A brand that has just approved a shampoo sample in Langfang will often ask the factory the wrong first question: does your plant hold the EU certificate. There is no such certificate. Regulation (EC) No 1223/2009 does not license factories and issues no approval a Chinese manufacturer can hold or fail to hold. It regulates the product and it regulates a person — and that person has to be established inside the European Union.
This one structural fact reorders the whole project. Almost every obligation deciding whether your cosmetic can legally be sold in Bremen or Barcelona attaches to an EU-side entity, usually you or your importer. The factory's job is to manufacture to specification and hand over the technical evidence you need to discharge those obligations. Getting that division straight before the first purchase order avoids the expensive version of this conversation, which happens after the goods have landed.
The Responsible Person is an EU entity, and it is probably you
Article 4 of Regulation 1223/2009 requires that every cosmetic product placed on the EU market has a designated Responsible Person established in the Union. Where a product is imported from outside the EU, the importer is the Responsible Person for the products it places on the market, unless it designates another person established in the Union by written mandate, with that person's written acceptance.
A manufacturer in China cannot be your Responsible Person, and neither can an office that exists only as a service address with no capacity to hold and produce records. The role carries real duties: keeping the Product Information File accessible, notifying the product, responding to competent authorities, handling serious undesirable effects, and acting on non-compliance. Market surveillance authorities contact the Responsible Person at the address printed on the pack, and expect an answer.
Brands selling into several member states through a distributor often assume the distributor absorbs this. Sometimes it does — a distributor that changes the product, or places it on the market under its own name or trademark, takes on Responsible Person duties itself. But that is a decision to make deliberately in the contract, not an assumption to inherit.
What CPNP notification is, and what it is not
Article 13 requires the Responsible Person to submit information to the Cosmetic Products Notification Portal before placing a product on the market. CPNP is a notification system, not an approval system. Nobody reviews your submission and returns a verdict. You are telling the Commission and, through it, national authorities and poison centres, that this product exists, what is in it, and who to call.
The submission covers the product category and name, the Responsible Person's identity and contact details, the country of origin for imports, the member state where the product is first placed on the market, the frame formulation or the formula itself for poison-centre purposes, the presence of any nanomaterials or substances classified as carcinogenic, mutagenic or toxic for reproduction, and the original labelling with a photograph of the packaging where reasonably legible.
Two consequences follow. First, notification is fast and cheap relative to the work that must precede it, which misleads first-time importers into thinking compliance itself is fast and cheap; the portal will accept a submission for a product whose safety assessment has not been written. Second, because notification is done by the Responsible Person, your factory has no visibility into whether it happened. Do not ask them to confirm it.
The Product Information File is where the real work sits
Article 11 requires the Responsible Person to keep a Product Information File for each product, held at the address given on the label, and to keep it available to the competent authority of that member state for ten years after the last batch was placed on the market, in a language the authority can readily understand.
The file is not a folder of factory certificates but a defined set of contents: a description of the product, the Cosmetic Product Safety Report set out in Annex I, a description of the manufacturing method with a statement on Good Manufacturing Practice compliance, proof of the claimed effect where the nature of the claim justifies it, and data on any animal testing performed by the manufacturer or its suppliers relating to development or safety assessment.
The Cosmetic Product Safety Report is the part that cannot be improvised. Annex I splits it into Part A, the safety information — formula and raw material specifications, physicochemical and microbiological quality, impurities and packaging material data, normal and reasonably foreseeable use, exposure to the product and to each substance, the toxicological profile of each substance, and any undesirable effects — and Part B, the assessment itself, with the reasoning, the assessor's credentials and their signature. Under Article 10 that assessment must be carried out by a person holding a recognised qualification in pharmacy, toxicology, medicine or a similar discipline.
| Obligation | Who performs it | What the factory contributes |
|---|---|---|
| Designating the Responsible Person | Importer or brand, in the EU | Nothing |
| CPNP notification | Responsible Person | Formula data and pack artwork |
| Cosmetic Product Safety Report | Qualified safety assessor engaged by the Responsible Person | Full formula, raw material specs, stability and microbiological data, packaging material data |
| Holding the Product Information File | Responsible Person, at the label address | Manufacturing method description and GMP statement |
| Manufacturing to GMP | Manufacturer | The production system itself, plus batch records |
| Label compliance under Article 19 | Responsible Person | INCI ingredient list, batch numbering, durability data |
The annexes decide your formula before your chemist does
Regulation 1223/2009 controls substances through its annexes: Annex II lists substances prohibited in cosmetic products, Annex III lists substances subject to restriction with the permitted conditions and concentrations, and Annexes IV, V and VI list the colorants, preservatives and UV filters that are allowed, each with its own limits and conditions of use. A formula that is entirely lawful in its home market can breach one of these lists in a single ingredient.
Preservative systems are the usual point of failure, because Annex V is a closed positive list — a preservative that is not on it cannot be used as a preservative, regardless of its safety record elsewhere. Colorants behave the same way through Annex IV, which matters for colour cosmetics and for anything tinted. Article 15 adds a separate regime for substances classified as CMR under the CLP Regulation, and Article 16 requires a further notification to the Commission six months before placing a product containing nanomaterials on the market.
