Questions sellers ask
EU cosmetics compliance questions, answered
Published Last updated
Straight answers to what cosmetics sellers ask Eldris before they sell in the EU and Great Britain: formulas, documents, tests, labels, the notification and the Responsible Person. 19 questions, put to Eldris 410 times between and , each answered in sixty words or fewer with a link to the full guide.
Most asked
What counts as a formula, and what is a variation?
A formula is one unique base recipe, and a product in several sizes counts once. The formula fee, £195, covers the first product; each further shade or scent is a variation at £39.95 sharing the formula's CPSR. A new scent can need its own CPSR if the fragrance ingredients change significantly, and a different SPF level usually does.
What does the per-formula fee include?
The £195 formula fee covers the signed CPSR (Part A and Part B), the PIF, the Article 19 label review and your INCI ingredient list for one formula, whatever the number of ingredients. Laboratory tests and the Responsible Person are not included. The EU notification is separate, in your quote total only when Eldris files it.
Is anything monthly or recurring?
The cosmetics fees are paid once, with no monthly fee for this service. Only the Responsible Person service runs on a monthly plan, cancellable 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.
I want to sell a cosmetic in the EU. What do I need?
Under Regulation (EC) No 1223/2009 you need a Responsible Person designated within the EU (Article 4(1)), a safety assessment with a CPSR (Article 10(1)), a Product Information File (Article 11), notification to the Commission before the product is placed on the market (Article 13(1)) and compliant labels (Article 19). Manufacture must also follow good manufacturing practice (Article 8).
What must be on the label, and does the box differ from the bottle?
As a rule, the container and the packaging carry the same core details. Under Article 19 of Regulation (EC) No 1223/2009 these include the Responsible Person's name and address, the nominal content, the date of minimum durability or, where allowed, the period after opening, and the batch number or product reference. The ingredients list may go on the packaging alone.
Where does a batch number come from, and where must it appear?
As a rule, the batch number of manufacture, or a reference identifying the cosmetic product, must appear on both the container and the packaging (Article 19(1)(e) of Regulation (EC) No 1223/2009). The rule allows either the batch number or the identifying reference. The Article 19 label review in the formula fee checks your label against these rules.
Which lab tests do I need, and does Eldris run them?
Eldris does not carry out, arrange or recommend laboratory tests. Stability, challenge, SPF and microbiology tests are done by a testing laboratory, which sets the price. 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. The test reports you supply go into the PIF.
Who files the CPNP notification, and under whose account?
The Responsible Person files the notification before the product is placed on the market (Article 13(1) of Regulation (EC) No 1223/2009). Eldris files the EU notification only when it is your EU Responsible Person and you order the filing, at £99 per CPSR. If you already have safety reports, appoint Eldris as your EU Responsible Person and order the filing.
Browse by topic
Selling in the EU
I want to sell a cosmetic in the EU. What do I need?
Under Regulation (EC) No 1223/2009 you need a Responsible Person designated within the EU (Article 4(1)), a safety assessment with a CPSR (Article 10(1)), a Product Information File (Article 11), notification to the Commission before the product is placed on the market (Article 13(1)) and compliant labels (Article 19). Manufacture must also follow good manufacturing practice (Article 8).
How do I register a non-EU-made cosmetic in the EU?
A non-EU-made cosmetic needs a Responsible Person designated within the EU (Article 4(1) of Regulation (EC) No 1223/2009), who notifies the product before it is placed on the market (Article 13(1)). For an imported cosmetic, each importer is the Responsible Person and may designate an EU person by written mandate (Article 4(5)). Eldris offers the role as a separate service.
Is my product a cosmetic at all?
A cosmetic is a substance or mixture for the external parts of the body, or the teeth and mucous membranes of the mouth, used mainly to clean, perfume, change appearance, protect, keep in good condition or correct body odours (Article 2(1)(a) of Regulation (EC) No 1223/2009). Anything meant to be ingested, inhaled, injected or implanted is excluded (Article 2(2)).
Formulas and variations
What counts as a formula, and what is a variation?
A formula is one unique base recipe, and a product in several sizes counts once. The formula fee, £195, covers the first product; each further shade or scent is a variation at £39.95 sharing the formula's CPSR. A new scent can need its own CPSR if the fragrance ingredients change significantly, and a different SPF level usually does.
Documents
Do I need GMP, and how do I prove it for small-batch or home manufacture?
Article 8 of Regulation (EC) No 1223/2009 requires manufacture to follow good manufacturing practice, and the PIF holds a statement on compliance with it (Article 11(2)(c)). Eldris asks for an ISO 22716 certificate from your manufacturer, or a GMP statement if the manufacturer has no such certificate. Neither is needed to start your order.
Tests
Which lab tests do I need, and does Eldris run them?
Eldris does not carry out, arrange or recommend laboratory tests. Stability, challenge, SPF and microbiology tests are done by a testing laboratory, which sets the price. 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. The test reports you supply go into the PIF.
The safety report
Who signs the CPSR, and what qualifications must the assessor hold?
At Eldris, a qualified safety assessor signs the CPSR, Part A and Part B. Under Article 10(2) of Regulation (EC) No 1223/2009, Part B must be carried out by a person with a diploma or other formal qualification from a university course in pharmacy, toxicology, medicine or a similar discipline, or a course a Member State recognises as equivalent.
