VEILTA
10/31/2026
No product can legally be placed on the EU market without a Responsible Person established inside the EU. Not a factory, not a distributor, not an agent who forwards email. A named legal entity with an address in a member state, whose name appears on the label.
If you are weighing manufacturers rather than reading for background, the private label development page sets out how development runs — brief to sample, MOQ per format and the documentation we hold.
That requirement surprises buyers who assume compliance travels with the goods. It does not. A Chinese factory can build a fully compliant product and hand you a complete documentation set, and the product is still not sellable in the EU until someone inside the EU accepts the obligations that come with putting it there.
This article sets out which obligations sit with the brand, what the factory must provide, and the label errors that get shipments stopped at the border.
This is a manufacturing view of the process, written for buyers evaluating a supply chain. It is not legal advice, and the responsibility for compliance sits with the Responsible Person you appoint.
Appoint a Responsible Person. The RP must be established in the EU and holds legal responsibility for the product's compliance. Some brands use a specialist RP service, some use their EU distributor, some set up an entity. All three work; choosing the cheapest and least available one is a recurring mistake, because the RP has to respond to authority requests and hold the product information file.
Hold a Cosmetic Product Safety Report. The CPSR is prepared by a qualified safety assessor and forms Part A and Part B of the Product Information File. It is a document about your specific formula in your specific packaging, not a generic report about a category.
Notify the product on CPNP. The Cosmetic Products Notification Portal notification is filed by the RP before the product is placed on the market. It is not the same as a registration number, and being on CPNP does not by itself make a product compliant.
Keep the Product Information File. The PIF must be available to the competent authority at the address of the RP, and retained for ten years after the last batch is placed on the market. This is a filing obligation with a long tail, and it is the one most often lost when brands change RP or agency mid-life.
A capable manufacturer provides the inputs. It cannot provide the assessment. The split looks like this:
| Item | Factory provides | You or your RP provides |
|---|---|---|
| INCI ingredient list | Yes | — |
| Batch certificate of analysis | Yes | — |
| SDS / MSDS | Yes | — |
| Stability data | Yes, at defined timepoints | — |
| Microbial challenge and release reports | Yes | — |
| GMP / ISO 22716 certificate | Yes | — |
| Cosmetic Product Safety Report (CPSR) | No | Yes, via a qualified assessor |
| CPNP notification | No | Yes, via the RP |
| Product Information File assembly | Inputs only | Yes, held by the RP |
| Label compliance sign-off | Artwork production | Final claim and wording review |
Ask for the stability timepoints, not just the existence of a stability report. A supplier who cannot state which timepoints were tested has not been asked the question before.
Buyers routinely ask for "the CPSR" as if it were a document on a shelf. It is not, for three reasons.
It is formula-specific. Change the fragrance, the preservative system or the active level and the assessment changes. A CPSR issued for a stock formula does not cover your modified version.
It is packaging-specific. A formula assessed in an aluminium-laminate four-side-seal sachet is not automatically assessed in a jar with an open-mouth exposure. Migration and stability behaviour differ, and the assessor needs the primary packaging specification.
It is assessor-specific. The report is signed by a named qualified person who takes professional responsibility for it. That person needs the full formula, not a marketing summary with proprietary percentages removed.
The practical consequence: budget for a CPSR per formula, not per product line, and get the assessor involved before you commit to packaging.
Most border stops are not about the formula. They are about the back of the pack.
Missing RP name and EU address. The single most common omission on packaging designed outside the EU.
Ingredient list not in INCI nomenclature, or not in descending order. Above 1% concentration, ingredients are listed in descending order. Below 1%, order is free but the list still has to be complete.
Net content missing or stated in a non-permitted format. Weight or volume, in metric units.
Batch number not durable. It has to remain legible for the life of the product. Inkjet on a curved sachet that rubs off in transit is not compliant, and it is also untraceable in a recall.
Date of minimum durability or period after opening, but not both where required. A "best before" date is required where durability is under 30 months; a period-after-opening symbol where it is over 30 months. Using both when only one applies is a defect, not a belt-and-braces approach.
Fragrance allergen declarations. The allergen labelling rules were updated by Regulation (EU) 2023/1545, which extended the list and set phased deadlines. Check the current compliance date against your launch date rather than relying on packaging templates from two years ago.
Claims that imply a medicinal action. "Treats acne" and "heals wounds" are medical claims, not cosmetic claims, in the EU. A hydrocolloid patch can claim to absorb exudate and protect the blemish; it cannot claim to cure the condition. This distinction decides whether your product is a cosmetic or a medicinal product, and the regulatory pathway for the second is entirely different.
A Guangdong plant making sheet masks, eye patches and acne patches for export can supply everything in the left column of the table above as standard, including the documentation an assessor needs. What it cannot do is act as your RP, hold your PIF, or make a claim decision on your behalf.
Three questions worth asking any supplier before the first order:
A supplier who answers the third question with "nothing" is telling you something useful.
Compliance is the part of a launch that does not compress.
Sampling runs 5–7 working days from a formula library, bulk production 20–25 working days after signed artwork. The compliance sequence runs in parallel and usually takes longer: assessor onboarding, formula and packaging review, CPSR drafting, RP appointment, CPNP notification, then label approval against the final CPSR wording.
Plan for the CPSR to become the critical path, not production. Starting the assessor conversation after you approve the sample is the standard way to lose three weeks.
Can my Chinese manufacturer file the CPNP notification for me? No. The CPNP notification is filed by the Responsible Person established in the EU. A manufacturer outside the EU cannot act as RP, so it cannot file. Some factories will introduce you to an RP service they work with, which is helpful but does not transfer the obligation.
Is a CPSR the same as a certificate of analysis? No. A certificate of analysis reports the test results for a specific batch. A Cosmetic Product Safety Report is a risk assessment of the formula and packaging, prepared and signed by a qualified safety assessor, and it forms part of the Product Information File. A COA is an input to the CPSR, not a substitute for it.
Do I need a new CPSR if I change the fragrance or the packaging? Usually yes, or at minimum an amendment reviewed by the assessor. Fragrance changes alter the allergen profile and the sensitisation risk. Packaging changes alter migration and stability. Both are within the scope of the original assessment, which is why the assessor should see the final packaging specification before signing.
How long must I keep the Product Information File? Ten years after the last batch of the product is placed on the market, held at the address of the Responsible Person and available to the competent authority on request. Brands that switch RP or agency mid-life frequently lose track of this, which becomes a problem only when an authority asks.
Can I sell a hydrocolloid acne patch as a cosmetic in the EU? A hydrocolloid patch that absorbs exudate and protects the blemish is generally treated as a cosmetic when no medicinal claim is made. The moment the labelling or marketing claims treatment of acne as a condition, it moves toward the medicinal framework, which requires an entirely different authorisation route. This is a claim wording question, and it is worth getting a written opinion rather than an assumption.
Send your formula brief, primary packaging specification and target EU markets. We will come back with the documentation set we can supply, the stability timepoints we test to, and a clear list of what your Responsible Person still needs to produce.
Send your spec — format, size, pieces per pack and destination market — and we will come back within two working days with a costed quotation on the line described above.