The annexes are amended regularly by Commission regulations, so the version that matters is the current consolidated text on EUR-Lex, not a summary in a supplier deck. Build the formula review into the sampling stage, because a reformulation requested after tooling and packaging are committed costs far more than the same request made in week two.
GMP, labelling and the animal-testing rules
Article 8 requires manufacture in compliance with Good Manufacturing Practice, and compliance is presumed where manufacture conforms to the harmonised standard EN ISO 22716. That presumption is useful, but certification is not written into the Regulation as a requirement — what the Responsible Person needs is a defensible description of the manufacturing method and a GMP statement that stands up to inspection.
Article 19 governs labelling, and is more prescriptive than most first-time importers expect: the name and address of the Responsible Person, nominal content at packaging, the date of minimum durability or the period-after-opening symbol, precautions for use, the batch number, the product function where presentation does not make it clear, and the ingredient list headed "Ingredients" in INCI nomenclature, in descending order of weight. Several elements must appear in the language of the member state where the product is made available.
Article 18 sets the animal-testing position: bans apply both to testing conducted for the purposes of the Regulation and to placing on the market products or ingredients tested on animals to meet its requirements. The Product Information File must carry data on any relevant animal testing performed by the manufacturer or its suppliers. This is a question to put to your factory in writing, about their raw material chain as well as their finished product.
What to ask a Chinese manufacturer for, and what not to
The productive request list is technical, not administrative. Ask for the full quantitative formula under a confidentiality agreement, raw material specifications and supplier declarations, the INCI listing, stability and compatibility data for your chosen pack, microbiological and preservative efficacy data, packaging material specifications, a description of the manufacturing method, batch numbering logic, and a written statement on animal testing across the supply chain. Each feeds directly into the safety report or the file behind it.
The unproductive request is a copy of an EU registration, because that document does not exist on the factory's side. Aozi Cosmetics, a personal-care manufacturer in Langfang, Hebei working across haircare, body care, skincare and hotel amenities, is a useful illustration of the normal shape of this: it holds a China cosmetics production licence for its own manufacturing, supplies documentation such as MSDS and certificates of analysis for export shipments, and treats destination-market registration — EU CPNP notification as much as US filings — as an obligation of the brand or importer. That is the correct allocation under the Regulation, not a gap in the supplier.
Two scheduling notes. Stability and preservative efficacy work takes real calendar time and cannot be compressed to fit a launch date, as our guide to stability testing and shelf life sets out. And the safety assessor will ask questions of the factory after samples are approved, so keep the technical channel open past sign-off rather than handing the project to purchasing. Buyers new to the category should also read how the formulation and sampling process is sequenced, and how the same product entering the United States is handled under FDA and MoCRA rules — the two regimes ask for overlapping data in incompatible formats, and it is cheaper to collect for both at once.
The wider due-diligence work does not change because the destination is Europe. Confirming that the entity on your contract is the entity that operates the plant, as covered in our supplier verification guide, still comes first; so does understanding what private-label manufacturing actually commits you to. Category choice matters here as well, because the annexes bite unevenly: a tinted product runs into the colorant list in a way a plain emulsion does not, which is worth weighing when reading a colour cosmetics OEM guide or assessing claims in the natural and organic segment, where the marketing vocabulary and the regulatory vocabulary diverge sharply. Buyers still shortlisting plants will find the landscape mapped in our overview of cosmetics OEM manufacturers in China. Compliance sits on top of a supplier relationship that already works. It does not substitute for one, and it does not rescue one.
Common questions
Can a Chinese factory be the Responsible Person for my EU cosmetic?
A manufacturer located in China cannot act as the Responsible Person for a cosmetic sold in the European Union, because Article 4 of Regulation (EC) No 1223/2009 requires that person to be a legal or natural person established within the Union itself. For imported products the importer holds the role by default, unless it designates another EU-established person by written mandate that the designated person accepts in writing.
Does CPNP notification mean my product has been approved?
CPNP notification is a declaration rather than an approval: the Cosmetic Products Notification Portal records that a product exists, what is in it and who is responsible for it, and no authority reviews or authorises the submission before the product goes on sale. The portal will accept a notification for a product whose safety assessment has not yet been written, so control happens through market surveillance afterwards.
What has to be in the Product Information File?
Article 11 requires a description of the product, the Cosmetic Product Safety Report set out in Annex I, a description of the manufacturing method with a statement of Good Manufacturing Practice compliance, proof of claimed effects where the claim justifies it, and data on relevant animal testing. The file is held at the label address and kept available for ten years after the last batch was placed on the market.
Does my manufacturer need ISO 22716 certification to supply the EU?
Certification to EN ISO 22716 is not itself a legal requirement of Regulation (EC) No 1223/2009, because Article 8 obliges manufacture in compliance with Good Manufacturing Practice and treats compliance as presumed where manufacture follows that harmonised standard. Certification is one way to evidence the presumption; what the Responsible Person must actually produce is a documented manufacturing method and a GMP statement that withstands inspection.
How early should formula review happen in a China OEM project?
Formula review against Annexes II to VI belongs in the sampling stage, well before tooling and packaging are committed, because Annex V for preservatives and Annex IV for colorants are closed positive lists and a single non-listed ingredient forces a full reformulation. Discovering that after moulds and printed components have been paid for converts a documentation problem into a scrapped-inventory problem.