How to Register a Cosmetic Aerosol on the CPNP
A cosmetic aerosol is not registered and needs no prior health authorisation: it is notified to the European Union through the CPNP portal. Before it goes on sale, the responsible person, usually the brand, commissions the safety assessment, compiles the product information file (PIF) and notifies it on the European Commission's CPNP portal; the manufacturer produces it under good manufacturing practice, which is presumed with ISO 22716.
Do Cosmetics Need a Health Registration?
There is no product registration or authorisation. Regulation (EC) 1223/2009 replaces that step with CPNP notification (Article 13). According to the European Commission, the portal is free of charge, and once a product has been notified there is no need for any further notification at national level within the EU.
What does exist in Spain is the declaration of activities filed with AEMPS, and the brand does not file it. According to AEMPS, it is filed by whoever physically manufactures, fills or labels in Spain and by whoever imports from outside the EU; a company that subcontracts all production does not file it even if it owns the brand, but must still meet the requirements of part A of the annex to Royal Decree 85/2018.
Who Is the Responsible Person?
The responsible person answers for the product to the authorities, and their name and address go on the label. The Regulation defines the manufacturer as whoever makes a cosmetic or has it made and markets it under their own name or trade mark, so if the aerosol carries your brand, the responsible person is you. You can designate another person established in the EU by written mandate, which they must accept in writing.
Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.
Ilerspray can act as the responsible person for the cosmetic under your brand, through a written mandate that Ilerspray expressly accepts, as Article 4 of Regulation 1223/2009 provides.
The Four Steps Before You Sell
These are the requirements the responsible person must have ready before the first unit:
| Step | What the Regulation requires |
|---|---|
| Safety assessment | Annex I report, signed by a qualified assessor |
| PIF | Kept for 10 years after the last batch is sold |
| CPNP notification | Before marketing, once for the whole EU |
| Label | Responsible person, batch, contents, INCI ingredients |
In an aerosol, the safety assessment must cover exposure by inhalation, because the product is sprayed into the air. And the label adds the aerosol dispenser requirements to the cosmetic ones: the conformity symbol and the pressurised-container warning.
What to ask for and how to check it before you approve production
Before you sign off the first run, ask for these four compliance documents and check each one against what the Regulation requires:
- The safety report: it must describe your formula and your aerosol format, not a similar one. Check that it is signed by someone with a university qualification in pharmacy, toxicology, medicine or a similar discipline (Article 10) and that it covers inhalation.
- The PIF: confirm that it holds the product description, the safety report, the manufacturing method with the good manufacturing practice statement and, if the label promises an effect, the proof of that effect (Article 11). It has to be available at the address shown on the label and in a language the authority understands.
- The CPNP notification: verify that the name and address notified match the ones on the label, because the portal asks for the address where the PIF is kept, a contact person and the frame formulation for poison centres (Article 13). Once the product is on sale, the original labelling is notified too, with a photograph of the packaging where it is legible.
- The written mandate: if the responsible person is not you, keep the mandate signed by both parties and check that their name is the one printed on the can.
Settle in that mandate who receives consumer complaints. The responsible person must report any serious undesirable effect to the authority without delay (Article 23), and to do that they need to hear about it in time.
What an ISO 22716 Certified Manufacturer Brings
Article 8 requires manufacturing in line with good manufacturing practice and presumes compliance when production follows the harmonised standard, which for cosmetics is EN ISO 22716. The PIF must include a description of the manufacturing method and a statement of compliance with that practice, and that part depends on the plant that fills the product.
Ilerspray makes cosmetic aerosols under ISO 22716 certification, on the same certified lines, with batch-by-batch quality control, where it produces its own APP household and cosmetics brand.
💡 Tip from our technical team: decide who the responsible person is before designing the label. Their name and address are mandatory information, and changing them later means redoing the artwork and the notification.
Once the responsible person is settled, the brief for making the cosmetic aerosol under your brand can already carry the final label text.