What do I receive, and what happens when I change the formula later?
Your signed CPSR (Part A and Part B) and PIF arrive in your portal; the formula fee covers the Article 19 label review and INCI ingredient list. A reformulated product needs an updated notification and a new CPSR, priced as a formula (£195). A new pack size of the same formula adds nothing to the CPSR and PIF.
Labels
What must be on the label, and does the box differ from the bottle?
As a rule, the container and the packaging carry the same core details. Under Article 19 of Regulation (EC) No 1223/2009 these include the Responsible Person's name and address, the nominal content, the date of minimum durability or, where allowed, the period after opening, and the batch number or product reference. The ingredients list may go on the packaging alone.
Where does a batch number come from, and where must it appear?
As a rule, the batch number of manufacture, or a reference identifying the cosmetic product, must appear on both the container and the packaging (Article 19(1)(e) of Regulation (EC) No 1223/2009). The rule allows either the batch number or the identifying reference. The Article 19 label review in the formula fee checks your label against these rules.
Notification
Who files the CPNP notification, and under whose account?
The Responsible Person files the notification before the product is placed on the market (Article 13(1) of Regulation (EC) No 1223/2009). Eldris files the EU notification only when it is your EU Responsible Person and you order the filing, at £99 per CPSR. If you already have safety reports, appoint Eldris as your EU Responsible Person and order the filing.
Responsible Person
Do I need a Responsible Person, and what does it cost?
Yes. Every cosmetic placed on the EU market needs a Responsible Person designated within the EU (Article 4(1) of Regulation (EC) No 1223/2009), and Great Britain needs a UK one. A business established in the EU can hold the role itself. Eldris offers it separately: a one-off £195 per market, then a monthly plan from £19.95 a month.
Great Britain and other markets
Where is a CPSR valid: EU, Great Britain, Switzerland, USA?
EU law requires a CPSR before a cosmetic is placed on the EU market (Article 10(1) of Regulation (EC) No 1223/2009). Great Britain has its own rules, including a UK-established Responsible Person and a PIF in English that includes the product safety report. Whether a CPSR is accepted in Great Britain, Switzerland or the USA is not stated here.
What about Great Britain: UK Responsible Person and SCPN?
Great Britain needs a UK Responsible Person, who notifies the product through the SCPN service before it is placed on the market. Eldris can be your UK Responsible Person: a separate appointment at the same market fee, £195, covered by the same monthly plan. Neither the UK Responsible Person nor the UK notification is in the formula fee.
Process and timing
Can you review my documents or sign an NDA before I buy?
Reviewing your documents is not within a quotation: a quotation does not include going through them before onboarding. Questions sent before you pay are answered, so reply to the email your quote came with. After you pay, upload what you have in your Eldris portal and Eldris tells you what is still missing.
How long does a CPSR take, and what restarts the clock?
Eldris delivers your CPSR and PIF 5–10 working days after receiving 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. You pay first, then upload your documents in your Eldris portal.
I already have a CPSR or PIF from another provider. Do you accept, review or redo it?
If you already have safety reports, you can appoint Eldris as your EU Responsible Person and order the notification filing, and Eldris files the EU notification at £99 per CPSR. A new CPSR and PIF from Eldris is priced per formula, at £195.
Pricing
What does the per-formula fee include?
The £195 formula fee covers the signed CPSR (Part A and Part B), the PIF, the Article 19 label review and your INCI ingredient list for one formula, whatever the number of ingredients. Laboratory tests and the Responsible Person are not included. The EU notification is separate, in your quote total only when Eldris files it.
Is anything monthly or recurring?
The cosmetics fees are paid once, with no monthly fee for this service. Only the Responsible Person service runs on a monthly plan, cancellable 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.
How this list is built
Where the questions come from. Every question here was put to Eldris by a seller, by email to [email protected] or in the chat on this site. Eldris's own system reads both every night and groups the questions that ask the same thing.
Anonymised. No seller is named and no message is quoted: each question is paraphrased, and the line under it says how often it was asked and by how many sellers.
What it does not show. Price tables and worked quotes are on the pricing page. The answers state the position of the Eldris service; they are not legal advice, and the terms apply to every order.
This edition covers questions asked between and .
From the Eldris channel
60-second answers
- Who Qualifies to Perform a Hair Clay Cosmetic Safety Assessment?
Length 0:29Must Perfume Batch Numbers Appear on the Container or Packaging?
Length 0:26Do Cosmetic Bottles and Boxes Need Different Label Information in the EU?
Length 0:36Who Must Be the Responsible Person for Cosmetics Under EU Law?
Length 0:31Could a Rabbit Skin-Irritation Test for Algerian Rules Affect a Favourable CPSR or EU Placing? (opens YouTube in a new tab)
Length 0:40When Do I Need Extra Evidence for My Soap’s Safety Assessment?
Length 0:49What Documents Are Required for Cosmetic Compliance Under EU Law? (opens YouTube in a new tab)
Length 0:32What Must a Responsible Person Do Before Selling Cosmetics in the UK?
Length 0:50Can You Use Alpaca Wool in Soap Under EU Cosmetics Law?
Length 0:52Do I Need Separate Safety Assessments for Each Perfume Scent or Just One?
Length 0:43What Is a Cosmetic Product Information File (PIF) and Why Is It Needed?