Launching Exosome SKUs in the EU: 1223/2009, CPNP and PIF, Step by Step
The EU is the most rule-bound cosmetic market, and exosome SKUs face one hard line before anything else: Regulation (EC) No 1223/2009's restricted-substance framework limits human-derived cells, tissues and products. Plant-derived, well-documented non-human EV material can enter under that framework; human-derived material cannot. Japan and Korea maintain comparable restrictions — the EU line is not an outlier.
The four moves of a compliant launch
| Step | What it is | Practical notes (benchmark costs/times) |
|---|---|---|
| 1 · PIF | Product Information File — formula, safety, claims evidence | Retained 10 years after the last batch placed on the market |
| 2 · CPSR | Safety assessment by a qualified assessor | Roughly $500–2,000 per formula specification |
| 3 · Responsible Person | The EU-legal face of the product | Service market ~€200–800 per product per year |
| 4 · CPNP notification | Portal notification before placement | 2–6 weeks from zero; 1–3 working days with an RP service in place |
EU compliance consultants repeat one sequencing rule: PIF first, CPNP second — never the reverse. plan: first the PIF, then the CPNP — not the other way around.
The nano-material clock
Annex-level nano notifications run on their own clock — six months before placement under Article 16. Exosome-scale particles sit near the definitional edge, which makes this a question for your formulator and notifier early, not a surprise at customs.
Where TONGNIAN sits in your file
The material line behind our programs carries INCI 41316 naming and DMF Type II documentation — the ingredient-side inputs your PIF and CPSR will ask for. Claims follow the common criteria of Regulation (EU) No 655/2013: appearance and feel level, evidence-backed.
Build your EU launch on our documentation chain · The claims ladder · Program playbooks
Get the test panel that matches your batch
Tell us your target category and expected first batch size (a sample run, around 100 units, or 1,000 and up). We will send the matching test panel, characterization references, and a sample COA for your tier.