For Indian brands selling into the EU
"Many raw materials commonly used and accepted in India may be banned or highly restricted in the EU. A complete re-formulation may be necessary for the export version."
— an Indian contract manufacturer, writing on its own blog
That is the factory talking. The formula is the risk, and the people who make it know it.
A published file from India
The opening product on this site is a PremaNature aloe gel, made in India, being taken through EU registration in public. As of 24 September 2026 the file is open and unsigned. The file, including the stuck parts →
The structural fact
An Indian company is not designated within the Community (Art. 4(1)). For an Indian export with no written mandate, Art. 4(5) puts the role on the EU importer — their address on your pack. A freight forwarder's paperwork is not a designation. How Art. 4 places the role →
We can be appointed as your EU Responsible Person, by written mandate. Registration covers the safety report and the file. Custody — keeping the file and watching the registers after that — is a yearly line. What each costs →
What travels out of an Indian file
| What you have | Into an EU file? |
|---|---|
| Indian licences | No. CPNP is a separate submission (Art. 13(1)) |
| The formula as sold in India | Screened against Annexes II–VI on your placing date — not assumed |
| Traditional / ayurvedic names | Resolved against the EU glossary first. An unresolved name stops the work |
| Batch records, CoAs, GMP evidence | Yes — file material |
| Safety data sheets | Partly. An SDS is not a cosmetic safety assessment |
| Your Indian label | Needs the EU responsible person's name and address (Art. 19(1)(a)) |
Every report is signed by David Vandevoort, pharmacist. Where a material cannot be identified, we name it before anything is printed on a container. Sourcing from Korea as well? For Korean brands →
All of it runs online, from where you are. You sign in to our user-friendly client portal with a link we email you, see the documents your product needs with the reason for each, and upload them next to their line. There are no couriers and no trip to Belgium. If your manufacturer already has the papers, your part takes about an hour. Once the last document is in and the formula is declared, the signed safety report usually follows within 3 working days. Comparing responsible persons before you sign a mandate? Nine questions to ask →
Registration starts at €345; the Responsible Person mandate is €360 per product, per year across the EU. What each line covers →
Questions people ask
My formula is botanical and some ingredients have no INCI name — can it be assessed at all?
Usually. Most of the time a glossary name exists and does not match what the supplier calls it. We do not invent names that look like INCI names.
My manufacturer won't send the documents. Can you still do this?
We can tell you which documents are missing. We cannot assess a composition we have not been given.
Tell us the product, the variants and the markets — a fixed quote in writing.