safety assessor signs the CPSR, Part A and Part B. The per-formula fee stays the same whatever the number of ingredients. Eldris delivers the CPSR and PIF 5–10 working days after it receives your complete documents. If the safety assessor needs more from you, the question appears in your portal, and the 5–10 working days start again from the day you answer.

What must be notified, and what goes on the label?

The Responsible Person notifies the product to the Commission electronically before placing it on the market (Article 13(1)), through the Commission's Cosmetic Product Notification Portal (CPNP), its free online notification system.

Your EU Responsible Person files the notification. Eldris files the EU notification only when it is your EU Responsible Person and you order the filing, for a fee per CPSR. Because the label carries the Responsible Person's name, the appointment is settled before the label is printed.

Labels follow Article 19, which puts the Responsible Person's name and address on the container and packaging (Article 19(1)(a)). As a rule, the label also shows the nominal content and a batch number or a reference identifying the product, and it carries the date of minimum durability or, where the rule allows, the period after opening (Article 19(1)). Article 19 has exceptions for small products, so read each point in full. The ingredients list may be given on the packaging alone (Article 19(1)(g)). The formula fee includes an Article 19 label review.

Where do good manufacturing practice and laboratory tests fit?

Article 8 requires cosmetics to be manufactured following good manufacturing practice, and compliance is presumed where manufacture follows the relevant harmonised standards published in the Official Journal.

Article 8 does not name ISO 22716. The PIF holds a statement on compliance (Article 11(2)). Eldris asks for a GMP document from your manufacturer: an ISO 22716 certificate or, without one, a GMP statement. Neither is needed to start, and certificates of analysis come from your ingredient suppliers.

Eldris is not a testing laboratory and does not carry out, arrange or recommend laboratory tests, and laboratory tests are not in the per-formula fee. Stability, challenge, SPF and microbiology tests are done by a testing laboratory, which sets the price, and the test reports you supply go into the PIF. Eldris asks for a challenge test report (ISO 11930) for products that contain water, not water-free ones, but you can start your order without it. This is a statement of Eldris's service, not a provision of the Regulation.

In what order do the steps run, and what comes after?

The Responsible Person comes first, because the safety report, the file and the notification all sit with that person. The notification is made before the product is placed on the market.

1. Appoint the Responsible Person. The Responsible Person comes first, because the safety report, the file and the notification all sit with that person.
2. Pay from the quote, then upload your documents. Pay first, then upload your documents in your Eldris portal. Upload what you have and Eldris tells you what is still missing.
3. Receive the CPSR and PIF in your portal. Your CPSR and PIF arrive in the same portal; the per-formula fee, the notification fee and the Responsible Person's fees are on the pricing page.
4. Notify before the product is placed on the market. The notification is made before the product is placed on the market.
5. Pass the marketplace's own listing checks. Marketplaces then add their own listing checks; each marketplace decides what it asks for.

Pay first, then upload your documents in your Eldris portal. Upload what you have and Eldris tells you what is still missing, and your CPSR and PIF arrive in the same portal. Marketplaces then add their own listing checks. Each marketplace decides what it asks for, so this guide promises no marketplace outcome. The Amazon checklist covers that platform, and the guide to Regulation 1223/2009 covers the law behind each step.

The per-formula fee, the notification fee and the Responsible Person's per-market fee and monthly plan are on the pricing page. Several formulas earn a volume discount on the formula fee: 5% from 4 formulas, 10% from 7 and 15% from 10. Variations neither earn nor receive it. The FAQ page answers what you need to sell a cosmetic in the EU in a few lines.

Frequently asked questions

Do I need a CPSR for every cosmetic?

Yes, for each cosmetic placed on the EU market (Article 10(1)). A further shade or scent of an assessed formula is a variation sharing that formula's CPSR. A new scent can need its own CPSR if the fragrance ingredients change significantly, and a different SPF level usually does.

Can I be my own Responsible Person?

Yes, if your business is established in the EU. For a cosmetic made in the EU, the manufacturer established in the EU is the Responsible Person (Article 4(3)). A seller based outside the EU needs an EU Responsible Person, and an importer is the Responsible Person for the product it places on the market (Article 4(5)).

Does the EU notification cost extra?

The notification is a separate line from the formula fee. Your EU Responsible Person files it. Eldris files the EU notification only when it is your EU Responsible Person and you order the filing. The fee is per CPSR, with the same volume discount as the formula fee.

What happens if I change the formula later?

A reformulated product needs an updated notification and a new CPSR, priced as a formula. A new pack size of the same formula adds nothing to the CPSR and PIF. A further shade or scent is a variation of the assessed formula, though a new scent can need its own CPSR if the fragrance ingredients change significantly.

Does Great Britain need separate steps?

Yes. In Great Britain a cosmetic may not be placed on the market without a Responsible Person established in the UK (Schedule 34). The UK Responsible Person and the UK notification are not in the formula fee. Whether a CPSR made for the EU is accepted in Great Britain is not stated here.

Is anything monthly?

The cosmetics fees are paid once, with no monthly fee for this service. Only the Responsible Person service runs on a monthly plan. You can cancel it at any time, effective at the end of the billing period. The appointment then ends, and Eldris's details must come off your labels and listings within 30 days.

Does a seller outside the EU need extra steps?

A seller based outside the EU needs an EU Responsible Person. For an imported cosmetic, each importer is the Responsible Person for the product it places on the market. The importer may designate an EU person by written mandate (Article 4(5)). Eldris offers the EU Responsible Person as a separate service.