Regulation (EC) No 1223/2009 governs every cosmetic product placed on the European Union market, whether it is manufactured in Lyon or in Brazil. It does not certify factories and it does not pre-approve products. Instead it makes one legal entity accountable for a documented file, and gives market surveillance authorities the right to ask for that file at any moment.
For a brand importing private label hair care, the practical consequence is simple: your launch depends on paperwork you assemble before the first pallet moves.
The four obligations in plain language
- Appoint a Responsible Person (RP) established in the EU. This is the legal entity accountable for compliance — never the non-EU manufacturer.
- Compile a Product Information File (PIF) and keep it at the RP's address, accessible for ten years after the last batch was placed on the market.
- Include a Cosmetic Product Safety Report (CPSR) in the PIF, signed by a qualified safety assessor.
- Notify the product on the CPNP portal before it is placed on the market.
What goes inside the Product Information File
| PIF section | Content | Who provides it |
|---|---|---|
| Product description | Trade name, category, intended use | Brand |
| Safety report (CPSR) | Parts A and B, signed by a qualified assessor | Safety assessor, on manufacturer data |
| Manufacturing method | Process description and GMP statement (ISO 22716 or equivalent) | Manufacturer |
| Formula and INCI | Full quantitative formula and INCI listing | Manufacturer |
| Proof of effect | Substantiation for any claim made on the label | Brand + manufacturer testing |
| Stability and compatibility | Stability data and packaging compatibility | Manufacturer |
| Microbiological | Challenge test and specification | Laboratory / manufacturer |
| Animal testing data | Statement on testing performed | Manufacturer |
Most of that table is manufacturer output. This is why the choice of factory decides how painful the European route is: a supplier that cannot issue quantitative formula, stability data and challenge testing leaves your safety assessor unable to sign.
The CPSR is not a formality
Part A gathers the safety data: composition, physicochemical characteristics, microbiological quality, impurities, packaging materials, exposure estimates and the toxicological profile of every ingredient. Part B is the assessor's reasoned conclusion and warnings. The assessor must hold a recognised qualification in pharmacy, medicine, toxicology or a similar discipline.
Rinse-off and leave-on products are assessed differently, because exposure differs. A leave-in spray and a mask with the same actives will not carry the same permitted concentrations.
Ingredient restrictions that catch hair care brands
- Formaldehyde and formaldehyde releasers: heavily restricted, and banned outright for hair straightening use. Every Eco Beauty formula is formaldehyde-free.
- Glyoxylic acid: under regulatory scrutiny in the EU for hair smoothing. We supply glyoxylic-acid-free versions of our smoothing lines for markets and buyers that require them.
- Preservative systems: several preservatives common outside the EU appear in the restricted annexes with maximum concentrations or use limits.
- Fragrance allergens: must be declared on the label above defined thresholds.
- Nanomaterials: require specific notification and labelling.
Labelling requirements
EU labels must carry the RP's name and address, nominal content, date of minimum durability or Period After Opening symbol, precautions, batch number, product function and the INCI list in descending order. Mandatory information must appear in the language(s) of every country where the product is sold — which is why a pan-European launch usually means multilingual artwork rather than one English label.
The CPNP notification
The RP submits the notification through the Cosmetic Products Notification Portal before the product is placed on the market: category, frame formulation, RP details, country of origin, label images and, where relevant, information for poison centres. Notification is free and near-instant once the file behind it exists — which is why nearly all delay lives upstream, in the PIF.
A realistic timeline
| Stage | Typical duration |
|---|---|
| Brief, formula development and sample approval | 45–60 days |
| Stability and challenge testing | runs in parallel with development |
| Safety assessment and CPSR | 2–4 weeks after final formula and packaging |
| Artwork and multilingual labelling | 2–3 weeks, in parallel |
| CPNP notification | days, once the PIF is complete |
| Production and sea freight from Santos | quoted per order and Incoterm |
How we support the European route
- ANVISA-registered, GMP-operated manufacturing with in-house quality control.
- PIF and technical dossier content, CPSR and MSDS supplied with the project.
- Stability testing in house and challenge testing through a third-party laboratory.
- Certificate of analysis per batch, certificate of free sale and certificate of origin.
- Compliant label design and artwork produced in house, in the languages your markets require.
- Direct support during notification, including introductions to providers who can act as Responsible Person or carry out the CPNP filing.
Can our Brazilian manufacturer be our Responsible Person?
No. The Responsible Person must be established in the European Union. It is the brand, its EU importer, or an appointed RP service provider. The manufacturer supplies the technical file that the RP relies on.
Do we need ISO 22716 certification from the factory?
The regulation requires manufacture in accordance with good manufacturing practice, with ISO 22716 as the harmonised reference. Our operation runs under GMP and ANVISA registration, and we document the manufacturing method for the PIF.
Is CPNP notification required per product or per range?
Per product, before it is placed on the market. Products that differ only in colour shade can sometimes be notified together, but different formulas require separate notifications.
How long must the PIF be kept?
Ten years from the date the last batch of the product was placed on the EU market, and it must be readily accessible at the Responsible Person's address.
This article is general guidance, not legal advice. Your Responsible Person and safety assessor make the final compliance determination for each product.
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