Distributors ask the same question early in a conversation: is the product approved? For cosmetics the honest answer is that most markets do not approve products at all. They require the company placing the product on the market to notify it, and then hold the evidence that the product is safe. The difference sounds like paperwork. It decides who carries the liability.
Notification is not approval
Under an approval regime an authority reviews a dossier before the product goes on sale and issues a decision. Medicines work that way. Cosmetics, in the EU and in Turkey, do not.
Under a notification regime the sequence is reversed. You assemble the safety evidence, you keep it in a file, and you tell the authority the product exists. Nobody signs off on it in advance. If a market surveillance inspector knocks, the file is what answers.
The practical consequence for a buyer: no supplier can hand you a certificate that says approved cosmetic, because no such certificate is issued. If a document with that wording is offered to you, read it carefully. It is usually a laboratory report, a free sale certificate or a trade document, and each of those means something narrower than approval.
The EU route: CPNP and the Responsible Person
Cosmetics in the EU sit under Regulation (EC) No 1223/2009. Before a product is placed on the market it is notified electronically through the Cosmetic Products Notification Portal, usually shortened to CPNP. The notification is a single filing for the whole Union, which is the one part of the process that does scale.
The filing is made by the Responsible Person, and that role is the centre of the whole system. The Responsible Person is a legal or natural person established inside the EU. For an imported product, the importer is the Responsible Person for what it places on the market, unless it appoints someone else in writing and that person accepts in writing.
Being the Responsible Person is not a formality. The name and address go on the label. The Product Information File is kept at that address. Complaints, recalls and correspondence with national authorities land there. Distributors who plan to rebrand a product tend to discover this late, because rebranding under your own name generally makes you the Responsible Person rather than a distributor.
What the CPNP filing contains
- Product category and name, in enough detail to identify the exact item
- Responsible Person name and address, and the address where the file is kept
- Country of origin for imported products
- The member state where the product is first placed on the market
- A contact for physical correspondence
- Formulation information for poison centres and medical treatment
- Presence of nanomaterials, and of substances classified as CMR
- The original labelling and, once legible, a photograph of the packaging
The Product Information File is the real work
The notification is a form. The file behind it is the substance, and it has to be readily accessible to the competent authority at the address on the label. It is kept for ten years after the last batch was placed on the market, which is longer than most people assume when they plan storage and staff handover.
The file holds a description of the product, the cosmetic product safety report, a description of the manufacturing method with a statement of compliance with good manufacturing practice, evidence for the effect claimed where the nature of the claim justifies it, and data on any animal testing.
The safety report has two halves: the collected data, and the assessment written on top of it by a qualified safety assessor. A manufacturer can supply most of the underlying data. The assessment is a signed professional judgement about the product as you intend to sell it, which means the formula, the packaging and the claims on your artwork all feed into it. Change the claims and the assessment has to keep up.
Labelling: the language is decided nationally
The mandatory particulars are set at EU level: the Responsible Person, the nominal content, the date of minimum durability or the period-after-opening symbol, precautions, the batch number, the function of the product unless it is clear from the presentation, and the ingredient list in INCI nomenclature.
The language is not set at EU level. Each member state decides the language for several of those particulars, so a single European artwork is rarely enough. The ingredient list stays INCI everywhere, which helps, but warnings, function statements and instructions get translated market by market. Budget artwork revisions per country and per production run, not once for the continent.
Turkey files through ÜTS
In Turkey the equivalent step is a notification to the Ministry of Health through the Product Tracking System, known as ÜTS, before the product is placed on the market. The logic matches the EU model: no approval decision is issued, the notification is recorded, and the dossier stays with the company that placed the product on the market.
One point matters for an importer buying from a Turkish manufacturer. The Turkish notification does not travel with the goods. It is not a substitute for your own CPNP filing, and it does not transfer the Responsible Person role to the manufacturer. What you should be asking your supplier for is the technical content that feeds your own filing: formulation data, safety documentation, manufacturing and quality evidence, and print-ready artwork you can adapt.
One classification question to settle first
Personal lubricants are not automatically cosmetics in every jurisdiction. Depending on the presentation, the intended purpose and the claims made, a lubricant can fall outside cosmetic rules and under medical device rules in the EU, which is a different route altogether: conformity assessment, a notified body, different labelling obligations and a different file.
This is worth resolving with a regulatory advisor before you build a launch plan around CPNP, because the two routes are not interchangeable and the wrong assumption is expensive to unwind. It also explains why the claims a supplier makes matter to you commercially: aggressive wording can push a product from one regime into the other. What we can share on documentation is on the quality page.
A short checklist before the first order
- Confirm how the product is classified in your target market, in writing.
- Decide who the Responsible Person will be, and get the acceptance in writing if it is not you.
- Request the supplier's technical dossier and check that it covers the exact variant you intend to sell.
- Map label language obligations country by country before you approve artwork.
- Set a retention plan: the file outlives the last batch by ten years.
- Review the claims on your own marketing material against the assessment in the file.
None of this is unusual for a cosmetics importer, and none of it is quick the first time. Suppliers who understand the sequence are easier to work with than suppliers who promise an approval that does not exist.
